Rewind 2011 Rewind 2011: Agriculture Newsletter Rewind 2011: Automobile Newsletter Rewind 2011: Aviation Newsletter Rewind 2011: Banking Newsletter Rewind 2011: Hotels & Tourism Newsletter Rewind 2011: Information Technology Newsletter Rewind 2011: Infrastructure Newsletter Rewind 2011: M&A Newsletter Rewind 2011: Metal & Mining Newsletter Rewind 2011: Oil & Gas Newsletter Rewind 2011: Real Estate Newsletter Rewind 2011: Retail Newsletter Rewind 2011: Telecom Newsletter

Domestic News - January 2011 Biocon's trials of oral insulin fails primary test Biocon said that the tests conducted for its experimental oral insulin, IN-105, have not met their primary end point. The company may continue its development with a global partner. Initial data analysis of the test showed that IN-105 did not meet its primary end point of lowering HbA1c levels by 0.7%, compared to a placebo. HbA1c is a test that measures the amount of glycated haemoglobin in the blood. Glycated haemoglobin levels indicate the effectiveness of a drug to control blood sugar levels. On secondary safety endpoints, IN-105 showed excellent overall safety profile with no incidence of serious adverse events, Biocon said in a statement. Kiran Mazumdar-Shaw, managing director and chairman, said, “Biocon is committed to continue its global development of IN-105 in partnership with a global pharmaceutical partner.” Wockhardt to demerge nutrition biz of Vinton Healthcare The Board of Directors of Wockhardt Ltd. at its meeting held on January 12, has considered and approved a Scheme of Arrangement in the nature of Demerger of nutrition business of Vinton Healthcare Limited, a wholly owned subsidiary of the Company into Wockhardt Limited with effect from the appointed date January 01, 2011. As Vinton Healthcare Limited is a wholly owned subsidiary of the Company, no shares would be issued by the Company pursuant to the aforesaid Scheme of Demerger. The said scheme of Arrangement in the nature of Demerger shall be subject to the approval of shareholders of the Vinton Healthcare Limited, the approval of Jurisdictional High Court in which Demerged Company is situated and requisite consent and approval of the statutory and regulatory authorities as may be required for the implementation of the scheme. Aurobindo Pharma to divest in Aurobindo (Dalong) Bio Pharma Aurobindo Pharma Ltd has announced that it has entered into agreement with China National Pharmaceutical Group Corporation (Sinopharm) to divest in its subsidiary company Aurobindo (Dalong) Bio Pharma Co Ltd, China, subject to regulatory approvals. Sinopharm will acquire the shares through its subsidiary company Sinopharm Weiqida Pharmaceutical Co Ltd. ADBPL is engaged in manufacturing of 6APA, a derivative of Penicillin-G & most of its production is consumed by APL, India. In past the performance of ADBPCL has been affected due to economies of scale and is incurring losses. After acquisition of 51% equity in ADBPL, the investors will further infuse capital to enhance its shareholding to 80.50%, reducing APL share in the JV to 19.5%. APL’s loan of US$23mn to ADBPL will entirely be paid back. Sinopharm group will infuse sufficient funds to relocate plant as required by local government in China and significantly enhance capacity and downstream products leading to better economies of scale and reduced cost of production. Read More Fortis Healthcare to set up dialysis and diagnostic centres: report Fortis Healthcare reportedly plans to set up standalone dialysis and diagnostic centres across cities. To start with, it will have 50 dialysis centres in a year from now. The first of it will be up and operational in NCR by March this year. According to reports, Each centre will cost anywhere between Rs. 60 and Rs. 80 lakh. Fortis, is also on the lookout to expand in the South. The company is aggressively looking at expanding its footprint in Tamil Nadu, Kerala and Andhra Pradesh, either through acquisition or greenfield properties. Glenmark gets final USFDA nod for atovaquone, proguanil hydrochloride tablets Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United

Yearly Industry Newsletter

1 of 118

States Food and Drug Administration (U.S. FDA) for atovaquone and proguanil hydrochloride 250mg/100mg tablets, their generic version of GSK’s Malarone tablets. In April 2010, the Company confirmed the settlement of litigation pending between Glenmark and GlaxoSmithKline LLC (GSK) over patent actions concerning atovaquone and proguanil hydrochloride 250mg/100mg tablets. Under the terms of the Settlement Agreements Glenmark will be able to market and distribute its atovaquone / proguanil 250mg/100mg tablets under a royalty-bearing license from GSK in the 3rd quarter of calendar year 2011, or earlier under certain circumstances. Glenmark believes that it is entitled to 180 days of exclusivity with respect to its atovaquone / proguanil 250 mg/100mg tablets as the first generic to file an ANDA for the product. GSK currently markets its product as Malarone in the United States, indicated for the prevention and treatment of malaria. Total U.S. sales as reported by IMS Health for the 12 month period ending December 2009 were approximately US$56mn. Read More Sanofi and Abbott win Tarka trial against Glenmark Sanofi-Aventis SA and Abbott Laboratories won a U.S. jury trial seeking to halt sales of Glenmark’s copy of their hypertension medicine Tarka. The federal jury in New Jersey has rejected Glenmark's challenge to the validity of a Sanofi patent that expires in February 2015. Glenmark had argued that the patent covered an invention that was protected by an expired patent. The court has also ordered Glenmark to pay damages of US$16mn (about Rs. 730mn) to compensate for the loss of profits for Abbott (that markets the drug in the US) till end December 2010. Abbott had demanded a higher compensation of about US$25mn (about Rs. 1.15bn). Generic Tarka was launched by Glenmark in June 2010 after the US District Court refused to issue an injunction against its launch (as placed by Sanofi and Abbott). Tarka tablets had achieved sales of US$64mn (about Rs. 2.94bn) for the 12-month period ending September 2009, according to IMS. Dr. Reddy's launches Pantoprazole Sodium Delayed released tablets Dr. Reddy's Laboratories announced that it has launched Pantoprazole Sodium Delayed released tablets (20mg and 40mg), a bioequavalent generic version of Protonix tablets in the US market. The Food & Drug Administration (FDA) approved Dr. Reddy's ANDA for Pantoprazole Sodium delayed- released tablets on January 19, 2011. Pantoprazole Sodium Delayed released tablets had total U.S sales of approximately US1.8bn for the twelve months ending September 30, 2010 according to IMS Health. Both strengths of Dr. Reddy's Pantoprazole Sodium Delayed-release tablets are available in 90 count bottles. Strides Arcolab arm signs agreement with BioChimico Strides Arcolab Ltd has announced that its wholly owned subsidiary Agila Specialities has signed an agreement with BioChimico of Brazil to set up a joint venture for the Brazilian hospital market in which BioChimico and Agila will transfer selected Brazilian IPs to the joint venture to market products jointly. Strides Arcolab gets USFDA nod for Adenosine injection USP Strides Arcolab Ltd. announced that the USFDA has granted approval for an additional package size of Adenosine Injection, USP, 3mg/MI packaged in 12 mg/ 4 mL single-dose vials. The product will be launched upon expiry of applicable innovator patents. September 2010 IMS data indicates that the US innovator market for Adenosine presentations approximated US$94mn. Strides had, 2010, received approval for Adenosine Injection 60 mg per 20 mL and 90 mg per 30 mL vials. The product will be launche under the partnership between Strides and Sagent Pharmaceuticals wherein Strides is developing and supplying more than 25 injectable products for the US market which is marketed by Sagent.

Yearly Industry Newsletter

2 of 118

R5 Pharma to create new facilities: report R5 Pharmaceuticals is reportedly set to double the size of its site and create new facilities, to introduce new services to its current provision, in 2011. According to reports, under the plan, R5 Pharma, a subsidiary of Aesica Pharmaceuticals, plans to build a new analytical chemistry laboratory this spring with the second stage of construction completing in the second half of 2011. The R5 expansion follows Aesica's recent announcement in December 2010 that it had acquired three manufacturing sites in Europe, almost doubling its workforce. Cipla denies stake sale news...Terms it as rumours

Cipla Ltd. denied that the promoters of the company are in talks with foreign drugmakers for a stake sale. Cipla said that it had received a query from a financial newspaper regarding stake sale by the company's promoters. In this connection, the Company had categorically denied the news vide letter dated December 20, 2010. Cipla said that it would once

again like to reiterate that these rumours are absolutely baseless and are purely speculative in nature. The promoters have no intention whatsoever to go for any stake sale. Earlier, a business daily reported that the promoters of Cipla are in talks to sell their stake to a global pharmaceutical company. The report stated that Cipla has appointed Kotak Mahindra Bank as the merchant banker for the deal and may conclude a deal some time this year. Cipla's talks with Germany's Merck KGaA are believed to be at an advanced stage. It may be recalled that Ranbaxy promoters sold their stake to Japan's Daiichi Sankyo and Piramal Healthcare promoters sold the domestic formulations business to US-based Abbott Labs. Ranbaxy CFO Omesh Sethi resigns

Ranbaxy Laboratories Ltd has announced that Omesh Sethi, President & Chief Financial Officer has resigned from the services of the Company, with effect from January 25 , 2011. This is the second exit by a top Ranbaxy official in five months, after former Chief Executive Officer Atul Sobti quit in August. Sethi joined Ranbaxy in 1989 and has made a

significant contribution to improve its financial performance and also was involved in mergers and acquisitions, Ranbaxy said in a statement. Sobti said on Aug. 12 that he quit because of disagreements with Daiichi Sankyo, Japan’s third-largest drugmaker, over the future course for Ranbaxy. Arun Sawhney replaced Sobti as Managing Director. The Company is yet to name a new CEO. Cadila and Bayer to set up new JV in India Bayer HealthCare and Zydus Cadila ("Zydus") signed an agreement to set up the Joint Venture Company Bayer Zydus Pharma for the sales and marketing of pharmaceutical products in India. Each party will hold 50 percent of the shares of Bayer Zydus Pharma, headquartered in Mumbai, and be equally represented on its management board. Bayer Zydus Pharma will start operations with Bayer HealthCare’s Pharmaceutical Division contributing its existing sales and marketing business in India to the new company, and Zydus contributing its women’s healthcare products, diagnostic imaging business and other products.

Yearly Industry Newsletter

3 of 118

Bayer Zydus Pharma will operate in key segments of the Indian pharmaceuticals market with a focus on: women’s healthcare, metabolic disorders, diagnostic imaging, cardiovascular diseases, anti-diabetic treatments and oncology. In addition to Bayer HealthCare’s currently existing pharmaceutical product portfolio in India, the Joint Venture is also intended to focus on the sales and marketing of future patented pipeline pharmaceutical products. Both Bayer HealthCare and Zydus will supply the Joint Venture with products sourced from its manufacturing operations at existing locations. Read More Aurobindo gets tentative USFDA nod for Levofloxacin

Aurobindo Pharma Limited is pleased to announce that the company has received tentative approval from the US Food & Drug Administration to manufacture and market Levofloxacin tablets 250mg, 500mg and 750mg. Aurobindo would launch the product immediately after final approval.

Opto Circuits arm gets US Military certification

Opto Circuits (India) Limited’s US-based subsidiary, Cardiac Science Corporation, a global leader in automated external defibrillator (AED) and diagnostic cardiac monitoring devices, has been awarded Airworthiness Release (AWR) from the U.S. Army’s Research, Development, and Engineering Command for the Powerheart® AED G3 Pro® automated defibrillator. The

certification indicates the Powerheart AED G3 Pro complies with U.S. Department of Defense medical device certification criteria and is tested for use in air, sea, and land operations.

Yearly Industry Newsletter

4 of 118

International News - January 2011 Genzyme cuts outlook amid Sanofi merger talks Genzyme Corp. reported today that discussions between its financial advisors and financial advisors for Sanofi-Aventis are continuing and have expanded to include representatives of both companies. These discussions have focused on potential terms for a negotiated transaction and have included the possible use of a contingent value right relating to alemtuzumab as part of any potential resolution of differences with respect to value. Genzyme can provide no assurance that these discussions will continue or will result in a transaction. It also can provide no assurance of the terms that may be obtained in any such transaction. Elite Pharma inks pact with Hi-Tech Pharma: report Elite Pharmaceuticals is reportedly set to develop an intermediate for a generic version of Hi-Tech Pharmacal's prescription product and will then incorporate into a final product, under an agreement signed between the companies. Under the agreement Hi-Tech Pharmacal will be responsible for submitting the abbreviated new drug application (ANDA) for the finished product, which will be filed under Hi-Tech Pharmacal's name. According to reports, Elite will take up the manufacturing responsibility of the intermediate product; however Hi-Tech Pharmacal will manufacture the finished product and will also take care of the sales and marketing of the final product. Upon commercialization, Hi-Tech Pharmacal will pay for the manufacturing of the intermediate product and a percentage of the profits generated from the sale of the product to Elite, adds report. Spectrum Pharma inks pact with Viropro Spectrum Pharmaceuticals Inc. announced the signing of a letter of agreement with Viropro Inc., for the development of a biosimilar version of the monoclonal antibody drug rituximab. Worldwide sales of rituximab in 2009 in all indications, including non-Hodgkin's lymphoma and chronic lymphocytic lymphoma, were around US$5.6bn. EyeGate Pharma secures additional US$5.9mn as part of Series D closing EyeGate Pharma, a privately held venture-backed pharmaceutical company developing ocular therapeutics, announces that it has secured an additional US$5.9mn as part of its Series D closing. With this additional tranche, Eyegate has raised a total of US$28.5mn in Series D funding to date. The funds will be used to continue development of EGP-437 for the treatment of Dry Eye Syndrome (DES), an ocular surface irritation affecting several million men and women in the United States. EGP-437 is a dexamethasone derived corticosteroid solution specially formulated for delivery using the EyeGate II Delivery System. EGP-437 is part of EyeGate's broader strategy of developing a pipeline of medicines for treating ocular diseases using its proprietary EyeGate II Delivery System, a non-invasive, iontophoretic drug delivery system. Watson Pharma's arm gets USFDA nod for generic Fentora Watson Pharmaceuticals, Inc. announced that its subsidiary, Watson Laboratories, Inc. has received U.S. Food and Drug Administration approval for the generic equivalent to Cephalon, Inc.'s Fentora tablets. The FDA approved Watson's Fentanyl Citrate Buccal tablets in the 100 mcg, 200 mcg, 300 mcg, 400 mcg and 800 mcg strengths. Optimer Pharma appoints key additions to management team Optimer Pharmaceuticals, Inc. announced the appointment of Linda Amper, Ph.D., as Senior Vice President of Human Resources, Hemal Shah as Senior Vice President of Health, Economics & Outcomes Research (HEOR), and John Womelsdorf, Ph.D., as Vice President of Business Development. These key

Yearly Industry Newsletter

5 of 118

positions will strengthen the management team as the Company prepares to become a commercial organization and prepares for the potential launch of its lead product candidate, fidaxomicin. Endo Pharma inks pact with Orion Corp: report Endo Pharmaceuticals reportedly reached a collaboration agreement with Orion Corp. for the discovery, development and commercialization of assets in Oncology. The formation of the R&D collaboration partnership allows the companies to bring forward a total of eight "discovery phase" candidates by combining an equal number of programs. Teva Pharma and APP Pharma launch Gemcitabine HCI for Injection: report Teva Pharmaceutical Industries Ltd. and APP Pharmaceuticals, Inc. reportedly announced the commercial launch of Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials, the generic version of Gemzar, in the United States, pursuant to a commercialization, manufacture and supply agreement signed by the two companies. Glaxo suspends US ad for Levitra: report GlaxoSmithKline PLC has reportedly suspended U.S. television advertisements for anti-impotence pill Levitra. Deirdre Connelly, president of Glaxo's North American pharmaceuticals unit, was quoted as saying that the company has stepped up its commitment to operate with integrity, to be more respectful of patients and more transparent in how it conducts business. USFDA denies approval GSK's Avodart: report USFDA reportedly declined to approve GlaxoSmithKline, Avodart as a cancer preventative which is currently marketed to treat benign prostatic hyperplasia. An approval would have allowed GSK to aim Avodart at the estimated 1 mn men at higher risk of prostate cancer, which could have added up to US$1bn to its sales. Novartis to acquire Genoptix: report Novartis AG is reportedly strengthening its personalized medicine and cancer portfolio with the US$470mn buy of U.S. cancer diagnostics company Genoptix. The deal, which comes after Novartis's US$52 bn purchase of U.S. eyecare group Alcon Inc, shows Novartis still has the financial clout to clinch smaller deals as it seeks to drive growth in its five main units pharmaceuticals, consumer health, eyecare, generic drugs and vaccines and diagnostics.

Yearly Industry Newsletter

6 of 118

Domestic News - February 2011 Sun Pharma announces USFDA approval for generic Razadyne ER

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Razadyne ER, galantamine hydrobromide extended-release capsules. These generic galantamine hydrobromide extended-release capsules, 8 mg (base), 16 mg (base) and 24 mg (base) are

indicated in the treatment of mild to moderate dementia of the Alzheimer’s type. Razadyne ER has annual sale of approximately US$50mn in the US. Venus Remedies GEMCITABINE gets UK MHRA approval Venus Remedies Limited, a leading research based Indian pharmaceutical company achieved yet another landmark by receiving the Market Authorisation for GEMCITABINE, one of the key products for the treatment of Cancer via de-centralised procedure from Medicine and Healthcare Regulatory Agency (MHRA) U.K. The other countries in the list are Poland, Germany, Slovenia and Portugal for which the same feat has been achieved. Pawan Chaudhary CMD Venus Remedies said, “Venus is all set to capture substantial market share by entering the highly lucrative market of Europe as it stands amongst the first few to receive the Market Authorisation for Gemcitabine”. Gemcitabine is a US$1.5bn drug world wide with more than 30% market share from Europe. Read More Opto Circuits arm bags contract for Powerheart AEDs Cardiac Science Corporation, wholly owned subsidiary of Opto Circuits India has been awarded a contract to deploy Powerheart AEDs in all Tyco Flow Control facilities globally. The first phase of the rollout, planned for the first quarter of 2011, will equip Tyco's Australian, Pacific and North and South American facilities. Tyco Flow Control is a US$3.4B division of Tyco International. The first phase of the rollout, planned for the first quarter of 2011, will equip Tyco’s Australian, Pacific, and North and South American facilities. “We are proud to have been selected for Tyco’s ‘Save a Life’ program and look forward to protecting their employees against sudden cardiac arrest,” said Dave Marver, Chief Executive Officer, Cardiac Science. “Tyco’s decision reinforces our status as a global leader in AED technology and services.” Read More Dr. Reddy’s Lab deploys Salesforce CRM across 200 users Salesforce.com, the enterprise cloud computing company, announced that India’s second largest pharmaceutical company, Dr. Reddy’s Laboratories, has deployed Salesforce CRM across 200 users within 60 days. Dr. Reddy’s decided to move its Active Pharmaceutical Ingredients (API) marketing business to the cloud in order to improve visibility into its deals pipeline, track its end-to-end sales cycle and better analyze its sales funnel. Dr. Reddy’s implemented Salesforce CRM with the help of IT consulting firm Bodhtree, who used its data integration engine MIDAS to integrate with existing Mail, Calendar, and SAP systems, By streamlining its sales business on salesforce.com, Dr. Reddy’s expects to increase revenue by more than 30%. “We eliminated bottle necks within the sales cycle almost immediately because of the greater visibility we gained into sales performance,” said B.V. Srinivas, Deputy CIO, Dr. Reddy’s Laboratories. “Salesforce.com’s ability to seamlessly integrate data captured offline with online systems, is of immense help to our field sales team who need to track and update customer data on regular basis but do not have access to internet connectivity at all times.

Yearly Industry Newsletter

7 of 118

Salesforce.com delivers all of the benefits of a world-class CRM system within a cost-effective ‘pay as you go’ model, which fits perfectly with Dr. Reddy’s ‘quality without the cost’ ethos.” Bayer MaterialScience inaugurates Color Competence and Design Center in Greater Noida Bayer MaterialScience inaugurated its Color Competence and Design Center in Greater Noida, near New Delhi today. This new Center provides products and solutions for polycarbonate compounds, ranging from color matching and small-scale production, to the broad range of technical services to support injection-molding and compounding processes. This enables customers to adapt quickly to fast-evolving trends, and explore new options for color, surfaces, geometries and design, while leveraging Bayer MaterialScience's global expertise and extensive know-how of the local markets. ”Our investment is a reflection of Bayer MaterialScience’s commitment to the India market, as well as of our vision to further strengthen our leading position in the polycarbonate market globally,” said Dr. Günter Hilken, Member of the Executive Committee of Bayer MaterialScience AG and global head of the polycarbonate business. “With our Color Competence and Design Center in Greater Noida, we believe we are in good stead to show how Bayer MaterialScience is delivering the best value for polycarbonate solutions in the market.” Ranbaxy Labs signs MOU with Government of Yaroslavl Region Ranbaxy Laboratories Ltd and The Government of Yaroslavl Region, Russia, has signed Memorandum of Understanding for cooperation in the field of Healthcare and Medical Science. The major areas of cooperation are the development of the healthcare system, new medical technologies in the Yaroslavl region. Aurobindo Pharma receives nod for Famciclovir Tablets Aurobindo Pharma Ltd has received approval from the US Food and Drug Administration to manufacture and market Famciclovir Tablets 125mg, 250mg and 500Mg. Famciclovir Tablets 125mg, 250mg and 500Mg.is the generic version of Novartis Pharmaceuticals Corp's Famvir Tablets 125mg, 250mg and 500Mg and is indicated for the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients. Stempeutics Research gets DCGI clearance for Stempeucel Stempeutics Research, a group company of Manipal Education & Medical Group announced today that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel allogeneic product is developed from mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has received approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction and Critical Limb Ischemia in March 2009. Stempeutics is funded by its share holders - Manipal Group and Cipla. Being the first of its kind stem cell product developed in India, it took almost 15 months to get DCGI clearance. DCGI referred Stempeutics proposal to Indian Council for Medical Research for review and recommendation. ICMR constituted an expert stem cell committee to examine the proposal and the committee accepted the study as Phase II clinical trials. The DCGI’s clearance of Stempeucel product for the four debilitating diseases is one of Stempeutics’s significant accomplishments towards its goal of bringing safe, effective and affordable stem cell based product in India in the near future. India becomes one of the leading countries after USA to enter this phase of Stem Cell research.

Yearly Industry Newsletter

8 of 118

Nova Medical Centers expands in Delhi Nova Medical Centers in support Max Healthcare, India’s leading Ambulatory Surgical Center Group, today announced its expansion in Delhi by joining hands with the historic Jeewan Mala Hospital (JMH). With this tie-up, Nova, headquartered in Bangalore will have two centers in the NCR. In NCR, Nova has a joint venture agreement with Max Healthcare. The first center under this joint venture agreement with Max Healthcare was inaugurated by Shri. Ghulam Nabi Azad, in Nov 2010 at East of Kailash. Jeewan Mala’s immense goodwill and the experience of Dr. Malvika and Dr. Vinay Sabharwal, coupled with Nova’s model of Ambulatory Surgeries will provide Nova significant presence in the NCR. Dr Malavika and Vinay Sabharwal will continue their surgical practice at NOVA and be involved in an advisory role. They are excited to be a part of Nova’s growing network and expansion in India. Speaking on the tie-up, Suresh Soni, CEO, Nova Medical Centers said, “Our Medical Centers provide the very best in terms of surgeons and surgical facilities. This collaboration with JMH shall be the cornerstone for Nova to provide quality and affordable medical care in the NCR.” Natco to accept ANDA for generic version of Oseltamivir Phosphate Natco Pharma Limited announced the acceptance of its Abbreviated New Drug Application for the generic version of Oseltamivir Phosphate capsules. Natco has tied up with Luxemburg based Alvogen IPCO S.a.r.l for marketing and sale of Oseltamivir Phosphate in the USA. Natco is the first applicant to file an ANDA for the generic version of Tamiflu and should the ANDA be approved may be entitled to 180 days of generic market exclusivity. Glenmark announces positive results from Crofelemer study Glenmark announces positive results from the multi-centre study of Crofelemer in acute watery diarrhoea in adult patients. In this multi-centre, placebo controlled trial, resolution of diarrhoea was significantly higher in the Crofelemer arm compared to placebo. The clinical success rate was also greater in the Crofelemer arm compared to placebo. Crofelemer was found to be safe with no apparent differences in adverse event profile in the Crofelemer group compared to placebo. This trial in mild to moderate adult patients with acute watery diarrhoea was the second proof of concept study conducted by Glenmark with Crofelemer. Adult patients with mild to moderate diarrhoea were dosed with Crofelemer over a period of 3 days with a follow-up period of 30 days. This was a 3 arm drug vs placebo study which included a 125 mg, 250 mg and a 500 mg dose of Crofelemer. Overall Crofelemer showed superiority to the placebo arm. For the efficacy parameter of stool frequency, there was a significant difference in the reduction of number of stools per day during 3 days of treatment period between both the lowest and highest Crofelemer doses versus Placebo. Read More AstraZeneca and Taj launch Gemcitabine HCI for Injection: report AstraZeneca Pharmaceuticals and Taj Pharmaceuticals, have commercially launched Gemcitabine HCI for Injection in 200 mg and 1 g single dose vials in the US. According to reports, Gemcitabine HCI for Injection, the generic version of Gemcitabine HCI, was launched pursuant to a commercialization, manufacture and supply agreement signed by AstraZeneca and Taj Pharmaceuticals. As per the agreement, AstraZeneca will manufacture Gemcitabine HCI for Injection and will receive a license to market the product within the India-based firm's 180-day exclusivity. Taj Pharma will get a royalty during the manufacturing period. Ankur Drugs sets up facility at Himachal Pradesh

Yearly Industry Newsletter

9 of 118

Ankur Drugs and Pharma Ltd has set up a stat of the art facilities at Baddi (Himachal Pradesh). In the quest for greater atomization and making the facilities most technologically advanced, the cost of the project has gone up significantly which was not envisaged. Since the project was to be completed on or before 31st March, 2010 to avail the concessions under the Industrial Package announced by the Central Government for the state of Himachal Pradesh, the company could not tie up with the long term funds and it was forced to raise funds from all available resources for completing the project. Panacea Biotec launches PacliALL Panacea Biotec, India’s 3rd largest biotechnology company is planning to introduce during Indian Cancer Congress 2011 at Bhubaneswar on 12th Feb 2011; their indigenously developed Albumin bound Paclitaxel particles formulation – PacliALL. PacliALL offers the advantage of improved safety over conventional formulations of Paclitaxel and is meant to be used as a chemotherapeutic agent for the treatment of Breast Cancer. PacliALL would be made available at a price point which is approximately 50% lower than competitive products in the domestic and global markets. PacliALL has been developed by Panacea Biotec’s state of the art Global Research and Development (GRAND) Centre, Navi Mumbai. Commenting on the same, Dr. Rajesh Jain, Jt. Managing Director, Panacea Biotec Limited said “The Objective of Panacea Biotec is to take Ideas from Grey Cells to the Market in a Proactive Manner and establishing brand India globally in sync with its adage “Think Medicine Think India”. Pacliall uses one of world’s most advanced particle size optimization technology to reduce serious adverse effects like severe anaphylaxis and sensory neuropathy associated with conventional Paclitaxel formulations in addition to offering several patient convenience aspects like shorter infusion time and elimination of need of premedication. We are in line with our vision to become the Greatest, Largest and Most Admired Biotechnology Company and we are proud to offer this technology to the global population. Panacea Biotec will remain committed to its mission providing the latest and most affordable preventive and therapeutic care to people across the globe. The launch of PacliALL reflects the hardwork of Panacea Biotec’s scientists, who worked tenaciously for the development of this drug – Added Dr. Rajesh Jain Cipla is Most Trusted Brand in Pharmaceutical industry in India Cipla, one of the leading global pharmaceutical companies from India is the ‘Most Trusted Brand’ in the pharmaceutical industry in India, according to a study by Trust Research Advisory (TRA) – a research company which surveyed 16,000 brands across 9 cities. Speaking on this recognition, Dr. Y. K. Hamied, Chairman and Managing Director Cipla said, “Cipla alleviates the sufferings and saves millions of lives worldwide each day. Every individual who experiences Cipla through its high quality drugs and devices, develops a sense of trust for the brand. Also, our unique humanitarian approach and integrity in functioning has helped us emerge as one of the most trusted names across geographies.” Commenting on Cipla’s achievement, N. Chandramouli, CEO Trust Research Advisory & Publisher of the report said, “Cipla has ranked as the most trusted pharmaceuticals’ brand, with overall 133rd rank among the 16,000 brands studied under this report. Trust is an essential prerequisite for the healthcare sector and having a high Trust Index displays intrinsic aspects like the brand’s empathy, sincerity, and competence. “ The Brand Trust Report, India Study, 2011 is based on a proprietary Trust Matrix developed by TRA which was used to launch a syndicated primary research on Brand Trust across 9 cities in India covering 2310 respondents who were classified into the ‘influencer’ category. Opto Circuits arm to deploy Powerheart AEDs at U.S Postal Inspection Service sites Cardiac Science Corporation, wholly owned subsidiary of Opto Circuits India has been awarded a contract to deploy Powerheart AEDs at U.S. Postal

Yearly Industry Newsletter

10 of 118

Inspection Service sites across the United States. The U.S. Postal Inspection Service is the primary law enforcement arm of the United States Postal Service. The Powerheart AED's RescueCoach user paced voice prompsts and CPR metronome guide resucred confidently through a stressful rescue situation. Vasan Health Care to establish 28 eye care centers in East, West and North India Vasan Health Care (VHC), one of India’s fastest growing healthcare companies, announced its expansion plans for a Pan India operations. Vasan Eye Care Hospital (A VHC Enterprise) which is a network of premier institution of eye care hospitals in South India is bringing its expertise to North, East & West. The eye care network has become the world’s largest eye care provider according to a market assessment by Frost & Sullivan. The chain of super specialty eye care hospitals has been making a difference to over 6 million patients every year. With a network of over 80 eye care hospitals, 15 Dental clinics spread across Tamil Nadu, Karnataka, Andhra Pradesh, Kerala & Pondicherry, Vasan Health Care plans to expand its presence Pan India. Dr. A M Arun, Chairman and MD, Vasan Health Care, is the finalist of Ernst & Young Entrepreneur of the Year 2011. Speaking at the conference Dr. Arun said, “Vasan Health Care has been progressing towards bringing world-class healthcare within the reach of every Indian citizen. We are proud to achieve the feat of becoming the world’s largest eye care network. By June 2011, Vasan Eye Care Hospital will be launching 28 eye care hospitals in the Cities of Delhi (4), Kolkata (5), Mumbai (4), Surat, Ahmedabad, Baroda, Rajkot, Nagpur, Pune, Kolhapur, Nashik, Amritsar, Jalandhar, Ludhiana, Chandigarh, Indore, Bhopal and Bhubaneshwar. The network also is opening up its operations in Dubai and Colombo by April 2011 and in Africa, Oman, Abu Dhabi, Sharjah and Doha in the next couple of months. Lincoln Pharma introduces India's first Long-Acting Paracetamol 'Pa-12' Lincoln Pharmaceuticals Ltd has announced the launch of a novel drug delivery system in Paracetamol, Pa-12-India;s first Long-Acting Paracetamol for Long term relief from Fever and Pain. Pa-12 contains 1000mg paracetamol, programmed for "Non-Stop 12 hours fever control with 1 tab only.". Kohinoor Hospital organizes funeral procession of cigatette Today, on the World Cancer Day, Kohinoor Hospital literally organized a funeral procession of the deadly ‘cancer stick’ – the lethal cigarette - to deter people from smoking and educate them about the alarming rise in the incidence of cancer, its main causes, preventive measures to be taken and how to fight against it. Kohinoor Hospital, a multi-specialty hospital, located at Kohinoor City, Kurla-Vidyavihar, organized this unique campaign of a funeral procession of the ‘cancer stick’ to strongly convey the message ‘Live Life, Stop Smoking’. A giant dummy of a Cigarette was erected and carried in a truck. The ‘funeral procession’ of the giant eco-friendly cigarette dummy started from Kohinoor Hospital, passed through Jolly Gymkhana, Ghatkopar East-West Bridge, LBS Road towards Ghatkopar Station to culminate at Samaj Mandir Hall Ground, opposite Pant Nagar Police Station, Ghatkopar East. More than 150 school children from Gandhi Balmandir, Kohinoor City, Children’s Aid Society Madhyamik Vidyalaya, Mankhurd, and S P R J K Shala, Ghatkopar (West), and other volunteers took part in the procession. There were continuous loud speaker announcements and banners were also displayed to increase public awareness about the fatal dangers of smoking.

Yearly Industry Newsletter

11 of 118

The ecofriendly dummy of the Cigarette was finally cremated at the end of the procession to strongly signify the death of the deadly smoking habit. Govt bans 4 drugs: report The Government reportedly banned four drugs, including popular anti-inflammatory drug nimesulide for children, and may also prohibit domestic sales of antibiotic gatifloxacine and tegaserod used to treat digestion disorders. The four drugs banned by the Health Ministry were under review by the Government for over a year. The Drug Technical Advisory Board (DTAB), headed by the drug controller general of India (DCGI) Dr. Surinder Singh, has reportedly examined three other drugs and may ban two of them, The third medicine, anti-depressant deanxit may be put under review as to whether it should also be taken off the market, according to reports. Glenmark’s novel molecule ‘GRC 17536’ entering human trials Glenmark Pharmaceuticals has announced that its Novel Chemical Entity (NCE) 'GRC 17536' is entering human trials. The new NCE program is targeting TRPA1 receptor antagonists for pain and respiratory disorders. TRPA1 belongs to Transient Receptor Potential (TRP) family of ion channels, which have generated a lot of interest as pain targets due to their distinguishing role in peripheral and/or central pain signal transmission. Glenmark has completed animal trials and Phase 1 enabling GLP studies for its selected lead molecule, GRC 17536 and has filed the Phase 1 application for first-in-man trial in Netherlands. Read More… Fortis International Centre for robotic surgery to launch in India Fortis Healthcare Ltd, India’s fastest growing hospital network, and International Centre for Robotic Surgery (ICRS) jointly announced a state-of-the-art robotic surgery centre, christened ‘Fortis International Centre for Robotic Surgery’ (Fortis ICRS). Fortis ICRS centres will be set up across the Fortis network, starting with Fortis Escorts Heart Institute in New Delhi, followed by Mumbai, Gurgaon, Bangalore, Chennai, Kolkata and tier II cities like Mohali and Jaipur. Fortis ICRS will bring the latest robotic surgery procedures to patients in India at a much lower cost. It will offer the full spectrum of robotic heart, lung, urology, gynaecology, general, head and neck surgeries. These surgeries will be performed by highly experienced robotic surgeons from the United States and other countries with their support teams, in conjunction with surgical teams at Fortis hospitals. Read More… Venus Remedies to enter Super Specialty Oncology segment Venus Remedies Limited, a leading research based pharmaceutical company has announced to enter Super Specialty Oncology segment with launch of a new dedicated sub business unit 'PASSION ONCOBIZ' with product basket of 21 products in injectable form for fighting practically all type of cancer. Speaking on the occasion Pawan Chaudhary CMD Venus Remedies said, “At present, the anti cancer drug segment is contributing 30% of the total sales of the company with more than 100 Market Authorizations from 25 countries including UK, Germany, Poland, Portugal; and with the launch of PASSION ONCOBIZ, Venus will further reinforce its industry position and expects growth of 10%% in the market share by 2015”. Read More… Emaar and Shamla Pharma to build pharma factory at KAEC: report Emaar, in collaboration with Shamla Pharmaceutical Industries, is reportedly set to build a pharmaceutical factory at the Industrial Valley in KAEC. According to reports, the collaboration came in line with EEC's special attention to the pharmaceutical sector primarily because of the quality of jobs they will create and the products they will produce which in turn will contribute to the well being of Saudi citizens. Zimmo Trading Est president Mohammed Zimmo was quoted as saying that the alliance is the first of its kind between 3 key industry players, setting the milestone for a major uplift

Yearly Industry Newsletter

12 of 118

in the pharmaceutical industry and contributing to its localization in the Kingdom. Ind-Swift Labs receives PMDA nod for Pioglitazone and Risedronate Sodium Pharma major Ind-Swift Laboratories Limited got the PMDA approval (Pharmaceutical & Medical devices Agency) from Government of Japan for Pioglitazone and Risedronate Sodium to be manufactured at its facilities at Derabassi (Punjab). With this achievement it has become the first Indian company to get Japanese Government approval without any observations. This is a significant development in the company’s history as it is aiming at huge exports to Japan. Speaking on the achievement N.R. Munjal Vice Chairman cum Managing, Director said, “The company has high regulatory standards where its facilities are already approved by USFDA/TGA/COS/KFDA and with this approval for Pioglitazone which is an anti diabetic drug with market size worth US$ 2.8 bn and Risedronate Sodium a drug for Osteoporosis with market size worth US$ 1.6bn, the company is aiming at capturing 15-20 per cent of the market share of these products by 2013.” Read More…. Jyothy Lab launches Multi Insect Repellants formulations Jyothy Laboratories Ltd announces the national launch of DEPA based Multi Insect Repellants formulations in the form of 'Cream', 'Spray' and 'Lotion' and 'Wipes' under the brand names 'Maxo - Military' and 'Maxo - Safe & Soft', on February 14, 2011 at a function in New Delhi. Fortis Global Healthcare enters in Singapore Fortis Global Healthcare has made its first foray in Singapore by acquiring an under construction specialized Cancer Hospital in the prime Adam Road area from First Real Estate Investment Trust, a Singapore listed healthcare real estate company. Fortis Healthcare group which has, within its fold, a 50 hospital network in India, aims to complete the construction of the hospital by the second quarter of 2012.The hospital plan is being redesigned to incorporate the needs of the patients and the medical fraternity in Singapore. Read More… HP accelerates transformation of healthcare HP announced a new solution portfolio designed to deliver flexibility and efficiency to health organizations. The new HP Digital Health solutions are based on HP’s extensive portfolio of products, solutions and partnerships. It enables health organizations to accelerate change and innovation, advance operational efficiencies and orchestrate care across the ecosystem. In short, it helps healthcare organizations become Instant-On Enterprises. Read More… Exemption from Service Tax will help in providing medical care at lower costs: Gautam Khanna Our expectations from the Union Budget come at a time when the sense of confidence towards the growth of the Indian economy is steadily improving. The Government’s efforts to initiate measures to control price rises, cut down fiscal deficit, and control the inflation rate is going to be key to building that confidence. An increase in healthcare budget allocation will help boost public health, insurance and infrastructure. We propose the following to ensure that we continue on the path of achievement of Affordable and Accessible Healthcare to the Indian. India, with the right infrastructure & predictable tax regime can emerge as an attractive destination for low-cost manufacturing. Read More…

Yearly Industry Newsletter

13 of 118

International News - February 2011 Valeant Pharma to acquire PharmaSwiss: report Valeant Pharmaceuticals International, Inc. reportedly signed a binding agreement to acquire PharmaSwiss S.A, a privately-owned branded generics and over-the-counter pharmaceutical company, for 350mn euros. The deal is expected to close in the first or second quarter of 2011 and to be immediately accretive to Valeant. According to reports, upon closing, PharmaSwiss is expected to have approximately 38mn euros cash on hand and no debt. The company noted that up to an additional 30 mn euros may be payable to certain PharmaSwiss stockholders based on certain milestones. Following the deal closure, PharmaSwiss' senior management team, including both the founder-partners, as well as Chief Executive Officer Pavel Mirovsky, will remain with Valeant and work closely with the Valeant Europe team. Over time, Valeant business in Central Europe would be combined under the PharmaSwiss corporate structure in Switzerland. Fera Pharma launches Puralube Ophthalmic Ointment: report Fera Pharmaceuticals has reportedly launched its over-the-counter (OTC) dry eye treatment, Puralube Ophthalmic Ointment. Fera Pharma is launching Puralube in a 3.5g tube as well as a carton of 20 1g tubes. Fera Pharma president Frank DellaFera was quoted as saying that Puralube is a product that fits perfectly with their eye care portfolio. We are so pleased to make Puralube available again, giving patients, pharmacists and physicians a cost effective and reliable treatment option for dry eye symptoms. Nestle SA acquires CM&D Pharma: report Nestle SA has reportedly acquired CM&D Pharma, a UK-based drug-maker start-up testing a chewing gum to help kidney-disease sufferers, the first move in the company’s effort to build a business selling food products that targets diseases. According to reports, Nestle’s deal for CM&D Pharma Ltd, to be announced on Wednesday, is likely the first of many for Nestle Health Science SA, a subsidiary that opened its doors last month. Nestle confirmed that it had made the deal but did not disclose terms. Apax Partners,KKR may buy Blackstone's stake in Emcure Pharma: report Apax Partners and Kohlberg Kravis & Roberts (KKR), are in talks to acquire Blackstone's stake in Emcure Pharmaceuticals for about US$100 mn, according to a report. The report stated that Emcure Pharmaceuticals IPO plan has been delayed and this may have prompted Blackstone to go for a secondary transaction to exit the company. Emcure researches, manufactures and markets formulations under its own brands in the domestic market and exports its own formulations to Asia, Africa, CIS, Europe, Latin America and the Middle East. First China Pharma inks pact with Changzhou Pharma for Enalaprilat: report First China Pharmaceutical Group, Inc. has reportedly announced the signing of a second exclusive drug distribution agreement further extending its vertical markets and regional penetration alongside resultantly notable revenue increases. The agreement with Changzhou Pharmaceutical Co. Ltd (Changzhou) of Changzhou city, Jiangsu Province permits First China to act as the exclusive distributor for the specialty drug Enalaprilat, a treatment for high blood pressure used in the treatment of hypertension and some types of chronic heart failure. According to reports, the product will be available to member hospitals and clinics across China within the next 30 days. Initial estimates target sales at over US$1mn annually with the potential for significant growth as the company extends its market base in China.

Yearly Industry Newsletter

14 of 118

Pfizer to acquire Ferrosan’s consumer healthcare business Pfizer Inc. announced that it has entered into a definitive agreement to purchase Ferrosan’s consumer healthcare business, which includes dietary supplements and lifestyle products, from Altor 2003 Fund GP Limited. Based in Copenhagen, Ferrosan is an innovative and long-established consumer healthcare company in the Nordic region with a portfolio of leading brands. Since 1920, Ferrosan has grown to serve a broader market including Russia, the Ukraine, Poland, Turkey and many countries throughout Central and Eastern Europe. Read More Kindred to acquire RehabCare Kindred Healthcare, Inc. and RehabCare Group, Inc. jointly announced the signing of a definitive merger agreement under which Kindred will acquire RehabCare. Under the terms of the merger agreement, each stockholder of RehabCare common stock will receive $26 per share in cash and 0.471 of a share of Kindred common stock. Based upon the average value of Kindred common stock, as defined, during the ten trading days preceding the signing of the merger agreement, each RehabCare stockholder will receive consideration with a current value of approximately $35 per share. Kindred expects to issue approximately 12 million shares in connection with the pending transaction. The aggregate value of the pending transaction approximates $1.3 billion, including approximately $400 million of existing indebtedness. This transaction will create the largest post-acute healthcare services company in the United States with over $6 billion in annual revenues and operations in 46 states. The combined company will operate 118 long-term acute care (“LTAC”) hospitals with 8,492 licensed beds, 226 nursing and rehabilitation centers with 27,442 licensed beds, 121 inpatient rehabilitation (“IRF”) hospitals (primarily hospital-based units) and 1,808 hospital, nursing center and assisted living rehabilitation therapy services contracts across the country. The merger agreement was unanimously approved by the Board of Directors of both Kindred and RehabCare. Under the terms of the merger agreement, two members of the RehabCare Board of Directors will join the Kindred Board following consummation of the transaction. Kindred believes the transaction will be highly accretive to earnings and operating cash flows, exclusive of one-time items related primarily to the pending merger, immediately upon closing. In connection with the pending transaction, Kindred expects the combined company to achieve operating synergies of approximately $40 million within a period of two years following consummation of the acquisition, with $25 million expected in the first year after closing. Astellas signs antibiotic deal with Optimer: report Astellas has reportedly bagged the European rights to Optimer Pharmaceuticals' new antibiotic in a deal that could be worth over US$220mn to the US firm. The agreement, which covers certain other countries in the Middle East, Africa and the Commonwealth of Independent States, as well as Europe, involves fidaxomicin for clostridium difficile infection. According to reports, the drug is an orally-administered macrocyclic antibiotic with a new mechanism and narrow spectrum of action, and in two Phase III trials has proved equally effective in clinical cure when compared to vancomycin, the only product approved by the US Food and Drug Administration for CDI. Astellas is paying an upfront fee of US$68mn and Optimer could pocket another US$156mn upon the achievement of certain regulatory and commercial milestones, double-digit royalties, adds report. Avesthagen introduces vegetarian DHAomega 3 essential fatty acid Avesthagen Limited announced completion of a landmark project for the development of AvestaDHA - a vegetarian source of DHA (docohexanoic acid) omega 3 essential fatty acid based on an innovative approach using naturally

Yearly Industry Newsletter

15 of 118

occurring microalgae. DHA is a polyunsaturated mega-3 fatty acid found throughout the body. More specifically, DHA Omega-3 is a major structural component found in the brain gray matter, eye retina and the heart. Numerous scientific studies confirm that everyone, from infants to adults, benefit from an adequate supply of DHA Omega-3. For mothers-to-be, DHA Omega-3 supports a healthy pregnancy. Read More… Sanofi-Aventis to buy Genzyme for about US$20bn Sanofi-Aventis SA said on Wednesday that it has reached an agreement, in principle, to acquire Genzyme Corp. for about US$20bn in cash plus future payments, bringing to an end a nine-month pursuit of the US biotechnology company. The Boards of both the companies have approved the deal, which is expected to close in the second quarter of 2011. Every Genzyme shareholder will receive a contingent value right (CVR) for each share they own, entitling the holder to receive additional cash payments if specified milestones are reached. The milestone payments are linked to the performance of the drugs Lemtrada, Cerezyme and Fabrazyme. Read More… Thermo Fisher selling Athena to Quest Diagnostics Thermo Fisher Scientific Inc the world leader in serving science announced today that it has signed definitive agreements to sell its Athena Diagnostics and Lancaster Laboratories businesses for a total of $940 mn in cash. The company reached an agreement to sell Athena Diagnostics to Quest Diagnostics Incorporated for $740 mn. Athena Diagnostics, based in Worcester, Mass., is a leading reference laboratory that provides comprehensive diagnostic testing for neurological and other diseases, with an emphasis on gene-based tests. Read More…

Yearly Industry Newsletter

16 of 118

Domestic News - March 2011 Strides arm gets EU approval for Carboplatin 10 mg/ml

Onco Therapies Ltd., the wholly owned oncology (cancer drugs) subsidiary of Strides, announced European Union (EU) approval for Carboplatin 10 mg/ ml in the first wave covering select European countries. This is the first European approval out of the 22 filings made by OTL in the year 2010 for products which have a combined market value of over US$5bn. The application for

Carboplatin 10 mg/ml was submitted through a Decentralized Procedure (DCP). The second wave of filing for Carboplatin will commence immediately to cover all the remaining EU countries. Approval for all countries is expected during 2011. Read More… Strides Arcolabs gets USFDA nod for Vancomycin Injection Omega Healthcare accelerates Application Performance and Improves Employee Productivity with Brocade Brocade has announced that Omega Healthcare, a premier Business Process Outsourcing company in the healthcare sector, has standardized on a enterprise-wide Ethernet switching infrastructure from Brocade at its facilities in India to improve application and network performance. These issues that Omega experienced with its legacy networking infrastructure had been causing frustration among the staff and adversely impacted employee satisfaction, leading to high attrition, company officials said. After an exhaustive evaluation process, Omega selected the Brocade BigIron RX for their network core and the Brocade FastIron Series switches to extend Power over Ethernet (PoE) at their network edge. This resulted in significantly faster application response times and screen refresh rates on the thousands of networked devices that access Omega’s campus-wide LAN. Read More… Group Healthcare premiums to see a further surge: Towers Watson survey A survey by Towers Watson has indicated a steady rise in the range of 15% to 25% in healthcare premiums, even as life insurance premiums are easing. The rise in healthcare premium cost is attributed to high claims to premium ratio of more than 100%, which the study has observed in 55% of the companies surveyed. As per the recent survey on Healthcare Trends 2010 by Towers Watson, a global multi-practice consultancy, all respondent companies with claim costs between 125% to 150% faced premium increase to the extent of 25% to 50% this year as against only 9% last year. One of the key drivers of healthcare costs is medical advancement and technology. Read More… Ranbaxy to market 4 Daiichi Sankyo products in Singapore Daiichi Sankyo Company Limited (hereafter, Daiichi Sankyo) and Ranbaxy Laboratories Limited (hereafter, Ranbaxy) today announced the start of synergistic initiative to leverage Ranbaxy’s presence in Singapore to market innovative products originally discovered by Daiichi Sankyo. Effective March 1, 2011, Ranbaxy will market four products of Daiichi Sankyo origin, including Cravit (levofloxacin) tab and Cravit IV in Singapore. The products were previously commercialized by Kyowa Hakko Bio Singapore Pte Ltd (hereafter, Kyowa Hakko Bio) in the country. Early this year, Daiichi Sankyo and Kyowa Hakko Bio had agreed to transfer the marketing rights of the products from Kyowa Hakko Bio to Ranbaxy. Read More…

Yearly Industry Newsletter

17 of 118

Amrutanjan Health Care enters into agreement with Siva's Soft Drink Cipla launches 'No Touch Breast Scan' in India

Cipla, one of the leading pharmaceutical companies from India, launched a breakthrough screening technology in India today called the ‘No Touch Breast Scan (NTBS);’ the first-ever painless, non-invasive and radiation-free breast scanning technique for detecting breast cancer at an early stage. As of today, 1 in every 22 women in India is expected to be diagnosed with breast cancer in their lifetime. Dr. Shekhar Kulkarni, Consultant Breast Cancer Surgeon, Magnolia Breast Surgery Clinic, Pune said, “Breast cancer is rising rapidly among urban women and is now the most common cancer in cities such as Mumbai and Delhi. Unfortunately most cancers are diagnosed when the disease is advanced leading to low chances of

cure. Although Mammography has been available for years it is not used that widely. There are many reasons for it such as lack of awareness, pain and discomfort during the procedure and a concern about repeated exposure to radiation. Welcoming the introduction of NTBS in India, Dr. Rakesh Sinha, Consultant Gynaecologist Surgeon, BEAMS Hospital, Mumbai said, “The No-Touch Breast scan is a painless option for women who wish to get themselves regularly screened. It is of particular use in younger women who have dense breasts and mammography is inconclusive. If a woman shows changes on the NTBS then she is sent for further investigation which includes mammography, sonography etc. At BEAMS Mumbai, of the 41 patients who have undergone the NTBS test, only 1 had to be referred for mammography.” LifeCell brings Menstrual Blood stem cell banking to India Marking the 100th International Women’s Day celebration as a yet another remarkable milestone, LifeCell International, pioneers in stem cell banking, today launched LifeCell Femme- Menstrual blood stem cell banking service in India. LifeCell is the first and only company offering menstrual blood stem cell banking in India and the launch of this break-through technology reinstates LifeCell’s pioneering and leadership positioning in the industry. Menstrual blood banking has been pioneered by Cryo-Cell International, USA who are the technology partners of LifeCell and have been offering this service in other countries under the brand C’elle. Read More... Dr Reddy's to launch 3 new drugs in US market: report

Dr Reddy's Laboratories is reportedly planning to launch three new drugs in the US market next fiscal. The report stated that the company may launch Rivastigmine, an anti-mild-to-moderate Alzheimer's drug, Desloratadine, used to treat allergies and Pseudoephedrine, a nasal/sinus decongestant. Dr Reddy's inked agreements in 2009 with Schering and Sepracor of the USA, will allow the

Indian drug-maker to manufacture and market generic versions of Desloratadine, beginning 2012, says report.

Yearly Industry Newsletter

18 of 118

Beams Hospitals opens new centre at Bengaluru Beams Hospitals, a name synonymous with the revolutionary science of minimal access surgery in Mumbai, has launched its new centre at Bengaluru today. Backed by expertise spanning over 15 years, Beams Hospitals is India’s foremost chain of surgery centres dedicated to Minimal Access Surgery (MAS) procedures founded in 1994 by Dr.Manju and Dr.Rakesh Sinha. Bengaluru is the 5th

Beams centre to be launched in India after successful operations in Mumbai, Amritsar, Indore and Hyderabad. Read More… Global Hospitals gains recognition for liver diseases Global Hospitals Group, the fastest growing tertiary care multi super specialty chain of hospitals in India with the largest multi organ transplantation centre, today updated that it has achieved the unique distinction of becoming the foremost hospital in the world for performing the widest variety of liver transplantations apart from treating all types of liver diseases. The Group announced that with the most comprehensive liver diseases & transplantation services on offer and with the one of the largest team of Specialists, it is now able to perform nearly 100 liver transplantations during a calendar year and it is expected to reach a number of 250-300 Liver transplants a year in the next 2 years. The Hospital today routinely performs split liver, auxiliary liver, living donor, cadaver liver transplantations. Read More… Ipca Labs SEZ Indore unit gets UK-MHRA approval Ipca Laboratories Ltd has announced that the Company's new formulations manufacturing unit situated at Pharma zone, SEZ Indore, Pithampur, Madhya Pradesh has been inspected and certified that it complies with the principles and guidelines of Good Manufacturing Practices laid down in the directives by the Medicines and Healthcare Products Regulatory Agency (MHRA), U.K. It is the fourth manufacturing unit of the Company to have received such approval from MHRA, U.K. Culling of birds ordered in state poultry farm of Agartala H5 strains of Avian Influenza have been confirmed in the poultry samples collected from State Poultry Farm, Gandhigram, Agartala, Tripura. The samples collected from the infected site were forwarded to the ERDDL, Kolkata and High Security Animal Disease Laboratory (HSADL), Bhopal for testing. The test conducted at both the laboratories confirmed that the samples from State Poultry Farm are positive for H5 strain of Avian Influenza. It has been decided to immediately commence the culling of birds and destruction of eggs and feed material etc. so as to control further spread of the disease without loss of time. It has also been decided that the entire poultry will be culled within a radius of 3 kms. of the focus of infection viz. State Poultry Farm, Gandhigram, Agartala. In addition to the culling strategy, surveillance will be carried out over a further radius up to 10 kilometers. Surveillance throughout the State is being intensified to monitor further spread of infection, if any. State Government has been asked to furnish a daily report on the control and containment operations to the Department of Animal Husbandry, Dairying and Fisheries in the Ministry of Agriculture. The Centre has advised that a series of strategic actions are required to be taken immediately in the above area by the Animal Husbandry and Public Health Departments. These include declaration of infected and surveillance areas, ban on movement of poultry and its products in the infected area/closure of poultry and egg markets and shops within a radius of 10 kms. from the infected site, ban on movement of farm personnel, restricting

Yearly Industry Newsletter

19 of 118

access to wild and stray birds; restricting access to the infected premises; destruction of birds; disposal of dead birds and infected materials; clean-up and disinfection followed by sealing of the premises and issue of sanitization certificate; post operations surveillance; imposition of legislative measures etc. along with necessary measures laid down in the Contingency Plan (2005) of the Ministry of Health and Family Welfare, Government of India. As regards compensation for loss of poultry on account of culling and destruction of birds, the rate for payment of compensation has been been indicated to the State Governments. The Government of India has conveyed the decision to share costs of compensation on 50:50 basis with the State Governments and authorized State Governments to utilize funds available with them under the programme of ‘Assistance to States for Control of Animal Disease’ (ASCAD), which is a Centrally Sponsored Scheme. The payment of compensation should be ensured immediately and simultaneously to culling. International Organizations will be notified by the Government of India at its level. Chemical leak at Shasun Pharmaceuticals factory Shasun Pharmaceuticals Ltd has announced that there was chemical leak in the stores area at the Company's Cuddalore factory on March 07, 2011 night which has been controlled. The production in the factory has been stopped on the direction of the government authorities. The Company is doing the needful to resume the operations at the earliest. NPPA hikes prices of 62 drugs The National Pharmaceutical Pricing Authority (NPPA) has reportedly increased the prices of 62 drugs, which are mainly based on indigenously manufactured insulin, giving a fillip to domestic firms. According to the reports, the drug price regulator has also reduced prices of 14 drugs, while that of 21 drugs remained unchanged in its latest review meeting held last week. The majority of the drugs, whose prices have been increased, are used in treatment of diabetes and tuberculosis. S M Jharwal, NPPA Chairman was quoted as saying, "We have to do a balancing act and provide a level playing field to the indigenous manufacturers who account for nearly 10 per cent of the total domestic market for insulin". Read More… Lupin to donate Yen 10mn for Japan's earthquake victims

In the wake of the recent earthquake and tsunami that hit the coastal regions of Japan, affecting the lives of hundreds, Kyowa Yakuhin, Pharma major, Lupin Ltd’s Japanese subsidiary, has announced that it would be donating Yen 10 mn to the Japanese Red Cross, apart from donations in the form of medicines. Commenting on the same, Vinod Dhawan, President, AAMLA

& Business Development, Lupin Ltd. said, "This is indeed an unprecedented event and our heart goes out to all those afflicted. Read More… Fortis Healthcare ties up with TotipotentRX

Fortis Healthcare (India) Ltd, India’s fastest growing hospital network and TotipotentRX Cell Therapy Pvt. Ltd, a leading provider of cutting-edge technologies in the stem cell and regenerative medicine market, announced a collaboration to set up centres of excellence offering cellular therapies and stem cell clinical trials, across select Fortis hospitals. These

Yearly Industry Newsletter

20 of 118

centres will undertake stem cell clinical research procedures relating to diabetes, cancer, cardiovascular disease, and neurological ischemia. TotipotentRX will also set up state-of-the-art cGMP laboratories in select hospitals, for processing stem cells before transplantation to patients. Read More… Venus Remedies to receive GCC approval to market its products Panchkula based Venus Remedies Limited, an existing Eu-GMP certified Pharmaceutical manufacturing company, has once again achieved a very significant landmark in its list of achievements. It has now been awarded the company registration from GCC (Gulf Cooperation Council). This approval holds significance and is prestigious as such registrations are obtained by the manufacturing facilities which meet world class standards and where quality is of the prime essence. On the occasion, Chairman cum Managing Director of Venus Remedies Limited Mr. Pawan Chaudhary said, “With this prestigious grant Venus Remedies will strengthen its footmark in GCC pharmaceutical market and will enhance its revenues by 10% per cent by 2013.” Read More… Wockhardt creditors can seek provisional liquidator: report Wockhardt Ltd. creditors can apply to the Bombay High Court to appoint a provisional liquidator after the court admitted a winding-up petition against the drug maker, says a report. Janak Dwarkadas, lawyer , was quoted a saying "A group of three bond holders, including U S hedge fund QVT Financial LP, filed the petition, seeking to recover their investments of Rs. 6.34 bn ($140 mn) through the sale of the company’s assets." Wockhardt can appeal the court’s decision to accept the petition, adds a report. MS Dhoni to promote digestive tonic Zandu Pancharishta

The Rs. 1100 cr. Emami Limited makers of Boroplus, Fair and Handsome, Zandu Balm and Navratna have announced the appointment of the Indian cricket team captain Mahendra Singh Dhoni to endorse its over-the-counter digestive tonic Zandu Pancharishta. He will join the galaxy of superstars associated with the Emami range of products, including Kareena Kapoor, Preity

Zinta, Bollywood Kings Amitabh Bachchan and Shah Rukh Khan. MS Dhoni also endorses the company’s latest initiative of Healthy and Tasty edible oil. Emami’s new promotion drive for Zandu Pancharishta will include print and radio campaign along with a six series television commercial featuring Dhoni. Adi Pocha's Squirkle Productions has won the creative mandate for the campaign, which will hit the screens soon. Talwalkars Better Value Fitness opens new health clubs in Kota, Ujjain and Pune Talwalkars Better Value Fitness Ltd., country's largest chain of health clubs has opened its new health clubs in the cities of Kota, Ujjain and Pune (Kothrud) as it's 93rd, 94th and 95th health club. With this, the Company now has 95 health clubs in 46 towns across India on a consolidated basis. MV Hospital organizes 'DRC Gold Medal Oration award' M.V. Hospital for Diabetes, Royapuram, Chennai the most renowned name for Diabetes and Diabetes Research in South India, organized the 20th edition of DRC Gold Medal Oration award. In 1988, late Prof M Viswanathan as the President of Diabetes Research centre has instituted the DRC Gold Medal Oration Award. This award is conferred every year on a distinguished Scientist from the field of medicine and another award Prof. M.Viswanathan Gold Medal Oration Award has been instituted by the Scientific Committee of

Yearly Industry Newsletter

21 of 118

the DRC honoring a distinguished doctor and it is conferred every year along with DRC Gold Medal. His Excellency, the Governor of Tamil Nadu, Surjit Singh Barnala, gave away the “Lifetime Achievement Award” to Dr. S.S.Badrinath, Chairman Emeritus, Sankara Nethralaya for the pioneering work done in the field of eye care. In his address Dr. Vijay Viswanathan, Managing Director, M.V. Hospital for Diabetes, Royapuram, Chennai said that the M.V.Hospital for Diabetes has been developing partnerships with the region in order to achieve the WHO’s action plan to prevent and control non communicable diseases. He mentioned about the partnerships with CBSE to reduce the childhood obesity and the partnership with the Govt. of Tamilnadu to train the doctors in diabetes prevention. He also mentioned that over 2000 doctors have been trained all over the country in prevention of diabetes and its complications. In Prof M Viswanathan Gold Medal oration 2010 Dr. Shanthi Mendis, Coordinator of the Cardiovascular Program and Global Program for Prevention and Management of Non Communicable Diseases, World Health Organization, Geneva, said, “India is fast becoming the diabetes capital in the world, with an increasing number of diabetic patients. It has been estimated that India has more than 50 mn people with diabetes in 2010, which is expected to rise to over 85 mn by 2030. JHS Svendgaard unveils preferential issue to Tano Mauritius JHS Svendgaard Laboratories Ltd. said that its Board of Directors at its meeting held on March 12, has decided to undertake a preferential allotment of 25,00,000 shares to Tano Mauritius India FVCI at Rs. 97.75. The preferential allotment in accordance with the SEBI (Issue of Capital and Disclosure Requirements) Regulations, 2009, Companies Act, 1956, and other applicable rules and regulations. The Company's Board has also approved the notice of the Extraordinary General Meeting which is scheduled to be held on April 9, to get the necessary shareholders' approval. Lupin to donate Yen 10mn for Japan's quake victims In the wake of the recent earthquake and tsunami that hit the coastal regions of Japan, affecting the lives of hundreds, Kyowa Yakuhin, Pharma major, Lupin Ltd’s Japanese subsidiary, has announced that it would be donating Yen 10 million to the Japanese Red Cross, apart from donations in the form of medicines. Commenting on the same, Mr. Vinod Dhawan, President, AAMLA & Business Development, Lupin Ltd. said, "This is indeed an unprecedented event and our heart goes out to all those afflicted. The human loss that this calamity has caused is truly shocking and we are deeply saddened by the extent of the damage caused by the disaster and have taken a small step forward to extend our support and solidarity with the Japanese people. We offer our full support and any help that authorities might require in relief operations and we will do as much as we can to help the disaster victims.” Lupin’s subsidiary Kyowa Yakuhin, located in Sanda, Japan has remained unaffected and all 355 personnel are safe. Kyowa is one of the largest generic players in the neurology segment and is amongst the fastest growing generic pharmaceutical companies in Japan today. Govt withdraws service tax on healthcare The Government withdrew the 5% service tax on healthcare services introduced in this year's Union Budget amid strong protests from several quarters. Finance Minister Pranab Mukherjee made the announcement in his reply to the debate on the Finance Bill in the Lok Sabha. In his Budget speech on Feb. 28, the Finance Minister had proposed a 5% service tax on air-conditioned hospitals with more than 25 beds and on diagnostic services. "The purpose of the new levy was not merely to mobilise revenue, but to pave the way for introduction of the GST. However, I have decided to exempt the new levy in its entirety both in respect of services provided by hospitals

Yearly Industry Newsletter

22 of 118

as well as by way of diagnostic tests until GST comes into force", Mukherjee said. He hoped that it will no more be called "misery tax". The announcement was made while moving the Finance Bill in the Lok Sabha. Bill and Melinda Gates visit health and development partners Bill and Melinda Gates will meet policy makers, non-government partners, business and community leaders, and public health figures in a visit to India this week to explore ways to build on achievements in health and development and tackle the significant burden of disease that still exists. “We are proud to partner with India because its innovative approaches are saving and improving lives every day,” said Gates. Yet, despite remarkable achievements, India endures some of the greatest health and development burdens in the world.” Read More… Bill & Melinda Gates call on Ghulam Nabi Azad Bill and Melinda Gates today called on the Union Health Minister Ghulam Nabi Azad. Issues relating to Immunization programme, Pentavalent vaccine, Polio vaccination efforts, HIV control and capacity building were discussed during the meeting held in Ministry of Health and Family Welfare. Ranbaxy stock falls as Mylan sues USFDA on Lipitor Ranbaxy shares slipped after reports emerged that US-based Mylan Laboratories has dragged the US Food and Drug Administration (USFDA) to court in a bid to block attempts by the Indian company to launch a generic copy of Lipitor in the American market. In a complaint filed March 18 in a district court in Washington, Mylan said that it and other generic-drug makers should be allowed to enter the market as soon as a patent expires. Ranbaxy had reached an agreement with Pfizer in 2008 to sell copies of the world’s best-selling medicine beginning November 2011. The Indian company, now owned by Japan's Daiichi Sankyo, has said that it is entitled to 180 days of marketing exclusivity for being the first to challenge the Lipitor patents. It has not yet received final USFDA approval on its application to sell the Lipitor copy. In January this year, Mylan announced that it had entered into a settlement agreement with Pfizer to resolve litigation related to Lipitor Tablets, 10 mg, 20 mg, 40 mg and 80 mg. The medicine is generically called Atorvastatin. The agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission. Lipitor had US sales of US$7.27bn for the 12 months period ending Sept. 30, 2010, according to IMS Health. Bombay HC stays winding up petition against Wockhardt Wockhardt Ltd. said that a division bench of the Bombay High Court, granted an ad-interim relief by staying the admission of the winding up petition filed by the Trustees to the Foreign Currency Convertible Bonds (FCCBs), issued by the Company. In the meantime, the Company has agreed to deposit in Court Rs. 1.15bn by May 3, as per direction of the Bombay High Court. The company’s appeal against the petition will be heard on May 4, according to reports. Wockhardt had failed conclude arrangement to pay its FCCB holders US$110mn as per terms and went into a corporate debt restructuring (CDR) process. The petitioners - QVT Financial LP, a Singapore based hedge fund and an overseas unit of Sun Pharmaceutical Industries Ltd. - moved the court against Wockhardt in October 2010. The three investors together hold FCCBs worth US$42mn. Sun Pharma is holding FCCBs worth US$20mn issued by Wockhardt in 2004.To reduce the debt burden, Wockhardt sold the animal health care division to Vetoquinol, France and divested the business of Esparma GmbH to Mova GmbH. As at March 2010 (15 months period), Wockhardt's total borrowings stood at Rs. 40.18bn.

Yearly Industry Newsletter

23 of 118

Aurobindo gets USFDA approval for Famciclovir tablets Aurobindo Pharma Limited is pleased to announce that its tentatively approved ANDA for Famciclovir Tablets 125mg, 250mg and 500mg has received the final approval from the US Food & Drug Administration (USFDA). Famciclovir Tablets 125mg, 250mg and 500mg is the generic version of Novartis Pharmaceuticals Corp's Famvir(r) Tablets 125mg, 250mg and 500mg

and is indicated for the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients and suppression of recurrent genital herpes in immunocompetent patients. The product has a market size of approximately US$175mn for the twelve months ending September 2010 according to IMS and is ready for commercial launch. Aurobindo now has a total of 132 ANDA approvals (100 Final approvals and 32 Tentative approvals) from USFDA We thank FM for rollback of service tax on healthcare: Apollo Hospitals With great relief and sense of deep appreciation I profusely thank and congratulate the Finance Minister for the roll back of service tax on healthcare services. Access to healthcare to all and that of highest standards has been the driving force for all of us who constitute healthcare sector in India and imposition of this service tax would have been a huge deterrent to this vision. Now with this progressive move to repeal the tax, the country will see our renewed efforts to serve the nation and we will relentlessly persevere to keep all Indians in good health. The health provider network is encouraged to take the health challenges of the nation with continuous support from the Government. Publicis Groupe acquires India-based Watermelon Publicis Groupe announced today that it has agreed to acquire a majority stake in a leading healthcare advertising agency in Mumbai, India-Watermelon Healthcare Communications Private Limited ("Watermelon"). On completion of this transaction, this entity will become part of Publicis Healthcare Communications Group (PHCG) and will be renamed Publicis Life Brands Watermelon. This transaction is subject to customary local closing conditions. Read More… Ind Swift Labs gets USFDA nod for DMFs Temozolomide and Telmisartan Pharma major Ind-Swift Laboratories Ltd, which has a strong basket of over 40 products across 16 therapeutic segments, has got the USFDA nod for two more DMFs Temozolomide and Telmisartan. Besides commercially supplying four molecules to the US, the company has hitherto filed 20 DMFs with the USFDA, of which all have been approved. NR Munjal, Vice-Chairman and Managing Director of Ind-Swift Laboratories Limited, said: “The company has high regulatory standards where its facilities are already approved by USFDA/MHRA/TGA/COS/KFDA/Who-GMP, and with this approval for Temozolomide, an anti-neoplastic drug with market size of US$ 700 mn, and Telmisartan, a drug for hypertension with market size worth $1.6 bn, the company is aiming at marketing these products once they go off patent.” Read More… Bafna Pharma to acquire Johnson & Johnson's Raricap: Bafna Pharmaceuticals Ltd has signed an agreement with an affiliate of Johnson & Johnson, for acquisition of the trademark for the latter's hemoglobin drug Raricap. The transaction is expected to close in the first

Yearly Industry Newsletter

24 of 118

week of April. The brand "RARICAP" has a legacy of over 40 years in the market. It is prescribed for iron deficiency anemia in pregnancy. Glenmark Generics gets USFDA nod for Norethindrone and Ethinyl Estradiol Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd has announced they have been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (U.S. FDA) for Norethindrone and Ethinyl Estradiol, USP 0.4 mg/0.035 mg tablets, their generic version of Ovcon 35 tablets by Warner Chilcott, Inc. The product will be marketed under the trade name Briellyn and distribution is expected to start immediately. Briellyn provides a continuous 28 day regimen for oral contraception derived from 21 tablets composed of Norethindrone and Ethinyl Estradiol to be followed by 7 inert tablets and is indicated for the prevention of pregnancy. According to IMS Health for the 12 month period ending December 2010, this combination achieved sales of USD30mn. Read More… Revised national TB control programme announces its new objectives, 2011 Having achieved globalobjectives of new case-detection of 70% and treatment success rate of 85% forthe last three consecutive years, the RevisedNational Tuberculosis Control Programme (RNTCP), has announced its new objective of Universal Access to QualityTB care for all TB patients. The intermediate target is to detect 90% ofall TB cases and successfully treat 90% of them by 2015. Hospital services, diagnostics tests exempted from service tax The Union Finance Minister Pranab Mukherjee has proposed to enhance the abatement from 40% to 55% of the Retail Sale Price for the Small Scale Industries (SSI) Garment Manufacturers. With this relief, a unit would continue to be eligible for SSI exemption in 2011-12, even if it had a turnover based on Retail Sale Price of Rs. 8.9 crore in the current year. The necessary notification in this regard will be issued in due course. This was announced by the Union Finance Minister while initiating the discussion on the Finance Bill 2011-12 in the Lok Sabha. ASSOCHAM welcomes relief to healthcare Apex chamber ASSOCHAM welcomed finance minister Pranab Mukherjee’s withdrawal of the proposed five per cent service tax on airconditioned hospitals with more than 25 beds and on diagonistic services. The service tax on healthcare would have hurt the common man, said ASSOCHAM’s secretary general D.S. Rawat. “We greatly appreciate the finance minister’s decision to rollback the proposed service tax. This will help quality-oriented healthcare and diagnostics companies to render services to patients at lower costs.” Khazanah acquires stake in Apollo Hospitals: report Integrated (Mauritius) Healthcare Holdings, an arm of Khazanah Nasional Bhd, has acquired 8.82% stake in corporate hospital chain Apollo Hospitals from Bisikan Bayu Investments, another arm of the Malaysian sovereign fund, for Rs. 4.7bn, according to a report.

Yearly Industry Newsletter

25 of 118

International News - March 2011 Daiichi Sankyo to buy US drug firm Plexxikon for US$805mn: report Japanese drug-maker Daiichi Sankyo Company has reportedly said that it will buy US-based pharmaceutical firm Plexxikon Inc for US$ 805 mn. According to reports, the acquisition is subject to anti-trust approval in the US, whereby the acquisition will help the Japanese firm obtain certain co-promotion rights in the US for late-stage cancer drug PLX4032, which is being jointly developed by Plexxikon and Roche. In addition, Daiichi will make additional payments totalling about US$ 130 mn based on near-term launch milestones with respect to the PLX4032 drug, adds a report. Fujifilm to buy Merck's biotech-drug makers: report Fujifilm reportedly said it would buy US and British biopharmaceutical companies from America's Merck for a reported half a billion dollars. According to reports, the Japanese film and camera maker said that it would buy all shares of Diosynth RTP Inc. of the United States and of Britain's MSD Biologics Ltd. from Merck, without disclosing the purchase price. Ventas to acquire Nationwide Health Properties Ventas, Inc. and Nationwide Health Properties, Inc. announced that the Boards of Directors of both companies have unanimously approved a definitive agreement under which Ventas will acquire all of the outstanding shares of NHP in a stock-for-stock transaction valued at $7.4 billion, creating one of the largest publicly traded REITs and the leading healthcare REIT by equity value. Under the terms of the agreement, NHP shareholders will receive a fixed exchange ratio of 0.7866 Ventas shares for each share of NHP common stock they own. Based on the closing stock price for Ventas on Friday, February 25, 2011, this consideration would be equivalent to $44.99 of Ventas stock for each NHP share, representing a premium to NHP shareholders of approximately 15% over NHP’s closing stock price on that day. Upon closing of the transaction, Ventas shareholders are expected to own approximately 65% and NHP shareholders are expected to own approximately 35% of the combined company. Japan suspends use of Pfizer, Sanofi vaccines after 4 deaths: reports Japan’s health ministry has reportedly suspended the use of pediatric vaccines made by Pfizer Inc. (PFE) and Sanofi- Aventis SA, after reports of four deaths following immunizations. According to reports, the temporary suspension is a precautionary measure following the deaths of four children who had previously been immunized simultaneously with several pediatric vaccines. Victor Carey, Medical Director, Sanofi’s vaccines was quoted as saying that "No causal relationship has been established between immunization and these fatalities, but an investigation is under way, which we’re fully cooperating with." More than 200 mn doses of ActHIB have been given to children in more than 120 countries, according to Paris-based Sanofi, adds a report. FACTBOX-Global pharma to push cash into Russia: report Genzyme (GENZ.O) is reportedly planning for a joint venture with Russian high-tech centre ChemRar to pave way for growing drugmakers seeking to gain a local presence. According to reports, establishing a foothold is a way for international drug companies to secure guaranteed sales in Russia, which wants to reduce dependence on imported drugs, and global drugmakers are expected to invest over $1 bn. These international pharmaceuticals producers that have existing facilities in Russia, are eyeing to set up local manufacturing sites, or are considering such a move, adds a report

Yearly Industry Newsletter

26 of 118

Domestic News - April 2011 Sun Pharma forms JV with Merck Merck & Co., Inc, a global health care leader, known as MSD outside the United States and Canada, and Sun Pharmaceutical Industries Ltd has announced the creation of a joint venture to develop, manufacture and commercialize new combinations and formulations of incrementally innovative, branded generics in the Emerging Markets. The partnership combines Sun Pharma's proven track record of leadership and expertise in rapid, innovative product development using Sun Pharma Advanced Research Company Ltd's ("SPARC") proprietary platform technologies, and Sun Pharma’s world-class manufacturing network with Merck's clinical development and registration expertise and a broad, geographic commercial footprint. The companies said that they will focus on 'innovative branded generics,' that bring together combinations of medicines using platform delivery technologies designed to enhance convenience for patients in Emerging Markets. Dr. Reddy’s launches OTC Fexofenadine HCl tablets Dr. Reddy’s Laboratories has launched its over-the-counter (OTC) Fexofenadine HCl tablets on April 13, 2011. The Food & Drug Administration (FDA) approved Dr. Reddy’s Abbreviated New Drug Application (ANDA) for Fexofenadine HCl tablets on April 12, 2011. Dr. Reddy’s will market the product under store brand labels in the U.S. market. The products are bioequivalent versions of sanofi-aventis’ Allegra® tablets which received Rx-to-OTC switch approval from the FDA on January 24th, 2011. The Fexofenadine HCl Rx market had brand and generic sales of approximately $452 million for the twelve months ending December 31, 2010 according to IMS Health. Lupin files suit against Ranbaxy on Fenofibrate launch: report Lupin Ltd has filed a second suit in the US against Ranbaxy Laboratories to prevent the from launching fenofibrate, a generic version of Lupin's cholesterol lowering drug Antara in the US, according to a report. The report stated that Lupin earlier sued Ranbaxy after the Gurgaon-based drugmaker, now owned by Japan's Daiichi Sankyo, sought marketing approval from the American drug regulator to sell fenofibrate capsules in 43 mg and 130 mg in the US. Glenmark Pharma enters into agreement with IDC Glenmark Pharmaceuticals, a leading player in dermatology and drug discovery has entered into an exclusive arrangement with Immanence-IDC, a leading Canadian company for the distribution of their high-end anti-aging cosmeceutical range of products. The agreement will span across eight operating countries for Glenmark. The countries are India, Brazil, Mexico, South Africa, Egypt, Vietnam, Malaysia and Thailand. This will mark Glenmark’s presence in this fast growing specialised dermatology segment which is growing at a rapid pace across emerging economies.This ten year agreement with Glenmark will open new markets for us, and through a network of more than 150,000 dermatologists, will allow us to reach more than 1.5 billion people. We are honored that a global leader in dermatology has recognized the science and quality behind our antiage care products, as well as our innovative approach.” stated Dr. Éric Dupont, PhD, Chairman of the Board at Immanence IDC. Divis Labs denies plan to buy US biotech firm Divis Laboratories Ltd has clarified that there are no plans or discussions or negotiations to acquire any biotech company or of any fund raising. Earlier the reports stated that Divi's Labs is looking to acquire US Biotech companies.

Yearly Industry Newsletter

27 of 118

International News - April 2011 Pfizer sells capsule-making Capsugel for $2.4 bn: report Pfizer, the world's biggest pharmaceuticals company has agreed to sell capsule-maker unit Capsugel to private-equity firm KKR for about US$2.4 bn in cash, according to a report. The report stated that the sale would be used to buy back stock in addition to the previously announced repurchase program of about $5 bn planned for 2011. Pfizer has reportedly said that the transaction was expected to close during the third quarter, subject to approval from US, European Union and other regulators. China NT Pharma plans to raise upto US$275 mn via IPO: report AstraZeneca gets FDA approval for vandetanib: report Pfizer gets FDA refusal-to-file for Tafamidis: report Merck to buy Inspire for US$430mn: report Cephalon rejects Valeant takeover offer: report Sanofi-Aventis completes offer for Genzyme

Yearly Industry Newsletter

28 of 118

Domestic News - May 2011 Lupin Pharma mulling another acquisition: report Lupin Pharmaceuticals is planning for another acquisition for US$50-100 mn in Japan, according to a report. The report stated that the through this buyout, company aims to achieve a 20% rise in revenue next financial year. The company is targeting cardiovascular, central nervous system (CNS), and gynecology space. Glenmark Pharma appoints Gracias Saldanha as Chairman Glenmark Pharmaceuticals Ltd has announced that the Board of Directors of the Company at their meeting held on May 10, 2011, has announced the following changes to the Board effective from May 10, 2011: Gracias Saldanha, Chairman has stepped down as the Chairman of the Board of Directors and has been re-designated as Founder & Chairman Emeritus. Glenn Saldanha, has been appointed as the Chairman of the Board in addition to his responsibilities as MD of the Company. A. S. Mohanty ceases to be a director of the Company. Hinduja Hospital celebrates International Nurses Day Marking the birth anniversary of Florence Nightingale, International Nurses Day is celebrated around the world every May 12. With nursing being the cutting edge of the Health Care industry today, Hinduja Hospital celebrates International Nurses Day to re enforce all the valuable, selfless contributions nurses make to the society. Sumita Bajaj, RNRM, Registered Nurse along with Mrs. Shreedevi Balachandran, Clinical Instructor will conduct a 3 day in house nursing workshop which will address around 400 nurses at Hinduja Hospital. The workshop will cover topics like Nursing in Hinduja Hospital over 60 years, Home care Nursing - A new perspective, Innovative ideas towards maintaining quality in nursing, best practices in ICU/PICU/NICU/EICU. Nursing in India versus that of Abroad will also be discussed with regards to Quality assurance in ICU, Best Practices in Operation Theatres and Peri- operative protocols in Cardiac surgery - A nursing perspective in Critical Care…Read More Sandvik launches Medical Technology Division in India Sandvik Asia, the Indian subsidiary of the US $13billion Sandvik AB of Sweden today announced the launch of the Medical Technology Division in India. Addressing media persons at the launch here today, Hakan Kingstedt, Managing Director and President, Sandvik Asia said: “To address the future growth in medical devices in India, Sandvik will offer premium quality raw material & manufacturing services for medical device OEM customers.” Stephen Cowen, Global Head, Sales and Marketing, Sandvik MedTech said: “India is an important market to Sandvik. Considering the future growth in medical devices here, Sandvik has taken the first step to set up and establish operations, in both sales & manufacturing. This set up gears up Sandvik to be ready to meet the growth of medical devices in India. We have established a R&D center in Pune, first time out of Sweden. Sandvik will strive, additionally, to work for further improvements in materials and products for medical devices in partnership with Medical OEMs.” Glenmark inks licensing deal for GBR 500 with Sanofi Glenmark Pharmaceuticals Ltd has entered into agreement with Sanofi to grant Sanofi a license for the development and commercialization of GBR 500,a novel monoclonal antibody for the treatment of Crohn's Disease and other inflammatory conditions.The transaction is expected to close in the coming month subject to customary closing conditions,including the expiration or early termination of the waiting period under the Hart-scott-Rodino Antitrust Improvements Act.

Yearly Industry Newsletter

29 of 118

Glenmark is likely to receive an upfront payment of US$50mn, of which US$25mn will be paid upon closing of the transaction and US$25mn , which is contingent upon Sanofi's positive assessment of certain data to be provided by Glenmark. The total of these payments could reach US$613mn.Sanofi will have exclusive marketing rights for North America, Europe, Japan, Argentina, Chile, and Uruguray. Phase 1 of testing for GBR 500 is already completed and Phase 2 will begin as soon as the deal is completed, said CEO Glenn Saldanha. CEO Glenn Saldanha tadded, "The company has six different molecules under different stages of development, including GBR 401, GBR 600, GBR 900. GVK Biosciences is preferred provider to global health Product Development Partners Consortium GVK Biosciences has been selected as a preferred provider to a consortium of 14 global Product Development Partners (PDPs) for clinical services in Asia. GVK BIO is the only partner that is headquartered in India. The PDPs, funded in part by the Bill and Melinda Gates Foundation are not-for-profit entities focused on developing new interventions for diseases that are often neglected by mainstream pharmaceutical and biotech companies, such as tuberculosis, malaria, kala-azar, HIV/AIDS, childhood pneumonia, and diarrheal diseases. Collectively the 14 PDPs anticipate funding 85 clinical trials in the developing world over the next two years and India features as a key developing world country. Transgene Biotek to commence commercial production of another API - DMA Transgene Biotek has succeeded in completing the technology development for another Biopharmaceutical product - DHA, a product in high demand Tor neutraceutieal and pharmaceutical formulations. The company has completed the production of this product in pilot batches and now, plan to commence the commercial production shortly at a iSiircl party facility having large fermentation infrastructure. DMA (Docosalicxacnoic acid) and EHA (Eicosapentaenoic acid are Omega-3 fatty acids, essential for tlie proper functioning of our brains as adults, and for the development of our nervous system and visual abilities during the first 6 months of life. In addition, omega-3 fatty acids are found to reduce heart disease and help in lowering triglycerides (fats in the blood) and loner blood pressure. DHA, an omega-3 rally acid is used as supplement in functional foods, food ingredients, beverages, neutraceuticals, nutritional oils, cosmaccuticals, consumer health care products, animal feed, and pharmaceutical industries. The market for Omega-3 fatty acids (DHA/EHA) was estimated at over US$2bn (2007), according to Scientia Advisors which since then grew 42% in 2009, according to market researcher Nielsen. With lot of emerging scientific evidence demonstrating the health benefits of DHA/ EPA and consumer awareness, the market is expected to drive >60% growth in the coming years, according to a recent Frost & Sullivan report (2010). Demand is projected lo outstrip available supply. Synefra E&C bags contract for super specialty hospital Pune’s leading Integrated Infrastructure Solutions’ provider Synefra Engineering & Construction Ltd – A Tanti Group Company, has bagged a major EPC order in South India. It will construct a super specialty hospital in Dharwad and the project is to be completed in 17 calendar months (by August 2012). It is valued at Rs. 21.05 crores and Synefra’s scope would cover civil, structural and architectural work. Awarded by Dharmasthala Manjunatheshwara College of Medical Sciences & Hospital, the contract involves construction of a 350 bed hospital with a total built up area of 3, 25,000 sqft. which will offer super-specialty services in the disciplines of Cardiology, Cardio Thoracic Surgery, Neurology, Neuro Surgery and Plastic Surgery to the population of Hubli-Dharwad and surrounding areas. The building when completed will accommodate 8 spacious operation theatres

Yearly Industry Newsletter

30 of 118

conforming to the modern principles of hospital planning; 100 intensive care beds to provide care for the patients admitted under the above specialties; three well designed cardiac catheterization labs; inpatient wards in combination of suite rooms, special rooms and general wards. An auditorium with 250 seating capacity and four classrooms with seating of 60 each have been included in the hospital building to support the academic activities of the institution. Commenting on the occasion, Sanjeev Nakhasi, Vice President - Operations, Synefra E&C said, “Synefra's experience, expertise in sustainable development and excellence towards an integrated approach has been a key to winning this deal. This project will provide us an opportunity to demonstrate our skills for highly specialized requirements at this Super specialty hospital. Synefra shall deploy cost effective measures and efficient technologies, state of the art tools & machinery apart from skilled resources to complete the project on time. We are confident to attract more such projects in South India in near future.” Synefra has proposed a comprehensive, cost effective approach plan enabling sustainable infrastructure development with limited resources. As the demand for super specialty hospitals is very high and is increasing with time, this project will be immensely welcomed by the people. SC upholds HC order restraining Cadila from selling 'Hb tone': reports The Supreme Court refused to vacate the Bombay High Court order, which restrained Cadila Healthcare from making and selling hemoglobin enhancing drug 'Hb Tone' for trade mark infringement, as alleged by a local manufacturer, according to reports. A vacation bench comprising justices GS Singhvi and Chandramauli Prasad said that the interim order passed by the High Court against Cadila was "well reasoned and there was no need to interfere with it". It, however, directed the High Court to decide soon on the main suit, pending before for six years, reports stated. Cadila, India's fifth largest pharma firm, was restrained by a single member bench of the Bombay High Court in 2006, which directed the Ahmadabad-based firm to stop all activities of manufacturing, selling and exporting under 'Hb Tone' trade mark till the pendency of the suit, said reports. The interim order was challenged by Cadila before a division bench, which in April upheld the order. It, then, moved the apex court, which has also denied it any relief, added reports. Glenmark confirms settlement for Hydrocortisone Butyrate Glenmark Pharmaceuticals Limited and Glenmark Generics Inc., USA (“Glenmark”) have entered into a settlement and license agreement with Triax Pharmaceuticals, LLC, Astellas Pharma Europe B.V. and Astellas Pharma International B.V. (“Astellas and Triax” ) to resolve a United States patent infringement suit related to Glenmark’s filing of an abbreviated new drug application (“ANDA”) for 0.1% hydrocortisone butyrate cream, Glenmark’s generic version of Locoid Lipocream. Subject to the terms of the settlement and license Agreement, Glenmark will be permitted to market and distribute Glenmark’s 0.1% hydrocortisone butyrate cream under a royalty-bearing license from Astellas and Triax in the United States near the end of 2013. Glenmark believes that it is entitled to 180 days of exclusivity with respect to its hydrocortisone butyrate cream, as the first generic company to file an ANDA for the product. Locoid Lipocream is available as a 0.1% hydrocortisone butyrate topical corticosteroid cream. According to IMS Health data, for 2010, Locoid Lipocream achieved sales of approximately USD 38 mn. Workers of Shasun Pharma call off strike Shasun Pharmaceuticals Ltd has said that an amicable settlement has been reached with the workers at the Company's Pondicherry API Unit. The strike has been called off and operations resumed from May 25, 2011 morning.

Yearly Industry Newsletter

31 of 118

Aurobindo Pharma receives warning from USFDA Aurobindo Pharma stated that in continuation to its press release dated 23rd February for the US Food & Drug Administration (USFDA) action on Unit VI, the company has received the Warning Letter from the American regulator detailing their observations. In addition, based on a field alert report for packaging and labeling compliance for unit III, the USFDA has also asked for submission of a detailed action plan for improvement in this letter. This is required to be submitted within 15 working days and the USFDA has also given an opportunity for regulatory meeting at their office. The company is requesting the USFDA for the meeting date as well as in the process of submitting a detailed action plan. Aurobindo Pharma had earlier received an import alert in February this year from the USFDA for its cephalosporin-producing Unit VI located at Chitkul Village, in Hyderabad, Andhra Pradesh. The USFDA had audited Unit VI of the Hyderabad-based company in December 2010. Subsequent to the audit findings, the USFDA had imposed an import alert for detention of Unit VI products. Aanjaneya Lifecare climbs in choppy debut Shares of Aanjaneya Lifecare Ltd. surged as much as 17.5% on Friday in a rising market despite the issue not receiving a favourable response. The stock rose as high as Rs. 274.95 on the NSE after listing at Rs. 218. At 9:44 am (IST), it is trading at Rs. 250 as against the issue price of Rs. 234. Total traded quantity stood at 3.34mn shares. On the BSE, the stock opened at Rs. 229, touched a day's low of Rs. 224 before rising to a day's high of Rs. 274.95. It was last quoted at Rs. 258. The IPO was subscribed 1.11 times. The IPO received bids for 55.47 lakh shares compared with 50 lakh shares on offer. Qualified institutional buyers (QIBs) category was subscribed 0.14 times. Non institutional investors category was subscribed 2.65 times and retail portion was subscribed 1.84 times. Aanjaneya Lifecare had planned to raise up to Rs. 1.2bn by offering 50 lakh shares in a price band of Rs. 228 to Rs. 240 per share. The company plans to use the IPO proceeds for setting up facilities, product marketing and registration expenses and for other corporate purposes. Aanjaneya Lifecare is a vertically integrated pharmaceutical firm with manufacturing and marketing capabilities in active pharmaceutical ingredients (API) with focus on anti-malarial, and finished dosage forms catering to various therapeutic segments. Venus Remedies capex stands at Rs2bn: Pawan Chaudhary Pawan Chaudhary, Managing Director, Venus Remedies Ltd has stated that "Our Capex plan is approximately Rs. 2bn over the next four years. This will be funded from internal accruals and banks. The amount would be used for value addition of existing manufacturing plants, Research facilities, infrastructure, creation of CCMB Labs and patents/IPR technologies such as Multi-country clinical trials, Market launches, Dossier Development and patent filings." He added, "We have product pipeline of 25 Research Products in the segment of Anti-Cancer, Anti-Infectives and Orthopedics-related products.Revenues from international market are approx 34% of the total sales. Venus is already present in 60 countries and 5 continents across the globe and is exporting to 22 countries. Venus is promoting 52 products across the globe and so far has launched 36 products in the International Market

Yearly Industry Newsletter

32 of 118

International News - May 2011 Sparsha Pharma to launch 3 products: report Sparsha Pharma International is planning to launch three products in a couple of months, according to a report. The company have already received approval from the Drugs Controller General of India (DCGI), says report. The report stated that the company already has a product, fentanyl transdermal patch, in the market. Fentanyl is a potent synthetic narcotic analgesic with a rapid onset and short duration of action, adds report. Takeda Pharma clarifies on Nycomed acquisition Takeda Pharmaceutical Company Limited said that the company has and always will comply with the rules governing the publication of any event of material significance to our business and our shareholders. The company would like to make clear that Takeda has not agreed to any such an agreement as suggested by certain newspaper publications. In addition, Takeda has a policy of not commenting on any rumors regarding our business. Takeda is constantly seeking and evaluating opportunities to increase shareholder value and enhance our business through strategic investment, however, there is nothing that needs to be announced at this point. Takeda Pharma to buy Nycomed for US$13.6bn: reports Takeda Pharmaceutical reportedly said it will buy privately held Zurich-based rival Nycomed for 9.6 billion euros ($13.6 billion) on a cash-free, debt-free basis. The transaction to make Nycomed a wholly owned subsidiary of Takeda is expected to be completed within 90 to 120 days, subject to antitrust clearance. The purchase excludes Nycomed's U.S. dermatology business, added reports. Teva Pharma plans to acquire 57% stake in Taiyo Pharma Teva Pharmaceutical Industries Ltd has announced that it has signed a definitive agreement to acquire 57% of the shares in privately-held Taiyo Pharmaceutical Industry Co. Ltd. for $460 mn in cash paid to private shareholders. Teva will also extend an offer to purchase all remaining outstanding shares of Taiyo. This transaction gives Taiyo an enterprise value of $1.3 billion. The transaction is expected to be accretive to GAAP earnings within four quarters after closing. Taiyo is the third largest generic pharmaceutical company in Japan with sales of $530 mn in 2010. The company has one of the most comprehensive generic product portfolios in the Japanese market with over 550 generic drugs in a variety of therapeutic areas and dosage forms. Taiyo has strong presence in all major distribution channels in Japan, particularly in hospitals due to its wide range of injectable product offerings. Taiyo's marketing efforts are supported by a strong back-end with top tier production capabilities in a wide range of technologies (including sterile manufacturing) in two manufacturing facilities, as well as a strong R&D team and local regulatory expertise. Commenting on today's transaction, Shlomo Yanai, Teva's President and Chief Executive Officer, said, "This acquisition will enable Teva to deliver on our strategic objective of becoming a leading player in the fast-growing Japanese generics market. In fact, we now expect to reach our 2015 target of $1 billion in sales in Japan ahead of schedule. Taiyo's strong market reach, cutting-edge production facilities, and impressively large product portfolio, combined with Teva's scale and capabilities as the world's largest generics company, will enable us to offer a much wider range of high quality, affordable generics to a much larger segment of the Japanese market." Merck completes acquisition of Inspire Pharma Merck, known as MSD outside the United States and Canada, announced that it is has completed its acquisition of Inspire Pharmaceuticals, Inc., a specialty pharmaceutical company focused on developing and commercializing

Yearly Industry Newsletter

33 of 118

ophthalmic products, for $5.00 per share in cash. "We are excited to complete this compelling and highly complementary acquisition of Inspire," said Beverly Lybrand, senior vice president and general manager, neuroscience and ophthalmology, Merck. "The successful completion of this transaction strengthens our ophthalmology business and positions us for future growth with an expanded portfolio and a best in class commercialization organization." Effective today, Monarch Transaction Corp. a wholly-owned subsidiary of Merck, has merged with and into Inspire, with Inspire surviving as a wholly owned subsidiary of Merck. As a result of the merger, Inspire shares have ceased trading on the NASDAQ Global Market and Inspire will no longer have reporting obligations under the Securities and Exchange Act of 1934, as amended. Novartis reports positive results on canakinumab Novartis AG reported positive results from two Phase III trials of ACZ885, also know as canakinumab, in patients with severe gouty arthritis. According to reports, Novartis said the studies showed that the drug provides superior pain relief and reduced the risk of new attacks by up to 68% compared to an injectable steroid. Amylin Pharma obtains temporary restraining order against Eli Lilly Amylin Pharmaceuticals, Inc. announced that the United States District Court for the Southern District of California issued a temporary restraining order (TRO) against Eli Lilly and Company relating to its litigation with respect to the Amylin / Lilly diabetes collaboration agreement. The U.S. District Court restrained Lilly from proceeding with its plans to use the same sales force to sell both exenatide and Boehringer Ingelheim GmbH's competitive linagliptin. The court also enjoined Lilly from disclosing any confidential information about exenatide to any of its sales representatives or employees participating in the marketing, promotion or sale of linagliptin. The complete order is being filed today on Amylin's Current Report on Form 8-K with the Securities and Exchange Commission. In 2002, Amylin entered an alliance with Lilly for the global development and commercialization of exenatide, a medicine indicated as a first line treatment for type 2 diabetes that is currently marketed as BYETTA (exenatide) injection. Exenatide is also the active ingredient in BYDUREON (exenatide extended-release for injectable suspension), a once-weekly version currently under review by the FDA.

Yearly Industry Newsletter

34 of 118

Domestic News - June 2011 Govt clears new pictorial warnings for tobacco products The Union Minister for Health and Family Welfare Ghulam Nabi Azad has cleared the new pictorial warnings for implementation for tobacco products packages. The new notification issued on 27.5.2011, provides for strong pictorial warnings for smoking (cigarettes, bidis, cigars etc) and smokeless or chewing forms of tobacco products. A set of four pictures each of lung and oral cancer have been notified and will come into effect from 1.12.2011. The warnings will be rotated every two years from then onwards. In exercise of the powers conferred by sub-section (1) of section 7, sub-section (2) of section 8, section 10 and section 31 of the Cigarettes and other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003 (34 of 2003), the Central Government hereby makes the following rules further to amend the Cigarettes and other Tobacco Products (Packaging and Labelling) Rules, 2008. These Rules may be called the Cigarettes and other Tobacco Products (Packaging and Labelling) Amendment Rules, 2011. Aurobindo Pharma gets approval from US FDA for denopezil hydrochloride tablets. Aurobindo Pharma Ltd. reportedly said it had received the final approval from the US FDA for its Donepezil Hydrochloride tablets 5mg and 10mg, pertaining to ANDA No.090056 and is expected to launch soon. Donepezil Hydrochloride tablets 5mg and 10mg is the generic equivalent to Aricept tablets 5mg and 10mg of Eisai Medical Research Inc. It is used for the treatment of mild, moderate and severe dementia of the Alzheimer's type and fall under the Central Nervous System (CNS) therapeutic segment. As per IMS data, the product had a market size of around $2.5bn for the twelve months ended September last year, added reports. Abhijit Konduskar arrested for drug trafficking The Directorate of Revenue Intelligence (DRI) has arrested Abhijit Konduskar, Managing Director of Kumud Drugs Pvt. Ltd. for allegedly indulging in illegal manufacture and trading of psychotropic substances. Kumud Drugs' general manager Nilesh Mehta, employee Sandeep Ahire and the Indian agent of UK-based buyer, Sean Jayantilal Kothari, have also been arrested. All have been booked under the provisions of the NDPS Act. Read More… Cipla drives up asthma awareness in Tamil Nadu

In an initiative to raise awareness on asthma and provide free lung tests and doctor consultation to the masses, Cipla, one of the leading pharmaceutical companies flagged-off the ‘Breathefree Yatra – A clinic-on-wheels’ from Chennai today. Equipped with diagnostic tools, educational materials and a team of counselors; the Breathefree Yatra will travel across

eight cities in Tamil Nadu offering free respiratory check-ups with the support of doctors in each of these locations viz Vellore, Salem, Coimbatore, Trichy, Madurai, Tirunelveli and Nagercoil. Asthma affects over 30milllion lives in India, of whom majority are either undiagnosed or do not have their asthma under control. “The paradox of asthma in India is that despite the availability and affordability of world-class treatment, this totally controllable disease is depriving the asthmatics in the country of a normal life; many a times subjecting them to traumatic attacks,

Yearly Industry Newsletter

35 of 118

hospitalization and even resulting in deaths. And the scenario in Chennai is also the same,” said Dr. Prasanna Kumar Thomas, Consultant Pulmonologist. “Kick the Butt” with Birlaveda Quitobac If the truth be told, stopping smoking is not easy. Even though education on the dangers of smoking is showcased seriously on cigarette packets, it is the persuasive campaigns around anti-smoking that is convincing people who smoke to consider smoking cessation on the strength of their own willingness to do so. One such initiative to commemorate “World No Tobacco Day” is spearheaded by the Yash Birla Group (YBG). Birla Veda, part of Birla Research & Lifesciences Ltd, of the Birla Wellness arm of the Yash Birla Group in association with Cancer Patients Aid Association (CPAA) has organized the “How to Quit for Life” campaign at The Courtyard, Phoenix Mills compound, Lower Parel, Mumbai, aimed to compel people who smoke to be driven into isolation and effectively into involuntary smoking cessation. Supporting the cause renowned celebrities like Shaina NC, & Shivani Mukherjee were present at the event. As a part of the campaign a close to 2000 people were screened for an ENT check aimed to counsel counsel those who have tobacco addictions to help them to quit. Followed by Street Plays by students of Terna Dental College to make the audience aware of the laws under (Framework Convention on tobacco Control (FCTC). Along with a story writing competition in which participants have been asked to share their journey to becoming tobacco free, “How I Quit”. Dr. Reddy's launches 3 generic products

Dr. Reddy's Laboratories announced that it has launched the three new generic products in the US market. Donepezil Hydrochloride tablets {5mg and lOmg strengths), a bioequivalent generic version of ARICEPT tablets. The Food & Drug Administration {FDA) approved Dr. Reddy's ANDA for Donepezil HCI tablets on May 31, 2011. Both strengths of Dr. Reddy's

Donepezil Hydrochloride tablets are available in 30, 90 and 500 count bottles. Veniafaxine Hydrochloride Extended Release capsules (37.5mg, 75mg and 150mg strengths), a bioequivalent generic version of EFFEXOR XR Extended Release capsules. The Food & Drug Administration {FDA) approved Dr. Reddy's ANDA for Veniafaxine Hydrochloride Extended Release Capsules on May 05, 2011. All three strengths of Dr. Reddy's Veniafaxine Hydrochloride Extended Release Capsules are available in 30, 90 and 500 count bottles. Letrozole tablets, USP (2.5mg), a bioequivalent generic version of FEMARA. The Food & Drug Administration {FDA) approved Dr. Reddy's ANDA for Letrozole tablets, USP on June 3, 2011. Dr. Reddy's Letrozole tablets, USP are available in 30 count bottles. Glenmark Generics receives final approval from USFDA for Mupirocin ointment Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited, has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Mupirocin ointment USP, 2%. Mupirocin ointment is indicated for the topical treatment of impetigo due to: Staphylococcus aureus and Streptococcus pyogenes and is available in a 22 gram tube presentation. Based on IMS Health sales data for the 12 month period ending March 2011, mupirocin ointment garnered annual sales of US$55mon and achieved a 9% increase in growth compared to the same period last year.

Yearly Industry Newsletter

36 of 118

Aurobindo Pharma receives final approval for Ramipril Capsules Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Ramipril Capsules USP 1.25mg, 2.5mg, 5mg and 10mg. Ramipril Capsules USP 1.25mg, 2.5mg, 5mg and 10mg is the generic equivalent to the reference listed drug Altace Capsules 1.25mg,

2.5mg, 5mg and 10mg of King Pharmaceuticals Inc. Ramipril Capsules are indicated for the treatment of hypertension and falls under the Cardiovascular (CVS) therapeutic segment. The product has a market size of approximately USD 95 million for the twelve months ending September 2010 according to IMS and will be launched soon. Aurobindo now has a total of 138 ANDA approvals (108 Final approvals and 30 Tentative approvals) from USFDA. Govt extends medical facilities to beedi workers The Cabinet approved extension of medical facilities to beedi workers under the Rashtriya Swasthya Bima Yojana (RSBY). The beedi worker and his family (unit of five) will be covered and the total sum insured would Rs. 30,000/-. The other benefits and procedures under the scheme will be the same as under RSBY. Any claims beyond Rs. 30,000/- will be reimbursed directly by the related Welfare Commissioner to the concerned empanelled hospital through the existing procedure. The estimated expenditure to be borne by the Central Government is approximately Rs. 311.25 crore (this includes 75% of the premium and the cost of the smart cards). The annual premium is estimated at Rs. 750 per annum of which 75% would be as Central share and the State Government’s share would be 25%. Read More… Redox Labs to train 10,000 people in 3 years: reports Redox Laboratories reportedly aims to train 10,000 people in the next three years, who will be hired by major companies and small and medium enterprises (SMEs). Durga Prasad, founder and managing director of Redox Laboratories, was quoted as saying “We will train 3,000people this year, assigned to us by the state government.” Redox has received a proposal from the central government to start similar training centers in Jammu & Kashmir, but yet has not been finalized on that front, added reports. Divi’s Lab up 1.3% on acquisition plans Divi’s Laboratories Ltd. shares rose after reports stated that the company plans to buy biotechnology research companies to enter the market for drugs made from living cells. Kishore Babu, CFO, Divi’s Laboratories Ltd., was quoted as saying that, we are looking at smaller R&D and research kind of companies in India and elsewhere. Elder Pharma to launch 35 new products in 30 months Elder Pharmaceuticals Ltd reportedly plans to launch about 35 new products in the next 30 months, which would be in therapeutic areas like female healthcare, osteoporosis, dermatology, pain management, cardiology, nutraceuticals, wound care and vitamin supplements. Aurobindo Pharma receives final approval from USFDA India seeks collective action against trade and IPR barriers

Yearly Industry Newsletter

37 of 118

Global Hospitals at Chennai performs country's most complex surgical exercise Bharat Biotech announces the price of "ROTAVAC" Bharat Biotech (www.bharatbiotech.com) today announced the price of ROTAVAC India’s first indigenously developed Rotavirus Vaccine. The vaccine will be sold to global public markets, Governments worldwide including UN procurement agencies at a price of US $ 1.0. Bharat Biotech hopes its new vaccine will help prevent part of the ~ 500,000 child deaths each year caused due to rotavirus diarrhea and improve access to better, affordable rotavirus vaccines. ROTAVAC expects India licensure during 2014 and WHO Prequalification in 2015 for supply to UN agencies. The Vaccine is currently undergoing Phase III clinical development for safety and efficacy in 8000 subjects, one of the largest such clinical trial ever conducted in India. According to CDC estimates, rotavirus causes approximately 352,000–592,000 deaths each year (median, 440,000 deaths) in children <5 years of age. Making the announcement Dr. Krishna Ella, Chairman and Managing Director Bharat Biotech said “Offering rotavirus vaccines at US $1 price is a reaffirmation of our commitment to make vaccines affordable globally. It is a great effort, by the Bharat Biotech team which made this a possibility. I am thankful to our technical and commercial teams for a decade of diligent efforts in delivering a world class product. The key to our success of bringing down cost of vaccine is our novel concepts in vaccine development and innovative manufacturing processes with Public Health in mind.”…Read More DCGI conducts surprise checks on over 130 drug outlets The Office of Drugs Controller General of India has conducted surprise inspections on more than 130 drugs sales outlets including hospitals in Delhi and Bhiwadi in Rajasthan. 13 teams comprising of 56 officials of the Central Drugs Standard Control Organization (CDSCO) participated in the surprise inspections in Delhi and Bhiwadi. During the inspections it was found that in 85 sale premises the prohibited drugs were still available for sale. Orders for not to dispofse of the stocks of prohibited drugs have been issued to the concerned licensees for the contravention of the provisions of the Drugs and Cosmetics Act and Rules. Further action will be taken against them after the investigations are over. Read More… Lupin acquires global rights for Goanna brand Lupin limited, announced that its Australian subsidiary, GenericHealth Pty Ltd. has acquired the worldwide rights to the GOANNA brand and the complete range of premium therapeutic oils, rubs and ointments marketed under the brand. Foundedin 1910, the GOANNA brand has been trusted by generations of Australians to provide effective relief of muscular aches and pains and other conditions such as arthritis. Read More… Novartis clarifies on news report Novartis India Ltd has issued a clarification with reference to the news item appearing in a leading financial daily titled "Novartis surges 12% on the BSE Amid Delisting Buzz". The company said the press report seem to be based on market speculation, while the Board of Directors of the Company has not considered any proposal for De-listing of the Company's Shares. LifeCell International to celebrate unique birth date LifeCell International, pioneers in stem cell banking brings an exceptional limited period offer for all the kids who would be born on the unique date 11.11.11. Under this special new born surprise offer, any pregnant woman who has enrolled with LifeCell International for their baby cord services from June 2011 onwards will be entitled for cash back of their total initial payment as per the standard storage plan which amounts to Rs. 36,000, if their child

Yearly Industry Newsletter

38 of 118

is born on 11th November, 2011. The excitement and celebration doesn’t end here as all the children born on November 2011 will receive a baby pram worth Rs. 6000 absolutely free. So be the part of the new born surprise offer by enrolling for LifeCell International’s Baby cord services, and present your child an unforgettable birthday gift. Max India allots shares to Goldman Sachs arm at hefty premium Max India Ltd. shares surged nearly 7% on Monday after the Company said that its Board of Directors has allotted 24,079,700 equity shares of Rs. 2 each at a premium of Rs. 214.75 per share to Xenok Ltd., a wholly owned subsidiary of GS Capital Partners VI Fund, LP. The Goldman Sachs unit bought a 9.1% stake in Max India for about Rs. 5.22bn. GS Capital Partners VI Fund has been floated by US-based Goldman Sachs Group Inc. The allotment of shares to GS Capital Partners VI Fund was done on conversion of 6,019,925 Compulsorily Convertible Debentures of Rs. 867 each (CCDs) on June 10. With the aforesaid allotment, the paid up share capital of the Company stood increased to Rs. 513,128,220, effective June 10. The Max India stock closed at Rs. 179.20, up Rs. 12.55 or 7.5% from the previous close. It had earlier been as high as Rs. 183.80 and as low as Rs. 165. It had opened at Rs. 167. Traded volume jumped to 10 lakh shares versus a two-week average of 33,000 shares on the BSE. NOVA Medical Centers announces a special breast and plastic surgery camp NOVA Medical Centers, India’s first multi-specialty standalone day surgical center has announced a special breast and plastic surgery camp at their Bangalore, Koramangala center. The camp will be conducted on 19th and 20th June, 2011 from 9 am to 2 pm. The attendees of this special camp has to pay just Rs. 149/- for the registration and consultation from renowned Nova Breast Specialists. Patients can avail expert consultation for various breast symptoms like breast deformity, breast lump, breast pain, breast swelling, breast tenderness, inverted nipple, nipple discharge, rash or sore on the breast or nipple and change in the shape and appearance of the breast. These symptoms if left undetected and untreated can cause serious life threatening complications. Consultation on cosmetic breast surgery can also be availed at the camp for breast augmentation, breast reduction, breast lift [Mastopexy] and Male Breast Reduction [Gynecomastia]. iON to power Razi Healthcare

The Hyderabad-based Razi Healthcare Private Limited, which is rapidly expanding its network of primary healthcare clinics in Andhra Pradesh, will be powered by solutions from iON, a strategic unit of Tata Consultancy Services (TCS), for Small and Medium Business to help in scaling up business and enhance customer experience.

N V Subba Rao, CEO of Razi Healthcare, said, “The healthcare industry is in an era of change, as companies are looking for ways to deliver services in more efficient, effective, and economical ways. “We decided to partner with TCS iON for its best-in-class, on-demand business solutions at affordable cost using the very latest in scalable cloud computing technology.” “I am confident that with this new endeavor Razi would offer superior healthcare solutions and services to its patients. With the help of iON we intend to modernize patient care profiles with electronic medical records and augmenting medical services for long term preservation, easy access and more accurate treatments”.

Yearly Industry Newsletter

39 of 118

V Ramaswamy, Global Head, iON, TCS, said, “We are delighted to have iON power the business of Razi Healthcare. With our strong domain expertise we are committed to bring about service improvements, business scalability and enhance the customer experience. “Healthcare is a fast growing sector and our endeavour is to ensure Razi offers its patient’s best-in-class healthcare products and services expand its footprint across India”. Over the last few months, Razi Healthcare has been setting up primary healthcare clinics in Hyderabad and elsewhere in the State, to offer accessible and affordable primary healthcare solutions. It has set up 33 such clinics in the State so far. All the clinics follow internationally-recognised, evidence-based clinical protocols and efficient practices for offering cost effective, rational and quality healthcare to its patients. The goal is to ensure that all patients receive the same standard of medical services, irrespective of their location and/or socio-economic strata. HealthLine 24x7 introduces Teleconsult and ePHR HealthLine 24x7, India'sfirst free round the clock Healthcare Information Assistance service,introducesTeleconsult & e-PHR (Electronic Personal Health Record). Teleconsult aims to connectpatients with doctors over phone so that patients don't have to cough up hugeamounts at clinics even for common ailments. e-PHR, on the other hand, willenable people to store and access their medical records free of cost. Through this initiative, Religare Technologiesplans to revolutionize India'shealthcare industry by reaching out to large section of society and provideround the clock quality healthcare services. Healthline 24x7 has a database ofover 1, 26,000 and is currently available in 6 metros namely Delhi/NCR, Mumbai,Bengaluru, Chennai, Kolkata and Pune. The company plans to expand its presenceinto more cities across Indiain due course. With the tele-consultation facility, HealthLine24x7 empowers consumers to consult the right doctor from the convenience oftheir home. A patient can easily avail a 2nd opinion without waiting in longqueues or traveling long distances to the clinic / hospital by dialing33006666. ePHR enables customers to access their personalmedical records anywhere, anytime. Patients can maintain a timely record oftheir medical appointments, gain access to significant medical alerts,conveniently book appointments with physicians and specialists, ascertainfaster and more efficient diagnosis and treatments, improve quality of care andtreatment by creating an ID on the website www.healthline24x7.com. Commenting on the launch of Teleconsult, Ashish Vijh, Senior Vice President, Healthcare IT division of ReligareTechnologies said "We dream to change the face of healthcare in India.In our busy schedules and hunger for success, health has gone down our prioritychart. Through tele-consultation, we aim to make lives easier for those withscarcity of time. People can now avail consultation by a doctor over phone bydialing 33006666 without having to wait in long queues. Our aim is to provideaffordable healthcare to each and every person in this country at a minimumcost and maximum benefits, hence Teleconsult". Despite renewed growth in 2010, Biotech Industry faces R&D challenges The global biotechnology industry delivered solid top- and bottom-line growth in 2010, with the industry achieving aggregate profitability for the second year in a row. Yet funding for research and development has grown increasingly scarce for the vast majority of firms in the sector, which tend to be pre-commercial stage companies that depend on years of funding to

Yearly Industry Newsletter

40 of 118

support drug development. This has placed new pressure on the traditional biotech business model, and may reshape how companies pursue R&D in the future, according to Beyond borders: global biotechnology report 2011, Ernst & Young's 25th annual report on the biotech industry. "While the biotech industry's aggregate performance improved in 2010, there is now a widening gap between large, established companies and those at earlier stages for whom access to capital continues to be difficult," said Glen Giovannetti, Ernst & Young's Global Biotechnology Leader. "Biotech firms will need to adapt creatively to this environment by doing more with the funding that is available and by working from the earliest stages of development to demonstrate the potential value of their products to investors, payers and regulators."…Read More Fox Chase Cancer Center signs agreement with Life Technologies Corporation Serum Institute pledges support to GAVI Dr. Cyrus Poonawalla, Chairman and Managing Director of Serum Institute, India’s largest vaccine company, today pledged Serum Institutes wholehearted support to the Global Alliance for Vaccines and Immunisation (GAVI). Announcing the support at an august gathering of global donors and international healthcare agencies, Dr. Poonawalla reiterated Serum’s commitment to cut prices for the company’s pentavalent vaccine by 60% making it available at the lowest possible cost of $1.75 (approx Rs. 100). This is in line with Serum’s philantrophic philosophy to further aid children’s health in developing countries and also assists GAVI’s mission by making vaccines available at the lowest affordable price to UNICEF and PAHO. Serum’s – Pentavalent Vaccine helps protect children against five potential killers namely – diphtheria, tetanus, pertussis, hepatitis B and haemophilus influenza type B. Dr. Poonawalla highlighted the fact that Serum is making the commitment recognizing its moral responsibility to keep these vaccines as affordable as possible. He was speaking at the conference on fundraising for global immunization programmes organized by Global Alliance for Vaccines and Immunisation (GAVI) at London. The conference aims to raise $3.7 billion and immunize 243 million around the world. Speaking at the GAVI Alliance conference today, Dr. Cyrus Poonawalla, Chairman, Serum Institute said, “The very genesis of Serum Institute was a quest to make vaccines more affordable for the common man. The partnership with GAVI serves as a good platform for us to reach out to those poor nations and bring comfort to the millions of underprivileged across the globe. But while we recognise our moral responsibility to keep these vaccines affordable, I strongly believe that it is appropriate for other manufacturers, especially the big Pharmaceutical companies, to also follow our lead and make vaccines available at more affordable prices; otherwise our effort to offer vaccines at lower prices will be defeated.” Calling upon global donors to ensure long term funding beyond 2015, Dr. Poonawalla urged them to consider the boons of vaccination for children in the most vulnerable countries. Serum Institute is also developing affordable vaccines for GAVI against Rotavirus and Pneumococcal diseases. The company hopes to achieve WHO prequalification for these vaccines in the near future. Jubilant and AstraZeneca announce successful delivery of Drug Discovery Jubilant Biosys Ltd., Bengaluru, based subsidiary of Jubilant Life Sciences Ltd., and AstraZeneca, announced another successful delivery of an early stage milestone in the Pain therapeutic area. The collaboration, initiated two years ago in the Neuroscience therapeutic area, has now expanded to Cardiovascular and Metabolic diseases and focuses on the delivery of a steady stream of preclinical outcomes to AstraZeneca, by Jubilant. AstraZeneca owns the compounds developed under the collaboration with

Yearly Industry Newsletter

41 of 118

worldwide development and commercialization rights. Jubilant derives research funding and success-based development and commercialization milestones. Read More… Dr. Reddy's announces launch of Levofloxacin tablets Dr Reddy’s Laboratories announced that it has launched Levofloxacin tablets (250 mg, 500 mg and 750 mg), a bioequivalent generic version of Levaquin tablets in the US market on June 20,201, following the approval by the United States Food & Drug Administration (USFDA) of Dr Reddy’s ANDA for Levofloxacin tablets. The Levaquin brand had US sales of approximately US$1.1bn for the most recent twelve months ending March 2011, according to IMS Health. Dr Reddy’s Levofloxacin tablets 250 mg and 500 mg strengths are available in 50 counts bottle and the 750 mg strengths is available in 30 counts bottles. Kilpest India wins new order worth Rs. 7mn Kilpest India Ltd. said that it has received an order worth Rs. 7mn for supply of pesticide to be used in mosquito control program, from Dept. of Health & Family Welfare, Govt. of Orissa. Further, the current order book position to be executed stands at Rs. 80mn (sans the above order) mainly from the agriculture sector. Orchid Chemicals Cephalosporin API unit clears USFDA re-inspected

Orchid Chemicals & Pharmaceuticals Ltd. on Tuesday announced that its Cephalosporin API manufacturing complex located in Alathur, Chennai has successfully cleared the recent USFDA inspection that it went through. The facility manufactures a range of oral and sterile Cephalosporin APIs and caters to the developed markets like USA, Europe and

Japan, Orchid said in a statement. This successful inspection would help the continuing supply of the niche APIs manufactured by Orchid in this location to the developed markets, it added. Apollo Hospital Bangalore presents comprehensive Health Check programs Apollo Hospitals, the leader in healthcare in Asia, ties-up with Group on India to leverage the web based platform for spreading awareness about their medical service offerings. In keeping with the expanding internet user base in India, Apollo Hospital, Bangalore will be launching Health Check programs for all age groups, through e-commerce major Group on. Social media, the game changer in the country’s economy, is here to stay and imparts great power to consumers. This novel initiative by Apollo will help in increasing brand awareness and harness the collective buying power of customers. The Health Check programs are designed by Apollo’s specialist doctors and then customized for separate age and genders. These programs will be offered, with a pre-specified validity period, at discounted prices (as compared to the hospital’s rack rate). Read More… Avesthagen granted US patent for its efficient Sunflower transformation Avesthagen Limited has been granted the patent by the US patent office for breakthrough Sunflower transformation and eco-friendly safe selection method that can replace the traditional antibiotic marker technology in GM

Yearly Industry Newsletter

42 of 118

crops. In the past, antibiotic resistance marker gene(s) have been used in developing GM crops which has raised world-wide opposition to the GM technology in general. Avesthagen’s Xylose Isomerase (XI) technology does not use antibiotics in the selection process thus successfully addressing public concerns. This positive selection process is based on the function imparted by the patented technology to metabolize certain carbohydrate compounds during the selection process. Read More… Sun Pharma, Coal India stocks rise after being included in Sensex Lupin announces launch of Generic Levaquin Tablets for the US Market Pharma Major, Lupin Limited announced today that its U.S. subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has been granted final approvalby the United States Food and Drugs Administration for the Company’s Abbreviated New Drug Application (ANDA) to market a generic version of OrthoMcNeil’s Levaqu in (levofloxacin) tablets. Commercial shipment of the product has commenced. The shares of Lupinare trading at Rs. 433, down by Rs. 1 or 0.39% over the previous close. It opened at Rs. 436, recording the day’s high at Rs. 438 and low at Rs. 432. The total traded quantity stood at 0.34 lakh shares on theBSE. Lupin’s levofloxacin 250 mg, 500 mg and 750 mg tablets are the AB-rated generic equivalent of Levaquin, a synthetic broad spectrum antibacterial agent used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Levaqu in tablets had annual sales of approximately $1.6 billion for the twelve months ended March 2011, based on IMS Health sales data. Nile Therapeutics to raise US$2.5mn in private placement Nile Therapeutics, Inc. a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced that it has entered into a definitive agreement to sell securities of the company in a private placement transaction, which will result in gross proceeds of US$2.5mn. The investment was led by Stonepine Capital, LP, and included participation from existing investors. Riverbank Capital Securities, Inc., a FINRA member broker-dealer, acted as the exclusive placement agent for the transaction. Under the terms of a securities purchase agreement, Nile will sell an aggregate of 5 million shares of its common stock and five-year warrants to purchase up 2.5 million additional shares of its common stock. The warrants will have an exercise price equal to US$0.60 per share. The warrants are redeemable by the Company, at a redemption price of $0.001 per warrant share, upon 30 days notice, if at any time, the volume weighted average price of the common stock for any 20 consecutive business days is equal to or greater than 250% of the exercise price of the warrants. The private placement is expected to close on or prior to June 24, 2011, subject to customary closing conditions. "We are pleased to have the support of a new, quality investor like Stonepine," said Joshua Kazam, Chief Executive Officer of Nile. "We believe these funds will enable us to operate well into 2012, beyond the full analysis of our ongoing Phase I trial of cenderitide. The trial is enrolling ahead of schedule and we look forward to providing an update on our timelines soon as we continue to explore options to enhance shareholder value." Strides Arcolab gets USFDA nod for antibiotic injection Strides Arcolab Limited (Strides) today announced that it has received US FDA approval for Levofloxacin Injection, 25 mg/mL packaged in 500mg/20 mL and 750mg/30 mLsingle-use vials. Levofloxacinis a synthetic fluoroquinolone antibiotic used to treat mild to severebacterial infections or bacterial infections that have failed to respond toother antibiotic classes. These include respiratory tract infections,cellulitis, urinary tract infections,

Yearly Industry Newsletter

43 of 118

prostatitis, anthrax, endocarditis,meningitis, pelvic inflammatory disease and traveller's diarrhea. Accordingto IMS September 2010 data, the total market for Levoflaxacin in the USA is approximated to be US$ 158 million ofwhich US$ 5.68 million is for vials and the rest of the market is forbags. The product patent expired on June20, 2011 and this approval is amongst the first wave of approvals post patentexpiry. The product is expected to belaunched shortly. Levofloxacinis the second approval for Sagent Strides LLC in 2011. Strides is developingand supplying more than 25 injectable products for the USA marketwhich will be marketed by Sagent. Pivotal study showed vismodegib helped shrink Tumours

Roche announced that a pivotal Phase II study with vismodegib showed positive results in people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate. Basal Cell Carcinoma is a form of skin cancer that can cause disfiguring and debilitating effects and can ultimately be life-threatening. Vismodegib is an investigational, oral medicine designed to selectively inhibit signalling in the Hedgehog pathway, which is

implicated in more than 90% of BCC cases. Birla Pacific Medspa fixes issue price at Rs. 10

Birla Pacific Medspa has reportedly fixed its issue price at Rs. 10 per share, the lower end of the price band. According to reports, Birla Pacific Medspa plans to utilize Rs. 49 crore for establishing 55 ‘Evolve’ outlets, and Rs. 6 crore for brand building and the balance for meeting working capital, Issue and other preliminary expenses. The company is considering locations in Delhi,

Bangalore, Ahmedabad, Pune, Chennai, Hyderabad, Jaipur and Goa for its centres, reports added. Wockhardt receives tentative US FDA approval for generic version Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing 0.1% solution of Olopatadine hydrochloride eye drops, which is used for allergic conjunctivitis. Olopatadine is the generic name for the brand Patanol, marketed in the United States by Alcon Laboratories Inc., now a subsidiary of Novartis AG. The patent covering this product is under litigation in the US courts and Wockhardt will launch the product after resolution of the same. "This is a major ANDA approval for Wockhardt in the ophthalmic segment", said Wockhardt Chairman Habil Khorakiwala. Read More… J.B. Chemicals launches a New Domestic Division J.B. Chemicals& Pharmaceuticals Ltd. (JBCPL) announces the launch of their new “FemidentDivision” catering to Gynecology and Dental products, in its domestic formulations business. The gynecology and dental segments, at present, have combined sales of about Rs. 20bn with annual robust growth of about 16%. The company has launched this division with over 100 medical representatives and 15 products some of which are first of its kind in its respective segment. The company plans to increase medical representative strength in this division to 300 in about 2 years time. Read More…

Yearly Industry Newsletter

44 of 118

Cipla loses US court case to Merial...To appeal the order Cipla Ltd. said that the Company has received an order dated June 21, from a United States District Court, Middle District of Georgia against a petition filed by Merial Ltd. The US court has ruled that sales of PetArmor Plus (an animal healthcare product) allegedly infringed a patent held by Merial. The court has suspended future sales in the United States. The District Court has stayed the above order for 60 days in order to enable Cipla to appeal. Cipla said that it was in the process of filing an appeal against this order. There was no determination as yet by the US court on the financial implication of the patent infringement, it added. …Cipla FY11 net profit at Rs9603.90 mn Fortis to launch low cost hospitals Fortis Healthcare (India) Ltd. marked a decade since the first hospital (Mohali) started, and kicked off celebrations across the country starting this week. Read More… …Fortis to add 25 more hospitals in 3 years Jubilant announces Drug Discovery Alliance in Neuroscience Jubilant Discovery Services Inc., Bedminster, New Jersey, a Jubilant Life Sciences Company, announced today that it has entered into a drug discovery alliance with Janssen Pharmaceutica N.V., Beerse, Belgium, that will aim to deliver preclinical candidates to Janssen. The alliance is set to span an initial period of 3 years and will focus on multiple targets in the area of neuroscience. Under the terms of the alliance agreement, Janssen will transfer ongoing efforts on selected drug discovery targets to Jubilant. Jubilant shall then carry out the research services and deliver preclinical candidates to Janssen for possible further development and commercialization. Read More… Strides Arcolab joins Malaysian Bio-xcell Ecosystem Agile Specialities (Malasia) SDN BHD, the specialities subsidiary of Strides Arcolab Ltd has exchanged agreements for the establishment of a customized facility to manufacture biopharmaceuticals and sterile injectables in the Bio-XCell ecosystem in Johor, Malaysia. Jubilant Life Sciences spurts on Belgian tie-up Shares of Jubilant Life Sciences surged as much as 14% on Tuesday after the company's US arm entered into a drug discovery alliance with Belgium-based Janssen Pharmaceutica N.V. The aim is to deliver pre-clinical candidates to Janssen. The alliance is set to span an initial period of three years and will focus on multiple targets in the area of neuroscience.

Yearly Industry Newsletter

45 of 118

International News - June 2011 Pfizer Files for European Regulatory Review of Axitinib Pfizer Inc. announced today that the European Medicines Agency (EMA) has accepted Pfizer's filing for regulatory review of axitinib for patients with advanced renal cell carcinoma (RCC) after failure of prior systemic treatment. This submission was based on Phase 3 data from the AXIS 1032 trial. Pfizer will present full results from this trial, as well as additional data on axitinib, at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO), being held in Chicago from June 3-7, 2011."While the prognosis for patients with advanced RCC has improved dramatically over the past five years thanks to the availability of new treatments, there is still a need for new options in this patient population," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. "This regulatory filing for our innovative investigational therapy axitinib, as well as ongoing studies of our existing medications, underscores Pfizer’s commitment to patients with advanced RCC and our leadership in helping physicians treat this disease." Each year, approximately 210,000 people worldwide are diagnosed with kidney cancer and nearly 102,000 people are expected to die from the disease. Within the last five years, great advances have been made in the treatment of patients with advanced RCC, the most prevalent form of kidney cancer. However, five-year survival rates for patients with advanced RCC remain low, at around 20 percent. NYU Langone Medical Center raises US$1bn in less than 4 Years NYU Langone Medical Center announced that it has reached a historic and unprecedented philanthropic milestone, raising US$1 billion in less than four years. "This is a historic moment for our medical center," said Kenneth G. Langone, chairman of the Board of Trustees. "We have the most extraordinary friends and benefactors who, through their generosity of spirit and action, have helped propel NYU Langone Medical Center to the forefront of clinical care, research and medical education. Their belief in us and the work we do is unsurpassed. We thank them from the bottom of our hearts." Since 2007, when Robert I. Grossman, MD, the Saul J. Farber Dean and CEO, took the helm of the medical center, more than 66,000 separate gifts – ranging from US$1 to four gifts of US$100mn or more – from 51,000 individuals have poured in. Read More… Northwest Biotherapeutics announces series of Financing Arrangements Northwest Biotherapeutics announced that it has put in place a series of financing arrangements, including a US$3mn investment already received, and access to up to US$25mn of further funding on fixed, specified and favorable terms, at such times and in such amounts as the Company chooses. This series of financing arrangements will provide a strong financial foundation for completion of the Company's ongoing 240-patient clinical trial of DCVax(R)-L for the treatment of Glioblastoma multiforme (GBM) brain cancer, and will also provide for certain other programs in the Company's near term pipeline. As the first component of the overall financing arrangements, the initial US$3mn investment has been provided by a multi-billion dollar institutional investment fund based in Minnesota. The investment is structured as a convertible note with warrants. The note is not convertible until maturity, 18 months after closing, and is only convertible into unregistered restricted stock at that time. Read More… Johnson & Johnson announces special charge related to restructuring plans Johnson & Johnson announced that it expects to record an after-tax restructuring charge in the range of $500-$600mn in the second quarter of 2011 as a result of restructuring plans announced by its subsidiary, Cordis

Yearly Industry Newsletter

46 of 118

Corporation. The restructuring charge will be treated as a special item. In its separate news release today, Cordis announced the discontinuation of its clinical development program for the NEVO Sirolimus–Eluting Coronary Stent, cessation of the manufacture of CYPHER and CYPHER SELECT Plus Sirolimus-Eluting Coronary Stents by the end of 2011, and other plans related to its cardiovascular business. AstraZeneca extends its investment in Russia AstraZeneca announced that it plans to establish a Predictive Science Centre in St. Petersburg over the coming year. The move strengthens AstraZeneca's investments in Russia and supports the Russian Government's strategy to modernise and develop the country's pharmaceutical sector. The new AstraZeneca Predictive Science Centre, the company's first in Russia, will leverage local scientific talent and focus on developing bioinformatics, data analysis methods, software and systems to better predict the safety and efficacy of potential new medicines. Approximately 30 people will work at the Centre through collaborations with local companies and organisations as part of a related agreement with the St. Petersburg government to be announced later this week. Read More… FDA warns of record drug shortages: reports The Food and Drug Administration warns that the number ofdrug shortages is at a record high and getting even worse. Regulators are seeing a large number of new drug shortagesin 2011 as well. The agency is especially concerned about the shortages ofinjectable drugs, which account for more than half of the shortages reportedlast year to the FDA, reports added. Bristol-Myers Squibb signs agreement to expand access to Reyataz Bristol-MyersSquibb Company announced a new agreement to expand access to Reyataz (atazanavir sulfate). The immunity-from-suit agreement signed withMatrix Laboratories Limited, a Mylan Company, enables the generic company tomanufacture and sell atazanavir, as well as stavudine and didanosine, in sub-SaharanAfrica and India. “The HIV treatment landscape has changed dramatically since 2001, when we first began our Global Access Program to help expand the availability of low-cost HIV medicines in the developing world,” said Frank Pasqualone, president, Intercontinental Region, Bristol-Myers Squibb. “Atazanavir is an important component of HIV combination therapy andthis agreement facilitates broader availability of the medicine to help ensurepatients can access appropriate treatment regimens.” Read More… …Bristol-Myers Squibb Foundation Awards $1.5 Million in Grants Bayer advances research in the area of pulmonary hypertension Bayer HealthCare is working with the Ludwig Boltzmann Institute (LBI) for Lung Vascular Research in the research area of lung vascular diseases - especially pulmonary hypertension. Other partners include the German medical device manufacturer NEBU-Tec and the Austrian Academy of Sciences. The research facility is also sponsored by Bayer and belongs to the Ludwig Boltzmann Gesellschaft (LBG). The LBI for Lung Vascular Research is located at the Medical University of Graz, which is also a partner of the LBI. "The Ludwig Boltzmann Institute for Lung Vascular Research has bundled renowned expertise in the field of pulmonary hypertension, an area with considerable unmet medical need," said Dr. Helmut Haning, Head of Global Innovation Sourcing at Bayer HealthCare on the occasion of the LBI opening ceremony. Read More…

Yearly Industry Newsletter

47 of 118

Domestic News - July 2011 PM seeks convergence of programmes for AIDS control

The Prime Minister Dr. Manmohan Singh today called for multi sectoral approach and greater integration of resources in dealing with response to HIV/AIDS. The Prime Minister was inaugurating the National Convention of Zila Parishad, Chairpersons & Mayors on HIV/AIDS organized by Forum of Parliamentarians on

HIV/AIDS in New Delhi today. The Prime Minister also called for other concerned Ministries to have a “HIV sensitive” policy and programmes so that the marginalized populations infected and affected by HIV/AIDS are not denied the benefits of these schemes. He said linkages should be made between the HIV/AIDS programme and the Mahatma Gandhi National Rural Employment Guarantee Programme to facilitate employment of HIV positive persons. Read More… Biomedical engineers to develop mobile phone malaria diagnostic sensor The University of Glasgow has received a grant from the Bill & Melinda Gates Foundation to further help in the diagnosis of Malaria. The $100,000 award will go towards developing a device which uses mobile-phone derived technology that can detect and separate red blood cells infected with malaria parasites. It is hoped that if successful, devices based on the technology could be mass produced for rapid and accurate malaria diagnosis. The project team comprises Jon Cooper, Wolfson Chair of Bioengineering of the College of Science and Engineering, Mike Barrett, Professor of Biochemical Parasitology and Senior Lecturer, Dr Lisa Ranford-Cartwright, both of the College of Medical, Veterinary and Life Sciences. Read More… USFDA bans import from Dr Reddy's Mexico plant: report The USFDA has imposed an import ban on products made at Dr Reddy's Laboratories' Mexican plant for violation of current good manufacturing practices, according to a report. The report stated that the company's Mexican arm, which had received a warning a letter from the USFDA last month. The import alert on Dr Reddy's drugs was issued under the category of 'Detention without physical examination of drugs from firms which have not met drug GMPs', says report. Fortis Healthcare appoints Aditya Vij as CEO

Fortis Healthcare (India) today has appointed former head of General Motors India, Mr Aditya Vij, as the Chief Executive Officer (CEO) of the company effective from July 5. Fortis said in a filing to the Bombay Stock Exchange (BSE). Fortis Healthcare (India) Managing Director, Mr Shivinder Mohan Singh, said, “His impressive track record of growing

businesses and delivering successful outcomes in the domain of quality and financial performance across geographies, his ability to develop and align large teams to deliver performance and his experience in managing cultural diversity position him strongly to take on the mantle of leadership for our fast-growing organization.” The filing further stated that prior to working with

Yearly Industry Newsletter

48 of 118

Punj Lloyd, Vij worked with General Motors for 18 years across five countries in Europe and Asia. Cardiac Science enters into agreement with Omron Healthcare Cardiac Science Corporation (an Opto Circuits (India) Ltd. company) has announced that it has entered into an exclusive distribution agreement with Omron Healthcare Co. Ltd. to distribute the JMHLW approved Omron Automated External Defibrillator Powerheart G3 HDF - 3000 in Japan. Omron, a leading healthcare company dedicated to the prevention of heart disease, will distribute the AEDs through its home-use and medical healthcare devices division and will optimally utilize sales channels of business partners. Vinod Ramnani, Chairman and Managing Director, Opto Circuits, commented: “We are pleased to partner with a well known brand like Omron Healthcare to gain a strategic re-entry into the lucrative Japanese market with our emergency life saving product. We consider this to be an important milestone for the Opto Circuits Group.” Read More… Wockhardt gets USFDA nod for generic version of Cymbalta Wockhardt Ltd has received tentative US FDA approval for marketing 20mg,30mg and 60mg delayed realeas capsules of Duloxetine hydrochloride whihc is used in treatment of depression. Duloxetine is the generic name for the brand Cymbalta. According to IMS Health, the total market for this product in the US is about $3.3 billion.“Wockhardt was amongst the first-to-file companies with a paragraph-IV certification for Duloxetine DR capsules” said Wockhardt Chairman Habil Khorakiwala. “We will now be amongst the first-to-market this product, as and when the generic market opens up. Wockhardt plans to sustain its rapid growth in the US market through a series of such first-to-market launches”, he commented further. Read More… Ozone Pharmaceuticals organises Blood Donation Camp July 1 is attributed as the Doctor’s Day in India. It is celebrated to remember the valuable services of medicos to human kind and express our gratitude for the dedication and sacrifice of the messengers of life and health. From dentists to neurosurgeons, homeopaths to heart specialists, physicians and pediatricians, each one of them play a very integral role in a patient’s life. This day has been chosen as a mark of respect to the contributions made by Dr. Bidhan Chandra Roy, who left an indelible mark in the history of medical profession in India. The Doctor’s Day is in commemoration of the birth anniversary of the eminent physician and patriot. Read More… Ranbaxy asked by UK MHRA to recall its drugs: report Ranbaxy Ltd has been asked by the UK Medicines and Healthcare products Regulatory Agency to recall its drugs used to treat skin infections, according to a report. The report stated that the company was recalling unexpired stock of Isotretinoin 20mg capsules due to a potential issue with bio-equivalence in comparison with the originator product. Glenmark Pharma announces settlement of litigation with Daiichi Sankyo Glenmark Pharmaceuticals Ltd, Glenmark Generics Ltd and Glenmark Generics Inc, USA announces the settlement of litigation with Daiichi Sankyo, Inc and Genzyme Corporation regarding Glenmark’s Abbreviated New Drug Application (ANDA) filed with the US Food and Drug Administration for Colosevelam Hydrochloride. The shares of Glenmark are trading at Rs. 320, up by Rs. 3 or 1.25% Apollo Hospitals to raise Rs 3.3bn via QIP: reports Apollo Hospitals will increase up to Rs. 3.3bne via qualified institutional placement for its expansion plan. Earlier, Apollo planned to raise Rs 9bn through a mix of equity and debt. The company plans to raise the QIP at current market price, according to reports. The funds will be used to add 2,400 beds by FY14. This will include 900 beds in the metros and 725 beds

Yearly Industry Newsletter

49 of 118

through Apollo Reach in small towns such as Nasik, Ayanambakkam (in suburban Chennai), Nellore and Trichy. Three large tertiary hospitals will come up in Mumbai. Apollo's current bed strength is 8,717 across 54 hospitals. All these are greenfield projects, added reports. Dr. Reddy's gets USFDA nod for Fondaparinux injection Dr. Reddy's Laboratories Ltd. said on Wednesday that the company, along with Australia's Alchemia Ltd. have received the USFDA approval for the Indian company's ANDA for Fondaparinux Sodium Injection. Fondaparinux Sodium Injection is a generic version of Arixtra. Dr. Reddy's will manufacture Fondaparinux under license, using a patented process developed by Alchemia. The US patent on Arixtra expired in 2002, the year before the drug was launched in the US. The Arixtra brand had US sales of approximately US$340mn (YoY growth of 16%) for the 12 months ended May 2011. Govt, Piramal Life begin Phase II of Drug Discovery PPP The Department of Biotechnology (DBT), Government of India and Piramal Life Sciences Limited (PLSL) have begun Phase II of their Drug Discovery Public Private Partnership to find new drugs from 14000 bioactive cultures discovered in a nationwide search for new drugs from biodiverse habitats across the country in collaboration with 9 national institutes. A total of 245000 different microbes were collected and characterized at the national centres. Extracts from these microbes were screened for biological activities across four different therapeutic areas namely Cancer, Diabetes, Inflammation and Infectious diseases. Based on the results of these studies, the team has identified greater than 14000 cultures that showed potent activities in the above disease conditions: 5000 extracts for anti-infective, 500 extracts for anti-cancer, 6000 for anti-diabetes and 2900 extracts with anti-inflammatory properties. Read More… Ranbaxy enters into a licensing agreement with Gilead Sciences Ranbaxy Laboratories Limited (Ranbaxy) announced today thai it has entered into an in-licensing agreement with Gilead Sciences, Inc. for three new HIV/AIDS drugs which are cmrenlly in late-stage elinical development. Ranbaxy will have the rights to produce and sell generic versions of these drugs, under license, in India and other developing nations, after gaining necessary regulatory approvals. Read More… J.B. Chemicals completes acquisition for Russian OTC brands J.B. Chemicals announces the successful completion of its transaction of sale of Russia- CIS OTC Business to Cilag GmbH International (“Cilag”), Switzerland, a wholly owned subsidiary of Johnson & Johnson, along with transfer of worldwide rights and registrations of three OTC brands namely Doktor MOM, Rinza and Fitovit. On May 23, 2011, the board of directors had approved the sale of this business and OTC brands to Cilag. The company’s Russian subsidiary has also achieved successful completion of its transaction of sale of OTC inventory and receivables to Johnson & Johnson LLC, a Cilag’s affiliate. Orchid receives US FDA nod for Venlafaxine ER Capsules The Chennai-based pharma major, Orchid Chemicals & Pharmaceuticals Ltd (Orchid) has announced that it has received approval from the US FDA for its ANDA (Abbreviated New Drug Application) for Venlafaxine Extended Release (ER) Capsules in the 37.5 mg, 75 mg and 150 mg strengths. SPARC Board approves Rights Issue Sun Pharma Advanced Research Co. Ltd. (SPARC) on Thursday said that a Committee of the Board of Directors has, vide its resolution passed on July 14, authorized the further issuance of equity shares of Re. 1 each of the Company, on a rights basis to the shareholders.

Yearly Industry Newsletter

50 of 118

The ratio, price and premium may be decided in consultation with the Lead Managers to the proposed rights issue, in such a way that the funds raised are not more than Rs. 2bn. The ratio of rights share entitlements, the issue price and the record date for fixing the entitlement of shareholders to such rights issue shall be informed in due course. Lupin grants options under ESOP Lupin Ltd has said that the Company has granted 19,000 options to its employee of its subsidiary Company, under "Lupin Subsidiary Companies Employees Stock Option Plan 2011", at the exercise price of Rs. 458.30 on July 13, 2011. One equity share of Rs. 2/- each is covered by each option. The options issued are exercisable at the 'market price' as defined in SEBI guidelines, in a phased manner after a minimum vesting period of 12 months but before the exercise period of 10 years from the date of grant. Venus Remedies launches "ACHNIL" in India Venus Remedies Limited, a leading research based global pharmaceutical company and amongst the prominent injectables manufacturers in the world, launched a novel formulation “ACHNIL” brand of “Aceclofenac- injection” in India. “ACHNIL” injection is a “single Shot... last day long” formulation. Dr. Manu Chaudhry, Joint Managing Director of the company on the occasion said, “This novel formulation based on NDDS (Novel Drug Delivery System) technology will fill in the gap of long standing demand for better pain management therapies especially for aged population. It is not only going to reduce the number of pricks but will also drastically reduce the side effects associated with the use of NSAIDs.” Discussing about the benefits of the drug Ms. Chaudhary added, “ACHNIL acts directly by giving instant relief from acute pain and is effective for the next 24 hours against the conventional daily dose of three injections of diclofenac given every 8 hours.” The development of ACHNIL commenced at VMRC and took more than seven years in the successful completion of phase-I, phase-II and phase-III clinical trials and regulatory approvals from DCGI for this product. The marketing team of Venus is fully geared upon all India launch to take this innovative pain solution drug in most needed Indian market. “The Indian market for pain management is approximately INR 2000 crores which is growing at the rate of 16% – 20% annually and is expected to be of INR 3500 crores by 2015. Venus is expecting substantial shares in the coming years” said Mr. Peeyush Jain, Deputy Managing Director and head Marketing unit of Venus. ACHNIL ensures immediate burst release action, which gives results with in 4-5 minutes and rest drug is released in controlled manner thereby passing the true benefits of Aceclofenac. Aceclofenac is a radical innovation of Venus Medicine Research Centre which is a non steroidal anti-inflammatory drug (NSAID) and is used to relieve acute as well as chronic pain and inflammation in rheumatoid arthritis, osteoarthritis, low back pain, ankylosing spondylitis, dental pain, post traumatic pain, gynecological pain and oncology pain. Aceclofenac is designed in such a way that the product is never released in super or sub therapeutic zones and hence is highly safe and practically free from side effects. Venus has already secured patents from India as well as from Europe for this research product which are valid up to 2025 and will further reinforce the market position of Venus Remedies in India and the major European economies such as Germany, UK, France, Spain, Sweden, Italy and Switzerland. Herbalife India enters 12th year...Grows 154% in Q1 Herbalife, the global nutrition and direct selling company entered their thriving 12th year of operations in India with a stellar growth of 154% in Q1; Herbalife India plans to further expand their presence across regions this year. The company is also looking at expanding the product portfolio, of inner

Yearly Industry Newsletter

51 of 118

and outer nutrition range over the next 6 months. Today, Herbalife has grown to over 1, 00, 000 distributors in India. Herbalife's growth over the past few years has placed India as one of the largest contributors globally. Commenting on this development, Ajay Khanna, country head, Herbalife India said, "Herbalife in India has done extremely well over the last one year, growing to be one of the top 10 markets out of the 76 countries that Herbalife is present in. Herbalife is also planning to invest heavily in technology and ramp up its manufacturing capacity. Read More… Rakesh Jhunjhunwala halves stake in Lupin: report Shares of Lupin Ltd. fell on Wednesday after media reports that billionaire investor Rakesh Jhunjhunwala had cut its stake in the domestic drug maker by half. Reports said that Jhunjhunwala sold about 66 lakh shares of Lupin in Q1 FY12. At the end of March this year, he held 1.43 crore shares in Lupin. Earlier this week, media reports said that Lupin was contemplating selling its domestic marketing unit. Promoters of the Mumbai-based company have started the process of finding a buyer for the operations, reports said. The Indian business may be worth at least US$1bn, reports added. The Indian medicines unit accounted for 32% of Lupin’s Rs. 57.1bn revenue in the year ended March 31, 2011. But, Lupin said it has no plans to sell its domestic operations. “This is baseless and there is no such activity going on,” the company said in a statement. Piramal Healthcare to transform into financial services conglomerate: reports Piramal Healthcare, is reportedly planning take step to transform into a financial services conglomerate as it negotiates to buy Enam Financial's stake in ING Life Insurance. According to reports, the insurance company may be valued at Rs. 24bn. There is no certainty the transaction will be completed as discussions are still on. Himalya International signs agreement with Guardian Pharmacy Himalya International Ltd has signed agreement with Guardian Pharmacy to market its nutritional supplements under it's brand '1 Daily'. Guardian will carry four variants; 1 Daily Total Health for Men & Women, 1 Daily Healthy Heart and Healthy Bones. The Products shall also be available at International Airports in India at Guardian Pharmacy stores. 1 Daily has also been launched at Apollo Pharmacy and Religare Wellness Pharmacy chains.' 1 Daily' nutritional Supplements are manufactured in technical collaboration with Global Reliance Inc. USA. Sun Pharmaceutical gets nod from USFDA to sell AstraZeneca Sun Pharmaceutical Industries has reportedly received approval from the U.S. Food and Drug Administration to sell a generic version of AstraZeneca PLC's (AZN) cancer drug Arimidex. According to reports, Sun Pharmaceuticals can sell anastrozole--the generic version of Arimidex--as 1 milligram tablets. CIFT signs MoU with Uniloids Biosciences Central Institute of Fisheries and Technology [CIFT] signed one of a kind MoU with Hyderabad based Uniloids Biosciences. With this MoU, Uniloids Biosciences will have access to the unique and innovative technology, developed at CIFT, to convert process waste to Chitin and Chitosan. Chitin and Chitosan finds wide usage in various industries like pharma, food processing, cosmetics, etc. Under the MoU, Zonal Technology Management - Business Planning & Development Unit [ZTM-BPD Unit] along with Fish Processing Division and Quality Assurance & Management Division will further provide training and support to Uniloids Biosciences for commercializing the technology. Read More…

Yearly Industry Newsletter

52 of 118

Some shareholders of Dr Reddy's want stock split Dr Reddy's Laboratories Ltd, some of the shareholders has reportedly asked its management to split the equity shares. According to reports, the split would help small investors to have liquidity as the scrip was now trading at a ‘high' price. The AGM approved payment of divided of Rs. 11.25 per equity share of Rs. 5 each (225%) of the company, added reports. Go to new heights in the fight against childhood CancerThis September, in honor of National Childhood Cancer Awareness Month, people worldwide have the opportunity to skydive with a collective purpose helping to raise money for the thousands of children, and their families, living with cancer. This year's "Global Leap for Life 2011" gives people the chance to join a worldwide skydiving fundraising initiative allowing them to "skydive for a cause" and raise money for cancer charities. People can make tax-deductible donations to sponsor a skydive and benefit Alex's Lemonade Stand Foundation, a nonprofit dedicated to finding a cure for all kids with cancer. In addition, people can also skydive for another cancer charity, Strength for Life, a New York-based not-for-profit dedicated to empowering people with cancer and cancer survivors through exercise. Alex's Lemonade Stand Foundation (ALSF) emerged from the front yard lemonade stand of cancer patient Alexandra "Alex" Scott who wanted to help find a cure for all children with cancer. Alex lost her fight with cancer at age 8, but since its inception, ALSF has raised more than US$40mn towards Alex's cancer cure dream. Nearly 13,000 children are diagnosed with pediatric cancer each year in the United States and, worldwide, approximately 11 million people are diagnosed with some form of cancer each year. Millions of dollars are needed to fund cancer research. In past events, Leap for Life has raised nearly $60,000 for various cancer charities. Their goal is to surpass that tally this year and encourage skydivers from around the world to participate in a unique skydiving adventure. US drugstore chain Rite Aid alleges Ranbaxy Labs: reports A retailer of Ranbaxy drugs in the US has filed a complaint alleging that Ranbaxy has refused to cover the legal costs and losses the retailer has suffered in defending the company for selling a generic drug that has shown undesirable side effects, according to reports. Reports further stated that in its complaint filed at the Eastern District Court of Pennsylvania last week, Rite Aid has asked the court to direct Ranbaxy to cover the cost it has incurred so far, defend and indemnify the company from the ensuing legal action. India and EU reach agreement on drug seizure European Union has proposed a settlement of the dispute by confirming the detailed principles agreed in the Understanding to guide border enforcement of intellectual property in the EU. In addition, EU agreed to India’s request for adoption of guidelines which would confirm the principles agreed to in the Understanding with a view to give greater and immediate legal certainty for producers and traders. EU also agreed to reflect the principles contained in the Understanding in its proposal for a new Regulation to replace Regulation 1383/2003. In return the EU sought an assurance that India would refrain from further steps in the ongoing dispute. Read More… Metropolis to invest in 1.5mn to set up labs Metropolis Healthcare Ltd, India’s one of the leading multi-national chain of diagnostics centers, is now coming up with 15 Greenfield laboratories in Tier II and tier III cities across India after the success of its 2ndsuch lab in Indore. The company is likely to make a total investment of around Rs. 1.5mn in this fiscal year. These well-equipped labs will be located in cities

Yearly Industry Newsletter

53 of 118

like Gorakhpur, Jalandhar, Amritsar, Lucknow, Allahabad, Udaipur, Agra, Bhopal and Ranchi. Read More… Fujifilm and Dr. Reddy's to form JV Fujifilm Corporation President and CEO, Shigetaka Komori and Dr. Reddy's Laboratories Ltd. Vice-Chairman and CEO, G V Prasad today signed a Memorandum of Understanding to enter into an exclusive partnership in the generic drugs business for the Japanese market and to establish a joint venture in Japan. A definitive agreement will be signed during the course of the calendar year. The new joint venture will have 51% stake owned by Fujifilm and 49% stake owned by Dr. Reddy's. Read More… Apollo Hospitals to add 3,000 beds in next 3 years: reports Apollo Hospitals Enterprise Ltd to reportedly add 3,000 beds, with an investment of Rs. 16bn in next three years. According to reports, the chain is planning to fund the expansion through debt and equity. Meanwhile, its planned foray into ayurveda in a big way has hit a block, after talks with Kottakkal Arya Vaidya Sala having failed. Lupin signs agreement with Medicis Lupin Ltd has signed joint venture development agreement with Medicis. Under the terms of the agreement, Lupin will receive a $20mn upfront payment from Medicis and will be primarily responsible for formulating certain novel therapeutic products for Medicis, utilizing several of Lupin's formulation technologies. Cadila Healthcare signs share purchase agreement with ICICI Venture: reports Cadila Healthcare has reportedly signed a share purchase agreement with ICICI Venture to acquire 100% shareholding of Finest Procuring Solutions Ltd, which in turn holds cent per cent shareholding of Bremer Pharma GmbH of Germany. According to reports, deal includes the transfer of all key assets, people, brands and export contracts of Bremer. After acquisition, Zydus AHL will be able to expand its animal health business and gain strategic access to the key markets across Europe, South America, Asia and Africa. Zydus' Baddi plant gets USFDA approval The formulations manufacturing plant of the Zydus group at Baddi, Himachal Pradesh has been approved by the USFDA. With the approval in place, the plant which currently caters to the domestic and emerging market requirements, will commence supplies to the US markets. Read More… Glenmark Pharma receives US$15 mn from Salix Pharma Glenmark Pharmaceuticals Ltd has announced that the Company has received US$15 mn from Salix Pharmaceuticals, Inc, USA. This is as per an Agreement for Advance against Commitment fee which is to cover Glenmark's risks associated with upgrading its manufacturing facilities to meet Salix's anticipated increased requirements in demand for Crofelemer. Through an agreement between the two companies, Salix agreed to pay Glenmark a $ 21.6 million commitment fee in five equal annual installments, with the first annual installment in July 2012, in view of Glenmark's investment in, and risks associated with, upgrading its manufacturing facilities to increase the production capacity of crofelemer. The commitment fee is in addition to the compound purchase price payable by Salix to Glenmark. After remitting the advance of USD 15 million to Glenmaric, Salix will pay Glenmark the remaining $ 6.6 mn of the conimitment fee in five equal annual installments. Strides Arcolab gets USFDA nod for Acarbose Strides Arcolab Limited (Strides) today announced that it has received US FDA approval for Acarbose Tablets,25mg, 50mg and 100 mg. Acarbose is a

Yearly Industry Newsletter

54 of 118

niche anti-diabetic drug used to treat type 2 diabetes mellitus. According to March 2011 IMS data, total US market for Acarbose Tablets approximated to USD 21 Million with no Indian generic players in the market. The Pharma division has a total of 37 filings with US FDA (21 under the PEPFAR programme and 16 as Generics). Approvals to date are 22 (17 under PEPFAR and 5 Generics). This product will be marketed and sold by Perrigo under a profit share partnership. Product is expected to be launched shortly, within Q3 ‘2011. Evolve unveils Ultra Z Evolve Medspa, a Yash Birla Group company is bringing Ultra Z, the latest technology in liposuction to India. Ultra Z is the 4th Generation ultrasound liposuction technology from South Korea. This is a very popular international device which loosens up and emulsifies fat cells from your face or other body parts leading to easier, safer and faster body sculpting. How does it work? The Ultra- Z system represents a major advance over traditional liposuction and earlier generation UAL devices; Ultra- Z was designed to efficiently emulsify fatty tissue with minimal amount of energy, thereby achieving exceptional contour finesse while preserving the tissue matrix. There is now a tissue selective ultrasound body shaping technology and surgical technique designed for precise and efficient sculpting. Why Ultra Z? The ultra-z system advanced ultrasound technology creates an efficient way of breaking down fatty tissue before it is removed, leaving nerves, blood vessels, and connective tissue largely intact. Rolling probes disperse energy to maximize efficiency in various types of fatty tissue, from delicate to fibrous, Because blood vessels and nerves are minimally disrupted, patients report little bruising, and low to minimal pain. Advantages of Ultra Z

The safest and the fastest lipo-sculpture Suitable for all body parts Protects from major tissue damages, skin burn Faster and more efficient Thinnest probe in the world for the most delicate zones Less pain, swelling and bleeding Fast recovery Even contour and enhanced skin tightening

Dr. Abhijit Desai, Make Over Expert & Managing Director – Birla Pacific Med Spa Pvt. Ltd said, “We at Evolve are always looking for the best technological advantage to provide to our customers, Ultra Z being the most advanced technology in liposuction we focus on delivering high quality treatment making it a pleasurable experience not painful.”

Yearly Industry Newsletter

55 of 118

International News - July 2011 Lonza to buy Arch Chemicals for US$1.4bn deal Swiss chemicals company Lonza Group Ltd is planning to acquire U.S.-based global biocides group Arch Chemicals Inc in an all-share deal valued at $1.4 bn, based on the offer price for all outstanding shares, according to a report. The report stated that Lonza will pay $47.20 in cash for Arch Chemicals' outstanding shares. The deal is expected to be completed by late 2011. Gilead signs pacts with 4 Indian Cos for HIV drugs Gilead Sciences, Inc. announced on Tuesday an expansion of its global access program in an effort to provide accelerated access to Gilead medicines for the treatment of HIV/AIDS. The changes announced today include new licensing terms with four India-based drug manufacturers-- Hetero Drugs Ltd., Matrix Laboratories Ltd., Ranbaxy Laboratories Ltd. and Strides Arcolab Ltd. - for three drugs which are currently in late-stage clinical development. These Indian partners have played an active role in supplying treatment to patients in the developing world. In addition, Gilead is the first pharmaceutical company to enter a licensing agreement with the Medicines Patent Pool Foundation (the Pool). The expanded licensing terms grant to the company's Indian partners and the Pool future rights to elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the "Quad," which combines four Gilead HIV medicines in a once-daily, single-tablet regimen. Gilead licensed rights to commercialize elvitegravir from Japan Tobacco (JT), and JT is working in close partnership with Gilead to ensure future access to elvitegravir in the developing world. "Gilead is proud to engage in innovative partnerships to expand access for patients in the developing world, and we welcome new opportunities to work with Indian manufacturers and the Medicines Patent Pool," said Gregg H. Alton, Gilead's executive vice president for corporate and medical affairs. "Our goal is to ensure that as new Gilead HIV therapies are developed and approved, low-cost versions will be rapidly accessible in developing countries without delay." Licensing agreements are a cornerstone of Gilead's efforts to increase access to the company's therapies in the developing world. Since 2006, when Gilead initially established licensing agreements with Indian partners, the lowest available price of a Gilead antiretroviral has decreased to US$6.15 per patient per month, or 21 cents per day. Today, more than 1.1 million patients in developing countries receive Gilead HIV medication produced by Indian partners. Sanofi to sell Dermik arm; reports Phase 3 result: reports Sanofi SA is reportedly selling its Dermik dermatology arm to Valeant Pharmaceuticals International Inc. for $425 mn in cash. According to reports, Sanofi has planned to sell the business, which owns brands including BenzaClin and Carac, in order to further concentrate on its growth platforms. Sanofi and its Genzyme subsidiary announced positive top-line results from the first of two Phase III clinical trials comparing the investigational alemtuzumab drug to the approved multiple sclerosis therapy Rebif, added reports. AstraZeneca wins USFDA nod for Brilinta (Ticagrelor) AstraZeneca announced that the US Food and Drug Administration (FDA) has approved BRILINTA (ticagrelor) tablets to reduce the rate of heart attack (myocardial infarction [MI]) and cardiovascular (CV) death in adult patients with acute coronary syndrome (ACS), compared to clopidogrel.

Yearly Industry Newsletter

56 of 118

BRILINTA, a new oral antiplatelet medicine, is indicated to reduce the rate of thrombotic cardiovascular events in patients with ACS (unstable angina [UA] non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). BRILINTA has been shown to reduce the rate of a combined endpoint of CV death, MI or stroke compared to clopidogrel. Read More… Novartis Q2 sales up 19%

The second quarter financial results for Novartis were published on July 19 with the company achieving 19% sales growth in constant currencies and excellent operating leverage. Its diversified healthcare portfolio generated sales and profit growth ahead of market with strong contributions from Alcon, Sandoz and Consumer Health. Recently launched products

grew 46% over previous-year quarter to US$3.8bn and best-in-class Gilenya launch with US$138mn in first half sales. Novartis also announced its commitment to innovation results in four major approvals and two major filings. FDA approved Afinitor for advanced pancreatic neuroendocrine tumors and Arcapta Neohaler for chronic obstructive pulmonary disease, while EU granted approval for Lucentis in retinal vein occlusion and for hypertension medicine Rasilamlo. Finally, Janus kinase inhibitor INC424 was filed for myelofibrosis in Europe and FDA accepted application to expand Menveo indication to toddlers and infants as young as 2 months. Express Scripts and Medco sign US$29.1bn merger pact Express Scripts, Inc. and Medco Health Solutions, Inc. announced that they have entered into a definitive merger agreement. Under the agreement, Medco shareholders will receive US$71.36 per share in cash and stock, or US$29.1bn, based on yesterday’s closing price. Medco shareholders will receive US$28.80 in cash and 0.81 shares for each Medco share they own upon closing of the transaction. The agreement has been unanimously approved by the boards of directors of both companies. The merger will combine the expertise of two complementary pharmacy benefit managers (PBMs) to accelerate efforts to lower the cost of prescription drugs and improve the quality of care for Americans. “The cost and quality of healthcare is a great concern to all Americans; this is the right deal at the right time for the right reasons,” said George Paz, chairman and CEO of Express Scripts. “Companies like ours have a responsibility to provide the leadership and resources required to drive out waste in healthcare and provide the best care in the world. The merger with Medco will accelerate our efforts to create greater efficiencies in the healthcare system and better protect American families from the rising costs of prescription medicine while improving health outcomes. “This continues Express Scripts’ commitment to strong growth, both organically and through strategic mergers and acquisitions. The opportunity with Medco represents an attractive strategic combination which will provide the opportunity to move forward with a wide array of tools and resources to accomplish our goals.” David Snow, chairman and CEO of Medco, commented: “Our organizations represent two great success stories in American business. We have each been successful in creating shareholder value because we are both passionate about driving value to our customers through service, innovation

Yearly Industry Newsletter

57 of 118

and a focus on cost and quality. We have a shared desire to improve the way healthcare is delivered in this country and I believe this creates a strong best-of-breed foundation, culturally, for a very successful merger. “We continue to have great confidence in moving forward as a stand-alone business, however, the incremental benefits of combining with Express Scripts are both logical and compelling.” ...Read More

Yearly Industry Newsletter

58 of 118

Domestic News - August 2011 Venus Remedies to out-licenses 4 drugs in US, Europe: report Venus Remedies is reportedly in talks with various firms in the U.S. and Europe to out-license four patent drugs over the next 2-3 years, according to reports. Pawan Chaudhary, chairman and managing director, was quoted as saying "We have short-listed a few companies in Europe, while talks are on with a few in the U.S. as we look to launch our four patented drugs by 2014." Venus also wants to out-license its anti-infectant 'Sulbactomax', pneumonia drug 'Potentox' and one-a-day pain killer 'Achnil', added reports. Claris receives MHRA approval Claris Lifesciences Limited (Claris) announced today that their plant has been approved by the Medicines and Healthcare product Regulatory Agency (MHRA) of the United Kingdom. With this approval Claris can re-launch its Bag products in the EU. This approval is a big step towards resolving the Bag issue in totality. Read More… Daiichi Sankyo and Ranbaxy to expand hybrid biz in Mexico Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Ranbaxy Laboratories Limited (hereafter, Ranbaxy) announced the expansion of business in Mexico to maximize their Hybrid Business Model, encompassing both innovative and affordable, high quality, generic medicines. Read More… Wockhardt to divest its Nutrition Business to Danone Wockhardt Ltd has said that the Pharmaceutical and Biotechnology major Wockhardt Ltd and its subsidiary on August 02, 2011 announced the signing of agreements to divest their Nutritional business to Danone, one of the fastest-growing food company in the world. Wockhardt has presence in India's nutritional category with Farex, Dexolac, Nusobee and Protinex. However, Wockhardt has retained its nutrition manufacturing facility at Jagraon, Punjab. Read More… Glenmark Generics gets approval for verapamil extended-release tablets Glenmark Generics Inc., USA, a subsidiary of Glenmark Generics Ltd, today announced they have been granted final approval for their abbreviated new drug application (ANDA) by the United States Food and Drug Administration (U.S. FDA) for Verapamil extended-release tablets, their generic version of Isoptin SR tablets by Ranbaxy. Read More… USFDA inspects Divis Lab unit near Hyderabad Divis Laboratories Ltd. said on Wednesday that it has had an inspection by the US Food and Drug Administration (USFDA), with no major observations, for its Unit-1 at village Lingojigudem, Choutuppal Mandal, near Hyderabad during July. The audit concluded with minor observations, primarily about additional records for further improvement of existing records. Venus Remedies' novel research product 'Vancoplus' receives US Patent Venus Remedies has received its first US patent from US PTO for its novel research product, Vancoplus. With this patent grant, which is valid up to December 2027, the company is all set to tap the US market by launching the product. Earlier, Vancoplus has already been granted the patents from countries like South Africa, New Zealand and Ukraine. Read More… Global health and Inp+ recommends Fornext Phase GHA India (Global Health Advocates, India) along with INP +(INP+ has over 2,75,000 members in 26 states and 282 districts) has prepared a list of recommendations for the Government of India to consider while planning the next phase of National AIDS Control Programme(NACP IV) which will run

Yearly Industry Newsletter

59 of 118

from 2012 to 2017. NACO is expected to examine these recommendations while drawing up the National Strategic Plan in September 2011 for NACP IV for 2012-2017. INP + is a part of the working groups on Care and Support, Stigma and Greater Involvement of People Living with HIV set up by the National AIDS Control Organisation (NACO) to develop these recommendations. The recommendations, developed from 7 regional nation-wide consultations( in Orissa, Calcutta, Pune, Imphal, Chennai, Lucknow and Delhi), cover three main areas: prevention of TB among PLHIV, improved ART treatment and early checking for resistance to first line of ARTs for people living with HIV/AIDS as well as with the TB-HIV co -infection and mainstreaming HIV into the health system. TB is the leading cause of death for PLHIV in India contributing to more than half the deaths. Among the major recommendations of TB/HIV consultation include a call for early scale up and availability of better and faster TB testing technology. These include the roll out of the molecular based NAAT (Nucleic Acid Amplification Test) tests which provides early diagnosis of pulmonary TB and Extra Pulmonary TB. The Stop TB partnership in its global plan to stop TB for 2011-2015 has listed a specific plan for saving a million lives by 2015 through scale up in testing for TB among PLHIV , earlier ART treatment and early and regular TB treatment. Stop TB targets an 80 percent detection and treatment rate for TB among PLHIV by 2015, currently less than 5 percent of PLHIV in India are automatically tested for TB K. K. Abraham, President of Indian Network for People Living with HIV/AIDS (INP+), pointed out that,” These tests in future will also help to bypass the reluctance of health care provider in taking samples in form of pus/blood or Cerebrospinal Fluid (CSF) fluid in the case of Extra Pulmonary TB . Apart from these INP + has three top recommendations which can help save lives. These are to ensure a better quality diagnosis for early detection of first line treatment failure cases . This will save lives of PLHA waiting to get second line of ART. Other recommendations are Alternate Drugs (Tenofovier based) for first line ART and involving the PLHIV community in monitoring and evaluation”. Lupin shares gain after inking pact with Eli Lilly The shares of Lupin are trading at Rs. 456, up by Rs. 1.40 or 0.31%, as against the previous close of Rs. 454. Early today, the stocks of Lupin rose by 1.4% to Rs. 461.25 after the company and Eli Lilly India agreed to a collaboratio to promote and sell Lilly’s Huminsulin range of products, according to reports. The shares had earlier opened at Rs. 461, touching the day’s high and low at Rs. 462 and Rs. 455, respectively. The total traded quantity stood at 0.34 lakh shares on the BSE. Intel Labs invests US$30mn in Cloud and Embedded computing Aimed at shaping the future of cloud computing and how increasing numbers of everyday devices will add computing capabilities, Intel Labs announced the latest Intel Science and Technology Centers (ISTC) both headquartered at Carnegie Mellon University. These centers represent the next US$30mn installment of Intel's recently announced 5-year, US$100mn ISTC program to increase university research and accelerate innovation in a handful of key areas. As with previously announced ISTCs for visual computing and secure computing, the new centers encourage tighter collaboration between university thought leaders and Intel. To encourage further collaboration, the ISTCs use open IP models with results publically available through technical publications and open-source software releases. "These new ISTCs are expected to open amazing possibilities," said Justin Rattner, Intel Chief Technology Officer. "Imagine, for example, future cars equipped with embedded sensors and microprocessors to constantly collect and analyze traffic and weather data. That information could be shared and

Yearly Industry Newsletter

60 of 118

analyzed in the cloud so that drivers could be provided with suggestions for quicker and safer routes. Piramal Healthcare to acquire 5.5% stake in Vodafone Essar

Piramal Healthcare and Vodafone Group has announced that Piramal has agreed to purchase approximately 5.5% of the issued equity share capital of Vodafone Essar Limited (“VEL”) from ETHL Communications Holdings Limited (“Essar”) for cash consideration of Rs. 2,856 crores (approximately US$640 million).The transaction follows the settlement

between Vodafone and Essar over the sale of Essar’s approximately 33% stake in VEL, announced on 1 July 2011. The transaction contemplates various exit mechanisms for Piramal, including both participation in a potential initial public offering of VEL and a sale of its stake to Vodafone.

Fortis to buy 65% stake in Hoan My Medical for US$64mn Fortis Healthcare International Pte Ltd (“Fortis International”) has taken another important step in its path to become a leading integrated healthcare provider in Asia Pacific. The company has entered into an agreement to acquire 65% stake in Hoan My Medical Corporation, Vietnam for US$ 64m. This marks the entry of

Fortis International into one of Asia's fastest growing economies and the group’s first acquisition of a hospital chain outside of India. Read More… Glenmark files arbitration claims against Napo

Glenmark wishes to inform the filing of a Statement of Claim with the American Arbitration Association against Napo Pharmaceuticals Inc. (“Napo”) seeking, among other things, a declaration that Glenmark’s exclusive rights to develop, commercialize and distribute Crofelemer in 140 countries for treatment of diarrhoeal disease includes the exclusive right to

distribute through relief agencies in these countries. Read more… Birla Pacific Medspa rises on Big B entry The shares of Birla Pacific Medspa were trading higher after Amitabh Bachchan bought 10 lakh shares of the company at an average price of Rs. 18.50. Ranbaxy introduces 'Volini Due', unique 2-in-1 pain killer The OTC business division of Ranbaxy Laboratories Limited, Ranbaxy Global Consumer Healthcare (RGCH) has launched "Volini Duo", India's first approved two-in-one pain killer, a unique bi-layered Acetaminophen tablet, specially formulated to give dual pain relief. The product has been introduced pan India. Commenting on the launch of the product, Brijesh Kapil, Vice President, RGCH, said, "Ranbaxy remains committed to developing and offering quality, sale, efficacious and innovative solutions to consumers. The introduction of 'Volini Duo' is a move in this direction." Read More…

Yearly Industry Newsletter

61 of 118

Glenmark initiates Phase IIb human trials globally for its novel molecule 'Revamilast' Glenmark Pharmaceuticals today announced that its Novel Chemical Entity "Revamilast" (GRC 4039) has initiated Phase lib human dose range finding trials globally. Revamilast is an orally active, potent and selective inhibitor of phosphodiesterase 4 (PDE 4) that is currently being developed by Glenmark for the treatment of chronic inflammatory disorders such as Asthma, Rheumatoid Arthritis (RA) and other inflammatory diseases. The Phase lib studies that will be carried out will help establish the efficacy and safety of the molecule and will also provide dose range finding data for Revamilast. Read More… Wockhardt rises on sale of Nutritional biz to Danone Shares of Wockhardt rose after the company and its subsidiary on August 2, announced the signing of agreements to divest their Nutritional business to Danone, one of the fastest-growing food company in the world. Its Board is scheduled to meet on Tuesday to consider and approve the unaudited financial results for the quarter ended June 30, 2011. The shares of Wockhardt are trading at Rs. 434, up by Rs. 11 or 2.81%, as against the previous close of Rs. 422. It had earlier opened at Rs. 416, touching the day’s high at Rs. 438 and day’s low of Rs. 410. The total traded quantity stood at 2.35 lakh shares on the BSE. SpectroCam now available with interchangeable optical filters The SpectroCamT Multispectral Imaging (MSI) Camera is now available from Ocean Thin Films (OTF) in a new development platform that combines a scientific-grade CCD array with a precision rotating optical filter wheel to create the world's first fully configurable MSI camera. Applications include water quality measurements, product screening, machine vision, medical imaging, surveillance and authentication. SpectroCam complements single-point spectroscopy by adding another dimension to spectral measurements. With a single-point spectrometer, users can analyze spectral differences from sample to sample and then, by selecting discrete filters in and around spectral areas with the most significant differences, use SpectroCam to create an image that shows vivid contrast between the samples. At the heart of the SpectroCam is a wideband CCD that is responsive from the visible through near infrared spectrum. The system's precision filter wheel and optics can be customized for a variety of applications. Image speed is 20 fps at full resolution and the standard F-Mount configuration accommodates a range of lens choices, focal lengths and fields of view. Each system includes a lens, eight standard interchangeable filters and software. OTF collaborated with miniature spectroscopy leader Ocean Optics to create this suite of tools, making multispectral imaging accessible to everybody from university researchers to high volume OEM equipment makers. The interchangeable optical filters and continuously rotating filter wheel overcome many of the shortcomings that prismatic MSI systems face. With interchangeable filters, users can try many filter options to narrow in on the best contrast, greatly reducing development time and allowing users to bring products to market faster. Sun Pharma receives nod for finasteride pill Sun Pharmaceutical Industries Ltd. reportedly received approval from the U.S. Food and Drug Administration for its finasteride pill, the generic version of Merck’s Proscar and Propecia. The drugs are used to treat enlarged prostate and hair-loss in men.

Yearly Industry Newsletter

62 of 118

Lincoln Pharma unveils lactation inducing drug Lincoln Pharmaceuticals Ltd. (LPL) reportedly introduced Ayurvedic product ‘ISL Granules’ in the mother and child healthcare segment. According to reports, ISL Granules helps initiate and sustain breast milk secretion and improves the general health of the mother without causing any side effects. The product has been developed by Teresa, a specialty division of LPL for the segment. ISL Granules contain extracts of eight proven herbs and natural calcium in a chocolate flavoured drink formulation and will be available in 300 gm pearl pet pack. Orchid resumes production in its API plant in Chennai Orchid Chemicals & Pharmaceuticals Ltd. (Orchid) today announced that its Cephalosporin API manufacturing facility located in Alathur (Chennai) has been re-opened and production activity will commence immediately. The Alathur API plant that had earlier received a Closure Notice from the Tamilnadu Pollution Control Board (TNPCB) has now been cleared and production activities will commence immediately. Panacea Biotec slumps 20% on WHO recall The shares of Panacea Biotec tumbled by the daily 20% limit after two of the company's vaccines were removed from the World Health Organisation's (WHO) pre-qualified list, citing non-compliance of manufacturing sites. The company's diphtheria-pertussis-tetanus based combination of two vaccines and another hepatitis B vaccine have been removed from the WHO list. WHO has, however, stated that there is no evidence of quality or safety defects with batches of these vaccines already distributed. These batches should not be recalled and should continue to be used, according to WHO. The company said it has initiated corrective measures against the WHO recall. Dr Reddys recalls cholesterol drug in US: reports Dr Reddy’s has reportedly recalled more lots of the cholesterol lowering drug simvastatin (80 mg) of different strengths from the US market. According to reports, the company informed USFDA that over 60,000 bottles of 10 mg and 40 mg of simvastatin will be recalled from the market. The recall comes under the Class II category, which means the probability of serious adverse health consequences is remote. Zenotech Laboratories appoints Executive Chairman Zenotech Laboratories Ltd has said that the Board of Directors of the Company has appointed Dr. Sudershan K. Arora, Chairman as Executive Chairman of the Company with effect from August 25, 2011, subject to requisite approvals. JB Chemicals declares special interim dividend JB Chemicals & Pharmaceuticals Ltd has announced that the Board of Directors of the Company at its meeting held on August 19, 2011, has declared Special Interim Dividend of Rs. 40 (Rupees Forty) per equity share of face value of Rs. 2 to reward the shareholders consequent to sale of the Russia-CIS OTC business. The dividend will be paid/dispatched on September 08, 2011. The payment of this Special Interim Dividend together with dividend distribution tax will absorb Rs. 393.78 crores. The shares of JB Chemicals & Pharmaceuticals Ltd were trading at Rs. 136.75, down 5.8% against the previous close. It touched a day's high of Rs. 152.00 and a low of Rs. 116.60. Dr. Reddy's and Pfizer settle Lipitor case Dr. Reddy's Laboratories Ltd. said that it has settled a lawsuit filed by Pfizer Inc. over a generic version of the latter's blockbuster cholesterol drug, Lipitor. Dr. Reddy's did not disclose the terms of the agreement, but said that the settlement with Pfizer is subject to review by the US Justice Department

Yearly Industry Newsletter

63 of 118

and the Federal Trade Commission. Lipitor is the biggest-selling branded drug in the world. Pfizer gets more than US$11bn in annual revenue from Lipitor, but the US drug giant is set to lose American patents on Nov. 30. Lipitor had second quarter global sales of US$2.6bn, including sales of US$1.4bn in the US alone. Dr. Reddy's had sought USFDA approval for generic Lipitor in 2009. Pfizer then filed a lawsuit accusing the Indian company of violating patents supporting Lipitor. It may be recalled that in 2008 Pfizer reached a settlement with Ranbaxy whereby the Indian drug firm is allowed to launch a generic copy of Lipitor on November 30. Ranbaxy is entitled to six months US marketing exclusivity as it was the first to approach the USFDA for a generic version of Lipitor. Ranbaxy is now owned by Japan's Daiichi Sankyo. Pfizer has signed an agreement with Watson Pharma to sell authorized generic of Lipitor beginning November. Wockhardt plans to unveil 12-15 products in US market: reports Wockhardt reportedly plans to introduce 12-15 products in the US market this fiscal and also expand its reach in the European market. According to reports, the company received 7 abbreviated new drug applications (ANDA) approvals this year. The detail of the products to be launched is not yet specified by the company. The company's sales during 2010-11 exceeded USD 225 million for the first time in the US. Global experts turn to India as a key pathfinder on battling Tuberculosis Tuberculosis - the world's number one infectious killer disease after AIDS - is facing an enemy with escalating power and determination: India. "India is moving towards universal access for quality TB care and has it in its power to become a global leader in TB research and innovation, as well as in manufacturing of essential anti-TB drugs and TB diagnostics," says Dr Vishwa Mohan Katoch, Secretary to the Government of India and Director-General, Indian Council of Medical Research. Read More… Lupin receives final approval to market Generic Ultram ER Lupin Pharmaceuticals Inc (LPI) has received final approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its Tramadol ER, shortly. Tramadol HO. ER is a centrally acting synthetic analgesic in an extended release formulation. It is the generic equivalent to Ortho-McNeil's Ultram ER Tablets and is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Tramadol HC1 ER tablets had annual sales of approximately $132 million for the twelve months ended June 2011 based on IMS Health sales data. Sanofi Aventis & Multicare ink strategic agreement in the Philippines Sanofi-Aventis Philippines Inc., which is part of the Sanofi Group, and Multicare Pharmaceuticals (Multicare), the Philippines subsidiary of Lupin limited, have entered into a marketing and distribution agreement whereby Multicare will market Sanofi-Aventis's Central Nervous System (CNS) global brands, Solian (Amisulpride) and Sulnox (Zolpidcm Hemitartrate) in the Philippines. The annual sales revenues of these brands arc valued at PHP 138 million (IMS). Read More… Fortis announces another 4 hospitals Fortis Healthcare (India) Ltd. today announced the launch of four hospitals as part of its plan to strengthen its presence across the country. This announcement fulfills the ‘10 in 10’ commitment made by the Company on its 10th Anniversary in end-June, to announce 10 new hospitals in 10 weeks.

Yearly Industry Newsletter

64 of 118

Fortis has now announced 10 launches in less than 10 weeks, taking its bed capacity to 10,270 beds. Besides setting up new hospitals in Cochin, Bilaspur and Bangalore, Fortis Healthcare will manage the Cardiac Care unit at HLG hospital in Asansol, West Bengal. Fortis marks its entry into Kerala with a 45 bed boutique hospital in Cochin, which will offer quality healthcare for women under the ‘Fortis La Femme’ brand. As part of the hub and spoke model, a multi-specialty hospital in Bilaspur, acting as a spoke to the Mohali hub, will cater to the Kullu-Manali-Mandi belt by FY 2012. Expanding its reach in West Bengal, Fortis will operate and manage a 50-bed Cardiac Care unit at multi-specialty HLG hospital in Asansol. The Group also strengthens its presence in the South with a world-class tertiary care hospital in Bengaluru, strategically located near the Marathalli Junction, which will commence operations by 2013. This follows the recent announcement to operate a 100-bed boutique hospital for women in the state. Polar Pharma receives order from Ministry of Health & Family Welfare Polar Pharma India Ltd has said that the Company has received two supply orders both dated August 04, 2011 aggregating to Rs. 853.38 lakhs from Ministry of Health & Family Welfare (MHFW), Government of India, New Delhi for supply within December 31, 2011. Aventis Pharma to buy Universal Medicare's nutraceutical unit Aventis Pharma is planning to acquire Universal Medicare's nutraceutical unit in India. The transaction has been approved by the Board of Directors of both companies. It is expected to close in the fourth quarter of 2011, subject to certain conditions precedent. HDFC Trustee acquires stake in Aurobindo Pharma: report Aurobindo Pharma has reportedly said that said that different funds belonging to HDFC Trustee Company had purchased 5.01% stake in the firm. The report stated that Different funds of HDFC Trustee Company have purchased 145,93,640 equity shares amounting to 5.01% of the paid up equity share capital. The purchase was carried out in open market. Cipla expects to scale up its revenue: reports Cipla is reportedly expecting to scale up its revenue by over six times to Rs. 150-200bn by 2020 and assured shareholders the promoters have no plan to divest their stakes with significant growth in the business. According to reports, the company had achieved net revenue of Rs. 61.35bn in FY11. This year with the rationalisation planned, the company is aiming to stabilise and consolidate. Takeda Pharma eyes pharma biz of Cipla and Lupin: report Takeda Pharmaceutical Co., Japan's largest drugmaker, is in talks with Indian drugmakers Cipla and Lupin for buying pharmaceutical business of one of the companies, according to a report. The report stated that the company is interested in buying Lupin's domestic formulations business, as well as its research facility. Takeda's talks with Lupin have progressed beyond the initial stages, but the company's founders are not willing to sell the research facility. They are not in talks with anyone to sell either a stake or any of its brands. NABH, BD collaborate to develop quality–of-care standards for hospitals NABH (National Accreditation Board for Hospitals & Healthcare Providers) and BD (Becton, Dickinson and Company) today signed a Memorandum of Understanding (MoU) to support hospitals in attaining quality-of-care

Yearly Industry Newsletter

65 of 118

standards for infection control. This collaboration is an effort to strengthen health systems in India and promote continuous quality improvement to ensure quality care for patients when visiting hospitals with effective infection control practices in place. With the wider rollout of community health insurance initiatives, there is an increased demand for bed capacity. Existing small and medium-size hospitals, estimated to account for more than two-thirds of all beds need to strengthen the quality systems and these hospitals can achieve quality-of-care systems by standardizing and adopting necessary infection control practices to ensure patient and healthcare worker safety. Speaking on the occasion of the signing, Dr Giridhar J Gyani, Quality Council of India, Secretary General and CEO, NABH said: “Our objective is to develop a basic infection-control standard for all hospitals delivering healthcare in India. The association with BD will enable us to provide on- and off-site technical support to collaborating institutions for upgrading their infection control practices.” NABH has recommended quality toward safe injection practices, waste management and infusion safety, to name a few, as minimum requirements across hospitals in India, following the lead of several facilities undertaking these processes. Most of these hospitals are high in volume and have the bandwidth as well as the desire to improve clinical outcomes; whereas the quality of care in smaller hospitals, especially which are government empanelled is much more varied in terms of infection control practices. NABH is currently operating in India with nearly 500 hospitals in various phases of accreditation, and nearly 100 hospitals are already accredited…Read More No investments in Jagathi Publications: Aurobindo Pharma Aurobindo Pharma Ltd has announced that the Company or any of its subsidiaries do not have investments in Jagathi Publications Private Limited or in any of its Associate Companies.

Yearly Industry Newsletter

66 of 118

International News - August 2011 JICA partners Bill & MelindaGates Foundation on Polio Eradication Sadako Ogata, President of the Japan International Cooperation Agency (JICA), and Bill Gates, co-chair of the Bill & Melinda Gates Foundation, today announced a strategic partnership to ensure continued progress in the fight against polio. As the first step in this formal partnership, Ogata and Gates also announced an innovative financing agreement to support the polio campaign in Pakistan. GE Healthcare to acquire PAA Laboratories GmbH GE Healthcare, a unit of General Electric Company announced that it has reached an agreement to acquire PAA Laboratories, a developer and supplier of cell culture media for biomedical research and the fast-growing biopharmaceutical and vaccine manufacturing industry. The acquisition of PAA Laboratories will allow GE Healthcare to expand its offering of products and services for cell biology research and for the discovery and manufacture of biopharmaceuticals including recombinant proteins, antibodies and vaccines. The strong strategic fit between the two businesses, combined with expanded capabilities in product development and marketing, will offer significant long-term customer benefits. Financial terms were not disclosed. Read More… FAO urges to prepare against resurgence of H5N1 FAO today urged heightened readiness and surveillance against a possible major resurgence of the H5N1 Highly Pathogenic Avian Influenza amid signs that a mutant strain of the deadly Bird Flu virus is spreading in Asia and beyond, with unpredictable risks to human health. The H5N1 virus has infected 565 people since it first appeared in 2003, killing 331 of them, according to WHO figures. The latest death occurred earlier this month in Cambodia, which has registered eight cases of human infection this year -- all of them fatal. Read More… Reckitt Benckiser to sell personal care biz of Paras Pharma: report Reckitt Benckiser Group Plc, the maker of Dettol handwash, is planning to sell the personal care business of its Indian Paras Pharmaceuticals unit, according to a report. The report stated that Reckitt Benckiser may sell the unit for about Rs 9 bn. The company, which paid $724 mn to acquire Paras last year, has hired JPMorgan Chase & Co. to manage the sale and will start the process by next month.

Yearly Industry Newsletter

67 of 118

Domestic News - September 2011 Ranbaxy climbs on Lipitor launch buzz Shares of Ranbaxy Laboratories Ltd. touched a three-month high after media reports suggested that the Company aims to start selling the generic version of Pfizer Inc.’s blockbuster drug Lipitor on schedule, in November. The stock closed at Rs. 507.25, up Rs. 21.25 or 4.4% over the previous close. It had earlier been as high as Rs. 512.15 after opening at day's low of Rs. 487. More than two lakh shares changed hands on the BSE versus a two-week average of 71,000 shares. The stock had touched a 52-week low of Rs. 414 on May 11. It hit a 52-week high if Rs. 624 on Nov. 11. Daiichi Sankyo Co., which owns Ranbaxy, is reportedly working with the U.S. Food & Drug Administration (USFDA) to resolve issues and get an approval to introduce the cholesterol-lowering pill in the US market. A legal settlement with Pfizer gave Ranbaxy six months’ exclusivity to market generic Lipitor in the US. Pfizer garnered US$10.7bn in Lipitor sales last year. Ranbaxy won’t sell its right to market generic Lipitor in the US and denied a Credit Suisse report that the Indian company will sell the right should it fail to win timely USFDA approval, said reports. Wockhardt asked to give timeline for clearing dues Wockhardt has been asked by the Bombay High Court to work out a plan and a timeframe for dues payment to its bondholders failing which the liquidator could take charge of the company, according to reports. Justice D K Deshmukh was quoted as saying that it was "not concerned if the company has to sell its assets to pay a bond holder" but added that it would mean that the pharmaceutical company was not in a position to pay its debts. If the company wanted permission of the court to sell its assets it would not give such a permission unless Wockhardt makes a statement that it would bring the amount due to the bond holders-Rs 4.73bn in dues-by a particular date, reports stated. Cipla shuts 2 marketing divisions: reports Cipla has reportedly closed Protec and Omnicare, two of its four marketing divisions, as there was certain rationalisation required for better productivity. The staff from these divisions will be accommodated in other areas of the company. According to reports, the company won't curb down on any of its products, rather it might want to phase out low margin and pain ending products which are at its base so that they could rationalise their product portfolio. Cipla is also planning to invest 6bn in research units. Ranbaxy UK launches esomeprazole Ranbaxy (UK) Ltd. announced that it has successfully launched esomeprazole 20 mg and 40 mg tablets, the first approved generic bio-equivalent version of the product NexiumTM, in the United Kingdom (UK), with annual UK sales of £ 60 Mn (IMS June 2011). Commenting on the development, Debashis Dasgupta, Regional Director, Ranbaxy Europe, said, “We are committed to bringing high quality, affordable medicines for the benefit of patients and healthcare systems worldwide and in Europe. The introduction of esomeprazole, in the UK, is an important and significant step in this direction.” The product will be offered through pharmacies, retail and wholesale stores with immediate effect. Esomeprazole is used in the treatment of dyspepsia, peptic ulcer disease (PUD), gastroesophageal reflux disease (GORD/GERD) and Zollinger-Ellison syndrome. Jubilant Life Sciences receives ANDA approval for Pantoprazole Sodium Tablets Jubilant Life Sciences Ltd, an integrated Pharma and Life Sciences Company and the largest Custom Research & Manufacturing player out of India announced today that it has received Abbreviated New Drug Application approval for Pantoprazole Sodium Delayed Release Tablets 20mg & 40mg, a

Yearly Industry Newsletter

68 of 118

generic equivalent of Protonix*, from the US FDA (U.S. Food and Drug Administration). Pantoprazole Sodium Tablets will be manufactured at the ‘state of the art’ dosage forms facility of Jubilant Life Sciences, at Roorkee, in India, with backward integration into the API manufactured at the Company’s USFDA approved API facility at Nanjangud in India. The product will be marketed by its US subsidiary Jubilant Cadista Pharmaceuticals Inc. under its own label. Read More… Parabolic Drugs adds 15% capacity to Cephalosporin facility Parabolic Drugs Ltd., a vertically integrated API manufacturer and exporter in India, today announced the commissioning of eighth manufacturing plant at its European GMP Accredited Derabassi facility - fully dedicated for the manufacturing of latest generation Cephalosporin, both in Oral and Sterile forms. Read More… Suven Life Sciences secures 4 Product Patents for their NCEs Suven Life Sciences Ltd (Suven) announces today that the grant of four (4) product patents, three (3) from Australia (2005328870, 200734063 and 2008315309), one (1) from New Zealand (578281) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegeneratlve diseases and these Patents are valid through 2027. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia. Read More… Hinduja Hospital begins new Rural Healthcare Program Hinduja Hospital is a super-specialty tertiary care trust hospital founded way back in 1951. Founder Sri Paramanand Deepchand Hinduja believed that health and education are the birthrights of every citizen. He wanted to create an institution that could provide “Quality Healthcare for All”. He, together with some like-minded individuals, worked towards this goal and Hinduja Hospital is a culmination of his vision. Our chairman, Sri S P Hinduja and his brothers continue to hold their father’s dream close to their hearts and Hinduja Hospital Rural Health Program is another milestone in this direction. Read More… Ranbaxy in talks with Ind Swift to source raw material: reports Ranbaxy Laboratories is reportedly in talks with Ind Swift to source raw material to make low-cost version of Lipitor, which hopes to roll out in the US by November end. N R Munjal, vice-chairman at Ind Swift was quoted as saying “We are discussing various options to supply intermediate or final API atorvastatin to Ranbaxy." API or active pharmaceutical ingredient is the basic chemical used in a drug, in this case, atorvastatin. Reports said that discussions for sourcing API confirms Ranbaxy's 'intention to produce' the medicine on its own. But it was unlikely that the API from this supply agreement would be used for the US launch, which subject to the approval of the US drug regulator, is slated for November 30. Infosys close to acquiring healthcare biz of Thomson Reuters: reports Infosys to reportedly buy Thomson Reuters Corp. (TRI)’s health-care business for as much as $750mn in the Indian company’s biggest acquisition. According to reports, Thomson Reuters is also seeking to sell its BARBRI bar-exam- preparation business and the risk-management Enterprise Risk unit. Infosys plans to add customers in industries outside of banking, while Thomson Reuters seeks to sell its health-care division. GE Healthcare to invest US$1bn in new oncology solutions

Yearly Industry Newsletter

69 of 118

GE Healthcare, the health business of General Electric, announced its plans to dedicate $1billion of its total R&D budget over the next five years to expand its advanced cancer diagnostic and molecular imaging capabilities, as well as its world-class technologies for the manufacture of biopharmaceuticals and for cancer research. Announced alongside a $100m open innovation challenge in New York City, the $1 billion investment crosses all lines of GE Healthcare’s global business and is an example of the company’s commitment to fighting cancer. The investment will enable the company to bring the most promising cancer ideas to market, unleashing technologies that improve accuracy of diagnosis to enable more effective treatment decisions and empower doctors and patients with better information. Read More… Jubilant HollisterStier signs contract with US pharma company: reports Jubilant Life Sciences Ltd reportedly said that its subsidiary, Jubilant HollisterStier has entered into a multi year contract with a US pharma company to manufacture over the counter (OTC) women health and personal care product. According to reports, it is a “take or pay” contract with a minimum quantity commitment and has a total value of over $ 70mn for a period of over 4 years with a possibility of extension for another 2 years for a higher quantity. The production of the product under this agreement started earlier this month. The product will be manufactured at Jubilant's Montreal facility in North America. Read More… GE Healthcare in alliance with Veran Medical GE Healthcare, the $17 billion healthcare unit of General Electric Company , and Veran Medical Technologies, Inc., a privately-held medical device company, announced that the companies have entered into a strategic alliance to advance and co-develop navigation technologies for interventional procedures to improve the care and management of cancer patients. Building on the alliance, the GE Healthymagination Fund, an equity fund that makes investments in highly promising healthcare technology companies, is investing in Veran. The financial terms were undisclosed. The alliance between the two companies reflects GE’s healthymagination initiative, which focuses on reducing cost, increasing access and improving quality in healthcare. Read More… Lupin announces launch of Generic KEPPRA XR Tablets Pharma major, Lupin Ltd., announced today that its subsidiary. Lupin Pharmaceuticals Inc. (LPI) has been granted final approval by the U.S. Food and Drug Administration (FDA) for the company's Abbreviated New Drug Application (ANDA) to market a generic version of UCB's KEPPRA XR tablets. Commercial shipment of the product has commenced. Lupin's Levetiracetam 500 mg and 750 mg extended-release tablets arc the AB-rated generic equivalent of KEPPRA XR , an antiepileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age with epilepsy. KEPPRA XR tablets had annual sales of approximately $161 million for the twelve months ended June 2011 based on IMS Health sales data. Read More… …Lupin receives approval from USFDA for Eszopiclone Sleep Medicine Strides Arcolab Bangalore unit inspected by USFDA Strides Arcolab Ltd has announced that its Oral Dosage Forms manufacturing sites in Bangalore was inspected by USFDA as part of GMP compliance audit and facility continues to be approved with Zero Inspectional observation reported in FDA 483. The last US FDA inspection and approval for this facility was in the year 2008. The KRS Gardens facility in Bangalore manufactures oral dosage forms such as tablets and capsules (both hard gelatine and soft gelatine). The manufacturing plant supports important current and future

Yearly Industry Newsletter

70 of 118

submissions for the US Market. Manish Gupta, CEO – Pharma of Strides said “this continued approval of the site with Zero observation in FDA 483 augurs very well for the Pharma division of the Company in this challenging regulatory and business environment”. Healing with Homeopathy by Dr. Mukesh Batra Dr. MUKESH BATRA, India's most famous homeopath and founder of the world's largest chain of homeopathy clinics, shares his professional expertise to help you diagnose and find answers for common and not-so-common ailments. A simple, user-friendly practical guide to holistic health, Healing with Homeopathy deals deftly with over 100 illnesses arranged alphabetically from A-Z. Writing simply and clearly, Dr. Batra explains each condition, its symptoms and variations and what homeopathic remedy is likely to work best. Included are useful dos and don'ts as well as illustrative case studies, culled from over 35 years of medical practice. An expert introduction to homeopathy and its application, Healing with Homeopathy arms you with the knowledge and confidence to recognise and deal with a variety of health issues in the comfort of your own home. Put simply, the book is an invaluable tool for anyone who wants to take charge and manage their health safely, gently and without the fear of side-effects. Dr. Reddy’s launches generic Dementia drug in US Dr Reddy’s Laboratories has reportedly introduced Rivastigmine Tartrate capsules in the US market. According to reports, capsules are a bioequivalent generic version of Exelon capsules (of Novartis Pharmaceuticals Corporation) in the US market. They are indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. The Exelon brand and generic rivastigmine tartrate had U.S. sales of approximately $92.6mn for the most recent twelve months ending June 2011. Biocon eyes US$1bn revenue in 3 years Biocon reportedly said that its target is to achieve revenues of $1bn in the next fiscals. According to reports, the company sees themselves among the top 10 global biotechnological companies in the world. The company will also mainly emphasis on chronic diseases like diabetes, cancer and auto immune diseases. Biocon plans to list its contract research and manufacturing services arm Syngene, which will be done in the next 18 months. The company needs to see sustained growth over four quarters before it starts with it, added reports. Fortis Healthcare pulls out of talks to buy stake in Acibadem: reports Fortis Healthcare International has reportedly pulled out of talks to buy a controlling stake in Turkish hospital group Acibadem. According to reports, the company took a step back due to valuation concerns and political unrest in the Middle East. The stake is being sold by Almond Holding. Abraaj has a 46% stake in Almond Holding, which controls 92% of Acibadem. Acibadem is in talks with investors including Fortis Healthcare, added reports. Lupin announces U.S. FDA approval of its first oral contraceptive Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (LPI) has been granted final approval by the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to market a generic version of Watson’s NOR-QD tablets. Lupin will commence shipping its norethindrone tablets, USP 0.35 mg shortly. NOR-QD (norethindrone tablets, USP 0.35 mg) is a progestin-only oral contraceptive indicated for the prevention of pregnancy. Combined annual sales for NOR-QD and its generic equivalents were approximately $52 million for the twelve months ended June 2011 based on IMS Health sales data. Read More… Apollo Hospitals to divest minority stake in Apollo Health Street: reports

Yearly Industry Newsletter

71 of 118

Apollo Hospitals will reportedly divest minority stake in Apollo Health Street, the group’s business process outsourcing division. According to reports, the company is scouting for partners from the IT space and looking at 3-4 contenders – both global and domestic firms – who want to strengthen their health IT portfolio. Apollo Hospitals is looking to invest Rs. 15bn. Part of this will be funded by Apollo’s recent QIP which raised Rs. 3.3bn; the group already has Rs. 6bn. Promoters will bring in Rs. 1bn. The rest will be raised via internal accruals, added reports. Aanjaneya Lifecare clarifies on acquisition reports Aanjaneya Lifecare Ltd. has clarified that the Company explores various strategic moves from time to time. However, as a policy and in the interest of its shareholders, the Company does not comment on any report relating to potential strategic initiatives unless they have reached the definite stage. The Company made it clear to the journalist that it does not comment on market speculation and the same has been mentioned by the newspaper article as well. "We once again reiterate that the news article is based on speculation and the Company had not issued any press release or notification regarding the same," Aanjaneya Lifecare said today. Sun Pharma subsidiary resolves USFDA warning letter Sun Pharmaceutical Industries Ltd has announced that the U.S. Food and Drug Administration ("USFDA") has informed Sun Pharmaceutical Industries, Inc., its wholly owned subsidiary, that after a June 2011 re-inspection of its Cranbury, New Jersey, US manufacturing facility, the site has an acceptable regulatory status. Therefore, the issues noted in the August 25, 2010 warning letter are considered to be resolved. Caraco, now wholly owned by Sun Pharma, continues to work with consultants to resolve the issues raised by the USFDA at its Detroit plant. Cabinet agrees to set up 6 National Institutes of Pharmaceutical The Union Cabinet approved the establishment of six new National Institutes of Pharmaceutical Education and Research (NIPERs) at Gandhinagar, Hyderabad, Kolkata, Hajipur, Guwahati and Rae Bareli at an estimated cost of Rs.633.15 crore. This will facilitate the establishment of full fledged NIPER Campuses at these places for imparting higher PG level education as well as undertake R&D projects. This will help in meeting the requirement of highly skilled manpower of the pharmaceutical industry, and focus on R&D. Read More… Strides Arcolab gets USFDA nod for Paclitaxel Injection Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited (Strides) has announced that it has received USFDA approval for Paclitaxel Injection USP, 6 mg/ ML packaged in 30 mg/ mL, 100 mg/16.7 mL and 300 mg/ 50 ML multiple dose vials. Paclitaxel is among the products in the drug shortage list of the American Society of Health-System Pharmacists and the USDFDA. According IMS data, the US market for generic Paclitaxel approximated US$46mn. The Company will launch the product immediately. Read More… Indian Red Cross Society to get benefits under I-Tax Act The Union Health Minister Ghulam Nabi Azad presided over the General Body meeting of the Indian Red Cross Society and St John Ambulance (India) on behalf of the President of India Smt. Pratibha Devisingh Patil . The meeting was convened after a gap of seven years at the initiative of Azad. Over 350 members of the General Body including Governors of the States of Uttar Pradesh, Chhattisgarh and UT Andaman and Nicobar Islands attended today’s meeting. Addressing the gathering Azad said that he is happy to note the increased role and recognition of Indian Red Cross. The Society now has the latest communication tools, including emergency response units, mobile disaster units and medical disaster units to initiate assessment and

Yearly Industry Newsletter

72 of 118

relief in times of calamity. There are six warehouses located in strategic locations in the country where these equipments and relief items are stored. Read More… Fire at Orchid Chemicals' Sholinganallur plant A fire broke out reportedly at one of Orchid Chemicals and Pharmaceuticals' plants at Sholinganallur, near Chennai. According to reports, short circuit is suspected to be the cause of the fire. The fire broke out at four of the labs. There was damage to office and laboratory equipment, furniture and building interiors. However, there were no injuries to anyone. The fire was brought under control by the Tamil Nadu Fire Services squad assisted by the Orchid safety team. The affected labs will be restored in a couple of weeks, said reports adding that investigations are on. India committed to complete polio eradication: Azad The Union Minister of Health and Family Welfare Ghulam Nabi Azad was honoured yet again by Rotary International as a Champion in Worldwide Efforts to Eradicate Polio. Azad was presented with the award at a function in Evanston, Chicago, USA on 23rd September 2011. Trustees and Board of Directors of Rotary Foundation from all over the world and Rotary International office bearers and members attended the function held to recognize the efforts made by India and to honour the leadership of Shri Ghulam Nabi Azad in particular. Accepting the award, Shri Azad said “I take this opportunity to re-affirm India’s commitment to complete polio eradication”. He reiterated that vaccination is one of the most cost effective public health interventions, since it provides direct and effective protection against preventable morbidity and mortality. India runs one of the world’s largest Immunization Programmes whereby around 26 million children born every year are covered. Read More… MDACS takes over SAADHAN helpline from PSI banner Mumbai District Aids Control Society (MDACS) has taken over Saadhan helpline from the PSI banner. The helpline (022 2411 4000) provided HIV, AIDS and Family Planning related information and counseling to thousands of callers from India and abroad under the PSI banner for last 15 years. The PSI Helpline counselors have been absorbed into the MDACS helpline program and the helpline has been re-launched as the MDACS Saadhan Helpline officially. The helpline will offer free counseling to caller on HIV & AIDS, simultaneously maintaining the confidentiality of the caller. 'Saadhan Helpline is the answer to the common man's inhibitions. Since HIV / AIDS is a subject that is related to sex which is a taboo in the Indian Society, it becomes very difficult for the common man to talk about it. Everyone is curious but no one knows how to get access to information. Read More… Glenmark Generics gets tentative approval for Zolmitriptan from USFDA Glenmark Generics Inc., USA, the United States subsidiary of Glenmark Generics Limited, announced that the U.S. Food and Drug Administration has granted tentative approval for their generic version of IPR's migraine treatment Zomig tablets. Glenmark believes there are no first to file applicants for Zolmitriptan tablets and therefore the Company would commence marketing and distribution of their zolmitripian product upon patent expiration in May 2013. Product launch is dependent upon receipt of final approval of its Abbreviated New Drug Application from the U.S. FDA. Read More… Ind Swift Labs gets shareholders’ nod to raise up to Rs 5bn Inds Swift Laboratories reportedly said its shareholders have approved raising funds up to Rs. 5bn through issue of Global Depositary Receipts (GDRs), Foreign Currency Convertible Bonds (FCCBs) and Convertible Bonds. According to reports, the company did not provide a time line for raising the

Yearly Industry Newsletter

73 of 118

funds. The members have also approved declaration of dividend of Re 1 per share of face value of Rs. 10 each for the financial year 2010-11. Zenotech Lab gets nod from US FDA for ondansetron injection Zenotech Laboratories Ltd. has reportedly received approval from the U.S. Food and Drug Administration (USFDA) for its ondansetron injection, a copy of Glaxosmithkline Plc.’s Zofran anti-nausea medicine. The shares of Zenotech Lab are trading at Rs. 39, down by Rs. 1 or 2% over the previous close. It had earlier opened at the day's low of Rs. 39 and high of Rs. 42. The total traded quantity stood at 277 lakh shares on the BSE. Nitta Gelatin to launch a slew of products Nitta Gelatin India Ltd (NGIL), a joint venture between KSIDC & Nitta Gelatin Inc. Japan, has plans to launch new products before the end of financial year 2011-12. Gelixer Collagen Pep which is a proven nutritional supplement for bone and joint health is now available in Kerala and Tamil Nadu and will soon be marketed in Karnataka. The new products are targeted at those with Osteoporosis, Sports men & women, and dancers. NGIL has now started to reach customers directly by making the products available online and has revamped the website to make it more consumer friendly and interactive (www.gelixer.com). Addressing media, G.Suseelan, MD, said that the last six months have been tough for the Company, since raw material costs have increased substantially. Supplies of crushed bones and hydrochloric acid, which are the basic raw material for producing gelatin were erratic and this impacted production. Now, the material prices have stabilized and the production is progressing as planned. NGIL is perhaps one of the few government promoted companies in India to foray into consumer marketing by launching OTC products. This shift of strategy from B2B to B2C has given us a thorough understanding of the dynamics of marketing and consumer perception and behavior. We are happy that our products have been well received and gained the acceptance of common man. About the other products like Gelatin, Suseelan said that the Pharma industry is doing well, particularly in India and demand for gelatin is constantly on the rise.

Yearly Industry Newsletter

74 of 118

International News - September 2011 Health Impetus to enter US pharma market Health Impetus (HI), a disease management partner to global pharmaceutical and life sciences companies is all set to starts its US operation in next 2-3 months, eyeing a 50 per cent growth in revenue over next two years, a top company official said. “We are all set to venturing into US market in next 2-3 months. We see a buoyant market for its differentiated and unique health care services in US. Currently, we are negotiating with more and more pharma companies in US to deliver on their ‘Disease Management’ strategies with their product line,” said Pankaj Sindhu, Chief Executive Officer, Health Impetus. Read More… Bristol-Myers Squibb, Pfizer announce results of Phase 3 clinical trial for ARISTOTLE Bristol-Myers Squibb Company and Pfizer Inc announced on Aug 28, 2011 the main results of the Phase 3 clinical trial ARISTOTLE (Apixaban for Reduction In Stroke and Other Thromboembolic Events in Atrial Fibrillation), which evaluated ELIQUIS (apixaban) compared to warfarin for the prevention of stroke or systemic embolism in 18,201 patients with atrial fibrillation and at least one risk factor for stroke. In the ARISTOTLE trial, ELIQUIS as compared with warfarin significantly reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent, and mortality by 11 percent. Results were presented on Aug 28, 2011 during the Hot Line session at the European Society of Cardiology Congress in Paris, France, and published in The New England Journal of Medicine. Read More… Nestor receives WHO GMP certificate from Ivory Coast Healthy Ministry Nestor Pharmaceuticals has received the certificate of Good Manufacturing Practices (GMP) from Ivory Coast’s health ministry for exporting products in the region. This approval is in accordance to the format prescribed by World Health Organisation (WHO). The approval has been granted for a period of 5 years initially. Announcing this Mr Rahul Sehgal, President Nestor pharmaceuticals said, “Ivory Coast had conducted a detailed inspection of the manufacturing facilities at Nestor’s Faridabad plant in July 2011 and found them to be compliant of all quality standard requirements as per Ivory Coast FDA and WHO-GMP norms.” With this certificate Ivory Coast market would be open for Nestor Pharmaceuticals making healthy contribution to its export sales from the area, added Mr. Sehgal. Read More… Boston Scientific names Michael Mahoney president Boston Scientific Corp. reportedly named Michael Mahoney of Johnson & Johnson its next chief executive officer as the world’s second-largest maker of implantable heart devices seeks to expand its product line and return to profitability. According to reports, Mahoney, 46, will join Boston Scientific Oct. 17 as president and will be elevated to CEO in November 2012. Hank Kucheman, currently executive vice president, will serve as interim chief executive officer until Mahoney fulfills his post-employment obligations to New Brunswick, New Jersey-based J&J. Boston Scientific CEO Ray Elliott will step down when Mahoney becomes president. Sanofi wins U.S. cancer drug patent ruling Sanofi has reportedly scored an important victory in a patent dispute with Sun Pharmaceuticals that will keep generic copies of its Eloxatin colon cancer drug off the United States market until August 2012. According to reports, ruling by the U.S. District Court for the District of New Jersey maintained Sanofi's market exclusivity for Eloxatin in the United States through Aug. 9, 2012.

Yearly Industry Newsletter

75 of 118

Bill Gates in Nigeria to Discuss Polio Eradication Bill Gates, co-chair of the Bill & Melinda Gates Foundation, will meet with national, state and local government officials and traditional leaders this week to discuss the ongoing campaign to end polio in Nigeria. Gates will be accompanied by the foundation's chief executive officer Jeff Raikes. Read More… Glaxo aims at $1b-2b deals in emerging markets: reports GlaxoSmithKline global CEO Andrew Witty was quoted as saying that the company has a war chest of $1-2bn to support its expansion plans in India but will be cautious against overpaying for any buyout. The company can afford a deal worth $1-2bn in the Indian pharmaceutical space. However, is not in a hurry to close a deal at a higher valuation. According to reports, foreign ownership in Indian drug companies will not increase product prices in South Asian nation. Glaxo aims $1b-$2b deals in emerging markets. The company also seeks at India deals but only at right price. Witty sees the increasing population in India as an opportunity for more effort in drug innovation in India. Though the innovations should be patent protected, it should not be a reason for higher drug prices, added reports.

Yearly Industry Newsletter

76 of 118

Domestic News - October 2011 Japan and India announce joint projects in biotech, life sciences Dr.Ashwani Kumar, Minister of State for Science and Technology, Earth Sciences and Planning and Japanese Senior Vice Minister of the Ministry of Economy, Trade and Industry, Seishu Makiano discussed about bio-technology, nanotechnology and life sciences projects. Dr Ashwani Kumar who is on an official visit to Japan met.Seishu Makiano yesterday at Tokyo. He informed that besides this the Japanese Government is ready and willing to encourage Japanese investment in all sectors of the Indian economy particularly in infrastructure development, bio-technology, nanotechnology, life sciences, supercomputing, environmental and water conservation in addition to automobile sector. PharmaVentures appoints Andy Smith as Head of Corporate Finance PharmaVentures today announced the appointment of Andy Smith as Head of Corporate Finance to significantly enhance Pharmaventures' advisory capabilities and offerings to the global healthcare and investment communities. Fintan Walton, PhD, PharmaVentures' Chief Executive Office says "We are delighted to welcome Andy to PharmaVentures. He brings a wealth of investment management experience and has also worked extensively across R&D and marketing in the healthcare sector. At PharmaVentures we are increasingly providing more investment bank style services to help our clients with their dealmaking and Andy's addition to PharmaVentures will therefore be of great benefit." Read More… Pharmexcil felicitates Venus Remedies with patent award in Gold category Venus Remedies, a leading research based global pharmaceutical company won Patent Award in Gold category for the year 2010-11 in the valedictory function of India —LAC Pharma Meet by Pharmexcil (Pharmaceuticals Export Promotion Council) held at Hotel Taj Krishna, Hyderabad on 30th September, 2011. Hon'able Chief Minister of Andhra Pradesh Mr. N. Kiran Kumar Reddy presented the award. Commenting on this, Mr. Pawan Chaudhary, Chairman and Managing Director, Venus Remedies Limited says, “The year 2010-11 was another exciting year at Venus as we forged Global alliances, received multi-country marketing approvals, patents, strengthening international alliances and won several awards, thus turning the global spotlight on us. This is extremely rewarding to see our efforts recognised by the Pharmaceuticals Export Promotion Council, an authorised agency of the Govt. of India for promotion of pharmaceutical exports from India.” Read More… Suven Life Sciences bags Pharmexcil's Gold "Patent Award" Suven Life Sciences Ltd (SUVEN) announces today that they bagged Pharmexcii's "Patent Award" for securing the most number of product patents during 2010/11 for their New Chemical Entities (NCE's) under Gold Category third year in a row. The Awards were presented during the "Awards Function for Exports and patents during India-LAC Pharma Business Meet" organized by Pharmexcil and by Department of Commerce, Government of India. Suven secured 108 product patents for their NCE's during 2010-2011 from several countries including all the developed countries like USA, Europe, Japan, Australia and Canada etc. So far Suven secured a total of 445 product patents globally for their NCE's since 2002. Read More… Ranbaxy to extend Daiichi Sankyo product reach to pharmacists across Italy Ranbaxy Italia S.p.A (Ranbaxy) and Daiichi Sankyo, Italia S.p.A (Daiichi Sankyo), today announced a partnership to leverage .Ranbaxy's distribution strengths and extensive relationships with Pharmacists across Italy, for the distribution of Daiichi Sankyo products. To start with, Ranbaxy will exclusively distribute two of Daiichi Sankyo's long established brands -

Yearly Industry Newsletter

77 of 118

CONGESCOR and LOPRESOR - to all pharmacies, in the country. These drugs are used extensively by Doctors in Italy for the treatment of Congestive Heart Failure and Hypertension. As per IMS Health, the total annual retail sales of CONGESCOR and LOPRESOR are around Euro 20 Mn. The partnership in Italy provides further impetus to the Hybrid Business Model between the two companies by comprehensively addressing Doctors and Pharmacists in improving the accessibility of drugs, for patients. Read More… Vivimed Labs acquires stake in Klar Sehen Vivimed Labs Ltd has acquired 100% equity stake in Klar Sehen Pvt. Ltd., (KSPL). a 30 year old Kolkata based Pharmaceutical Company with strong marketing presence in North East. Bihar and Andhra Pradesh. KSPL operates in a niche ophthalmic segment and owns about 50 trademarks and some very well known brands such as Renicol, Lysicon-V. Care Tears. Dexacort etc, in eye care segment. In a research conducted by C-Marc (India) Pvt Ltd for the period Nov-Feb 2011. KSPL for its wide range of Ophthalmic products has bagged an All India corporate standing rank of No. 1 in the East Zone and bagged a rank of No. 5 in India (in Indian, Dist HQ & Extra-Urban and rural markets). KSPL has cGMP compliant manufacturing facilities at Kolkata, Hyderabad and also has arrangements to manufacture some of its products in Uttaranchal. KSPL presently operates from its headquarters in Kolkata with over 150 medical sales professionals. Vivimed's acquisition of KSPL complements its strategy to increase its domestic presence in specialty pharmaceutical areas, its extensive knowledge and experience in manufacturing. R&D will help grow this business to new levels. Sparsha Pharma launches new generation transdermal patches Scores of patients in India depend upon their daily dose of analgesics either in form of oral medication or injections to subside their intense pain. To help such patients Sparsha Pharma International Pvt. Ltd, India’s first WHO certified Fentanyl Transdermal Patch manufacturing company, today launched two new-generation transdermal patches meant for effective pain management. Chief Guest D.L. Ravindra Reddy, Hon’ble Medical & Health Minister of Andhra Pradesh, unveiled Artho-Touch TM and Diclo-Touch TM transdermal patches at a press conference here. Also present at the launch were Guests of Honor – Dr. A.V. Gurava Reddy, CEO Sunshine Hospital and Dr. V. Sarath Chandra Mouli, Chief Rheumatologist, KIMS Hospital, Dr. Dange Veerapaneni, Managing Director, Sparsha Pharma and Rajeev Sindhi, Managing Director, Sandor Medicaids, the marketing and distribution partner for the new products. Ailments such as Tennis elbow, Arthritis Deformans (chronic form of arthritis), Peritendinitis (swelling of tendons), pain after trauma, shoulder blade pain, neck pain, back pain, Myalgia (muscle pain), Spondylitis (swelling of vertebrae), menstrual pains etc are often intensely painful conditions that afflict scores of men and women. Patients are often required to take large doses of painkillers either orally or intravenously (through injection) to get relief from their condition. However, long term use of painkillers in form of oral medication may have serious systemic side effects. Also, many patients find it difficult to take measured doses of these medicines on their own. For such patients transdermal patches are the best answer. These ensure long lasting controlled release of the drug into the body. The design of Artho-Touch TM and Diclo-Touch TM patches is such that these can be comfortably worn on the skin. These are easy to apply and remove. These products have flexibility due to elastic fabric backing. Speaking on the launch, Dr. Dange, said, “Transdermal patches are an effective mode of drug delivery into the human body. Since they are equipped to release controlled doses of the drug/painkiller medicine, they help in an effective management of pain. Sparsha Pharma’s transdermal patches Artho-Touch and Diclo-Touch have

Yearly Industry Newsletter

78 of 118

advanced designs. Also, these are esthetically acceptable and are capable of delivering sustained dosing of active compounds. These products will tremendously benefit patients who have developed painful conditions such as Myalgia, shoulder pain, neck pain etc. owing to their poor lifestyle habits.” Max Healthcare to sell 26% stake to Life Healthcare Max India Ltd. said on Tuesday that its subsidiary Max Healthcare Institute Ltd. has entered into a non-binding term sheet with Life Healthcare Group (Proprietary) Ltd., a company incorporated and existing under the laws of South Africa, to issue and allot shares constituting 26% of the post-issue Equity Share Capital for an aggregate consideration of Rs. 5,165mn. Max India owns over 91% equity stake in Max Healthcare Institute. Life Healthcare Group is a leading healthcare service provider in South Africa with a market capitalization of over US$2bn. The Investor Group's network includes 63 hospitals with 8,000+ beds with a 27% market share in the healthcare industry in South Africa. The transaction is subject to completion of due diligence and necessary regulatory approvals to the Investor at South Africa, Max India said in a statement. The Board of Directors of the Company in its meeting held on October 11, accorded its in-principle approval to Max Healthcare Institute Ltd. to go-ahead on aforesaid transaction. Read More… Fortis Malar posts net profit up 99% Fortis Malar Hospitals Ltd., a subsidiary of Fortis Healthcare (India) Ltd., one of India’s leading healthcare service providers with a network of 66 hospitals and a capacity of ~ 10,300 beds, today announced its unaudited results for the quarter ended September 30, 2011. Financial Highlights

Fortis Malar Hospitals recorded a revenue of Rs. 24.46 Cr during the quarter, a growth of 16.4% compared to the corresponding quarter of the previous year.

Operating Profit (EBIDTA) for the quarter stood at Rs.3.73 Cr, a growth of 14% compared to the corresponding quarter of last fiscal.

Net profit after tax (PAT) for the quarter stood at Rs. 2.51 Cr against Rs.1.26 Cr reported during the same period in last fiscal, representing a growth of 99%

The growth was mainly driven by Cardiac Sciences, Renal Sciences, Gastroenterology sciences and Oncology which grew by 10%, 66%, 15% and 255%, respectively compared to the corresponding period of last fiscal. Read More…

Lupin launches Generic Diabetes drug Lupin has reportedly launched the generic version of Watson's Fortamet despite an impeding patent suit against Lupin in the US. According to reports, drug sales could contribute as much as 3-4% of the annual operating profit, or Rs. 350mn-400mn. Lupin also has a firstto-file status on its application with the US Food and Drug Administration (FDA) for the drug, which will give the company an exclusive period to sell the drug for 180 days after the litigation, is settled. …Lupin launches Authorized Generic of Femcon Fe Wockhardt told to pay up FCCB creditors by Aug. 2012 The Bombay High Court on Tuesday directed Wockhardt Ltd. to clear all dues to its bondholders by August next year and set a timeline for the repayment of Rs. 4.17bn. The court was hearing a winding-up petition against Wockhardt filed by a group of foreign currency convertible bond (FCCB) holders, led by Singapore-based hedge fund QVT Financial LP and an overseas unit of Sun Pharmaceutical Industries Ltd. Read More…

Yearly Industry Newsletter

79 of 118

Ranbaxy bags NJBIA Award Ranbaxy Inc., a research-based pharmaceutical company that manufactures generic product formulations, OTC and branded drug products, has been honored with the New Jersey Business Industry Association’s (NJBIA) Award for Excellence in Business Expansion and Economic Contribution to the State. The NJBIA award acknowledges Ranbaxy’s commitment and contribution to the State, providing jobs for more than 700 New Jerseyans and with recent investments in its state-of-the-art manufacturing facilities in New Brunswick. NJBIA President Philip Kirschner will honor Ranbaxy and other recipients at an awards dinner on October 18, 2011 in Edison, NJ. Read More… Granules receives US nod for Naproxen Sodium: reports Granules India Ltd has reportedly received an approval from the US Food and Drug Administration (US FDA) for Naproxen Sodium, its abbreviated new drug application. According to reports, Naproxen Sodium is used to reduce pain, fever and inflammation. It is sold under various brand names including Aleve and Midol in the US. It is a non-steroidal anti-inflammatory drug. C. Krishna Prasad, Managing Director, Granules India was quoted as saying “We are excited to offer Naproxen Sodium, which is used in more than six billion doses per year. The company was in discussions with several US generics drug manufacturers. The commercial orders for naproxen sodium finished dosages were expected to commence in the first half of 2012." Sales for naproxen sodium annually in the US exceeded $200mn for the 12 months ending March 31, added reports. Aurobindo Pharma receives final approval for Gabapentin Tablets Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Gabapentin Tablets USP 600mg and 800mg. Gabapentin Tablets are the generic equivalent of Pfizer Pharmaceuticals' Neurontin Tablets, which are indicated for the treatment of partial seizures and other nervous system disorders. The annual sales of Gabapentin Tablets USP 600mg and 800mg in the US were approximately US$ 220 Million for the twelve months ending June 2011 according to IMS and will be launched soon. Aurobindo now has a total of 139 ANDA approvals (110 Final approvals and 29 Tentative approvals) from USFDA. LifeCell International receives accreditation from NABL LifeCell International, India’s largest and premier umbilical cord and menstrual blood stem cell bank has been accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL), against the meticulous standard of ISO 15189: 2007 for the proficiency of its Labs. This recognition makes LifeCell the first, and currently the only stem cell bank in the country to receive this respected and recognized certification. NABL provides formal third party recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Read More… Trivitron Healthcare invests in Kiran Medical Systems Trivitron Healthcare, the largest medical technology of Indian origin, today announced the completion of a strategic investment in Kiran Medical Systems Ltd; making Trivitron the most comprehensive product and solution provider in the country for medical imaging space. Kiran Medical, global leader in image enhancement and radiation protection join hands with Trivitron Healthcare. Kiran Medical manufactures products such as Cassettes, Screens, Grids, Shields and Computer Radiography Systems, with a leadership position in US, Europe, Japan and Latin America. The investment which combines a cash component and a stock swap ensures wealth maximization for the shareholders of both companies. The agreement between the two companies also provides for Trivitron to increase its shareholding over the next few years. This investment further strengthens Trivitron’s presence in

Yearly Industry Newsletter

80 of 118

South/ South East Asia, Middle East and Africa, which are its key export markets and make an entry in to US, Europe, Japan & Latin America where Kiran has a strong presence. As a result of this strategic investment, the board of directors for Kiran Medical will now have two members, Dr. G.S.K. Velu and Mr. Ramesh Verkot for Trivitron Healthcare. Mr. Ramesh Modi, CEO, Kiran Medical will continue to operate the business of Kiran as an independent entity, with complete operational freedom. A core cross functional group with representation from Kiran Medical and Trivitron Healthcare will evaluate synergies and implement strategies that benefit both the entities. Kiran exports its products to over 160 countries across the world; USA, Europe, Japan and Latin America being the primary markets. Both companies will benefit from cross contributions coming from each product portfolio, sharing of network in export markets and gaining from each other's innovation and manufacturing base and knowledge. Self care attitude of Indians may harm themselves: Dr. Kamal B Kapur Eyes are often referred as the mirror of the inner soul, are one of most sensitive of all sensory organs and essential part of human body. Therefore it’s most important that one should not neglect and discomfort related to the eyes. Fortunately, many common eye disorders disappear without treatment or can be managed by self-treatment. Various products from artificial tears and ointments to steroid drops and ocular decongestants are available over the counter (OTC). While these products can help with minor eye problems, a word of caution: In some instances, what may seem like a minor eye problem may lead to a severe, potentially blinding conditions due to unsupervised self medications by using these over the counter eye medicines. Redness, itching, watering, pain or discharge is the common symptoms of many eye problems and hence we generally tend to ignore or confuse then with daily infections. Often, one tends to rush to the nearest chemist for expert advice and medication and accept an unqualified medical recommendation. Only once the problem becomes severe or irreversible do we resort to specialist advice. According to Dr. Kamal B Kapur, Medical Director- Sharp Sight Medfort group of hospitals, “As an Indian mindset we don’t realize the importance of a specialist and try to cure the problem ourselves. It is however important to remember that many medicines offered by chemist for the eye can damage not only eyes but other organs of the body too. This is especially relevant in India where even non-OTC drugs are sold over at the counter by chemist without a prescription from the ophthalmologist.” New malaria vaccine trial throws up promising results Millions of lives, especially that of kids in backward regions of the world, could be saved from the deadly malaria after a clinical trial of a vaccine produced promising results in Africa. The new vaccine could reduce the risk of children contacting malaria by half, according to the results from a clinical trial conducted by GlaxoSmithKline and partners. The trial cut the risk of clinical malaria for young children by 56% and the risk of severe malaria by 47%, GlaxoSmithKline said. Severe malaria affects the brain, kidneys and blood and can kill. Malaria kills about 800,000 people each year, most of them young children in sub-Saharan Africa. Read More… Natco Pharma to foray into bio-generics NATCO Pharma Ltd. on Tuesday said that it has entered into an exclusive agreement with Mabxience, the bio-similar division of Chemo Sa Lugano, Switzerland, to purchase four ingredients that will be used in the manufacture of finished drugs. Under the agreement, NATCO will purchase

Yearly Industry Newsletter

81 of 118

four mAb drug substances from Chemo and use the same for manufacturing finished dosage pharmaceutical formulations. Three of these products viz., Trastuzumab, Bevacizumab, Rituximab belong to the oncology segment, while Etanerceptis is for the treatment of auto-immune disease. NATCO's obligations under the agreement will include manufacture of drug products, undertaking local clinical trials, filing registration of dossiers, applying for market authorizations and to commercialize the product in India and a few other Asian countries. Oncology is the largest therapy area within the mAb market, with eight marketed products. The mAb market is highly innovative and a key trend has been the move from murine to humanized and fully human antibodies, with insignificant generic presence. Worldwide, the market for mAbs has grown rapidly and is currently at a revenue level of around US$ 35bn. With the product combinations chosen by NATCO, the mAb initiative is likely to be completed in a period of 24 to 36 months. Sun Pharma offers to acquire remaining stake in Taro Pharma Sun Pharmaceutical Industries Ltd has announced that on October 18, 2011, the Company (together with its subsidiaries & affiliates, “Sun Pharma") delivered a letter to Sun Pharrna’s Israeli subsidiary, Taro Pharmaceutical Industries Ltd’s Board of Directors proposing acquisition by Sun Pharma, of all of the outstanding shares of Taro not held by Sun Pharma for per share consideration of US $ 24.50 in cash representing a 25.96% premium over the most recent closing price of Taro common stock. This offer is subject to the approval of Taro Board and such other authorities as may be required and subject to completion of necessary cornpllances/formalities as may be required. Strides Arcolab receives US FDA approval for Bupivacaine Hydrochloride Injections Strides Arcolab Limited (Strides) today announced that it has received 2 ANDA approvals from US FDA for Bupivacaine Hydrochloride Injection, USP, a general anaesthetic for the following strengths:

Bupivacaine Hydrochloride Injection, USP, 0.25%, 0.5% and 0.75% packaged in 10 mL and 30 mL Single-dose Vials (Preservative Free).

Bupivacaine Hydrochloride Injection, USP, 0.25% (2.5 mg/ mL) and 0.5% (5 mg/ mL) each packaged in 50 mL Multiple-dose Vials.

According to IIV15, the 2011 U.S. market for Injectable Bupivacaine Hydrochloride approximates to USD 29 million. The product is expected to be launched shortly. Bupivacaine is the thirteenth product approved under the Sagent - Strides partnership. Strides is developing and supplying more than 25 injectable products for the USA market which will be marketed by Sagent. Jain Hospital opens research centre for Spine Care Osteoporosis, the disease of bones that is expected to impact over 36 million patients in India by 2013, is the single largest cause of spinal fractures. 20% of women and 10-15% of men aged above 50 suffer from Osteoporosis. Despite 83% of all spinal fractures occurring due to Osteoporosis, the disease significantly lacks the required awareness, diagnosis, preventive and treatment measures. ‘Why bend to Osteoporosis!’ Commemorating World Osteoporosis Week, the All India Association of Spine Surgeons (ASSI) made a call to action by reaching out to general public. Objective of the campaign is to sensitize masses about symptoms and significance of early diagnosis and right treatment of the disease that enormously impairs quality of life of the patients. Millions of patients can avoid severe consequences by adopting preventive measures and timely

Yearly Industry Newsletter

82 of 118

treatment. This campaign is supported by India Medtronic. The repercussions of spinal fractures can be severe. Spinal fractures can result in stooped back or change in spinal alignment, acute and chronic debilitating pain, loss of height, immobility, depression, significant performance impairments in physical, functional and psychosocial domains in older patients. It leads to five fold increase in risk of future spinal fractures after the first fracture and 75 fold increase in risk after two or more spinal fractures. Patient experiences reduced pulmonary function, increased dependence on family and even premature death. These fractures Birla Pacific Medspa launches State-of-art IVF Centre in Mumbai Birla Pacific Medspa- part of the dynamic Rs. 30bn Yash Birla Group has announced its foray into fertility clinics. The State – of the art centre will be branded as ‘BIRLA IVF’. The first centre has been set up in Kandivali East. The group known for its successful penetration in the sunrise sectors has set its focus on the highly potential Indian infertility market. The IVF Centre offers consultations, unrivalled expertise, standardized, transparent and ethical fertility clinic services, quality processes and diagnostic services, hand-holding at every step from pre-conception to post delivery and treatment facilities. At the launch, Mr. N. Venkat, Managing Director & CEO, Birla Wellness & Healthcare Pvt Ltd said, “Birla IVF is a very promising investment of approx. Rs.2 crores (approx.) made by Birla Pacific Medspa Ltd. We see substantial growth potential and aim to help deliver a dream to aspiring parents by offering the best quality standards and technology. With our current team of experts we plan to expand to 10 centres in Metros and tier1 cities in the next 2 years. At Birla IVF it will be our constant effort to create consistent success stories and capture a significant market capital. Medical tourism will also play a major role in our domain.” With a higher success rate in helping infertile couples building a family and advantages of highly-skilled manpower, substantially lower cost of treatment are making India the 'mother destination' for those seeking 'their own child'. At Birla IVF Centre, the issue on infertility is addressed as a “couple problem”. Both the mother and father-to-be are holistically evaluated to provide the most workable treatment solutions, in line with the latest medical advancements. Announcing the launch of the Centre, Dr. Abhijit Desai, MD Birla Pacific Medspa, said, “At Birla IVF our primary goal has always been to deliver the highest quality to our patients. With the expertise of 8 renowned doctors in the field of infertility treatments and the assurance of the best of practices that comes associated with Yash Birla Group, we aim at providing a holistic view to healthcare” The Birla IVF Centre is the fruition of efforts with the aim providing the best of expertise and treatment options; very few can match up to. Wockhardt Foundation & Welspun launch Mobile Medical Unit in Mumbai

Wockhardt Foundation has entered into a strategic alliance with Welspun to jointly launch Mobile Health Reach, a healthcare programme in Mumbai. Flagging off the mobile healthcare unit launched the initiative in Lower Parel, Mumbai. Dipali Goenka, Director, Welspun India Limited announced the official launch of Mobile Medical Unit during the flag-off ceremony;

Yearly Industry Newsletter

83 of 118

she was also accompanied by Ms. Mangala Tambe, DGM-CSR, Welspun India Ltd and Vijay Batna-ED, CEO Welspun Max Steel India Ltd. Wockhardt Foundation through its Mobile Health Reach aims to provide free primary healthcare at the doorstep of the poor families in slum areas of urban India through a pan-India network of mobile healthcare units. Through its Mobile Health Reach healthcare outreach programme in Mumbai, Wockhardt Foundation and Welspun aim to offer free primary healthcare aid to nearly 22,500 patients annually in this area. Advanced Gynecological Robotic Surgeries performed at KIMS Traditionally, when medication and non-invasive procedures are unable to relieve symptoms, Surgery is the only accepted and most effective treatment for a range of gynecologic conditions in and out of developed world. Traditional open gynecologic surgery, using a large cut to access the uterus and surrounding anatomy has been the standard practice for many years. This open surgery can bring significant amount of pain, trauma and a long recovery process. There is sometimes even a threat to the surrounding organs. Surgery causes lot of anxiety to the women. Till recent times, laparoscopy was used by surgeons but it had its limitations. The surgical locations in cases of Gynecology are narrow and maneuvering in these areas with laparoscopic instruments is not easy. The very thought of Gynaecological surgery brought up images of pain, discomfort, extended time away from daily chores usually associated with traditional surgery. Now with the advent of the Robotic surgery, patients can be back to their normal life within a much shorter time compared to traditional surgery. Today, Robotic Surgery in gynecology is one of the fastest growing fields of robotic surgery. Read More… Dr. Reddy’s and Teva launch generic Zyprexa in US Teva Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories announced the commercial launch of Olanzapine Tablets, the generic version of Eli Lilly’s Zyprexa. Annual sales of Zyprexa were approximately US$3.2bn in the United States as of September 2011, based on IMS sales data. Teva’s Olanzapine Tablets in 2.5 mg, 5 mg, 7.5 mg, 10 mg and 15 mg and Dr. Reddy’s Olanzapine Tablets in 20 mg have each been awarded a 180-day period of marketing exclusivity in the U.S. Dr. Reddy's is supplying the 20 mg version of the product following an April 2011 commercialization, manufacture and supply agreement with Teva. In addition, as per the terms of the agreement, Dr. Reddy's will launch their 2.5 mg, 5 mg, 7.5 mg, 10 mg ,15 mg and 20 mg of Olanzapine tablets upon expiration of the 180-day exclusivity period. Read More… Wipro launches new version of Hospital IMS Wipro Infotech, the India, Middle East and Africa, IT Business unit of Wipro Ltd and a leading provider of IT and business transformation services announced today the launch of a new version of its Hospital Information Management System (HIMS) with enhanced business functionalities. The new version of the HIMS has been developed by Healthcare IT services division of Wipro and specially designed to cater to the future needs of large healthcare providers, Hospital chains, Government hospitals, clinics, and diagnostic centers in India, the Middle East and Africa. The comprehensive solution automates the clinical, Electronic Medical Records (E), administrative and inventory functions, thereby enabling increased operational effectiveness, reduction in costs & medical errors, while raising the quality of patient care. Read More… Aanjaneya clarifies news on talk of Buying Formulation Co Aanjaneya Lifecare Ltd has clarified about the earlier reported news "Aanjaneya Hits Upper Circuit on Talk of Buying Formulation Co" as under :

Yearly Industry Newsletter

84 of 118

"The Company explores various strategic moves from time to time. However, as a policy and in the interest of its shareholders, the Company does not comment on any report relating to potential strategic initiatives unless they have reached the definite stage. The Company has made it clear to the journalist that it does not comment on market speculations and the same has been mentioned by the newspaper article as well. We once again reiterate that the news article is based on speculation and the Company had not issued any press release or notification regarding the same. The Company's policy is to inform the stock exchange(s) whenever it enters into any formal agreement on such sensitive subjects." GVK Biosciences extends license of its SAR Databases to Astellas Pharma GVK Biosciences (GVK BIO), Asia’s leading drug discovery research & development organization, announced today that Astellas Pharma Inc.extended and renewed its license to the GVK BIO SAR Databases (GOSTAR). GOSTAR (GVK BIO Online Structure Activity Relationship (SAR) Database) is an online scientific database product of GVK BIO. It integrates information on compounds from discovery & development stages and marketed drugs. Information provided includes SAR, ADME, toxicity, preclinical, clinical and structural data for over 5.1 million compounds and 16.7 million SAR points. Sreeni Devidas, Vice President, Sales & Marketing, Informatics, at GVK BIO said, “We are excited that Astellas has decided to extend the license to the GOSTAR database. The GOSTAR database is becoming an indispensible tool for scientists in drug discovery. Several publications that have used the GOSTAR data validate the utility of this product.” Informatics at GVK BIO The Informatics division is responsible for analyzing data to transform chemical / biological patterns into knowledge. Informatics offers Custom Curation, Cheminformatics and Bioinformatics services to global clients. It also licenses and sells databases to Biotech and Pharma companies. Carestream Health India unveils new CARESTREAM DRX-Ascend System Carestream Health India has recently unveiled the new CARESTREAM DRX-Ascend System, which is designed for small to mid-size hospital radiology departments, imaging centers, clinics and specialists’ offices. The DR system offers a versatile, floor-mounted tube stand and a wide and elevating float-top table with a patient weight capacity of 295 kilograms. In India, the first CARESTREAM DRX-Ascend System has been recently installed at the state-of-the-art Siddhant Diagnostic Center, Varanasi, Uttar Pradesh. Speaking on the uniqueness of the new DR system, Prabir Chatterjee, Managing Director, Carestream Health India, says, “The CARESTREAM DRX-Ascend System is well suited for smaller rooms, imaging centers and orthopedic applications. This floor-mounted DR system delivers high-end features at an affordable price.”Read More… Breast Cancer Seminar held at Apollo Hospital Breast cancer is curable when detected early. This message was effectively spread through Apollo Hospital’s ‘Precious 5 Minutes’ campaign, which culminated in a seminar, today. The resounding messages throughout the campaign were that five minutes is all it takes to protect oneself from breast cancer & that five minutes spent to do a breast self examination, once every month, is the first step to early detection of this disease. Read More… Apollo Hospital & Dr Santosh Hegde encourage Bangaloreans to pledge to donate their eyes

Yearly Industry Newsletter

85 of 118

And they lived happily ever after...This familiar ending does not have to be limited to fairytales alone. You can make this a reality in someone’s life – by donating your eyes. As part of World Eyesight Day, Apollo Hospital conducted an awareness program with former Lok Ayukta, Justice Dr. Santosh Hegde, to spread the message that one can bequeath eyes by taking a pledge, resolving to donate them after death. Donated human eyes help preserve and restore sight through corneal transplantation. Infants born with cloudy corneas gain sight from transplantation. Donated eyes also aid supporting valuable research and education purposes. Encouraging the nobel act of eye donation, Dr Umapathy Panyala, COO, Apollo Hospital Bangalore, said, “Impairment of vision threatens ones ability to be physically or financially self-sufficient. Read More…

Yearly Industry Newsletter

86 of 118

International News - October 2011 Boehringer Ingelheim and Eli Lilly announce Expansion of Strategic Diabetes Alliance Boehringer Ingelheim India and Eli Lilly India (Lilly) announced that they are entering into an agreement specific to India to co-promote a portfolio of diabetes compounds currently either in late-stage development or on the market. The collaboration includes Boehringer Ingelheim’s oral anti-diabetic agent, Linagliptin, not yet approved for marketing in India and Lilly’s insulin analogue, Humalog (Lispro), which is already on the Indian market. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor discovered by Boehringer Ingelheim and developed as an oral once-daily single dose tablet for the treatment of Type 2 diabetes. It is already approved in the United States, the European Union and Japan, among other countries. The alliance will leverage the collective scientific expertise and business capabilities of two leading research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic. Read More… Teva, Cephalon get European approval on merger Teva Pharmaceutical Industries Ltd. has reportedly said that the company has received approval from the European Commission to proceed with its buyout of Cephalon. According to reports, as part of the process, Teva must divest Cephalon's right to market generic modafinil in France. The deal is expected to close Friday. The Israeli drugmaker also has to grant the purchaser of the authorisation "certain additional rights with respect to the entire European Economic Area, including a covenant not to sue effective as of October 2012", added reports. Roche sales off 13% in Swiss francs; confirms view Roche Holding sales reportedly totalled 31.49 billion Swiss francs ($35.1 billion) in the first nine months of the year, which was flat on constant exchange rates, but a 13% fall in Swiss francs and a 6% rise in U.S. dollars against the year-ago period. According to reports, excluding Tamiflu, nine-month sales rose to CH31.19 billion. "Roche's solid sales performance in the third quarter is in line with our expectations. We're on track to achieve our targets for 2011. Roche is targeting core earnings-per-share growth of around 10% at constant exchange rates for 2011. It aims to grow the dividend in line with core EPS growth and at least maintain last year's dividend in Swiss francs, added reports. Abbott to split into two companies Abbott announced that it plans to separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals. The diversified medical products company will consist of Abbott's existing diversified medical products portfolio, including its branded generic pharmaceutical, devices, diagnostic and nutritional businesses, and will retain the Abbott name. The research-based pharmaceutical company will include Abbott's current portfolio of proprietary pharmaceuticals and biologics and will be named later. Both companies will be global leaders in their respective industries. "Today's news is a significant event for Abbott, and reflects another dynamic change in our company's 123-year history, strengthening our outlook for strong and sustainable growth and shareholder returns," said Miles D. White, chairman and chief executive officer, Abbott. Abbott's proprietary pharmaceutical business has delivered market-leading performance with a sustainable mix of products and built a strong pipeline of proprietary medicines through internal discovery, in-licensing and collaboration efforts. Abbott also has leadership positions in its diversified

Yearly Industry Newsletter

87 of 118

businesses, including established pharmaceuticals, nutritionals, diagnostics, and vascular devices, where the company is now the global leader in interventional cardiology. Read More… Novartis to curb jobs: reports Novartis reportedly launched a major job and cost cutting program as the Swiss pharma giant reported a weaker-than-expected 7.9% rise in third-quarter net profit, as last year's multi-billion dollar acquisition of eye care company Alcon only partly offset the impact of the strong franc. According to reports, the company said that the net profit for the three months to the end of September rose to $2.46 billion from $2.28 billion a year-earlier, missing market forecasts of $2.81 billion due to the franc's strength and drug price cuts. Novartis said it is responding with a cost-cutting program that will see the loss of around 2,000 positions, mostly in the U.S. and Switzerland, and the closure of two sites in Switzerland and one in Italy. The measures are scheduled to be occur over the next three to five years. Novartis had around 120,000 full-time associates at the end of 2010, added reports.

Yearly Industry Newsletter

88 of 118

Domestic News - November 2011 GlaxoSmithKline reaches agreement to resolve US probes GlaxoSmithKline plc (GSK) has announced that it has reached an agreement in principle with the US Government to conclude the Company’s most significant ongoing Federal government investigations, specifically: the investigation into GSK’s sales and marketing practices begun by the US Attorney’s office of Colorado in 2004 and later taken over by the US Attorney’s Office of Massachusetts; the U.S. Department of Justice’s investigation of possible inappropriate use of the nominal price exception under the Medicaid Rebate Program; and the Department of Justice’s investigation of the development and marketing of Avandia. The final settlement, which is expected to address civil and criminal liabilities, remains subject to negotiation of specific terms and is expected to be finalised in 2012. The settlement of $3 billion is covered by existing provisions and GSK expects to make payments under the final agreement in 2012. These payments will be funded through existing cash resources. Read More… Sun Pharma announces USFDA approval for generic Cardizem CD Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Cardizem CD, Diltiazem HCl extended-release capsules. These generic Diltiazem HCl extended-release capsules, are equivalent to Valeant International’s, Cardizem CD, 120 mg, 180 mg, 240 mg, 300 mg and 360 mg. Annual sale in the US for these strengths is approximately $ 300 million. Diltiazem HCl extended-release capsules are indicated in the treatment of hypertension, for the management of chronic stable angina and angina due to coronary artery spasm. Fortis Healthcare to acquire Fortis Healthcare International for US$665mn Fortis Healthcare India Ltd. said on Tuesday that it would acquire Fortis Healthcare International Pte. Limited, Singapore for US$665mn. Fortis Healthcare International Pte. Limited has sales of ~US$500mn, according to reports. The consolidated debt of Fortis Healthcare India would be US$1bn post the acquisition of Fortis Healthcare International Pte. Limited. The Board of Directors of the Company at its Meeting held on November 01, 2011, has approved the valuation of US$ 665 Million, for consolidation of Fortis Healthcare International Pte. Limited, Singapore with Fortis Healthcare (India) Limited. Lupin receives tentative FDA Approval for generic Combivir Tablets Pharma Major, Lupin Limited announced today that its U.S. subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its Lamivudine and Zidovudine Tablets, 150 mg/300 mg. from the United States Food and Drugs Administration for the Company’s Abbreviated New Drug Application (ANDA) to market a generic version of Combivir Tablets, 150 mg/300 mg of ViiV Healthcare. Lupin’s Lamivudine and Zidovudine Tablets are the AB-rated generic equivalent of Viiv Healthcare’s Combivir® Tablets, 150 mg/300 mg. Lamivudine - Zidovudine is a combination of two nucleoside analogue reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Combivir Tablets, 150 mg/300 mg had annual U.S sales of approximately US$ 295 million for the twelve months ending June 2011 (IMS Health sales data). Parabolic Drugs gets Japanese nod for Cephalosporin Drugs The Company has received an official accreditation from Japan's ministry of Health, Labour and Welfare, enabling it to manufacture and supply Cephalosponn non sterile drugs to the Japanese market. The 5-year

Yearly Industry Newsletter

89 of 118

accreditation has been awarded to PDL's manufacturing site at Derabassi in Punjab and is in accordance with Article 13-3 of the Pharmaceutical Affairs Act, which classifies Parabolic Drugs as a certified foreign drug manufacturer. Japan, the second single largest drug market in the world is also a leading nation in terms of pharma research, technology, machinery and medical research and is valued at USD 107 billion in 2010. The Japanese certification denotes the Company's technical capability in the non-sterile market and also differentiates it from many of its competitors. Read More… Aamby Valley City wins 7th Hospitality India International Award It has certainly been a year of awards and recognition for Independent India’ first planned hill city “Aamby Valley”. Recognized for its finest of luxuries and the rarest of pleasures that are exquisitely assembled for the delight and joy of its patrons, Aamby Valley City has achieved another milestone by winning the two most prestigious awards at the 7th Hospitality India International Award. Vivek Kumar, CEO Aamby Valley City set a new benchmark by achieving the Best Tourism Destination 2011 award for Aamby Valley City and being honoured with Best CEO 2011 award. The revered award has increased their drive to perform manifolds. With these encouraging words from their leader and benevolent mentor to inspire the team at Aamby Valley City, the city shall outshine all expectations and have many more such laurels to its name. GE Healthcare set to revolutionize imaging of live cells Applied Precision Inc., a GE Healthcare company, today announced the launch of DeltaVision OMX Blaze, a research microscopy system designed to reach the next level in the evolution of super-resolution imaging by employing a proprietary, ultra-fast, illumination module and the latest advanced high-speed camera technologies. The new DeltaVision OMX Blaze system’s speed of image acquisition enables researchers to follow tagged proteins within the same living cell, over time, in three-dimensional space, at near molecular resolution. This makes it possible to start answering new kinds of research questions about how certain structures in cells behave, what they interact with, and how long the events last. Paul Goodwin, Director of Advanced Applications, API, said, “It’s a pretty extraordinary feeling, to see moving images of live cells at a greater level of detail than anyone has witnessed before. The implications of this advance in imaging technology are hugely exciting for researchers. With the OMX Blaze we can start to answer questions that we never could before.” Dr Amr Abid, General Manager of Cell Technologies, GE Healthcare Life Sciences, said, “We are only at the beginning of what this technology can do. The ability to follow cellular interactions, over time at the molecular level will open up new frontiers in so many areas of life science research. This is a hugely important step forward for cellular imaging.” Researchers at the UC Davis-based Center for Biophotonics Science and Technology (CBST) collaborated early as beta testers for the technology. The system is also being installed at a number of early adopter sites around the world which are expected to go live in the next two months. Dr Frank Chuang, Associate Research Director, CBST, said, “We’re at the point where we need to understand mechanisms of health and disease at the molecular level. The OMX Blaze has tremendous potential as a research tool, and we are very excited to apply this in our laboratory models to observe the response of cancer cells to chemotherapy, the cell-to-cell transmission of HIV and other viruses, and the dynamics of engineered nanoparticles.” Strides Arcolab gets nod from US FDA for Doxorubicin Injection Strides Arcolab Ltd's Onco Therapies Ltd. reportedly received approval from the U.S. Food and Drug Administration for its doxorubicin chemotherapy

Yearly Industry Newsletter

90 of 118

injection. Strides Arcolab Ltd's Onco Therapies Ltd. reportedly received approval from the U.S. Food and Drug Administration for its doxorubicin chemotherapy injection. The shares of Strides Arcolab are trading at Rs. 402, up by Rs. 6 or 1%, as against the previous close of Rs. 395. It had earlier opened at the day's low of Rs. 394 and high of Rs. 404, stating the volume of total traded quantity at 0.11 lakh shares on the BSE. as against the previous close of Rs. 395. It had earlier opened at the day's low of Rs. 394 and high of Rs. 404, stating the volume of total traded quantity at 0.11 lakh shares on the BSE. Uttam Air products launches only Oxygen Plant in Leh Uttam Air Products, a leading gas manufacturer with an excellent record in the manufacturing and distribution of medical and industrial gases for over 35 years, recently set up an Oxygen Plant at the Indian army base camp in Leh, Ladakh. Uttam is the first ever gas manufacturing company in the country to take up a project in association with DIPAS - a research organization under the Defence Research & Development Organisation (DRDO), Min. of Defense, Govt. of India for Ladakh. At 10,500 feet above the seal level, the environmental conditions in Leh are hostile with low concentrations of oxygen in air. This often results in hypoxic situations where due to the lack of oxygen people (often non-natives), experience loss of consciousness and other insidious and irreversible consequences such as comatose state and paralysis. Uttam Air Products is now working closely with Army Research Organization and has undertaken a project for the Indian soldiers deployed at this height. The company has set up a plant that offers ‘oxygen enrichment’ facilities. The plant provides assured high percentage of oxygen under medical supervision at such high altitudes. In the day to day operability of the plant, oxygen is produced on site and its regulated transfer in certain pre-specified and designed rooms or chambers is done. This is done under medical supervision and with a lot of precision. The oxygen plant tremendously benefits the Indian army personnel, posted there, who face medical problems due to lack of natural oxygen. Availability of such a facility so close to their posts greatly assists the medical staff in treating them early. According to Mr. Karan Bhatia, Executive Director, Uttam Air Products, “Uttam Air Products is proud to be the first gas manufacturing company to establish and operate an oxygen plant at Leh. This is the highest and one-of-a-kind plant in the world that is helping our India army soldiers at such great altitudes.” Strides Arcolab receives US FDA approval for Carboplatin Injection Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited (Strides) announced that it has received US FDA approval for Carboplatin Injection 10 mg/ mL packaged in 50 mg/ mL, 150 mg/15 mL, 450 mg/ 45 mL and 600 mg/ 60 mL Multi-dose vials. According to IMS data June'll, the US market for generic Carboplatin is approximately USD 35 Million. Carboplatin is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. Ranbaxy and Daiichi Sankyo step up Community initiatives Ranbaxy Laboratories Limited (Ranbaxy) and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced their joint community initiatives in India with the Flag-off of two free Mobile Rural Healthcare Service Vans for District Dewas in Madhya Pradesh. This is the first CSR programme being undertaken jointly by the two companies as part of their commitment towards global social contribution activities. The Mobile Healthcare Vans were Flagged-off by Mr. Mukesh Chand Gupta, District Collector, Dewas, in the presence of Guests of Honour, Mr. Anil

Yearly Industry Newsletter

91 of 118

Sharma, Superintendent of Police, Dewas, Dr. Amar Singh Vishnar, Chief Medical & Health Officer, Dewas, Mr. Akira Toyama, Consul, Consulate General of Japan, Mumbai and other distinguished guests. Read More… Birla research and lifesciences launches Nutrinext- Nutraceutical Range Rebirth, the branded wellness stores of the Yash Birla Group (YBG) is introducing the new Nutrinext Nutraceutical Range. These products are 100% Natural and Vegetarian, hence they have no side-effects, the company stated. The new range offers 4 distinctive products- Double Action Slimming Stack, Healthy Heart, Natural Anti-Ageing and Longevity. Double Action Slimming Stack- The two way action comes from the presence of 2 ingredients- GarciniaCambogia and Camellia Sinensis. GarciniaCambogia helps increase your body metabolism so that it burns more calories in the most natural way and Camellia Sinensis gives an anti-fat deposition action by reducing the conversion of carbohydrates into fats. Read More… Agada brings Joslin Diabetes Care to Chennai Pioneer in diabetes care for over 100 years Agada Hospitals, an upcoming world class Medical Centre promoted by Dr. Mohan Thanikachalam today announced, that it has tied up with Joslin Diabetes Centre, Boston, USA to provide the citizens of Chennai with world class diabetes care and treatment. The Agada Health Care (AHC) is located in the heart of the city on Dr. Nair road in T. Nagar and will be open to public from 14th November 2011, which coincides with the World Diabetes Day. The Joslin Diabetes Center, Boston, USA, is an affiliate of the Harvard Medical School, Boston. Joslin Diabetes Center is the World’s First and most respected diabetes care facility. Since its founding in 1898, Joslin Diabetes Center has helped to revolutionize the diagnosis, treatment and prevention of diabetes. It is well proven that Joslin’s clinical care and education program improves the clinical outcomes, reduces hospital admission rates, and cuts down health care cost. Read More… Apollo Hospital launches MRI-HIFU for treatment of uterine fibroids Apollo Hospitals Group today unveiled a breakthrough MRI-guided high intensity focused ultrasound (HIFU) solution from Philips at its Hospital in New Delhi. This was announced by Dr. Prathap C. Reddy, Chairman, Apollo Hospitals Group and Mr. Krishna Kumar, President, Philips Healthcare, India, here. MRI Guided HIFU offers a non-invasive alternative to the traditional treatments for uterine fibroids in women. It combines magnetic resonance (MR) imaging, with high-intensity focused ultrasound (HIFU). The benefits for women include – no surgery, no radiation, no scar, no anesthesia, quicker recovery, more precise image guided treatment and only little stress. The technology has tremendous applications in the non-invasive treatment of benign and malignant tumors. Two-Day Symposium on Pediatric Epilepsies held in Hyderabad Pediatric Epilepsy Society, Hyderabad and Department of Neurosciences, Krishna Institute of Medical Sciences (KIMS) jointly organised a Two-Day Symposium on Pediatric Epilepsies held in Hotel Taj Deccan on Saturday and Sunday in city. The two day meet was attended by 230 International Faculty from USA, Japan, England, Europe and Pediatricians and Neurosurgeons from across India. Pediatric epilepsy is epilepsy, a disorder characterized by recurrent seizures, which occurs in a young patient. There are several potential causes of seizures and epilepsy in children. The objective of the meet according to Dr. Alladi Venkatesh, Founding President of Pediatric Epilepsy Society, was to discuss epidemiology, genetics

Yearly Industry Newsletter

92 of 118

and classification of childhood epilepsies. Also to discuss the state-of-the-art diagnostic and treatment approaches in epilepsy. Also to review medical, surgical treatment strategies that affect epilepsy outcomes in children. The symposium was an attempt to bring the latest in research and developments in the specialised filed of Pediatric Epilepsy for common good. And to support doctors and to treat and benefit patients using the latest edge of scientific progress. The symposium helps doctors to keep abreast of the latest developments in their area of specialisation. The major focus of the symposium was to create awareness that if the Pediatric Epilepsy cannot be cured by medicines, it can be cured by surgery. Nearly 30% children do not respond to medicines. In such cases Epilepsy Surgery offers best solution. India adds 5 lakh new Pediatric Epilepsy cases every year. Nearly 10% of this number can be cured by the surgery, informed Dr. Manas Panigrahi, Neurosurgeon at KIMS hospital. Not many are aware of the Epilepsy Surgery. Only 500 kids are operated every year while there is a need to operate 40 to 50,000 people in the country every year, he said. Unfortunately there is no awareness. And also infrastructure required for Epilepsy Surgery is also not available in many hospitals. Lupin acquires I'rom Pharmaceuticals Pharma Major Lupin Limited (Lupin) announced that its Japanese subsidiary, Kyowa Pharmaceutical Industry Co., Ltd. (Kyowa), has entered into an agreement with I’rom Holdings Co,, Ltd. (IH), an integrated Japanese healthcare provider, to acquire up to 100% of the outstanding shares of its subsidiary I'rom Pharmaceutical Co., Ltd (IP). Established in 1947, IP is a specialty injectables company headquartered in Tokyo. For the fiscal year ended March 2011, IP recorded sales revenues of JPY 5,361 Million. IP has a significant presence in the DPC hospitals within Japan. Injectable products enjoy a significant usage in the DPC Hospital segment, and generic injectable penetration is slated to grow significantly in future. There are currently over 1,400 DPC hospitals in Japan, covering over 35% of all hospital beds nationwide, and a market size of USD 11 Billion. Read More… Indian Pharma bets high on US oral contraceptive market: reports The pharmaceutical companies of India are reportedly betting high on the American Oral Contraceptive (OC) market. Apart from Glenmark, Sun Pharma and Lupin are set to tap part of the $4.5-billion US market for OCs, through new generic versions. Nilesh Gupta, group president and executive director, Lupin, was quoted as saying “Though the first of the OC products off the block, the generic version of Nor-QD tablets, is a small one, with estimated sales of $52 million for the year ended June 2011, Lupin has built a 30-product OC pipeline for the US market. We could very well look at $100-million in revenues over the next three years from our OC pipeline.” Lupin had set up a dedicated OC facility in Indore, inspected and certified by the US FDA as early as November 2009. Indian pharma companies with generic products would do well to focus on high growth and value therapeutic segments to be successful in the developed markets, added reports. Glenmark Pharma forays into cosmeceutical segment Glenmark Pharmaceuticals Ltd has announced its foray into the high-end cosmeceutical segment in India with the launch of Canadian Company Immanence-IDC'S scientific and sophisticated anti-ageing product line in India. The company recently entered into a ten-year agreement with Immanence-IDC to distribute the Canadian company high-end dermatology products in 8 countries. Rajeev Sibal, Senior Vice President, Glenmark Pharmaceuticals observed “Our foray into cosmeceuticals will significantly enhance Glenmark’s dermatology product offerings and will further consolidate our leadership position in the segment. IDC products are based on strong scientific foundation and we are proud to offer the advanced cosmeceutical line to our wide network of cosmetologists and dermatologists

Yearly Industry Newsletter

93 of 118

across the country.” He added “Through the CosmoCare division, we aim to be a leading player in the cosmeceutical space and one of the most recommended brands by cosmetologists and dermatologists in India.” Read More… Fortis announces new hospitals in Hyderabad and Agra Fortis Healthcare (India) Ltd. announced the launch of two hospitals, in Hyderabad and Agra. Continuing its aggressive growth in India, Fortis Healthcare has increased its India network to 68 hospitals. The super-speciality hospital in Hyderabad with a 150-bed capacity will be functional in FY 2013 and is the second project from the company in the city, the first being a tertiary care hospital with a 450-bed capacity, which is expected to be operational end 2013. The hospital in Agra will initially function as a Cardiac Care Centre, in a hub and spoke model, and expand eventually to become a multi-speciality hospital. The 75-bed hospital will be operational by the end FY2012. Speaking of expansion plans, Aditya Vij, Chief Executive Officer, Fortis Healthcare (India) Ltd. said, “These two new projects are in line with our commitment to increasing the network and making quality healthcare accessible across the country. We are currently present in 17 Indian states and will continue to expand to newer geographies, while strengthening our presence and increasing bed-capacity in existing cities and states.” …Fortis Healthcare CFO quits Indian vaccine market reaches US$900mn India has made a significant contribution to Vaccine development. Speaking at the opening ceremony of International Vaccine Symposium here at Surajkund, Dr Ashwani Kumar, Minister of State for Science and Technology, and Earth Sciences said, India produces 60 percent of the world’s vaccines and account for 60-80 percent of annual UN vaccine purchases. Several Indian vaccine manufacturers are WHO pre-qualified. The current Indian vaccine market is estimated at around $ 900 million and targets $4.6 billion revenue by 2017. It is poised to grow 23% during 2011-2012. Vaccines are the most cost-effective public health products known to us. And they are means to prevent or the potential to develop preventive solutions. Every year, about eight million children globally never make it to their fifth birthday that can be saved with vaccines. Read More… Experts recommend banning of OTC sale of second line of TB drugs Senior Government officials from the Central TB Control Division, Government of India, today heard strong recommendations from pediatric TB experts,on screening for TB to be done at the child health programme level, for timely detection of children living with TB. Speaking at the function, Ms. Rashmi Singh, IAS, Executive Director, National Mission On Empowerment of Women, Ministry of Women and Child Development , Government of India , said that early diagnosis is critical and there is a lot of apathy even among the community when it comes to timely treatment for women and children. She also recommended a multi - pronged approach to fighting pediatric TB pointing out that," Can any one strategy work in a segmented manner. We need to work together,no one Ministry or NGO can tackle the issue" . Ms. Singh also highlighted the role of personalised model of communication and said that the Anganwadi workers and ANMs( Auxillary Nurse Midwives) are being trained to look out for signs of Pediatric TB to ensure early diagnosis of TB. Read More… Protest at Dr Reddy's Srikakulam unit affects its production: reports Dr Reddy's Laboratories production was reportedly hit at Srikakulam unit for the past 3-4 days as some workers are on a strike. According to reports, employees and workers in all the 13 production blocks are on strike, which

Yearly Industry Newsletter

94 of 118

has left the productions affected. The production is made based out of orders. Venus Remedies receives Market Authorisation for Meropenem in UK & New Zealand Venus Remedies, a leading research based global pharmaceutical company has received approval for Market Authorisation from MHRA (UK) via DCP route (which covers Ireland, Poland, Slovenia, Netherlands, Finland, Austria, Slovakia, Denmark, Germany, Sweden, France and Italy also) for its generic broad spectrum injectable antibiotic carbapenem. The company is all set to launch this drug soon within this fiscal year. Besides this, Venus has also got Market Authorisation for the same product from New Zealand's Ministry of Health. These grants have once again proved Venus Remedies’ R&D capabilities and its expertise in developing world class products with regulatory might. Read More… Strides Arcolab receives US FDA approval for Carboplatin injection Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited (Strides) announced that it has received US FDA approval for Carboplatin Injection 10 mg/ mL packaged in 50 mg/ mL, 150 mg/ 15 mL, 450 mg/ 45 mL and 600 mg/ 60 mL Multi-dose vials. According to IMS data June’11, the US market for generic Carboplatin is approximately USD 35 Million. Carboplatin is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. Suven Life Sciences presents pre-clinical data of their NCEs at SFN-2011 Suven Life Sciences Is presenting several data presentations from their portfolio of Investigations! neuroscience new chemical entitles (NlCEs) at SFN 2011 from 13 'Mo 16th of Nov held at Washington DC, USA. Neuroscience is the annual meeting of the Society for Neuroscience (SFN) and more than 30 thousand Neuro- Scientists from all over the world covering all the major Pharma, biotech and research institutes will be participating. Suven's nine (9) data presentations covers the early-stage compounds from Histamine-3 receptor antagonist, Nicotinic acetylcholine alpha-4-beta-2 receptor agonist and antagonist, Serotonin 5-HT4 receptor agonist in addition to 5HT6 antagonists to treat unmet medical needs of patients living with cognitive dysfunction associated with Alzheimer's, Schizophrenia, ADHD; Depression & Mood Disorders and Neuropathic Pain. These data presentation highlights Suven's continued commitment to exploring new treatment options addressing unmet medical need through novel mechanisms and targets and address a market size of more than $30 billion. During SFN-2011 Suven lined up several face to face meetings with major Pharma and Biotech companies to explore integrated collaborative research programs (CRP) and also Drug Discovery and Development Support Services (DDDSS) in addition to continued discussions with global pharma majors regarding their clinical candidate SUVN-502. Suven is committed to neuroscience research and for development of new treatments for neurological disorders. Suven's discovery research focuses on Central Nervous System (CNS) disorders through novel mechanisms using small-molecule medicinal chemistry approaches. Suven's CNS drug discovery scientists at Hyderabad, India are pursuing innovative ways to develop treatments for a variety of CNS disorders like Alzheimer's, Schizophrenia, Depression, Cognitive disorders, Sleep, Neurodegeneration and Obesity through CNS targets. Mughda Godse launches Aditya Birla Hospital’s new Cosmetology department A person attending the conference shared, "12 years back, my daughter due to skin problem wasn't getting a boy for marriage. After seeing her, they use to ask for dowry. It was a case of depression for my family and her. We went to a cosmetologist, who treated her on concessional rate. We went for 500

Yearly Industry Newsletter

95 of 118

seating’s and the end result was excelled. As guaranteed by the doctor she was married without a dowry within 6 months." He further added, "Making this kind of advanced technology available in India, gives an opportunity to all those girls who are not getting married for some skin, facial problem. The Cosmetology Department is the most sophisticated liposuction unit located at the Chinchwad unit of Aditya Birla Memorial Hospital. Dr. Hitesh Laad, an expert known for his skills in cosmetology is the in-charge of the Department. He is being supported by a team of efficient and highly trained doctors for the facility. He shares, “At this department we provide the most sophisticated service to people; we use the power assisted Liposuction System which is as per U.S. standards. This advanced technology is used for augmenting the body such as body contouring (removing fat from unwanted parts of body and putting in the desired part). It has sectional co2 laser and advanced diode laser which is used for facial rejuvenation – like wrinkles around the eyes, acne scars hair removal from unwanted parts of body. Pigmented lesions on the face can also be corrected.” He further added that, “We have planned the most advanced and sophisticated department. There are many people who are not satisfied with the services provided to them at other places and are looking for good doctors. We give services in the most scientific way to those who are looking for the best.” IDMA to celebrate Golden Jubilee in January Indian Drug Manufacturers’ Association (IDMA) will be celebrating the completion of 50 Glorious Years in January 2012. Accordingly the 50th Annual Day Golden Jubilee Year Celebrations will be held on 6th & 7th January 2012 at Hotel Intercontinental – The Lalit, Sahar Airport Road, Andheri (East), Mumbai. In its Golden Jubilee 50th year IDMA carried out many activities in co-ordination with and support of all our State Boards and Members. The activities included CSR initiatives such as free Healthcare and Medical Camps in Mumbai where over 2000 needy people benefitted and were provided the required medicines free of cost. We also organized an All India Mega Blood Donation Drive on 14th June 2011 with over 75 camps all over India to mark ‘World Blood Donation Day’, and over 6300 bottles of life-saving blood were collected by the blood banks. Other initiatives that have been undertaken on a Pan India basis are supporting ‘No Tobacco Day’, ‘Save the Girl Child Campaign’, free Medicines worth about Rs. 1.5 crores provided to BPL families in Himachal Pradesh, ‘CME programmes for Doctors’ etc. We have also conducted various Seminars, Conferences, Workshops, Exhibitions, Table Top Exhibitions and Training Programs to promote and support the Indian Pharmaceutical Industry. This year at the 50th Golden Jubilee Annual Day Celebrations, we have invited Eminent National and International personalities to address our Members over two days. We will also be recognizing Top Achievers in the Indian Pharmaceutical Industry, who have made India Proud and respected world over as providers of affordable quality medicines. As part of the Annual Celebrations, the winners of Best Patent Awards, Gold & Silver Quality Excellence Awards, the IDMA J B Mody Awards and Indian Drugs Best Review Article and Research Awards will be announced and the Awards would be presented. Your Association has come a long way and many milestones have been met in the last 50 years. We are sure you will be a part of the Golden Jubilee Year celebrations. Ranbaxy climbs on Lipitor settlement buzz Ranbaxy shares gained amid reports that it may get approval from the US Food and Drug Administration (USFDA) to sell copies of Pfizer's Lipitor as early as next week. Ranbaxy and the American authorities are inching toward a settlement over the Indian company's regulatory troubles in the world's largest drug market, according to a business daily. Ranbaxy might shell out US$350 to US$400mn as a penalty and settle its outstanding issues with the USFDA. According to an agreement between Pfizer Inc. and Ranbaxy, the

Yearly Industry Newsletter

96 of 118

Indian company can launch its version of Lipitor on November 30, 2011. In 2008, the USFDA had banned Ranbaxy from selling 30 drugs and stopped approving fresh products from its two Indian plants citing violation of US manufacturing practices. Pfizer earns around US$6bn from Lipitor sales in the US, and Ranbaxy is expected to garner US$500-600mn during the six-month exclusivity period. Dr Reddy's requests govt to denotify Medak SEZ: reports Dr Reddy’s Laboratories (DRL) has reportedly urged the government to denotify its Special Economic Zone (SEZ) at Medak in Andhra Pradesh. Umang Vohra, chief financial officer, DRL was quoted as saying “We have requested for denotification of entire SEZ (in Medak). We are locating both our SEZs close together (at Visakhapatnam). Having an API unit at one place and formulation unit at another place complicates the whole matter.” Reports stated that DRL has given an undertaking to the commerce ministry for refunding the duty benefits availed of in the name of SEZ and the development commissioner of VSEZ has recommended the proposal. The company is expected invest around $200mn in both the SEZs and the SEZ land, after denotification, will be used for other expansion plans, added reports. …Strike at Dr. Reddy's Labs AP factory called offStrides Arcolab gets 2 more USFDA approvals for Oncology products Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited (Strides) today announced that it has received approvals from USFDA for:

Carboplatin Injection 10 mg/ mL (Aqueous solution), packaged in 1000 mg/100 mL, Pharmacy Bulk Packages.

Oxaliplatin for Injection USP (Lyopholized) packaged in 50 mg and 100 mg single-use vials (Tentative approval)

The Company had earlier received approval for Carboplatin Injection 10 mg/ mL packaged in 50 mg/ 5 mL, 150 mg/ 15 mL, 450 mg/ 45 mL and 600 mg/ 60 mL Multi-dose vials. According to IMS data, the US market for generic Carboplatin is approximately USD 35 Million. Carboplatin is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. The Company also received tentative approval for additional strength of Oxaliplatin Injection. According to IMS data, the US market for Oxaliplatin is approximately USD 1.4 Billion. The Company had earlier received tentative approval for Oxaliplatin Injection, 5 mg / mL, packaged in 50 mg / 10 mL, 100 mg/ 20 mL, and 200 mg/ 40 mL single dose vials. While other generic Companies approved for this product are expected to launch the product in August 2012, Strides will issue further updates on this product in April 2012. Transgene Biotek to sell technology for rh-EPO for US$5mn Transgene Biotek Ltd, one of the fastest growing biotechnology companies in India announced the sale of technology for recombinant human Erythropoietin (rh-EPO) to TSS EXPORT GmbH FZE, one of the group companies of the TSS Group for US$5.0 million. The technology transfer and sale of this technology is expected to be completed during a period of approximately 5-6 months. Transgene Biotek Ltd has made headlines in recent years for having out-licensed two of its technologies - including a recombinant Hepatitis B Vaccine to one of the largest vaccine producers in the world, and more recently Orlistat to one of the biggest Indian pharma companies with a significant presence on the global arena.

Yearly Industry Newsletter

97 of 118

Speaking to us about the transaction Dr. K.K.Rao, Managing Director, Transgene Biotek Limited said “This transaction fulfills the pledge we made earlier this year to focus on revenue generation whilst monetizing the sale of underutilized Bio-generic drug assets; those developed by the company during the last 7-8 years but which we now feel do not fit into our new agenda for sustained growth” Read More… UBM announces CPhI India 2011 UBM India, a part of UBM plc. a leading global business media company, will host CPhI India, the largest and most comprehensive pharmaceutical event in South Asia, from 30th November to 2nd December ‘11 at the Bombay Exhibition Centre in Mumbai, India. Focused on pharmaceutical ingredients, CPhI India will be joined by co-located events: P-MEC India for pharmaceutical equipment, machinery and technology; ICSE India for contract services, clinical trials; and CRO and the BioPh track for the biopharma market. Catering to all sectors in the pharma industry, both domestic and international and with 825 exhibitors from 21 countries, this year’s CPhI and its co-located events will offer attendees a dedicated platform to network with key decision makers in the global and Indian pharmaceutical industry, connect with existing partners and facilitate serious business deals. “With the Indian pharmaceutical market growing at 13% annually, twice of the world market growth rate, CPhI India and its co-located events have been geared to deliver significant return on investment (ROI) for pharma professionals who are currently working with or looking to establish relationships with Indian pharmaceutical companies, commented Sanjeev Khaira, MD, UBM India. Read More… Global Hospitals & Health City to conduct Master Class in Liver diseases The stage is set for the major international conference at Chennai between 2nd – 4th Dec 2011. The World renowned liver transplantation surgeon Prof. Mohamed Rela, Global Hospitals & Health city spearheads this international liver conclave as course director with eminent international & national faculties. MASTER CLASS IN LIVER DISEASES is first of its kind, 3days scientific conference, incorporating Histopathology along with Clinical aspects of Liver diseases & Transplantation, which will give the audience a holistic and indepth understanding of liver diseases. International Faculties include, Prof. Bernard C. Portmann, Dr. Alberto Quaglio, Prof. Elwyn Elias, Prof. Diedre Kelly, Prof. S. Wali, Prof. Ashley D’Cruz, Prof. Abid Suddle, Prof. Jack Lake, Prof. Julia Wendon, Prof. Nigel Heaton and Prof. Anil Dhawan amongst many national faculties. Read More… GVK Biosciences presents Frost & Sullivan Growth Leadership Award GVK Biosciences , Asia’s leading drug discovery research and development organization, announced that it was awarded the Frost & Sullivan 2011 Best Practices Award for Growth Leadership in the Contract Research Services Market. The Frost & Sullivan Award for Growth Leadership is presented to the company that has demonstrated excellence in capturing an impressivegrowth rate. GVK BIO is a notable growing Contract Research Organization; the Growth Leadership Award is a prestigious recognition of GVK BIO’saccomplishments in the Contract Research Service Market. With over ten years of experience and with more than 2000 employees, GVK BIO offers a spectrum of stand- alone and integrated services across the life Sciences R&D value chain. “GVK BIO has skilfully forward and upward integrated its service portfolio in sync with the changing pharma & biotech environment. Their recent

Yearly Industry Newsletter

98 of 118

milestones in discovery validate GVK BIO's ability and leadership in discovery programs.” quoted Dr Ajaykumar Sharma, Frost & Sullivan's Industry Manager - Pharma and Biotech. Read More… Ranbaxy wins USFDA nod for generic Lipitor Ranbaxy Laboratories Ltd. has finally received a green light from the US Food and Drug Administration (USFDA) to launch its copy of Lipitor. Lipitor is Pfizer’s cholesterol-lowering blockbuster medicine. Lipitor's US sales for the 12 months ended Sept. 30 were US$7.8bn, according to data provider IMS Health. New York-based Pfizer recorded global sales of US$10.7bn for Lipitor in 2010. The USFDA said in a statement late on Wednesday that Ranbaxy would make generic Atorvastatin calcium in 10, 20, 40 and 80 milligram tablets. The US regulator said that the generic drug would be manufactured by Ohm Laboratories in New Brunswick, New Jersey. Earlier, the USFDA withdrew a press statement on the approval, saying it had been issued in error. Watson Pharmaceuticals Inc. launched an "authorized" version of Lipitor. Watson said that it had begun shipping the pills, calling it the largest generic product launch in US history. Arun Sawhney, CEO & MD, Ranbaxy, said, "Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received U.S. FDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor. We are committed to continuing to expand our portfolio of products offered in the U.S. market for the benefit of patients, prescribers and the U.S. healthcare system." Pursuant to an agreement between Ranbaxy and Teva Pharmaceuticals USA, Inc., a portion of the profits from sales of Atorvastatin during Ranbaxy's 180-day first-to-file exclusivity period will be paid to Teva. Terms of the agreement will not be disclosed. Ranbaxy is expected to earn US$600-700mn if it manages to sell the Lipitor generic, exclusively for six months, said some media reports. Govt committed to provide quality medicines at affordable prices The Government is committed to make available quality medicines at affordable prices to the people+. In this context, Jan Aushadhi scheme for providing generic medicine to maximum number people is important significant initiative of the Ministry. This scheme needs proper sensitization and marketing strategy. Inaugurating the 3rd India Pharma Summitt-2011 here today, Srikant Kumar Jena, Minister of State for Chemicals and Fertilizers said that Indian Pharmaceutical sector has potential to grow in global market and can play lead role in this sector. He further said that research and development is important for new innovations in Pharma sector. He said that the recommendations and deliberation of the Summit will help stake holders to evolve new ideas and plans in this sector. The focus of the Summit is to address the key issues, identify challenges and opportunities in preparing a Roadmap for Global Leadership in Generic Medicine. The objective of the summit is to offer insight into the challenges and opportunities to become global leader in generics, address regulatory challenges in global generics and foster global industry-institutional and academia linkage in partnership mode for the benefit of all stake holders. On the occasion, G. Balachandran, Chairman, National Pharmaceutical Pricing Authority delivered the key note address. A power point presentation on Pharma Sector was made by. Devendra Chaudhry, JS, Department of Pharmaceuticals. Dr. Nata Menabde, WHO Representative to India was also present. Senior officials from Government, representative of leading Pharma industry and academia of this sector are taking part in this summit. Draft pharma pricing policy circulated to stakeholders Patented drugs are not defined in the drugs (Price Control) Order, 1995 (DPCO, 1995). Under the provisions of the DPCO, 1995, prices of 74 scheduled bulk drugs and the formulations containing any of these scheduled

Yearly Industry Newsletter

99 of 118

drugs are controlled. National Pharmaceutical Pricing Authority (NPPA) fixes or revises prices of scheduled drugs / formulations as per the provisions of the DPCO, 1995. Anti-cancer medicines are non-scheduled drugs, i.e. not covered under DPCO, 1995. In respect of non-scheduled drugs, manufacturers are at liberty to fix the prices by themselves without seeking the approval of Government / NPPA. Department of Pharmaceuticals has prepared a draft National Pharmaceutical Pricing Policy 2011 (NPPP-2011) based on the criteria of essentiality and requirements as stipulated by the Ministry of Health & Family Welfare. The draft Policy envisages bringing the National List of Essential Medicines (NLEM) – 2011 and associated medicines under price control. The draft NPPP-2011 has been circulated among the concerned Ministries/Stake holders asking them for the feedbank. CBI issues notices to Dr Reddy’s Laboratories: reports The Central Bureau of Investigation (CBI) has issued a notice to Dr Reddy’s Laboratories seeking details of the tax benefits it had availed during the reign of N Chandrababu Naidu as chief minister in Andhra Pradesh, according to reports. GV Prasad, vice-chairman and chief executive officer, Dr Reddy’s Laboratories reportedly said that they have received a letter from the CBI and have already responded to it. The report stated that CBI notice follows a public interest litigation filed by YS Vijaya Lakshmi, former chief minister YS Rajasekhara Reddy’s widow, in the Andhra Pradesh high court on the issue of amassing of wealth by Naidu. 3 people injured in fire at Aurobindo Pharma unit Aurobindo Pharma Ltd has announced that there was a fire incident in a powder processing area at early hours on November 28, 2011 at Unit 11, which is located at Pydibhimavaram, Srikakulam near Vizag, A.P. Three persons were injured and they were taken to the hospital. The powder processing area is isolated from the intermediate block. There was no impact to the operations as well as to the assets. Ind-Swift Labs clarifies MD's remarks on Lipitor Ind-Swift Laboratories Ltd. said that the statement of its Managing Director N.R. Munjal has been misinterpreted by a business daily. This is with reference to a news item published in a financial newsaper dated November 30 titled "World’s Best Seller Drug goes off patent today". Replying to a question, Munjal said that the company was not supplying any intermediate to Ranbaxy for Atorvastatin drug. The said quote has been misinterpreted as there was nothing left for Ranbaxy with regards to Lipitor now. Ranbaxy gets USFDA nod for Mohali Plant: report Ranbaxy Laboratories Ltd. has reportedly received an approval from the U.S. Food and Drug Administration (USFDA) for it’s manufacturing plant in Mohali. Ranbaxy shares declined amid concerns about its near-term business outlook as the company has not been able to resolve outstanding regulatory issues with the USFDA, delaying the launch of generic Lipitor in the US market. The blockbuster drug, which is manufactured and sold by US drug major Pfizer is going off patent in the world's biggest market. Ranbaxy still has to get final clearance from the US drug regulator to launch its product in the US market. Ranbaxy has 180-day exclusivity for launching its copy of Lipitor as it was the first to challenge the Pfizer patents. As of now there are no clues as to when Ranbaxy will be able to launch its version of Liptor in the US. The reported USFDA approval for the Mohali plant might just help the company in its endeavour. Meanwhile, Watson Pharma announced the launch of an authorised generic version of Lipitor. Pfizer’s Lipitor generated revenue of over US$10bn in 2010. The USFDA had blacklisted two of Ranbaxy’s plants in India - Dewas and Paonta Sahib - in 2008. That led to the banning of 30 drugs while approvals for new ones manufactured at these plants were also put on hold.

Yearly Industry Newsletter

100 of 118

Global Hospitals organises “Master Class in Liver Diseases” Global Hospitals Group is organizing a 3 day international liver conclave, ‘Master Class in Liver Diseases’ in Chennai starting 2nd December to 4th December 2011. This 3 day scientific conference will be spearheaded by the world renowned Liver transplantation surgeon Prof. Mohamed Rela. Over 30 eminent doctors from USA & Europe and over 300 nationally renowned liver specialists will be present to demonstrate the current concepts and trends on liver transplantation across the globe. MASTER CLASS IN LIVER DISEASES is the first of its kind, a 3 day scientific conference, discussing various Clinical aspects of Liver diseases & Transplantation, which will give the Indian audience a holistic and in depth understanding of liver diseases. International Faculties participating in the conclave include, Prof. Bernard C. Portmann, Dr. Alberto Quaglio, Prof. Elwyn Elias, Prof. Diedre Kelly, Prof. S. Wali, Prof. Ashley D’Cruz, Prof. Abid Suddle, Prof. Jack Lake, Prof. Julia Wendon, Prof. Nigel Heaton and Prof. Anil Dhawan amongst many other national faculties. Global Hospitals acknowledged as the world’s most comprehensive centre for Liver, Pancreas diseases and transplantation offers the largest Liver Transplant program in the country. The Global Liver Transplant program is currently available in three centers across South India, Hyderabad, Chennai & Bangalore and is soon expected to be operational in Mumbai. With all the facilities and the technical knowhow, Global Hospitals has successfully set new standards in the management of liver diseases. The incidence of liver diseases in India is on a rise. Cases related to hepatitis, liver cirrhosis, liver tumours are being frequently reported. A liver infection is considered to be a serious medical condition thus it should not be taken lightly Honeywell unveils new film for pharma packaging Honeywell introduced a new pharmaceutical packaging film that provides the highest moisture barrier of any film of its type. Part of the Aclar family of films, the new product, Aclar UltRx 6000, is effective at protecting moisture-sensitive medicines in all climates, even the hottest and most humid locations. This allows pharmaceutical companies to standardize their product packaging with one solution that will work in all regions of the world. Aclar films, including Aclar UltRx 6000, can also help reduce drug package sizes by up to 55 percent compared with the alternative, cold-formed foil. Aclar UltRx 6000 can be used in existing equipment, with only minor adjustments, that pharmaceutical companies use to thermoform their packages. Also, like all Aclar films, Aclar UltRx 6000 is clear, allowing pharmaceutical companies to differentiate their brand by allowing the pill to be seen through the packaging. “This Aclar film gives pharmaceutical companies a clear, ultra-high barrier choice for their most moisture-sensitive drugs sold in the most challenging regions,” said Jeff Czarnecki, global leader of Honeywell’s health care and packaging business. “This new film will help pharmaceutical companies around the world protect their medicines, simplify their supply chains, and improve their branding.”

Yearly Industry Newsletter

101 of 118

International News - November 2011 Gilead Sciences announces New Drug Application to U.S. FDA Gilead Sciences, Inc.announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of the “Quad”, a complete single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate for the treatment of HIV-1 infection in adults.If approved, the Quad would be the only once-daily, single-tablet regimen containing an integrase inhibitor. “We continue to dedicate our HIV research and development efforts to advancing single-tablet regimens that address important patient needs,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Based on data from our pivotal studies, we believe that the Quad has the potential to be an important new treatment option for people living with HIV, and we are pleased to have reached this significant milestone less than six weeks after the unblinding of the second pivotal Phase 3 study.” Read More… P&G and Teva Pharma form OTC partnership The Procter & Gamble Company and Teva Pharmaceutical Industries Ltd. announced the creation of a new partnership and joint venture (JV) in consumer health care. The JV, to be named PGT Healthcare, will be headquartered in Geneva, Switzerland and will operate in essentially all markets outside of North America. The partnership between P&G and Teva will also develop new brands for the North American market. PGT Healthcare, a new model in the industry, will focus on best-in-class development and state-of-the-art commercialization of branded OTC medicines. The JV will bring together each company’s complementary capabilities and existing over-the-counter (OTC) medicines. As a result, PGT Healthcare expects to accelerate growth for its parent companies and compete for leadership in the fast-growing, $200 billion consumer health care industry. The partnership will start from a solid base of approximately $1.3 billion in annual sales with the potential to grow to $4 billion in annual sales towards the end of the decade. Read More… Gilead announces positive 5-year data showing effect of Viread Gilead Sciences, Inc. announced new five-year data from the open-label phase of two pivotal Phase 3 clinical trials (Studies 102 and 103) evaluating the efficacy of Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus (HBV) infection among primarily treatment-naïve patients. Results show that Viread maintains long-term viral suppression of HBV and is associated with a reduction in liver fibrosis and a reversal of cirrhosis. Among patients in both studies, the majority (88%) experienced an improvement in overall liver histology. Together, these two studies represent one of the largest datasets evaluating the impact of an oral antiviral therapy on histologic changes and showing a reduction in liver fibrosis. These findings are being presented Monday, November 7 at the 62nd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2011) in San Francisco. Read More… Bayer sales in region to grow to well over EUR 11bn by 2015 The Bayer Group plans to further expand its production, distribution network and research activities in Asia and considerably increase its sales in the region in the coming years. “We aim to achieve a more than 60 percent increase in our sales in Asia by 2015,” Management Board Chairman Dr. MarijnDekkers said on Wednesday at Bayer’s international press conference “Perspective on Growth in Asia,” held in Shanghai, China. This would mean annual sales of well over EUR 11 billion by 2015 at today’s exchange rates. Dekkers officially inaugurated a new production facility for TDI – a raw

Yearly Industry Newsletter

102 of 118

material for the production of flexible foams – at the Bayer Integrated SiteShanghai. At the press conference, attended by more than 100 media representatives – with journalists in India, Vietnam and Indonesia participating via live video link – Dekkers explained the company’s perspectives in the emerging countries of Asia. He said the Bayer Group already does a significant proportion of its business in Asia. Twenty years ago, Asia accounted for only about 10 percent of sales, equivalent to just over EUR 2 billion. Ten years ago, the proportion had grown to about 15 percent, and last year the region already accounted for some 20 percent of sales. In the Asian region, Bayer achieved sales of EUR 6.9 billion in 2010, and anticipates further growth in 2011. “We have made capital expenditures of EUR 3.4 billion in Asia over the past 10 years, creating a basis for outperforming market growth in this region,” said Dekkers. Bayer has laid a firm foundation for expansion. “Our country organizations here have had local roots for many years, in fact we have been operating for more than a century in India, Chinaand Japan,” said Dekkers. “We are familiar with the markets, and we know how to tune our approaches to the different conditions prevailing in different markets in order to further expand our business.” Gilead Sciences to acquire Pharmasset, paying sizable premium in $11bn deal Gilead Sciences, Inc. and Pharmasset, Inc. announced today that the companies have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash. The transaction, which values Pharmasset at approximately $11 billion, was unanimously approved by Pharmasset's Board of Directors. Gilead plans to finance the transaction with cash on hand, bank debt and senior unsecured notes. The company expects the transaction, when completed, to be dilutive to Gilead's earnings through 2014 and accretive in 2015 and beyond. Further guidance will be provided when the transaction closes, which is expected to be in the first quarter of 2012. Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company's lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog, has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients. Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014. PSI-938, an unpartnered guanosine nucleotide analog, is being tested in a Phase 2b interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analog, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine. Read More… Pfizer to acquire Excaliard Pharmaceuticals Pfizer Inc. and Excaliard Pharmaceuticals, Inc. announced today that they have entered into a definitive agreement under which Pfizer will acquire Excaliard, a privately owned biopharmaceutical company focused on

Yearly Industry Newsletter

103 of 118

developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring. The acquisition is expected to close before the end of the year. Excaliard’s lead product, EXC 001, an antisense oligonucleotide in phase 2, is designed to interrupt the process of fibrosis by inhibiting expression of connective tissue growth factor (CTGF). CTGF is a growth factor that can be over expressed in damaged skin or tissue following surgery or traumatic injury and lead to disfiguring skin scarring. The phase 2 program for EXC 001 has thus far produced positive clinical results in reducing scar severity. Upon completion of the acquisition, Pfizer plans to continue development of EXC 001 to address unmet medical needs in patient groups who suffer from excessive skin scarring. Currently, there are no FDA-approved products to reduce scar severity. “The acquisition of Excaliard is part of our corporate research and development strategy to actively complement our robust internal project pipeline with innovative and differentiated drugs from biotech partners,” said Mikael Dolsten, president, Worldwide Research and Development, Pfizer. Read More… Merck to settle US Vioxx charge for US$950mn Merck known as MSD outside the United States and Canada, announced it has reached a resolution with federal and state authorities regarding a previously disclosed investigation concerning Vioxx. Merck voluntarily withdrew Vioxx from the market in September 2004. The company previously recorded a charge of US$950mn in October 2010 in anticipation of today's agreements. Under civil settlement agreements signed with the United States and individually with 43 states and the District of Columbia, Merck will pay approximately two-thirds of the reserved charge to resolve civil allegations related to Vioxx. As a result, the United States and the participating states have released Merck from civil liability related to the governments' allegations regarding the sale and marketing of Vioxx in the United States. Previously disclosed litigation with seven states remains outstanding. The civil settlement does not constitute any admission by Merck of any liability or wrongdoing. "We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx," said Bruce N. Kuhlik, executive vice president and general counsel of Merck. Merck sends Assistance to flood-ravaged Thailand Merck KGaA and its Life Science division Merck Millipore have sent thousands of state-of-the-art water test kits to Thailand in an effort to ensure the safety of municipal drinking water following months of devastating flooding in that region. In addition to the product shipment, the company has donated €110,000 to assist flood victims. “Safe drinking water is a basic human right,” said Robert Yates, Head of Merck Millipore. “When it became apparent that public drinking water might be impacted by the floods, we did not hesitate to send our test kits. It is our collective hope that in some small way Merck can help the people of Thailand recover from these devastating floods.” The Merck Millipore division has shipped more than 10,000 test kit elements that will be distributed to various Thai organizations, including the National Metal and Materials Technology Center (MTEC), a member of National Science and Technology Development Agency (NSTDA); the Ministry of Science and Technology; and the Samsen office of the Metropolitan Waterworks Authority. The test kits will be used to detect any evidence of contamination in the drinking water. Read More… Lilly provides additional funding to Infectious Disease Research Institute Eli Lilly and Company is providing more than $4 million in additional funding to the Infectious Disease Research Institute. The funding will allow IDRI to continue its early phase drug discovery efforts focused on identifying new

Yearly Industry Newsletter

104 of 118

and better therapies in the fight against tuberculosis, including multidrug-resistant strains known as MDR-TB. In addition, Lilly will provide more than $1 million in-kind for volunteer time from Lilly scientists and access to the company's drug discovery expertise, chemical libraries, and research tools. These additional commitments bring Lilly's total support of early stage TB drug discovery efforts through IDRI to more than $20 million - and Lilly's total funding of TB and MDR-TB efforts to more than $170 million. IDRI is a member of the Lilly TB Drug Discovery Initiative, a not-for-profit public-private partnership focused on accelerating early stage drug discovery for potential new treatments for TB. TB and MDR-TB disproportionately affect people in countries with developing economies. "While preventable and treatable, nearly 1.5 million people die from TB and MDR-TB every year," said John C. Lechleiter, Ph.D., Eli Lilly and Company chairman, president and chief executive officer. "Today's TB drugs are decades old and must be taken for extended periods of time, which present challenges for patients and health care providers. More effective medicines with fewer side effects are desperately needed." Read More… FDA Commissioner announces decision on Avastin for Metastatic Breast Cancer Roche announced that the FDA Commissioner is revoking the approval of Avastin (bevacizumab) for the treatment of mBC in the United States. "We are disappointed with the outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Despite today's action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin." Enbrel (etanercept) patent issued Amgen announced the issuance of U.S. Patent No. 8,063,182 related to Enbrel (etanercept). This patent is owned by Hoffman-La Roche Inc. ("Roche") and exclusively licensed to Amgen. Immunex Corporation (acquired by Amgen in 2002) originally licensed this patent application from Roche in 1999, and in 2004, Amgen paid Roche a one-time payment and obtained an exclusive, fully paid-up license to the application which issued today as the '182 patent. The patent describes and claims the fusion protein that is etanercept, and by statute, the '182 patent has a term of 17 years from today. Pfizer completes acquisition Ferrosan Consumer Health's business: reports Pfizer Inc. has completed its previously announced acquisition of Ferrosan Consumer Health's business, which includes dietary supplements and lifestyle products, from Altor 2003 Fund GP Limited, according to reports. Paul Sturman, President, Pfizer Consumer Healthcare reportedly said that Ferrosan Consumer Health's innovative products and geographic footprint are a strong fit for our business. AstraZeneca commits an additional $100 million to venture MedImmune Ventures AstraZeneca has committed an additional $100 million to its venture capital arm, MedImmune Ventures, increasing the total capital under management to $400 million. MedImmune Ventures is an evergreen venture capital fund that focuses on equity investments in private companies in the areas of biopharmaceuticals, medical and healthcare technology. "With the additional funding from AstraZeneca, we look forward to expanding our investment

Yearly Industry Newsletter

105 of 118

activities globally and across therapy areas. We believe that in the current financial environment, there is a growing role for corporate venture capital funds such as MedImmune Ventures," said Ron Laufer, Senior Managing Director, MedImmune Ventures. Simon Lowth, Chief Financial Officer, AstraZeneca said: "We continue to support MedImmune Ventures strategy that combines commitment to advance science and technology in the life science industry while generating financial returns expected of venture capital funds." Additionally, AstraZeneca also announced that MedImmune Ventures has co-led the second round of financing for NeuProtect Pty Ltd, an Australian life science company specialised in the reduction of cardiac remodelling post myocardial infarction. Ron Laufer said: "We are delighted to co-lead with Starfish Ventures a new round of financing for NeuProtect Pty Ltd, our first investment in an Australian company." Pradaxa awarded Prix Galien for most innovative product in Canada Boehringer Ingelheim's breakthrough novel oral anticoagulant Pradaxa (dabigatran etexilate) was awarded the prestigious Prix Galien in Canada. At a Gala Ceremony during the Tenth Annual Canadian Health Research Awards Ceremony in Ottawa, Pradaxa (Pradax in Canada) was recognised as the most innovative Canadian product in 2011. Pradaxa has now received this award for the second time, after winning the German Prix Galien in 2010, in the Primary Care category. The Prix Galien is awarded for new drugs representing a significant advance in pharmaceutical research. "We are proud that Pradaxa® has been awarded the Canadian Prix Galien," says Prof. Dr. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. "The decision by the jury underlines the outstanding innovation Pradaxa brings for patients and doctors, providing a much needed advance in stroke prevention in atrial fibrillation, an area of high therapeutic need." The approval of Pradaxa in prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (SPAF) was based on data from the landmark RE-LY trial (Randomized Evaluation of Long term anticoagulant therapY), a global, Phase III trial of 18,113 patients, enrolled in over 950 centres in 44 countries. 1 Compared to well-controlled warfarin (median time in therapeutic range (TTR) 67.3%2), the following results were seen with Pradaxa in the landmark RE-LY trial:(1,2,3) Pradaxa 150mg bid significantly reduced the risk of stroke and systemic embolism by 35%, providing clinically important stroke prevention in non-valvular atrial fibrillation (AF). Read More… Sanofi Confirms its Decades-Long Commitment to the Fight against Malaria Sanofi confirmed today its decades-long commitment to the fight against malaria at the opening of 10th Edition of the Pan-African Conference against Malaria. The 10th Edition of this conference gathers together the directors of 34 African National Malaria Control Programs (NMCPs), representatives of the Global Fund To Fight Aids, Tuberculosis and Malaria, the World Health Organization, the Roll Back Malaria partnership, and scientific experts. During his opening ceremony speech, Christopher A. Viehbacher, Chief Executive Officer of Sanofi declared: "Understanding that drugs are not enough to win the fight against malaria, Sanofi has undertaken a decade-long strategy of partnership with African National Malaria Control Programs, to propose solutions beyond existing treatments including prevention and diagnosis to meet the challenges of the emergence of treatment-resistance strains. Thanks to these major partnerships combining public and private actors, as well as non-profit organizations, the elimination of malaria, which

Yearly Industry Newsletter

106 of 118

yesterday seemed utopian, has now become an achievable goal.” Read More… Watson Pharma launches generic Lipitor Watson Pharmaceuticals, Inc. on Wednesday confirmed that Watson Pharmaceuticals, Inc., has launched an authorized generic version of Lipitor (atorvastatin calcium tablets) as part of an exclusive agreement with Pfizer Inc. Watson began shipping the product. Lipitor is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL, triglycerides and to increase HDL cholesterol. Under the terms of the exclusive supply and distribution agreement, Pfizer manufactures and supplies Watson with all dosage strengths of the authorized generic product. Watson markets and distributes the product in the United States. Pfizer will receive a share of the net sales from Watson's sales of the product. The agreement runs until November 30, 2016. Other terms of the agreement were not disclosed. For the most recent twelve months ending September 30, 2011, Lipitor had sales of ~US$7.8bn, according to IMS Health data. Mylan gets nod for Generic version of Zinecard for Injection Mylan Inc has announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dexrazoxane for Injection, packaged in 250 mg and 500 mg Single-use Vials. This product is the generic version of Pharmacia & Upjohn’s Zinecard® for Injection, a chemoprotective agent. Dexrazoxane for Injection, when indicated for the same use as Zinecard for Injection, had U.S. sales of approximately $3.4 million for the 12 months ending Sept. 30, 2011, according to IMS Health. Mylan Institutional is shipping this product immediately. Currently, Mylan has 161 ANDAs pending FDA approval representing $97.7 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.9 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health

Yearly Industry Newsletter

107 of 118

Domestic News - December 2011 Dilip Shanghvi buys minority stake in Natco Pharma Dilip Shanghvi has reportedly bought a minority stake in Natco Pharma for 183.4mn, triggering speculation it may lead to a larger alliance between the two. According to reports, Shanghvi bought Rs. 7.25 lakh shares, or 2.6% of Natco, from Orange Mauritius Investments at Rs. 253 apiece. Natco shares surged 15% to 278.6, coinciding with the company's sale of shares to institutional investors under the qualified institutional buyers' plan. It is not clear how much it planned to raise through the share sale and whether it is complete. Natco's promoters and the promoter group own 63% of the company, according to the company's website, added reports. …Natco Pharma announces closure of QIP issue EU not to detain Indian generic drugs: Govt India initiated dispute settlement consultations on 11 May 2010 at the World Trade Organisation (“WTO”) with the European Union (EU) on the issue of detention of Indian generic medicines while in transit through EU. The detentions were made by invoking the EC’s Regulation 1383/2003 which contains customs procedures for taking action against goods suspected of infringing intellectual property rights (IPRs). India and Brazil jointly held two rounds of consultations with the EU on 7-8 July, 2010 and 13-14 September 2010. During these consultations, EU acknowledged that some provisions of the EC Regulation 1383 were misinterpreted by the customs authorities while detaining the Indian generic drugs. EU showed willingness to resolve this dispute without resorting to the WTO dispute panel. Read More… Shionogi & Co procures injunction order against Lupin: reports Shionogi & Co has reportedly procured an injunction order against Lupin, barring it from further selling a generic version of Fortamet in the US. According to reports, before the district court renders a decision in the on going litigation, injunction prevents Lupin from further importing and selling a generic version. Lupin is currently evaluating options and is seeking a speedy resolution on the same matter. Reports said that the US court has denied the motion of Shionogi for recall of Lupin's already distributed generic Fortamet during the two weeks of at-risk launch in October 2011. The Court also ordered Shionogi to deposit a security bond of $15 million for losses likely to be suffered by Lupin in next one year, pending the outcome of the case. Lupin had launched the generic Fortamet at-risk triggering its 180-days exclusivity on September 30, 2011, added reports. Fortis Healthcare to invest upto Rs. 300mn to set up dialysis centres: reports Fortis Healthcare has reportedly said that it plans to invest up to Rs. 300mn to set up 50 standalone dialysis centres for treatment of patients suffering from kidney failure in the next 2 years across the country. Aditya Vij, CEO, Fortis Healthcare (India) was quoted as saying "Our target is 50 centres in the next two years. Depending upon the varied locations across the country, the investment per centre would be in the range of Rs. 50-60 lakh." Fortis Healthcare launched Renkare, a chain of stand-alone dialysis centres. These stand-alone centres will expand Fortis’ reach and help meet the rising demand for quality dialysis. The company plans to set up 50 stand-alone dialysis centres across the country over the next two years, in a phased manner. In the first phase, six centres will come up across Delhi & NCR covering the territory in the North, South, West and East. The company plans to set up six centres across Delhi and the National Capital Region (NCR) in the first phase, while the remainder would come up in other metros and Tier-II and III cities, added reports.

Yearly Industry Newsletter

108 of 118

…Fortis launches RENKARE Ranbaxy announces consent decree with U.S FDA Ranbaxy Laboratories Ltd. announced that it has signed a consent decree with the U.S. Food and Drug Administration (“FDA”). Ranbaxy has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The consent decree is subject to approval by the United States District Court for the District of Maryland. Separately, Ranbaxy also announced that it intends to make a provision of $500 million in connection with the investigation by the U.S. Department of Justice, which the company believes will be sufficient to resolve all potential civil and criminal liability. “We are pleased to have resolved this legacy issue with the FDA as we begin the next chapter in Ranbaxy’s history,” said Arun Sawhney, Ranbaxy CEO & Managing Director. “While we were disappointed by the conduct that led to the FDA’s investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes. Ranbaxy’s new management team, and its new majority shareholder, Daiichi Sankyo, are committed to the utmost levels of professionalism and integrity, and to ensuring that all Ranbaxy facilities meet the high standards that patients, prescribers and the public expect from a leading global generic pharmaceutical company. We look forward to continuing to work cooperatively with the FDA to strengthen the public trust in our company.” Sawhney continued, “With greater clarity around the outlook for our business in the U.S., we look forward to continuing to serve the U.S. market with safe, effective and affordable products, including our recent launches of Atorvastatin (*brand Lipitor) and Atorvastatin-Amlodipine besylate (** brand Caduet). Importantly, these developments bring greater predictability to Ranbaxy’s U.S. operations and allow us to focus all of our efforts on bringing high quality products to market for the benefit of consumers.” …Ranbaxy to market Daiichi Sankyo's innovative products in Malaysia Indian pharma exports facing competition from China As per available information, Indian Pharmaceutical exporters are facing intense competition in international markets from China, particularly in Bulk drugs sector. Competition in formulations is also increasing gradually from China. Government has already prepared strategies to double the pharma exports to USD 25bn by 2013-14, including ‘Increase in the share of India’s Pharma exports to China’. As per extant FDI policy, FDI, up to 100% under the automatic route, is permitted for Greenfield investments in the pharmaceuticals sector, while FDI, up to 100%, is permitted for brown field investments (i.e. investments in existing companies), in the pharmaceuticals sector, under the Government approval route. This information was given by Shri Jyotiraditya M. Scindia, Minister of State for Commerce and Industry in written reply to a question in the Lok Sabha. Dr Reddy’s to focus on new chemical entities: reports Dr Reddy’s Laboratories Limited is reportedly exiting from cardiovascular diseases (CVD) and diabetes and focusing on new segments, including dermatology and pain management due to high costs involved for the latter.GV Prasad, Vice Chairman and CEO, Dr Reddy's Laboratories was quoted as saying "We have now selected areas, which are available for innovation...we moved away from cardiovascular diseases (CVDs) and diabetes towards pain and inflammation, dermatology and of course anti-infectives." According to reports, Dr Reddy's is looking at a product which will directly address this segment of post surgical infections to improve its performance in India and Europe. Biosimilars is one such major area

Yearly Industry Newsletter

109 of 118

company is seeking for its growth from 2016 to 2020. The company could not afford for some of the trials like CVDs as it required at least 30,000 patients, added reports. …Dr Reddy's Labs announces VRS for employees of Mexico subsidiary: reports Strides Arcolab gets continued US FDA approval status for Sterile Products Division Strides Arcolab today announced the following US FDA approvals: The Sterile Products manufacturing facility (SPD 1) in Bangalore, the principal sterile facility of Agila, which was recently inspected by the US FDA as part of the routine GMP compliance audit and the facility has been classified as acceptable. This facility manufactures lyophilized, liquid, dry powder injectables and pre-filled syringes. The last inspection and approval of this site was in March 2009. V.S.Iyer, Executive Director and CEO - Agila said "this approval endorses our commitment to continued compliance with cGMP. Fludarabine Phosphate Injection USP 25 mg/mi, packaged in 50 mg/2 mL Single-dose vials. Approval for Onco Therapies Limited (a wholly owned subsidiary of Strides). According to IMS data, the US market for Fludarabine is approximately USD 15 Million. Fludarabine is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. Orchid Pharma ties up funds for FCCB redemption Chennai-based Global Pharma major, Orchid Chemicals & Pharmaceuticals has announced that it has received sanction for US$ 100 mn by way of ECBs (External Commercial Borrowings) from the banking system to redeem the outstanding FCCBs (Foreign Currency Convertible Bonds) of US$ 117 mn, along with the yield-to-maturity when they fall due in February 2012. “We are fully geared to redeem the maturing FCCBs. The ECB sanction that we have received, coupled with our internal accruals will enable us to comfortably redeem the outstanding FCCBs on the due date. With over 85% of Orchid’s sales being exports billed in US$, the company has a natural hedge against currency fluctuations”, said K Raghavendra Rao, Chairman & Managing Director, Orchid Chemicals & Pharmaceuticals Ltd. …Orchid-Merck anti-infective program meets preclinical milestone Cadila acquires 100% stake in Mumbai-based Biochem Zydus Cadila has acquired 100% stake in Biochem, one of the top 40 pharma companies in India. A privately-held company headquartered in Mumbai, Biochem is a well-integrated pharma player with a presence in the antibiotics, cardiovascular, anti-diabetic and oncological segments. Biochem has reported sales of Rs. 264,5 crores for the year 2010-2011. Established in 1959, Biochem has proven strengths in manufacturing and marketing of antibiotics. The top 5 brands of the company are Ampilox, Biotax, Monotax, Amicin and Zithrocin which together contribute to 40% of the company's sales. Three of Biochem's brands fall in the top 300 pharma brands of India. The acquisition strengthens Zydus' operations in the Indian pharma market. Speaking on the latest acquisition, Zydus Cadila's Chairman and Managing Director. Mr. Pankaj RL Pate! said, "The Formulations Business in India has always been the bulwark of our operations and we have looked at every strategic opportunity to grow and contribute to this market, either by way of novel initiatives, collaborations or acquisitions. Biochem represents the right

Yearly Industry Newsletter

110 of 118

fit as they have a significant presence in our core therapy areas and also add value to our product offerings in the key growth segments." Opto Circuits group firm launches cardiac science products Advanced Micronic Devices Limited’s (AMDL) healthcare division – AMDL Health, a leading provider of medical equipment and devices, today announced the launch of Cardiac ScienceTM family of advanced cardiac diagnostic products in India. The products are being showcased at the 63rd Annual Conference CSI, Mumbai, 8th -11th December 2011. This marks AMDL Health’s foray into the Indian cardiovascular market. The products to be sold are under the brands of Cardiac Science, Quinton, Burdick, and Powerheart. “India is the second largest potential cardiovascular market in the world and is expected to reach $589M by 2017,” said Arindam Sen, Chief Executive Officer, AMDL. “We are committed to make technologically advanced devices accessible to the Indian healthcare market.” AMDL Health plans to target Tier 1 and Tier 2 cities that are changing the landscape of Indian medical equipment industry. Powerheart automated external defibrillators (AEDs) are easy to use devices that are utilized for emergency treatment of sudden cardiac arrest (SCA). The proven Burdick and Quinton brands bring ECG, stress test systems, Holter monitors and supplies to physicians’ offices and hospitals. Quinton QStress and Burdick ECG products are renowned for their reliability and accuracy. Elder Pharmaceuticals set to enter Japanese pharma market Elder Pharmaceuticals Limited, the Indian pharma major, which has already received accreditation from Ministry of Health-Japan for its Active Pharmaceutical Ingredients (API) plant at Patalganga, Maharashtra is all set to enter in the US $ 70 billion Japanese pharma market during the current Financial year. “The Japanese pharmaceutical market is actually valued at about US$70 billion. The opportunity which we are targeting is about USD 1 billion. Our plan is to actually try to get about 1-2%. We have also filed for new patents in these markets so hopefully we should get these during the current financial year which would open up another USD 500 million market for us,” said Mr Alok Saxena, Joint Managing Director, Elder Pharmaceuticals Limited “The free trade agreement signed between the two countries earlier this year is also expected to boost the supply of ingredients to Japanese players. The Japanese pharma market, the second largest market, is an untapped, high value market with lot of opportunities for Indian pharma ingredients companies, in terms of supplies of APIs and intermediates to generic companies in Japan. Elder is also positioning itself to become a supplier of APIs and advanced intermediates to tap the vital Japanese market for the future growth of the company.” said Saxena. Read More… SC allows export of Endosulfan insecticide The Supreme Court reportedly allowed export of unused stock of endosulfan insecticide, while retaining the complete ban imposed by it on its production, sale and use in the country. A three-judge Bench headed by Chief Justice S.H. Kapadia was quoted as saying that the “dilution, packaging and export” of the agrochemical will be handled by public sector unit (PSU) Hindustan Insecticide Ltd. Its previous order to propose mechanism for packaging and export of the insecticide will be followed. The company manufacturing endosulfan was allowed by the Bench to export nearly 1,100 tonnes of the pesticide to meet their contractual obligations while maintaining the ban on its use and production on September 30, added reports.

Yearly Industry Newsletter

111 of 118

Roche loses case vs Intas in Madras HC Madras High Court has reportedly dismissed suit filed by Hoffman La Roche against Intas, regarding the former's lung-cancer drug erlotinib due to lack of jurisdiction. Mohan, advocate at the Madras HC was quoted as saying that Intas' application said that the Court should not have granted permission for Roche's case to be registered in the first place. According to reports, to stop the sale of erlotinib, Roche had filed a case against Intas on the basis of a single sale from a retail chemist in Chennai. The single sale was from a retailer not authorised by Intas and did not tantamount to a commercial sale. Roche was already fighting a patent-infringement suit against Natco, on the same drug, at the Delhi High Court, added reports. Glenmark Pharma seeks arbitration against Napo Pharma Glenmark Pharmaceuticals Ltd. said on Tuesday that it was seeking a declaration from an arbitration panel that Napo Pharmaceuticals, Inc.'s claims of breach are unfounded. Napo recently issued a press release in which it claims to have terminated a July 2, 2005 Collaboration Agreement between it and Glenmark Pharma. On December 9, Glenmark formally requested that the arbitration panel issue an interim order directing Napo to comply with the Collaboration Agreement during the pendency of the arbitration. On August 8, 2011, Glenmark filed a statement of claim with the American Arbitration Association against Napo seeking, among other things, a declaration that Glenmark's exclusive rights to develop, commercialise and distribute Crofelemer in 140 countries for treatment of diarrhoeal diseases includes the exclusive rights to distribute though relief agencies in these countries. Glenmark recognises the importance of relief agency distribution of Crofelemer to populations in emerging countries with the most critical need for the product. Glenmark believes that contractually it has exclusive rights with respect to relief agency distribution in the countries and indications licensed to Glenmark. Lupin eyes US$300mn from Japan in 2 years: report Lupin is reportedly looking to take a jump of over 80% in its revenues to $300 million (about Rs. 1,5570mn) from the Japanese market in the next two ears on the back of its enhanced presence in the country. According to reports, the company has strengthened its presence with the acquisition of I’rom Pharmaceuticals for an undisclosed amount. Japan is a priority market for Lupin, and between the two companies in Japan (Kyowa and I’rom), Lupin looks to clock in revenues of about $300 million over the next two years from the present about $165 million. The company is also eyeing to enter other markets, including Latin America and Europe, added reports. Sun Pharma gets USFDA nod for generic Ultram ER Tablets Sun Pharmaceutical Industries Ltd. announced that USFDA has granted Its subsidiary sn approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Ultram ER, Tramadol hydrochloride extended release tablets. These generic TramaUol hydrochloride extended release tablets, 100 mg, 200 mg and 300 mg. are therapeutically equivalent to Ultram ER tablets of Valeant. These tramadol HCL ER tablets have annual sales of approximately USD 125 million in US. Tramadol HCL ER tablets are indicated for management of moderate to moderately severe chronic pain in adults who need around-the-clock treatment of their pain for an extended period of time. Strides's Onco Therapies get US FDA approval for 3 ANDAs of Cytarabine Injection Onco Therapies Limited, a wholly owned subsidiary of Strides Arcolab Limited (Strides) today announced that it has received approvals from USFDA for Cytarabine Injection 20 mg/ mi, packaged in 500 mg/ 25 mL Multiple-dose vials, 20 mg/ mi, packaged in 100 mg/5 mi Single-dose vial and 20 mg/mi,

Yearly Industry Newsletter

112 of 118

packaged in 1000 mg/ 50 mi Pharmacy Bulk Packages. According to IMS data, the US market for Cytarabine is approximately USD 12.3 Million. Cytarabine is part of the Oncology portfolio licensed to Pfizer in January 2010 for the US market and expected to be launched shortly. Ranbaxy's generic Lipitor wins 2.5% market share in US Ranbaxy Laboratories has reportedly managed to capture close to 2.5% of the generic Lipitor's market share in the US within the first few days of the launch. According to reports, government procurement agencies have so far purchased over 29.18 lakh tonnes of paddy and delivered over 3.24 lakh tonnes of custom milled rice to Food Corporation of India (FCI). Over 10.58 lakh tonnes of paddy have been purchased by the Food and Supplies Department and over 10.10 lakh tonnes by HAFED. Karnal district led the State in terms of paddy arrivals, with over 8.52 lakh tonnes making its way to the mandis so far, followed by Kurukshetra district, where over 7.90 lakh tonnes of paddy has arrived in the markets, added reports

Yearly Industry Newsletter

113 of 118

International News - December 2011 Pfizer completes acquisition of Excaliard Pfizer Inc. has completed its acquisition of Excaliard Pharmaceuticals, Inc., a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis, more commonly referred to as skin scarring. "It is imperative at Pfizer that we continue to develop new and innovative treatments to address unmet medical needs, and there is currently no FDA-approved treatment for excessive skin scarring," said Jose-Carlos Gutierrez-Ramos, senior vice president, Biotherapeutics, Worldwide Research and Development, Pfizer. "Acquiring Excaliard allows us to continue the development of its lead compound EXC 001 to potentially fill a gap and bring a novel new treatment to patients." Nicholas Dean, PhD., Founder and Chief Scientific Officer of Excaliard: "We are excited that Pfizer will continue to develop EXC 001, which has shown evidence of reducing scar severity in Phase 2 clinical trials." While specific financial terms are confidential, Pfizer provided Excaliard's shareholders, which include Isis Pharmaceuticals, Alta Partners, ProQuest Investments and RiverVest Venture Partners, an upfront payment and will make contingent payments if certain milestones are achieved in the future. AstraZeneca to cut US sales forces AstraZeneca announced that it will reduce its US sales force by approximately 1,150 leadership positions and sales representatives as part of the company's ongoing strategy to operate its business more efficiently to best serve patients in the US. These changes, which were not included in previously announced efficiencies to the US business, will account for roughly 24 per cent of the company's sales organisation in the US. The impact of the changes will vary by geography and selling teams. "These are difficult decisions that impact valued employees," said Rich Fante, President, AstraZeneca US. "The changes we are making, however, will help us deliver better results for our business and, most importantly, continue delivering on our mission of patient health." Employees will have the option to self-identify to potentially leave the company. All decisions will be finalised by early February 2012. This change to the US sales force is incremental to the ongoing second phase of the company's restructuring programme that was announced in January 2010. As a result, a discrete restructuring cost associated with today's announced changes, estimated at between $50 million to $100 million, will be charged in the fourth quarter of 2011. Restructuring costs are excluded from the company's core financial measures, so this initiative has no impact on guidance for core earnings per share for 2011. GlaxoSmithKline launches $50mn Life Sciences Innovation Fund in Canada GlaxoSmithKline Inc. (GSK) today announced the launch of the GSK Canada Life Sciences Innovation Fund, a new national $50 million fund that will significantly advance the commercialization of scientific innovation in Canada by investing in early stage breakthrough research. The fund will identify strategic investment opportunities within Canada’s life sciences industry including academic and health institutions, translational research centres and start-up companies. The announcement was made today in Toronto at an event hosted by GSK in Canada President and CEO, Paul Lucas and Dr. Moncef Slaoui, GSK’s Global Chairman of Research and Development. The event was attended by federal and provincial government representatives and leaders from Canada’s life sciences community. Read More… Pfizer CEO Ian Read named new Chairman of Board Pfizer Inc. announced that its Board of Directors has elected current President and Chief Executive Officer, Ian Read, as Chairman of the Board

Yearly Industry Newsletter

114 of 118

and Chief Executive Officer, effective immediately. Read succeeds George Lorch as Chairman of the Board. The independent members of the board named Lorch as Lead Independent Director. “Over the past year, Ian has clearly demonstrated the leadership and vision necessary to drive Pfizer’s strategies and achieve the company’s objectives in the continued challenging industry and macroeconomic environment,” stated George Lorch. “His broad experience at Pfizer and his deep understanding of the vital role that the pharmaceutical industry plays in advancing global health and in the global economy make Ian the right person for the chairmanship. We are fortunate to have someone of Ian Read’s caliber lead Pfizer.” “I am deeply honored to have been named chairman of Pfizer,” stated Ian Read. “Working alongside Pfizer’s dedicated leaders and talented workforce, I remain confident in the strength of our business and of our late-stage pipeline. I believe in the future of this company and of our continued ability to deliver value to shareholders and to improve the global health and well-being of people around the world.” GE Healthcare and M+W Group form strategic alliance GE Healthcare, the healthcare business of GE (NYSE: GE) and M+W Group, a leading global engineering, construction and project management company, have formed a strategic alliance aimed at overcoming the lack of key biopharmaceuticals, especially in emerging nations. The alliance, which will combine GE Healthcare's expertise in technologies for biopharmaceutical manufacture with M+W Group's global capabilities in bio-engineering and construction, will assist countries worldwide to become self-sufficient in the manufacture of vital biopharmaceuticals such as vaccines, insulin and biosimilars. Together, the companies will offer governments and pharmaceutical companies an integrated, cost-competitive "turn-key" approach for the construction of biopharmaceutical manufacturing plants, to help meet the rapidly increasing worldwide demand for these potentially life-saving treatments. The alliance between the two companies aligns with GE's healthymagination initiative, which focuses on reducing cost, increasing access and improving quality in healthcare. Read More… Simcere and Bristol-Myers Squibb enter innovative partnership Bristol-Myers Squibb Company and Simcere Pharmaceutical Group, a leading pharmaceutical company in China, have expanded the strategic partnership formed last year to include a second collaboration in a different therapeutic area. The companies agreed to co-develop BMS-795311, Bristol-Myers Squibb's preclinical small molecule inhibitor of the Cholesteryl Ester Transfer Protein (CETP). Inhibiting CETP could potentially raise HDL (good cholesterol) levels and help prevent cardiovascular disease. This collaboration is expected to accelerate the delivery of clinical Phase IIa proof-of-concept by leveraging the complementary strengths of a premier Chinese pharmaceutical company and a global biopharmaceutical company. Under the terms of the agreement, Simcere will receive exclusive rights to develop and commercialize BMS-795311 in China while Bristol-Myers Squibb will retain exclusive rights in all other markets. The companies will together determine the strategic development plan to explore the potential of BMS-795311 to treat and prevent progression of cardiovascular disease. Simcere will run and fund initial development work. Financial terms were not disclosed. Read More… Merck helps eliminate Schistosomiasis in Africa Merck KGaA announced its intention to further boost its efforts in the fight against the tropical disease schistosomiasis and to continue until the disease has been officially eliminated in Africa. The company plans to double its

Yearly Industry Newsletter

115 of 118

annual donation of tablets containing the active ingredient praziquantel from 25 million to 50 million in the medium term. The company committed itself to doing so at a meeting with the World Health Organization (WHO) in Geneva. Having originally planned to end the project in 2017, Merck now intends to continue its efforts to fight schistosomiasis indefinitely. Complementary to this donation, Merck will financially support a WHO-led school-awareness program in Africa. The objective is to educate children about the consequences of schistosomiasis and ways to prevent the disease. In addition, Merck intends to improve the tablet formulation and to step up its schistosomiasis research efforts. Read More… Mylan receives approval for 3 antiretroviral therapies Mylan Inc. announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received approval for three antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization’s (WHO) Prequalification of Medicines Programme. The products include: Atazanavir Capsule, 300 mg, Ritonavir Tablet, 100 mg (heat-stable), and Tenofovir Disoproxil Fumarate and Lamivudine Tablet 300 mg/300 mg, or “second-line-in-a-box” Fixed-dose combination Atazanavir Sulfate and Ritonavir Tablets, 300 mg/100 mg Fixed-dose combination Abacavir Sulfate, Lamivudine and Zidovudine Tablets, 300 mg/150 mg/300 mg Mylan President Heather Bresch said: “With these three approvals, Mylan will further enhance our portfolio of more convenient, more affordable treatment options for people in the developing world living with HIV/AIDS. In particular, we are proud to deliver on a previous commitment that we made through an announcement with President Bill Clinton on August 6, 2009[1], to lower the price of second-line treatments for patients with drug-resistant HIV in developing countries. Further, these product combinations and packaging solutions are an example of our continued commitment to innovation in an effort to increase treatment adherence and effectiveness. By bringing these medicines to market through WHO’s Prequalified Medicines Programme, we are again delivering on our promise to expand access to critical, life-saving ARV medicines for patients who need them in the developing world.” Read More… Pfizer initiates to prevent pneumococcal disease in infants and young children Pfizer Inc. has entered into a second supply agreement which will broaden and extend the duration of the Company's commitment to help protect millions of infants and young children in the developing world from pneumococcal disease - the leading cause of vaccine-preventable death in young children. Pfizer is now committed to supply up to a total of 480 million doses of Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]) through 2023 building on its original commitment announced in March 2010 to supply up to 300 million doses of the vaccine under the auspices of the Advance Market Commitment (AMC) for pneumococcal vaccines. The AMC, an innovative program piloted by the GAVI Alliance, is a public-private approach to health funding designed to create a sustainable marketplace, ensure an affordable and stable supply of pneumococcal vaccines at a steeply discounted price and stimulate the development and expansion of manufacturing capacity for vaccines specifically for the world's poorest countries. The agreements for supply of pneumococcal vaccines have been financed by GAVI, five donor countries - Italy, the United Kingdom, Canada, the Russian Federation, Norway - and the Bill and Melinda Gates Foundation. Read More…

Yearly Industry Newsletter

116 of 118

AstraZeneca to take US$381.5mn charge on failed studies AstraZeneca announced that its investigational compound olaparib will not progress into Phase III development for the maintenance treatment of serous ovarian cancer. In addition, AstraZeneca announced that the second RENAISSANCE Phase III study of TC-5214 for patients with major depressive disorder did not meet its primary end point. As a result, AstraZeneca will take pre-tax impairment charges totalling $381.5 million to R&D expense in the fourth quarter of 2011. The company confirms its expectation for full year Core EPS in the range of $7.20 to $7.40, but with the inclusion of these intangible impairments, Core EPS is likely to be in the lower half of this range. The decision to discontinue olaparib’s development in serous ovarian cancer was made following a review of an interim analysis of a Phase II study (study 19) which indicated that the previously reported progression free survival benefit is unlikely to translate into an overall survival benefit, the definitive measure of patient benefit in ovarian cancer. In addition, attempts to identify a suitable tablet dose for use in Phase III studies have not been successful. No new safety concerns were identified for patients. Read More…

Yearly Industry Newsletter 117 of 118

Notes

118

Published in 2011. © India Infoline Ltd 2011 This report is for the personal information of the authorised recipient and is not for public distribution and should not be reproduced or redistributed without prior permission. The information provided in the document is from publicly available data and other sources, which we believe, are reliable. Efforts are made to try and ensure accuracy of data however, India Infoline and/or any of its affiliates and/or employees shall not be liable for loss or damage that may arise from use of this document. India Infoline and/or any of its affiliates and/or employees may or may not hold positions in any of the securities mentioned in the document. The report also includes analysis and views expressed by our research team. The report is purely for information purposes and does not construe to be investment recommendation/advice or an offer or solicitation of an offer to buy/sell any securities. The opinions expressed are our current opinions as of the date appearing in the material and may be subject to change from time to time without notice. Investors should not solely rely on the information contained in this document and must make investment decisions based on their own investment objectives, risk profile and financial position. The recipients of this material should take their own professional advice before acting on this information. India Infoline and/or its affiliate companies may deal in the securities mentioned herein as a broker or for any other transaction as a Market Maker, Investment Advisor, etc. to the issuer company or its connected persons. India Infoline Ltd. IIFL Centre, Kamala City, Senapati Bapat Marg, Lower Parel (W), Mumbai 400 013. For any content related queries, write to: The Editor at editor@indiainfoline.com

Yearly Industry Newsletter

of 118