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A CenterWatch Publication Volume 16, Issue 12. Copyright © 2012 by CenterWatch. All rights reserved. March 26, 2012 page 4 » page 5 » CenterWatch Information Services The CenterWatch Monthly A monthly newsletter featuring in-depth stories on the clinical trials industry and grant opportunities. Annual subscriptions start at $399. JobWatch www.centerwatch.com/jobwatch A web-based service listing clinical research jobs, career resources and a searchable resume database. Clinical Trials Listing Service™ www.centerwatch.com/clinical-trials/listings An international listing service of actively enrolling clinical trials to support sponsors and CROs in their patient enrollment initiatives. Market Research Services Custom surveys for organizations to gain competitive insight into the market and their business. Contact Steve Zisson, (617) 948-5142, [email protected]. Drugs in Clinical Trials Database A searchable database of 4,000+ detailed profiles of new drugs in development in hundreds of disease conditions worldwide. Request a 5-day trial. Contact Sales, (617) 948-5100, [email protected]. CenterWatch Publications CenterWatch publishes a wide range of CME-accredited training guides, directories, brochures and drug intelligence information. Visit http://store.centerwatch.com. CenterWatch Main and Editorial Offices 10 Winthrop Square, Fifth Floor, Boston, MA 02110 Tel (617) 948-5100 Fax (617) 948-5101 [email protected] Breaking News and Market Intelligence for the Clinical Trials Industry Abbott names new research-based company AbbVie…2 Canadian government renews partnership with Rx&D to boost nation’s clinical trial industry…3 The Pulse on Latin America…6 Drug & Device Pipeline News…7 CenterWatch has identified 18 drugs and devices that have entered a new trial phase this week. Trial Results…8 CenterWatch reports on results for four drugs. Visit www.centerwatch.com for real-time updates on drugs in clinical trials. Biotech Review…9 Biotech briefs from BioWorld Today. CWMarketPlace…10 Industry service provider profiles. S trategic partnership agreements between sponsors and CROs have been all the rage over the last year or so. But are they working out well? While the curtain has been largely drawn on that, except for the occasional comment from a CRO or sponsor, the industry now has its first real look. Research and consulting firm The Avoca Group surveyed sponsors and CROs about their interactions in the out- sourcing space, and in doing so asked some very provocative questions about strategic partnership agreements. Perhaps the most revealing: Have you ever discontinued one? The results of Avoca’s annual State of Clin- ical Outsourcing Industry Survey, just released this month, showed a whopping 22% of the 244 respondents (147 sponsors and 97 clinical service providers) had discontinued a strategic partnership agreement—and not because a sponsor decided to go from, say, four partners down to two. Rather, quality was the issue. Poor quality and performance was cited by 85% of those who said they had severed a strategic partnership agree- ment. To Patricia Leuchten, CEO of The Avoca Group, this came as a shock. “Companies i nVentiv Health is about to surge more deeply into the functional service pro- vider (FSP) space. Last week the CRO announced it was buying Kforce Clinical Research, the clini- cally focused arm of publicly traded, Tampa, Fla.-based staffing firm Kforce, which in the last few years has grown its clinical staffing division into a robust FSP offering. inVentiv is paying $50 million for Kforce Clinical. The deal is expected to close by the end of the month. inVentiv—which started out primarily as a staffing, sales and communications firm serving pharma companies, but then grew exponentially last year with its purchase of i3 and Pharmanet—already has a leader- ship position in the staffing and FSP space. But the addition of Kforce Clinical gives the company even more depth and flexibility in that realm, said Gregg Dearhammer, president of FSP/Staffing for inVentiv, and formerly president and CEO of i3 Statprobe before inVentiv bought i3. “We believe that now, with the Kforce ad- dition, we have an interesting offering that not many can match,” said Dearhammer. “We can now offer short-term staffing and complex FSP help all under the same roof so that when sponsors’ staffing needs shift and change, they don’t have to go elsewhere for help. We can offer flexibility if they change their minds.” Neal McCarthy, managing director of investment firm Fairmount Partners and a Survey: Sponsor-CRO strategic partnerships don’t always work, poor quality and performance cited inVentiv to acquire Kforce Clinical Research, adding more FSP depth to its staffing services

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A CenterWatch Publication

Volume 16, Issue 12. Copyright © 2012 by CenterWatch. All rights reserved.

March 26, 2012

page 4 »

page 5 »

CenterWatch Information Services

The CenterWatch MonthlyA monthly newsletter featuring in-depth stories on the clinical trials industry and grant opportunities. Annual subscriptions start at $399.

JobWatchwww.centerwatch.com/jobwatchA web-based service listing clinical research jobs, career resources and a searchable resume database.

Clinical Trials Listing Service™www.centerwatch.com/clinical-trials/listingsAn international listing service of actively enrolling clinical trials to support sponsors and CROs in their patient enrollment initiatives.

Market Research ServicesCustom surveys for organizations to gain competitive insight into the market and their business. Contact Steve Zisson, (617) 948-5142, [email protected].

Drugs in Clinical Trials DatabaseA searchable database of 4,000+ detailed profiles of new drugs in development in hundreds of disease conditions worldwide. Request a 5-day trial. Contact Sales, (617) 948-5100, [email protected].

CenterWatch PublicationsCenterWatch publishes a wide range of CME-accredited training guides, directories, brochures and drug intelligence information. Visit http://store.centerwatch.com.

CenterWatch Main and Editorial Offices10 Winthrop Square, Fifth Floor, Boston, MA 02110Tel (617) 948-5100 Fax (617) [email protected]

Breaking News andMarket Intelligence forthe Clinical Trials Industry

Abbott names new research-based company AbbVie…2

Canadian government renews partnership with Rx&D to boost nation’s clinical trial industry…3

The Pulse on Latin America…6

Drug & Device Pipeline News…7CenterWatch has identified 18 drugs and devices that have entered a new trial phase this week.

Trial Results…8CenterWatch reports on results for four drugs. Visit www.centerwatch.com for real-time updates on drugs in clinical trials.

Biotech Review…9Biotech briefs from BioWorld Today.

CWMarketPlace…10Industry service provider profiles.

S trategic partnership agreements between sponsors and CROs have been all the rage over the last year or

so. But are they working out well?While the curtain has been largely drawn

on that, except for the occasional comment from a CRO or sponsor, the industry now has its first real look. Research and consulting firm The Avoca Group surveyed sponsors and CROs about their interactions in the out-sourcing space, and in doing so asked some very provocative questions about strategic partnership agreements.

Perhaps the most revealing: Have you ever discontinued one?

The results of Avoca’s annual State of Clin-ical Outsourcing Industry Survey, just released this month, showed a whopping 22% of the 244 respondents (147 sponsors and 97 clinical service providers) had discontinued a strategic partnership agreement—and not because a sponsor decided to go from, say, four partners down to two. Rather, quality was the issue. Poor quality and performance was cited by 85% of those who said they had severed a strategic partnership agree-ment.

To Patricia Leuchten, CEO of The Avoca Group, this came as a shock. “Companies

inVentiv Health is about to surge more deeply into the functional service pro-vider (FSP) space.Last week the CRO announced it was

buying Kforce Clinical Research, the clini-cally focused arm of publicly traded, Tampa, Fla.-based staffing firm Kforce, which in the last few years has grown its clinical staffing division into a robust FSP offering.

inVentiv is paying $50 million for Kforce Clinical. The deal is expected to close by the end of the month.

inVentiv—which started out primarily as a staffing, sales and communications firm serving pharma companies, but then grew exponentially last year with its purchase of i3 and Pharmanet—already has a leader-ship position in the staffing and FSP space.

But the addition of Kforce Clinical gives the company even more depth and flexibility in that realm, said Gregg Dearhammer, president of FSP/Staffing for inVentiv, and formerly president and CEO of i3 Statprobe before inVentiv bought i3.

“We believe that now, with the Kforce ad-dition, we have an interesting offering that not many can match,” said Dearhammer. “We can now offer short-term staffing and complex FSP help all under the same roof so that when sponsors’ staffing needs shift and change, they don’t have to go elsewhere for help. We can offer flexibility if they change their minds.”

Neal McCarthy, managing director of investment firm Fairmount Partners and a

Survey: Sponsor-CRO strategic partnerships don’t always work, poor quality and performance cited

inVentiv to acquire Kforce Clinical Research, adding more FSP depth to its staffing services

Page 2: Avoca CenterWatch Insider Insights Article

Sponsors

■■ Abbott has dubbed its new, independent research-based pharmaceutical company AbbVie (pronounced Abb-vee), which it will launch by the end of 2012. Abbott chose the name as a combination of Abbott and “vie,” which is a reference to the Latin root “vi” meaning “life.” “The beginning of the name connects the new company to Abbott and its heritage of pioneering science. The ‘vie’ calls attention to the vital work the company will continue to advance to improve the lives of people around the world,” said Richard A. Gonzalez, executive vice president of global pharmaceuticals at Abbott. Gonzalez will head AbbVie as chairman and CEO. Last Oc-tober Abbott announced it would separate into two publicly traded companies, one in diversified medical products and the other in research-based pharmaceuticals. AbbVie, the research-based company, will include Abbott’s current portfolio of pharmaceuti-cals and biologics. The diversified medical products company, which will retain the Abbott name, will consist of Abbott’s existing diversified medical products portfolio.

CROs/Service providers

■■ Campbell Alliance, an inVentiv Health company and management consulting firm, has launched Encuity Research, a market research and analytics subsidiary. The launch immediately follows the acquisition of SDI Health’s promotional and medical audit businesses from IMS Health, which closed March 20. “The audit businesses acquired from IMS will be combined with our existing market research and analytics service lines to create a business that will drive accelerated growth for us in the mar-ket research segment,” said Nader Naeymi-Rad, CEO of Campbell Alliance. Encuity Research, to be based in Newton, Penn., will provide services to the pharmaceutical and biotech industry in five specific areas

including custom quantitative research and analytics; qualitative research; key opinion leader identification and mapping; message tracking, including Rapid Recall (SM) mes-sage effectiveness studies; syndicated audits including the Metropolitan Area Promotion-al Audit, which tracks promotional activity across 15 specialty therapeutic areas; and a range of SDI Health medical and promo-tional audits acquired from IMS Health.

■■ CRO QED Clinical Services has created a wholly owned subsidiary, QED Clinical Services India Private Limited, in Ahmedabad, India, to enhance its global delivery of clinical trials. The subsidiary adds operational and therapeutic expertise to QED, and expands its capacity and capability to offer more global coverage. QED operations in India will be spearheaded by country head and director of operations Ali Saijad Bohra, who has led clinical monitoring, FSP models and project management across India, Southeast Asia, Japan, South Korea and Australia. “India and the Asia Pacific region will continue to have focus and will remain key markets for the drug development activities for biopharma-ceutical companies on account of a variety of benefits,” said Bohra. In addition to conduct-ing trials in India, QED India will act as a hub for QED’s Asia Pacific operations for control and oversight of its local partners across the region. “The creation of QED Clinical, India means that we can better meet the global development needs of our sponsors by giving access to vast patient populations via regional experts on the ground,” said CEO Thomas Ogorka.

■■ The Trudeau Institute, a Saranac Lake, N.Y.-based research center, has expanded the scope of its biomedical research by creat-ing a nonprofit CRO, the Trudeau Institute Contract Research Organization (TICRO). The expansion is in response to the drug industry’s increased reliance on CROs for specialty research to reduce the costs and delays associated with the development of new vaccines and therapeutics. As experts in the immunological, biological and molecular basis of infectious diseases and immune dis-orders, Trudeau scientists will offer their ex-pertise and models through TICRO. The new CRO will provide project-specific expertise to biopharmaceutical companies and academic researchers, assist clients with the design and execution of efficient studies with well-defined endpoints and help accelerate the drug development process. The Institute hopes to develop translational research part-nerships with biotech and pharmaceutical companies and help bring new therapeutics to patients safely and more efficiently.

R&D trends

■■ The quality of dementia research in the U.K. is second only to the U.S., despite the low number of scientists working in the field, and finding a cure can be accelerated by increas-ing the number of dementia researchers and investment, according to the Intellectual Property & Science business of Thomson Reuters. The findings are featured in an Alzheimer’s U.K. research report titled Defeat-ing Dementia. The analysis revealed the U.K.

CWWeekly (ISSN 1528-5731)Cheryl Appel Rosenfeld Editor-in-ChiefTracy Lawton Drug IntelligenceMelissa Nazzaro AdvertisingHeather Johnston AdvertisingHolly Rose Production

Send news submissions to Cheryl Appel RosenfeldTel (617) 948-5172 Fax (617) [email protected]

© 2012 CenterWatch, LLC. All rights reserved. No part of this publication may be distributed or reproduced in any form or by any means without the express written consent of the publisher. Permission requests can be obtained via fax at (617) 948-5101 or emailed at [email protected]. Single-user annual subscriptions are $249. Reprints and discounted multi-reader or corporate subscription rates are available. Email [email protected] or call (617) 948-5100.

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CWWeekly March 26, 2012 2 of 10

Industry Briefs

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CWWeekly March 26, 2012 3 of 10

Industry Briefs (continued from page 2)

published more research on dementia than any other country except the U.S. and ranks second in the world after Sweden in citation impact, the number of times U.K. research is referenced in dementia studies around the globe. Despite its high performance and influence, dementia research capacity in the U.K. is low when compared to cancer, stroke and heart disease. For every dementia research scientist there are six who work on cancer. The study was commissioned by the U.K.’s leading dementia research charity, Alzheimer’s Research U.K., in an effort to raise awareness and increase investment for the underfunded field. The report’s 14 recommendations to the U.K. government include forming a cohesive national strategy, increasing social awareness of the need for dementia research, simplifying funding and reporting procedures, revising scientific ca-reer paths, strengthening research networks and streamlining the regulatory process.

■■ Canada’s Research Based Pharmaceuti-cal Companies (Rx&D) and the Canadian Institutes of Health Research (CIHR) have renewed a partnership to strengthen clinical research conducted in Canada. The partner-ship seeks to strengthen Canada’s position as a preferred location to conduct clinical research. The partnership will play a key role in the implementation of the Strategy for Patient-Oriented Research, a national initiative to ensure better translation of research find-ings into clinical practice that was announced in August 2011. CIHR and Rx&D member companies will fund clinical research across

Canada through a competitive, peer-reviewed process and improve the coordination of research activities. Rx&D member companies have set an objective to match CIHR clinical research commitments dollar for dollar.

■■ Index Ventures, a venture capital firm, has launched its first fund solely dedicated to investing in the life sciences sector. The fund, $198 million, includes investments from several of Index’s largest existing limited partners and two companies, GlaxoSmithKline (GSK) and the venture capital affiliate of the Janssen pharmaceu-tical companies of Johnson & Johnson. With this investment in the fund, the two global pharmaceutical companies will share their expertise by participating in the fund’s scientific advisory board. Index will maintain full decision making rights to the portfolio companies and the fund rules and procedures will follow previous Index Ventures funds. This pharma/venture partnership model is intended to stimulate promising, early-stage R&D innovation. Index’s “asset centric” model focuses on investment in companies with just one or two projects, rather than companies with multiple programs. The fund will primar-ily consider opportunities across Europe, but also in the U.S., with assets that have first-in-class or best-in-class mechanisms of action and target areas of unmet medical need. “We believe that supporting and nurturing start-ups and encouraging entre-preneurship and innovation will be good for the entire industry,” said Dr. Paul Stoffels,

worldwide chairman, pharmaceuticals group, Johnson & Johnson.

■■ The Wellcome Trust’s board of governors has approved the creation of a new business that will invest in emerging businesses and technologies in the healthcare and life sci-ences sectors. The business’ initial capital will be $317 million, drawn from the Wellcome Trust’s endowment. The business is currently operating under the working title Project Sigma and will be a directly owned and managed business. It will provide financial resources to advance the Wellcome Trust’s vision of achieving extraordinary improve-ments in human and animal health by sup-porting the brightest minds in biomedical research and the medical humanities. “The Wellcome Trust is known as an investor that takes a long-term view. Sigma will extend this successful approach to direct invest-ments in emerging healthcare technologies, to give small and medium-sized companies the support they require to fulfill their potential,” said Sir Mark Walport, director, Wellcome Trust. Sigma will also enable Wellcome Trust to take and retain ownership positions in the companies. It will be able to contribute proactively to their development over the long term, for example by bringing together complementary expertise from different companies and scientific fields. Although Sigma has the primary goal of generating returns for the Wellcome Trust, its investments will also provide emerging businesses with a valuable new source of funding and guidance.

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CWWeekly March 26, 2012 4 of 10

Features (continued from page 1)

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Kforceclose watcher of the space, said the combina-tion of the Smith Hanley and MedFocus brand names—which inVentiv started out with—Pharmanet’s staffing group, i3’s meaningful staffing arm and now Kforce Clinical makes inVentiv a very big player in the space.

“The combination of the three, plus Kforce should put them well over $300 million, and that is likely the largest clinical staffing group, substantially ahead of RPS, which was a large staffing and functional outsourcing firm but is transitioning to a full-service CRO,” he said.

One downside of the acquisition, though, is that Kforce Clinical is losing one of its biggest clients, though the companies would not divulge the client’s name. Kforce Clinical posted revenue of $106.2 million in 2011, but inVentiv said it’s expecting its new acquisition to have annualized revenue of about $70 million for this year. The contract is winding down, but Kforce Clinical will work on it through 2012, said Dearhammer. And though the contract constituted half of Kforce Clinical’s revenue for 2011, Dearham-mer said inVentiv wasn’t put off.

“We knew it; we went in with eyes wide open,” he said. “But we know how that is; we’re going through the same thing with a customer. And we know we can easily

redeploy Kforce employees working on that contract to our other contracts.”

inVentiv would not say how many employees the Kforce Clinical acquisition includes.

Kforce Clinical operates only domestically, and this was hindering it, said Dearhammer. That’s one of the reasons its parent company sold. “It’s one of the strong reasons they’re joining us,” he said. “They have customers that wanted them to expand into Europe, but that was not in their strategic plan.”

And that’s an upside for inVentiv. “One of the attractive parts of this is we can immedi-ately go through their list of customers who have been asking for services in Europe and say, ‘Okay, we can do this for you now,’” said Dearhammer.

Though Pfizer recently eschewed the FSP model—in which a sponsor outsources all work across a particular function—

Dearhammer said the model is still going strong. Of the top 20 sponsors, 80% to 90% currently use the FSP model for one or more functions, he said.

Interestingly, there’s no uniformity in exact-ly which functions are outsourced, so it is hard to predict where the model may be going over time, said Dearhammer. “Some companies will use it for data management and not clinical, while others will use it for clinical and not data management,” he said. “It’s all over the place and it depends on their culture, their history and the size of their portfolio.”

Thus, this is a good time to be the market leader, he said.

“It really is an interesting time, and I think that flexibility and creativity is key right now.”

inVentiv has 550 biotech, pharma and life sciences clients and 13,000 employees in 40 countries. It’s privately owned by inVentiv Group Holdings, an organization sponsored by affiliates of Thomas H. Lee Partners, Liberty Lane Partners and members of the inVentiv management team.

Other large players in the staffing/FSP space include Icon’s DOCs group, the Clin-Force division of Cross Country, On Assign-ment’s clinical staffing group and private staffing companies including ASG (part of Ockham) and Aerotek/Maxim Healthcare.

—Suz Redfearn

“It really is an interesting time, and I think that flexibility and

creativity is key right now.”

—Gregg Dearhammer, president, FSP/Staffing, inVentiv

The long road to successful clinical trials just got shorter.Here’s how Xcellerate™ can help guide you to success.

© Copyright 2012. Covance Inc. All rights reserved.

Call or visit our website today to see how we can help you get a better return on your clinical trial investment.

Call 1.888.COVANCEwww.covance.com/Xcellerate

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CWWeekly March 26, 2012 5 of 10

Features (continued from page 1)

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Surveyput a lot of time, energy and resources into establishing these partnerships,” she said. “When you choose a partner, the assumption is that you’re in for the long haul, so they’re usually really savvy and careful about due diligence.”

But sometimes, all that due diligence doesn’t translate into seamless collaboration between multiple departments once the partnership is in place, said Leuchten. “As part of our consulting practice, we have seen some companies struggle with the imple-mentation of the overall strategy. Sometimes their operational teams are not clear on what it means to be in that particular strate-gic partnership. There can be gaps in com-munication, and the change-management aspects have been difficult.”

Many companies have strategic partner-ship agreements in place but will not speak publicly about them. The Avoca survey shed light on that, too. Of 147 sponsors, 47% said their company had at least one strategic partnership in place (49% didn’t know). Among those who said their company had such agreements, 58% said the company had two to three in place; 21% had one in place; 16% had four to six in place; and 2% had six or more in place.

When asked what their company’s main objectives were in launching strategic partnerships, the top five responses were: reduced costs, improved quality, improved efficiency in use of internal staff, access to operational expertise and process improvement.

But sponsors’ expectations are not always being met. With regard to cost savings, 16% said the partnerships were failing to meet their expectations, and 36% said their ex-pectations were being met only sometimes. The sparing of internal resources showed even less success. Twenty-one percent said the partnerships were failing to meet their expectations, and 33% said their expecta-tions were only sometimes being met. For operational/process improvement, 17% said the partnerships were failing to meet their expectations, and 40% said their expecta-tions were only sometimes being met.

But are they expecting too much, too soon? Maybe. Those who have had strategic partnerships in place for three years or more, and thus have the long view, were asked

how long these things tend to take. Among them, 40% said process improvement can take between one and two years—though about a quarter of this group said their expectations in this area were never met. A little more than half said if cost savings are to be achieved, it usually takes one year or less—though almost 25% said cost savings were never achieved. Just over half said improved quality, if it were to be seen, would be apparent in a year or less. And yet, 21% of those respondents said quality improvement was never achieved.

The Avoca Group, said Leuchten, plans to keep an eye on the strategic partner-ship agreement trend to see if the numbers improve.

Kicking off the strategic partnership agreement trend back in 2008 was Eli Lilly’s announcement it had inked large deals with Covance, Quintiles and i3 Statprobe. There was no noticeable partnership movement among other companies for two years, but then in 2010 a flurry of public partner-ing began. Some of the larger deals have included Bristol-Myers Squibb choosing Parexel as its clinical development partner; GlaxoSmithKline selecting PPD and Parexel for clinical development; Sanofi-Aventis choosing Covance for all of its drug develop-ment; and Pfizer selecting Parexel and Icon for clinical development.

Analysts and other industry observers say as the work of drug development shifts more and more to CROs, several more such agree-ments will come.

—Suz Redfearn

“We have seen some companies struggle with

the implementation of the overall strategy. Sometimes their operational teams are

not clear on what it means to be in that particular strategic

partnership. There can be gaps in communication, and the

change-management aspects have been difficult.”

—Patricia Leuchten, CEO, The Avoca Group

Specialized Clinical Trial Management Systems

®

from

http://www.ForteResearch.com/allegro

Page 6: Avoca CenterWatch Insider Insights Article

The consequence of the important role the pharmaceutical industry has played in the prevention, improvement and cure

of illnesses and diseases has been not only an increase in life expectancy, but also an improve-ment in the quality of life of humans worldwide. This is no different in Latin America, where pharmaceutical products and medical devices reach the region several years after being tested and marketed in other countries. Nonetheless, they serve their purpose of preventing diseases and curing common, as well as degenerative and quickly debilitating, ailments.

The drug industry’s aims include selecting a target population while analyzing the market needs for developing molecules, pinpointing a formula that can be used for several dis-eases and conducting research in areas such as pharmagenomics for personalizing treatment to specific populations. Pharmaceutical companies determine early on whether certain molecules should continue into clinical trials.

Pharmaceutical research in Latin America moves forward concomitantly with a country’s technological and scientific development. Phar-maceutical medicine is aimed at preventing, treating and curing diseases, improving quality of life and lengthening life expectancy. Huge corporations with offices in Mexico, Argentina and Brazil, for example, gather new knowledge favoring the development of innovative drugs and devices for countrywide and regional health improvement. Along the way, they strengthen the relationship with the local and national health authorities to expedite the availability of new medicines to consumers. This also improves the commercial sector, while favoring the eco-

nomic growth of each country.Pharmaceutical companies establish clear

and specific variables based on their objectives and purposes in developing innovative drugs and devices. Modern science and technology are used to search and select molecules as candidates for future drugs, including genomics, DNA splicing and bioinformatics for structuring and innovating new molecules.

It is often said that of 10,000 new molecules, after 15 years and $900 million invested, only one drug reaches the market. Pre-clinical and clinical research have clearly demonstrated the efficacy and safety of the drug, first in the labo-ratory, then in animals and finally in humans.

In Latin America as well as in other nations globally, pre-clinical trials often are conducted in selected countries. Before being tested in humans, a new molecule must be proven safe in several animal experimental models. This stage lasts an average of two to three years, minimiz-ing the risk of its exposure to humans.

The clinical portion includes several distinct stages. Phase I’s main objective is to assess the drug’s effect on a target organ, determine the exact dosage and corroborate the molecule’s pharmacological properties. This phase includes toxicology, pharmacodynamic and pharmacoki-netic studies that specify the absorption, distri-bution, metabolism and excretion of a drug. The volunteers generally are healthy and comprise 20 to 50 subjects. Usually they are conducted at a specialized center for carefully monitoring and analyzing pharmacological results and can last about six months to two years.

Phase II trials aim at corroborating the desired effect on the target organ or disease,

and measure the safety of the drug more than its efficacy. They also corroborate and assess the effects on other organs and systems. Often, over 200 patients are involved, and the new molecule is compared either to one already marketed or to placebo. Questionnaires on quality of life and data on pharmacoeconomics also can be used to contribute further knowledge on life expectancy rates and marketing forecasts. These trials are complex and are conducted at many sites, often lasting two to three years.

Phase III trials measure efficacy more than the safety, while considering tolerability. Used to register a drug at country regulatory agencies, these studies are conducted at several sites in several countries worldwide, often lasting three to four years. Additional information on quality of life and health economics often is gathered.

The pharmaceutical industry has trans-formed the way it views and focuses on therapeutic indications. Seventy years ago, physicians and drug companies were concerned with curing diseases involving parasites, diges-tive and respiratory tract infections. Between 1960 and 2000 transmitted diseases decreased, while deaths involving different types of cancer, accidents and violence increased. Today, we have options for treating heart disease, diabetes mellitus and malignant tumors.

Latin America is a rich region for all clinical trials, in which clinical research can grow and expand while providing a new outlook for healthcare and increased life expectancy.

Dr. Marlene Llópiz is president of AMEIFAC-Mexico for the 2011-13 term, secretary for IFAPP and CEO of Clinica Responsable Operativa Mexicana, S.C.

Copyright © 2012. Duplication or sharing of this publication is strictly prohibited. CWW1612

CWWeekly March 26, 2012 6 of 10

The Pulse on Latin America By Marlene Llópiz

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CWWeekly March 26, 2012 7 of 10

Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor Info

Alnylam Pharmaceuticals

ALN-TTR02 TTR-mediated amyloidosis

Phase I trials initiated enrolling 32 subjects in the U.K.

(617) 551-8200 www.alnylam.com

Repligen RG2833 Friedreich’s ataxia Phase I trials initiated enrolling 20 subjects in Turin, Italy

(781) .250-0111 www.repligen.com

Trillium Therapeutics TTI-1612 interstitial cystitis Phase I trials initiated enrolling 28 women in Canada

(416) 595-0627 www.trilliumtherapeutics.com

Jennerex JX-594 colorectal cancer Phase I/II trials initiated enrolling 42 subjects internationally

(415) 281-8886 www.jennerex.com

Celgene pomalidomide systemic sclerosis, interstitial lung disease

Phase II trials planned for 88 subjects internationally

(908) 673-9000 www.celegene.com

GlaxoSmithKline belimumab kidney transplant rejection

Phase II trials planned for 20 subjects in the U.K.

(888) 825-5249 www.gsk.com

Convergence Pharmaceuticals

CNV1014802 trigeminal neuralgia Phase II trials initiated enrolling 30 subjects internationally

+44 (0)1223 755 501 www.convergencepharma.com

Mesoblast Mesenchymal Precursor Cells

chronic low back pain Phase II trials initiated enrolling 100 subjects in the U.S.

(212) 880-2060 www.mesoblast.com

Pfizer axitinib adenoid cystic carcinoma Phase II trials initiated enrolling 32 subjects in the U.S.

(646) 888-4235 www.pfizer.com

PROLOR Biotech hGH-CTP pediatrics with growth hormone deficiency

Phase II trials initiated across international sites

(866) 644-7811 www.prolorbiotech.com

SK Biopharmaceuticals YKP10811 chronic constipation Phase II trials initiated enrolling 100 subjects in the U.S.

(201) 421-3842 www.skbp.com

TOPICA Pharmaceuticals

luliconazole distal subungual onychomycosis

Phase IIb/III trials planned enrolling 300 subjects in the U.S.

(650) 209-3700 www.topicapharma.com

Novo Nordisk liraglutide obesity/sleep apnea Phase III trials planned for 300 subjects in North America

(609) 987-5800 www.novonordisk.com

PaxVax PXVX-0200 cholera vaccine Phase III trials planned in the U.S. (858) 450-9595 www.paxvax.com

Abbott adalimumab hidradenitis suppurativa Two phase III trials initiated enrolling 600 subjects globally

(847) 937-6100 www.abbott.com

CSL Behring fibrinogen concentrate (human)

hemorrhage during aortic aneurysm surgery

Phase III trials initiated 200 subjects internationally

(610) 878-4000 www.cslbehring.com

Lexicon Pharmaceuticals

telotristat etiprate carcinoid syndrome Orphan drug designation granted by the FDA

(281) 863-3000 www.lexgen.com

QLT Visudyne central serous chorioretinopathy

Orphan drug designation granted by the FDA

(800) 663-5486 www.qltinc.com

MAGI’sClinical Research Conference – 2012 East

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Clinical Trial Operations, Regulatory Compliance, Contracts & Budgets

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Trial Results

Cardiovascular

■■ Xention issued results from a phase I trial of XEN-D0103 for the treatment of atrial fibrillation. This combined single- and multiple-ascending oral dose study enrolled 30 healthy subjects in the U.K. The study evaluated the safety and pharmaco-kinetics of various dosages of XEN-D0103. Treatment was well tolerated and dem-onstrated good pharmacokinetic proper-ties. No significant adverse events were reported. An analysis of electrocardiogram data collected from the first cohort of 30 healthy subjects indicated XEN-D0103 had no effect on the QTcF interval. This absence of any detectable effect on QTcF confirmed the atrial selectivity of XEN-D0103. Xention plans to move into phase II trials shortly.

Dermatology

■■ Provectus reported results from a phase IIc trial of PH-10 (Rose Bengal) for psoriasis. This multicenter, randomized, controlled study (PH-10-PS-23) enrolled 99 subjects with mild to moderate plaque psoriasis who received placebo or PH-10 (0.01%, 0.005% or 0.002%) applied once daily to affected skin areas for 28 days. The primary efficacy endpoint was treatment success, assessed at day 29 after initial PH-10 treat-ment. Success was defined as 0 or 1 on all Psoriasis Severity Index (PSI) components and 0 or 1 on the Plaque Response scale. The Pruritus (itching) Self Assessment scale was also measured. Results for all three

efficacy parameters showed improve-ment, with the low dose of PH-10 (0.002%) providing uniformly consistent improve-ment, while reduced therapeutic activity was observed at the two higher doses. After 28 days of treatment with PH-10 (all strengths), 23-29% of subjects achieved complete or nearly complete resolution of all PSI components, compared to no subjects in the placebo arm. In the low-dose PH-10 arm, 38% of subjects reported no itching after 28 days compared with 14% of those receiving placebo. PH-10 at 0.002% and 0.005% exhibited maximum improvement in Plaque Response Assess-ment, with the improvements for 0.002% achieving high significance (p < 0.001) after two weeks of treatment; all strengths were superior to placebo after 28 days, with the highest strength exhibiting the least activity. The company plans to move forward with development.

Gastroenterology

■■ POZEN released results from two phase III trials of PA32540, a coordinated-delivery tablet of immediate-release omeprazole and delayed-release aspirin, under devel-opment for the secondary prevention of cardiovascular disease in subjects at risk for aspirin-induced ulcers. The random-ized, double-blind, multi-center studies enrolled 1,049 subjects at risk for develop-ing aspirin-associated ulcers and already taking aspirin at 325mg once daily for at least three months. The subjects received

treatment with either PA32540 or 325mg enteric-coated aspirin once daily. The pri-mary endpoint, a significant reduction in the cumulative incidence of gastric ulcers following administration of PA32540 versus 325mg enteric-coated aspirin over six months, was met in both studies. Second-ary endpoints were also reached, including a reduction in gastroduodenal ulceration and a reduction in discontinuation due to upper gastrointestinal adverse events. POZEN plans to file for regulatory approval in the third quarter of 2012.

Neurology

■■ Addex Therapeutics issued results from a phase IIa trial of dipraglurant for the treatment of Parkinson’s disease levodopa-induced dyskinesia (PD-LID). This double-blind, placebo-controlled study enrolled 76 subjects with moderate or severe PD-LID. The subjects followed a dose-titration regimen, receiving 50mg doses from day one to day 14 and then 100mg from day 14 until day 28. Dipraglurant met the primary objective of the study by exhibiting a good safety and tolerability profile. Dipraglurant also demonstrated statistically significant reduction in LID severity with both 50mg and 100mg doses. Efficacy was measured using the modified Abnormal Involuntary Movement Scale (mAIMS). Peak mAIMS was significantly reduced on Day 1 (50mg; p = 0.042) and on Day 14 (100mg; p = 0.038). Addex is seeking a partner to move development forward.

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■■ The Senate is heading for a vote on the Jumpstart Our Business Startups (JOBS) Act. H.R. 3606, which recently passed the House 390-23, would benefit emerging growth companies by providing a five-year on-ramp to the public market, raising the SEC’s Regula-tion A cap to $50 million, increasing the SEC registration shareholder threshold to 1,000 and opening the door to crowd funding. In Senate debate Sen. Jack Reid (D-R.I.) offered a substitute bill with more protections for investors. But industry groups including the Biotechnology Industry Organization (BIO) are urging the Senate to pass the House bill as is. If the bill passes, small biotechs like Regulus Therapeutics of La Jolla, Calif., could see immediate benefits. Regulus CEO Kleanthis Xanthopoulos said his company currently spends $1 million to $2 million each year to comply with Sarbanes-Oxley require-ments. When opportunity costs are added, the cost of compliance accounts for up to 10% of Regulus’ total annual budget of $25 million to $30 million.

■■ MediVector of Boston was awarded a $138.5 million contract from the Department of Defense’s Joint Project Manager Transfor-mational Technologies (JPM-TMT) to further develop favipiravir (T-705), a broad-spectrum therapeutic against multiple influenza viruses, including the 2009 H1N1 pandemic virus and drug-resistant strains. JPM-TMT said phase III trials could begin this fall.

■■ As branded drugs with more than $117 billion in U.S. sales fall off patent by 2016, Congress may need to maintain the proper balance of lower drug prices through ac-cess to generics and an environment that encourages innovation. That may require new or expanded incentives, a Congressional Research Service (CRS) report suggested, especially if the U.S. is to maintain its status as a leader in biopharma innovation. Congress could explore ways to incentivize innova-tion through changes to data or marketing

exclusivities for new and improved drugs, the report said. Or it could weigh in on patent term extensions and reforms. Those options may involve tweaking the 1984 Hatch-Waxman Act that has helped speed generics to market and encouraged price-lowering competition. The cost of developing a drug has doubled since the early 1980s, to more than $1 billion, whereas new generics, which get free access to the brand drug’s R&D under Hatch-Waxman, cost about $1 million to $2 million. Contributing to the high costs for a new drug is the increased expense of conducting clinical trials. The number of trials necessary to file a new drug application has doubled in the past 30 years, and the number of subjects needed in those trials has tripled, the CRS said. The success rate in bringing a drug to market was 4% between 2005 and 2009. As a result of the increased costs and risks, the rate of return on investment in a new drug has dropped by 12% over the past three decades, according to the report. Prior to Hatch-Waxman, a drugmaker had no generic competition for an average of three years after patent expiration, which meant an extended time to generate funding for R&D, CRS said. Biopharma has developed a number of strategies, including mergers and acquisitions, branded generics or biosimilars, reformulations of the original brand product, price increases or deals to lower the cost of the drug. However, other than delayed-release formulations to delay generics, most of those strategies won’t slow the patent drop-off or spur innovation, CRS found.

■■ The National Center for Advancing Translational Sciences (NCATS) is teaming up with Eli Lilly to profile the effects of thousands of approved and investigational drugs. Over the next 12 to 18 months, Lilly will use its Phenotypic Drug Discovery panel to screen NCATS’ 3,800 drugs to reveal novel mechanisms or pathways of medicines. The goal of the profiles, which will be publicly available, is to make drug development

pipelines more productive by enabling researchers to better predict treatment outcomes, improve development and lead to more specific and effective approaches.

■■ Merck has helped launch a new non-profit translational institute in San Diego, the California Institute for Biomedical Research (Calibr), to accelerate translation of basic biomedical research into commer-cialized medicines. Merck will fund Calibr $90 million over seven years in exchange for an option to exclusively license any protein or small-molecule candidates derived. Pete Schultz, director of Calibr and a professor of chemistry at the Scripps Research Institute, said Calibr would be a 501(c)(3) organiza-tion and would form collaborations with other nonprofits, leveraging translational capabilities and expertise to advance early-stage science to the clinical proof-of-concept stage. Companies working with Calibr could then form partnerships with Merck for clini-cal development. Calibr would be a place for pharma and academic scientists to meet as equal partners. Calibr will offer facilities and staff to support partner projects. Although Merck will be first to license any therapeutics that make it past proof-of-concept, partner companies could shop them elsewhere if Merck declines. Participation in Calibr will be granted to academic scientists based on proposals judged on novelty, biomedical impact and technical feasibility.

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Biotech Review

The stories included in Biotech Review have been provided to CenterWatch with full permission of BioWorld Today and its publisher, AHC Media LLC. Copyright ©2012 AHC Media LLC.

BioWorld is located at 3525 Piedmont Road, Building 6, Suite 400, Atlanta, GA 30305. U.S.A. Please call (800) 688-2421 or (404) 262-5476 for more information. Or visit www.bioworld.com.

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