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6 September 2013

Kabi strikes venture with 2Indonesian firmEndo’s Qualitest bids US$225m for Boca 3Russia’s Veropharm gains a new owner 4Stada strikes a deal for OTC firm in UK 5Impax seeks deals to diversify portfolio 6Japan’s Sawai posts double-digit advances 7Mallinckrodt lifts its Concerta rival goal 8CIS advance keeps Egis’ sales growing 10Doxycycline raises forecast for Hikma 11Buried object delays Towa’s 12bulk-drug siteMore efficient Lupin adds profit and sales 13Valeant hails rises in Mexico and Poland 14

MARKET NEWS 15

GermanAOK tender spans 116 molecules15Australian changes risk market stability 16FTC lobbies court over settlement deal 17France’s ANSM reveals highest sellers 18

PRODUCT NEWS 19

Australia publishes biosimilars guidance 19Firms fail to conquer dutasteride patent 20Way is clear for rival to 21Nexium in the USTykerb’s salt patent is obvious, India says 22Lilly pursues Canada over promise doctrine23

FEATURES 28

Mylan plans to play at scale 28as it aims for 13% growthInjectables, respiratory drugs, biologics andgeographic expansion are all key elements inMylan’s plan to achieve 13% annual salesgrowth up to 2018. Aidan Fry reviews thegroup’s strategy.

REGULARS

Paragraph IV Watch – Nucynta 24Events – Our regular listing 26Price Watch UK – Our in-depth 27look at pricing trends in the UKPeople – Müller resigns from 31Stada board position

COMPANY NEWS 2

Akorn has agreed to pay US$640 million in cash for fellow US generics player Hi-TechPharmacal. The sterile injectables and ophthalmics specialist said the deal – which

it expects to complete during the first quarter of next year – would create “a larger, morediversified speciality generics player” with “critical mass” and an annual turnover ofmore than US$500 million.

Raj Rai, Akorn’s chief executive officer, said the “transformative event” would bring aHi-Tech portfolio that was “a great strategic fit to our currently marketed products, as it diversifiesour offering to retail customers with other niche dosage forms, such as oral liquids, topical creamsand ointments, nasal sprays and otics”. It would also “strengthen Akorn’s current position asthe third-largest US generic ophthalmics player”.

In its financial year ended 30 April 2013, Hi-Tech generated 84%, or US$196 million, ofgroup sales from its portfolio of almost 60 generics in dosage forms including nasal sprays,creams, ointments, oral liquids and sterile ophthalmic liquids. Around 44% of the Long Island-based firm’s generics sales – and 37% of its group turnover that edged ahead by 1% to US$232million – came from fluticasone nasal spray sales, which fell by 13% to US$86.1 million, dueto price erosion (Generics bulletin, 9 August 2013, page 2).

Hi-Tech’s ECR division – which promotes prescription brands including DexPak(dexamethasone), TussiCaps (hydrocodone/chlorpheniramine) and Zolpimist (zolpidem) througha doctors salesforce – contributed US$18.4 million. Another US$17.7 million came from theUS firm’s Health Care Products unit, which markets OTC diabetes products.

Rai said Hi-Tech’s OTC portfolio would complement the TheraTears eye-care brand thatAkorn had gained by acquiring Advanced Vision Research (AVR) in 2011. “We also plan tocapitalise on the manufacturing capabilities of Hi-Tech to expand further our presence in theprivate-label OTC business,” he stated, valuing the addressable market at US$500 million.

Hi-Tech has two facilities in Long Island, New York. One makes non-sterile products suchas nasal sprays and oral liquids – including in unit-dose packaging – while the other will addto Akorn’s existing ability to produce sterile ophthalmic products. Rai said Hi-Tech’s plantwould bring the ability to make ophthalmic suspensions and would add capacity that could

Continued on page 7

Akorn to pay US$640mfor Hi-Tech Pharmacal

International relations expert Adrian van den Hoven has become the director general of theEuropean Generic medicines Association (EGA) from 2 September. He takes over from Beata

Stepniewska, who reverts to her previous position of deputy director general, having led theindustry association on an interim basis for the past eight months since Greg Perry left to becomeexecutive director of the Medicines Patent Pool (Generics bulletin, 23 November 2012, page 1).

EGA president Gudbjorg Edda Eggertsdottir hailed van den Hoven’s“proven track record of high-level advocacy with European institutions,large portfolio industries and other European stakeholders”. He joins theassociation from BusinessEurope, where he was deputy director generalwith responsibility for the Brussels-based organisation’s InternationalRelations department, covering industrial, energy, environmental and researchpolicy. Having previously worked as an international-relations researcherand visiting professor in Canada, France and Italy, van den Hoven obtained adoctorate in political science from the University of Nice, France, in 2000. G

EGA appoints director general

Gen 6/9/13 Pg. 1_Gen 18/11/05 Pg. 1 03/09/2013 21:18 Page 1

Teva will seek strategic alliances in Brazil and China as it undergoes“a fundamental change in its business model”. The Israeli firm plans

to turn away from its previous practice of using the cash flow generatedby first-to-file generic exclusivities in the US to expand its turnoverand geographic footprint rapidly through large-scale acquisitions.

Addressing a Canaccord Genuity conference in Boston, US,president and chief executive officer Jeremy Levin acknowledged thattwo of Teva’s key “economic engines” – paragraph IV exclusivitiesin the US and its Copaxone (glatiramer acetate) blockbuster fortreating multiple sclerosis – were “dying off”.

However, he stressed, Teva’s history of multiple acquisitions hadgiven the firm “an unprecedented set of technological capabilities”in drug formulation and delivery. When coupled with the group’sextensive portfolio of active pharmaceutical ingredients (APIs), hesaid, this expertise promised to deliver a highly lucrative pipeline ofnew therapeutic entities (NTEs) – known molecules that are formulated,delivered, combined or used in a novel way (Generics bulletin, 9August 2013, page 5).

Furthermore, Levin outlined, Teva was using its vast productioncapacity to become a manufacturing partner for pharma companies.“Rather than attack them and take the value of a paragraph IV – whichis not a great thing to do – we are starting to talk to them about howwe can help them with lifecycle management,” he stated. And throughTeva’s alliance with Procter & Gamble, he added, the group was rapidlyexpanding its presence in the consumer healthcare arena.

But while Teva possessed a vast network of manufacturing andmarketing assets around the world – giving it the ability to meet thediverse needs of payers – it had “no presence in any meaningful way”in the fast-growing pharma markets of Brazil and China. “I am notlooking to do large acquisitions to penetrate these markets – I amlooking to find the right partners to work with,” Levin stated.

“The old strategy of acquiring top-line [growth] is no longer ourstrategy,” Levin asserted. “Every business we have is under scrutinyas regards its return on capital,” he added. G

COMPANY NEWS

2 GENERICS bulletin 6 September 2013

6 September 2013 Issue 197

Editor: Aidan FryDeputy Editor: DavidWallaceBusiness Reporter: Dean RudgeProduction Controller: Debi MinalProduction Editor: Jenna LawrenceDirector of Subscriptions: Val DavisManaging Director: Mike Rice

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BUSINESS STRATEGY

Teva seeks partnersin Brazil and China

Fresenius Kabi has formed a joint venture with Indonesia’s PT SohoGlobal Health that will focus on intravenous generic drugs and

infusion solutions. Kabi claims the alliance – whereby it will acquirea 51% stake in PT Soho’s Ethica Industri Farmasi (EIP) subsidiary –will make it “the market leader in intravenous generics in Indonesia”.The two firms have not disclosed financial details of the deal, whichthey expect to complete by the end of September.

Founded in 1946, EIP was “the first manufacturer of injectabledrugs in Indonesia”. Kabi said the company had a broad productportfolio as well as extensive experience through producing drugs ata plant in Jakarta and marketing a portfolio that generated sales ofmore than C40 million (US$53 million) last year.

“Entering the joint venture brings us valuable local manufacturingcapabilities and a strong market presence to provide patients andhealthcare professionals in Indonesia with immediate access to highquality, affordable drugs,” said Kabi’s chairman, Mats Henriksson.“At the same time, we will establish a strong hub for further expandingour business in the south-east Asian region.”

Demand for healthcare in Indonesia, Kabi observed, had beengrowing steadily and would accelerate due to the implementation nextyear of a universal health-insurance programme.

Tan Eng Liang, president commissioner of PT Soho Global Health,stated: “This joint venture gives us the possibility of strengtheningour leading position in our home market, as well as capturing thegrowth opportunities in the region in a fast and sustainable way.” G

STRATEGIC ALLIANCES

Kabi strikes venturewith Indonesian firm

ENALTEC LABORATORIES has passed a US Food and DrugAdministration (FDA) inspection with “zero 483 observations”.The Indian bulk-drugs supplier will market bromfenac, dronedarone,nepafenac and tetrabenazine through ChemWerth, its distributionpartner for the US and other regulated markets. G

IN BRIEF

Gen 6/9/13 Pgs. 2-14_Layout 1 03/09/2013 21:18 Page 2

Endo’s Qualitest generics subsidiary has agreed to pay US$225million for privately-owned niche generics player Boca Pharmacal.

Endo – which expects to complete the deal by the end of this year –will fund the deal through its cash on hand. The US firm expects Bocato generate earnings before interest, tax, depreciation and amortisation(EBITDA) of around US$50 million this year.

“The revenue and earnings contribution of this transaction –combined with the unique commercial portfolio and strong pipelineof abbreviated new drug applications (ANDAs) – make this an ideal fit,”insisted Endo’s president and chief executive officer, Rajiv De Silva.

Formed in 1998, Florida-based Boca aims to “offer niche itemsoverlooked by some of the larger generics companies”. Products suchas hydrocodone/acetaminophen tablets would “build on Qualitest’sstrength in controlled substances”, De Silva said. Boca’s portfoliocovers semi-solids and liquid forms, including multivitamin drops,stavudine powder and zidovudine syrup.

“The acquisition of Boca Pharmacal,” De Silva stated, “is the firstof several acquisitions we plan to execute as we transform Endo into amore focused speciality healthcare firm with a lean operating model.”

Shortly before it announced the Boca deal, Endo had launched a“multi-year capital expenditure programme” that the firm expects to“significantly increase manufacturing capacity and efficiency” forits Qualitest generics unit. Noting that the firm’s “general approach toQualitest is to play to its strengths”, De Silva said this meant focusingdevelopment on “the two areas in which we believe we have a substantialcompetitive position: controlled substances, and liquids and semi-solids”.

“The future of our generics business is going to be better served byinvesting in difficult-to-manufacture formulations,” De Silva stated, addingthat Qualitest might more actively pursue paragraph IV opportunitieswith future abbreviated new drug application (ANDA) filings.

Qualitest’s sales in the second quarter of 2013 grew by 7% toUS$171 million. However, De Silva remained confident that the unitwould achieve “low double-digit growth” over the full year. “This is alumpy business, and we do expect quarter-to-quarter variations,” hestated, observing that over the first six months of the year Qualitest’sturnover had risen by 14% to US$349 million.

Noting that Endo expected to face generic competition from Actavison its Lidoderm (lidocaine) brand from mid-September, De Silva said heexpected the generic to capture around 70% of the market. A secondgeneric competitor – which Endo expects “sometime in the first half of2014” – would further erode the firm’s market share, De Silva added.

Endo – which recorded total sales that fell by 2% to US$767million in the second quarter – is already facing competition to itsOpana ER (oxymorphone) extended-release tablets from generics.These are based on an older version that the originator withdrewand replaced with a reformulated product (Generics bulletin, 17 May2013, page 1). However, the firm plans to “assert the patents that webelieve are infringed by generic versions of the old formulation”. G

COMPANY NEWS

3GENERICS bulletin6 September 2013

MERGERS & ACQUISITIONS

Endo’s Qualitest bidsUS$225m for Boca

Aurobindo Pharma is considering whether to spin off its injectablesoperation into a standalone business. A board sub-committee

comprising most of the Indian group’s independent directors will byearly October give its view on the proposal, which Aurobindo believescould “provide focused growth” for its injectables unit.

The Indian firm has a dedicated marketing arm for injectables,AuroMedics, in the US, which generates almost US$30 million in annualsales. AuroMedics recently introduced sumatriptan, levofloxacin andondansetron injectables that the firm made in its ‘Unit 4’ sterileinjectables facility. A fourth product, lidocaine, is set for launch, whileAurobindo expects US approval soon for aciclovir and bupivacaine.

Aurobindo has received approval for six of the 30 abbreviatednew drug applications (ANDAs) it has filed from the Unit 4 site.

The proposed standalone injectables entity would include not onlyexisting marketing and production subsidiaries such as AuroMedics

and the Auronext sterile penems plant, but also a planned joint venturewith Celon Laboratories to make hormonal and oncology injectables.

Aurobindo’s board has agreed “in principle” to pay Rs156 million(US$2.43 million) for a 60% stake in a hormones and oncologyproduction plant that is currently being constructed by Celon. The boardhas also cleared investing another Rs323 million over the next 12months in completing the facility located near Hyderabad, India, securingapprovals for the plant and creating a hormones and oncology pipeline.

“The skill-set required for an injectables business is different fromthe typical skill-set you need for an orals facility,” Aurobindoexplained. “Our objective is to bring all our injectables businesses underone umbrella so that we have management which can focus towardsthe various aspects of operations, such as quality or regulatory aspects.”

Furthermore, the firm’s board has backed raising by 57% the firm’sholding in Silicon Life Sciences. The deal with VVR and TridentChemphar would raise to 75% Aurobindo’s stake in the non-sterilepenem active pharmaceutical ingredients (APIs) manufacturer.

In its financial first quarter ended 30 June 2013, Aurobindoincreased its turnover by 41.3% to Rs17.2 billion on Formulations salesthat shot up by 68.1% to Rs11.0 billion (see Figure 1).

US Formulations sales almost doubled to Rs6.25 billion on recentlaunches – including a reintroduced line of cephalosporin antibiotics –and stronger market shares for the firm’s base portfolio. In Europeand the rest of the world – where Formulations turnover advancedby 52.6% to Rs2.84 billion – Aurobindo’s operations in Germanyand Spain were now profitable, the firm said. G

BUSINESS STRATEGY/FIRST-QUARTER RESULTS

Aurobindo pondersspinning injectables

Business/ First-quarter sales Change Proportionregion (Rs millions) (%) of total (%)

US 6,248 +90.3 36Europe/Rest of world 2,839 +52.6 17Antiretrovirals 1,918 +36.8 11Formulations 11,005 +68.1 64

Active Ingredients 6,469 +10.2 38

Dossier Licensing 30 -55.9 –

Eliminations/other -348 +2.1 -2

Aurobindo 17,156 +41.3 100

Figure 1: Breakdown of Aurobindo Pharma’s sales in its financial first quarterended 30 June 2013 (Source – Aurobindo)

PHARMSTANDARD has completed its US$590 million acquisition ofBever Pharmaceutical, a company owned by one of its directorsthat supplies the active pharmaceutical ingredients (APIs) for thegroup’s Arbidol (umifenovir) and Aphobazolum (afobazole) OTCbrands (Generics bulletin, 9 August 2013, page 7). G

IN BRIEF


US generics specialist Breckenridge Pharmaceutical has agreed topay US$30 million for several generics assets of Pernix

Therapeutics’ Cypress subsidiary. The deal includes seven currentlymarketed products, 11 abbreviated new drug applications (ANDAs)that are pending approval by the US Food and Drug Administration(FDA), and several generic projects that are at the development stage.

“The Cypress assets are a natural fit to, and complement, theBreckenridge portfolio,” insisted the US firm’s executive vice-president,Larry Lapila. Among the acquired products are solid oral-dose drugs,ophthalmics, nasal spays, oral solutions, syrups and powders.

Breckenridge – which forms part of Spain’s Esteve group –currently markets more than 70 products in dosage forms includingtablets, hard and soft-gel capsules, liquids, suspensions and powders.

Under the terms of the agreement, Breckenridge will pay US$20million upfront, followed by two further instalments of US$5 millioneach over the next two years. The two firms expect the deal to closeby mid-September.

Pernix – which currently markets generics under the Cypress andMacoven labels – acquired Cypress Hawthorn at the end of last yearin a deal valued at up to US$102 million (Generics bulletin, 11January 2013, page 6). At the time, Pernix said combined annualsales by Cypress and its sister branded drugs unit Hawthorn totalledaround US$50 million. G

COMPANY NEWS



Breckenridge will buyCypress assets in US

Veropharm will soon have a new owner after Pharmacy Chain 36.6agreed to sell its majority stake in the Russian pharmaceutical

company to local businessman Roman Avdeev for RUB5.0 billion(US$150 million). The deal has already received antitrust clearance.

The Russian retailer said selling its 52% stake in Veropharm –which produces a range of prescription, OTC and traditional healthcareproducts – to Avdeev’s GardenHills vehicle would help it reduce debtand restructure its core pharmacy-retail business.

“I believe in the potential of the Russian pharmaceutical market,and consider that the acquisition of one of the industry’s leadingmanufacturers is a sound investment,” Avdeev stated. “There will be nomajor changes in the company’s strategy in the near future, and the corefocus will continue to be on completing the ambitious investmentprogramme planned for 2014.”

Pharmacy Chain 36.6 originally owned 100% of Veropharm, butin 2006 sold through an initial public offering a 48% stake for aroundUS$140 million to help fund the growth of its retail business (Genericsbulletin, 19 May 2006, page 5).

Prescription drugs accounted for three-quarters, or RUB1.79billion, of Veropharm’s group turnover that tumbled by 25% toRUB2.39 billion in the first half of this year.

The firm’s gross profit fell by 31% to RUB1.59 billion, givinga gross margin of 66.3%. G

MERGERS & ACQUISITIONS/FIRST-HALF RESULTS

Russia’s Veropharmgains a new owner


Stada Arzneimittel has paid just over £221 million (US$346 million)for Thornton & Ross, an OTC specialist based in Huddersfield,

UK. The German group said the deal corresponded to £193 millionon a cash- and debt-free basis.

Explaining the rationale behind the deal, Stada said that Thornton& Ross would strengthen its activities in the UK, especially in the“strategically important” OTC market. The German group plans tointroduce its own OTC brands in the UK.

Thornton & Ross increased its turnover in the year ended 31March 2013 by 11% to £66.2 million, which Stada said ranked it fifthin the UK’s pharmacy OTC market. The UK firm’s range of OTCbrands – including Covonia cough medicines, Hedrin head-licetreatments, Metanium nappy-rash products and Radian B topical

analgesics – accounted for three-quarters of that total, prescriptiondrugs 11% and household products the other 14%. Stada saidThornton & Ross achieved annual earnings before interest, tax,depreciation and amortisation of around C20 million (US$27 million).

Branded products accounted for 84% of Stada’s UK sales in thefirst half of this year. These fell by 3% to C26.0 million as “increasedcompetition” cut the firm’s local generics turnover by 8% to C4.2 million.

As can be seen from Figure 1, the German group’s domesticoperations made up a quarter of Stada’s total Generics sales that advancedby 6% to C618 million. German Generics turnover fell by 7% to C155million as Stada’s Aliud label suffered from the effects of tenders.

Russian Generics turnover climbed by 16% to C76.7 million, whilea 24% advance to C74.2 million made Italy Stada’s third largest countryin terms of Generics sales. Italy overtook Belgium, where Stada’s salesslipped slightly to C67.6 million due to reforms implemented last yearthat led to “a significant increase in price competition”.

In Spain, Generics turnover slid down by 14% to C46.8 million,which Stada attributed to “increasingly intense price and discountcompetition”, as well as having last year pulled out of the hospitals sector.But “significant growth in volume” outweighed reimbursement cuts inFrance, where Stada increased its Generics sales by 17% to C40.9 million.

Including Branded Products sales that rose by 18% to C337 million –in part due to acquisitions – Stada’s group turnover advanced by atenth to C974 million. G

COMPANY NEWS


MERGERS & ACQUISITIONS/FIRST-HALF RESULTS

Stada strikes a dealfor OTC firm in UK

GermanyC154.7m, -7%

RussiaC76.7m, +16%

ItalyC74.2m, +24%

BelgiumC67.6m, -1%

SpainC46.8m, -14%

FranceC40.9m, +17%

OthersC123.6m

SerbiaC33.8m, +40%

Figure 1: Breakdown by country of Stada Arzneimittel’s Generics sales thatincreased by 6% to C618 million in the first half of 2013 (Source – Stada)

Wockhardt says it is “in the process of responding to observations”following inspections of its facility in Chikalthana, India, by both

the US Food and Drug Administration (FDA) and the UK Medicinesand Healthcare products Regulatory Agency (MHRA) during July.

The 12,000 sq m Chikalalthana plant near Aurangabad, India,supplies solid oral-dose products for sale in the US and UK. Wockhardt’sannual turnover from products made at the site – including extended-release metoprolol for the US – totals around US$230 million.

Managing director Murtaza Khorakiwala said the nature of theChikalthana observations varied. However, he added, the situationappeared “not as serious” as the firm’s problems at its Waluj campus.

Wockhardt’s Waluj complex – which includes one oral-solids andtwo injectables units – is currently the subject of an FDA warningletter and import alert on drugs other than enalapril. Meanwhile, theMHRA has ordered a precautionary recall of 16 drugs made at thesite (Generics bulletin, 9 August 2013, page 3).

Khorakiwala said Wockhardt had – at the FDA’s recommendation –brought in Lachman as good manufacturing practice (GMP) consultantsat Waluj and Chikalthana. The firm’s UK operation, he added, wasworking to mitigate the recall’s effects by sourcing third-party products.

An FDA inspection of a cephalosporins unit at Waluj had passed“satisfactorily”, Khorakiwala stated, while an MHRA audit of itsShendra liquids facility had produced “no critical or major observations”.

US sales ahead by 11% to Rs7.22 billion (US$112 million) –equivalent to local-currency growth of 7% – enabled Wockhardt toreport group turnover 1% higher at Rs13.6 billion in its financial firstquarter ended 30 June 2013.

In Europe, French sales almost halved to Rs280 million, whileturnover in the UK edged ahead by 1% to Rs2.38 billion. Wockhardtsaid its sales growth in the UK had slowed due to lower sales of itsPinewood product portfolio. And the firm’s Pinewood operation inIreland suffered from a local transition from a branded generics to asubstitution-led model (Generics bulletin, 12 July 2013, page 6) as thecompany’s Irish turnover tumbled by 31% to Rs390 million.

The Indian group’s turnover in its domestic market and otheremerging countries declined by 5% to Rs3.10 billion. A 3% rise insales of Indian branded formulations to around Rs2.50 billion – despitepricing controls and a ban on selling dextropropoxyphene – failedto offset fully a 28% decline in other emerging markets amid weakerorders in Russia. Meanwhile, a considerable ramp-up to Rs980 millionin research and development spending contributed to the Indian firm’spre-tax profit slipping by 8% to Rs3.61 billion. G

MANUFACTURING/FIRST-QUARTER RESULTS

Wockhardt respondsto site observations

Orchid Chemicals & Pharmaceuticals expects to complete a deal tosell its penicillin and penem active pharmaceutical ingredient (API)

business – along with an API plant in Aurangabad, India – to Hospiraby the end of September. The two firms had agreed a US$200 millionpurchase price a year ago (Generics bulletin, 14 September 2012, page3). Having extended its financial year by six months to 30 Septemberin light of the pending transaction, Orchid said its turnover in the 15months ended 30 June 2013 had totalled Rs14.8 billion (US$218 million).Sales in the three months to June declined by a fifth to Rs2.50 billion. G

MERGERS & ACQUISITIONS/QUARTERLY RESULTS

Orchid nears Hospira move


Impax will look to use some of its US$452 million cash reserves todiversify its portfolio beyond solid oral dosage-forms, through both

acquisitions and strategic partnerships, according to Carole Ben-Maimon,president of the firm’s Global Pharmaceuticals generics division. Chieffinancial officer Bryan Reasons added that the company would seek“product opportunities that make strategic sense”.

However, Reasons insisted that the “priority” for Impax’ cash wouldbe addressing manufacturing deficiencies at its facility in Hayward,California. Earlier this year, the US Food and Drug Administration(FDA) issued a ‘Form 483’ with 12 observations following a reinspectionof the plant by the agency (Generics bulletin, 8 March 2013, page 9).Quality issues had previously been highlighted in an FDA warningletter two years ago (Generics bulletin, 30 June 2011, page 5).

Chief executive officer Larry Hsu revealed that Impax wasawaiting word from the FDA over the firm’s proposed meeting to discussthe Form 483. “We are very anxious,” said Hsu, who announced earlierthis year that he would be stepping down as chief executive officeronce a replacement was found (Generics bulletin, 12 July 2013, page23). “We want to hear feedback from the FDA,” Hsu insisted.

Meanwhile, Ben-Maimon confirmed that the firm is looking tomove production of some of its immediate-release products to its Taiwanfacility, where the firm’s Rytary (carbidopa/levodopa) brand – scheduledfor a first-quarter 2014 release – will be manufactured.

Impax has not received any new product approvals from the agencyin over two years due to the issues at Hayward. This, coupled withadditional competition on its existing generics, led turnover for Impax’Global Pharmaceuticals generics division to slide by 29% to US$94.0million for the three months ended 30 June 2013. Group sales dippedby more than a fifth to US$130 million.

Adderall XR hit by competitionSales of Adderall XR (amphetamine salts) extended-release

capsules and fenofibrate tablets continued to suffer due to genericcompetition, with the former seeing its market share decline fromaround 30% to 10% since the beginning of the year. Furthermore, theUS firm’s exclusivity for Zomig (zolmitriptan) tablets and orally-disintegrating tablets expired during the quarter. “While sales in thesecond quarter increased by US$7 million, seven generic competitorsintroduced both tablet dosage-forms in mid-May,” explained Reasons.Zomig nasal spray has patents running until 2021, although thisdosage form only accounts for around a tenth of Impax’ Zomig sales.

“We’ve launched a couple of generic products this year, includinggeneric oxymorphone in early January and an authorised generic ofTrilipix (fenofibrate) several weeks ago,” said Reasons, although180-day exclusivity for Impax’ generic version of Endo’s Opana ER(oxymorphone) expired at the end of June. “Revenues and profits fromour base generics business over the past two years have declinedsignificantly due to price erosion and competition,” he acknowledged,adding: “We are likely to experience net operating losses in the secondhalf of this year.”

Increasing Impax’ portfolio with the release of four new productsthis year could not offset the decline in sales caused by Hayward andgeneric competition. The Global Pharmaceuticals generics division’soperating margin fell by almost 11 percentage-points to 24.2% whilethe group’s operating profit fell from US$30.2 million to US$5.77million, giving Impax an operating margin that declined by 13.7percentage points to just 4.4%. G

COMPANY NEWS


BUSINESS STRATEGY/SECOND-QUARTER RESULTS

Impax seeks deals todiversify its portfolio

IPCA’s sales rose by a quarter to Rs8.10 billion (US$133 million)in its financial first quarter ended 30 June 2013. The Mumbai-based firm enjoyed a rise of more than a third in exports – whichaccount for 61% of its total sales – to Rs4.96 billion. Ipca alsoachieved double-digit rises in domestic sales of its formulations andactive pharmaceutical ingredients (APIs), taking its total in India toRs2.96 billion. The firm’s earnings before interest, taxes, depreciationand amortisation (EBITDA) rose by 21% to Rs1.71 billion.

BEXIMCO’s sales rose by 14.3% to Tk4.96 billion (US$63.7 million)in the first six months of 2013 after it claimed to be the firstBangladeshi firm to export its own pharmaceutical formulations toEurope. Exports jumped by just over two-thirds to Tk331 millionafter the company launched latanoprost and latanoprost/timololthrough partners in Germany and Austria (Generics bulletin, 15February 2013, page 15). Sales in its domestic market grew by 11.6%to Tk4.63 billion after launching 18 products.

TORRENT reported double-digit growth in both domestic and exportsales for the Indian company’s financial first quarter ended 30 June2013, leading its group net sales to rise by 23% to Rs9.03 billion(US$148 million). Domestic sales saw a rise of 15% to Rs3.79billion, while sales outside of India jumped by nearly a third toRs5.26 billion. Torrent reported significant increases in its exportmarkets, as sales grew by nearly half in Europe and 43% in the US.Conversely, sales slipped by 2% in Brazil. The Ahmedabad-basedfirm’s pre-tax profit rose by almost Rs500 million to Rs1.87 billion.

HYPERMARCAS reported Pharma sales ahead by 13.3% to R$601million (US$255 million) in the second quarter of 2013, accountingfor just over half of the Brazilian group’s turnover that grew by 11.7%to R$1.07 billion. Group earnings before interest, taxes, depreciationand amortisation (EBITDA) rose by 7.6% to R$248 million.

ALKALOID enjoyed turnover growth of 3.8% in the first six monthsof 2013, despite the firm’s sales in Russia and the Commonwealthof Independent States (CIS) dropping by almost a fifth to C3.38 million(US$4.46 million). The Macedonian company’s total of C55.5 millionincluded domestic sales ahead by 12.1% to C20.3 million as well asEuropean Union (EU) turnover that advanced by a tenth to C2.92million. OTC sales slipping by 13.9% to C8.11 million were morethan offset by growth in other product categories, including a riseof more than a tenth for central nervous system drugs.

ALEMBIC almost doubled its generics exports to Rs850 million(US$14 million) in the Indian firm’s financial first quarter ended30 June 2013. This helped the company’s turnover to advance by16% to Rs4.29 billion, despite a 6% drop in its domestic genericssales to Rs254 million and Indian active pharmaceuticalingredient (API) sales plummeting by a third to Rs202 million.

PODRAVKA’s sales slipped by 1% to CrK1.70 billion (US$296million) in the first six months of 2013 despite Pharmaceuticalsturnover rising by 4% to CrK402 million. Exports ahead by 7%boosted the division’s total, whilst the Croatian firm’s domestic salesalso advanced “due to increased sales of prescription products”.

JUBILANT said its Pharmaceuticals sales falling by 7.2% to Rs6.51billion (US$98.4 million) in its financial first quarter ended 30June 2013 were responsible for the Indian firm's total declining by2.5% to Rs13.6 billion during the period. Life Sciences sales edgingahead to Rs7.07 billion failed to offset the decline. Jubilantregistered a pre-tax loss of Rs159 million for the quarter. G

IN BRIEF


Perrigo expects to almost double the rate of sales growth by itsPrescription Pharmaceuticals business segment in its current financial

year ending June 2014. The forecast excludes any impact from the USgroup’s pending US$8.6 billion takeover of Elan (Generics bulletin,9 August 2013, page 3).

Having reported a 15% turnover increase to US$710 million in theyear ended 29 June 2013, the US-based group expects the Prescriptionsegment to achieve sales of growth of 25% to 29% up to June 2014as it benefits from the recent acquisitions of liquids specialist Rosemontin the UK and a range of ophthalmic drugs from Fera in the US.

Having recently launched generic rivals to Cutivate (fluticasone)lotion and Derma-Smoothe (fluocinolone) oil and lotion (see page 20),Perrigo’s Prescription pipeline for its current financial year includesat least three liquid drugs, two “extended topicals” and an oral soliddrug with combined annual branded sales of around US$600 million.

Perrigo has 34 abbreviated new drug applications (ANDAs)currently pending approval by the US Food and Drug Administration(FDA), among which are seven ANDAs that it says have confirmedfirst-to-file status. The firm claims to hold three US first-to-file approvals

for which it has agreed date-certain launches, while it is engaged inparagraph IV patent litigation over brands including AndroGel(testosterone) 1.62% gel, Astepro (azelastine) nasal spray, Axiron(testosterone) 2% topical solution and ProAir HFA (albuterol) inhalers.

At the mid-point of Perrigo’s forecasted range, the Prescriptionsegment should achieve a turnover of around US$900 million, a grossmargin of 52.9% and an operating margin of 40.9% in the year endingJune 2014. In the 12 months ended 29 June 2013, the segment improvedits gross margin by 4.2 percentage points to 50.9%, and raised itsoperating margin by 2.5 points to 37.1%.

Perrigo’s group turnover in the year ended June 2013 advancedby almost 12% – and by 6% on an organic basis – to US$3.54 billion,while its operating margin rose by 1.3 points to 19.2%. The ConsumerHealthcare OTC segment contributed almost three-fifths of groupturnover with sales ahead by 15% to US$2.09 billion (see Figure 1).

In the year ending June 2014, Perrigo expects rolling out store-brand versions of Mucinex (guaifenesin), Delsym (dextromethorphan)liquid suspension and Claritin (loratadine) 24-hour liquid gel to driveConsumer Healthcare sales growth of at least a tenth.

Having fallen by 4% to US$159 million in the year ended June2013, active pharmaceutical ingredient (API) sales are expected tobounce back to grow by between 3% and 8%, aided by supplying bulktemozolomide to Teva (see page 19). G

COMPANY NEWS


RESULTS FORECAST/ANNUAL RESULTS

Perrigo is to doublePrescription growth

Business Annual sales Change Operatingsegment (US$ millions) (%) margin (%)

Consumer Healthcare 2,089 +15 17.4Prescription Pharma 710 +15 37.1Nutritionals 508 +1 6.9API 159 -4 30.7Other 74 ±0 4.6

Perrigo 3,540 +12 19.2*

* includes US$34.8 million of unallocated expenses

Figure 1: Breakdown by business segment of Perrigo’s sales and operatingmargin in its financial year ended 29 June 2013 (Source – Perrigo)

Increasing its sales of central nervous system (CNS) drugs by 14.2%contributed to Sawai’s turnover rising by 11.3% to ¥21.9 billion

(US$225 million) in its financial first quarter ended 30 June 2013.And improving its gross margin by 3.7 percentage points to 49.5%helped the Japanese generics specialist to push its operating profitup by 42.1% to ¥5.83 billion, giving it an operating margin of 26.6%.

Sawai’s turnover from cardiovascular drugs – boosted by strongsales of atorvastatin – moved ahead by 12.5% to ¥6.61 billion. Sales ofgastrointestinal drugs grew by 12.1% to ¥3.88 billion, while CNSdrugs contributed ¥1.46 billion.

The Japanese firm said it had seen a “promising start” fromproducts listed for reimbursement during its current financial year.These contributed ¥185 million to turnover. Sales of drugs listed inthe previous financial year more than doubled to ¥486 million.

Sawai noted that it had achieved double-digit turnover growth even“without major promotion policies for using generic drugs”. Earlierthis year, Japan’s Ministry of Health, Labour and Welfare (MHLW)stated that it intends to see generics account for at least 60% of allprescriptions by volume in Japan’s off-patent pharmaceuticals marketby March 2018 (Generics bulletin, 7 June 2013, page 12). But howthis goal will be achieved is unclear.

Anticipating higher operating expenses, the Japanese groupmaintained its full-year forecast for an operating margin of 20.7% onturnover of ¥87 billion (Generics bulletin, 7 June 2013, page 11). G

FIRST-QUARTER RESULTS

Japan’s Sawai postsdouble-digit advances

Continued from front pagerender unnecessary Akorn’s plans to invest in expanding its ownophthalmics site in Somerset, New Jersey.

As of 30 June, Akorn had 57 abbreviated new drug applications(ANDAs) filed, addressing brands with combined annual sales ofUS$5.6 billion. Hi-Tech’s 18 ANDAs pending approval targetted brandswith combined annual sales of US$2.6 billion and included fourparagraph IV patent challenges, while it also had around 25 developmentprojects at the pre-filing stage.

Akorn – which increased its turnover in the first half of this yearby 31% to US$151 million, comprising US$83.0 million from hospitaland injectable drugs, US$54.2 million from ophthalmics and US$13.6million from contract services – said its US$43.50 per share offerrepresented a 23.5% premium over Hi-Tech’s closing price on 26August. The debt-funded deal includes Hi-Tech’s cash and equivalents ofjust over US$100 million as of 30 April 2013. Through operatingefficiencies, Akorn expects to generate annual synergies of US$15-US$20 million within 12 months of closing. G


Akorn plans to buy Hi-Tech

SENTISS PHARMA – the Indian ophthalmics specialist formerlyknown as Promed – has received a warning letter from the US Foodand Drug Administration (FDA). Among the manufacturingdeficiencies identified by the agency at Sentiss’ facility in KheraNihla, India, are “poor aseptic practices”. G

IN BRIEF


Ranbaxy’s North American sales almost halving to Rs8.52 billion(US$139 million), following the loss of exclusivities for products

such as the firm’s US rival to Lipitor (atorvastatin), caused exports tofall by more than a fifth to Rs20.8 billion in the second quarter of 2013.

In western Europe – where turnover fell by nearly a third to Rs1.96billion (see Figure 1) as the “developed markets of France, the UKand Italy witnessed a decline in sales” – Ranbaxy had to recognisea goodwill impairment of Rs1.19 billion. This related to the firm’sbusiness in France, where Ranbaxy said the generics industry hadfaced “continuing pricing and trade challenges”. Along with currency-related losses due to the depreciation of the Indian rupee, this ledRanbaxy to register a pre-tax loss of Rs4.87 billion for the quarter.

In eastern Europe and the Commonwealth of Independent States(CIS), sales stagnated at Rs3.26 billion, while turnover in the firm’sAfrica and Middle East region advanced by almost a tenth to Rs2.83billion, supported by rising branded generics sales in Africa.

Meanwhile, growth in Brazil and the launch of rosuvastatin inAustralia helped Ranbaxy’s Asia-Pacific and Latin America salesto grow by 13% to Rs2.08 billion.

Domestic turnover improved slightly to Rs5.43 billion as the Indianfirm witnessed “slow growth in the anti-infectives market”, as well aslocal “pricing policy and trade concerns”. This led Ranbaxy’s total salesto decline by 17.8% as reported to Rs26.3 billion, although the companyinsisted that on a like-for-like, adjusted basis, global “base business”turnover had grown “in double-digits” over the prior-year period.

Sales of branded and OTC products that reached Rs13.4 billionaccounted for just over half of Ranbaxy’s sales, whilst unbrandedgenerics and active pharmaceutical ingredients (APIs) contributedthe remaining Rs12.9 billion to the group’s total.

Ranbaxy said it had made “satisfactory progress” overmanufacturing deficiencies identified by US authorities after agreeing topay US$500 million to settle criminal and civil charges over violationsof manufacturing and data-integrity standards (Generics bulletin,17 May 2013, page 1). During the quarter, the Indian firm filed oneabbreviated new drug application (ANDA) in the US.

Elsewhere, Ranbaxy said it planned to take advantage of synergiesthrough a “hybrid business model” with parent company DaiichiSankyo in markets including Africa, India, Mexico, Romania, Peruand Thailand. The Indian company has also been allocated a site fora new manufacturing facility that it plans to set up in Malaysia. G

COMPANY NEWS


SECOND-QUARTER RESULTS

Ranbaxy falls a fifthafter exports slump

Region/ Second-quarter sales Constant-currency Proportionbusiness (Rs millions) change (%) of total (%)

North America 8,516 -44 32

India 5,426 +1 21

Eastern Europe/CIS 3,260 ±0 12

Africa/Middle East 2,828 +9 11

Asia-Pacific/ 2,082 +13 8Latin America

Western Europe 1,958 -31 7

APIs/Others 2,263 +31 9

Ranbaxy 26,332 -20 100

Figure 1: Breakdown by region and business of Ranbaxy Laboratories’ sales inthe second quarter of 2013 (Source – Ranbaxy)

Mallinckrodt expects its US rival to Janssen’s Concerta(methylphenidate) extended-release tablets to contribute sales

totalling US$135-US$150 million in its financial year ending inSeptember 2013. The firm had previously predicted that annual salesof the product would total at least US$125 million.

By 28 June 2013 – the date on which Mallinckrodt completedboth its financial third quarter and its split from former parent groupCovidien – the attention deficit hyperactivity disorder (ADHD)treatment had achieved total sales of US$88.3 million.

The US company had secured approval from the US Food andDrug Administration (FDA) for three strengths of methylphenidateextended-release tablets at the end of December 2012, but it initially

launched only the 27mg version. The 36mg and 54mg strengthsfollowed in late-March (Generics bulletin, 5 April 2013, page 14).

While UCB’s Kremers Urban recently secured FDA approval forall three strengths (Generics bulletin, 9 August 2013, page 19),Mallinckrodt believes its separate 180-day exclusivity periods willdelay Kremers’ market entry on the higher strengths.

Including anticipated sales of its Exalgo (hydromorphone)analgesic of at least US$115 million, Mallinckrodt expects its SpecialtyPharmaceuticals turnover in its financial year ending September toincrease by 22% to 25%. In its third quarter ended 28 June 2013,Specialty Pharmaceuticals sales advanced by 21.2% to US$309 million,while turnover by its Medical Imaging business segment stalled atUS$248 million. Including US$13.5 million of sales to Covidien, groupturnover grew by 10.4% to US$570 million.

As can be seen from Figure 1, Mallinckrodt’s turnover from salesof acetaminophen, or paracetamol, active pharmaceutical ingredient(API) increased by a fifth to US$65.1 million. Hydrocodone andoxycodone API and tablet sales each showed double-digit sales growthto US$36.2 million and US$35.8 million respectively, while extended-release methylphenidate contributed US$17.4 million.

Due to US$44.2 million in costs linked to spinning off from Covidien– as well as US$12.1 million of restructuring and related charges –Malinckrodt reported a US$0.6 million operating loss. G

RESULTS FORECAST/THIRD-QUARTER RESULTS

Mallinckrodt lifts itsConcerta rival goal

Acetaminophen APIUS$65.1m, +19.9% Oxycodone

US$35.8m, +14.0%

HydrocodoneUS$36.2m, +15.7%

Methylphenidate ERUS$17.4m

Other Generics& APIs

US$99.2m, +3.2%

Pharma BrandsUS$54.9m, +32.0%

OtherUS$13.5m, -9.4%

Medical ImagingUS$247.9m, +0.5%

Figure 1: Breakdown by product type of Mallinckrodt’s turnover that increased by10.4% to US$570 million in its financial third quarter ended 28 June 2013(Source – Mallinckrodt)


A7% rise in exports to the Commonwealth of Independent States(CIS) enabled Egis to increase its group turnover by 2% to HuF100

billion (US$445 million) in the nine months ended 30 June 2013.Egis’ total sales in the CIS region – where it recently started

selling biosimilar infliximab in Belarus through an agreement withSouth Korea’s Celltrion (Generics bulletin, 12 July 2013, page 12)– reached C130 million (US$171 million).

In Russia – where the Hungarian firm derives almost two-thirdsof its turnover from products on the country’s essential drugs list –turnover rose by 4% to C90.5 million. Sales in Ukraine shot up by 24%to C14.6 million against a relatively weak prior-year period, whileturnover in other CIS countries rose by 13% to C25.1 million.

A 5% sales gain to C41.1 million in Poland was a major factor inEgis’ exports to its Eastern Europe region growing by 3% to C92.0million. Recent launches fuelled sales rises of 6% to C14.1 million in theCzech Republic and of 9% to C13.9 million in Romania. These gainshelped to compensate for “a 13% slump” to C8.25 million in Slovakia.Sales in other East Europe countries grew by 1% to C14.7 million.

Other exports of finished and bulk drugs – largely to Egis’ parentgroup, Servier – increased by 17% to C47.2 million. Total exportsturnover advanced by 7% to C269 million, or HuF78.7 billion.

The Hungarian firm suffered a 9% sales decline to HuF21.7 billionin its domestic market, as it was hit by ‘blind-bidding’ tenders andquarterly reimbursement cuts. Lower prices in Hungary contributed to thegroup’s operating margin falling by 2.4 percentage-points to 16.2%. G

COMPANY NEWS


NINE-MONTH RESULTS

CIS advance keepsEgis’ sales growing

Higher sales of allergy, antiretroviral and asthma medicines enabledCipla to raise its turnover from exports of finished-dose formulations

by 27.7% to Rs10.3 billion (US$167 million) in the Indian firm’sfinancial first quarter ended 30 June 2013.

Formulation exports accounted for just over two-fifths of groupturnover, which advanced by 25.3% to Rs24.9 billion. Total exportsrose by slightly more than a fifth to Rs11.8 billion, despite turnoverfrom active pharmaceutical ingredients (APIs) declining by 13.1% toRs1.46 billion (see Figure 1). In its domestic market, the Indian firmbenefitted from higher sales of antibiotic, asthma and cardiovasculardrugs as its sales grew by 16.7% to Rs11.3 billion. The Indiancompany’s operating margin was almost static at 27.1%. G


Cipla raises sales by quarter

First-quarter sales Change Proportion(Rs millions) (%) of total (%)

Formulations 10,344 +27.7 41APIs/others 1,463 -13.1 6Exports 11,807 +20.7 47

India 11,321 +16.7 45

Other 1,792 +339.1 7

Cipla 24,920 +25.3 100

Figure 1: Breakdown of Cipla’s sales in its financial first quarter ended 30 June2013 (Source – Cipla)

NEULAND LABS said its “continued progress on our campaign toreduce costs and increase profitability” had led the Indian firm’searnings before interest, taxes, depreciation and amortisation (EBITDA)to improve by almost a third to US$3.44 million in its financial firstquarter ended 30 June 2013. The EBITDA rise came despite turnoverfalling by 4% to US$20.3 million in the same period, Neuland noted.

NIPPON CHEMIPHAR’s generics sales fell by 5.9% to ¥5.76 billion(US$58.0 million) in the Japanese firm’s financial first quarter ended30 June 2013. Generics made up the majority of the company’stotal Pharmaceuticals sales that slipped by 8.6% to ¥7.51 billion.Nevertheless, the firm expects by the end of its full financial yearending March 2014 to achieve generics sales 23.2% higher thanthe previous year at ¥24.9 billion.

JB CHEMICALS & PHARMACEUTICALS said a “favourableproduct mix” had helped the Indian company’s total sales to advanceby 23.0% to Rs2.37 billion (US$35.8 million) in its financial firstquarter ended 30 June 2013. Domestic formulations sales aheadby 18.5% contributed around Rs940 million, while formulationsexports accounted for Rs1.09 billion after growing by more thana quarter. Turnover from active pharmaceutical ingredients (APIs)rose by three-fifths to Rs227 million. Meanwhile, cost-containmentmeasures enabled the firm’s pre-tax profit to jump from Rs58.0million to Rs275 million.

BLUEFISH PHARMACEUTICALS more than halved its earningsbefore interest, taxes, depreciation and amortisation (EBITDA) lossto SEK10.0 million (US$1.51 million) after streamlining its ‘productflows’ and reducing its inventory levels in the first half of 2013. TheSwedish company’s sales during the six-month period rose by justover a tenth to SEK89.9 million.

INDOCO said its formulations exports declining by more than a fifthto Rs390 million (US$5.89 million) were responsible for the firm’soverall turnover dropping by 2.1% to Rs1.48 billion in the Indiancompany’s financial first quarter ended 30 June 2013. The firm's“shift from the low-cost contract-manufacturing business to high-margin contract research and manufacturing services (CRAMS)”had “resulted in muted growth in international business”, Indocoacknowledged. Active pharmaceutical ingredient (API) sales thatgrew by almost two-thirds domestically and by just over two-fifthsin export markets failed to offset the fall in formulations exports.This decline was not reflected by Indian formulations sales thatgrew by 4.0% to Rs977 million.

LITHA HEALTHCARE said it was still “on track” with integratingthe Pharmaplan business purchased by the South African group lastyear, noting that it had seen “strong product, value and volumegrowth since the acquisition”. Benefits and efficiencies from recentacquisitions were “starting to bear fruit”, the company insisted,noting that its Pharmaceuticals business had sales of ZAR286 million(US$28.0 million) in the first six months of the year, compared to justZAR82.2 million in the first half of 2012. However, deconsolidatingits Biovac joint venture led total turnover for the period to almosthalve to ZAR532 million. During the second quarter, Litha said ithad submitted 12 products for registration in South Africa.

CLARIS LIFESCIENCES reported sales ahead by 2.5% to Rs3.84billion (US$58.1 million) in the first half of 2013, of which the Indianfirm’s domestic turnover contributed 46%. The company said it had“finalised and commenced a product-development plan for 31 products,of which 20 are targeted for the US and European Union (EU)”. G

IN BRIEF


Double-digit sales rises by both its unbranded Generics and brandedgeneric Specialty Formulations business units enabled Glenmark

Pharmaceuticals to increase its group turnover by 19.0% to Rs12.4billion (US$201 million) in its financial first quarter ended 30 June 2013.The Indian firm improved its operating profit by 54.2% to Rs2.16 billion.

“We continue to do well in markets like India, the US and Russia,despite challenges in the operating environment,” stated chairman andmanaging director Glenn Saldanha, adding that the group had five newchemical or biological entities in clinical trials.

The firm’s global Generics turnover advanced by 17.8% to Rs6.24billion (see Figure 1). Glenmark generated almost three-quarters ofthat total in the US, where its sales of finished-dose drugs rose by13.9% to Rs4.47 billion. The company filed three abbreviated new drugapplications (ANDAs) during the quarter, and secured US approvalsfor riluzole tablets and rizatriptan orally-disintegrating tablets, as wellas for zolmitriptan as both standard and orally-disintegrating tablets.Glenmark currently has 53 ANDAs pending approval, of which 26contain paragraph IV patent challenges.

Turnover from generic formulations in western Europe climbedby 40.0% to Rs465 million. But sales by Glenmark’s Argentina-basedoncology business – which filed 12 dossiers during the quarter –declined by 6.2% to Rs37.0 million.

Sales of active pharmaceutical ingredients (APIs) increased by26.5% to Rs1.27 billion.

Specialty Formulations turnover rose by just over a fifth to Rs6.07billion. In the Indian group’s domestic market, sales advanced by 17.4%to Rs3.29 billion as it gained market share.

Turnover in Africa, Asia and the Commonwealth of IndependentStates (CIS) increased by a quarter to Rs1.69 billion on “positive trends”in Kazakhstan, Ukraine and Uzbekistan, as well as strong performancesin Kenya, Nigeria, South Africa and Sudan.

Launching atorvastatin in the Czech Republic and Slovakia – aswell as introducing ibandronate in Slovakia, and levocetirizine inRomania – failed to prevent a 3.1% sales slide to Rs261 million incentral and eastern Europe. The Indian firm said it had captured a 10%volume share with the imatinib oncology drug that it had launchedinto Romanian pharmacies in the previous quarter. G

COMPANY NEWS



Glenmark grows onbroad-based advance

Annual sales Change Proportion of(Rs millions) (%) total (%)

US 4,470 +13.9 36Western Europe 465 +40.0 4Latin America 37 -6.2 –APIs 1,271 +26.5 10Generics 6,243 +17.8 50

India 3,286 +17.4 27Africa/Asia/CIS 1,686 +25.0 14Latin America 841 +33.5 7Central/Eastern Europe 261 -3.1 2Specialty 6,074 +20.4 49

Others 62 +7.7 1

Glenmark 12,379 +19.0 100

Figure 1: Breakdown by business segment and region of Glenmark Pharmaceutcals’sales in its financial first quarter ended 30 June 2013 (Source – Glenmark)

Hikma Pharmaceuticals has raised its full-year forecast for groupturnover growth to 20% after its US solid-dose Generics operation

more than doubled its first-half turnover on “exceptional sales ofdoxycycline”. If it hits its target, the Jordanian group’s turnover shouldexceed US$1.3 billion.

Having initially predicted a 13% rise in group turnover in 2013,Hikma in early July upgraded its growth forecast to 17%. The USGenerics business was set to contribute US$200 million to the grouptotal (Generics bulletin, 12 July 2013, page 5).

Given the continued strong demand for doxycycline, the firm nowbelieves its full-year Generics turnover could reach US$230 million,having already registered growth of 137% to US$132 million in the

first half of 2013. Hikma said the rest of its US solid-dose portfoliohad made only a “limited contribution” as it was “having to rebuildour market position” as it tackled deficiencies at its US solid-dosefacility in Eatontown, New Jersey. The firm plans to have completedremediation work at Eatontown by the end of this year.

The Jordanian group increased its total first-half turnover by 19.9%to US$638 million as sales by its global Injectables business rose byalmost a tenth to US$247 million. That advance included a 21.1%sales increase to US$165 million in the US on “product launches andprice improvements”.

While Injectables turnover in Europe – where Hikma is investingin its Portuguese research and development facilities – grew by justover a tenth to US$41.1 million on recent launches and strong contract-manufacturing demand, sales in the Middle East and North Africa(MENA) region tumbled by more than a fifth to US$40.1 million.The Jordanian firm blamed pulling out of low-margin business andthe timing of tenders in Algeria and Saudi Arabia. Hikma expects“low double-digit” growth in its global Injectables turnover this year.

As reported, first-half turnover by Hikma’s MENA-based Brandedoperation advanced by just 3.2% to US$257 million. But the firmsaid the rise equated to 8.7% constant-currency growth.

Aided by the US Generics business’ strong margin, Hikma almostdoubled its first-half operating profit to US$144 million. The groupimproved its operating margin by 8.5 percentage points to 22.6%,although that excluded a US$15.0 million impairment charge as Hikma’sassociate company, India’s Unimark Remedies, was hit by lowerbulk-drug prices and worked to restructure its debt. G

RESULTS FORECAST/FIRST-HALF RESULTS

Doxycycline raisesforecast for Hikma

Business First-half sales Change Operatingsegment (US$ millions) (%) margin (%)

Branded 257 +3.2 20.0

US 165 +21.1 –Europe 41 +10.6 –MENA 40 -22.3 –Injectables 247 +9.5 26.6

Generics 132 +136.6 37.4

Others 3 – –*

Hikma 638 +19.9 22.6**

* operating loss of US$2.90 million** includes unallocated corporate expenses of US$19.4 million

Figure 1: Breakdown by business segment of Hikma Pharmaceutcals’ sales andoperating margin in the first half of 2013 (Source – Hikma)


Sagent Pharmaceuticals is poised to file its first US abbreviated newdrug application (ANDA) for a product fully developed and

manufactured at its premises in China. Having completed two stabilitybatches for the cytotoxic drug, the injectables specialist plans to filewith the US Food and Drug Administration (FDA) later this year aheadof a planned launch upon generic market formation in 2015.

As it in June completed a deal to acquire the outstanding 50%stake in its Kanghong Sagent Chengdu joint venture – now renamedSagent China Pharmaceuticals – the US firm at the same time securedFDA approval for carboplatin made at the 28,000 sq m site in Chengdu.

In the longer term, Sagent expects to make a third of its portfolioin China. The company plans to use the FDA’s CBE-30 process totransfer production of certain drugs to the Chengdu sterile facility. It isalso exploring ways to use the site as a platform for commercialactivities in China.

Introducing zoledronic acid vials at US generic market formationhelped Sagent to increase its turnover by 40% to US$59.6 million in thesecond quarter of this year. The firm is preparing to launch a pre-mixbag version of the bone-cancer drug for which it just got approvalvia the FDA’s hybrid 505(b)(2) route.

A total of 15 products in 29 presentations launched since 30 June2012 contributed US$24.9 million to Sagent’s group turnover. TheUS firm posted an operating profit of US$13.4 million. G

COMPANY NEWS

12 GENERICS bulletin

BUSINESS STRATEGY/SECOND-QUARTER RESULTS

Sagent starts filingfrom Chinese facility

Construction at the ¥5.5 billion (US$55.8 million) activepharmaceutical ingredients (APIs) facility that Towa started

building earlier this year in Fukusaki, Japan, has been temporarilysuspended due to an object found buried beneath the construction site,the Japanese firm has revealed.

Having initially planned to start operating at the plant in Aprilnext year (Generics bulletin, 8 March 2013, page 7), the Japanese firmsaid production would be “delayed by more than half a year” as itconsidered how to deal with the object. Towa plans to produce 20 to30 active pharmaceutical ingredients (APIs) at the site, therebyproviding up to one in 10 of the bulk drugs that it uses.

Meanwhile, production levels at the firm’s Yamagata formulationsfacility have reached 50 million tablets per month, and the firm believesit will soon reach 60 million tablets per month, in line with its targetfor the plant’s first year of operation.

In its financial first-quarter ended June 2013, Towa increased itsturnover by 6.2% to ¥14.6 billion. Amlodipine contributed around¥1.8 billion to that total, which also included about ¥700 million fromatorvastatin, following the firm’s launch of the cholesterol-loweringdrug in late-2011 (Generics bulletin, 9 December 2011, page 6).

But higher staff and depreciation expenses contributed to Towa’soperating profit falling by more than a quarter to ¥1.79 billion. As aresult, Towa’s operating margin slid by 5.7 percentage-points to 12.2%.G

MANUFACTURING/FIRST-QUARTER RESULTS

Buried object delaysTowa’s bulk-drug site


6 September 2013

Acquiring a majority stake in its existing Chinese distributionbusiness, as well as establishing a second trading company in the

country, was largely responsible for Gedeon Richter increasing itsPharmaceuticals turnover by 6.4% to C526 million (US$705 million)in the first half of this year.

China contributed C24.9 million to that total – compared to justC2.1 million in the prior-year period – after Richter took control ofa joint venture with its Chinese marketing partner, Rxmidas (Genericsbulletin, 22 March 2013, page 6). Cavinton (vinpocetine) and Panangin(asparaginates) were among the firm’s best-selling drugs in China.

Strong sales of Cavinton and Panangin were also major factorsin Richter’s Pharmaceuticals turnover in the Commonwealth ofIndependent States (CIS) advancing by 3.9% to C246 million.

In Russia, turnover edged ahead by 0.9% to C174 million as growthin sales of oral contraceptives and Verospiron (spirinolactone) – as wellas the impact of introducing aceclofenac and clopidogrel – compensatedfor a C11.5 million hit to sales from a licensing agreement for Suprax(cefixime) being terminated last year. Launches of Dvella (ulipristal)and Ekvator (lisinopril/amlodipine) helped to push up Ukrainian salesby 21.8% to C35.8 million.

Second-quarter domestic launches of Ophylosa (zinc hyaluronate)and zoledronic acid added to growth from Aflamil (aceclofenac), Aktil(amoxicillin/clavulanic acid), Esmya (ulipristal acetate) and Tanydon(telmisartan) as the Hungarian group’s domestic Pharmaceuticalssales increased by 3.4% to C58.1 million.

Excluding Hungary, Richter’s Pharmaceuticals turnover in theEuropean Union (EU) moved ahead by 1.5% to C154 million. Thisgrowth came despite a 4.6% slide to C39.4 million in the firm’s largestmarket in the region, Poland, upon the expiry of a licensing deal forAvonex (interferon beta). Romanian sales slipped slightly to C15.9 million.

Introducing Maitalon (drospirenone/ethinylestradiol) contraceptiveshelped to lift sales in Germany by 16.9% to C29.7 million. US turnoverslumped by almost a quarter to C18.1 million on a lower share of profitsfrom drospirenone and weaker sales of Plan B contraceptives.

With revenues through its Wholesale & Retail division ahead by atenth to C87.5 million, Richter’s group turnover grew by 6.9% to C601million. But its operating margin declined by half a percentage point to16.8% as its sales and marketing expenses increased by nearly a fifth. G

COMPANY NEWS


FIRST-HALF RESULTS

Acquisition in Chinalifts Richter’s sales

First-half sales Change Proportion of(C millions) (%) total (%)

Russia/CIS 245.5 +3.9 41European Union* 154.0 +1.5 26Hungary 58.1 +3.4 10China 24.9 – 4US 18.1 -23.9 3Rest of World 25.3 +4.5 4Pharmaceutical 525.9 +6.4 87

Wholesale & Retail 87.5 +10.1 15

Eliminations/Other -12.2 – -2

Gedeon Richter 601.1 +6.9 100

* excluding Hungary

Figure 1: Breakdown of Gedeon Richter’s sales in the first six months of 2013(Source – Gedeon Richter)

Reducing its cost of goods, manufacturing expenses and personnelcosts enabled Lupin to raise its pre-tax profit by 53.4% on a

turnover that increased by 9.1% to Rs24.2 billion (US$367 million)in the Indian firm’s financial first quarter ended 30 June 2013. Apre-tax profit of Rs6.23 billion produced a margin ahead by 7.4percentage points to 25.7%.

“We have had a good quarter, fuelled by a strong businessperformance in the US, as well as improved operational efficienciesthat have led to stronger margins,” commented Lupin’s managingdirector, Kamal Sharma.

As Figure 1 shows, Lupin raised its Formulations sales in the USand Europe by 29% to Rs10.9 billion. In the US – where the firm

launched four products during the quarter – Formulations turnoverhad advanced by a fifth to US$180 million, the firm said. Lupin claimsto be market leader for 25 of the 52 generics it markets in the US, whileeight abbreviated new drug application (ANDA) approvals – and onefiling – during the three-month period resulted in 86 of the firm’scumulative 177 US submissions having been approved.

The Indian firm’s domestic Formulations sales fell by 5% toRs5.89 billion. Lupin said a 12% turnover slide to Rs2.92 billion inJapan equated to a 5% local-currency rise.

Lupin said 13% sales growth to Rs746 million in South Africaranked its local Pharma Dynamics subsidiary fifth in the country’sgenerics market, “with clear leadership in the cardiovascular space”.Turnover from Lupin’s active pharmaceutical ingredients (APIs) roseby 5% to Rs2.43 billion. G


More efficient Lupinadds profit and sales

Annual sales Change Proportion of(Rs millions) (%) total (%)

US/European Union 10,994 +29 46India 5,894 -5 24Japan 2,923 -12 12South Africa 746 +13 3Rest of World 1,221 +4 5Formulations 21,778 +10 90

APIs 2,429 +5 10

Lupin 24,207 +9 100

Figure 1: Breakdown by region and business of Lupin’s turnover in its financialfirst quarter ended 30 June 2013 (Source – Lupin)

Higher volumes through DSM’s Pharmaceutical Products divisionhelped to drive up sales for the Dutch firm’s Pharma unit by 3% to

C187 million (US$247 million) in the second quarter of 2013. The firmsaid this was underpinned by organic growth of 4%, adding that thedivision had also registered earnings before interest, taxes, depreciationand amortisation (EBITDA) of C14 million. Whilst this represented an18% drop from the prior-year period’s EBITDA of C17 million, DSMnoted that C7 million of the 2012 figure had been a one-off benefit dueto restructuring. Group sales increased by 9% to C2.47 billion. G


DSM enjoys higher volumes


Double-digit sales growth in the US and India propelled SunPharmaceutical Industries to a 31% rise in gross turnover to Rs35.3

billion (US$551 million) in its financial first quarter ended 30 June 2013.The Indian firm reported Formulations turnover ahead by a third

to Rs33.3 billion, largely due to a 32% sales increase to Rs20.3 billionin the US. A 28% local-currency advance to US$364 million in theUS was boosted by the additions of URL Pharma’s generics businessand Dusa dermatology brands. However, the US launch of repaglinidewith 180-day exclusivity came too late to affect the first-quarterperformance of Sun’s US marketing unit, Caraco.

Sun’s double-digit US growth came despite a 4% dip in turnoverby its majority-owned affiliate, Taro, to US$153 million. The Indianfirm said Taro – which is facing opposition from minority shareholdersover its plans to re-elect two independent directors to its board – hadsuffered from “price adjustments on contractual obligations”.

Received nine ANDA approvalsDuring the quarter, Sun filed four abbreviated new drug applications

(ANDAs) and received approvals for nine, including for the injectabletestosterone that the company is “in the process of launching” in theUS. As of 30 June, Sun had 133 ANDAs pending approval.

Adjusted for a weak prior-year period, a reported 44% leap inIndian Formulations to Rs8.49 billion (see Figure 1) equated to salesgrowth of 11%. Formulations turnover in the rest of the world increasedby 23% to Rs4.51 billion, more than offsetting a 4% dip to Rs1.93billion in third-party sales of bulk drugs as Sun focused on “verticalintegration for key products”.

Sun made a pre-tax loss of Rs10.1 billion due to a Rs25.2 billionprovision linked to its agreement to pay Pfizer and Takeda US$550million to settle damages claims over the Indian firm’s at-risk launchof pantoprazole in the US (Generics bulletin, 28 June 2013, page 17). G

COMPANY NEWS



Sun raises its salesby just under a third

First-quarter sales Change Proportion(Rs millions) (%) of total (%)

US 20,314 +32 58India 8,486 +44 24Rest of world 4,508 +23 13Formulations 33,308 +33 94

Bulk Drugs 1,928 -4 5

Other 34 +87 –

Sun Pharma 35,270 +31 100

Figure 1: Breakdown of Sun Pharmaceutical Industries’ sales in its financial firstquarter ended 30 June 2013 (Source – Sun Pharma)

Growing at around double the market average in Mexico and Polandhelped Valeant to increase its Emerging Markets sales by 26%

to US$304 million in the second quarter of this year. Group turnovermoved ahead by 34% to US$1.10 billion, as Developed Markets salesgrew by 37% to US$792 million following several acquisitions.

Central and Eastern Europe (CEE) accounted for just over three-fifths of Valeant’s Emerging Markets turnover, with sales 30% higherat US$186 million. The Canada-based group said it was outpacingthe local market in Russia, where it benefitted from having last year

acquired a portfolio of branded generics from Gerot Lannach (Genericsbulletin, 23 March 2012, page 4).

Valeant’s purchase at around the same time of Brazilian OTC playerProbiotica boosted its Latin American turnover, which advanced by21% to US$89.1 million (see Figure 1).

In south-east Asia – where turnover increased by 14% to US$28.4million, including a contribution from South Africa – Valeant recentlybought the Euvipharm branded generics operation in Vietnam for aroundthree-times the acquired business’ annual turnover of US$7 million.

On a constant-currency basis, Valeant’s Emerging Markets turnoverrose by 23%. Organic “same-store” growth was 14%, comprising 13%in Central and Eastern Europe, 17% in Latin America and 11% inSouth-East Asia and South Africa.

Having completed its takeover of ophthalmics specialist Bausch &Lomb in early August, Valeant is forecasting group turnover of aroundUS$6 billion this year. G


Valeant hails rises inMexico and Poland

Region Second-quarter sales Reported Constant-currency(US$ millions) change (%) change (%)

Developed Markets 792 +37 +37

CEE 186 +30 +26Latin America 89 +21 +18South-east Asia, Africa 28 +14 +22Emerging Markets 304 +26 +23

Valeant 1,096 +34 +33

Figure 1: Breakdown by region of Valeant’s sales in the second quarter of 2013(Source – Valeant)

IND-SWIFT said its exports in the quarter ended 30 June 2013 hadrisen by 14.1% compared to the quarter ended March 2013, takingits sales total outside India to Rs1.67 billion (US$25.3 million).This helped to drive the firm’s overall turnover up by 12.7% toRs2.53 billion on the same basis. However, compared to the prior-yearperiod, the sales total represented a drop of 17.0%. G

IN BRIEF

Exports of active pharmaceutical ingredients (APIs) and finisheddosage-forms continued to drive growth for Natco in the three

months ended 30 June 2013, according to the Indian firm. Natco’stotal sales increased by 22% to Rs1.73 billion (US$26.1 million) inthe company’s financial first quarter.

Meanwhile, Natco said it was “awaiting US Food and DrugAdministration (FDA) approval of its abbreviated new drug application(ANDA) for glatiramer acetate” after a US Court of Appeals ruledthat certain US patents protecting Teva’s Copaxone multiple sclerosisdrug should be declared invalid (Generics bulletin, 9 August 2013,page 1). The Indian firm – which has developed its version withMylan – said it expected “a possible launch in May 2014”. G


Exports drive Natco’s growth


Atotal of 116 active ingredients or combinations are covered by the12th tender round organised by Germany’s AOK group of statutory

health insurance funds. The 116 molecules have a combined annualturnover through the AOK funds of around C2.1 billion (US$2.8 billion).

Suppliers have until 10 October to submit offers for the 116ingredients, 93 of which are currently covered by the AOK’s seventhtender round that expires on 31 March next year. “Once we haveconsidered the offers,” stated the funds’ chief negotiator, Dr ChristopherHermann, “we plan to inform companies of the results and awardcontracts in November.”

Two-year supply deals will start on 1 April 2014. Each of the 116ingredients is divided into eight regional sub-lots. For 25 of the 116ingredients – including amoxicillin, clindamycin, fentanyl matrixpatches, montelukast and salbutamol – the AOK intends to awardsupply contracts to up to three companies per sub-lot. Contracts for theother 91 molecules – such as anastrozole, esomeprazole, levetiracetam,pantoprazole and repaglinide – will be awarded exclusively.

Noting that the AOK had awarded contracts to 34 companies inits seventh round, Hermann said he expected “lively participation byall relevant generics suppliers” in the 12th round. With 230 off-patentmolecules or combinations already under supply contracts –representing an annual AOK spend of C3.8 billion – the funds expectto save more than C1 billion this year through tenders. In 2012,Hermann pointed out, the AOK had accounted for almost C950 millionof total tender-driven savings by German statutory health insurancefunds totalling nearly C2.1 billion. Contracts under the 10th and 11thAOK tender rounds began on 1 June this year.

Meanwhile, German generics industry association Pro Generikahas criticised the AOK for including biosimilar filgrastims in a recenttender (Generics bulletin, 12 July 2013, page 15).

“Tenders give a completely wrong signal,” argued Pro Generika’smanaging director, Bork Bretthauer. “By aiming simply to achievethe lowest price, they threaten the future of biosimilars,” he insisted,adding that tenders deprived companies of the opportunity to provideprescribers with detailed information about individual products.

Bretthauer said biosimilars’ market share remained small inGermany, having accounted last year for just C60 million of statutoryfunds’ total C3.54 billion spending on biological drugs. “The fundsshould consider how to smooth the way for biosimilars rather thanplace stones in their path,” he said. G

MARKET NEWS


PRICING & REIMBURSEMENT

German AOK tenderspans 116 molecules

Austria has become the first country to ratify an agreement onestablishing a unified patent court in Europe. In total, a majority of

the 25 European Union (EU) member states that agreed to create aspecialist unitary court must ratify the deal before the unitary patentcourt agreement can come into force.

That majority must include France, Germany and the UK. Withthe UK not planning to present a statutory instrument to change nationallegislation “until the summer of 2014 at the earliest” – provided itreceives clarification on the unified court’s fee structure – it appearsunlikely that the unitary patent court will start to hear intellectual-property disputes before 2015. G

INTELLECTUAL PROPERTY

Austria ratifies patent court

State legislation that would place additional responsibilities onpharmacists who dispense biosimilars has been passed by

California’s Assembly. Following the vote on bill SB-598 – which sawthe draft legislation approved by a majority of 60 votes to four – thebill will be returned to the state Senate so that any changes can bereconciled with the Senate version before the legislation can be signedinto law by the state’s governor.

The bill would allow substitution only when a biosimilar has beendeemed interchangeable with the equivalent brand by the US Foodand Drug Administration (FDA), the prescribing doctor has not barredsubstitution and the prescriber is informed of the substitution. However,these measures are limited by a “sunset clause”, meaning they willonly be required until 1 January 2017.

US state governors in Oregon and Florida recently signed similarbills into law (Generics bulletin, 28 June 2013, page 11), in a move thatwas welcomed by local brand association the Biotechnology IndustryOrganization (BIO). Calling the Oregon bill “a model for legislationnecessary in all 50 states”, BIO also praised the Florida legislation,even though it “stops short of ensuring physicians are notified if theirprescription directives are modified after the fact”.

The US Generic Pharmaceutical Association (GPhA) highlighteda statement it received from the FDA that – while not taking a positionon state legislation – pointed out that “Congress deliberately set a veryhigh bar for biosimilar product approval”. “Efforts to undermine trustin these products are worrisome and represent a disservice to patientswho could benefit from these lower-cost treatments,” the agency warned,adding that federal law permitted substitution of an interchangeablebiosimilar without consulting the prescriber. Such substitution, theFDA added, would “foster competition in the biologic drugs market”.

However, Actavis – which has a partnership with Amgen to developcertain biosimilar monoclonal antibodies (Generics bulletin, 13January 2012, page 21) – had voiced support of the California bill inadvance of the Assembly vote. In a letter to California Assemblymember Richard Gordon, Actavis’ president and chief executive officer,Paul Bisaro, observed that opponents to the legislation “claim that thebill’s notification provisions represent a barrier to patient access”.However, he insisted, “this position is inaccurate and represents afundamental misunderstanding of the proposed legislation”. Instead,he claimed, the requirements would increase confidence in biosimilarsand “enhance the acceptance of these critical products”. G

LEGISLATION

California gives nodto bill on biosimilars

User-fee rates payable to the US Food and Drug Administration(FDA) between 1 October 2013 and 30 September 2014 have been

published by the agency in the country’s Federal Register. The fee forfiling an abbreviated new drug application (ANDA) has risen toUS$63,860 compared to US$51,520 in the financial year ending 30September 2013. Meanwhile, Drug Master Files (DMFs) will incur aUS$31,460 fee, or almost 50% higher than in the previous year.

Domestic active pharmaceutical ingredient (API) facilities willincur a fee of US$34,515, while for non-US API plants the fee will beUS$49,515. Fees for domestic and non-US finished-dosage formfacilities will be US$220,152 and US$235,152 respectively. G

REGULATORY AFFAIRS

FDA announces user-fee rise


Indian Pharmaceutical Alliance (IPA) has refuted claims by Pfizerthat Indian intellectual-property (IP) provisions discriminate against

US companies. In a letter to the originator aimed at “clarifyingperspectives” over Indian IP policy, the IPA’s secretary-general, DilipShah, insisted that a “continued dialogue” on the subject would beuseful for both parties, despite disagreement over “a number of issuesincluding interpretations of events and facts”.

Pfizer’s chief IP counsel, Roy Waldron, had earlier this year tolda US House of Representatives Energy and Commerce committeethat Indian industrial policy on pharmaceuticals was “protectionistand discriminatory” and “exploits US IP to benefit its own industry”(Generics bulletin, 12 July 2013, page 10). But Shah maintained thatthere was “no discrimination against US companies in the grant ofcompulsory licences”, such as the one granted to Natco Pharma lastyear for a version of Bayer’s Nexavar (sorafenib) brand (Genericsbulletin, 23 March 2012, page 17).

Moreover, Shah insisted, “it would have made no difference” tocertain recent Indian IP matters – such as denying Novartis an Indianpatent for its Glivec (imatinib) due to a lack of improved efficacy(Generics bulletin, 5 April 2013, page 1) or extended litigationover Pfizer’s own Sutent (sunitinib) brand (Generics bulletin, 19October 2012, page 13) – if the patentee had been an Indian, ratherthan a US-based, company.

No data had been provided by Pfizer to support Waldron’s assertionthat India’s patent laws had adversely affected US jobs, Shah observed,noting that Pfizer’s own imports into India had almost trebled between2005 and 2012. “India’s patent law has remained unchanged since itwas amended in 2005 to comply with the requirements of the WorldTrade Organisation’s (WTO’s) agreement on Trade Related Aspectsof Intellectual Property Rights (TRIPS),” he observed.

Furthermore, Shah insisted that section 3(d) of India’s Patents Act –which prohibits the grant of patents to new forms of known substancesthat do not demonstrate increased efficacy – was consistent with TRIPS.If the US took an opposing view, he suggested, dispute-resolutionmechanisms existed through which the matter could be pursued.

Nevertheless, the IPA conceded that there was “a perception in theUS that India has ‘weak’ IP laws and this has the potential to adverselyaffect US investment into India”, and that Waldron’s testimony hadreflected these concerns. “The issue needs to be addressed,” Shahacknowledged, “but whether it is best prompted by pejorative commentor constructive debate mindful of India’s problems, priorities andviews needs consideration.” G

MARKET NEWS


INTELLECTUAL PROPERTY

Indian body refutesUS bias accusations

Adraft concept paper on developing “product-specific guidance ondemonstration of bioequivalence” has been released for consultation

by the European Medicines Agency (EMA).Comments on the paper – which is aimed at developing product-

specific guidance to ensure “a consistent approach to the assessmentof applications based on bioequivalence data across all submissionroutes” – are sought by 30 September. “It is planned that such guidanceis first developed for immediate-release formulations for oral use,” theEMA said. Product-specific guidelines will follow later this year. G

REGULATORY AFFAIRS

EMA considers bioequivalence

Shortening price-disclosure periods for generics manufacturersunder Australia’s expanded and accelerated price disclosure (EAPD)

policy risks destabilising the country’s generics market, according tothe local Generic Medicines industry Association (GMiA). The policyis used to revise reimbursement prices listed on the country’sPharmaceutical Benefits Scheme (PBS) to bring them into line withactual market prices paid by pharmacists.

By deciding to shorten the price-disclosure periods “withoutconsulting industry”, Australia’s government had apparently chosento “ignore sensible policy solutions that will deliver real ongoingsavings”, the GMiA stated. Rather than focusing on price, the associationmaintained, the government should introduce policies to support agreater uptake of generics.

“The heavy discounting occurring under EAPD is unsustainableand may force participants from the market, resulting in market exitof companies, possible interruption of supply of medicines, and pricerebounds,” the association maintained. While the GMiA acknowledgedthat “the commoditisation of generic medicines is driving significantsavings”, the association also insisted that “commoditisation of amarket also reduces the commercial incentive to service the market,and at risk is the continued and reliable supply of medicines”.

Meanwhile, Australia’s government has announced that it expectspatients to save around A$20 million (US$17.9 million) annuallythrough price cuts of up to 35% for around 500 medicines listed onthe PBS that came into effect from the start of August. These cutswere made through the price-disclosure scheme, noted health ministerTanya Plibersek, adding that “price disclosure is already expected tosave patients up to A$1.6 billion over the next 10 years”. G

PRICING & REIMBURSEMENT

Australian changesrisk market stability

Draft guidance aimed at clarifying US requirements surroundingstability testing for abbreviated new drug applications (ANDAs)

has been published by the country’s Food and Drug Administration(FDA). The detailed question-and-answer document responds to publiccomments received by the agency on stability guidelines that werepublished in their final form earlier this year (Generics bulletin, 12July 2013, page 6).

Meanwhile, the FDA’s Office of Generic Drugs (OGD) haspublished a manual outlining the agency’s policies and procedures forresponding to ANDA suitability petitions. The document sets out theresponsibilities of agency employees when responding to such petitions,which need to be accepted if an ANDA product differs from the referencedrug in either route of administration, dosage form, strength or activeingredient. Suitability petitions should be approved or denied within90 days of being submitted, the document confirms.

Separately, the FDA has launched a secure supply-chain pilotprogramme that will “enable qualified firms to expedite the importationof active pharmaceutical ingredients (APIs) and finished drug productsinto the US”, thus allowing the agency to focus resources on high-riskimports. The voluntary scheme – which will run from February 2014to February 2016 – will see up to 100 “qualified firms” submit fivedrugs for “expedited import entry review”. Firms may apply to jointhe scheme between 16 September and 31 December 2013. G

REGULATORY AFFAIRS

FDA clarifies ANDA stability


Agreements by originators not to market or supply authorisedgenerics as part of US litigation settlements amount to ‘reverse’

payments that should be subject to antitrust scrutiny, according to anamicus curiae brief written by the US Federal Trade Commission (FTC).

The competition watchdog submitted the brief to a New Jerseydistrict court as part of ongoing antitrust litigation regarding asettlement between Teva and Pfizer. Under the deal, Teva agreed not tolaunch a generic version of Pfizer’s Effexor XR (venalfaxine) before1 July 2010, provided the originator did not offer an authorised genericof its brand during a set period.

The two pharma companies contend that their settlement fallsoutside of the scope of the antitrust analysis described in the USSupreme Court’s landmark AndroGel ruling because the agreement doesnot involve a cash payment. But the FTC maintained that “acceptingthe defendants’ claim of immunity whenever patentees use vehiclesother than cash to share the profits from an agreement to avoidcompetition” would “elevate form over substance”.

Allowing the parties to rely on this defence, the FTC claimed,would “allow drug companies easily to circumvent” the recent USSupreme Court ruling that settlements containing a reverse paymentwere liable to review under competition law, using a ‘rule of reason’approach (Generics bulletin, 28 June 2013, page 1).

“The Supreme Court’s opinion speaks in terms of ‘payments’ and‘money’ not because cash has a unique economic effect, but because[that case] involved allegations of cash payments,” the FTC pointed out.The settlement between Teva and Pfizer should “raise the same typeof antitrust concern” despite the brand company “paying for delayedentry with something other than cash”, the watchdog maintained. G

MARKET NEWS


LITIGATION

FTC lobbies US courtover settlement deal

Guidance on variations to the terms of marketing authorisationshave been revised by the European Medicines Agency (EMA)

following similar action by the European Commision. Under the revisedguideline – which came into effect on 4 August – two new categoriesof variation have been created.

These include those “related to obligations and conditions of amarketing authorisation, including risk-management plans” and those“related to submission of studies to a competent authority”. Referringto the second category, the EMA notes that “some of the data previouslysubmitted as a post-authorisation measure will now need to be filedas variations applications”.

A question-and-answer document aimed at assisting companiesin implementing the new requirements has been published by the EMA,containing “an overview of the most important changes”. Revisedguidance on work-sharing procedures for variations has also beenreleased, as well as an amended template for firms to use whensubmitting variations to the agency.

The European Heads of Medicines Agencies’ Co-ordination Groupfor Mutual Recognition and Decentralised Procedures for human drugs(CMDh) has also amended its variations guidance in line with thechanges. Meanwhile, the CMDh has also announced that a pilot work-sharing scheme for assessing active substance master files (ASMFs)will begin on 1 December 2013. G

REGULATORY AFFAIRS

EU variations guide revised

SOUTH AFRICA’s cabinet has moved closer to overhauling thecountry’s Medicines Control Council (MCC) after submitting a billto the South African parliament that the cabinet says “seeks toestablish a strong, efficient and effective medicine regulatory authority”.

MOODY’S – the US-based credit rating business – says genericsfirms will face “higher legal, regulatory and insurance costs”following recent industry developments in the US. According to areport issued by the company, costs could be driven up following arecent Supreme Court ruling that patent-litigation settlements betweenoriginator and generics firms are liable to review under competitionlaw (Generics bulletin, 28 June 2013, page 1), as well as by potentialchanges to labelling requirements for generics (Generics bulletin,12 July 2013, page 7). “As industry risks rise, generic drugcompanies’ capacity for leverage will decline and better liquiditywill be necessary,” the report states.

EFCG – The European Fine Chemicals Group – has announced thatits sixth annual dinner will be held on 23 October in Frankfurt.Professor Utz-Hellmuth Felcht, former chairman of Evonik Degussa,will be the event’s speaker.

US legislators have introduced a bill in the country’s House ofRepresentatives aimed at providing “incentives for the developmentof new combination drugs”. The draft legislation – backed byRepresentative Jason Chaffetz – would allow the US Food andDrug Administration (FDA) to grant five-year new chemical entity(NCE) exclusivity for a new combination of drugs even if bothwere previously approved separately.

INDIAN legislation should be introduced to make it compulsory forthe country’s doctors to prescribe generics, a parliamentary commercecommittee has recommended. In a report titled “Foreign directinvestment (FDI) in the pharmaceutical sector”, the committee“recommends that government bring in legislation to make it legallybinding on all doctors to prescribe generic drugs in their prescriptionsand/or clearly prescribe generic equivalents of branded medicines”.Furthermore, the report suggests a “blanket ban” on FDI in“brownfield” pharmaceutical projects, and strongly recommends thatthe government “take all measures to stop any further takeover oracquisition of domestic pharma units”.

EU – the European Union – has been urged by lobbying group ActUp-Paris to exclude “medicines in transit” from being seized underEuropean anti-counterfeiting measures. EU regulation 608/2013 on‘customs enforcement of intellectual property rights’ continues toallow “the seizing of goods over a simple suspicion of intellectual-property infringement without checking beforehand whether thesegoods are headed to the European territory or just in transit”, ActUp-Paris points out. The group insists that the legislation should bealtered to make it “consistent with the commitments taken by theEU regarding access to treatments”.

GPhA – the US Generic Pharmaceutical Association – has welcomedthe support of local brand associations the Pharmaceutical Researchand Manufacturers of America (PhRMA) and the BiotechnologyIndustry Organization (BIO) over bills introduced in the country’sSenate and House of Representatives aimed at exempting US Foodand Drug Administration (FDA) user fees from automatic federalbudget cuts under ‘sequestration’ measures (Generics bulletin, 7August 2013, page 13). Medical device associations the AdvancedMedical Technology Association (AdvaMed) and the MedicalImaging & Technology Alliance (MITA) have also praised the bills.G

IN BRIEF


MARKET NEWS


Rank Product Sales Generics market(packs millions) share (%)

1 Amoxicillin 35 4.82 Zolpidem 20 2.73 Metformin 19 2.64 Omeprazole 19 2.55 Ibuprofen 18 2.56 Amoxicillin/clavulanic acid 18 2.47 Alprazolam 18 2.48 Chlorhexidine/chlorobutanol 17 2.29 Esomeprazole 16 2.110 Zopiclone 14 1.911 Furosemide 14 1.912 Prednisolone 12 1.713 Bisoprolol 11 1.514 Paroxetine 11 1.515 Cefpodoxime 11 1.516 Macrogol 4000 10 1.417 Allopurinol 10 1.418 Pantoprazole 10 1.319 Atorvastatin 10 1.320 Domperidone 9 1.321 Diclofenac 9 1.222 Desloratadine 8 1.123 Ramipril 8 1.124 Pravastatin 8 1.125 Simvastatin 8 1.1

Figure 1: France’s 25 top-selling generics by volume in 2012 (Source – ANSM) Figure 2: France’s 25 top-selling generics by value in 2012 (Source – ANSM)

Rank Product Sales Generics market(C millions) share (%)

1 Omeprazole 110 4.02 Clopidogrel 100 3.63 Atorvastatin 93 3.44 Esomeprazole 79 2.95 Simvastatin 64 2.36 Amoxicillin/clavulanic acid 63 2.37 Pravastatin 63 2.38 Ramipril 53 2.09 Metformin 52 1.910 Pantoprazole 48 1.711 Bioprolol 46 1.712 Amoxicillin 43 1.613 Cefpodoxime 39 1.414 Amlodipine 37 1.315 Venlafaxine 35 1.316 Paroxetine 35 1.317 Lercanidipine 35 1.318 Tramadol 34 1.319 Valaciclovir 33 1.220 Risperidone 32 1.221 Olanzapine 32 1.222 Perindopril 31 1.123 Fenofibrate 30 1.124 Lansoprazole 27 1.025 Prednisolone 25 0.9

Amoxicillin maintained its position as France’s top-selling genericby volume in 2012, according to figures published by the country’s

medicines agency, ANSM. With sales of 35 million packs, the productrepresented 4.8% of France’s generics market by volume. Zolpidemtook second place with sales of 20 million packs, while metforminand omeprazole both achieved sales of 19 million (see Figure 1).

Meanwhile, omeprazole was the top-selling generic by value,with a turnover of C110 million (US$147 million) representing 4.0%of total generics sales (see Figure 2). Clopidogrel rivals to Sanofi’sblockbuster Plavix brand had sales of C100 million, while turnoverfrom atorvastatin reached C93 million, following the onset of genericcompetition to Pfizer’s Tahor (atorvastatin) – sold as Lipitor in othermarkets – from May 2012.

Despite atorvastatin ranking third in terms of value sales, themolecule achieved sales of just 10 million packs. This made it onlythe 19th-highest selling generic by volume and suggested an averageprice of around C9.30 per pack. Local health insurer CNAMTS recentlypublished figures indicating that France had saved C115 million throughusing generic versions of the cholesterol-lowering drug in 2012(Generics bulletin, 28 June 2013, page 10).

Following atorvastatin rivals entering the French market, simvastatinslipped from third place in 2011 – when generic versions of themolecule had sales of around C66 million (Generics bulletin, 23November 2012, page 26) – to fifth place in 2012, with turnover ofC64 million. At the same time, pravastatin dropped from fourth placeto seventh in terms of value sales. Both molecules achieved volumesof around eight million packs.

Meanwhile, esomeprazole rose up the value rankings from 10thplace in 2011 to fourth in 2012 as the molecule’s sales more thandoubled to C79 million. However, pantoprazole slipped two positionsto 10th place in the value rankings despite sales rising by just over atenth to C48 million. And lansoprazole slipped from 21st to 24th placewith sales that remained static at around C27 million.

Data published by ANSM recently indicated that 2012 had seen,for the first time, generics account for more than one in four packssold in France (Generics bulletin, 9 August 2013, page 14). Totalgenerics sales by volume represented 26.4% of France’s overallreimbursable pharmaceutical market, which was 3.4 percentage pointshigher than the share captured in 2011. Meanwhile, in value terms,generics represented 13.9% of reimbursed sales worth C27.2 billion(US$35.7 billion), compared to 10.9% in the previous year.

CNAMTS recently published its own report indicating that theproportion of eligible prescriptions substituted with a generic hadrisen by almost 12 percentage points to 83.6% between April andDecember last year. This “significant progress” was attributed largelyto introducing the tiers payant contre génériques scheme, which allowspatients to be instantly reimbursed for their prescription at the pointof dispensing if they accept a generic substitute (Generics bulletin,14 September 2012, page 11). ANSM agreed that the mechanism hadacted as a “strong financial incentive” to accept substitution.

At the start of this year, France’s generics industry association,GEMME, renewed its own efforts to drive up the use of generics inFrance through a public awareness campaign (Generics bulletin,11 January 2013, page 8). G

MARKET RESEARCH

France’s ANSM reveals highest sellers


Teva has launched a generic version of Merck & Co’s Temodar(temozolomide) 5mg, 20mg, 100mg, 140mg, 180mg and 250mg

capsules in the US with 180-day exclusivity. However, the value ofthat exclusivity has been diminished by the authorised generic of thechemotherapy drug that Sandoz has introduced through an agreementwith the originator.

Furthermore, Teva is splitting profits from its sales of temozolomidewith Perrigo, which is supplying the active pharmaceutical ingredient(API) for the Israeli company to formulate in the US.

Temodar achieves annual US sales of approximately $425 million,according to market researcher IMS Health.

Held approval for three yearsThe Israeli firm had obtained approval for its abbreviated new

drug application (ANDA) shortly after a Delaware district court ruledthat US patent 5,260,291 was unenforceable due to inequitableconduct (Generics bulletin, 12 February 2010, page 15).

However, Teva agreed not to market generic temozolomide duringMerck’s appeal against the district court’s ruling. In return, Merckgranted Teva rights to start selling the oncology drug from August 2013,effectively ignoring Merck’s six-month paediatric extension for the‘291 patent that runs until 11 February 2014.

Towards the end of 2010, the US Court of Appeals overturned theDelaware district court’s ruling and found that the ‘291 patent wasenforceable (Generics bulletin, 3 December 2010, page 19). G

PRODUCT NEWS


Guidance setting out Australia’s approach to evaluating andregistering biosimilar medicines has been published by the country’s

Therapeutic Goods Administration (TGA). “The purpose of the guidanceis to assist sponsors to identify the data necessary to support applicationsfor the registration of biosimilars,” the TGA said, adding that it would“clarify the scientific and regulatory principles used by the TGA”.

Sections of the guidance cover the definition of biosimilarmedicines and how such products are evaluated, including process anddata requirements, registration applications and pre-submission meetings.

A chapter on reference products states that “a reference productmanufactured and sourced overseas may be used, provided that theproduct is registered in Australia and a bridging comparability studybetween the Australian-sourced product and all batches of the referenceproduct is provided”.

Guidance is also given on what should be included in comparabilitystudies, as well as on post-registration regulation and pharmacovigilance.

“In certain cases, it may be possible to extrapolate therapeuticsimilarity shown in one indication to other indications of the referencemedicinal product,” the Australian guidance states, citing the EuropeanMedicines Agency’s (EMA’s) guidance on extrapolating indications.This will depend on factors including clinical experience, availableliterature, and whether the same mechanisms of action or the samereceptors are involved in all indications. “Possible safety issues indifferent subpopulations should also be addressed,” the guidance states.

In a section covering naming conventions, the guidance states thatthe TGA requires that the Australia Biological Name (ABN) for abiosimilar be composed of the reference product ABN – “thus identifyingthe reference product with which the biosimilar has demonstrablecomparability” – combined with “a biosimilar identifier”. Thisidentifier should consist of the prefix “sim” along with a three-lettercode obtained by applicants from the World Health Organization’s(WHO’s) International Non-proprietary Name (INN) Committee.

“As small differences between biosimilars can give rise todifferences in clinical behaviour, in particular in immunogenic effects,certain nomenclature provisions are necessary to ensure that it is possibleto distinguish between biosimilars and clearly identify the referenceproduct,” the guidance explains. “A biosimilar is not identical to itsreference product and must be assumed to be different to any otherbiosimilar, as no direct comparability study has been conducted.”G

BIOSIMILAR DRUGS

Australia publishesbiosimilars guidance

ONCOLOGY DRUGS

Sandoz rivals Teva’stemozolomide launch

Indian generics player Ajanta Pharma has secured revocation of twoIndian composition patents protecting Allergan’s Ganfort (bimatoprost/

timolol) and Combigan (brimonidine/timolol) combination ophthalmicdrugs. The patents – IN212,695 and IN219,504 – had been granted bythe Kolkata Patent Office in December 2007 and May 2008 respectively.Ajanta said it would continue to market its Bimat T and Bidin LSalternatives in India.

Meanwhile, Roche told Generics bulletin it would not pursueIndian patent IP205,534 and related divisional applications for itsHerceptin (trastuzumab) breast-cancer treatment after the KolkataPatent Office acceded to opposition to three divisional applications.The patent office said Roche had failed to attend a hearing or submitdocuments, so the applications had been considered withdrawn. G

OPHTHALMIC DRUGS/BIOLOGICAL DRUGS

India hits Allergan and Roche

Dutch developer Synthon has triumphed over Astellas in its domesticmarket in a dispute over tamsulosin sustained-release tablets. A

district court in The Hague rejected the originator’s allegation thatforms of the urology drug made by Synthon infringed the Dutch partof European patent EP0,661,045, which covers sustained-releasehydrogel preparations and expires on 10 September this year.

The court found that Astellas had failed to show that Synthon’stablets met the patent’s requirement for a gelation index of at least 70%. G

UROLOGY DRUGS

Synthon wins on tamsulosin


GlaxoSmithKline’s US dutasteride patent 5,565,467 has withstoodparagraph IV challenges brought by Actavis, Banner, Impax, Mylan

and Roxane. Delaware District Judge Richard Andrews rejected thegenerics firms’ arguments that the ‘467 patent was invalid due toanticipation by prior art, lack of written description and lack of utility.

The ‘467 patent protects the originator’s Avodart (dutasteride) andJalyn (dutasteride/tamsulosin) capsules until 20 November 2015.GlaxoSmithKline reported US Avodart sales down by 1% to £159million (US$247 million) in the first half of this year.

Andrews ruled that Merck’s synthesis of dutasteride in May 1994could not serve as anticipatory prior art that would have rendered the‘467 patent invalid. “There is substantial uncertainty of whether Merckindependently conceived of dutasteride, and this uncertainty preventsdefendants from meeting the clear and convincing evidence standard.”

Solvate testing would have been routineOn written description, the generics firms argued that the ‘467

patent failed to disclose or enable a single solvate of dutasteride. ButAndrews accepted GlaxoSmithKline’s contention that selecting andtesting a solvate would have been routine for a skilled person.

Andrews also rejected Roxane’s allegation that the ‘467 patentlacked utility, finding that there was “enough information within thefour corners of the ‘467 patent to conclude that dutasteride producedin vivo and in vitro activity”.

GlaxoSmithKline had in 2010 reached a litigation settlement withTeva that allows the Israeli firm to launch its generic version of Avodart“in the fourth quarter of 2015”. And in January this year, the brand firmreached a deal that permits Par’s Anchen to launch a rival to Jalynat around the same time. Under the terms of both settlements, thegenerics firms can launch “earlier under certain circumstances”. G

PRODUCT NEWS


UROLOGY DRUGS

Firms fail to conquerdutasteride patent

Par Pharmaceutical and its partners IntelGenX and LTS Lohmannhave been sued by Reckitt Benckiser over their paragraph IV

challenge to US patents protecting the originator’s Suboxone(buprenorphine/naloxone) sublingual film.

A lawsuit that Reckitt and its partner Monosol Rx have filed ina Delaware district court alleges that Par’s abbreviated new drugapplication (ANDA) infringes US patents 8,017,150 and 8,475,832,which expire on 13 February 2023 and 2 March 2030 respectively.

According to the suit, Par’s version of the sublingual film fortreating opioid dependence uses IntelGenX’s VersaFilm drug-deliverytechnology that will be manufactured by LTS Lohmann.

Reckitt said it had sued the defendants within 45 days of receivingPar’s notification letter, thereby triggering a 30-month stay on finalANDA approval. Quebec-based IntelGenX believes Par’s ANDAdoes not infringe the ‘150 and ‘832 patents, nor any other patents.

Actavis and Amneal introduced US rivals to Reckitt’s Suboxonetablets earlier this year (Generics bulletin, 8 March 2013, page 16).However, Reckitt recently claimed its patented film had retained 69%of the US market by volume as of the end of June 2013. Suboxonetablets held just a 1% share, generic buprenorphine/naloxonecombination tablets 13%, and generic buprenorphine tablets 18%. G

OPIOID DEPENDENCE DRUGS

Par targets US Suboxone film

ACTAVIS believes it may be entitled to 180-day exclusivity in theUS for the generic version of Horizon Pharma’s Rayos (prednisone)1mg, 2mg and 5mg delayed-release tablets for which it recently filedan abbreviated new drug application (ANDA). Horizon and itspartner Jagotec responded by suing Actavis in a New Jersey districtcourt, thereby triggering a 30-month stay on final ANDA approvalfor the anti-inflammatory and immunosuppressive agent.

BECTON DICKINSON has added a third drug, ondansetron 4mg/2ml,to the BD Simplist line of generic pre-filled syringes that it recentlyintroduced in the US. The range also includes diphenhydramineand metoclopramide.

SANDOZ CANADA has extended its consumer healthcare rangewith Salinex ProTect, a nasal spray containing an algae extractthat forms a protective layer in the nose to hinder cold viruses.

BANNER PHARMACAPS and its partner Actavis have been suedin a North Carolina district court over their abbreviated new drugapplication for a rival to Depomed’s Zipsor (diclofenac) 25mgcapsules. Depomed is alleging infringement of five US patents.

ARROW has struck a deal with New Zealand’s Pharmac agencyover the Actavis affiliate’s venlafaxine extended-release tablets. Inreturn for roughly halving the antidepressant’s reimbursement pricefrom 1 September, Pharmac has removed prescribing and dispensingrestrictions that still apply to Pfizer’s Efexor XR original.

PERRIGO plans during September to launch flucinolone acetonide0.01% scalp and body oils in the US. The treatments for atopicdermatitis are equivalent to Hill’s Derma-Smoothe/FS products.

BAYER has failed to obtain from the US Court of Appeals a rehearingof the court’s ruling in favour of Actavis, Lupin and Sandoz on theinvalidity of Bayer’s reissued US patent RE37,564 (Generics bulletin,3 May 2013, page 18). The patent had protected Bayer’s Yaz(drospirenone/ethinylestradiol) oral contraceptive until 30 June 2014.

STADA has introduced rizatriptan orodispersible tablets as amigraine remedy in Germany.

FRESENIUS KABI has launched in the US levofloxacin 5% dextroseinjection in its ‘Freeflex’ solution containers that use polyolefin film.

GLENMARK has convinced a court in the Netherlands that the localpart of European patent EP0,670,719 – which protectsGlaxoSmithKline’s Malarone (atovaquone/proguanil) malariatreatment – is invalid for lack of inventive step. In its ruling, thecourt in The Hague referred to a recent UK ruling to the same effect(Generics bulletin, 15 February 2013, page 21).

ZYDUS CADILA has secured final US approval to marketlansoprazole 15mg and 30mg delayed-release capsules.

LUPIN has acquired exclusive US rights to market Romark’s Alinia(nitazoxanide) oral suspension. The Indian firm will market thepaediatric diarrhoea treatment through its existing 160-member USsalesforce that promotes brands including Suprax (cefixime).

ACTAVIS AND SANDOZ will be able to launch generic versionsof Avanir’s Nuedexta (dextromethorphan/quinidine) in the USfrom 30 July 2026 under the terms of patent-litigation settlementsover the treatment for pseudobulbar affect. G

IN BRIEF


Teva will have to defend itself against an accusation brought in aNew Jersey district court that its lipegfilgrastim biological drug

infringes Amgen’s US patent 8,058,398 covering its Neupogen brand.The Israeli firm is currently preparing to launch its drug under the Granixor Tbo-Filgrastim brand name in the US, while it has just obtained apan-European marketing authorisation under the name Lonquex.

According to Amgen, Teva’s lipegfilgrastim contains a modifiedgranulocyte-colony stimulating factor (G-CSF) polypeptide, “whereina polysaccharide is attached directly to an external loop of G-CSF,and polyethylene glycol (PEG) is attached to the polysaccharide”. This,the biotech firm alleges, infringes the ‘398 patent. Amgen is seekinga declaratory judgement confirming infringement, as well as aninjunction to prevent the generics firm from infringing.

Meanwhile, Rob Koremans, president and chief executive officerof the Teva Specialty Medicines unit, has described the EuropeanCommission’s decision to grant a pan-European marketing authorisationfor Lonquex as “an important milestone”.

The approval allows Teva to launch in all 28 European Union(EU) member states as well as Iceland, Liechtenstein and Norway.The European Medicines Agency’s (EMA’s) committee for humanmedicinal products (CHMP) had issued a positive opinion in earlyJune (Generics bulletin, 7 June 2013, page 1). The Commission’sapproval followed eight weeks later. G

PRODUCT NEWS


BIOLOGICAL DRUGS

Teva faces lawsuitover lipegfilgrastim

South Korea’s Hanmi Pharmaceutical is now free to marketesomeprazole strontium delayed-release capsules in the US through

its marketing partner Amneal. The US Food and Drug Administration(FDA) has approved the firm’s 24.65mg and 49.3mg capsules as anew drug application (NDA) using the hybrid 505(b)(2) route thatallows applicants to rely in part on third-party data.

Having shown that its capsules were bioequivalent to AstraZeneca’sNexium (esomeprazole magnesium) blockbuster, Hanmi recentlyreached a patent-litigation settlement with the originator in which thelitigants agreed that two Nexium patents were valid but not infringedby Hamni’s capsules (Generics bulletin, 28 June 2013, page 23). TheSouth Korean firm does not expect to face competition from genericesomeprazole magnesium salts until May next year.

Hanmi said it would be marketing its product under the nameEsomezol. IMS data indicated that Nexium had US sales of aroundUS$6 billion in 2012, the South Korean firm claimed.

Separately, Amneal has enlisted Mallinckrodt to market its rivalto Reckitt Benckiser’s Suboxone (buprenorphine/naloxone) sublingualtablets to US addiction-treatment centres. The deal will last for at leastthree years and will cover both the 2mg/0.5mg and 8mg/2mg strengths.

Amneal has also recently launched five oral solid-dosage formsin the US market, including metaxalone, nevirapine, potassiumchloride, sildenafil and warfarin sodium. G

GASTROINTESTINAL DRUGS

Way is clear for rivalto Nexium in the US


Mylan and Par have both received US Food and Drug Administration(FDA) approvals for supplementary abbreviated new drug

applications (sANDAs) that were submitted to the agency to confirmthe bioequivalence of their bupropion 300mg extended-release tabletswith Valeant’s Wellbutrin XL. The sANDAs were requested by the FDAin late 2012 after the agency found that Teva’s version of the product –manufactured by Impax – was “not therapeutically equivalent” to thebrand (Generics bulletin, 19 October 2012, page 1).

A bioequivalence study had demonstrated that Teva’s Budeprion XL300mg tablets “fail to release bupropion into the blood at the same rateand to the same extent as Wellbutrin XL 300mg”, according to the FDA.The agency had approved Teva’s drug based on bioequivalence studiescomparing the 150mg strength to Wellbutrin XL 150mg. These werethen “extrapolated to establish bioequivalence of the 300mg product”.

A study in 2008 had concluded that Teva’s Budeprion XL 300mgwas just as safe and effective as Wellbutrin XL (Generics bulletin, 2May 2008, page 11). But following the more recent study, the agencyadmitted that “this extrapolation did not provide the right conclusion”and pledged to revise its guidance on bupropion bioequivalence studies.

Noting that it had not conducted bioequivalence studies of othergeneric versions of Wellbutrin XL 300mg available in the US –manufactured by Par’s Anchen, Actavis and Mylan – the FDA said atthat time that it had asked the firms to conduct their own bioequivalencestudies and submit data no later than March 2013. The agency said itbelieved “the study results may be unique to the Impax/Teva versionof 300mg bupropion”, adding that it did not have any data indicatingthat the other generics lacked bioequivalence with the brand. G

PRODUCT NEWS


ANTIDEPRESSANTS

Mylan and Par gainFDA bupropion nod

Oncobiologics has formed a global alliance with InVentiv Healthfor clinical development of biosimilars. Through the partnership –

which could be extended to cover original molecules – InVentiv will“provide leadership and execution for clinical studies”, and will alsosupply bioanalytical support.

As Oncobiologics secures approvals for biosimilar projects thatinclude alternatives to Avastin (bevacizumab), Erbitux (cetuximab),Herceptin (trastuzumab), Humira (adalimumab) and Rituxan (rituximab),the privately-held developer will draw on InVentiv’s “significantcommercialisation capabilities in select countries”.

Earlier this year, New Jersey-based Oncobiologics announcedmarketing deals with Malaysia’s Viropro for emerging markets,excluding China, and with Zhejiang Huahai for China and more than30 developed markets (Generics bulletin, 17 May 2013, page 14). G

BIOLOGICAL DRUGS

Oncobiologics forms alliance

ACTAVIS has extended its range of generic analgesics in the UK byintroducing oxycodone 5mg, 10mg and 20mg capsules under theLynlor brand name. The company claims its list prices for 56-capsulepacks of £8.00 (US$12.55), £16.00 and £32.00 offer up to a 30% savingcompared to Napp’s OxyNorm original. The firm has also launched arival to Merck & Co’s Maxalt Melt (rizatriptan) orodispersible tablets. G

IN BRIEF

Fresenius Kabi has persuaded India’s Intellectual Property AppellateBoard (IPAB) to revoke a patent protecting a specific salt of

GlaxoSmithKline’s (GSK) breast-cancer drug Tykerb (lapatinibditosylate) until 2021. But the generics firm failed in its challenge to apatent covering the lapatinib active pharmaceutical ingredient (API).

In its verdict on the ditosylate salt patent IN221,171, the IPABwas unconvinced by GSK’s claims that the salt form’s properties ofmoisture absorption and stability amounted to improved efficacy thatcould be patented.

Section 3(d) of India’s Patent Act prohibits patents for “the merediscovery of a new form of a known substance which does not resultin the enhancement of the known efficacy of that substance, or the merediscovery of any new property or new use for a known substance”. This,the act clarifies, covers salts, esters, ethers, polymorphs, metabolitesand other derivatives of known substances “unless they differsignificantly in properties with regard to efficacy”.

No enhanced therapeutic efficacy“As regards the Section 3(d) bar, the respondent’s own statements

and the expert’s affidavit demonstrate that this invention cannot be heldto have enhanced therapeutic efficacy,” the IPAB said, adding that itsdecision was in line with the Indian Supreme Court’s ruling on Novartis’Glivec (imatinib) leukaemia drug (Generics bulletin, 5 April 2013,page 1). In any case, the IPAB panel stated, the salt was obvious inlight of prior-art references.

But the IPAB panel upheld Indian patent IN221,017 protecting“bicyclic heteroaromatic compounds” such as lapatinib until 2019.In its revocation arguments, Fresenius had not shown that lapatinibwas a derivative of a known substance as described in Section 3(d),the panel ruled. And prior-art documents submitted by the genericsfirm in support of its obviousness attack proved unpersuasive. “Toomany randomly-made right choices cannot be called a matter ofobviousness,” the panel stated. G

ONCOLOGY DRUGS

Tykerb’s salt patentis obvious, India says

Mylan has secured non-exclusive marketing rights in France tomeropenem products produced by Venus Remedies. Having

just secured a marketing authorisation for the antibiotic in France, theIndian company said its “registration process is in advanced stages”in Australia, Malaysia, South Africa, Spain and Switzerland, as wellas in Gulf Cooperation Council (GCC) countries. Venus already holdsapproval to market meropenem in much of Europe, as well as inMexico and New Zealand.

Meanwhile, Actavis has expanded its French portfolio withrizatriptan 10mg standard and orodispersible tablets. They are rivalsto Merck’s Maxalt and Maxaltlyo originals.

The generics firm’s 10mg orodispersible version of the migrainetreatment is already included in France’s répertoire list of reimbursableequivalent medicines, whilst the standard 10mg tablets are in theprocess of being listed.

At the same time, Actavis has launched riluzole 50mg tablets inFrance that are equivalent to Sanofi’s Rilutek brand for treatingamyotrophic lateral sclerosis. G

ANTIBIOTICS/MIGRAINE REMEDIES

Mylan France gets meropenem


PRODUCT NEWS


Eli Lilly is seeking at least C$500 million (US$476 million) indamages from the Canadian government. The originator claims – in

a notice of intent to seek arbitration under Chapter 11 of the NorthAmerican Free Trade Agreement (NAFTA) – that “illegal” decisionsby Canadian courts to invalidate the firm’s patents protecting Strattera(atomoxetine) and Zyprexa (olanzapine) contravened the country’scommitments under NAFTA.

Having previously sought similar arbitration and damages of “notless than C$100 million” over a decision to find the Canadian Stratterapatent 2,209,735 invalid for lack of utility (Generics bulletin, 11January 2013, page 14), Lilly has added C$400 million to its damagesclaim as compensation for a similar finding on the Zyprexa patent2,041,113. Pointing out that Canada’s Supreme Court had refused tohear appeals of either case (Generics bulletin, 7 June 2013, page 18),Lilly said it had exhausted all domestic routes of appeal.

Promise doctrine is unique to CanadaAt the heart of Lilly’s complaint is Canadian courts’ application

of a “non-statutory ‘promise doctrine’ [that] is not applied in any otherjurisdiction in the world”. This, Lilly says, measures the utility ofpatents against the ‘promise’ that courts derive from patent specifications.According to Lilly, this doctrine – applied in invalidating the Stratteraand Zyprexa patents – contravenes Canada’s treaty obligations and is“discriminatory, arbitrary, unpredictable and remarkably subjective”.

Lilly argues that the promise doctrine creates “Catch-22 situations”.“To establish non-obviousness, a patent application may need to describethe expected advantages over previous inventions or prior art. Theadvantages stated – relevant only to the requirement that the inventionbe non-obvious – are then construed as the ‘promise of the patent’,against which utility is measured.”

Furthermore, Lilly complains, “pharmaceutical patents are beinginvalidated [in Canada] for a failure to meet a disclosure requirementthat did not exist at the time the patent applications were filed”. The‘735 Strattera patent, the firm notes, fell victim of this requirement –that patents disclose a sound factual basis for predicting utility – whichhas “no basis in Canada’s patent legislation”. G

PATENT LITIGATION

Lilly pursues Canadaover promise doctrine

ABelgian court of appeals was right to suspend a commercial court’srevocation of Lundbeck’s supplementary protection certificate

(SPC) for Sipralexa (escitalopram) while the originator lodged anappeal, according to the country’s Supreme Court.

In 2012, the Court of Appeals in Brussels ruled that an appeal hada “suspensive effect” on a decision by a lower court to revoke an SPC(Generics bulletin, 9 March 2012, page 19). Pending Lundbeck’sappeal against the escitalopram ruling, the appeals court thereforeissued an injunction against Eurogenerics preventing the generics firmfrom launching a rival, despite the revocation decision.

It was reasonable for the appeals judge to have issued the injunction,the Supreme Court concluded, before a definitive final decision hadbeen reached on the validity of the SPC. The appeals court had at thetime justified its decision by stressing that patents and SPCs couldnot be reinstated once they had been revoked. G

ANTIDEPRESSANTS

Belgium backs SPC injunction

TEVA has sued Perrigo and Catalent in a Delaware district court overtheir abbreviated new drug application (ANDA) for a rival to Teva’sProAir HFA (albuterol sulfate) inhaler. Teva said the suit – whichfollows an earlier action – had been triggered by Perrigo amendingits ANDA to reflect a change in its actuator to include a dose counter.The latest action alleges infringement of four US patents.

AMGEN says it has temporarily suspended enrolment of patients in apivotal study for its biosimilar version of Herceptin (trastuzumab)due to delays in receiving product from its contract manufacturer.“Some of the clinical material has not been at the high qualitystandards that we require,” stated Amgen, which – along with itspartner Actavis – licensed the molecule from Synthon (Genericsbulletin, 3 May 2013, page 17).

SANDOZ SOUTH AFRICA claims to have introduced the country’sfirst generic esomeprazole under the Nexmezol brand name. Thetreatment for gastro-oesophageal reflux disease (GORD) will competewith AstraZeneca’s Nexium proton-pump inhibitor.

GLENMARK has obtained final US approval for acamprosatedelayed-release tablets. They are equivalent to Forest’s Campralbrand for treating alcohol dependence.

LANNETT has extended its US contract to distribute butalbital/aspirin/caffeine/codeine capsules, digoxin tablets and levothyroxine sodiumtablets supplied by Jerome Stevens Pharmaceuticals. The five-yearextension runs until March 2019.

SUN PHARMA has won a contract to supply zoledronic acid toGerman health insurance fund Techniker Krankenkasse (TK). TheIndian firm was the only firm to bid for the contract.

FDA – the US Food and Drug Administration – has released a draftguidance on bioequivalence studies for injectable risperidone. Itrecommends performing both in vitro and in vivo studies.

PAR PHARMACEUTICAL has settled its US patent litigation withHorizon over Duexis (ibuprofen/famotidine) tablets. The deal allowsPar to launch a version of the arthritis treatment from 1 January 2023.Horizon had sued Par last year over US patent 8,067,033, whichexpires on 18 July 2026 (Generics bulletin, 20 April 2012, page 12).

TEVA has been warned by Russia’s Federal Anti-Monopoly Serviceover the firm’s refusal to supply its Copaxone (glatiramer acetate)multiple-sclerosis brand to local distributor Biotek.

AMNEAL faces litigation in a New Jersey district court over itsabbreviated new drug application (ANDA) for a rival to NovoNordisk’s Vagifem (estradiol) pessaries. The suit alleges infringementof US patent 7,018,992, which expires on 17 September 2022.

ACTAVIS – through its Andrx affiliate – has failed to secure from aNew York district court a summary judgement that AstraZeneca is notentitled to damages over validation batches of omeprazole producedby Andrx. The generics firm’s argument – that it was not liable fordamages because it had not sold the batches it made – lacked merit,the court said. The batches, the court said, represented “commercialmanufacture” that could incur damages. Actavis has also been sued ina New Jersey district court over its abbreviated new drug application(ANDA) for a rival to Supernus’ Oxtellar XR (oxcarbazepine)extended-release tablets for treating epilepsy. The suit concerns USpatents 7,722,898 and 7,910,131, both of which expire in April 2027. G

IN BRIEF


PARAGRAPH IV WATCH


Teva’s president and chief executive officer, Jeremy Levin, recentlytold investors that paragraph IV patent challenges in the US were

“dying off”. With fewer targets for certifying that US brand patents areinvalid, unenforceable or not infringed by its generic formulations, theworld’s largest generics player is looking for alternative growth drivers.

However, interest in paragraph IV challenges does not seem to bediminishing at present. As observed by Thomson Reuters – whichcompiles a database of paragraph IV certifications – Pfizer’s Toviaz(fesoterodine fumarate) extended-release tablets drew no fewer thaneight abbreviated new drug application (ANDA) filers on the first daypossible (Generics bulletin, 12 July 2013, page 14). And it appearsthat UCB’s Vimpat (lacosamide) tablets attracted at least 16 applicants.

US Hatch-Waxman legislation allows companies to submit ANDAscontaining paragraph IV certifications exactly one year before theexpiration of new chemical entity (NCE) exclusivity. This is the so-called ‘NCE minus 1’ (NCE-1) date.

When coupled with the potential for 180-days of generic exclusivityfor the first applicant to file an ANDA with a paragraph IV certification,the certain date for first ANDA submission that the NCE exclusivityprovides is a tempting target for generics companies. However, in lightof the Toviaz and Vimpat examples, one might reasonably ask ifcompanies will turn away from first-day paragraph IV challenges onproducts covered by NCE exclusivity, put off by such intensecompetition that threatens to diminish the value of first-to-file statusand render misplaced the investments made in developing such drugs.

Janssen’s pain-relief products, Nucynta (tapentadol hydrochloride)tablets and Nucynta ER extended-release tablets, may offer a counter-example to show that such intense competition is not inevitable.

The NCE exclusivity for tapentadol will expire on 20 November2013, and the US Food and Drug Administration (FDA) reports thefirst ANDAs for generic versions of Nucynta and Nucynta ER werefiled exactly one year earlier on 20 November 2012. On 13 June thisyear, Janssen and patent owner Grünenthal received a paragraph IVnotification letter concerning Actavis’ ANDA for a generic version ofNucynta ER. A week later, Janssen and Grünenthal received noticeof Alkem’s ANDA for a generic rival to immediate-release Nucynta.

On 25 July, Janssen and Grünenthal filed a joint suit against Actavisand Alkem in a New Jersey district court. The suit initially allegedthat Alkem’s proposed generic infringed US patents 7,994,364 andRE39,593. It also said Actavis’ ANDA infringed those two patents aswell as US patent 8,309,060 (Generics bulletin, 9 August 2013, page17). Subsequently, the plaintiffs amended the suit to cover immediate-release tablets filed by Actavis and extended-release tablets from Alkem.The amended suit does not enforce the ‘060 patent against Alkem.

“The Actavis and Alkem ANDAs may have been the only ones filedon the NCE-1 date, but it is quite possible that more lawsuits againstadditional filers are coming,” comments Thomson Reuters. To secure a30-month stay of ANDA approval, the brand owner or patent holdermust file an infringement suit within 45 days of receiving notice of theANDA. That notice, however, may not be sent until the FDA hasevaluated the ANDA submission for completeness and accepts it forfiling. The time it takes the FDA to accept an ANDA for filing can vary,so it is possible that slower acceptance has delayed the filing of other suits.

In the case of Vimpat, the first suits were filed against Teva –

the leading paragraph IV exponent, according to Thomson Reuters,notwithstanding Levin’s comments (see Figure 2) – and Zydus on 28June 2013. But the plaintiffs filed complaints against another 14 firmstwo weeks later. “It remains to be seen,” notes Thomson Reuters, “whetherNucynta and Nucynta ER will be examples of prescient targetting byActavis and Alkem, or another case of drugs with NCE exclusivitiesattracting more generic competition than the market can likely support.”G

Nucynta filings may belie first-day trendKEY DETAILS: NUCYNTA/NUCYNTA ER

Brand: Nucynta/Nucynta ER

Active ingredient: tapentadol hydrochloride

Delivery form: 50mg, 75mg and 100mg tablets50mg, 100mg, 150mg, 200mg and250mg extended-release tablets

Brand owner: Janssen Pharmaceuticals

US brand sales: US$86 million (Nucynta ER only)

First paragraph IV filing 20 November 2012submitted to FDA:

Known paragraph IV filers: Actavis; Alkem

Patents at issue – 7,994,364 – 27 June 2025RE39,593 – 5 August 20228,309,060 – 20 November 2023

District court location: New Jersey

Litigation reference: Janssen vs Actavis et al. – 2:13-cv-04507

Figure 1: Paragraph IV challenges to Janssen’s Nucynta and Nucynta ER (tapentadol)immediate-release and extended-release tablets (Source – Thomson Reuters)

Thomson Reuters draws on strategic intelligence and competitive analysis information on the US genericsindustry to create Newport Premium™, the critical product-targeting and global business-development systemfrom the industry authority on the global generics market.

For further details contact Benjamin Burck, Thomson Reuters API Intelligence, 215 Commercial Street, Portland, Maine 04101, USA.Tel: +1 207 871 9700 x35. Fax: +1 207 871 9800. E-mail: [email protected]. Website: scientific.thomsonreuters.com/newport.

Figure 2: Numbers of compounds subject to patent challenges by company, asrecorded by Thomson Reuters to 30 June 2013 (Source – Thomson Reuters)

180

160

140

120

100

80

60

40

20

0

Num

ber

ofpa

tent

chal

leng

es

PATENT CHALLENGES

Teva

Actavis

Mylan

Sandoz

Apotex

Sun Pharma

ParLupin

Dr Reddy’s

Ranbax

y

Perrigo

172

141136 135

100

82

68 65 64

443941

Aurobindo

38

Impax

Gen 6/9/13 Pg. 24_Layout 1 03/09/2013 21:21 Page 2

PartnershipsGrow Businesses

Showcase your businessA posting on the SourceGenerics website will showcase your genericsbusiness opportunities to potential partners around the world(free-of-charge* to Generics bulletin subscribers)

Target the right peopleBacked by the industry knowledge of Mike Rice, Editorial Director ofGenerics bulletin, and Deborah Wilkes, Co-Founder of Generics bulletin,SourceGenerics can help put your message in front of the right people

Drive decision-makers to your websiteA banner advertisement on the SourceGenerics website can drivegenerics business development executives from all around the world toyour website

www.sourcegenerics.comThe Resource for Business Development

Find out how SourceGenerics can help you find the right partners to grow your business by contacting Deborah Wilkes, Director of Source Publishing Limited by telephone on +44 121 314 8757 or by email at [email protected]

* Subscribers to Generics bulletin can post up to fi ve business opportunities on the SourceGenerics website free-of-charge for a year. Shorter periods can be arranged, depending on your needs. Confi dential listings are subject to a small fee. To take advantage of this off er, contact Deborah Wilkes by phoning +44 121 314 8757 or sending an email to [email protected].

in association with

SourceGenadvert-Oct29.indd 1 29/10/2012 15:02

EVENTS


24-25 September

■ 2nd Annual BiopharmaAsia CongressSingaporeThis two-day meeting will discuss marketopportunities, regulatory topics andbiosimilars. There will be case studies thatwill look at issues such as clinical trials.

Contact: Oxford Global.Tel: +44 1865 304 925.E-mail: [email protected]: www.biopharmasia-congress.com.

1-2 October

■ Biosimilars & BiobettersLondon, UKWith speakers from firms including Eli Lillyand Novartis, this two-day event willcover topics such as biosimilar guidelinesin the US, litigation and market access.

Contact: SMi.Tel: +44 870 9090 711.E-mail: [email protected]: www.biosimilars-biobetters.co.uk.

3-4 October

■ Paragraph IV DisputesMaster SymposiumChicago, USAThis two-day event will provide informationon issues including market exclusivities,regulatory affairs, at-risk launches andinequitable-conduct challenges.

Contact: American Conference Institute.Tel: +1 212 352 3220.E-mail: [email protected]: www.americanconference.com.

15-17 October

■ 14th Annual Businessof BiosimilarsBoston, USAPreceded by a one-day workshop lookingat regulatory issues, this event will covertopics such as the European Union market,policy making and clinical development.

Contact: IIR USA.Tel: +1 888 670 8200.E-mail: [email protected]: www.biosimilarsevent.com.

16-18 October

■ 10th TOPRAAnnual SymposiumLisbon, PortugalHeld in conjunction with Infarmed, thisthree-day forum will look at regulatoryissues within the generics industry. Thepharmaceutical sessions will look at issues

including clinical trials, the centralisedprocedure and bulk drugs.

Contact: Topra.Tel: +44 207 510 2560.E-mail: [email protected]: www.topra.org.

21 & 22-24 October

■ CPhI Pre-Connect Conference& CPhI WorldwideFrankfurt, GermanyCPhI Worldwide is a three-day exhibitionand networking opportunity which willalso include the co-located events iCSE,P-MEC and Innopack. The event will bepreceded by the Pre-Connect Conferencetaking place in the same location.

Contact: UBM Information.Tel: +44 207 921 8039.E-mail: [email protected]: www.cphi.com.

28-30 October

■ GPhA 2013 FallTechnical ConferenceMaryland, USAWith presentations from US Food and DrugAdministration (FDA) representatives,this three-day meeting of the US GenericPharmaceutical Association (GPhA) willlook at key regulatory and technical issuesand their impact on the generics industry.

Contact: GPhA.Tel: +1 202 249 7127.E-mail: [email protected]: www.gphaonline.org.

6-8 November

■ 16th APIC/CEFIC EuropeanConference on APIsMadrid, SpainThis conference will discuss the latestdevelopments in regulatory compliance.There will be representatives frominternational authorities including the FDAand the European Medicines Agency (EMA).

Contact: Concept Heidelberg.Tel: +49 6221 84 440.E-mail: [email protected]: www.api-conference.org.

11-14 November

■ 8th Generics AsiaSingaporeThis four-day event will cover issuesincluding collaborations, market entry,product portfolios as well as pricing policies.

Contact: IBC Asia.Tel: +65 6508 2401.E-mail: [email protected]: www.generics-asia.com.

12-13 November

■ 2nd Annual World BiosimilarCongress EuropeGeneva, SwitzerlandThis two-day event will discuss topicssuch as production, regulation and to-market models for the internationalbiosimilars industry. There will also benetworking opportunities.

Contact: Terrapinn.Tel: +44 207 092 1000.E-mail: [email protected]: www.terrapinn.com.

19-21 November

■ World Generic MedicinesCongress Americas 2013Boston, USAFocusing on issues including policy updates,IP developments, commercial strategiesfor biosimilars and building market share,this three-day event is co-located with theBiosimilar Drug Development Conference.

Contact: Health Network Communications.Tel: +44 207 608 7055.E-mail: [email protected]: www.healthnetworkcommunications.com.

25-26 November

■ EuroPLX 53Barcelona, SpainThis meeting will provide a forum in whichfirms can discuss licensing, marketing anddistribution for patented medicines, generics,biosimilars, OTC products and nutraceuticals.

Contact: Raucon.Tel: +49 6222 9807 0.E-mail: [email protected]: www.europlx.com.

SEPTEMBER 9-11 December 2013

■ 16th IGPA Annual ConferenceBrussels, BelgiumThis three-day conference is being organised by the European Generic medicines Association(EGA) and is the global event of the worldwide generics industry. It is the annual joint meeting ofthe Canadian, European, Japanese, South African and US generics industry associations,the CGPA, EGA, JGA, NAPM and GPhA.

Contact: Cristina Romagnoli, GPA Conferences. Tel: +377 93 501 348. E-mail: [email protected]: www.igpagenerics.com or www.gpaconferences.com/igpa13.htm.

NOVEMBER

OCTOBER


PRICE WATCH ............ UK


Massive proportional increases in the average prices of atenololtablets were recorded by WaveData during August, even if the

cash amounts were relatively small. As Figure 3 shows, the averagetrade prices of all three strengths of the beta-blockers more thandoubled during the month. This meant, however, that the average tradeprice per tablet still amounted to no more than £0.03 (US$0.05).

Independent pharmacists were not out of pocket either, despitethe steep price rises. The Drug Tariff of pharmacy reimbursementprices listed all three strengths at between £0.87 and £0.94 for 28-tablet packs in August. For the 100mg strength, this would have meantan average pharmacy dispensing margin of just over 21%, based on a£0.94 reimbursement price and a £0.74 average trade price. The marginwould have risen to an 80% margin if independent pharmacists had

shopped around for the best deal, which was £0.19 per pack.Time will tell whether atenolol gets given an official monthly price

concession because of apparent stock shortages. Six ingredients in 11presentations were given price concessions by the Department of Healthin August. Only one ingredient from the list appears below. The twopresentations of isosorbide are not among the ‘biggest risers’, however,but can be found in the ‘biggest fallers’ of Figure 2. Isosorbide is the onlyingredient in recent months to be officially declared to be in shortage(Generics bulletin, 8 March 2013, page 25). Since then, however,stocks have been returning to normal, judging by the falling prices.

Among the ‘fast movers’ in Figure 1, donepezil 10mg tablets were59% more expensive on average than a month earlier, while pramipexole700µg tablets were a third more costly. G

BIGGEST RISERS

Product/Strength/Pack size Lowest Change Average Changeprice (%) price (%)

Atenolol tabs 100mg 28 £0.19 +19 £0.74 +176

Atenolol tabs 25mg 28 £0.15 +36 £0.47 +139

Atenolol tabs 50mg 28 £0.10 +11 £0.53 +138

Senna tabs 7.5mg 60 £0.60 +3 £9.44 +98

Propranolol tabs 40mg 28 £0.21 +5 £0.56 +83

Pramipexole tabs 88µg 30 £0.64 +16 £1.80 +70

BIGGEST FALLERS


Zolmitriptan oro tabs 5mg 6 £0.70 -7 £1.38 -35

Amlodipine tabs 5mg 28 £0.20 -9 £0.35 -31

Isosorbide mononitrate tabs 20mg 56 £5.97 -25 £9.31 -26

Glycerol suppositories 4g 12 £0.54 +17 £0.93 -25

Isosorbide mononitrate tabs 10mg 56 £6.84 -5 £9.42 -22

Diclofenac tabs 50mg 84 £0.25 -17 £0.48 -21

Figure 1 (below): Comparison between the periods 1-31 July 2013 and 1-26 August2013 of the lowest and average UK trade prices of fast-moving generics. Eachaverage price was calculated from at least 18 data points. Figure 2 (above) andFigure 3 (above right): Biggest changes recorded between the periods 1-31 July

2013 and 1-26 August 2013 in lowest and average UK trade prices of about 748commonly-dispensed generics. The basket specifically excludes the ‘fast movers’shown below, but includes other presentations of the same products. Each averageprice was calculated from at least 15 data points (Source – WaveData).

Detailed product price comparisons and other price analyses areavailable at www.wavedata.net.

To find out more about subscribing, please email your contact details [email protected] and quote ‘GB online enquiry’ in the title line.

■ For further information see www.wavedata.co.uk.Alternatively, contact Charles Joynson atWaveData Limited, UK. Tel: +44 (0)1702 425125.E-mail [email protected].

WANT MORE LIKE THIS?

FAST MOVERS


Alfuzosin tabs 2.5mg 60 £4.05 +5 £4.95 +4Anastrozole tabs 1mg 28 £1.19 +9 £2.74 +9Atorvastatin tabs 20mg 28 £0.52 -2 £0.75 -3Bicalutamide tabs 50mg 28 £1.29 ±0 £2.47 +1Buprenorphine tabs 2mg 7 £1.68 -1 £2.12 -9Candesartan tabs 8mg 28 £0.96 -9 £1.28 -3Clopidogrel tabs 75mg 28 £0.96 +4 £1.41 +21Cyclizine tabs 50mg 100 £10.50 +6 £11.79 -3Desloratadine tabs 5mg 30 £0.87 -2 £1.17 -10Donepezil tabs 10mg 28 £0.57 ±0 £1.46 +59Dorzolamide eye drops 2% 5ml £1.23 -8 £1.83 +1Entacapone tabs 200mg 30 £6.45 +8 £8.12 +9Esomeprazole tabs 40mg 28 £3.99 -9 £5.59 -2Exemestane tabs 25mg 30 £2.84 -11 £5.17 +2Finasteride tabs 5mg 28 £0.62 -5 £0.94 ±0Irbesartan tabs 75mg 28 £0.62 -3 £0.84 -2Latanoprost eye drops .005% 2.5ml £0.90 +5 £1.33 ±0Lercanidipine tabs 10mg 28 £0.64 +2 £1.02 +2Letrozole tabs 2.5mg 14 £0.67 ±0 £1.22 -7Levetiracetam tabs 500mg 60 £0.94 +4 £3.09 +24Losartan tabs 100mg 28 £0.49 -2 £0.87 +14Montelukast tabs 10mg 28 £1.47 -1 £1.91 -5Mycophenolate tabs 500mg 50 £6.40 +9 £9.54 +20Naratriptan tabs 2.5mg 6 £0.73 ±0 £1.46 +6Nebivolol tabs 5mg 28 £0.85 -1 £1.22 ±0

FAST MOVERS


Olanzapine tabs 5mg 28 £0.41 +2 £0.78 ±0Pioglitazone tabs 15mg 28 £0.68 ±0 £1.10 ±0Pramipexole tabs 700µg 30 £1.25 ±0 £2.99 +34Quetiapine tabs 25mg 60 £0.69 -1 £1.09 +1Rabeprazole tabs 10mg 28 £1.84 -4 £2.41 -1Riluzole tabs 50mg 56 £40.90 ±0 £52.96 ±0Risedronate tabs 35mg 4 £0.44 ±0 £0.68 -3Risperidone tabs 2mg 60 £0.75 +6 £1.74 +4Terbinafine cream 1% 15g £1.19 ±0 £1.52 -3Tolterodine tabs 2mg 56 £1.98 ±0 £2.90 -2Topiramate tabs 25mg 60 £0.88 -4 £1.71 -6Trandolapril caps 2mg 28 £0.97 +1 £1.42 +7Valsartan caps 80mg 28 £0.89 ±0 £1.38 +2Venlafaxine tabs 75mg 56 £1.57 ±0 £2.18 +4Zolmitriptan tabs 2.5mg 6 £0.45 -6 £1.02 +9

Average atenolol prices more than double


Even in the often uncompromising world of generics,it is rare for senior executives to comment directly

on the strategies of their competitors. But Mylan’sexecutive chairman, Robert Coury, had no reservationsas he sought to differentiate his company from itspublicly-listed peers: Teva, Valeant and Actavis.

Reviewing the spectrum of Mylan’s competitors,Coury observed that the past 18 months had seenindustry consolidation continue at a rapid pace. “It seemsthat a lot of our competitors are redefining themselves,”he told a recent investors’ day. “They are taking a lookat themselves and saying: ‘Maybe I need to look different,because maybe I don’t have what it takes to continuesustainable growth’.”

Examining those publicly-listed peers he consideredto be Mylan’s closest competitors, Coury said Tevahad made it “abundantly clear” that it was becominga company focused on drug development. “We all knowthe risk profile with a straight development company.”

Turning to Valeant, Coury contended that theCanada-based group had little development capacity,but was focusing rather on “buying anything it cansell”. “And the risk profile of that is you can’t keepdoing it forever,” he added.

“Actavis, as it redefines itself over and over again,keeps changing things around and keeps figuring outwhat it wants to be when it grows up,” Coury continued.“What they have in development will not sustain the kindof growth they need to have to deliver to shareholders.That has its own risk profile, notwithstanding the factthat they have not matured yet. They are still integrating,and there is still execution risk.”

While Coury remained open to bolt-on acquisitionsand deals to add scale in specific therapeutic categoriesor product technologies – such as dermatology andophthalmology – he ruled out making large-scale deals.“We will not be doing anything transformational,” hestated. Moreover, Mylan would not pursue deals drivenby economic, rather than strategic, rationale, such as toreduce its corporate tax rate. “We are not going to dotransactions for financial engineers,” he assured investors.

Coury insisted Mylan’s risk profile was unique,

due to how the company had matured following itstransformational acquisitions in 2007 of Merck Genericsand Matrix. “We have come a long way with de-riskingand taking the volatility out of our business model,” hemaintained. “And now that we have got differentiationwith our customers, with patients and with doctors, it istime to get that differentiation with our investors.”

To display its confidence, Mylan has set ambitiousfinancial goals for the period up to 2018. At the mid-point of its current forecast, group turnover should reacharound US$7.20 billion this year, with single-digitGenerics growth in North America – excluding the effectof last year’s shared exclusivity for escitalopram – anddouble-digit advances in the Europe, Middle East andAfrica (EMEA) and Asia-Pacific regions. If the companyachieves its goal of a 13% compound annual growthrate (CAGR), sales should exceed US$10 billion in2016 and reach around US$13.3 billion in 2018.

Over the same period, Mylan is targetting a 16%CAGR for its adjusted, diluted earnings per share (EPS).This would see Mylan more than double its projectedEPS this year of around US$2.85 to US$6.00 by 2018.

In the first half of this year, Mylan’s turnoveredged up by 2% to US$3.33 billion. The group said thatequated to a 12% sales rise, excluding the impact ofcurrency shifts and US$264 million of escitalopramproceeds from shared exclusivity in the first half of 2012.

Global Generics turnover stalled at US$2.86 billionas the prior-year exclusivity period for escitalopramcaused sales in North America to fall by almost a tenth toUS$1.45 billion. The North American decline was all butoffset by a 12.5% EMEA sales rise to US$745 million ondouble-digit growth in France, as well as by Asia-Pacificturnover that grew by 9.3% to US$663 million.

According to chief executive officer Heather Bresch,Mylan’s first-half results showed the benefits of havinga diversified product pipeline and portfolio, verticalintegration through its former Matrix activepharmaceutical ingredients (APIs) operation, and aglobal marketing platform that gave the groupopportunities to operate on a large scale. Mylan plans tolaunch around 600 products per year through to 2018.

“Today we produce 80% of what we sell,” Breschpointed out, noting that the Merck Generics businessthat Mylan acquired in 2007 had licensed-in around70% of its portfolio. “Being in control of our owndestiny is a critical differentiator for us,” she stated.

Bresch said Mylan intended to be first in, and lastout, in all major markets, operating at a scale that madeit an attractive partner for customers that were growinglarger through consolidation. This, she said, would allowMylan to capitalise on rising rates of generic penetration,both in southern European countries, as well as in othermajor markets, including Australia and Japan.

The pending takeover of Strides Arcolab’s Agiladivision would give the group “critical mass ininjectables”, with over 800 injectable drugs slated forlaunch by 2018, including 150 in the US. Mylan, shepledged, would use the cash generated by its current

BUSINESS STRATEGY


Injectables, respiratory

drugs, biologics and

geographic expansion

are all key elements

in Mylan’s plan to

achieve 13% annual

sales growth up to

2018. Aidan Fry reviews

the group’s strategy.

Mylan plans to play at scaleas it aims for 13% growth

Generics69%

Generics50%

Biologics13%

Respiratory18%

Biologics25%

Respiratory25%

2014 2018

Figure 1: Breakdown by product type of Mylan’s anticipated research and development investmentin 2014 and 2018 (Source – Mylan)


operations to invest in a pipeline that included respiratorydrugs and biosimilars.

To ensure its global marketing platforms are well-stocked through an extensive pipeline, Mylan has anetwork of nine research and development sites, two ofwhich – in Hyderabad, India and Morgantown, US – areglobal centres. The other seven sites focus on specifictechnologies, including three for respiratory drugs inthe UK and Ireland. Of around 2,600 scientists andregulatory experts across the nine centres, 150 areworking on respiratory projects, 90 on transdermalpatches and 470 on APIs. Once the Agila deal iscompleted (Generics bulletin, 8 March 2013, page 1),Mylan will have more than 400 researchers dedicatedto injectables development, while a further 265 areworking on biologic projects – including analogueinsulins – through the firm’s alliance with India’s Biocon.

Over the next five years, Mylan anticipatescumulative research and development spending ofaround US$2.8 billion. Next year, 18% of that budgetis earmarked for respiratory projects, and 13% forbiological drugs (see Figure 1). By 2018, each productgroup will account for a quarter of Mylan’s investment.

Once the Agila deal closes, Mylan will have morethan 1,200 products in its global pipeline, with almost2,200 submissions pending approval around the world.In the US, the company believes 38 of its 325 pendingabbreviated new drug applications (ANDAs) arepotential first-to-file opportunities.

Mylan’s president, Rajiv Mailk, noted that in 2007 –when Mylan completed the Merck Generics and Matrixtransactions – the group had been primarily an oralsolid-dose player. But as of 30 July 2013 – and includingAgila on a pro forma basis – only 571, or 47%, of 1,218development projects were oral solid-dose drugs. Anotherthird, or 410, were injectables. The firm had 54 topicaldrugs and 39 ophthalmics in development, with between20 and 30 projects each in patches, soft-gel capsules,inhalants, nasal sprays and solutions and suspensions.

And with Agila on board, approaching half – or965 – of Mylan’s 2,167 global pending submissionswould be for injectables.

Chief operating officer Hal Korman observed thatby 2016, Mylan would have a commercial presence orproducts in development in 19 of the world’s 20 leadingtherapeutic classes, as measured by IMS Health. Theonly exception would be vaccines, he noted.

Looking at Mylan’s US Generics operation, Maliksaid the firm’s marketed portfolio covered products withan annual brand value of US$54 billion (see Figure 2).On the same basis, its submitted dossiers targettedUS$83 billion of brand sales, while its developmentportfolio was targetting US$110 billion of annual value.This left US$80 billion of brand sales still to aim for.

As can be seen from Figure 3, North America playsa fairly minor part in Mylan’s global launch schedule,which it anticipates ramping up from fewer than 800this year to more than 1,300 in 2016.

Having 18 months ago pledged to double itsmanufacturing capacity to meet anticipated globaldemand as a large-scale generics supplier (Genericsbulletin, 23 March 2012, page 22), Mylan has beeninvesting heavily in its global supply chain. “Over thepast year, we have added almost 500 kilolitres to ourAPIs capacity,” Malik highlighted.

“Being one of the largest API manufacturers in the

world enables vertical integration,” he maintained. Thegroup’s 10 bulk-drug facilities currently produced3,500 kilolitres of API across 230 molecules, he said,adding that the firm held 173 US drug master files(DMFs) in the US and 186 comparable approvals inEurope. “Approximately 50% of our global pipeline,and 25% of our commercial portfolio, is verticallyintegrated,” he revealed.

By controlling its cost of goods, Malik continued,Mylan could ensure its portfolio was durable. “More than50% of our generics gross profit in the US comesfrom products that have been on the market for four ormore years,” he pointed out.

In the oral solid-dose sector, Mylan plans to raise itscurrent output of 54 billion units to 82 billion by 2016 asthe group capitalises on growing generic utilisation.

“We have more than doubled our patch capacityfrom 105 to 260 million packs,” Malik said, noting thatMylan’s pipeline included products such as a rival toEndo’s Lidoderm (lidocaine) analgesic. Mylan had alsodoubled its semi-solids and aerosols capacity over thepast year or so (see Figure 4), while Agila would vastlyincrease the relatively small injectables capacity that ithad gained by acquiring Bioniche’s plant in Galway,Ireland (Generics bulletin, 17 September 2010, page 9).

Once Agila adds sites in Brazil, India, Poland andSingapore, 13 of Mylan’s 28 finished-dosage formfacilities will be for injectables. An expected annual outputof 650 million units in 2016 would create an “injectablesmanufacturing powerhouse”, Malik claimed.

Agila will double the size of Mylan’s injectablesoperation to around US$600 million next year. As Figure5 shows, it will have more than1,250 injectables approvedaround the world, and almostanother 1,000 dossiers pendingapproval. The group will havemore than 400 injectabledrugs in development.

Korman pointed out thatAgila would strengthenMylan’s presence in bothdeveloped and developingcountries. In North America,it would double the formerBioniche portfolio in the USand add to the group’scurrent fifth-placed rankingin Canada. The US$1.85billion deal would diversify

BUSINESS STRATEGY

“Approximately 50%

of our global pipeline,

and 25% of our

commercial portfolio,

is vertically integrated”


NorthAmerica

Agila Antiretrovirals/Exports/India

Europe, MiddleEast, Africa

Asia-Pacific

770841

1,162

1,344

95 101 82 79

350300

500775

110240

150

300300

300

300

2530

40

40

2013 2014 2015 2016

Figure 3: Breakdown by region and product type of Mylan’s global launch schedule, by numbers ofproducts, between 2013 and 2016 (Source – Mylan)

Current portfolioUS$54 billion

Pipelinesubmitted

US$83 billion

Pipeline indevelopment

US$110 billion

OtherUS$80 billion

Figure 2: Breakdown by brand value of Mylan’s US genericsportfolio and pipeline (Source – Mylan)


Mylan’s customer base and add scale in Australia, hesaid, and would give the group “the ability to go pan-European” in the injectables arena.

“Agila’s presence in Brazil provides a launching padfor Mylan’s entry into a key growth market,” Kormancontinued. Building on the firm’s penems and penicillinsfacilities in Campos, Brazil – as well as its limited localpresence in APIs and antiretrovirals – Mylan wouldexplore opportunities to roll out other dosage forms andtherapeutic classes in Brazil and neighbouring countries.

In India, Agila’s injectables would allow Mylan toexpand its commercial presence beyond antiretroviralsand women’s health products (Generics bulletin, 12July 2013, page 11). Korman said the acquiredinjectables business would also provide a platform fromwhich to expand in other emerging markets, such as inAfrica, the Middle East and in south-east Asia. In severalcountries, he added, Mylan already had a significantoperation through its portfolio of 14 antiretroviralmolecules offered in 43 formulations.

While Agila will not give Mylan a way into China’sfinished-dose market, the US-based group is currentlyexploring strategic collaborations that would move itbeyond its existing small presence in the APIs sector.A strategic alliance with Pfizer is already provingvaluable in Japan. Having launched its first product,tacrolimus, under a joint Pfizer/Mylan label in June thisyear, Mylan said the combined salesforce of around800 representatives had “more than doubled our marketshare in Japan”. “I think [the Pfizer alliance] is a model toroll out in some other emerging markets,” Coury stated.

Across all emerging markets, Mylan regardslaunching its pipeline of respiratory and biologic drugs –including insulin analogues – as a “future opportunity”.

The group is currently building capacity for dry-powder inhalers at a purpose-built facility in Dublin,Ireland, as it works towards filing for a generic versionof GlaxoSmithKline’s Advair/Seretide (fluticasone/salmeterol) brand in both the US and Europe. In the US,a pivotal clinical study is scheduled to start during thesecond half of this year, ahead of a planned ANDAfiling for a fully-substitutable generic in the first halfof 2015. A US launch of an inhaler offering “the samesize, shape and patient experience” as the Advair deviceis expected in the second half of 2016.

In the European Union (EU), Mylan expects tolaunch a fluticasone/salmeterol dry-powder inhaler inthe second half of 2015, as “definitive pharmacokinetictrials” get underway this year. A planned dry-powderfiling in the second half of 2014 will come about a year

later than the firm’s expected submission for a pressuredmetered-dose inhaler (pMDI) version of Seretide, thanksto the deal Mylan recently struck with 3M (Genericsbulletin, 9 August 2013, page 23).

An alliance with India’s Biocon is spearheadingMylan’s drive into the biosimilars arena. Globaldevelopment programmes are underway for biosimilarversions of five immunology and oncology products. Thealliance recently started enrolling patients for a Phase IIItrial for a rival to Herceptin (trastuzumab) in Europe(Generics bulletin, 7 June 2013, page 22), whilealternatives to Neulasta (pegfilgrastim) and Humira(adalimumab) should enter clinical trials during thenext 12 months. Rivals to Avastin (bevacizumab) andEnbrel (etanercept) are at the pre-clinical stage.

Meanwhile, Mylan has set up its own biosimilarsdevelopment laboratory that is working on cell-linedevelopment for three undisclosed monoclonal antibodies.

Earlier this year, Mylan extended its collaborationwith Biocon to cover three insulin analogues that theIndian firm had previously licensed to Pfizer (Genericsbulletin, 8 March 2013, page 19). The most advancedof the three diabetes candidates is a rival to Sanofi’sLantus (glargine) that is set to enter Phase III trials infirst half of 2014, ahead of a planned filing in regulatedmarkets in the first half of 2016. Alternatives to Lilly’sHumalog (lispro) and Novo Nordisk’s NovoLog (aspart)are at the process-scale-up phase.

The US group is confident of launching a genericversion of Teva’s Copaxone (glatiramer acetate) multiple-sclerosis blockbuster in May next year, following itsrecent US Court of Appeals victory on patents expiringin 2015 (Generics bulletin, 9 August 2013, page 1).

Mylan’s 13% turnover CAGR through to 2018assumes that it will record no biosimilars sales in theUS before that date. Biosimilars in other markets andthe firm’s generic respiratory portfolio are each expectedto contribute no more than 5% of group sales in 2018,while the group’s Specialty respiratory brand EpiPenshould add a similar amount. The company expects asubstitutable generic to enter the US market in 2015.But the group believes its injectables business will beapproaching an annual turnover of US$2 billion by 2018.More than 3,000 cumulative launches will contributea similar sum to turnover, which will also be swelledby geographic and portfolio expansion. G

BUSINESS STRATEGY


A US launch of an

inhaler offering “the

same size, shape and

patient experience” as

the Advair device is

planned for the second

half of 2016

North America European Union Rest of World

Approved(Mylan)

Approved(Agila)

Pendingapproval

In development

515

1,1011,023

19570

145

158473 334

105

372 453

57

18691

Figure 5: Mylan’s current injectables portfolio and pipeline by numbers of products (Source – Mylan)

2012 2013 2016(Units mns) (Units mns) (Units mns)

API (reactor 3,000 3,500 5,700capacities inkiloliters)

Oral solid dose 45,000 54,000 82,000

Transdermal 105 260 290patches

Semi-solids and 15 32 42aerosols

Injectables* 11 350 650

Dry-powder – 0.5 25inhalation* post Agila close

Figure 4: Mylan’s current and forecasted manufacturing capacity(Source – Mylan)


Stada’s chief production and development officer, Alex Müller, hasresigned from the firm’s executive board with immediate effect.

“This step is being taken for personal reasons,” the company stated,adding that Müller “wants to devote himself to other tasks in future”.

Noting that the firm’s board had decided not to replace Müller“for the time being”, Stada said group chairman Hartmut Retzlaffwould “take on additional responsibility for the areas of production,research and development, as well as purchasing and procurement”.Chief financial officer Helmut Kraft “will in future assume additionalresponsibility for biotechnology”, while chief corporate developmentand central services officer Matthias Wiedenfels will take over qualityassurance and quality control. G

PEOPLE


RESIGNATIONS

Müller resigns fromStada board position

Elite Pharmaceuticals has named Nasrat Hakim, Actavis’ formervice-president of quality assurance, as its president, chief executive

officer and director. He replaces Jerry Treppel, who will remainchairman of the New Jersey-based controlled-release specialist. Formerpresident and chief executive officer Chris Dick had stepped downearlier this year (Generics bulletin, 7 June 2013, page 39).

Meanwhile, Doug Plassche has been appointed as Elite’s vice-president of operations, overseeing the firm’s manufacturing activities.Plassche also previously worked at Actavis, serving as managingdirector of the firm’s solid oral-dose operations in New Jersey.

At the same time, Elite said it had bought 12 approved abbreviatednew drug applications (ANDAs) and one pending ANDA from MikahPharma, the firm founded by Hakim in 2009. G

APPOINTMENTS

Actavis’ Hakim leads at Elite

Kent Pharmaceuticals has appointed Thomas Broeer to becomemanaging director of the UK-based generics manufacturer.

Broeer most recently served as managing director of Mylan Dura inGermany, before which he held the same position at Mylan in the UKwhilst also acting as European area director for the generics firm.

Heike Streu – former managing director of Ranbaxy’s operationsin Austria, Germany and Switzerland – has replaced Broeer at Mylan. G

APPOINTMENTS

Kent appoints Broeer as head

Teva’s former group vice-president of human resources, IkaAbravanel, has been promoted to become the firm’s corporate vice-

president in Israel and of global community alliances. Abravanel –who has been with Teva since 2007 – had also held the position ofchief integration officer since 2009.

Meanwhile, Mark Sabag, who was Abravanel’s deputy, hasbecome Teva’s vice-president of human resources. G

APPOINTMENTS

Teva promotes from within

AUTEN ANDA LITIGATION GROUP is the name of the consultinggroup founded by Steve Auten, a Chicago-based lawyer specialisingin US Hatch-Waxman litigation and biosimilars.

DR REDDY’S has named Sripada Chandrasekhar as its newpresident and head of human resources. Chandrasekhar was previouslyhead of human resources for IBM in India and south Asia.

ACTAVIS has appointed James D’Arecca as the firm’s chiefaccounting officer. D’Arecca – who previously occupied a similarpost at Bausch & Lomb – will report to Todd Joyce, Actavis’ globalchief financial officer.

DEXCEL PHARMA’s senior director of business development andlicensing, Oren Weininger, has left the company after eight yearswith the Israeli firm.

PERRIGO’s product-development team has welcomed SameerKulkarni as a senior scientist at its New Hope, Minnesota location.The firm said Kulkarni had experience in validation and analyticalmethods for ophthalmic and solid oral-dose drugs. Thomas Diezialso joins the US-based player as senior scientist in the same team,while Perrigo has promoted Michael Burgos to become a businessanalyst for its lifecycle-management team in Allegan, Michigan.

AESICA has appointed Bhavesh Kotecha to the newly-created positionof corporate services director for the UK-based active pharmaceuticalingredients (APIs) and formulations supplier. Reporting to Aesica’schief executive officer, Robert Hardy, Kotecha will oversee safety,audit and certain merger and acquisition business-integration processes.The firm has also established a new quality assurance team aimedat bolstering its ‘qualified person’ service throughout Europe.

OSMOTICA PHARMACEUTICAL has appointed Steve Banet tobecome head of commercial development and vice-president of thedrug-development company. Banet – who previously held a similarrole at UCB – will be responsible for developing sales and marketing,building commercial infrastructure and leading business development.

CHILTERN has named Andrew Monaghan as director of globalpharmacovigilance. Monaghan brings over 30 years’ of experiencein clinical development to the contract research organisation (CRO).

APTUIT has named Maurizio Denaro as general manager fordiscovery and development.

DIAPHARM has named Julia Kruse – formerly of BoehringerIngelheim – as a new member of its market access business division.

EFPIA – the European Federation of Pharmaceutical Industries andAssociations – has appointed Sanofi’s chief executive officerChristopher Viehbacher as president for a two-year term. TheGerman-Canadian is the former chairman of Pharmaceutical Researchand Manufacturers of America (PhRMA).

PROSONIX has named Frank Condella as its new non-executivedirector. Upon his appointment, Condella, who has over thirty yearspharmaceutical experience, praised the firm’s “unique platform fordeveloping generic and novel respiratory medicines”.

ALCHEMIA is looking for a permanent chairman following theretirement of Mel Bridges. Nathan Drona will step into the positionat the Australian drug-development firm on an interim basis. G

IN BRIEF


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