companynews par pharm plans to pay us$410mn for anchen...companynews 2 par pharmaceutical has agreed...

2 September 2011

Sun is seeking deals in Brazil and Mexico 2Claris’ UK approval “resolves bag issue” 3Authorised US drugs drive 4Sanofi’s growthAurobindo ponders 5restructuring optionsImpax expects quick resolution with FDA 5Biocon plans to grow biogenerics portfolio 6Wockhardt sells its nutrition business 7Pharmstandard eyes full 7control of BiolekRanbaxy will build on African platform 8Stada’s Swiss deal with Spirig delayed 9Orchid solves issues at 10antibiotics plantBluefish to acquire BioPhausia’s BMM 11Perrigo will explore OTC Lipitor options 11Shortages and China aid 12Fresenius’ salesLower fentanyl sales hold back Cephalon 13

MARKET NEWS 14

FDA agrees budget for user-fee scheme 14Agencies complete joint 14inspection pilotsGerman AOK insurer issues more tenders15Canada intends to revise linkage guide 16England’s NHS saved £9.5bn during 2010 16

PRODUCT NEWS 17

Enoxaparin will act as a model for FDA 17Farmalider finds deals for 17oncology drugsItaly defers decision over Xalatan abuse 18Consilient can claim two firsts in the UK 19Teva Canada wins 20atomoxetine appealGerman body slams deal on biosimilars 21US firms lose out in ruling on Treximet 21

REGULARS

Pipeline Watch – Reteplase 23

Events – Our regular listing 24

Price Watch UK – Our regular 25look at pricing trends in the UK

People – Alvogen appoints in 27Poland and Croatia

COMPANY NEWS 2

PPar Pharmaceutical has agreed to pay US$410 million in cash for privately-held USgenerics developer Anchen Pharmaceuticals. “Anchen has an excellent development

track record and robust product pipeline which, when combined with Par’s existingcapabilities and pipeline, more than doubles our product opportunities,” commented Par’schairman, president and chief executive officer, Patrick LePore.

At present, Anchen – which was founded in 2002 by former Andrx executive Chih-MingChen – markets five products in the US, including extended-release forms of bupropion,ciprofloxacin and divalproex, as well as the zolpidem 12.5mg extended-release tablets for whichit enjoyed 180-day exclusivity during the first half of this year (Generics bulletin, 14 January2011, page 22). These products are expected to generate combined sales of around US$125million this year. Par said the acquisition price represented a multiple of around 11-timesAnchen’s anticipated earnings before interest, tax, depreciation and amortisation (EBITDA)in 2011. The firms expect to close the transaction by the end of this year.

Based in Irvine, California, Anchen has 27 abbreviated new drug applications (ANDAs)pending approval by the US Food and Drug Administration (FDA), five of which Par believesto be first-to-file opportunities. These are the sole exclusivity positions on Kapvay (clonidine)extended-release tablets, Hectorol (doxercalciferol) 0.1mg capsules and Jalyn (dutasteride/tamsulosin) capsules, as well as shared exclusivity for generic Cymbalta (duloxetine) delayed-release capsules and Enablex (darifenacin) extended-release tablets (Generics bulletin, 15 May2009, page 17). Anchen has also confirmed US patent challenges to Amrix, Avodart, Intunivand Luvox CR, as well as Ryzolt, Seroquel XR, Trilipix and Zemplar (Generics bulletin,12 November 2010, page 16). Furthermore, Anchen has 26 products under development.

Observing that Anchen had filed 12 ANDAs during the past 12 months, Par’s generics headPaul Campanelli said the combined company – including Indian developer Edict, for whichPar is paying up to US$37.6 million (Generics bulletin, 10 June 2011, page 7) – would havea pipeline of nearly 70 ANDAs. Anchen has 218 staff, including 70 in research and development,and possesses 6,700 sq m of expandable manufacturing and warehousing facilities. G

Par Pharm plans to payUS$410mn for Anchen

Spain’s government has passed legislation that it expects to generate annual savings ofC2.4 billion (US$3.46 billion). It will require doctors to prescribe by international non-

proprietary name (INN) and make pharmacists dispense the cheapest available product. The figurerepresents around a fifth of the country’s annual pharmaceutical spending. Additionally, brandswithout generic competition that have been on the market for more than ten years will have theirprices cut by 15%. The measures are part of a wider package aimed at saving C5 billion.

However, Spain’s generics industry association, Aeseg, said it rejected measures that would“exhaust and put at risk a sector committed to saving, productivity, development, employment,investment and economic stability”. The association also recently opposed proposals to enforcemandatory prescribing by active ingredient in Spain’s semi-autonomous healthcare regions(Generics bulletin, 5 August 2011, page 14). Earlier this year, a joint manifesto issued byAeseg and brand industry association Farmaindustria claimed Spain’s pharmaceutical supplychain was already making “an extraordinary contribution to the economic sustainability of thepublic health system” (Generics bulletin, 11 February 2011, page 12). It highlighted royaldecrees passed in March 2010 (Generics bulletin, 9 April 2010, page 1) and May 2010 thatcut C2.86 billion – or 14% – from the country’s annual drugs bill. G

Spanish measures to save C2.4bn

Gen 2_9_11 Pg.1.qxd 1/9/11 07:00

Sun Pharmaceutical Industries is keen to follow up acquiring Taroand taking full control of its Caraco affiliate by striking further

deals in the US. And the Indian company also wants to strengthen itspresence in emerging markets such as Brazil and Mexico, which arecovered by Sun’s strategic joint venture with Merck & Co.

“We remain interested in inorganic opportunities in several markets,especially in the US and some of the large emerging markets,” statedSun’s chairman and managing director, Dilip Shanghvi. “Liquidityavailable within the company has been earmarked for investment insuch long-term, value-creating opportunities,” he added.

Shanghvi identified Brazil, China, Mexico and Russia as keyemerging markets in which Sun was hunting for “sizeable” targets.“Depending on where we get a company which is in line with whatwe are looking for, we will then decide whether we would have themanagement capability to manage additional acquisitions during theyear,” he said, adding that it would be around three years before Sunsaw approvals in emerging markets, excluding India, through its alliancewith Merck (Generics bulletin, 22 April 2011, page 3).

The consolidation from September last year of Taro – whichgenerates around quarter of its turnover outside the US – more thanquadrupled Sun’s formulations sales in markets other than India andthe US to Rs2.52 billion (US$56 million) in the firm’s financial firstquarter ended 30 June 2011 (see Figure 1). Taro’s total turnover in thethree-month period increased by 14.2% to US$112 million.

Including Taro’s authorisations for cetirizine solution, imiquimodcream, meprobamate tablets and ranitidine syrup, Sun secured sevenUS approvals during the quarter. This took the group’s total to 232,leaving 151 abbreviated new drug applications (ANDAs) awaitingfinal approval. During the quarter, the Sun group filed six ANDAs.

Launching docetaxel in May – as well as injectable sumatriptan6mg/0.5ml following approval in June – helped to offset the impactof having withdrawn oxaliplatin following US patent litigation.Nevertheless, even with the addition of Taro, Sun’s US formulationssales edged forward by just 1.7% to Rs6.22 billion. Shanghvi saidSun was making progress on remediating manufacturing deficienciesat its facilities in Detroit and New Jersey.

The Indian firm said a reported 11.9% rise to Rs6.38 billion in itsdomestic formulations sales equated to an 18% branded generics increaseonce discontinued contract-manufacturing operations were excluded.Bulk-drugs turnover grew by 4.1% to Rs1.48 billion, as group net salesimproved by a fifth to Rs16.4 billion. But higher expenses reducedearnings before interest and tax (EBIT) by 3.3% to Rs5.48 billion. G

COMPANY NEWS

2 GENERICS bulletin 2 September 2011

MERGERS & ACQUISITIONS/FIRST-QUARTER RESULTS

Sun is seeking dealsin Brazil and Mexico

Region/ First-quarter sales Change Proportion ofbusiness (Rs millions) (%) total (%)

India 6,385 +11.9 38US 6,220 +1.7 37Rest of world 2,521 +306.6 15Formulations 15,126 +21.6 91

Bulk drugs 1,476 +4.1 9

Others 2 -66.6 –

Sun Pharma 16,604 +19.8 100

Figure 1: Breakdown by region and business of Sun Pharmaceutical Industries’gross sales in its financial first quarter ended 30 June 2011 (Source – Sun Pharma)

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

Claris Lifesciences says it has resolved problems with its intravenousbags in the European Union (EU) after the UK’s Medicines and

Healthcare products Regulatory Agency (MHRA) cleared the Indianfirm’s Ahmedabad facility following an inspection. Having paved theway to relaunching bags in the EU, Claris said it was working towardsinviting the US Food and Drug Administration (FDA) to re-audit theplant by the end of this year.

The Indian firm had in June last year withdrawn intravenousciprofloxacin, metronidazole and ondansetron after the FDA warnedhealthcare professionals not to use the products due to contamination(Generics bulletin, 18 June 2010, page 17). Resulting recalls in theEU have, in some instances, led to the firm’s marketing partnerssuing Claris (Generics bulletin, 15 July 2011, page 4).

Arjun Handa, Claris’ managing director and chief executive officer,told investors the firm had made good progress on “three majormilestones” towards resolving the FDA issue: revising standardoperating procedures and manufacturing controls by working with aUS-based consultant; installing two new machines, one to inspect bagsand the other to employ new printing technology; and generating testdata through validation batches.

While it waits for the FDA re-inspection – potentially openingthe door for US approval of propofol – Claris is focusing on expandingin India and emerging markets, while using proceeds from its initialpublic offering (IPO) at the end of last year to expand its productioncapacity (Generics bulletin, 14 January 2011, page 5). The Indian firmrecently launched propofol in the UK and is gradually rolling out theanaesthetic in other European markets.

Handa said he had no plans for Claris to enter into a majortransaction. “I do not believe in big acquisitions, I do not think theywork,” he stated.

In the second quarter of this year, Claris achieved a turnover ofRs1.92 billion (US$42.0 million), of which Rs860 million was generatedin India and Rs1.06 billion in international markets. The firm’s pre-taxprofit was Rs444 million. G

COMPANY NEWS

3GENERICS bulletin2 September 2011

MANUFACTURING/SECOND-QUARTER RESULTS

Claris’ UK approval“resolves bag issue”

Par Pharmaceutical may have to audit or re-perform bioequivalencestudies for three of the generic drugs it currently markets. The

original studies were conducted by Cetero Research, the contractresearch organisation (CRO) that was recently pulled up by the USFood and Drug Administration (FDA) over “widespread falsificationof dates and times in laboratory records” at its facility in Houston,Texas (Generics bulletin, 5 August 2011, page 20). Paul Campanelli,president of Par’s generics division, told investors that the companyexpected to meet with the FDA in the near future to discuss retestingrequirements. None of Par’s pipeline products were affected, he added.

Having recently submitted a paragraph IV challenge to Avanir’sNuedexta (dextromethorphan/quinidine) capsules (see page 19), Parbelieves 13 of the 31 abbreviated new drug applications (ANDAs) itcurrently has pending FDA approval are first-to-file opportunities. TheUS firm recently agreed with Norway’s ProNova to dismiss pollutant

patents from US patent litigation over Lovaza (omega-3 ethyl esters).In the second quarter of this year, capturing around half the US

market with its authorised generic of AstraZeneca’s Entecort EC(budesonide) enteric-coated capsules failed to stop Par’s generics salesfalling by 12.7% to US$202 million.

As Figure 1 shows, second-quarter budesonide sales totalledUS$16.4 million. This compensated in part for a US$26.3 milliondecline in sales of clonidine patches following manufacturing problemsat Par’s supply partner, Aveva. Rivals to Rythmol SR (propafenone)and Novartis’ Lotrel (amlodipine/benazepril) launched at the start ofthis year (Generics bulletin, 14 January 2011, page 17) contributedsales of US$13.3 million and US$12.5 million respectively.

Par’s generics decline was largely attributable to turnover fromits authorised generic of AstraZeneca’s Toprol XL (metoprolol) almosthalving to US$63.7 million amid additional competition.

With turnover by its Strativa brands division down by 7.6% toUS$21.7 million as it shelved promotion of Oravig (miconazole) buccaltablets and returned marketing rights to Zuplenz (ondansetron) oral-soluble films to MonoSol Rx, Par’s group turnover in the second quarterfell by 12.2% to US$224 million. The weaker sales of low-marginmetoprolol helped to lift Par’s gross margin by 8.4 percentage pointsto 44.2%. But a US$27.0 million charge for restructuring Strativacaused Par’s operating profit to drop by 26.3% to US$17.8 million. G

SECOND-QUARTER RESULTS

Par feels the force offallout from Cetero

Figure 1: Breakdown by product of Par Pharmaceutical’s sales of US$224 millionin the second quarter of 2011 (Source – Par)

Metoprolol ERUS$63.7m, -46.7%

BudesonideUS$16.4m, –

SumatriptanUS$15.3m, -12.5%

PropafenoneUS$13.3m, –

Other genericsUS$81.3m, -14.3%

Amlodipine/benazeprilUS$12.5m, –

Strativa brandsUS$21.7m, -7.6%

Ajanta Pharma has received approval from the UK’s Medicines andHealthcare products Regulatory Agency (MHRA) for its formulations

facility in Paithan near Aurangabad, India. The Indian firm’s managingdirector, Yogesh Agrawal, described the clearance as a “significantmilestone, paving the way for entry into the European Union market”.

The Paithan facility has already been cleared by the US Food andDrug Administration (FDA), and Ajanta has secured its first abbreviatednew drug application (ANDA) approval in the form of a rival to UCB’sKeppra (levetiracetam) 250mg, 500mg, 750mg and 1g tablets. AnotherANDA is awaiting approval, while several more US dossiers arealmost ready for filing.

Mumbai-based Ajanta has a US subsidiary located in Raritan, NewJersey, as well as operations in Mauritius, the Philippines and Vietnam.It exports products to more than 25 countries. In its financial firstquarter ended 30 June 2011, the Indian company increased its turnoverby 30% to Rs1.27 billion (US$27.8 million) and improved its pre-tax profit by 58% to Rs136 million. G

BUSINESS STRATEGY/FIRST-QUARTER RESULTS

Ajanta cleared in UK and US

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Akorn has agreed to acquire a 16% share in US ophthalmic drugdeveloper Aciex Therapeutics for US$8.00 million in cash. The two

firms have signed a global licensing deal for “a novel OTC eyecareproduct” and Akorn will make one of Aciex’ prescription products.

Raj Rai, Akorn’s chief executive officer, said the deal would roundout the firm’s ophthalmics offering to cover branded prescription,generic and OTC products; provide access to a range of licensing andcontract-manufacturing opportunities; and allow Akorn to participatein the financial success of the Massachusetts-based company, which isbacked by private-equity investors.

Akorn’s previous US$26.0 million cash takeover of OTC dry-eyespecialist Advanced Vision Research (AVR) from 3 May this yearadded US$3.74 million to the US firm’s second-quarter Ophthalmicssales, which more than doubled to US$18.2 million (see Figure 1).

Launches including erythromycin ointment also helped, while priceincreases for certain products contributed to the business segment’s grossmargin improving by 1.7 percentage points to 59.8%.

Strong hydromorphone sales helped to lift turnover from HospitalDrugs and Injectables by 64% to US$11.7 million, as the segment’sgross margin rose by 7.6 points to 51.9%.

Akorn’s group gross margin strengthened by 6.7 percentage pointsto 55.6% on turnover that was ahead by 59% to US$32.1 million.The US firm’s operating margin improved by nearly 14 points to20.8%, while its net profit of US$17.9 million included proceedsfrom selling its share in the Akorn-Strides joint venture to Pfizer(Generics bulletin, 14 January 2011, page 1). G

COMPANY NEWS


2 September 2011 Issue 157

Editor: Aidan FryAssistant Editor: David WallaceAssistant Editor: Matt StewartAssociate Editor: Deborah WilkesProduction Controller: Debi MinalSubscriptions andMarketing Manager: Val DavisEditorial Director: Mike RiceEditorial enquiries: GENERICS bulletin,54 Creynolds Lane, Solihull,West MidlandsB90 4ER, UK.

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While due care has been taken to ensure the accuracy ofinformation contained in this publication, the publishermakes no claim that it is free of error and disclaims anyliability whatsoever for any decisions or actions taken as aresult of its contents.

MERGERS & ACQUISITIONS/SECOND-QUARTER RESULTS

Akorn pays US$8mnfor a share in Aciex

Business Second-quarter sales Change Gross marginsegment (US$ millions) (%) (%)

Ophthalmics 18.2 +111 59.8Hospital/Injectables 11.7 +64 51.9Contract Services 2.2 -51 41.1

Akorn 32.1 +59 55.6

Figure 1: Breakdown by business segment of Akorn’s sales and gross margin inthe second quarter of 2011 (Source – Akorn)

Selling generic versions of its own brands in the US helped Sanofi toboost its total generics sales by 17.6% at constant exchange rates

(CER) to C434 million (US$619 million) – and by 13.9% as reported –in the second quarter of this year. An authorised generic of Taxotere(docetaxel) contributed C24 million, whilst sales of a generic versionof Ambien CR (zolpidem) reached C15 million. Along with losartan,these products led US generics sales to almost double to C34 million.

Sanofi’s president for global operations, Hanspeter Spek, said thefirm’s “opportunistic approach to generics” meant that it concentratedlargely on emerging markets, where sales grew by 13.8% at CER toC279 million, or nearly two-thirds of total generics turnover. This risewas driven by launches of products through Brazil’s Medley, improvingturnover in Latin America by 21.7%. In Western Europe, genericssales rose by 13.4% to C111 million, whilst in the rest of the worldthey increased by a tenth to C10 million, both in CER terms.

Although Sanofi’s CER global sales rose by 6.9% to C8.35 billion,turnover excluding the firm’s deal for Genzyme fell by 4.0%. Thisreflected C778 million of sales lost due to generics, the company said,largely from rivals to Taxotere and Sandoz’ alternative to Lovenox(enoxaparin) in the US (Generics bulletin, 5 August 2011, page 1). G


Authorised US drugsdrive Sanofi’s growth

Zydus Cadila claims it will “gain a global footprint in the animalhealthcare business” by acquiring Germany’s Bremer Pharma from

ICICI Venture for an undisclosed fee. The share-purchase agreementincludes the transfer of all Bremer’s key assets, brands, employees andexport contracts. The German firm’s manufacturing facility in Warburg-Scherfede, Germany, can make powders, tablets, liquids and parenteraldelivery forms. Bremer has distributors in more than 50 countries.

Meanwhile, Zydus has completed its US$60 million acquisitionof KV Pharmaceutical’s Nesher generics operation in the US (Genericsbulletin, 30 June 2011, page 3). The deal includes manufacturing,packaging and laboratory facilities, as well as certain equipmentand intellectual-property rights. G

MERGERS & ACQUISITIONS

Zydus buys veterinary firm

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Impax Laboratories is optimistic of resolving by early next year currentgood manufacturing practice (cGMP) deficiencies at its facility in

Hayward, California that were detailed in a warning letter from theUS Food and Drug Administration (FDA). “We hope to close out thewarning letter within the next six to eight months,” the US firm’spresident and chief executive officer, Larry Hsu, told investors.

Acknowledging that the timing of cGMP clearance would dependon the FDA re-inspecting the solid-dose plant, Hsu said Impax hadfiled its response to the FDA warning letter on 27 June. The firm hadrevised its technology-transfer and process-validation procedures, hesaid, and had replaced and upgraded equipment to minimise thelikelihood of metal contamination recurring (Generics bulletin, 30 June2011, page 5). Impax expects to incur charges of approximatelyUS$10.0 million this year for improving manufacturing and quality-control systems at the Hayward site.

Hsu said resolving the cGMP deficiencies by early in the firstquarter of 2012 would allow Impax to obtain the tentative FDA approvalfor its rival to Abbott’s Trilipix (choline fenofibrate) by the deadline

of 1 March 2012, after which the generics firm could forfeit its 180-dayfirst-to-file exclusivity. A 30-month stay on final FDA approval endsin July next year, while no trial date has been scheduled as yet inongoing patent litigation.

In the second quarter of this year, sales by Impax’ Global Genericsdivision fell by 19% to US$121 million, largely as a result of tamsulosinsales tumbling by US$23.7 million, or 87%, to US$3.7 million. TheUS firm had launched its rival to Boehringer Ingelheim’s Flomax urologybrand in March 2010, eight weeks before other generic competitors(Generics bulletin, 26 March 2010, page 19).

Ongoing supply shortages of the authorised generic to Shire’sAdderall XR (amphetamine salts) controlled drug also dented second-quarter Generics sales (see Figure 1). A trial over Impax’ supply-contract dispute with Shire over the attention deficit hyperactivitydisorder (ADHD) treatment is scheduled for 9 January 2012.

Additional competition on tamsulosin cut the Generics division’sgross margin by 8.6 percentage points to 47.5%. Generics research anddevelopment spending nearly a third higher at US$13.5 million – andpatent-litigation costs up by a quarter to US$2.21 million – more thanoffset a 20% reduction in other operating costs as the division’soperating margin declined by 13.4 points to 32.1%.

Impax’ group operating margin – including its loss-making Brandsdivision – slid down by almost 18 percentage points to 14.3% onturnover that fell by 18% to US$126 million. G

COMPANY NEWS



Impax expects quickresolution with FDA

Second-quarter sales Change Operating(US$ millions) (%) margin (%)

Amphetamine salts 58.2 -8 –Tamsulosin 3.7 -87 –Other generics 58.7 ±0 –Generics 120.6 -19 32.1

Brands 5.3 +47 –*

Impax Laboratories 125.9 -18 14.3**

* operating loss of US$9.49 million ** includes unallocated expenses of US$11.2 million

Figure 1: Breakdown by product and division of Impax Laboratories’ sales andoperating margin in the second quarter of 2011 (Source – Impax)

Aurobindo Pharma said a restructuring committee it has chargedwith exploring and evaluating options for reshaping the Indian

company will complete its work within the next two months. Thereafter,it will make recommendations to Aurobindo’s board on how the firmcan “strengthen and provide focus to the growing volume of activepharmaceutical ingredients (APIs) and formulations business”, suchas by spinning-off or demerging certain parts of the group.

As Figure 1 shows, finished-dose formulations accounted for57% – and APIs 42% – of Aurobindo’s gross sales of Rs11.0 billion(US$243 million) in the Indian firm’s financial first quarter ended 30June 2011. Excluding excise duties totalling Rs236 million, Aurobindo’snet sales grew by 16.8% to Rs10.8 billion.

A quarter of Aurobindo’s total gross turnover came from USformulations, sales of which advanced by 26.7% to Rs2.74 billion. Sixabbreviated new drug application (ANDA) filings during the three-monthperiod took the cumulative total to 215.

Seven final ANDA approvals during the quarter – for fosinopriland galantamine tablets; alprazolam and divalproex extended-releasetablets; ramipril capsules; venlafaxine extended-release capsules; andinjectable piperacillin/tazobactam – took Aurobindo’s total USauthorisations to 109. As of 30 June 2011, the company also held29 tentative ANDA approvals.

Chairman Ramprasad Reddy said Aurobindo was “taking all thesteps necessary to address and resolve the regulatory challenges”relating to the firm’s ‘Unit VI’ cephalosporin manufacturing facilityafter the US Food and Drug Administration (FDA) had imposed animport ban on the antibiotics site (Generics bulletin, 4 March 2011,page 5). Aurobindo’s ‘Unit III’ non-betalactams formulations facilityin Bachupally, near Hyderabad, India, has also recently fallen shortof the FDA’s standards regarding packaging and labelling (Genericsbulletin, 10 June 2011, page 7).

Nevertheless, Reddy insisted a recently commissioned ‘Unit VII’formulations facility in a Hyderabad special economic zone (SEZ) would“contribute significantly” to Aurobindo’s growth during the financialyear. He promised a “better operational performance in coming quarters”.

A 25.1% rise in staff costs to Rs1.23 billion contributed toAurobindo’s first-quarter earnings before interest and tax (EBIT) –excluding a foreign-exchange gain of Rs31.8 million – declining byalmost a tenth to Rs1.22 billion. G


Aurobindo pondersrestructuring options

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

US 2,740 +26.7 25Rest of world 1,370 +9.3 12Antiretrovirals 2,116 +39.3 19Formulations 6,226 +26.2 57

Cephalosporins 1,943 +4.9 18Penicillins 1,567 +18.7 14Antiretrovirals/others 1,080 +14.3 10Active Ingredients 4,590 +11.5 42

Dossiers 189 -51.0 2

Aurobindo Pharma 11,005 +16.6 100

Figure 1: Breakdown by region and business of Aurobindo Pharma’s gross salesin its financial first quarter ended 30 June 2011 (Source – Aurobindo)

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

COMPANY NEWS


Hypermarcas has restructured its Pharma business unit to deliver“sustainable growth” and “high profitability levels”. An integrated

sales team will now make 150,000 visits to Brazilian doctors eachmonth, compared to 90,000 previously. And the company’s pharmacysalesforce has almost trebled its coverage to 23,000 stores.

Production at a 90,000 sq m facility in Anápolis, Brazil – whichhas an annual capacity of around 10 billion tablets – began in early April.The Brazilian firm expects to launch 39 products this year, while 64drugs are awaiting approval by the country’s Anvisa regulatory agency.

Having integrated Mantecorp and its Brainfarma generics unit(Generics bulletin, 14 January 2011, page 5), Hypermarcas reportedfirst-half Pharma sales 36.8% higher at R$961 million (US$603 million).On a pro forma basis, the growth was 2.7%. However, Hypermarcas’generics market share slipped to 6.0% by the end of the reportedperiod “mainly due to the increased competitiveness of some players”.

The Pharma unit’s gross margin improved by 7.6 percentage pointsto 74.2%, while the group’s gross margin strengthened by 4.5 points to61.3%. Hypermarcas’ pre-tax profit increased by 8.8% to R$180million on group turnover 27.8% higher at R$1.78 billion. G

BUSINESS STRATEGY/FIRST-HALF RESULTS

Hypermarcas restructuresArise of a third to Rs1.31 billion (US$28.6 million) in Generics

sales – coupled with a 16% increase to Rs6.08 billion in sales ofLife Science Ingredients, including active pharmaceutical ingredients(APIs) – improved the total turnover of Jubilant’s Life Science Productsdivision by 19% to Rs7.39 billion in the Indian group’s financial firstquarter ended 30 June 2011.

During the quarter, Jubilant filed three abbreviated new drugapplications (ANDAs) for central nervous system drugs in the US, andalso submitted one drug master file (DMF). The firm received an ANDAapproval for donepezil made at its solid-dose facility in Roorkee, India,which was recently certified by Japan’s Pharmaceuticals and MedicalDevices Agency (PMDA). The company’s APIs facility in Nanjangud,India, was cleared by Brazil’s Anvisa agency during the quarter.

Turnover from Life Science Services, such as contractmanufacturing, advanced by 4% to Rs2.05 billion, as group sales grewby 16% to Rs9.48 billion. A greater degree of vertical integration helpedto lift the group’s earnings before interest, tax, depreciation andamortisation (EBITDA) margin by 2.5 percentage points to 20.1%.Jubilant’s pre-tax profit improved by 68% to Rs926 million. G

FIRST-QUARTER RESULTS

Jubilant’s generics up by third

Krka is expanding its sales and marketing presence in western Europeby setting up wholly-owned subsidiaries in Italy and Spain. The

Slovenian firm has already registered Krka Farmacéutica in Madrid,Spain, and is currently registering Krka Farmaceutici in Milan, Italy.

In the first half of this year, Krka increased its turnover in westernEurope and overseas markets by 7% to C113 million (US$163 million), or21% of group turnover that rose by 6% to C529 million (see Figure 1).

Russia was Krka’s largest single market with sales that rose by 5%to C92.8 million. This made up the bulk of Eastern European turnoverthat grew by 12% to C135 million. Sales in Central Europe increasedby just 1% to C156 million, while turnover in South-East Europeadvanced by 7% to C73.5 million. The Slovenian company’s domesticsales rose by 2% to C51.6 million, representing a tenth of the group total.

Expanding its annual production capacity for oral solid-dosage formsat its Locna plant to 2.5 billion units, and for ampoules to 130 millionunits, are among Krka’s goals, following investment of C53.1 million inthe first half of 2011. The Slovenian firm is also “increasing productivity”at its Sinteza 4 active pharmaceutical ingredients (APIs) plant.Construction of a C135 million solid-dose plant and distribution centre inRussia began in February (Generics bulletin, 10 June 2011, page 8). G

BUSINESS STRATEGY/FIRST-HALF RESULTS

Krka creates units inboth Italy and Spain

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

Central Europe 156.4 +1 30Eastern Europe 134.6 +12 25Western Europe/Overseas 112.6 +7 21South-East Europe 73.5 +7 14Slovenia 51.6 +2 10

Krka 528.8 +6 100

Figure 1: Breakdown by region of Krka’s sales in the first half of 2011 (Source – Krka)

Diversifying its portfolio of biogeneric insulins and monoclonalantibodies, expanding into emerging markets and striking more

partnership agreements are key objectives for Biocon in ensuring futuregrowth. The Indian company said it was making “steady progress onthe biosimilar insulins front with a number of registration processesinitiated in emerging markets”, adding that it also planned imminentlyto launch its Insupen insulin pen in India.

Biocon also plans to start supplying Pfizer with insulin for theIndian market within the next two months as part of the global dealfor biogeneric insulin products that the two firms struck last year(Generics bulletin, 1 November 2010, page 13). The Indian companyhas also signed an agreement with Endo Pharmaceuticals to collaborateon developing novel biological oncology drugs, whilst Biocon continuesto develop biosimilar monoclonal antibodies through a partnershipwith Mylan (Generics bulletin, 8 July 2009, page 1).

Sales increased by 11%Sales during Biocon’s financial first quarter ended 30 June increased

by 11% to Rs4.54 billion (US$102 million) on higher sales ofimmunosuppressants and branded formulations. The firm’s earningsbefore interest, tax, depreciation and amortisation (EBITDA)increased by a similar proportion – 12% – to Rs1.33 billion, givingBiocon an EBITDA margin that remained constant at 29%. Salesby AxiCorp in 2010 were excluded from the comparison. Biocondivested its holding in the German generics and parallel importsspecialist earlier this year (Generics bulletin, 6 May 2011, page 3).

Atorvastatin and fluvastatin sales remained “buoyant”, whilst thecompany also began supplying the active pharmaceutical ingredient(API) fidaxomicin to Optimer Pharmaceuticals in June. The diabetestreatments voglibose and metformin/voglibose would be launched inIndia later this year, Biocon added, along with the chemotherapydrugs gemcitabine, oxaliplatin and epirubicin. G


Biocon plans to growbiogenerics portfolio

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

Wockhardt has agreed to sell its infant and medical nutrition businessin India to Danone for about C250 million (US$357 million).

The deal includes the Dexolac and Nusobee infant formulas and theFarex baby-food range, as well as the Protinex nutritionalsupplement. Danone will also get a manufacturing plant in Lalru,India. But Wockhardt will retain its nutrition facility at Jagraon.

The firm said its “strategy to consolidate and rationalise all its coreoperations is showing encouraging results”. “Wockhardt is reinventingitself by taking fundamentally strong and positive steps with a firmfocus on its core human pharmaceutical business,” it insisted.

In its financial first quarter ended 30 June 2011, the Indiancompany’s domestic sales increased by almost a quarter followingseven product launches, contributing to Wockhardt’s total turnoveradvancing by 14.3% to Rs10.5 billion (US$231 million).

Three launches following four abbreviated new drug application(ANDA) approvals more than doubled US sales, while three launcheshelped to raise Wockhardt UK’s turnover by 17%. In Ireland, Pinewood’sNexazole (esomeprazole) had captured a 35% market share after itsintroduction in June last year, the firm reported.

Static expenses led the firm’s earnings before interest, tax,depreciation and amortisation (EBITDA) margin to improve by nearly10 percentage points to 29.5%, while its pre-tax profit – excluding theprevious year’s exceptional losses – almost doubled to Rs2.16 billion. G

COMPANY NEWS


DIVESTMENTS/FIRST-QUARTER RESULTS

Wockhardt sells itsnutrition business

Pharmstandard may take full control of Ukraine’s Biolek by the endof 2011, the Russian firm has suggested. Stating that it viewed the

55% shareholding in Biolek that it acquired at the start of this year(Generics bulletin, 1 February 2011, page 3) as merely “investmentin an associate enterprise”, Pharmstandard nonetheless acknowledgedthat it did not “exclude the possibility of obtaining full control overthe entity by the end of the current year”.

Biolek added RUR207 million (US$7.32 million) to the firm’ssales that rose by 59.8% to RUR18.5 billion in the first half of 2011.This was underpinned by organic sales growth of 14.6%.

Turnover from Pharmstandard’s own pharma products grew by14.0% to RUR8.28 billion. However, sales of third-party products –including Roche’s Mabthera (rituximab) and Takeda’s Velcade(bortezomib) – more than doubled to RUR9.75 billion, driving up theRussian firm’s Pharmaceuticals total by 61% to RUR18.2 billion. Salesof medical equipment grew by 7.7% to RUR271 million.

Sales of Pharmstandard’s own prescription pharmaceuticals roseby 3.2% to RUR1.64 billion, including a contribution from brandedproducts 6.8% higher at RUR1.44 billion, as turnover from unbrandedprescription generics declined by 17.4% to RUR196 million.

OTC sales increased by 17% to RUR6.64 billion. Pharmstandardsaid recent legislation to make codeine available only on prescriptionfrom 1 June 2012 would have only an “insignificant” sales impact. G

MERGERS & ACQUISITIONS/FIRST-HALF RESULTS

Pharmstandard eyesfull control of Biolek

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

Ranbaxy Laboratories intends to “strengthen manufacturing inAfrican regions” as it looks to capitalise on strong local growth,

driven in part by winning tender contracts. In particular, the Indianfirm is keen to add to its production platform in Nigeria, one of thecontinent’s largest markets. Antiretroviral tenders helped to liftRanbaxy’s African turnover by a third to US$51 million in the secondquarter of this year. The region accounted for a ninth of group turnover,which crept up by 1% to US$461 million (see Figure 1).

Meanwhile, Ranbaxy intends to close by 1 October this year itsUS liquids manufacturing plant in Gloversville, New York. The facility –which the Indian firm acquired in 2002 and operates through its Ohmsubsidiary – was the subject of a warning letter that was issued by theUS Food and Drug Administration (FDA) at the end of 2009 (Genericsbulletin, 15 January 2010, page 5).

The firm insists it is “progressing well” in its negotiations withthe FDA and the US Department of Justice to address manufacturingdeficiencies at its facilities in Dewas and Paonta Sahib, India.

Ranbaxy’s second-quarter sales in the US – where the firm recentlyfiled an abbreviated new drug application (ANDA) for oxycodoneextended-release tablets – fell by 35% to US$95 million as 180-dayexclusivity for donepezil that partly ran into the quarter failed tocompensate fully for the loss of similar exclusivity for valaciclovirin the prior-year quarter (Generics bulletin, 3 September 2010, page 8).Ranbaxy’s total sales in North America were US$112 million.

Sales ahead by 15% to US$79 million in Europe included US$30million from Romania, where Ranbaxy launched letrozole on ‘day one’after patent expiry. Introducing olanzapine on ‘day one’ in Spain alsohelped, while the Indian firm’s French operation grew its sales.

Market-share gains and strong consumer healthcare sales pushedup the Indian group’s domestic sales by 11% to US$108 million.“Higher sales in most of the larger markets” increased turnover in theAsia-Pacific region by nearly a quarter to US$23 million.

Sales in Russia and the Commonwealth of Independent States(CIS) improved by 5% to US$21 million. Ranbaxy blamed “transientissues”, such as having completed tender contracts, for sales decliningby 13% to US$17 million in Latin America. Turnover from activepharmaceutical ingredients (APIs) totalled US$40 million.

With the lower contribution from first-to-file products in the US,Ranbaxy’s pre-tax profit fell by 18% to US$59 million. G

COMPANY NEWS



Ranbaxy will buildon African platform

Region/ Second-quarter sales Change Proportionbusiness (US$ millions) (%) of total (%)

India 108 +11 23US 95 -35 21Europe 79 +15 17Africa 51 +33 11Asia-Pacific 23 +24 5Russia/CIS 21 +5 5Latin America 17 -13 4APIs 40 – 9Others 27 – 6

Ranbaxy 461 +1 100

Figure 1: Breakdown by region and business of Ranbaxy Laboratories’ sales inthe second quarter of 2011 (Source – Ranbaxy)

IPCA LABORATORIES has strengthened its contract-manufacturingoperation by acquiring UK-based Onyx Scientific for £4.60 million(US$7.59 million). Onyx – which in its financial year ended 31March 2011 achieved a 17% earnings before interest, tax, depreciationand amortisation (EBITDA) margin on a turnover of £3.85 million –will continue to provide services such as custom synthesis and small-scale manufacturing from its facility in Sunderland, UK.

ENDO PHARMACEUTICALS posted generics sales of US$133million – or just over a fifth of group turnover that rose by 53% toUS$608 million – in the second quarter of this year. Noting that saleshad been hit by tornadoes cutting power to its facility in Huntsville,Alabama, in April, the US firm said it expected to file 14 abbreviatednew drug applications (ANDAs) this year and to receive a similarnumber of approvals. Having acquired Qualitest for US$1.2 billionlast year (Generics bulletin, 1 October 2010, page 1), Endo isforecasting full-year generics sales of US$550-US$575 million.

NEULAND LABORATORIES is launching a commercial-scale peptidemanufacturing service. In its financial first quarter ended 30 June2011, the Indian active pharmaceutical ingredients (APIs) producermore than trebled its earnings before interest and tax (EBIT) to Rs82.6million (US$1.81 million) on turnover 16.0% higher at Rs1.04 billion.

TAKEDA can acquire Nycomed, the European Commission has statedafter deciding that the two firms would not have an anti-competitiveposition in the proton-pump inhibitors market. In the first half of2011, Nycomed – which will spin-off its US dermatology business,including Fougera generics, into a separate entity upon the C9.6billion (US$13.7 billion) takeover being completed – reportedturnover by its US operation down by 22.8% to C133 million.

DIVIS LABORATORIES said its ‘Unit I’ facility near Hyderabad,India, had passed a pre-approval and general current goodmanufacturing practice (cGMP) inspection by the US Food and DrugAdministration (FDA) with “no major observations”. “The auditconcluded with minor observations, primarily about additionalrecords for further improvement of existing records,” stated theIndian active pharmaceutical ingredients (APIs) specialist.

CAMBREX said higher volumes of generic active pharmaceuticalingredients (APIs) and stronger sales of some custom-manufacturedproducts lifted its turnover by 17.6% to US$67.5 million in thesecond quarter of this year. On a constant-currency basis, the growthwas 6.9%. Higher volumes and lower production costs partiallyoffset pricing pressure as the US firm’s operating profit improvedby 5.6% to US$7.29 million.

GRANULES INDIA said strong demand for metformin more thandoubled its formulations sales to Rs370 million (US$8.09 million) inits financial first quarter ended 30 June 2011. Including sales ofintermediates and active pharmaceutical ingredients (APIs), theIndian firm raised its turnover by 9% to Rs1.19 billion, while itspre-tax profit improved by a third to Rs44.0 million.

SIMCERE PHARMACEUTICAL said its sales crept up by 0.3% toRMB546 million (US$84.4 million) in the second quarter of this year.But the Chinese firm’s operating profit increased by 27.5% to RMB79.9million, even though government-mandated price cuts reduced marginson certain of its branded generics such as Zailin (amoxicillin).

VIVIMED LABS has set up subsidiaries in Spain and the UK, as wellas in Mauritius, as “part of its global expansion strategy”. G

IN BRIEF

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

Stada Arzneimittel now believes it will have to wait until the firstquarter of next year to acquire a Swiss portfolio of 56 prescription-

only and 15 non-prescription generics from local company SpirigPharma. The German group had initially hoped to strike a deal for theSwiss business – which has an annual turnover of around SFr45 million(US$55.4 million) – within three months of opening negotiationswith Spirig (Generics bulletin, 10 June 2011, page 4).

Hartmut Retzlaff, Stada’s executive chairman, said “technicalprocessing aspects” had delayed the prospective transaction. In particular,he identified legal aspects of spinning off the generics business fromSpirig’s other activities and harmonising information-technology systems.

Meanwhile, Stada is aiming to divest an Irish facility (Genericsbulletin, 20 May 2011, page 9), as well as two plants in Russia.

In the first half of 2011, Stada’s turnover in western Europe rose by2% to C580 million (US$838 million), even though the group’s domesticsales fell by a tenth to C233 million on a 14% generics decline to C170million as the business was hit by an injunction on selling leflunomide.

Belgian generics sales increased by 6% to C68.9 million, whilegenerics turnover in Italy climbed by 18% to C54.2 million on recentlaunches and market growth despite reimbursement cuts from 1 April.Spanish generics sales shot up by 36% to C53.2 million followingthe launch of valsartan (Generics bulletin, 4 March 2011, page 25).

Total turnover in France – where Stada is looking to strike similardeals to its recent 20% holding in pharmacy co-operative Pharm Ortho

Pedic – was static at C38.4 million. Sales in the Netherlands rose by35% to C26.5 million, while turnover in the UK – where Stada isacquiring outright the Cetraben skincare brand currently marketedunder licence by its Genus operation – edged up 1% to C26.3 million.

In eastern Europe – where the German firm plans to strengthenits position by acquiring a range of Grünenthal brands from the fourthquarter of this year (Generics bulletin, 20 May 2011, page 21) – groupsales increased by a quarter to C216 million. Russian generics saleswere 7% stronger at C52.8 million. In Serbia, a restructuring planbetween Stada’s local Hemofarm and wholesaler Velefarm helped tolift generics sales by 56% to C41.6 million.

Lower wholesaling revenues in the Philippines caused a 15%turnover decline to C21.6 million in Asia, where Stada has increasedits stake in the Pymepharco venture from 23.7% to 49.0%. Turnoverin Africa and the Americas rose by 17% to C12.2 million.

As Figure 1 shows, total turnover by Stada’s Generics segmentincreased by 5% to C572 million, but the segment’s operating marginfell by 0.7 percentage points to 13.3%. The group’s operating marginrose by 0.3 points to 13.0% on turnover 7% higher at C830 million. G

COMPANY NEWS


MERGERS & ACQUISITIONS/FIRST-HALF RESULTS

Stada’s Swiss dealwith Spirig delayed

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

Generics 572 +5 13.3Branded Products 231 +14 25.3Commercial 18 -39 3.9Corporate/other 9 – –*

Stada 830 +7 13.0

* operating loss of C27.7 million

Figure 1: Breakdown by business segment of Stada Arzneimittel’s sales andoperating margin in the first half of 2011 (Source – Stada)

A21% sales increase to Rs1.07 billion (US$23.6 million) in Brazilhelped to raise Torrent Pharmaceuticals’ turnover by a fifth to Rs6.47

billion in its financial first quarter ended 30 June. The Indian firm’searnings before interest and tax (EBIT) grew by 35% to Rs1.36 billion.

As Figure 1 shows, Torrent’s International sales outside of Indiaalso increased by a fifth, reaching Rs3.17 billion, or almost half ofgroup turnover. Sales in the US shot up by 56%, while Torrent’sHeumann operation in Germany posted an “impressive performance”with a 20% turnover gain. Contract-manufacturing revenues ahead by74% to Rs780 million included Rs170 million in non-recurringdossier development and licensing fees.

In India – where Torrent has finished-dose facilities in Baddi andSikkim, as well as a plant in Chhatral that makes both finished dosesand bulk drugs – formulations turnover rose by a tenth to Rs2.46 billiondespite “lower sales growth in acute therapies”. G


Brazil takes Torrentturnover up by fifth

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

India 3,084 +14 48International 3,166 +20 49Other/Duties 226 +270 3

Torrent Pharma 6,475 +20 100

Figure 1: Breakdown of Torrent Pharmaceuticals’ sales in its financial firstquarter ended 30 June 2011 (Source – Torrent)

Beximco Pharmaceuticals plans to target “lucrative generics marketsin Europe” after it received good manufacturing practice (GMP)

accreditation from Austrian authorities for its facility in Bangladesh.The plant makes both oral solid-dose products, such as tablets andcapsules, and sterile eye drops (Generics bulletin, 15 July 2011, page 5).

“This is an important step towards our aspiration to become a globalgeneric drugs player, and particularly for building our presence in theregulated markets of the US and the European Union (EU),” insistedBeximco’s managing director Nazmul Hassan. The Bangladeshi firmrecently entered the US market by acquiring an abbreviated new drugapplication (ANDA) for the cardiovascular drug carvedilol. In the EU,Beximco has filed two marketing authorisation applications. Meanwhile,a facility for metered-dose inhalers is just starting trial production runs.

In the first half of 2011, Beximco’s export sales increased by 21.6%to BDT174 million (US$2.32 million), accounting for just under 5%of total turnover ahead by 22.7% to BDT3.64 billion as the Bangladeshifirm’s domestic sales rose by 22.8% to BDT3.47 billion. Beximcoimproved its pre-tax profit by 9.6% to BDT765 million. G

MANUFACTURING

Beximco gains EU approval

WATSON is investing US$23.5 million in building a 21,750 sq mfacility in DeSoto County, Mississippi, for its Anda distributionbusiness. It is set to open in the second quarter of 2012, replacinga leased facility in Groveport, Ohio. G

IN BRIEF

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

Orchid Chemicals and Pharmaceuticals has resumed production atits cephalosporin active pharmaceutical ingredients (APIs) facility

in Alathur, India. The Indian firm has resolved issues highlighted bythe Tamil Nadu Pollution Control Board in a notice that forced atemporary closure (Generics bulletin, 5 August 2011, page 11).

Having raised its turnover by 23.2% to Rs4.49 billion (US$99.2million) in its financial first quarter ended 30 June 2011, Orchid isconfident it can sustain strong growth. Earnings before interest, tax,depreciation and amortisation (EBITDA) rose by 7.9% to Rs889 million.

“We have entered into long-term contractual agreements with largemultinationals, including Hospira, to supply our niche APIs andformulations,” pointed out Orchid’s chairman and managing director,K Raghavendra Rao. Last year, Orchid sold its generic injectablesbusiness to Hospira for US$400 million in a deal that included a bulk-drug supply agreement (Generics bulletin, 9 April 2010, page 4).

In the APIs arena, 83 US drug master files (DMFs) submitted todate comprise 27 cephalosporins, 11 carbapenems, two betalactamsand 43 other products. Of 21 European certificates of suitability (CoS)filed by Orchid, 14 are for cephalosporins.

Orchid’s cumulative abbreviated new drug application (ANDA)filings in the US have reached 43, of which 21 have been approved andeight are said to be first-to-file opportunities. Around half of 25 dossierssubmitted to date in the European Union are for cephalosporins. G

COMPANY NEWS


MANUFACTURING/FIRST-QUARTER RESULTS

Orchid solves issuesat antibotics plant

Obtaining approvals from the US Food and Drug Administration(FDA) for its sterile injectables and oncology facilities in Bangalore

will allow Strides Arcolab to “continue our focus on more productlaunches in key markets,” according to the firm’s chief executive officer,Arun Kumar. Following the FDA approvals (Generics bulletin, 6 May2011, page 3), Strides was “amongst the first wave of players” toreceive FDA approval at the end of July for a US rival to Eli Lilly’sGemzar (gemcitabine) 200mg, 1g and 2g. The Indian firm noted it was“amongst the few companies approved for all three dosage forms”.

The approval for Strides’ gemcitabine – which will be launchedthrough Pfizer – represented the firm’s first injectable oncology approvalfor the US market. The Indian company also recently received Europeanapproval for oral oncology drugs made at the Bangalore plant (Genericsbulletin, 15 July 2011, page 3).

Sales during Strides’ financial second quarter ended 30 June roseby 28% to Rs6.18 billion (US$140 million). This included turnoverfrom the firm’s Agila Specialties division that was virtually unchangedat Rs2.20 billion, along with Pharma sales that grew by more thanhalf to Rs3.98 billion. However, the Specialties segment’s earningsbefore interest, tax, depreciation and amortisation (EBITDA) marginof 34% was double the Pharma division’s 17% margin. The company’stotal EBITDA rose by 11% to Rs1.45 billion.

The FDA approved three products during the quarter, taking Strides’total US approvals to 60. Seven products were launched in the US inthe first six months of 2011, giving the firm a total of 18. In Europe,Strides held nine marketing authorisations of 48 applications filed, whilstin Australia and New Zealand, 21 of 40 filings had been approved. G


FDA approvals helpStrides’ focus on US

Sales of both cardiovascular and central nervous system drugs risingby more than a quarter helped to boost Alkaloid’s pharmaceutical

sales by 12.9% to C43.5 million (US$61.6 million) in the first halfof 2011. Sales of cardiovascular products that grew by 28.8% contributedC8.57 million, whilst turnover from central nervous system treatmentsthat increased by 28.9% added C6.84 million to the total. Turnoverfrom OTC remedies rose by 3.0% to C9.09 million, whilst sales ofantibiotics grew by 8.7% to C8.60 million.

Sales in the Macedonian firm’s domestic market increased by 15.3%to C17.6 million, whilst the company’s turnover grew by 11.8% inboth south-east Europe and Russia and the Commonwealth ofIndependent States (CIS) to C20.1 million and C3.32 million respectively.In the European Union, sales rose by 3.3% to C2.36 million.

Alkaloid’s total turnover – including C8.94 million from the firm’snon-pharma businesses – grew by 13.4% to C52.5 million. However, thecompany’s operating margin fell by a percentage point to 10.8%. G

FIRST-HALF RESULTS

Alkaloid grows by over a tenth

GEDEON RICHTER has been awarded US$40 million in damagesfrom Polpharma’s owner, Genefar. The International Chamber ofCommerce made the award after Richter’s planned takeover ofPolpharma was thwarted (Generics bulletin, 1 August 2008, page 3).G

IN BRIEF

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

US store-brand specialist Perrigo is exploring options to launch anOTC generic version of Pfizer’s prescription-only cholesterol drug

Lipitor (atorvastatin calcium) in the US, according to the firm’s chiefexecutive officer, Joseph Papa.

Papa told investors that Perrigo had a programme to look at“atorvastatin in terms of moving it over-the-counter”, and that thecompany believed that it could be a “very significant opportunity” ifthe switch took place. However, he did not believe Lipitor would beavailable OTC “this year or next year”, adding that it would take“several years to ultimately see that happen”.

While simvastatin had been switched to OTC status in marketsincluding the UK, Papa pointed out that the US Food and DrugAdministration (FDA) had three times denied bids to switch a statinfrom prescription-to-OTC status. Nevertheless, he felt Pfizer had a“very good way of talking about moving the product from prescriptionto OTC”. There was “good data on statins that really talk about thetreatment of patients based on risk-factor analysis”, Papa said.

Pfizer says it has “strategic plans in place for Lipitor’s loss of USexclusivity” in November this year, but has not publicly stated that itplans to switch the blockbuster to OTC status.

Perrigo reported a 7% rise in Consumer Healthcare sales to US$1.68billion in the year ended 25 June 2011, including the impact of launchingfexofenadine in late April and a US$22 million contribution fromacquiring Australia’s Orion Laboratories (Generics bulletin, 26 March2010, page 2) and .

Prescription Pharmaceuticals turnover shot up by 45% to US$344million, largely due to the firm’s generic rival to Aldara (imiquimod),along with favourable pricing for some products. Switching from anauthorised generic to imiquimod cream that the firm produces itselfhelped to raise the business segment’s gross margin by two percentagepoints to 47.5%, while its operating margin improved by 14.6 pointsto 35.0% (see Figure 1).

Shipping triamcinolone nasal sprayShipping triamcinolone nasal spray through marketing partner Teva

contributed to fourth-quarter Prescription Pharmaceuticals sales risingby 12% to US$92.5 million.

Full-year turnover by Perrigo’s active pharmaceutical ingredients(APIs) segment increased by 11% to US$156 million, largely drivenby shipping bulk temozolamide in Europe. The segment’s operatingmargin more than doubled to 24.3%. Nutritionals sales almost doubledto US$503 million following the consolidation of infant-nutritionspecialist PBM, which contributed US$283 million.

Including unallocated expenses, Perrigo’s group operating marginrose by three percentage points to 17.8% on turnover that increasedby 21% to US$2.76 billion.

The US company expects group turnover in its current financialyear ending June 2012 to increase by 15% to 18%, including PrescriptionPharmaceuticals sales up by 55% to 57%, following the completionof Perrigo’s US$540 million takeover of Paddock on 26 July.

Prescription products scheduled for launch in Perrigo’s currentfinancial year include rivals to Cenestin (oestrogen) tablets, Clobex(clobetasol) lotion, Duac (benzoyl peroxide/clindamycin) gel and Xyzal(levocetirizine) solution. In the OTC arena, the US firm plans to introducealternatives to Reckitt Benckiser’s guaifenesin-based cough and coldbrand Mucinex, as well as to Novartis’ heartburn remedy Prevacid24 HR (lansoprazole). G

COMPANY NEWS


BUSINESS STRATEGY/ANNUAL RESULTS

Perrigo will exploreOTC Lipitor options

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

Consumer Healthcare 1,685 +7 17.4Nutritionals 503 +94 13.5Prescription Pharma 344 +45 35.0APIs 156 +11 24.3Others 67 +17 1.9

Perrigo 2,755 +21 17.8*

* includes US$30.4 million of unallocated operating expenses

Figure 1: Breakdown by business segment of Perrigo’s sales and operatingmargin in its financial year ended 25 June 2011 (Source – Perrigo)

Bluefish Pharmaceuticals has agreed to pay SKr26 million (US$4.12million) to buy BMM Pharma, the generics business of fellow

Swedish company BioPhausia. The deal also includes Bluefish payinga further SKr12 million for BMM’s inventory. No BMM staff willtransfer to Bluefish as part of the acquisition, which will be financedthrough a SKr40 million bridging loan and share issue.

Acquiring BMM gives Bluefish access to a portfolio of 19 products,most of which are analgesics, anti-inflammatory medicines andgastrointestinal treatments. The combined business will have a portfolioof 68 products, of which 41 have been launched. Bluefish said itexpected the deal to add around SKr30 million to its annual turnover.

After the firm’s sales in the first half of 2011 grew by 43% toSKr64.9 million, Bluefish predicted that its turnover for the full year –excluding the BMM portfolio – would increase by 60% to SKr150million. The firm’s sales more than doubled to SKr92.7 million in2010 (Generics bulletin, 18 March 2011, page 11).

Selling BMM was “a natural last step in the concentration and focusof BioPhausia’s business”, said BioPhausia’s chief executive officer,Maris Hartmanis. Last year, the firm sold its Dutch generics arm backto its original owner and discontinued generics operations in Polandand the Baltic States (Generics bulletin, 3 September 2010, page 14).And in April, it accepted a SKr565 million takeover bid from Sweden’sMedivir (Generics bulletin, 22 April 2011, page 5). Hartmanis addedthat BioPhausia would “now be focusing on the ongoing commercialdevelopment of our proprietary products and parallel-import products”.

Bluefish’s chief executive officer, Karl Karlsson – who foundedthe company in 2005 – said the firm’s “scale, together with our broadpresence throughout the rest of Europe, offers new pan-Europeanbusiness opportunities”. “Our flexibility, strong platform and efficientorganisation allow us to take advantage of attractive local businessopportunities such as the acquisition of BMM, thereby enhancing ourcompetitiveness and increasing our margins,” he insisted.

Launching products in Ireland and France in the first six monthsof 2011 meant that Bluefish was now present in 19 European markets.The company struck nine profit-sharing distribution agreements duringthe first half of the year, which it said “resulted in a substantiallyincreased portfolio of distribution products”.

Having launched products in several markets in 2010 – including theCzech Republic, Greece, Hungary, Italy and Poland, as well as Portugal,Romania, Slovakia and Spain – Bluefish said it was aiming to increasemarket share in all markets in 2011. G

MERGERS & ACQUISITIONS

Bluefish to acquireBioPhausia’s BMM

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

Market shortages of intravenous drugs in North America, alongwith strong demand in emerging markets, increased Fresenius

Kabi’s turnover by 13% to C1.97 billion (US$2.85 billion) in the firsthalf of this year. “We are very pleased with Fresenius Kabi’s growthin North America and emerging markets, especially in China,”commented the German group’s chief executive officer, Ulf Schneider.

The North American shortages were reflected in Fresenius Kabi’sglobal sales of intravenous drugs rising by 21% as reported – and by24% at an organic, constant-currency basis – to C732 million (seeFigure 1). The company is currently expanding its US APP subsidiary’smanufacturing facility in Grand Island, New York, by investingUS$38 million over the next two years in setting up six additionallines for intravenous drugs (Generics bulletin, 30 June 2011, page 5).

Including all businesses, total turnover in North America advancedby 17% to C519 million. Organic growth of 22% was “driven by new

products and continued shortages”, while the region’s earnings beforeinterest and tax (EBIT) margin rose by 7.5 percentage points to 38.5%.

Fresenius Kabi’s European operation saw its EBIT margin dipby 0.3 points to 21.0% on a 9% sales rise to C909 million.

Emerging markets accounted for 28% of Fresenius Kabi’s turnoverwith 16% organic sales growth, including a 20% advance in China onstrong demand for parenteral nutrition products.

Organic growth accounted for all of the Asia-Pacific region’sreported 19% advance to C332 million, or 17% of turnover. Another 11%of total sales came from Latin America and Africa, where turnoverincreased by 14% as reported, and 12% organically, to C211 million. Thetwo regions’ combined EBIT margin moved up by 1.7 points to 19.2%,while Fresenius Kabi’s corporate expenses totalled C84 million.

A one percentage-point gain in Fresenius Kabi’s total EBIT marginto 20.9% was “mainly attributable to the strong development in NorthAmerica”. Organic sales growth was 13%, as currency effects offsetthe impact of acquisitions. Fresenius Kabi accounted for a quarter ofthe German parent group’s total turnover of C8.00 billion.

On the basis of the strong first-half showing, Fresenius Kabi raisedits full-year sales forecast from 5% to 8% organic growth, with an EBITmargin at the top end of the previously-announced 19-20% target. G

COMPANY NEWS


FIRST-HALF RESULTS

Shortages and Chinaaid Fresenius’ sales

Business First-half sales Reported Organic(CC millions) change (%) change (%)

Intravenous Drugs 732 +21 +24Clinical Nutrition 560 +9 +9Infusion Therapy 443 +8 +5Devices/Transfusion 236 +10 +9

Fresenius Kabi 1,971 +13 +13

Figure 1: Breakdown by business of Fresenius Kabi’s sales in the first half of2011 (Source – Fresenius)

VALEANT said branded generics sales of US$181 million – comprisingUS$116 million in Europe and US$64.7 million in Latin America –accounted for 30% of group turnover that reached US$609 million inthe second quarter of this year. Having last year merged with Biovail,the Canada-based firm recently strengthened its presence in central andeastern Europe by acquiring branded generics specialist PharmaSwiss(Generics bulletin, 11 February 2011, page 3). Valeant also completedits C364 million (US$525 million) takeover of Lithuania’s Sanitas on19 August (Generics bulletin, 10 June 2011, page 3).

JB CHEMICALS & PHARMACEUTICALS said “reasonable growth”by its domestic formulations business helped the Indian firm to registeran 11.7% total turnover rise to Rs1.77 billion (US$38.8 million) inthe three months ended 30 June 2011. Pre-tax profits increased by8.9% to Rs269 million. Shortly after the quarter ended, JB completedthe sale of its OTC business in Russia and the Commonwealth ofIndependent States (CIS) to Johnson & Johnson. It expects to finalise asimilar deal to divest its prescription business in Russia and theCIS to Dr Reddy’s during the current financial quarter (Genericsbulletin, 5 August 2011, page 1).

PODRAVKA increased its Pharmaceuticals sales by 2% to CrK355million (US$68.1 million) in the first half of this year. A 2% declinein its home market of Croatia was more than outweighed by a 9%advance in other markets, including growth of 4% in Russia, 9% inBosnia and Herzegovina and 44% in Slovenia. Podravka’s turnoverin Turkey almost trebled. The Croatian firm said its sales of prescriptioncentral nervous system drugs increased by around a tenth.

PFIZER blamed US competition to its Effexor (venlafaxine), Protonix(pantoprazole) and Zosyn (piperacillin/tazobactam) brands for salesby its Established Products division falling by a fifth on a constant-currency basis – and by 15% as reported – to US$2.32 billion in thesecond quarter of this year. That total included US$146 million fromdrugs acquired through taking over King Pharma in January 2011,but excluded US$963 million generated through sales of EstablishedProducts in emerging markets. Competition to Lipitor (atorvastatin)in Brazil, Canada, Mexico and Spain – as well as US rivals to Aricept(donepezil), Vfend (voriconazole) and Xalatan (latanoprost) – alsocontributed to group turnover dipping by 1% to US$17.0 billion.

ANTIBIOTICE increased its turnover by a fifth to RON139 million(US$46.9 million) in the first half of this year. The Romanian firmsaid higher sales of central nervous system and cardiovascular drugshad added to its strong position in anti-infectives, while nystatin hadled its exports rise. Gross profit grew by 35% to RON28.2 million.

DSM said the financial performance of its Pharma business clusterwas “still well below acceptable levels”, even after it showed a slightimprovement in the second quarter of this year. The cluster brokeeven in terms of earnings before interest and tax (EBIT) on a 9%sales decline to C178 million (US$256 million) in the quarter. Theprofit improvement over a C10 million first-quarter loss (Genericsbulletin, 6 May 2011, page 4) was due to better margins at DSMAnti-Infectives and volume gains at DSM Pharmaceutical Products.

OLAINFARM’s chairman, Valerijs Maligins, has launched a bid toacquire a majority shareholding in the company for LVL1.95(US$3.97) per share. Maligins said he did not plan to relocate theLatvian company, delist shares, or make any major changes to itsstaff or composition. The firm said the offer met legal requirementsbut reflected “neither the current market price of Olainfarm’s sharesnor the company’s future development potential”. G

IN BRIEF

NAVAMEDIC says it will launch its first two generics within the nextfour months, followed by another eight next year. The Norwegianfirm increased its second-quarter turnover by 43% to NOK18.2million (US$3.38 million), all from its Vitaflo distribution business. G

IN BRIEF

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

Double-digit sales advances in Russia and Romania – as well as11.6% growth to C68.1 million (US$97.0 million) in its domestic

market – enabled Hungary’s Gedeon Richter to report a 12.7% increasein Pharmaceutical sales to C480 million in the first half of this year.Including its wholesale and retail operations, Richter’s turnover rose by7.5% to C542 million (see Figure 1), but Richter’s operating margindeclined by 5.7 percentage points to 16.0% as it expanded its women’shealth salesforce in western Europe to sell contraceptives bought fromGrünenthal (Generics bulletin, 12 November 2010, page 15).

Russian Pharmaceutical sales 28.5% stronger at C162 millioncontributed the bulk of a 17.7% increase to C210 million in theCommonwealth of Independent States (CIS). Richter said its Mydeton(tolperisone), Panangin (asparaginates), Quamatel (famotidine) andSuprax (cefixime) brands had fared well in Russia, as had its range oforal contraceptives. “Political stabilisation” had helped to expandUkranian turnover by 8.6% to C21.4 million.

Romanian sales that were ahead by 11.8% – driven by the Duador(dihydrochandone), Rostat (rosuvastatin) and Tessyron (clopidogrel)branded generics – added C16.1 million to sales in the EuropeanUnion, excluding Hungary, that grew by 23.9% to C140 million.

Strong sales of the seasonal antiviral Groprinosin (inosine pranobex)– as well as of Mydocalm (tolperisone), Nortivan (valsartan), Protevasc(trimetazidine) and Zaranta (rosuvastatin) – contributed to a 4.7% salesincrease to C37.7 million in Poland. Lunaldin (fentanyl) and Mertenil(rosuvastatin) drove growth of around a tenth to C12.6 million in theCzech Republic; while Lunaldin also lay behind a similar advance toC11.1 million in Slovakia. Sales in the Baltic States improved slightlyto C7.2 million, but Bulgarian turnover stalled at C5.6 million.

Acquiring Grünenthal’s contraceptives added C22.4 million inwestern Europe, where sales of other products fell by 5.1% to C27.7million. Half of Richter’s C50.1 million total in the region was achieved inGermany, with France, Italy and Spain each adding around C5 million.

In the Hungarian firm’s domestic market, local-currency growthwas 10.4% as the company benefitted from second-quarter launches ofParnassan (olanzapine) and Silderec (sildenafil). Nortivan, Pananginand Xeter (rosuvastatin) also put in strong performances, as did theTysabri (natalizumab) monoclonal antibody licensed from Biogen.

“Increased competition” to drospirenone reduced Richter’s USsales by nearly a third to C34.1 million. G

COMPANY NEWS


FIRST-HALF RESULTS

Russia and Romaniaraise Richter’s sales

Region/ First-half sales Change Proportion ofbusiness (CC millions) (%) total (%)

Russia/CIS 210.4 +17.7 39European Union* 140.4 +23.9 26Hungary 68.1 +11.6 13US 34.1 -32.7 6Rest of world 27.2 +22.5 5Pharmaceutical 480.2 +12.7 89

Wholesale/Retail 63.2 -17.2 12

Corporate eliminations -1.2 – –

Gedeon Richter 542.2 +7.5 100

* excluding Hungary

Figure 1: Breakdown by region and business of Gedeon Richter’s sales in thefirst half of 2011 (Source – Gedeon Richter)

US lozenge sales of oral transmucosal fentanyl citrate – the activeingredient in the Actiq analgesic brand – falling by more than a

fifth to US$20.6 million caused Cephalon’s total turnover from genericpain-relief drugs to dip by 1% to US$89.2 million in the second quarterof this year. Including cyclobenzaprine, US generic pain-relief saleswere 16% lower at US$45.6 million (see Figure 1), largely offset bya 22% advance to US$43.6 million in Europe through the Mephaoperation that Cephalon acquired last year.

Cephalon’s total generics sales stalled at US$197 million as theUS decline was compensated in part by turnover from European centralnervous system (CNS) generics rising by 17% to US$10.0 million,and European oncology turnover growing by 8% to US$6.19 million.

Including proprietary brands, total sales by the US firm – whichis awaiting European and US antitrust clearance to become part ofTeva – advanced by 2% to US$730 million. G


Lower fentanyl saleshold back Cephalon

Product Second-quarter sales Change Proportion oftype (US$ millions) (%) total (%)

Proprietary Brands 532.8 +4 73

Pain-relief 43.6 +22 6CNS 10.0 +17 1Oncology 6.2 +8 1Others 87.4 -3 12European Generics 147.2 +5 20

Pain-relief 45.6 -16 6Others 4.5 +48 1US Generics 50.1 -13 7

Cephalon 730.1 +2 100

Figure 1: Breakdown by product type of Cephalon’s sales in the second quarterof 2011 (Source – Cephalon)

Sawai Pharmaceutical made a slow start to its financial year endingin March 2012 as first-quarter sales edged up by 0.5% to ¥15.9

billion (US$208 million). The Japanese firm pointed out that sales inthe first quarter of the previous financial year had been boosted by theintroduction of higher generic dispensing fees.

A 7.1% rise to ¥7.98 billion in sales through wholesalers morethan offset a 4.3% decline to ¥6.83 billion in turnover through salesagencies. And higher sales of gastrointestinal drugs – largely throughbetter pricing – compensated for a decline in turnover from cardiovasculardrugs as Sawai’s overall volume sales slipped down by 2.5%.

The company’s gross profit margin strengthened by nearly twopercentage points to 48.3%, but higher operating expenses – includinga 16% rise in research and development investment to ¥987 million– caused the Japanese company’s operating margin to dip by 0.8percentage points to 21.3%.

Nevertheless, Sawai said it expected its performance to pick upin the remainder of its financial year, propelling it towards its full-yearsales goal of ¥72.5 billion and an operating margin of 20.0%. G


Sawai starts its year slowly

Gen 2_9_11 Pgs.2-13.qxd 1/9/11 07:27

Nine joint inspections of active pharmaceutical ingredient (API)manufacturers and the exchange of nearly 100 inspection reports

were the main fruits of a 24-month pilot programme of collaborationsbetween the US Food and Drug Administration (FDA), the EuropeanMedicines Agency (EMA) and Australia’s Therapeutic GoodsAdministration (TGA). Other participating authorities in the collaboration– which identified 97 API sites common to all three regions – wereFrance, Germany, Ireland, Italy, the UK and the European Directoratefor the Quality of Medicines & Healthcare (EDQM).

The Australian, European and US agencies have also carried outa pilot programme of joint inspections of good clinical practice (GCP).This involved the exchange of more than 250 documents relating to54 different medicines, and resulted in 13 collaborative inspections ofclinical trials. Reports on the two pilot programmes, according to theEMA, highlight their success in information-sharing.

Noting that the FDA had prohibited imports into the US of a firm’sAPI products based on the negative findings from a European inspection,the FDA’s deputy commissioner for global regulatory operations andpolicy, Deborah Autor, commented: “We cannot do it alone. It isimperative that the FDA works closely with its counterparts to ensurethe safety and quality of products and the integrity of clinical trials.”

Based on the positive experience in the two pilots, the EMA said,the agencies have agreed to continue with their collaboration oninspections, “taking into account the experiences and lessons learnedduring the pilot phases”. G

MARKET NEWS


REGULATORY AFFAIRS

Agencies completejoint inspection pilots

France’s generics industry association, Gemme, has sent an openletter to the president of a doctors’ association, the Conseil National

de l’Ordre des Médecins, to refute public criticism of generics in theFrench media. Gemme said it was aiming to draw the organisation’sattention to “the possible consequences of inaccurate statements withoutscientific basis that could lead to a loss of confidence in generics”.

Whilst promoting a book about France’s healthcare system innational newspaper France Soir, general practitioner (GP) SauveurBoukri said using different excipients meant that generics were not thesame as originator medicines. The France Soir article claimed thatgenerics firms ran businesses based in Europe but cut production costsby manufacturing at plants “in Hungary, Pakistan or in Asia” that weremore difficult to regulate. Generics firms “squeezed costs”, thenewspaper added, by using cheap starting materials from China or Indiathat could contain impurities. “We are putting economic interests beforehealth,” Boukri concluded.

Gemme said these “incorrect data and statements that could bequalified as defamatory” damaged the reputation both of generics andof the health authorities that granted marketing authorisations. Theassociation noted that generics were subject to the same rigorous qualitymeasures as branded medicines, adding that France’s medicines agency,Afssaps, had not received any pharmacovigilance alerts relatingspecifically to generics.

Furthermore, Gemme pointed out, 95% of generics sold in Francewere manufactured in the European Union, with more than 55% ofthese being produced in the country. G

INDUSTRY ASSOCIATIONS

Gemme hits back at criticism

GLOBAL generics medicines sales will reach US$300 billion annuallyby 2020, according to IMS Health, and would be split equally betweenmature and emerging markets. The compound annual growth rate ofgenerics between 2010 and 2020 in mature markets would be 8%,but their share would decline from 56% currently. G

IN BRIEF

Ageneric drug user-fee programme being negotiated in the US will befully funded at US$299 million from the first year of the programme,

the US Food and Drug Administration (FDA) and industry associationshave agreed. This amount will be adjusted for inflation annually.

Initially, the US Generic Pharmaceutical Association (GPhA) hadproposed escalating fees starting from the first year and fully funding theprogramme only from the third year, when the FDA will begin reportingspecific performance information. However, the FDA insisted that fullfunding was needed from the first year for the agency to build thenecessary staff and resources to achieve the programme’s agreed goals.

In the first year of the programme, part of the US$299 million totalwill be derived from a one-time supplementary fee for each pendingapplication in the FDA’s backlog. Last year, the agency admitted therewas a growing queue of more than 2,000 applications awaiting review.Around 800 abbreviated new drug applications (ANDAs) are nowsubmitted each year, whereas fewer than 600 approvals have been grantedannually since 2007 (Generics bulletin, 12 November 2010, page 14).

Four types of fees will be implemented by the user-fee programme.Along with the one-off supplementary fee for ANDAs in the backlog,fees will be payable for facilities, for drug master files (DMFs), andfor filing new ANDAs and prior approval supplements (PASs).

Goals already agreed between industry and the FDA includeclearing the backlog of ANDAs to reach a “steady state, where whatcomes in can go out within the review time” within five years ofimplementing the programme (Generics bulletin, 30 June 2011,page 9). All primary application reviews should be completed within10 months by the fifth year of the programme. The FDA will continueto adopt a ‘first in, first reviewed’ approach to reviewing ANDAs.

The GPhA called the programme a “welcome paradigm shift forindustry with goals for timely application reviews and parity ofinspections of foreign and domestic establishments”.

Finished-dosage form manufacturers will provide 80% of resourcesfor the programme, whilst the remaining 20% will come from activepharmaceutical ingredient (API) producers. Fees for foreign facilitieswill be adjusted to reflect additional travel costs for foreign inspections.

Further discussions between the FDA and industry will coverproposals to ensure that non-payment of fees will not affect the receiptdate of an ANDA and will therefore not affect issues relating to first-to-file exclusivity. The FDA said the date of receipt of paragraph IVapplications would not be affected if fees were paid within 20 calendardays of the application being submitted. However, if payment was notreceived, the agency would ‘refuse to receive’ the application.

The GPhA has also requested a 75% refund of fees for applicationsthat fall foul of the agency’s ‘refuse to receive’ criteria, whilst the FDAhas offered to refund three-quarters of the DMF fee for DMFs that arenot referenced after five years. A deadline of 9 September has been setby the FDA to produce a final ‘agreed goals’ letter and draft legislationfor internal review. The programme must be approved by Congress. G

REGULATORY AFFAIRS

FDA agrees budgetfor user-fee scheme

Gen 2_9_11 Pgs.14-16.qxd 1/9/11 07:35 Page 2

Australia’s government should reverse its decision to deferimplementing price increases, according to a report by the country’s

Senate Finance and Administration References Committee. The increaseshad been recommended by the country’s Pharmaceutical BenefitsPricing Authority (PBPA) for products listed on the PharmaceuticalBenefits Scheme (PBS). Listing certain new medicines on the PBSshould also not be deferred, the committee recommended.

“Sponsors must be confident that price increases for medicineswill be granted when recommended by the PBPA, after its rigorousreview mechanism,” the Australian Generic Medicines IndustryAssociation (GMiA) told the committee in July (Generics bulletin,5 August 2011, page 12). The association emphasised that suchincreases were “generally only recommended by the PBPA where thesponsor can demonstrate both a clear commercial need and where thereis no alternative medicine available at a more competitive price”. Oneof the GMiA’s members had already delisted a product from the PBSas a result of the government’s decision.

The report’s recommendation that the Australian government shouldnot indefinitely defer listing a number of new brands on the PBS wasendorsed by more than 50 submissions from interested parties. TheGMiA acknowledged that the government’s decision to exclude thesenew products – which the committee called a “false economy” – wouldeventually affect the generics industry. G

MARKET NEWS


PRICING & REIMBURSEMENT

Committee supportsGMiA on PBS pricing

Companies have until 17 October to submit offers to supply 105active ingredients or combinations to the 25 million Germans

covered by the AOK statutory health insurance fund. As in the fund’sprevious six tender processes, the AOK will award an exclusive, two-year supply contract for each molecule in a given region. Contracts willstart on 1 April 2012. However, it has extended from seven to eightthe number of regions by splitting a region covering the Rhine valley.

The portfolio put out to tender has a combined annual turnover ofmore than C2 billion (US$2.9 billion) and comprises largely moleculesfor which current contracts will expire on 31 March next year, as wellas recent patent expiries such as anastrozole and esomeprazole. Amongthe best-selling drugs on the list published in the European Union’sOfficial Journal on 27 August are olanzapine and pantoprazole.

The AOK – which is currently investigating thousands of casesof false invoices for drugs never dispensed by pharmacists – savedC601 million last year through supply contracts, according to officialfigures, accounting for 46% of all funds’ C1.31 billion saving. TheAOK anticipates making a similar saving in 2012.

Meanwhile, the DAK fund has awarded two-year supply contractsfor 30 active ingredients, starting on 1 October. For most of themolecules – which include anastrozole, esomeprazole, repaglinideand risedronate – the fund has awarded deals to three suppliers. Theportfolio has combined annual sales of C123 million. G

PRICING & REIMBURSEMENT

German AOK insurerissues more tenders

Gen 2_9_11 Pgs.14-16.qxd 1/9/11 07:35 Page 3

Interested parties have until mid-October to comment on HealthCanada’s proposed revisions to its guidance on the country’s Patented

Medicines (Notice of Compliance) or PM(NOC) patent-linkageregulations. The regulatory agency said the proposed changes reflected“growing concerns and challenges” about requirements imposed onfirms that submitted administrative drug submissions under licensingagreements. These had to re-address patents listed on the country’spatent register against the reference drug.

Under the planned changes, licensees that seek an NOC –effectively a marketing authorisation – by cross-referencing anothernew drug submission (NDS) or abbreviated new drug submission(ANDS) will not have to re-address patents. Nor will they be able tochallenge patents under the PM(NOC) regulations.

According to Health Canada’s recently-released report on thePM(NOC) regulations and data protection, the regulator’s Office ofPatented Medicines and Liaison (OPML) rejected 153 of 599 patentssubmitted for listing last year. While the vast majority of products hadno more than three patents listed against them, eight were protectedby 20 listed patents.

During 2010, originators started 61 applications to prohibit genericapproval in Canada’s Federal Court. With one such application grantedand 14 discontinued, 46 were still pending at the end of the year. Threecourt cases over data protection were started in Canada last year. G

MARKET NEWS


INTELLECTUAL PROPERTY

Canada intends torevise linkage guide

Generic competition saved England’s National Health Service (NHS)around £9.5 billion (US$15.5 billion) last year, the British Generic

Manufacturers Association (BGMA) has stated, drawing on statisticsjust released by the NHS Information Centre. The savings total washigher than the NHS’ total drugs bill of £8.2 billion, the BGMA pointedout. The figure was based on calculating the drugs bill if all prescriptionmedicines had cost the NHS the average price of a branded drug.

According to the NHS prescribing statistics, generics cost onaverage £4.01 per item, compared to £16.25 for each item prescribedand dispensed as a proprietary brand. Items prescribed generically butdispensed with a brand cost an average of £23.66.

Of 927 million prescriptions – representing an increase of 4.6%over 2009 and a rise of more than two-thirds compared to 2000 – 67.4%were dispensed with generic medicines. However, generics accountedfor just 29.6% of the total cost. The overall average cost of genericsto the NHS was 3% lower than in 2000, the BGMA pointed out, whilstthe cost of branded drugs had risen by 23% over the same period.

Losartan reduces costs by nearly £25mnGeneric versions of losartan entering the market in 2010 resulted

in prescriptions for the product rising by 5.9%, while costs droppedby more than a third, or £24.9 million. More than three million packsof generics were dispensed at a cost of just £35.7 million. At the sametime, volumes dispensed of branded 50mg and 100mg losartan tabletsfell by more than 90%, or 2.5 million packs worth £51.0 million.

Rivals to Sanofi’s Plavix (clopidogrel) 75mg tablets were launchedat the start of 2010, driving prices down from over £36 for a pack of30 tablets to just under £30. Prices fell even further to under £4 bythe end of the year when the product was classified in category M ofthe Drug Tariff reimbursement list, which is based on actual tradeprices. A similar trend was seen for venlafaxine, whilst category M pricesfor metformin, omeprazole and simvastatin increased slightly. G

MARKET RESEARCH

England’s NHS saved£9.5bn during 2010

Brazil, India and Israel have been added to the list of countries fromwhich prescription drugs can be imported into Bermuda. The

country’s health minister, Zane DeSilva, said the list had previouslyincluded “a handful of countries that exclude the leading manufacturersin quality generic drugs”. Expanding the list to include the three “keygeneric manufacturing markets” would “increase the range of optionsfor Bermudian suppliers”, he added.

At the same time, quality-assurance measures – including arequirement that all importers of prescription drugs be registered withBermuda’s department of health and that manufacturing plants mustmeet “best practice standards” and be approved by regulators in Canada,the European Union (EU) or the US – will be introduced into Bermuda’simport legislation.

However, political party One Bermuda Alliance criticised DeSilvafor having chosen to expand the import list “without consulting thePharmacy Inspector or the Bermuda Pharmaceutical Association”.The minister had also failed to provide any evidence to back up hisclaim that “Mr and Mrs Bermuda can save up to US$2,000 a monthusing generic drugs”, the party complained. G

REGULATORY AFFAIRS

Trio join Bermuda shortlist

Gen 2_9_11 Pgs.14-16.qxd 1/9/11 07:35 Page 4

Spanish generics player Farmalider has formed a strategic allianceto develop and market oncology generics and biosimilars with

privately-owned biotechnology specialist Curaxys. Furthermore, thetwo Spanish firms plan to set up a production plant for injectableoncology drugs, proteins and vaccines.

The two firms said the deal would give Madrid’s Farmalider accessto Curaxys’ development portfolio, which includes erythropoietin,granulocyte-colony stimulating factor (G-CSF), growth hormones andinsulin, as well as the monoclonal antibodies rituximab and trastuzumab.In turn, Cadiz-based Curaxys would benefit from Farmalider’s broadgenerics portfolio and formulation expertise.

An initial phase of the facility construction, allowing the partnersto make biopharmaceuticals, is scheduled for completion by September2012. A second phase will add capacity for other injectable drugs,using technology developed by Farmalider, and will give the two firmsan annual capacity of 20 million oncology units by early 2014. G

PRODUCT NEWS


ONCOLOGY DRUGS

Farmalider finds dealfor oncology drugs

Asupplementary protection certificate (SPC) protecting MerzPharma’s Ebixa (memantine) Alzheimer’s disease brand until 14

April 2014 is invalid because the underlying patent was invalid,Germany’s supreme court, the Bundesgerichtshof, has ruled. ChemoIbérica, Neuraxpharm, Synthon and Teva had each challenged the SPC.

“The basic patent teaches the use of adamantine derivatives for bothcerebral ischaemia and Alzheimer’s disease,” the federal supreme courtstated in upholding a federal patent court decision from 2007. “The useof a medicine with the active ingredient memantine for treatingParkinson’s disease had already at the time of filing been disclosedas effective in the state of the art,” the court stated.

“The basic patent,” the court continued, “neither provides a technicalteaching of how to treat an illness that had not previously been treatedwith memantine, nor discloses memantine’s suitability for treating apatient group in which the active ingredient had not previously beenused.” Therefore, both the basic patent and the associated SPC werenot novel, it found.

Given this finding, the German court did not have to address theissue recently covered by a decision of the European Court of Justice(ECJ), namely whether the SPC was valid in light of memantinemarketing authorisations granted before European Directive 65/65was implemented (Generics bulletin, 5 August 2011, page 17). G

ALZHEIMER’S DISEASE DRUGS

Germany rejects Ebixa SPC

The ‘totality-of-the-evidence’ approach that the US Food and DrugAdministration (FDA) adopted last year in approving Sandoz’

generic enoxaparin sodium will also serve as the agency’s model forassessing biosimilars, senior FDA officials have stated in an articlepublished in The New England Journal of Medicine. Learning fromthe path taken by the European Medicines Agency (EMA) will alsobe important, the officials add.

Acknowledging that enoxaparin – which was approved under theabbreviated new drug application (ANDA) pathway reserved for small-molecule generics (Generics bulletin, 6 August 2010, page 1) – differsfrom proteins, although it is “structurally complex”, the FDA officialssuggest that the same “fingerprint-like” identification of productcharacteristics used for that product should also apply to biosimilars.

“Although additional animal and clinical studies will generally beneeded for protein biosimilars for the foreseeable future, the scope andextent of such studies may be reduced further if more extensivefingerprint-like characterisation is used,” state the FDA authors – RachelBehrman, Steven Kozlowski, Karen Midthun and Janet Woodcock.

Noting that EMA guidance “has suggested product-specificrequirements for structural, animal and clinical studies”, the officialsmaintain that “it’s unlikely that a ‘one size fits all’ systematic assessmentof biosimilarity can be developed”. According to the officials, the draftguideline on biosimilar monoclonal antibodies released by the EMAlate last year (Generics bulletin, 3 December 2010, page 1) “suggestsan increasing alignment with the totality-of-the-evidence approachfavoured by the FDA”. That guideline, they add, “introduces conceptsrelevant to the design of biosimilarity studies, including the use ofpopulations, pharmacodynamic markers and end points that are sensitiveto the potential differences between products”.

In the article entitled ‘Developing the nation’s biosimilars program’,the officials say the new biosimilars pathway “will require a newparadigm for sponsor-FDA interactions”. Before providing advice onthe scope of animal and human studies, the agency “should already havecompleted an in-depth review of comparative analytical characterisationand in vitro data,” they believe. Such a review of approval data neededwill be more extensive than current meetings with sponsors ofinvestigational new drug applications, the authors state, adding that theFDA is currently considering how to structure such interactions inlight of the biosimilars user-fee programme enshrined in legislation.

Promising a “risk-based approach” to safety factors such asimmunogenicity, the officials insist the FDA’s process “must includeproduct-specific safety monitoring” that allows adverse events to betracked and traced to individual products and manufacturers.

On the issue of interchangeability – for which the BiologicsPrice Competition and Innovation (BPCI) Act signed into law in March2010 requires a biosimilar developer to demonstrate that its productcan be expected to produce the same clinical result in any patient,and switching between products to generate no greater risk thancontinuing to use the reference product – the authors say the FDA will“carefully consider what data will be necessary”. However, they add,the agency will also “develop standards to ensure that products notdeemed interchangeable are not inadvertently substituted for a referenceproduct without the prescriber’s consent”.

According to a survey conducted by market researcher DecisionResources, clinical trials that run for six to 12 months will be insufficientto convince US payers that biosimilar monoclonal antibodies or fusionproteins have safety and efficacy equivalent to reference biologics. G

BIOGENERICS

Enoxaparin will actas a model for FDA

Teva intends to launch its Zoely (nomegestol acetate/17-beta estradiol)oral contraceptive in Europe by the end of this year after the European

Commission granted a pan-European marketing authorisation. TheEuropean Medicines Agency had given a positive opinion in March.Under the terms of its deal for Merck-Serono’s Théramex women’shealth unit (Generics bulletin, 12 November 2010, page 5), Teva holdsexclusive rights to Zoely in Belgium, France, Italy and Spain. G

ORAL CONTRACEPTIVES

Teva lines up contraceptive

Gen 2_9_11 Pgs.17-21.qxd 1/9/11 07:42 Page 3

Sandoz is seeking a declaratory judgement from a Michigan districtcourt regarding US patent 6,677,358 in a bid to trigger Caraco’s

180-day exclusivity period for repaglinide. Caraco’s dispute withNovo Nordisk challenging the ‘358 method-of-use patent’s listingagainst the Prandin diabetes brand is pending before the US SupremeCourt (Generics bulletin, 15 July 2011, page 13).

According to Sandoz, Novo Nordisk – by listing the ‘358 patentagainst Prandin in the Orange Book maintained by the US Food andDrug Administration (FDA), but failing to sue Sandoz over the patent –has created a “legal uncertainty that impairs Sandoz’ right to market anon-infringing generic product without the risk of catastrophicinfringement damages”. Thus, a declaratory judgement of non-infringement, invalidity and unenforceability is needed.

Sandoz alleges that Novo Nordisk committed inequitable conductby failing to disclose to the US Patent and Trademark Office (USPTO)the findings of three studies that contradicted the originator’s claimsthat combining repaglinide and metformin had a synergistic effect.

Furthermore, Sandoz alleges in court filings, Novo Nordisk“illegally submitted materially misleading and incomplete informationto the FDA” to prevent generics firms marketing repaglinide for non-infringing uses. The originator did so by changing a ‘use code’ for thepatent to one that did not match the patented method of use.

In January this year, the same Michigan court found that a keyclaim of the ‘358 patent – which protects Prandin until 12 June 2018 –was invalid as obvious and that the patent was unenforceable due toinequitable conduct (Generics bulletin, 1 February 2011, page 15).The originator has lodged an appeal, which has been stayed pendingthe Supreme Court’s ruling on the use-code listing. G

PRODUCT NEWS


DIABETES DRUGS

Sandoz seeks rulingon US Prandin patent

Italy’s competition commission has deferred until 14 October a decisionon its procedure against Pfizer for delaying generic competition to

its Xalatan (latanoprost) glaucoma treatment. The commission said ithad extended the original closing date of 29 July in light of the “quantityand complexity of the evidence collected during the investigation”.

Acting on information supplied by Teva’s Ratiopharm, thecommission had last year opened an investigation into whether Pfizerhad abused a dominant position by improperly obtaining asupplementary protection certificate (SPC) for Xalatan (Genericsbulletin, 12 November 2010, page 1). Pfizer earlier this year offereda settlement deal that included granting an irrevocable, royalty-freelicence to a disputed divisional patent and withdrawing a request for apaediatric SPC extension. The originator also offered to drop litigationagainst generics firms including Alapis, Arrow, EG, Mylan, Ratiopharm,Sifi and Tubilux (Generics bulletin, 30 June 2011, page 14). G

OPHTHALMOLOGY DRUGS

Italy defers decisionover Xalatan abuse

Apotex has failed in its broad attack on the validity of Australianpatent 670,491, which protects Sanofi’s Arava (leflunomide) until

29 March 2014. Federal Judge Jayne Jagot found that Apotex’ genericinfringed not only the ‘491 patent, but also Sanofi’s copyright on Arava’sproduct information.

Having decided that claim 1 of the ‘491 patent covered a methodof leflunomide being administered such that it treated or preventedpsoriasis, Jagot said neither the Bartlett nor Rozmann prior-art articlescited by Apotex “discloses any matter which undermines the noveltyof the patent”. Furthermore, she added, “the evidence does not supportthe inference that European Patent EP0,013,376 was part of the commongeneral knowledge before the priority date of the [‘491] patent”. Apotex’attacks on the sufficiency and utility of the patent also failed.

Turning to infringement, Jagot noted that Australia’s TherapeuticGoods Administration (TGA) had approved product information forApo-leflunomide in July 2008. “Apotex’ approved product information,on any view, instructs a medical practitioner to use Apotex’ leflunomideproduct for the treatment of psoriatic arthritis,” she observed, addingthat this amounted to direct infringement of claim 1 of the ‘491 patent.

On the issue of copyright, Jagot noted that similar disputes wouldin future be rendered moot by recent changes to Australia’s copyrightlaws (Generics bulletin, 20 May 2011, page 16). Nevertheless, she foundthat Apotex had – before the recent legislative changes – infringedSanofi’s copyright by reproducing large parts of Arava’s productinformation. Jagot was unimpressed by Apotex’ argument that therewas an implied licence for generics firms to copy originators’ productinformation, especially as generic labelling was not required to beidentical to that of the reference brand. G

ARTHRITIS DRUGS

Australia upholds Arava patent

Teva’s Ratiopharm has failed to convince Germany’s federal patentcourt, the Bundespatentgericht, that a supplementary protection

certificate (SPC) protecting Lundeck’s Cipralex, Entact and Prilect(escitalopram oxalate) antidepressants until 1 June 2014 is invalid.

In September 2009, Germany’s federal supreme court, theBundesgerichtshof, had rejected an attack on the SPC made on thegrounds the escitalopram enantiomer was not a distinct active ingredientfrom the citalopram racemate from which it had been separated.However, Ratiopharm – which was not a party in that litigation – arguedthat new facts about how the two ingredients worked were now clear.

Noting that the escitalopram enantiomer had first been authorisedin Germany on 8 April 2003 as the oxalate salt form, the patent courtrejected Ratiopharm’s argument that as escitalopram was essentiallythe same active ingredient as the racemate citalopram, so the true dateof the first marketing authorisation should have been 1996, whenLundbeck’s Cipramil was approved.

“In light of the totality of the evidence provided,” the courtconcluded, “it is not sufficiently clear that the authorised medicinesCipralex and Cipramil … possess the same therapeutic effect.” The factthat citalopram and escitalopram had recently been placed in the sameGerman reference-price group (Generics bulletin, 15 July 2011, page17) was not indicative of the same effect, the court added, decliningRatiopharm’s request to refer the case to the European Court of Justice.G

ANTIDEPRESSANTS

Ratiopharm fails in SPC case

ALMUS PHARMACEUTICALS is launching a range of brandedvitamins in the UK in conjunction with local firm Vitabiotics. Chiefexecutive officer Tony Foreman said Almus’ “first-ever vitaminsrange” would be tailored “specifically for independent pharmacies”.G

IN BRIEF

Gen 2_9_11 Pgs.17-21.qxd 1/9/11 07:42 Page 4

Teva Pharmaceuticals USA has failed to have Pfizer’s US method-of-use patent 6,469,012 ruled invalid and/or unenforceable by a Virginia

district court. The ‘012 patent – which covers compounds, includingViagra’s active ingredient sildenafil, as treatments for erectile dysfunction– expires on 22 October 2019. With Teva having admitted infringementduring a 12-day bench trial held in June, Judge Rebecca Beach Smithruled that the ‘012 patent was not obvious in light of the prior art,such as European patents EP0,463,756 and EP0,526,004. While thetwo European patents between them disclosed all of the compoundscovered by the US ‘012 patent, Smith noted, the potential cardiovascularuses of the listed compounds did not include erectile dysfunction.

Citing the US Supreme Court’s landmark KSR ruling on combiningprior-art references, Smith said “the mere fact that the course oftreatment was suggested is not sufficient to demonstrate that it wouldhave been obvious to try”. Even if a skilled person had been motivatedto test one of the compounds disclosed in the European patents, he wouldhave had “no reasonable expectation of success” in treating erectiledysfunction, she added. The claimed compounds were vasodilators,which were known to cause erectile dysfunction, Smith pointed out.

Teva had also challenged the ‘012 patent as invalid for obviousness-type double patenting in light of US patent 6,100,270, which was issuedtwo years before the ‘012 patent and covered compounds for treatingimpotence. “The structural differences between the formula in Claim 1of the ‘270 patent and the compounds in the ‘012 patent render thempatentably distinct,” Smith decided.

On enforceability, Smith rejected Teva’s inequitable-conduct attackin light of the recent Federal Circuit Therasense decision (Genericsbulletin, 10 June 2011, page 15) that tightened the requirements forproving inequitable conduct. There was “utterly no evidence” thatPfizer’s failure to disclose a ‘statement of claim’ from Canadian patentlitigation was material and deliberately withheld with intent to deceive.

The only other patent listed against Viagra in the Orange Bookmaintained by the US Food and Drug Administration (FDA) – USpatent 5,250,534, which is the counterpart to the European ‘756patent – expires on 27 March 2012. In April 2007, Teva had receivedtentative FDA approval that would have allowed it to enter thesildenafil market once the ‘534 patent expires next year.

Pfizer – which noted that no trial dates had been set in its disputeswith other generics firms over the ‘012 patent – reported US Viagrasales in the first half of this year slightly higher at US$488 million. G

PRODUCT NEWS


ERECTILE DYSFUNCTION DRUGS

Viagra patent in USstands up to attack

Acino has reached a settlement with Mundipharma over Europeanpatent-infringement lawsuits relating to the Swiss firm’s generic

oxycodone. All litigation between Acino and Mundipharma involvingpatents protecting the Oxycontin and Oxygesic brands to November2012 has been dropped and Acino’s marketing partners will be ableto continue selling the Swiss company’s formulation of the opioidanalgesic in Germany. The terms of the deal were not disclosed.

In December, a Norwegian Court of Appeals ruled that Acino’sproduct infringed Mundipharma’s oxycodone patents (Generics bulletin,14 January 2011, page 19). However, a district court in Helsinki,Finland, found for the Swiss firm in a similar dispute. G

ANALGESICS

Acino settles on EU oxycodone

Actavis and Par Pharmaceutical have each filed abbreviated new drugapplications (ANDAs) in the US for generic versions of Avanir’s

Nuedexta (dextromethorphan/quinidine) 20mg/10mg capsules. Theoriginator responded by suing the two firms for infringing US patentsRE38,115 and 7,659,282, which expire on 26 January 2016 and 13August 2026 respectively. Another patent listed against the treatmentfor involuntary laughing or crying in the Orange Book maintained bythe US Food and Drug Administration (FDA) expires on 27 Marchnext year. However, Avanir – which reported Nuedexta sales ofUS$1.93 million in the three months ended 30 June 2011, havinglaunched the brand in late-January – said it had secured 30-month stayson ANDA approval by suing within the statutory 45-day window. G

NEUROLOGY DRUGS

Actavis takes aim at Nuedexta

Alvogen has launched generic versions of Pfizer’s Aromasin(exemestane) 25mg tablets and Campto (irinotecan) 20mg/ml vials

in Romania, along with a rival to Novartis’ Femara (letrozole) tablets.Noting that all three oncology treatments were fully reimbursed by thecountry’s national health insurance fund, Alvogen said it was planningto launch a total of 13 products in Romania during 2011. G

ONCOLOGY DRUGS

Alvogen adds three in Romania

Consilient Health claims it is the first generic player to bring bothgalantamine prolonged-release capsules and pioglitazone

tablets to the UK market. The company’s 28-count packs of Galsya XL(galantamine) 8mg, 16mg and 24mg prolonged-release capsules areequivalent to Shire’s Reminyl XL treatment for Alzheimer’s disease.“UK sales of galantamine XL prolonged-release capsules wereestimated at £24 million (US$40 million) at manufacturers’ pricesin 2010,” Consilient commented, citing IMS Health data.

Putting UK pioglitazone sales in the same period at £72 million,Consilient said its 15mg, 30mg and 45mg tablets – supplied in 28-count packs – were the country’s first rival to Takeda’s Actos diabetesbrand. The generic version included all the new contraindications andwarnings required following a recent review by the European MedicinesAgency’s committee for human medicinal products (CHMP), theUK-based firm noted (Generics bulletin, 5 August 2011, page 20).

Consilient’s first-to-market introductions of galantamine andpioglitazone came shortly after it had claimed a similar head start withlevetiracetam tablets (Generics bulletin, 5 August 2011, page 17). G

ALZHEIMER’S DISEASE DRUGS/DIABETES DRUGS

Consilient can claimtwo firsts in the UK

HOSPIRA has secured US approval for gemcitabine 38mg/mlsolution. The injectables specialist intends to launch the equivalentto Eli Lilly’s Gemzar in early September, joining its existing freeze-dried formulations. Hospira and Lilly have now settled their USgemcitabine patent litigation. G

IN BRIEF

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Teva Canada has held off Eli Lilly’s appeal against a Canadianfederal court’s earlier ruling that Lilly’s Canadian patent 2,209,735

was invalid for lack of utility. The ‘735 patent protected Lilly’s Strattera(atomoxetine) brand for attention deficit hyperactivity disorder (ADHD).

A panel of the Federal Court of Appeal judges found “no palpableand overriding error” in the lower court’s decision that the single pilotstudy on which Lilly had relied to demonstrate that atomoxetine was aneffective ADHD treatment did not meet the required utility criterion ofCanada’s Patent Act.

Meanwhile, a Vancouver federal court has rejected Apotex’ utilityattack on Roche’s Canadian patent 1,333,285, which protects itsCellCept brand. The court barred Apotex from receiving a Notice ofCompliance (NOC) – or marketing authorisation – for mycophenolatemofetil until the ‘285 patent expires on 29 November this year. JudgeJames O’Reilly found that studies in rats and monkeys were sufficientto show mycophenolate mofetil’s utility as an immunosuppressant. G

PRODUCT NEWS


ATTENTION DEFICIT HYPERACTIVITY DISORDER DRUGS

Teva Canada winsatomoxetine appeal

Mylan believes it will be entitled to 180-day exclusivity when itlaunches frovatriptan succinate 2.5mg tablets that are equivalent

to Endo’s Frova migraine remedy.Endo has just sued the US generics firm in a Delaware district

court for alleged infringement of US patents 5,637,611 and 5,827,871– which expire on 10 June 2014 and 27 October 2015 respectively – aswell as US patent 5,464,864 which expires on 7 November 2015. TheOrange Book maintained by the US Food and Drug Administration(FDA) lists two other patents against Frova with expiry dates of 16December 2013 and 1 April 2014.

The analgesics specialist said it had sued Mylan within the 45-daywindow that would trigger an automatic 30-month stay on final FDAapproval, provided there was no earlier court ruling on the patents.

Quoting IMS Health data that showed Frova had US sales ofUS$68.2 million in the year ended 30 June 2011, Mylan said frovatriptantook to 43 the number of first-to-file opportunities it had within its 162abbreviated new drug applications (ANDAs) awaiting approval. G

MIGRAINE REMEDIES

Mylan expects first on Frova

PRASCO has started shipping rivals to Furadantin (nitrofurantoin)25mg/5ml oral suspension and Ponstel (mefenamic acid) 250mgcapsules in the US through an authorised generics deal with the brands’owner, Shionogi. In May this year, Amneal launched the first – and todate only – generic alternative to Furadantin antibiotic suspension(Generics bulletin, 10 June 2011, page 22). India’s Lupin has justjoined Micro Labs in holding a US approval for the non-steroidalanti-inflammatory drug (NSAID) mefenamic acid as 250mg capsules.

DR REDDY’S is set to have its atorvastatin 10mg, 20mg, 40mgand 80mg tablets reimbursed in New Zealand from 1 November thisyear under proposals unveiled by the country’s pharmaceuticalmanagement agency, Pharmac. Reddy’s would face a reimbursementprice cut on 1 September 2012 when Pfizer’s Lipitor original willlose protection from delisting or a reduction in reimbursement.

PAR has received a letter from Taiwan’s TWi Pharmaceuticalsnotifying it of a paragraph IV challenge to two patents protecting thefirm’s Megace ES (megestrol acetate) oral suspension. The UScompany said with its partner Elan it was examining TWi’s letter,and intended to enforce US patents 6,592,903 and 7,101,576, whichexpire on 21 September 2020 and 22 April 2024 respectively. Patentlitigation would likely result in an automatic 30-month stay ongeneric approval, Par said, adding that TWi had alleged both patentinvalidity and non-infringement.

HELVEPHARM has secured a Swiss marketing authorisation foratorvastatin 10mg, 20mg, 40mg and 80mg tablets, while Mepha hasgained clearance for the three lower strengths. Helvepharm’s sistercompany, Zentiva, has received approvals for irbesartan 150mg and300mg tablets, including in combination with hydrochlorothiazide.

FIVE COMPANIES – Apotex, Mylan, Sun Pharma, Teva and Torrent –secured final US approval for alfuzosin hydrochloride 10mgextended-release tablets after six-month paediatric exclusivity attachedto US patent 4,661,491 ended on 18 July this year. The tablets areequivalent to Sanofi’s Uroxatral treatment for benign prostatichyperplasia, which had US sales of US$241 million in the 12months ended 30 June 2011.

AMNEAL has bolstered its US generics portfolio by launching fourproducts. They are lorazepam 0.5mg, 1mg and 2mg tablets; meclizine12.5mg and 25mg tablets; promethazine 12.5mg, 25mg and 50mgtablets; and venlafaxine tablets in five strengths.

HEXAL has introduced an “exclusive” 70mg/100ml once-a-weeksolution to its range of alendronate medicines in Germany. TheSandoz subsidiary said the orange-flavoured, sugar-free solutionreached the stomach four-times faster than alendronate 70mg tablets.

TEVA has failed to overturn on appeal a New York district court’sruling that US formulation patent 5,214,052 – which protects until30 June 2014 the Argatroban anticoagulant that is marketed byGlaxoSmithKline for Mitsubishi Tanabe – was neither anticipatednor obvious in light of prior-art articles.

SANDOZ has extended its exclusive development and marketing dealfor Vectura’s VR315 combination asthma therapy to cover marketsincluding Australia, Canada, Japan and South America. Sandoz alreadyhas rights to the drug – which also treats chronic obstructive pulmonarydisease (COPD) – in Europe, but returned US rights to the UK-baseddeveloper (Generics bulletin, 26 March 2010, page 18). Vectura hasnow licensed US rights to VR315 to an undisclosed company. G

IN BRIEF

Pfizer has been ordered to clarify advertisements for its authorisedgeneric of Efexor-Exel (venlafaxine) 75mg and 150mg extended-

release capsules in Belgium after the country’s medicines agency,AFMPS, concluded that the firm’s advertising could mislead doctors.

In June, advertisements in the pharmacy press and mailed directlyto doctors promoted Pfizer’s venlafaxine using the slogan: “Finally,the true generic of Efexor-Exel”. However, AFMPS said theseadvertisements could create confusion. The agency ordered Pfizerto write a ‘dear doctor’ letter explaining that the firm’s product wasnot the only generic venlafaxine available in Belgium, and that allgeneric versions of Efexor-Exel met the same scientific standardsof quality, efficacy and safety. G

ANTIDEPRESSANTS

Pfizer fools Belgian doctors

Gen 2_9_11 Pgs.17-21.qxd 1/9/11 07:42 Page 6

Mylan’s Alphapharm, Dr Reddy’s and Par Pharmaceutical havefailed to convince a Texas district court that two US patents that

protect Treximet (sumatriptan/naproxen) tablets until August 2017are invalid, unenforceable and not infringed by their abbreviatednew drug applications (ANDAs). Furthermore, a Treximet patentrunning until February 2025 is valid, enforceable and infringed byReddy’s and Par, Judge Leonard Davis decided.

Teva had last year agreed to be bound by the outcome of the districtcourt’s verdict, which can be appealed (Generics bulletin, 23 April2010, page 11). Davis earlier this year issued an injunction to preventPar launching a rival to Treximet ‘at risk’ with 180-day exclusivity(Generics bulletin, 22 April 2011, page 13).

Davis denied that US patents 6,060,499 and 6,586,458 – both ofwhich expire on 14 August 2017 – were anticipated and obvious inlight of prior-art references, most of which had been considered by theUS Patent and Trademark Office (USPTO) before granting the patents.“The references, separate or in combination, do not teach or suggest thesimultaneous administration of sumatriptan and naproxen,” he stated.

Furthermore, the prior-art references did not “establish that it wasobvious to a person of ordinary skill in the art to formulate naproxensodium and sumatriptan into a bi-layer configuration”, as disclosed inPozen’s US patent 7,332,183, which expires on 2 February 2025. Indismissing inequitable-conduct defences, Davis said there was noevidence that Pozen had intentionally misled the USPTO.

Addressing infringement, Davis said “the ‘499 patent does notsupport defendants’ attempt to limit the term ‘therapeutic package’ to aparticular type of packaging”. Furthermore, the ANDA labelling wouldinduce infringement of the ‘499 patent, he said. The generics firms’argument on the ‘458 patent – that Pozen had improperly compared theANDA products to Treximet, rather than the patent – was also dismissed.

Turning to the ‘183 patent covering tablets containing sumatriptanand naproxen that are “segregated into separate layers”, Davis said that,under the doctrine of equivalents, Reddy’s and Par’s formulations metthe patent’s claim that “substantially all of the triptan is in a first layerof said tablet, and substantially all of the said naproxen is in a second,separate layer”. Pozen did not assert the patent against Alphapharm.

GlaxoSmithKline – which markets the Treximet migraine remedyin the US under licence from Pozen – reported US brand sales of £28million (US$46 million) in the first half of this year. G

PRODUCT NEWS


MIGRAINE REMEDIES

US firms lose out inruling on Treximet

Adeal between Germany’s statutory health insurance funds, theGKV, and the German pharmacists’ association, the DAV, that states

that biosimilars should be substituted for one another, but not for originalbiologic drugs, will damage industry and severely limit savings,according to the country’s generics industry association, Pro Generika.

Bork Bretthauer, Pro Generika’s managing director, insisted thatswitching solely between biosimilars would not create savings. “Patientswith serious illnesses will be severely unsettled by this substitutionfor substitution’s sake,” he argued, insisting that substituting biologicdrugs should be a matter solely for doctors.

Under the latest amendment to the framework agreement betweenthe GKV’s management committee and the DAV that comes into effecton 1 October 2011, those products considered to contain the same activeingredient for the purposes of substitution will include three epoetinalfa drugs – Abseamed from Medice, Binocrit from Sandoz andEpoetin alfa Hexal from Hexal. Hospira’s Retacrit and Silapo fromStada’s Cellpharm will be considered to be interchangeable epoetinzeta biosimilars, while pharmacists will be able to switch betweenCT Arzneimittel’s Biograstim and Ratiopharm’s Ratiograstim filgrastimproducts. The agreement also groups together two interferon beta-1bbrands – Bayer’s Betaferon and Novartis’ Extavia. G

BIOGENERICS

German body slamsdeal on biosimilars

Grupo Uriach believes it will be among the vanguard of Spanishgenerics players offering alternatives to UCB’s Keppra

(levetiracetam) epilepsy treatment. The Spanish firm stressed that thelevetiracetam 250mg, 500mg, 750mg and 1,000mg film-coated tabletsthat it developed and manufactured in-house were the only rivals toKeppra to obtain a favourable opinion during a recent meeting of theevaluation committee for human medicinal products, Codem, withinSpain’s Aemps regulatory agency.

Barcelona-based Uriach – which achieved a turnover of C125million (US$180 million) last year – said it was also developing genericdossiers for aripiprazole, bosentan and memantine tablets, as well asfor strontium ranelate sachets. G

EPILEPSY DRUGS

Uriach leads on levetiracetam

Sandoz has expanded to 11 its range of injectable oncology drugs inthe US by introducing ready-to-use single-vial formulations of

docetaxel, the active ingredient in Sanofi’s Taxotere brand. Citing IMSHealth data for the year ended June 2011 that showed total US sales ofbranded and generic docetaxel at US$1.1 billion, Sandoz said its20mg/2ml, 80mg/8ml and 160mg/16ml ready-to-use vials required lesshandling by healthcare professionals than Taxotere’s two-vial format.

Hospira also offers a single-vial alternative to Taxotere, while Intasand Sun Pharma have entered the US market with dual-vial formulations.Speaking at the end of July, Hospira’s chief executive officer Mike Ballsaid the firm had obtained “peak market-share levels of over 50% atstable pricing levels of 40-45% off” the price of Taxotere (Genericsbulletin, 5 August 2011, page 7). G

ONCOLOGY DRUGS

Sandoz offers docetaxel vials

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PIPELINE WATCH


August brought the expiry of European supplementary protectioncertificates (SPCs) for two major recombinant biologic drugs – the

thrombolytic product Rapilysin (reteplase), as well as Novo Nordisk’sfast-acting diabetic treatment NovoLog/NovoRapid (insulin aspart),which achieved 2010 worldwide sales of US$2.3 billion. However, patentprotection remains in force for Novo Nordisk’s other formulationscontaining insulin aspart, notes patent intelligence expert GenericsWeb,including for the Danish company’s NovoMix preparations.

GenericsWeb also highlights the expiry of the Swiss SPC forNovartis’ Diovan (valsartan) blockbuster antihypertensive (see Figure 1).“As Swiss SPCs are governed by national law, the Swiss SPC has notbenefitted from a six-month paediatric SPC extension, in contrast toother European territories,” it points out.

In several European countries, drospirenone and ethinylestradiol –both of which are used in many leading oral contraceptives – also lostexclusivity during August (see Figure 2). Roche’s Valcyte (valganciclovir)antiviral has lost data-exclusivity protection in those European Unionmember states that historically applied 10-year terms: Belgium, France,Germany, Italy, Luxembourg, the Netherlands, Sweden and the UK.

GenericsWeb has also identified potential targets for future genericdevelopment: extension applications have been filed in Japan for Chugaiand Taisho’s osteoporosis vitamin D3 analogue eldecalcitol (see Figure 3);and in Europe, new SPC applications have been identified for twoveterinary drugs – tildipirosin, indicated for treating bacterial respiratorydisease in cattle and swine; and Du Pont’s pesticide indoxacarb forpreventing and treating fleas in cats and dogs. G

Want more? This data is extracted from the monthly update for Pipeline Scope, an online intelligence tool that provides fastaccess to reliable information on key patent, SPC and data-protection expiries, covering 44 countries and over 1,500 INNs.

INN Event

Eldecalcitol First extension applications published in Japan

Indoxacarb First patent family for this molecule has beenidentified as ‘key’ following publication ofSPC applications in Bulgaria and Italy

Tildipirosin First patent family for this molecule has beenidentified as ‘key’ following publication of anSPC application in the Netherlands

Figure 3: Molecules in the spotlight, based on recent regulatory or litigationevents (Source – GenericsWeb)

Molecules in the spotlight

INN Country

Dorzolamide Cyprus

DTPA vaccine; FranceDTPA-HB vaccine

Etoposide Switzerland

Florfenicol Hungary

Insulin Aspart Austria, Belgium, Czech Republic, Denmark,Finland, France, Germany, Greece, Ireland,Italy, Luxembourg, Netherlands, Norway,Portugal, Spain, Sweden, Switzerland, UK

Lamivudine Denmark, Finland, France, Italy, Luxembourg,Netherlands, Sweden

Mizolastine Switzerland

Olive oil/Soybean oil Netherlands

Pegfilgrastim Norway

Reteplase Austria, Belgium, Denmark, Finland, France,Germany, Ireland, Italy, Luxembourg,Netherlands, Norway, Sweden, UK

Valsartan Switzerland

Figure 1: Molecules for which supplementary protection certificates (SPCs)expire in certain markets in August 2011 (Source – GenericsWeb)

SPCs expiries in August

INN Country/Region

Agalsidase alfa European Union

Agalsidase beta European Union

Agalsidase alfa/beta European Union

Conjugated oestrogens/ Austria, Belgium, Cyprus, Czechdrospirenone Republic, Denmark, Estonia, Finland,

Greece, Hungary, Iceland, Ireland, Latvia,Lithuania, Malta, Norway, Poland,Portugal, Romania, Slovak Republic,Slovenia, Spain

Drospirenone Austria, Belgium, Cyprus, CzechRepublic, Denmark, Estonia, Finland,Greece, Hungary, Iceland, Ireland, Latvia,Lithuania, Malta, Norway, Poland,Portugal, Romania, Slovak Republic,Slovenia, Spain

Ethinylestradiol Austria, Belgium, Cyprus, CzechRepublic, Denmark, Estonia, Finland,Greece, Hungary, Iceland, Ireland, Latvia,Lithuania, Malta, Norway, Poland,Portugal, Romania, Slovak Republic,Slovenia, Spain

Gadofosveset Australia

Human papillomavirus Australiavaccine

Nitric oxide European Union

Solifenacin Australia

Valganciclovir Belgium, France, Germany, Italy,Luxembourg, Netherlands, Sweden, UK

Data exclusivity expiries in August

Figure 2: Molecules for which data or market exclusivities expire in certainmarkets during August 2011 (Source – GenericsWeb)

For further information, visit www.genericsweb.com, or contact:Europe: +44 870 879 0081 North America: +1 704 665 1986

Or e-mail: [email protected]

Reteplase loses protection from SPCs

Gen 2_9_11 Pg.23.qxd 1/9/11 07:04 Page 3

EVENTS


26-27 September

■ Biosimilars & BiobettersLondon, UKTopics addressed at this two-day eventwill include regulatory issues, monoclonalantibodies and commercial strategies.

Contact: SMi Group.Tel: +44 207 827 6000.E-mail: [email protected]: www.smi-online.co.uk.

26-27 September

■ Generics R&D andPartnering Asia 2011Shanghai, ChinaThis event will look at emerging markets,development strategies, licensing,bioequivalence and research on stabilityof generic drugs. There will also be casestudies and panel discussions.

Contact: Broadshare Group.Tel: +86 21 6429 9855.E-mail: [email protected]: www.broadsharegroup.com.

27-28 September

■ Generics & BiosimilarsStrategiesIstanbul, TurkeyThis is a two-day conference organised byCPhI Conferences which will offer insightsinto business strategies, marketing andregulatory issues, together with thechallenges and opportunities present inthe Turkish market.

Contact: UBM Conferences.Tel: +44 207 921 8039.E-mail: [email protected]: www.generics-emea.com.

3-4 October

■ PharMeetMadrid, SpainThis event will offer opportunities to networkas well as to strike licensing deals for a widerange of products including biosimilars.

Contact: PharMeet.Tel: +34 91 637 0660.E-mail: [email protected]: www.pharmeet.com.

3-5 October

■ GPhA Technical ConferenceMaryland, USAThis annual meeting of the US GenericPharmaceutical Association (GPhA) willfeature presentations by top US Food andDrug Administration (FDA) officials

addressing key regulatory and technicalissues affecting generics firms.

Contact: GPhA.Tel: +1 202 249 7100.E-mail: [email protected]: www.gphaonline.org.

19-20 October

■ Asia Biosimilars SummitShanghai, ChinaTopics covered at this two-day event willinclude regulatory guidelines for biosimilars,accessing the market, marketing strategiesand production processes.

Contact: IQPC.Tel: +65 6722 9388.E-mail: [email protected]: www.asiabiosimilars.com.

24 October

■ CPhI WorldwidePre-Show ConferenceFrankfurt, GermanyThis half-day conference will have moduleson global API sourcing strategies, challengesand opportunities in biosimilars andbiobetters, and analysing market growth ingenerics and supergenerics.

Contact: UBM Information.Tel: +44 207 955 3833.E-mail: [email protected]: www.cphi.com/pre-show-conference.

25-27 October

■ CPhI WorldwideFrankfurt, GermanyThis three-day exhibition and networkingopportunity will also include the co-locatedevents iCSE, P-MEC and Innopack.

Contact: UBM Information.Tel: +31 2040 99 544.E-mail: [email protected]: www.cphi.com.

31 October - 3 November

■ Generics Asia SummitSingaporeWith speakers from organisations includingSanofi, Merck Serono and Wockhardt,

this is a two-day meeting with pre- andpost conference events. Topics coveredwill include regulatory issues, strategicalliances, and branded generics.

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

1-2 November

■ DIA Canadian Annual MeetingOttawa, CanadaTopics covered at this two-day conferencewill include biosimilars, risk management,pharmacovigilance, the use of scientificdata and legislative and regulatory issues.

Contact: DIA.Tel: +1 215 442 6180.E-mail: [email protected]: www.diahome.org.

15-17 November

■ World Generic MedicinesCongress Americas 2011Washington DC, USAIssues covered at this three-day event willinclude healthcare reforms, the regulatoryenvironment for biosimilars, emergingmarkets, lifecycle management, andlicensing and industry challenges.

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

21-22 November

■ EuroPLX 47Geneva, SwitzerlandThis two-day meeting provides a forumfor companies to discuss licensing,marketing and distribution opportunitiesfor patented drugs, generics, OTCmedicines and nutraceuticals.

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

1-3 November

■ 14th IGPA Annual ConferenceCape Town, South AfricaThis three-day conference is being organised by South Africa’s National Association ofPharmaceutical Manufacturers (NAPM) and is the global event of the worldwide genericsindustry. It is the annual joint meeting of the Canadian, European, Indian, Japanese,South African and US generics industry associations, the CGPA, EGA, IPA, JGA, NAPMand GPhA. Speakers will include chief executive officers of the world’s leading genericscompanies, as well as acknowledged experts in identifying market opportunities.

Contact: The Conference Company. Tel: +27 31 303 9852. E-mail: [email protected] online at www.igpacapetown2011.com.

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


Three generic ingredients were launched in the UK within days ofeach other recently, but their price decay since has followed different

paths. Actavis was among the firms to seize on expiry of a supplementaryprotection certificate (SPC) to launch levofloxacin rivals to Sanofi’sTavanic antibiotic on ‘day one’ at a 30% discount (Generics bulletin,30 June 2011, page 16). Other suppliers, however, were prepared todiscount more savagely.

Actavis also claimed ‘day one’ launches upon patent expiry foribandronic acid 50mg tablets as well as repaglinide 0.5mg, 1 mg and2mg tablets. The firm’s list prices for repaglinide equivalents to NovoNordisk’s Prandin diabetes treatment followed the 30% discountsoffered for levofloxacin. However, its list price for a 28-tablet pack ofibandronic acid 50mg was £165.32 (US$270.64), which representedjust a 10% discount to Roche’s Bondronat osteoporosis brand.

List prices are never the last word, but Actavis’ prices forlevofloxacin were dramatically undercut by others on or soon after theJune launch. Taking the example of five-tablet packs of levofloxacin250mg, Actavis’ launch price with 30% discount on the brand pricewas £5.06. WaveData was soon picking up wholesalers’ prices for thesame levofloxacin product from unnamed generics suppliers that wereas low as £1.08. This was an immediate 85% discount on the brandprice of £7.23, and a massive saving on Actavis’ list price.

The Icelandic firm soon opted for a list price of £3.80, but thiswas still more than half of the brand price.

By last month, the lowest price for five-tablet packs of levofloxacin250mg had dropped still lower to £0.77. This was an 89% discountwithin two months of generic launch. Teva seemed happy to stick at£1.08 with its price offer (see Figure 1). Nevertheless, independentpharmacists and dispensing doctors would have been smiling. Evenat £1.08, they were making an 85% dispensing profit at the Drug Tariffreimbursement price, which for the moment remains tied to the brandprice. A similar pattern was apparent for five-tablet packs of levofloxacin500mg. Last month the product could be obtained for £1.44, whichwas an 89% discount on the equivalent brand price (see Figure 2).

Figure 3 describes the price decay for 28-tablet packs of ibandronicacid 50mg. This started slowly, vindicating Actavis’ cautious discountingapproach at launch, but has since accelerated. Nevertheless, the lowestprice in August of £85.00 was only a 54% discount on both the brandprice and the Drug Tariff reimbursement price. WaveData recordedprices for Actavis and Consilient products of nearly £124 last month.Both were offering discounts of about a third on the brand price, butwere nearly £40 more expensive than some wholesalers’ offers ofproduct from unnamed suppliers.

Repaglinide discounts a few months after launch fell between thoseof levofloxacin and ibandronic acid. Taking a 30-tablet pack ofrepaglinide 1mg as an example, pharmacists could obtain the product forjust £0.64 in August. This was 84% less than the £3.92 they were payingfor the Prandin brand just two months earlier. As with levofloxacin, Tevawas much closer in price than Actavis to the lowest offers, despite acut to Actavis’ list price in July. Aspire was another generics supplierthat WaveData identified by name among the various price offers. G

Three newcomers undergo price plunges

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Figure 1: Price decay from launch for five-tablet packs of levofloxacin 250mg,showing Tavanic/Drug Tariff, lowest and some supplier prices (Source – WaveData)

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Figure 2: Price decay from launch for five-tablet packs of levofloxacin 500mg,showing Tavanic/Drug Tariff, lowest and some supplier prices (Source – WaveData)

Figure 3: Price decay from launch for 28-tablet packs of ibandronic acid 50mg,showing Bondronat/Drug Tariff, lowest and some supplier prices (Source – WaveData)

Figure 4: Price decay from launch for 30-tablet packs of repaglinide 1mg, showingPrandin/Drug Tariff, lowest and some supplier prices (Source – WaveData)

Long-term product price trends or other price analyses are available.

Please specify the product and period of time you would like toinvestigate and email your request to [email protected].

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

WANT MORE LIKE THIS?

Teva

Drug Tariff Lowest Actavis Teva


Drug Tariff Lowest Actavis Consilient



Drug Tariff Lowest Actavis Teva

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Alvogen has furthered its ambitious plans in central and easternEurope (CEE) by appointing country managers in Poland and

Croatia. The US-based firm – which is headed by former Actavis chiefRobert Wessman – currently has a CEE pipeline of more than 160products in development or pending approval.

Tomasz Czekala will lead Alvogen’s activities in Poland. Heholds a medical degree and has most recently served six years ascountry manager in Poland for injectables specialist Ebewe Pharma.

In Croatia, Alvogen has recruited former Sandoz sales andmarketing manager Jerko Jaksic to lead its local operation. A qualifiedpharmacist, Jaksic has also held several positions at Pliva.

“With solid backgrounds in the local generics industry, these newleaders will play vital roles in our regional activities,” insisted LaurentiuScheusan, Alvogen’s executive vice-president of sales and marketingfor the CEE region (Generics bulletin, 4 March 2011, page 31). G

PEOPLE


Finding information is easy these daysBut finding GOOD information is just as tough as everThat’s why OTC bulletin is Essential Reading

Visit www.OTC-bulletin.com

APPOINTMENTS

Alvogen appoints inPoland and Croatia

Lannett has appointed Jeffrey Farber as vice-chairman of its boardof directors. Farber, 50, has served on Lannett’s board since May

2006. He is the founder and president of generics distributor AuburnPharmaceutical. His father, William Farber, recently took on therole of chairman emeritus, having handed over the post of chairmanto Ronald West (Generics bulletin, 10 June 2011, page 38).

Meanwhile, the US generics specialist has named Martin Galvanas chief financial officer, replacing Keith Ruck who left to pursue otherinterests. Galvan joins from a similar role at CardioNet, having alsoheld financial roles at Rhône-Poulenc Rorer and Bristol-Myers Squibb.G

APPOINTMENTS

Farber steps up at Lannett

UK generics supplier Goldshield has promoted Jeremy Devaney tounit head for its domestic hospital generics and non-promoted

brands operation. Devaney has been with Goldshield’s hospital drugsbusiness for more than a decade.

Following a restructuring of Goldshield’s UK commercialdepartments, Pradip Mukherjee has become head of marketing, whileJane Hill is head of UK sales. Meanwhile, Bharat Karbal has addedthe role of head of speciality brands to his position as director ofmedical and regulatory affairs. G

PROMOTIONS

Goldshield promotes Devaney

The former chairman and principal shareholder of Agis Industries,Mori Arkin, is to resign from Perrigo’s board at the US group’s

annual general meeting to be held on 26 October. “Arkin’s retirementis not the result of any disagreement with the company,” Perrigo stated.

Arkin has sat on Perrigo’s board since March 2005, when the USfirm completed its US$818 million takeover of Agis (Generics bulletin,25 March 2005, page 4). He also served as president of Agis – whichwas subsequently renamed as Perrigo Israel Pharmaceuticals – fromDecember 2000 until March 2008.

Since September 2007, Arkin – who lives in Israel – has beenchairman of the board of Exalenz Bioscience, an Israeli developer ofmedical diagnostic equipment. He holds a similar position at softwarespecialist Mobile Solid.

Joe Papa, Perrigo’s chairman and chief executive officer, toldinvestors that Arkin would continue to act as an advisor to Perrigo. G

RESIGNATIONS

Arkin will step downfrom Perrigo’s board

Aceto has brought in pharma chemicals specialist Nick Shackleyto lead its “core” active pharmaceutical ingredients (APIs) business.Shackley – who will report to president and chief operating officer,

Vincent Miata – has been appointed as international senior vice-presidentof APIs. For the past three years, he has served as North Americanvice-president at BASF Pharmaceutical Ingredients and Services. G

APPOINTMENTS

Aceto brings in head of APIs

Former Mylan executive John Montgomery has decided to quithis position as head of Pfizer’s Established Products business

unit in Australia and New Zealand within weeks of having taken upthe post (Generics bulletin, 5 August 2011, page 27). “Regrettably,John and Pfizer had different expectations about his role and thebusiness,” the company told Generics bulletin. G

RESIGNATIONS

Montgomery quits Pfizer role

DSM said Philip Eykerman would become its executive vice-president of corporate strategy and acquisitions. The McKinseypartner will replace Hein Schreuder, who will soon retire. G

IN BRIEF

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