lovenox rival brings in us$292mn for sandoz - generics bulletin · 2010. 11. 1. · companynews 2...

1 N ovember 2010

Domestic sales drive Alembic’s increase 2Unichem boosted by 2formulations growthPfizer buys stake in Brazilian firm Teuto 3Teva intends to shut several 3German sitesAlliance Boots is to buy 4Germany’s AnzagIsrael’s Dexcel ships directly in Germany 6Reddy’s plans to file regulated biosimilars 7Gains in US increase Zydus’ sales growth 7

MARKET NEWS 9

UK drops plans for generic substitution 9Denmark revises its 9reimbursement rulesGermany’s AOK fund adjusts 10tender rulesCGPA slams research 11for “garbage” reportSwedish brand body promotes biosimilars11

PRODUCT NEWS 12Actavis unveils US rival to Ambien CR 12Biocon is to supply its insulin to Pfizer 13Mepha offers Swiss 14topiramate and herbsLupin strikes deal on Loestrin and Femcon 15NICE backs a wider use of clopidogrel 15Mylan plans appeal on 16paroxetine rulingReckitt is fined for abusing UK position 17

FEATURES 20Focus on differentiation 20accelerates Sandoz’ rise –A strategic focus on biosimilars, injectablecancer therapies and respiratory drugs ispaying off for Sandoz, the company’sglobal head Jeff George told Aidan Fry.

REGULARS

Events – Our regular listing 18

Price Watch UK – Our regular 19look at pricing trends in the UK

People – Caraco names Singh 22as chief executive

COMPANY NEWS 2

Sandoz’ unique generic rival to Sanofi-Aventis’ Lovenox (enoxaparin) blockbuster inthe US generated sales of US$292 million in just over two months between its launch

on 23 July and 30 September. With a market share climbing to more than 45%, theantithrombotic agent – developed in collaboration with Momenta – exceeded Sandoz’expectations, according to Sandoz’ head Jeff George.

Describing enoxaparin as “the most successful generic injectables launch ever”, Georgeacknowledged that the third-quarter sales of almost US$300 million included a degree of initialtrade stocking after Sandoz launched immediately upon US approval (Generics bulletin, 6August 2010, page 1). Further generic competition, he said, could come “at any time”.

George said Sandoz believed it was now the world’s second-largest generic injectablesplayer, behind Hospira but ahead of Fresenius Kabi and Teva. Furthermore, he added, otherfirst-to-market and exclusive launches such as extended-release amoxicillin/clavulanic acid,metaxalone and tacrolimus – as well as authorised generics of lansoprazole and losartan – hadmoved Sandoz into second place in the overall US generics market. Turnover from retailgenerics and biosimilars in the US increased by 76% in the third quarter of this year, whileSandoz’ total US sales – including bulk anti-infectives – were 78% higher at US$768 million.

Organic volume growth of 26% worldwide – in part through the enoxaparin launch – wasaugmented by an additional four percentage points from acquiring injectable oncology specialistEbewe. With average price erosion of 7% across the company, Sandoz’ constant-currency salesgrowth was 23%, which it said was almost three-times the industry average of 8%. At actualexchange rates, Sandoz’ turnover increased by 18% to US$2.18 billion in the quarter, whileefficiency improvements raised its operating margin by 2.2 percentage points to 19.1%. G

Now turn to page 20 for an exclusive interview with Jeff George.

Apotex must pay back 50% of its sales of US$884 million – plus compound interest at theannual US prime rate, totalling US$108 million – following the Canadian firm’s at-risk

launch of a rival to Sanofi-Aventis’ Plavix (clopidogrel) anticoagulant blockbuster in August2006, New York judge Sidney Stein has ruled. However, even after paying damages, interest andcosts, the generics firm still appears to have made a healthy profit on its sales in the threeweeks between its at-risk launch and Sanofi securing an injunction on 31 August 2006.

Awarding legal costs to Sanofi, Stein noted that the two firms had agreed before Apotex’launch that the generics firm would be liable for damages equal to 50% of its net clopidogrelsales if the patent at issue – US patent 4,847,265, expiring on 17 November 2011 – was foundvalid and enforceable. Stein rejected Apotex’ argument that, by cutting the price of Plavix,Sanofi had effectively rendered the brand an authorised generic, and had therefore reducedApotex’ liability to 40% of sales under the terms of the agreement.

Having failed to overturn the ‘265 patent on appeal, Apotex was last year unable to get the USSupreme Court to hear its case (Generics bulletin, 13 November 2009, page 20). Stein earlierthis year refused to grant a stay on Sanofi’s motion for US$442 million in damages (Genericsbulletin, 23 April 2010, page 15). “Apotex is liable to Sanofi for 50% of its net sales resultingfrom a three-week period in August 2006 during which it flooded the market with its genericproduct,” Stein stated. “While the settlement agreement explicitly limits damages,” he pointedout, “it does not in any way restrict an award of interest on those damages.” G

Apotex pays half for Plavix rival

Lovenox rival brings inUS$292mn for Sandoz

Gen 1_11_10 Pg.1.qxd 28/10/10 07:35

COMPANY NEWS

2 GENERICS bulletin 1 November 2010

1 N ovember 2010 Issue 141

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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Sales growth of 15.7% lifted Unichem Laboratories’ turnover toRs2.02 billion (US$45.6 million) in the three months ended 30

September 2010. The Indian company’s operating profit grew by4.9% to Rs427 million, although its operating margin fell by morethan two percentage points to 21.1% due to higher sales, marketing,research and development expenses, as well as costs related tocommissioning two new production facilities in Baddi and Sikkim.

A 12.3% decline to Rs39.3 million in domestic sales of activepharmaceutical ingredients (APIs) was more than offset by formulations

sales in India growing by 14.8% to Rs1.57 billion (see Figure 1).Domestic sales of branded generics had increased by 19.1%, Unichemsaid, but sales of unbranded generics had fallen sharply.

Unichem said that its international formulations sales had grownby almost a third to Rs294 million, whilst sales of APIs outside Indiahad increased by 1.0% to Rs93.9 million, giving the companyinternational sales growth of 22.2%. In August, Unichem receivedapproval for its abbreviated new drug application (ANDA) for a genericversion of Duramed’s Ziac (bisoprolol/hydrochlorothiazide) tabletsfrom the US Food and Drug Administration (FDA). And in September,the company obtained a European certificate of suitability (CEP) forits alfuzosin hydrochloride from the European Directorate for theQuality of Medicines and Healthcare (EDQM). G

SECOND-QUARTER RESULTS

Unichem boosted byformulations growth

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

Formulations 1,573 +14.8 78APIs 39 -12.3 2India 1,613 +13.9 80

Formulations 294 +31.0 15APIs 94 +1.0 5International 388 +22.2 20

Other 20 +43.1 1

Unichem 2,020 +15.7 100

Figure 1: Breakdown by region of Unichem Laboratories’ sales in the threemonths ended 30 September 2010 (Source – Unichem)

Increasing its domestic formulations sales by more than a quarter toRs2.07 billion (US$46.6 million) helped India’s Alembic to boost its

overall turnover by 28% to Rs3.65 billion in the three months ended30 September 2010. The company also more than doubled its domesticsales of active pharmaceutical ingredients (APIs) to Rs547 million.

Alembic said that it had maintained a share of 1.9% in India’sformulations market. Higher turnover from several of its leadingbranded generics such as Azithral (azithromycin) had outpaced industrygrowth, the company said, adding that it had made “good progress”in the speciality product segments it had entered recently.

International formulations sales also increased, rising by a tenthin regulated markets to Rs398 million and growing by 50% to Rs151million in other territories (see Figure 1). However, the company’sexports of APIs to regulated markets fell by almost a third to Rs222million, a decline that was not offset by a rise of 27% to Rs231 millionin API sales to other international markets. This resulted in an 11%drop to Rs453 millon in international API sales.

Alembic noted that it had filed a total of 31 abbreviated new drugapplications (ANDAs) and 39 drug master files (DMFs) to date withthe US Food and Drug Administration. G


Domestic sales driveAlembic’s increase


India 2,068 +27 57Regulated markets 398 +10 11Other exports 151 +50 4Formulations 2,618 +25 72

India 547 +127 15Regulated markets 222 -31 6Other exports 231 +27 6APIs 999 +33 27

Others 38 +58 1

Alembic gross sales* 3,654 +28 100

* includes Rs28 million in excise duties

Figure 1: Breakdown by business and region of Alembic’s gross sales in the threemonths ended 30 September 2010 (Source – Alembic)

Gen 1_11_10 Pgs.2-8.qxd 28/10/10 07:40

Around 600 employees are set to be affected as Teva restructuresits operations in Germany following the recent acquisition of

Ratiopharm. Sven Dethlefs, head of the group’s German business,said negotiations were underway with employees’ representativesto “find a socially acceptable solution”.

Teva’s German generics unit in Mörfelden-Walldorf near Frankfurt– from which the firm markets hospital products such as nephrologyand oncology drugs – is to be closed by the middle of next year. Andby the end of 2011, Teva plans to shut its offices in Radebeul nearDresden that have served as its administrative headquarters in Germanysince June 2009 following the group’s takeover of Barr’s AWDpharma.

AWDpharma’s sales and marketing activities are to be integratedinto those of Ratiopharm’s Berlin-based subsidiary CT Arzneimittel.

At the start of 2012, Teva also intends to close the Mannheimoffices of BioGenerix, the wholly-owned biogenerics subsidiary thatRatiopharm set up in June 2000. Production of biosimilars is conductedby Ratiopharm’s Merckle Biotec facility located next to its headquartersin Ulm, southern Germany (Generics bulletin, 17 March 2006, page 1).

Production capacity at the Ulm site – from which Dethlefs willlead all of Teva’s German operations (Generics bulletin, 17 September2010, page 27) – is to be expanded by 300 million capsules per yearto supply Teva’s international network. G

COMPANY NEWS

3GENERICS bulletin1 November 2010

BUSINESS STRATEGY

Teva intends to shutseveral German sites

Stada’s Serbian subsidiary Hemofarm has officially opened anexpanded and refitted production plant for solid-dosage forms in

Banja Luka, Bosnia and Herzegovina. With two new packaging linesin place, the 10,000 sq m facility’s capacity has been more than doubledto 30 million packs per year.

“The plant’s original capacity of 300 million tablets per year nowamounts to over 650 million,” commented Hemofarm’s vice-presidentDragomir Curcic. Following further investment, he added, the BanjaLuka site would be capable of making 1.5 billion tablets annually.

The Bosnian facility currently exports more than 90% of the drugsit produces to other markets in which Stada has a presence. G

MANUFACTURING

Stada’s Hemofarm opens plant

Japan’s Nichi-Iko is to acquire a 33.4% stake in South Koreanbiotech firm Aprogen. The Japanese firm said it would appoint

representatives to the South Korean company’s board of directors,adding that Aprogen was working on biogeneric versions of infliximab,rituximab and trastuzumab, the active ingredients in Johnson &Johnson’s Remicade and Roche’s Rituxan/MabThera and Herceptinbrands respectively.

Nichi-Iko – which recently formed a generics joint venture withSanofi-Aventis (Generics bulletin, 18 June 2010, page 7) – said theJapanese market for biological products was currently worth around¥700 billion (US$8.64 billion) and was growing by around 10%.Infliximab, rituximab and trastuzumab made up a sixth of that total. G

STRATEGIC ALLIANCES

Nichi-Iko invests in AprogenDr Reddy’s Laboratories has secured exclusive marketing rights to

a range of prescription and OTC products in the Commonwealthof Independent States (CIS) from its fellow Indian firm Cipla. Reddy’swill start distributing the dermatology, gastrointestinal and oncologyproducts in Russia immediately, while launches in Ukraine – includingalso Cipla’s respiratory portfolio – will follow in 2011.

Reddy’s has also struck a CIS deal to market the Dietrim weight-management and Jointace joint-care supplements supplied by UK-based firm Vitabiotics. “We see long-term synergies, as Dr Reddy’shas a strong sales and marketing network and our partners have abasket of products already registered and distributed in these markets,”commented the Indian firm’s managing director and chief operatingofficer, Satish Reddy. In the three months ended 30 September 2010,Russia and the CIS accounted for a fifth of the Indian firm’s genericssales totalling US$307 million (see page 7).

Meanwhile, Dr Reddy’s has acquired the outstanding 40% stake inits South African business of the same name. And the Indian firm haspaid around US$60 million to regain royalty rights to 36 US genericsfrom ICICI Venture (Generics bulletin, 8 April 2005, page 3). G

STRATEGIC ALLIANCES

Reddy’s acts for Cipla in CIS

THREE RIVERS – the US company that markets the Ribasphere andRibaPak ribavirin brands and is developing a portfolio of oncologygenerics – has been acquired for an undisclosed fee by KadmonPharmaceuticals. Kadmon is a privately-held biotech firm headedby ImClone’s founder, Dr Samuel Waksal, who was released fromprison last year after pleading guilty to fraud. G

IN BRIEF

Pfizer is strengthening its generics presence in emerging markets byagreeing to pay BRL400 million (US$238 million) for a 40% stake

in Brazil’s Laboratorio Teuto. Through a series of agreements withTeuto, Pfizer will have the opportunity to register and commercialisethe Brazilian generics firm’s products under its own brands both inBrazil and internationally.

Teuto’s portfolio of unbranded and branded generics comprisesaround 250 products in more than 400 presentations. These includeanti-infectives, cardiovascular drugs, central nervous system treatments,inflammation and pain medicines, and respiratory products. Teutoclaims it was Brazil’s third-largest generics player last year.

Under the terms of the deal, Pfizer will also have the option totake control of the Brazilian firm by acquiring the remaining 60% stakefrom 2014. The US firm will also appoint two representatives to theboard of directors of the Brazilian firm, which will also be able todistribute certain Pfizer products under the Teuto brand in Brazil, andwill be eligible to receive a performance-related milestone payment.

Noting that unbranded and branded generics accounted for around60% of the Brazilian pharmaceutical market by value, Pfizer said thedeal with Teuto provided access to “significant distribution networks inrural and suburban areas in Brazil” and demonstrated its “commitmentto pursue focused investments in key emerging markets”. G

STRATEGIC ALLIANCES

Pfizer buys stake inBrazilian firm Teuto

Gen 1_11_10 Pgs.2-8.qxd 28/10/10 07:40

US generics player Amneal Pharmaceuticals has officially openedan expanded distribution and sales centre in Glasgow, Kentucky.

The 10,700 sq m site combines the firm’s existing sales operations inGlasgow with distribution activities that were based in Fountain Run,Kentucky. Following a transition phase, Amneal plans to shift somedistribution to Glasgow from its site in Long Island, New York.

Amneal has invested US$6.6 million in the project and has created48 jobs. Kentucky’s economic development finance authority hascleared the firm to receive tax incentives worth up to US$2.5 million.

The generics firm noted that the Glasgow site was close to aUnited Parcel Service (UPS) hub. “This convenience – coupled withits Central Time Zone locale – makes it a one-day drive to 75% of the

US population,” Amneal noted, adding that its Long Island facility gavethe firm flexibility and allowed it to distribute controlled substances.

Amneal – which is based in Hauppauge, New York – has researchand development centres in Branchburg and Brookhaven, New York,as well as in Ahmedabad, India. The firm’s production sites are all inthe US at Brookhaven, Hauppauge and Paterson, New Jersey, for oralsolids and soft-gel capsules, and in Branchburg for liquid formulations.

Having a year ago added the first US rival to Braintree’s Axid(nizatidine) oral solution to its portfolio (Generics bulletin, 11December 2009, page 12), Amneal said it had become the ninth-largestsupplier of generic drugs in the US. IMS Health data for the yearended June 2010, recently presented by Watson, ranked Amneal justbehind Covidien’s Mallinckrodt – and just ahead of Actavis (seeFigure 1) – with 83 million prescriptions dispensed. G

COMPANY NEWS


BUSINESS STRATEGY

Amneal expands itsUS distribution hub

Ranking Company Annual prescriptionsdispensed (millions)

1 Teva 6422 Mylan 3613 Watson 2494 Sandoz 2045 Qualitest 1196 Lupin 1107 Greenstone (Pfizer) 1088 Mallinckrodt 889 Amneal 8310 Actavis 70

Figure 1: The top 10 generics players in the US, ranked by prescriptions dispensedin the year ended June 2010 (Source – IMS Health/Watson)

European wholesaling and pharmacy retailing group Alliance Bootsis set to make its first major acquisition in Germany after agreeing

to pay around C143 million (US$198 million) for a further 51.65%stake in the country’s third-largest pharmaceutical distributor, Anzag,from three German wholesalers: Celesio, Phoenix and Sanacorp.

Alliance Boots – which has held a 29.99% stake in Anzag since2004 – intends to launch a voluntary tender offer for the outstanding18.36%. This will be at around the C26.00 per share that it paid toCelesio, Phoenix and Sanacorp. Both the acquisition and tender offer –which collectively value Anzag at around C277 million – are subjectto approval from European competition authorities. Alliance Bootsexpects to complete the acquisition by March next year.

Stefano Pessina, Alliance Boots’ executive chairman, said takingcontrol of Anzag – which achieved a pre-tax profit of C40 million ona turnover of C4.2 billion in the year ended 31 August 2010 – wouldallow the UK-based group “to reinforce our strategic ties withmanufacturers throughout Europe”.

Privately-owned Alliance Boots has more than 360 distributioncentres in 16 countries and owns a network of nearly 3,150 pharmacies.Anzag – which has welcomed the takeover – has around 1,100 membersof its Vivesco virtual pharmacy chain in Germany as well as wholesalingoperations or affiliates in Croatia, Lithuania and Romania.

Under the terms of the deal, Alliance Boots will pay around C69.4million for Sanacorp’s 24.99% stake in Anzag and C39.3 million forCelesio’s 14.15% holding. The company has also agreed to payapproximately C34.7 million for Phoenix’ 12.50% stake. Germanwholesaler Noweda and Dutch distributor Mediq, which hold the bulkof Anzag’s remaining shares, have not yet announced whether theywill sell to Alliance Boots.

The deal for Anzag comes four years after Sanacorp – Germany’sfourth-largest pharmaceutical wholesaler – was prevented by aDüsseldorf court from taking control of the firm due to competitionconcerns. Alliance Boots’ only presence in the German wholesalemarket is through its Megapharm oncology logistics subsidiary.

In the year ended 31 March 2010, Germany accounted for £343million (US$544 million) – or around 2.8% – of sales by Alliance Boots’Wholesale division, which were ahead by 10.3% to £12.4 billion. G

DISTRIBUTION

Alliance Boots is tobuy Germany’s Anzag

IPCA LABORATORIES of India increased its pre-tax profit by 22% toRs1.79 billion (US$40.2 million) on an 18% net sales rise to Rs9.29billion in the six months ended 30 September 2010. G

IN BRIEF

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Gen 1_11_10 Pgs.2-8.qxd 28/10/10 07:40

Dexcel Pharma has started to ship its prescription-only genericsdirectly to German pharmacies, rather than using wholesalers as

intermediaries. The Israeli group – which recently installed Dr MathiasPietras as managing director for Germany (Generics bulletin, 1October 2010, page 23) – claims pharmacists can save up to 8% offstandard wholesale prices by ordering directly from the firm.

Pietras said he was determined to strengthen Dexcel’s ties withGerman pharmacists, such as through the direct-delivery scheme. Thecompany already ships its OTC products such as acetylsalicylic acidand ibuprofen directly to pharmacies.

Noting that Dexcel had rebate deals to supply some Germaninsurance funds with certain products, Pietras said the firm wouldcontinue to meet large demand through wholesalers. “We will operatea ‘first come, first served’ principle,” he stated, adding that the firm’srecent recall of amlodipine maleate 5mg and 10mg batches due toinstability beyond 15 months should not affect Dexcel’s ability tomeet demand through its contracts with the AOK and TKK funds. G

COMPANY NEWS


BUSINESS STRATEGY

Israel’s Dexcel shipsdirectly in Germany

RPG LIFE SCIENCES improved its net sales by a tenth to Rs885million (US$19.9 million) in the six months to 30 September 2010.G

IN BRIEF

Biocon said the first of the biosimilar monoclonal antibodies thatit is developing through a partnership with Mylan had “entered

the pre-clinical phase”. The alliance – which the two firms struck lastyear (Generics bulletin, 8 July 2009, page 1) – was “progressing well”,the Indian firm insisted.

Meanwhile, Biocon has started a Phase III clinical trial in Europefor biosimilar recombinant human insulin. The Indian firm has justagreed a global marketing deal with Pfizer for four insulin and insulin-analogue products (see page 13). Biocon’s domestic diabetes divisionis about to launch a 100IU strength of its Insugen insulin brand,whilst the Indian firm is also rolling out a domestic Immunotherapydivision on the back of introducing pimecrolimus and tacrolimus.“There has been a significant increase in sales of both mycophenolatemofetil and tacrolimus in the US and European markets,” it said.

Sales by Biocon’s German generics and parallel imports business,Axicorp, climbed by 30% to Rs5.23 billion (US$118 million) in thesix months ended 30 September 2010. Axicorp’s generics sales morethan doubled as it won supply contracts for amoxicillin, fluconazole,metformin, metoprolol and simvastatin.

In the six-month period, Biocon improved both its turnover andearnings before interest, tax, depreciation and amortisation (EBITDA)by 24% to Rs13.6 billion and Rs2.93 billion respectively. The firm’spre-tax profit climbed by 29% to Rs2.03 billion. G

STRATEGIC ALLIANCES/FIRST-HALF RESULTS

Biocon gets on withMylan’s monoclonals

Gen 1_11_10 Pgs.2-8.qxd 28/10/10 07:40

COMPANY NEWS


A40.8% leap to Rs2.26 billion (US$50.9 million) in US sales waslargely responsible for Zydus Cadila’s exports turnover increasing

by 24.6% to Rs5.28 billion in the Indian firm’s financial secondquarter ended 30 September 2010.

During the quarter, Zydus filed two abbreviated new drugapplications (ANDAs) with the US Food and Drug Administration(FDA) and received two approvals. This took the Indian firm’scumulative ANDA totals to 115 filings and 58 approvals.

In Europe – where Zydus’ formulations exports increased by11.3% to Rs588 million (see Figure 1) – the firm submitted eightdossiers during the quarter. Its cumulative filings total in the EuropeanUnion reached 98, of which 42 have been approved to date.

Sales by Zydus’ Brazil-based Latin American operation improvedby just over a quarter to Rs584 million, while in Japan – whereZydus three years ago bought local company Nippon Universal –turnover rose by more than a third to Rs98 million. The Indian firmalso achieved double-digit growth in emerging markets – where it

has a deal to supply branded generics to Abbott (Generics bulletin, 28May 2010, page 3) – and in its oncology joint venture with Hospira.

However, the company’s active pharmaceutical ingredient (API)exports declined by 7.1% to RS965 million, due in part to a 21.4%fall to Rs164 million in turnover through its joint venture withNycomed that is about to start making commercial quantities of APIsat a facility in India (Generics bulletin, 15 October 2010, page 2).

With domestic turnover ahead by 18.4% to Rs5.93 billion – duelargely to formulations sales rising by 18.6% to Rs4.67 billion – Zydus’group gross sales improved by 21.2% to Rs11.2 billion. ExcludingRs150 million in excise duties, net turnover also grew by 21.2% toRs11.1 billion. Zydus’ earnings before interest and tax (EBIT)improved by 22.2% to Rs2.18 billion. G


Gains in US increaseZydus’ sales growth


US 2,258 +40.8 20Europe 588 +11.3 5Latin America 584 +26.7 5Emerging Markets 474 +43.0 4Japan 98 +36.7 1Zydus Hospira 312 +53.8 3Formulations 4,314 +34.9 38

APIs 965 -7.1 9

Exports 5,279 +24.6 47

India 5,934 +18.4 53

Zydus gross sales* 11,213 +21.2 100

* includes Rs150 million in excise duties

Figure 1: Breakdown by region and business of Zydus Cadila’s gross sales in thethree months ended 30 September 2010 (Source – Zydus Cadila)

Dr Reddy’s Laboratories is preparing to submit dossiers for thebiogenerics it markets in territories such as India to agencies in the

highly-regulated markets of the European Union and the US. “We havehad initial meetings with regulators on Reditux (rituximab) and we arebuilding a team in New Jersey, US, to design clinical trials and developour regulatory strategy,” the Indian firm’s vice-chairman and chiefexecutive officer GV Prasad told investors. A European developmentprogramme for the monoclonal antibody would run in parallel with theUS work, Prasad said. “We have the scientific evidence and experienceto give us confidence,” he maintained, adding that the firm would belikely to need marketing partners in both Europe and the US.

Following a recent launch in Chile, Dr Reddy’s now marketsReditux in seven countries worldwide. The treatment is one of threebiogenerics that the Indian firm offers in its domestic market, where5% of its turnover is now derived from follow-on biologics. Havingrecently launched its third Indian biogeneric – the Cresp (darbepoietinalfa) anaemia brand (Generics bulletin, 3 September 2010, page 18) –Reddy’s expects approval for a fourth product by March next year.

Launches such as Cresp over the past 12 months contributed ninepercentage points of the Indian firm’s 25% domestic generics growth toUS$71 million in its financial second quarter ended 30 September2010 (see Figure 1). In Russia – where Reddy’s has just agreed adeal to market brands for Cipla (see page 3) – generics sales roseby 28% to US$49 million.

Launches including tacrolimus and amlodipine/benazepril raisedNorth American generics turnover by 7% to US$95 million. The firmsaid it had also improved its market shares for vertically-integratedmolecules such as ciprofloxacin and omeprazole. As of 30 September2010, the firm had 74 abbreviated new drug applications (ANDAs)pending approval, of which 12 were felt to be first-to-file opportunities.

Price erosion due to tenders cut the Indian firm’s generics salesin Germany by 14% to US$27 million, but Reddy’s said its localBetapharm operation had cut costs and was seeing an “improvedsuccess rate for vertically-integrated products in recent tenders”.

An 8% rise to US$307 million in Global Generics turnover wasoffset in part by a 14% slide to US$104 million in sales by the firm’sPharma Services and Active Ingredients (PSAI) division. Includingproprietary brands, group turnover grew by 2% to US$420 million,while a six percentage-point gross margin rise to 53.4% on strong USlaunches lifted the firm’s operating profit by 27% to US$72 million. G

BUSINESS STRATEGY/SECOND-QUARTER RESULTS

Reddy’s plans to fileregulated biosimilars

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

North America 95 +7 23India 71 +25 17Russia 49 +28 12Germany 27 -14 6Rest of Europe 10 +13 2Others 55 – 13Global Generics 307 +8 73

Pharma Services, Active Ingredients 104 -14 25

Proprietary/Other 9 +46 2

Dr Reddy’s 420 +2 100

Figure 1: Breakdown by region and business of Dr Reddy’s Laboratories’ sales inthe three months ended 30 September 2010 (Source – Dr Reddy’s)

PIRAMAL HEALTHCARE could buy back 20% of its shares after theUS$3.8 billion sale of its Indian formulations business to Abbott. G

IN BRIEF

Gen 1_11_10 Pgs.2-8.qxd 28/10/10 07:40

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The UK’s Department of Health has dropped its plans to introducegeneric substitution. “No clear consensus” had emerged from its

public consultation, the department said, but there was a “strongly-heldperception” that such a move would pose a threat to patient safety.

Warwick Smith, director of the British Generic ManufacturersAssociation (BGMA), said the generics industry shared the Departmentof Health’s “frustration” at the remaining small amount of brandprescribing when there was no clinical reason not to use the equivalent,but much more cost-effective, generic.

However, the brand industry body, the Association of the BritishPharmaceutical Industry (ABPI) stirred up the debate by adding thatmany patients “need modern branded medicines to be adequatelytreated”. “We see parts of the NHS inappropriately switching suchpatients to low-cost generics and so putting their welfare at risk,” it said.

In its consultation document, the department had identified that just5% of prescriptions were available for generic substitution in the UK(Generics bulletin, 15 January 2010, page 11). More than eight out of10 prescriptions were written by international non-proprietary name(INN), it said, and generics were unavailable for over two-thirds of theremainder. “Patients can continue to receive a specific manufacturer’sproduct when their treating clinician judges that this is necessary tomeet clinical need,” the department stated when it launched theconsultation earlier this year. But the then health minister Mike O’Brienadded: “Where clinically appropriate, it is only sensible to allow moreexpensive branded products to be substituted with the same genericmedicines which are just as effective as the branded version.”

However, rejecting substitution last month, the department said: “Inthe light of the strong perception that generic substitution poses athreat to patient safety, the inconclusive position on cost-effectivenessand the ability to utilise or explore other mechanisms to support theuse of generic medicines, [the department] will not be progressingany further the implementation of generic substitution.”

O’Brien’s successor, Lord Howe, said it was not clear whether theproposals would have provided substantial benefit to the NHS,compared to the efforts of frontline staff to implement them.Nevertheless, the department would be “looking at more appropriateways of supporting the use of generic medicines”. “In the long term,”he said, “value-based pricing will help to ensure we pay a price fordrugs which better reflects their value.”

Responding to the department’s change of heart, Smith said hewelcomed its commitment to look for further ways to support the useof generic medicines and its recognition that there were furthersavings to be made in this way.

Three options were offered by the department in its consultationdocument: introducing a positive list of branded medicines able to besubstituted by pharmacists, which was favoured by the BGMA;applying a negative list of branded medicines that could not besubstituted; or maintaining the existing ban on generic substitution. G

MARKET NEWS


GOVERNMENT LEGISLATION

UK drops plans forgeneric substitution

Regulatory processes being developed by the US Food and DrugAdministration (FDA) will eventually allow biologic medicines

to achieve the same market penetration as that achieved by traditionalgenerics, according to Momenta’s Craig Wheeler, who sits on the USGeneric Pharmaceutical Association’s (GPhA’s) executive committee.Addressing the GPhA’s Fall Technical Conference recently, Wheelersaid that demonstrating the safety and efficacy of biosimilars would“change the face of our industry”.

Wheeler, whose Momenta recently developed a rival to Sanofi-Aventis’ US$2.3 billion anticoagulant biologic Lovenox (enoxaparinsodium) in collaboration with Sandoz (Generics bulletin, 6 August2010, page 1), said biogenerics were becoming increasingly importantto generics manufacturers. He added, however, that investing in thetechnology required to bring these products to market “will both addto the risk and change the economics required for industry to succeed”.Generics firms would need to invest in the “characterisationtechnologies, process engineering and clinical tools” required to provethat biosimilars were safe and effective, he said.

Tracking and controlling biosimilars throughout the entiredistribution chain was “critically important”, Wheeler said, but it wasalso necessary to agree on “cost-effective tracking solutions” that couldbe used in “the lower-margin world of generic drugs”. G

REGULATORY AFFAIRS

GPhA bullish on biosimilars

Removing reimbursement from products with cheaper therapeuticequivalents is how the Danish Medicines Agency (DMA) plans to

“ensure that public funds only go to effective medicines which arereasonably priced”. From 15 November, certain drugs used to treat acid-related disorders and to lower blood pressure will lose reimbursementin Denmark, based on the availability of alternative treatments that theagency says “provide the same effect at only a fraction of the cost”.

For acid-related disorders such as heartburn and ulcers, the DMAsaid that only lansoprazole, omeprazole and pantoprazole wouldcontinue to be reimbursed. Patients currently being prescribed otherdrugs in the same therapeutic category could be treated equallyeffectively, but much more cheaply, using these three products, it added.

All angiotensin II receptor antagonists and renin inhibitors exceptthose containing losartan will also lose reimbursement this month, theDMA said. Doctors had been keen to prescribe losartan after it recentlylost patent protection, the agency noted, which showed that they wereconscious of the cost of their prescriptions.

However, whilst the Danish Generic Medicines IndustryAssociation (IGL) welcomed tightening the reimbursement rules, itsaid generics firms that had been preparing rivals to the dereimbursedproducts would lose out on their investment. “When you remove thesubsidy for a drug a few years before its patent expires, it is primarilythe generics industry that loses money because we begin developmentand production five to ten years before patent expiration,” the IGL said.

The IGL also urged Denmark’s patent authorities to address theproblem of patents being granted for products that did not offer asignificant improvement over their predecessors. These products wereoften only launched to spoil the market for generic versions of anolder product, the association said. G

PRICING AND REIMBURSEMENT

Denmark revises itsreimbursement rules

AESEG – Spain’s generics industry association – has for the first timeparticipated officially in a national congress of the country’s primary-care doctors’ society, Semergen. Aeseg said the theme of thecongress – evidence, competence and quality – was closely alignedto the generics industry’s focus on quality, safety and efficacy. G

IN BRIEF

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Atotal of 48 organisations, including both the US GenericPharmaceutical Association (GPhA) and the European Generic

medicines Association (EGA), will speak at the public hearing onbiosimilars organised by the US Food and Drug Administration (FDA)on 2 and 3 November. Each organisation will have precisely eightminutes to put its points across at the hearing, which will explore anapproval pathway for biosimilar and interchangeable biologicalproducts (Generics bulletin, 1 October 2010, page 9).

The EGA has put forward Teva’s Sandy Eisen and Sandoz’ JoergWindisch as its speakers at the hearing. They are chair and vice-chairof the EGA’s European Biopharmaceuticals Group, which comprisescompanies with “vast experience”, according to the EGA, in developingand manufacturing biosimilar products over the past 15 years.

The two-day hearing – into implementing last year’s BiologicsPrice Competition and Innovation (BPCI) Act – will concern itself withquestions surrounding biosimilarity and interchangeability, althoughthe FDA also wants to know what user-fee programme should beapplied to the new abbreviated approval pathway. Electronic or writtencomments will be accepted after the public hearing until a closing dateof 31 December 2010. Other issues the agency has identified includewhat would constitute an optimal pharmacovigilance framework. Inputinto reference-product exclusivity is also requested, as well as somefeedback on setting priorities for developing guidance documents. G

MARKET NEWS


BIOGENERICS

FDA has 48 for public meeting

Major German health insurance fund, the AOK, has adjusted itsmodel for its latest tender published in the Official Journal of

the European Union. But the fund is persisting with its controversialstance of awarding supply contracts for each molecule to just onecompany per region.

Whereas the AOK had previously split its nationwide tender intofive regions, it now has seven, each of which is open to independentbids. Furthermore, the fund has opened up the option for bidding firmsto quote several prices, which would depend on the extent to whichpharmacists dispense their products rather than an alternative. Thefund believes that, on average, successful bidders will account for70% of packs dispensed during the two-year duration of the contracts.

Interested parties have until midday on 22 November to submitbids for 87 different active ingredients or combinations. The supplycontracts are set to start on 1 June 2011, immediately after two-yeardeals struck in 2008 expire on 31 May.

Noting that 63 of the 87 active ingredients covered by the latesttender were currently covered by two-year contracts, the AOK said itexpected 2011 savings of around C700 million (US$980 million) fromthe tender, the sixth it has run. The 87 molecules accounted for around100 million prescriptions for the fund’s 25 million members, generatinga combined annual bill for the AOK of about C2.2 billion.

Insisting that raising the number of regions from five to sevenwould make it easier for smaller firms to compete, the AOK’s chiefnegotiator Dr Christopher Hermann noted that for the first time thefund would allow firms to table offers for products in their pipelinethat they had not yet launched.

Meanwhile, the DAK fund has announced the names of the 46manufacturers to which it has awarded two-year supply contracts from1 January 2011. For each of 54 active ingredients – which have acombined annual turnover through the fund of C125 million – the DAKhas handed contracts to up to three suppliers. It expects savings fromthe tender to run to “double-digit millions” of euros. G

PRICING & REIMBURSEMENT

Germany’s AOK fundadjusts tender rules

Generic drugs in Austria are on average 22% cheaper than theequivalent off-patent brand, the country’s generics industry

association, Österreichischer Generikaverband, has pointed out. Notingthat figures from Austria’s health insurance funds showed that genericpacks cost C10.36 (US$14.30) on average compared to C13.24 for an off-patent brand, the industry association said the price gap was widening.

“Switching between generics is of little benefit to the insurancefunds,” insisted Österreichischer Generikaverband’s president BerndLeiter. Whereas differences in generics prices were often only afew cents, he said, each prescription for an off-patent brand cost thefunds C2.87 more than necessary.

Leiter said the example of a contentious ‘medicines list’ inSalzburg – whereby the local SGKK insurance fund obliges doctorsto prescribe the cheapest medicine possible from within a list ofproducts considered to be equal (Generics bulletin, 27 November2009, page 12) – showed “how important generics are for financinghealthcare”. Salzburg’s 62% generic penetration of the off-patentmarket was the highest in Austria, he noted. G

PRICING & REIMBURSEMENT

Austrian body stresses gap

Europe’s Bolar provision, first introduced in 2004, should be clarifiedto cover all administrative acts required to launch a generic on the

day immediately following patent expiry, the European Genericmedicines Association (EGA) said last week. Unveiling its ‘Vision2015’ to the heads of medicines agencies, the EGA noted that theBolar provision should be extended “clearly to cover” pricing andreimbursement by including the measure in the expected revision tothe European Union’s price transparency directive.

“The Bolar provision introduced by Directive 2004/27/EC is notsufficiently explicit in the legislation, which has led to a series ofcourt cases,” comments the EGA in Vision 2015. Applying for, andbeing granted, both a marketing authorisation and a pricing andreimbursement status, it adds, should be covered “and consequentlyfall out of the scope of patent protection”.

“Pathways leading to patent-linkage should be abandoned,” insiststhe EGA, which “strongly opposes” any proposal for making genericsfirms give notice to the patent holder as part of an application for amarketing authorisation.

Noting that 83% of all Europe’s decentralised and 68% of all itsmutual-recognition procedures involve generics – as well as almost 50%of all centralised applications – the EGA says the procedures should be“better adapted to the realities of the off-patent market”. Thecentralised procedure should be opened wider for generics, it adds,and a more pragmatic approach taken to duplicate applications.

Looking beyond Europe, the EGA would like to see a broaderinterpretation of the EU reference product, allowing developmentbatches to be used from the “ICH region”. This would support theglobal development of biosimilars and generic medicines, it says.G

INDUSTRY ASSOCIATIONS

EGA would prefer abetter Bolar by 2015

Gen 1_11_10 Pgs.9-11.qxd 28/10/10 07:43 Page 4

The Swedish brand industry body, the LIF, has joined forces with thegenerics industry body, the FGL, to promote biosimilars to doctors

in Sweden. In a jointly-authored article for the Swedish MedicalAssociation’s Läkartidningen magazine, the LIF’s managing directorRichard Bergström and his FGL counterpart, Kenneth Nyblom, pointout the use of biosimilars remains low in Sweden, but that usedappropriately they can “set free a lot of money in the healthcare sector”.

“The healthcare sector needs to be more active to set free thoseunreleased resources,” they tell the doctors, “since the savings will notautomatically appear by substitution at pharmacies.”

“LIF and FGL have the same view on this issue,” they add.“Together we want to contribute to an increased use of biosimilarsin Sweden in a way that saves money without jeopardising patientsafety – which is the most important thing for us.”

Explaining that biosimilars are “not as cheap as generics” and thatthey are “not interchangeable in the same way”, the authors notebiologics can produce different responses in individuals and thatchanges of medicine may cause immune reactions. As a result, theyurge some caution when changing the medicine of long-term patients.“A switch to biosimilars must occur in an orderly manner – not backand forth,” they say. But managed correctly and with a consciousstrategy at the clinical level, biosimilars offer “a large potential savingfor new patients”, they insist. G

MARKET NEWS


BIOGENERICS

Swedish brand bodypromotes biosimilars

Flawed methods were used by a think-tank to claim Canadians payalmost twice as much for generic prescription drugs as Americans,

according to the Canadian Generic Pharmaceutical Association(CGPA). The Fraser Institute’s findings – for the prices of the 100most commonly-prescribed drugs in Canada in 2008 – were “garbage”and were based on methodology that “did not meet the most minimumof acceptable academic standards”, the CGPA said.

In its report, the Fraser Institute claimed that Canadian priceswere on average 90% higher than US prices for the same drugs. It alsosaid that average generics prices in Canada were 73% of the price oftheir branded equivalents, compared to just 17% in the US.

However, the CGPA said the Fraser Institute had compared IMSHealth sales data for Canada from 2008 with US prices “derived fromcruising the internet” in August 2010. These prices had then beenfurther manipulated by the report’s authors. Canada’s generics markethad seen massive decreases in retail and reimbursement prices since2008, the CGPA pointed out, such as the 50% price reduction inOntario. Furthermore, the think-tank had provided no explanation forits decision to use 2008 data for Canada when IMS sales data wasavailable until June 2010, and not to use IMS data for the US at all.

There was “not one single case of the Fraser Institute taking aposition opposing brand-name drug companies on any topic relatedto pharmaceuticals in Canada”, the CGPA noted, despite the think-tank’s claims that accepting funding from brand companies had notaffected its conclusions. Last year, the CGPA also severely criticisedthe Institute’s work (Generics bulletin, 16 January 2009, page 15).However, it said this time that the 2010 report was “if possible, evenworse than in previous years”. G

MARKET RESEARCH

CGPA slams researchfor “garbage” report

Creating an official European Union (EU) quality-inspection groupand adopting a centralised inspection and certification scheme for

importers of active pharmaceutical ingredients (APIs) are two waysthat controls on the quality of medicines could be improved, accordingto Suzette Kox, the European Generic medicines Association’s (EGA’s)senior director of scientific affairs.

Addressing the European Directorate for the Quality of Medicinesand Healthcare’s (EDQM’s) annual conference in Prague recently,Kox also said the EGA strongly recommended treating issues relatedto counterfeit medicines separately from those related to quality control.The two issues were too often treated in parallel, she said, despitecounterfeiting being a criminal matter and API quality supervisionbeing dealt with transparently through the EU’s legal framework.

An EU inspection group operating within the current frameworkwould help to optimise the resources of the EU’s existing networkof national inspectors, Kox maintained. In the long term, the EGArecommended creating an EU inspectorate that could operate bothwithin the EU and internationally, with an equal focus on EU andforeign inspections. International co-operation could be encouragedby building on the Pharmaceutical Inspection Co-operation Scheme(PIC/S) to establish common international quality standards anddevelop information-sharing agreements. The eventual goal, shesuggested, would be to create a global inspection framework. G

REGULATORY AFFAIRS

EGA urges unified inspections

Gen 1_11_10 Pgs.9-11.qxd 28/10/10 07:43 Page 5

Actavis has started shipping the first alternative to Sanofi-Aventis’Ambien CR (zolpidem tartrate) 6.25mg tablets in the US. As the

first company to have filed a paragraph IV challenge to the only patentlisted against the sleeping aid in the Orange Book maintained by theUS Food and Drug Administration (FDA) – US patent 6,514,531, forwhich paediatric exclusivity expires on 1 June 2020 – Actavis hassecured 180-day market exclusivity. Quoting IMS Health data for theyear ended 30 June 2010, Actavis said annual US sales of Ambien CR6.25mg were US$129 million. “This approval – along with the first-to-file exclusivity – underscores Actavis’ emphasis and commitment tobringing complex controlled-release products to the marketplace,”insisted Doug Boothe, head of the firm’s US operations.

At the same as it awarded Actavis final approval for the 6.25mgtablets, the FDA also granted tentative approval for the 12.5mg strengthto both Actavis and Dutch developer Synthon. A third firm, Anchen,believes it was first-to-file on the 12.5mg strength.

Sanofi-Aventis had sued Synthon more than three years ago overthe ‘531 patent, which claims, among other things, a controlled-release form of zolpidem or one of its salts (Generics bulletin, 2March 2007, page 16). Teva’s Barr and Watson have also challengedthe ‘531 patent (Generics bulletin, 27 April 2007, page 16).

Meanwhile, Actavis has recalled 18 lots of fentanyl 25µg/hourpatches in the US as a precaution against accelerated release. G

PRODUCT NEWS


SLEEPING AIDS

Actavis unveils USrival to Ambien CR

Synthon believes it is one of the generic frontrunners in Europe foribandronic acid, whose compound-patent protection will expire in

most major European markets next year. The firm now has regulatoryclearance in 25 European countries for 50mg and 150mg tablets, whichare bioequivalent to Roche’s Bondronat 50mg and Bonviva 150mgsodium ibandronate tablets.

European sales of ibandronic acid were C358 million (US$495million) in 2009, according to IMS Health data quoted by Synthon,which pointed out that Bondronat was indicated for preventing skeletalevents in patients with breast cancer and bone metastases, whileBonviva was an osteoporosis treatment for postmenopausal women.

Meanwhile, the European Medicines Agency (EMA) has said thatPharmathen’s branded ibandronic acid, Iasibon, has received a positiveopinion from the agency’s committee for human medicinal products, theCHMP. A generic of Bondronat, Iasibon should now receive a centralisedapproval from the European Commission for all European Union states.

Two other positive opinions were given to centralised genericapplications at the CHMP’s October meeting. The branded genericPotactasol (topotecan) from Actavis is a generic of GlaxoSmithKline’sHycamtin and is for treating metastatic carcinoma of the ovary, small-celllung cancer and carcinoma of the cervix; while Docetaxel Teva Pharmalike its reference product, Sanofi-Aventis’Taxotere, is for treating locally-advanced or metastatic breast cancer and small-cell lung cancer, as wellas metastatic prostate cancer. G

OSTEOPOROSIS DRUGS

Synthon is Europeanfor ibandronic acid

Natco Pharma believes it could be entitled to 180-day US marketexclusivity for lenalidomide 5mg, 10mg, 15mg and 25mg capsules.

The Indian firm thinks it was among the first companies to file aparagraph IV challenge to patents protecting Celgene’s Revlimidmyeloma treatment. The US Food and Drug Administration (FDA) saysit received the first paragraph IV challenge – or challenges – to Revlimidon 12 July this year. However, Celgene has secured a 30-month stayon final approval for Natco’s abbreviated new drug application (ANDA)by suing the Indian firm in a New Jersey district court for allegedinfringement of 10 Revlimid patents with expiry dates rangingbetween 24 July 2016 and 22 April 2026. G

ONCOLOGY DRUGS

Natco eyes first on Revlimid

Bezafibrate, ciprofibrate, fenofibrate and gemfibrozil have benefitswhich outweigh their risks in treating patients with blood-lipid

disorders, the European Medicines Agency has concluded, but the agencyhas confirmed that they should not be prescribed to newly-diagnosedpatients as a first-line treatment. The exceptions are patients with severehypertriglyceridaemia or patients who cannot take statins.

The UK had referred the matter to the EMA’s committee for humanmedicinal products, the CHMP, for a Europe-wide recommendation ofwhether existing marketing authorisations should be changed better toreflect the views of the CHMP’s pharmacovigilance working party. G

CHOLESTEROL-LOWERING DRUGS

EMA still puts fibrates second

Gen 1_11_10 Pgs.12-17.qxd 28/10/10 07:47 Page 2

Biocon has reached an agreement with Pfizer that gives the brandcompany exclusive global marketing or co-marketing rights to

the Indian firm’s four insulin and insulin-analogue products. In return,Pfizer will make an upfront payment of US$200 million to Biocon.This will be followed by additional development and regulatorymilestone payments of up to US$150 million as well as royaltypayments on product sales.

Products covered by the agreement include Biocon’s recombinanthuman insulin as well as the company’s insulin analogues aspart,glargine and lispro. Biocon will be responsible for developing,manufacturing and supplying the products, as well as for securingtheir regulatory approval. Noting that by 2015 a number of insulinanalogues were expected to lose patent protection, the companies saidthey expected to be “well positioned to be the first movers in thispotentially large [biogenerics] market opportunity”.

Although Pfizer will have exclusive marketing rights in manyterritories, the brand company will share this exclusivity with Bioconin Germany – where the Indian firm acquired a majority stake inparallel-imports and generics specialist AxiCorp in 2008 (Genericsbulletin, 1 March 2008, page 3) – as well as in India and Malaysia.Pfizer will also share its exclusive marketing rights for some of theproducts with existing Biocon licensees in certain developing markets.

Biocon also entered into a biogenerics partnership agreement withMylan in 2009 for developing, manufacturing, supplying and marketingseveral generic biologic compounds on a global scale (Genericsbulletin, 8 July 2009, page 1). However, a spokesperson for Biocontold Generics bulletin that the agreement with Mylan was limited onlyto monoclonal antibodies (see page 6).

Noting Biocon’s recombinant human insulin had been approvedin 27 developing markets and launched in 23, and that India hadrecently been the launch market for the company’s glargine product(Generics bulletin, 19 June 2009, page 14), Biocon’s chairman andmanaging director Kiran Mazumdar-Shaw said the deal with Pfizerwas a significant step in the Indian firm’s path to globalisation. “Pfizerbrings brand strength and a vast and unrivalled global marketingnetwork that will enable Biocon to realise its objective of seeing itsinsulin portfolio have a worldwide presence,” she added. DavidSimmons, president and general manager of Pfizer’s EstablishedProducts business unit, said the collaboration with Biocon “supportsour stated efforts to become a strong player in follow-on biologics aswell as in the diabetes disease area”. G

PRODUCT NEWS


BIOGENERICS

Biocon is to supplyits insulin to Pfizer

Teva is rolling out a generic rival to Takeda’s Prevacid SoluTab(lansoprazole) 15mg and 30mg orally-disintegrating tablets in the

US following final approval with 180-day exclusivity from the USFood and Drug Administration. But Sandoz – which put annual USbrand sales at just over US$400 million – is supplying an authorisedgeneric of the prescription ulcer and heartburn treatment throughan agreement with Takeda. Earlier this year, the US Court of Appealsaffirmed without comment a Delaware district court’s ruling that Teva’slansoprazole orally-disintegrating tablets did not infringe Takeda’s USpatent 5,464,632, for which paediatric exclusivity expires on 7 May2013 (Generics bulletin, 1 February 2010, page 14).

Delaware Judge Sue Robinson had found that as the StarLacexcipient used in Teva’s tablets to cause rapid disintegration containedboth lactose and maize starch, it was “questionable exactly whichcomponent induces this disintegration”. “Because the starch in StarLaccannot meet both the disintegrating-agent and swelling-agent limitationsof the ‘632 patent, a finding of non-infringement is proper,” she said(Generics bulletin, 13 November 2009, page 1).

Both Teva and Sandoz – along with Mylan’s Matrix – hadcapitalised on paediatric exclusivity attached to another Prevacid patentexpiring on 10 November last year to launch lansoprazole 15mg and30mg delayed-release capsules. Dr Reddy’s has just secured a similarapproval and is preparing to start shipping the capsules.

Meanwhile, Teva has failed to get a US court order that wouldhave forced Sandoz and its partner Momenta to provide 10 days’ noticebefore launching a generic version of the Israeli firm’s Copaxone(glatiramer acetate) blockbuster for multiple sclerosis. Noting thatSandoz had offered to notify Teva within two hours of receivingapproval for glatiramer from the US Food and Drug Administration(FDA), New York district Judge Barbara Jones said Teva had insistedit needed at last 10 days’ notice to file a motion for a temporaryrestraining order and preliminary injunction.

“The plaintiff’s request amounts, in essence, for the court to orderthe defendants to provide plaintiffs with confidential businessinformation which, for all intent and purposes, would function as aninjunction by prohibiting defendants from launching their product evenif they have FDA approval and the 30-month statutory stay [onapproval] has expired,” Jones said in denying Teva’s motion.

Teva recently fought off Sandoz’ motion for a summary judgementof invalidity against key US patents protecting Copaxone until 2014. Adate for a full trial to consider Sandoz’ allegations that the patents areinvalid because their claims are indefinite has not yet been set (Genericsbulletin, 17 September 2010, page 1).

Peptide copolymer developer Peptimmune recently submitted acitizen petition calling on the FDA not to approve any generic versionsof Copaxone unless their manufacturers can produce pre-clinical andclinical studies demonstrating equivalence in biological and biochemicalassays (Generics bulletin, 15 October 2010, page 17). Teva – which isalso suing Mylan over Copaxone (Generics bulletin, 1 October 2010,page 10) – has had two Copaxone petitions turned down by the FDA. G

GASTROINTESTINAL DRUGS

Teva battles Sandozon US lansoprazole

GENERIC HEALTH has obtained a listing for amoxicillin/clavulanicacid, omeprazole and pantoprazole tablets in the latest update toAustralia’s Pharmaceutical Benefits Schedule (PBS). G

IN BRIEF

Mylan has obtained marketing authorisations for fentanyl matrixpatches in five strengths from New Zealand’s Medsafe agency

in advance of a sole-supply deal struck earlier this year with thecountry’s pharmaceutical management agency, Pharmac.

Mylan’s equivalent to Janssen-Cilag’s Durogesic will be listed onNew Zealand’s Pharmaceutical Schedule from 1 February next yearand will be the sole reimbursed fentanyl patch from 1 August 2011to 30 June 2013 (Generics bulletin, 9 April 2010, page 18). Pharmacsaid the six-month transition period would allow most patients tocomplete treatments with Durogesic to avoid switching brands. G

ANALGESICS

Mylan secures NZ fentanyl

Gen 1_11_10 Pgs.12-17.qxd 28/10/10 07:47 Page 3

Mepha Pharma has extended its range of epilepsy therapies inSwitzerland by introducing topiramate coated tablets in three

strengths. The local generics market leader is starting to roll out arange of company-branded herbal remedies.

According to Mepha, its topiramate 25mg, 50mg, 100mg and200mg tablets – which have retail prices for 60-count packs rangingbetween SFr46.20 (US$47.97) and SFr185.10 – offer a discount of upto 23% versus original, Johnson & Johnson’s Topamax. Topiramatejoins Mepha’s stable of epilepsy treatments, which also includesgabapentin and lamotrigine.

The first two herbal remedies introduced by Mepha are coatedtablets containing 20mg monk’s pepper (agnus castus) extract forpremenstrual syndrome and St John’s wort (hypericum) coated tabletsin 250mg or 500mg strengths for anxiety and mild depression.According to the Swiss company, its retail prices for Agnus Castus-Mepha and Hypericum-Mepha are comparable with other reimbursableproducts containing the same active ingredients.

Next year, the Swiss company intends to launch herbal remediesfor joint pain and nervous heart complaints, and further products arein the pipeline. “Mepha is responding to the growing trend for naturaltherapies,” stated the company, which had revealed earlier this yearthat it planned to push into herbals.

Meanwhile, Switzerland’s medicines agency Swissmedic hascleared Hospira to launch its Retacrit (epoetin zeta) biosimilar. Theanaemia treatment will be available as pre-filled syringes in 11strengths ranging between 1,000 and 40,000 international units.

Other recent Swissmedic approvals include nebivolol 5mg tabletsfrom Helvepharm, Mylan and Teva; metoprolol succinate 25mg, 50mg,100mg and 200mg extended-release tablets from Actavis andHelvepharm; and olanzapine orodispersible tablets in a variety ofstrengths from OrPha and Spirig. G

PRODUCT NEWS


EPILEPSY DRUGS/OTC MEDICINES

Mepha offers Swisstopiramate and herbs

Apotex has voluntarily withdrawn its generic sibutramine from theCanadian market following Abbott’s withdrawal of the Meridia

brand. A study had suggested that the anti-obesity drug increased therisk of ‘serious cardiovascular events’ in patients with heart problems.Apotex said it had decided to withdraw Apo-sibutramine afterdiscussing the issue with local agency Health Canada. Teva confirmedthat its own equivalent, Novo-sibutramine, had not been marketed.

Abbott has also withdrawn Meridia in the US. John Jenkins,director of the US Food and Drug Administration’s (FDA’s) Office ofNew Drugs (OND), said the continued availability of sibutramine was“not justified when you compare the very modest weight loss thatpeople achieve on this drug to their risk of heart attack or stroke”.

Meanwhile, Apotex has been told by a Canadian Federal Court thatShire will not be able to rely on the outcome of a separate patent-infringement lawsuit to support its defence in litigation between the twofirms over Alertec (modafinil). Apotex is seeking to recover damagesfrom Shire for a two-year delay in launching. Shire had attemptedto appeal against an earlier Federal Court ruling that prohibited thedefence, calling it “the essence of a speculative and hypotheticalpleading” (Generics bulletin, 17 September 2010, page 19). G

WEIGHT-LOSS DRUGS

Apotex pulls Apo-sibutramine

CIPLA is claiming a world first by introducing a generic form ofpirfenidone in India under the Pirfenex brand name. US-basedbiotech firm InterMune currently has a marketing authorisationapplication for pirfenidone under review by the European MedicinesAgency as a treatment for idiopathic pulmonary fibrosis, a chronicform of lung disease. “Until now, there was no approved treatmentof IPF,” the Indian firm pointed out. Cipla – which last year said ithad also launched the world’s first generic bosentan – is makingPirfenex at its facility in Himachal Pradesh, India.

LANNETT has started shipping fluphenazine 1mg, 2.5mg, 5mg and10mg tablets in the US as equivalents to Apothecon’s discontinuedProlixin schizophrenia brand. Fluphenazine marks Lannett’s secondlaunch of an acquired abbreviated new drug application (ANDA).

WATSON has started shipping alternatives to Novartis’ Lotrel(amlodipine/benazepril) 2.5mg/10mg, 5mg/10mg, 5mg/20mg and10mg/20mg capsules in the US. The US firm gained the abbreviatednew drug application (ANDA) for the antihypertensive through itstakeover of Arrow. Companies including Dr Reddy’s, Lupin, Sandozand Teva already offer the combination drug.

HEXAL has extended its Omep (omeprazole) branded generic forulcers and heartburn in Germany with multiple unit pellet tablets(MUT). The Sandoz subsidiary claims its Hexal Omep MUT 10mg,20mg and 40mg offer a discount of up to 42% versus the referenceproduct, AstraZeneca’s Antra MUPS. Pointing out that the newcomerwas free from gelatine, lactose and gluten – and was made inGermany – Hexal said Omep was Germany’s most commonlyprescribed brand of proton-pump inhibitor.

TEVA has entered into an exclusive licence-option agreement withCell Cure Neurosciences in the US to develop and commercialiseCell Cure’s biologic OpRegen treatment for age-related maculardegeneration. The product is a proprietary formulation of embryonicstem cell-derived retinal pigment epithelial cells.

MATRIX LABORATORIES has received tentative approval fromthe US Food and Drug Administration (FDA) for its abbreviatednew drug application (ANDA) for a generic version of BristolMyers-Squibb’s Reyataz (atazanavir) capsules in 150mg and 300mgstrengths. The Mylan subsidiary received FDA approval for the HIVtreatment under the US President’s Emergency Plan for AIDS Relief(PEPFAR). Other recent PEPFAR tentative approvals includeStrides Arcolab’s lamivudine/zidovudine 150mg/300mg tablets,equivalent to Viiv’s Combivir, and Hetero Drugs’ abacavir sulfate300mg tablets, which are equivalent to Viiv’s Ziagen.

PROLOR BIOTECH’S growth hormone deficiency treatmenthGH-CTP has been granted orphan drug designation by the USFood and Drug Administration (FDA). The product, which is alonger-acting version of human growth hormone, is intended toprovide treatment that requires only once-weekly or bi-monthlyinjections, rather than multiple injections per week. It is currentlyundergoing Phase II clinical trials.

MYLAN has received tentative approval from the US Food and DrugAdministration (FDA) for its generic version of Sanofi-Aventis’ Plavix(clopidogrel) 75mg tablets. India’s Torrent Pharmaceuticals hasalso received a similar approval for its clopidogrel tablets in thesame strength. Meanwhile, Mylan has also launched a US rival toGlaxoSmithKline’s Wellbutrin XL (bupropion hydrochloride)extended-release tablets in 150mg and 300mg strengths. G

IN BRIEF

Gen 1_11_10 Pgs.12-17.qxd 28/10/10 07:47 Page 4

Clopidogrel’s availability as a generic has encouraged the UK’sNational Institute for Health and Clinical Excellence (NICE) to

recommend widening the use of the cardiovascular treatment.Publishing draft guidance on using clopidogrel, NICE said a fall inprices since generic rivals to Sanofi-Aventis’ Plavix brand had beenlaunched had led the UK body’s Appraisal Committee to recommendusing clopidogrel more widely to prevent ischaemic stroke and heartattack in people who had previously had a stroke or who had beendiagnosed with peripheral arterial disease.

In April, NICE reviewed the use of clopidogrel, noting that at leasteight generic versions of the drug had been launched in the UK. Theseincluded products from Actavis, Arrow, and Beacon Pharma, as wellas Consilient Health, which had claimed the first UK launch of genericclopidogrel in July 2009 (Generics bulletin, 1 August 2009, page17). Dexcel Pharma, Dr Reddy’s, Mylan and Sandoz had also enteredthe market for generic clopidogrel by April this year, with competitionbetween the firms pushing down the Drug Tariff reimbursementprice for a 30-tablet pack of clopidogrel 75mg to £10.90 (US$17.20)in category M of the tariff.

By October, the average price of a 30-tablet pack of clopidogrel75mg tablets had fallen from £5.13 in the July-September quarter to£3.40, NICE said. Plavix’ official trade price is £35.64. It wasappropriate for the Appraisal Committee to take account of the fallingprice of generic clopidogrel in its considerations, NICE said, becauseof the resulting impact on the cost-effectiveness of the drug. Theinstitute has now recommended clopidogrel over BoehringerIngelheim’s Asasantin Retard (dipyridamole/aspirin) modified-releasebrand, another secondary treatment for ischaemic stroke that costs£7.79 for a 30-day course of treatment. G

PRODUCT NEWS


CARDIOVASCULAR DRUGS

NICE backs a wideruse of clopidogrel

Lupin has reached a settlement agreement with Warner Chilcott overUS litigation relating to the brand company’s Loestrin 24 Fe

(norethindrone/ethinylestradiol) oral contraceptive and its FemconFe chewable contraceptive tablets, which also contain norethindroneand ethinylestradiol.

Under the terms of the agreement, Lupin will not launch a genericversion of Loestrin 24 Fe until after the product’s US patent 5,552,394expires on 22 July 2014, unless a third party launches its own genericversion of the drug ‘at risk’ before this date. Warner Chilcott will retainthe right to bring a patent-infringement suit against Lupin if the Indiancompany launches its own generic under these circumstances. Thebrand company previously reached a settlement over Loestrin 24 Fewith Watson, allowing the generics firm to launch on the earlier of22 January 2014 or the date on which another generic enters themarket (Generics bulletin, 16 January 2009, page 18).

Warner Chilcott has also granted Lupin a licence to market anauthorised generic of Femcon Fe, which would be supplied by the brandcompany. The licence also allows Lupin to begin marketing its owngeneric version of the brand on 1 January 2013, or 180 days after Tevalaunches a generic under a prior settlement agreement if this is earlier.

Teva was the first company to file an abbreviated new drugapplication (ANDA) containing a paragraph IV challenge to Femcon’sUS patent 6,667,050, which is entitled ‘Chewable oral contraceptive’and is set to expire on 6 April 2019. The company reached anagreement with Warner Chilcott in 2008 allowing the Israeli firm tolaunch a generic rival to Femcon Fe two years after another companyfiled an ANDA challenging the ‘050 patent (Generics bulletin, 25September 2009, page 19). Lupin filed its ANDA in early 2009,meaning that Teva could launch in early 2011. G

ORAL CONTRACEPTIVES

Lupin strikes deal onLoestrin and Femcon

Sandoz and Hospira have extended their US injectable antibioticsportfolios by introducing piperacillin/tazobactam vials in the same

2g/0.25g, 3g/0.375g and 4g/0.5g sizes as offered by the original,Wyeth’s Zosyn injectable antibiotic.

Quoting IMS Health data for the year ended August 2010, Sandozsaid branded and generic piperacillin/tazobactam for injection hadannual US sales of US$797 million. The only other generic approvedby the US Food and Drug Administration (FDA) is the version thatApotex launched last year with 180-day exclusivity through a supplydeal with Hospira’s Orchid injectables unit (Generics bulletin, 25September 2009, page 21).

The only patent listed against Zosyn in the FDA’s Orange Bookis US patent 6,900,184, which expires on 14 April 2023 and covers arevised piperacillin/tazobactam formulation with a citrate buffer andedetate disodium dihydrate (EDTA) as a particulate-formation inhibitor.At the same time as it approved Orchid’s generic, the FDA respondedto citizen petitions submitted by firms including Sandoz and Wyethby stating that the original, discontinued Zosyn formulation withoutcitric acid and EDTA was safe and effective.

Hospira – which intends to offer a version in its proprietary ADD-vantage safety vial – said it also planned to launch piperacillin/tazobactam in several Asian markets over the next few months. G

ANTIBIOTICS

Sandoz and Hospira competeWatson’s Cobalt Pharmaceuticals has settled US litigation with

Sunovion – which changed its name from Sepracor last month –over the brand company’s Lunesta (eszopiclone) sleeping-aid tablets.Cobalt’s abbreviated new drug application (ANDA) filed with the USFood and Drug Administration (FDA) contained paragraph IV challengesto US patents 6,319,926, 6,864,257 and 7,381,724, which protect theproduct until 2012, and US patent 6,444,673 which is due to expireon 14 February 2014.

Under the terms of the settlement, both Sunovion and Watson haveagreed that their respective infringement claims and defences will bedismissed. Earlier this year, Glenmark reached a settlement agreementwith Sunovion – which for the past year has been part of Japan’sDainippon Sumitomo – allowing the generics firm to launch a genericversion of Lunesta on 30 November 2013, or on 30 May 2014 ifSunovion obtains a six-month period of paediatric exclusivity for the‘673 patent (Generics bulletin, 3 September 2010, page 20).

Watson has also filed an ANDA with the FDA for a generic versionof Shire’s Intuniv (guanfacine hydrochloride) extended-release 4mgtablet. The brand company said it was reviewing the details of Watson’sparagraph IV notice letter. Actavis, Anchen and Teva have all previouslyfiled ANDAs for guanfacine in 1mg, 2mg, 3mg and 4mg strengths(Generics bulletin, 7 May 2010, page 16). G

SLEEPING AIDS

Watson settles over Lunesta

Gen 1_11_10 Pgs.12-17.qxd 28/10/10 07:47 Page 5

Mylan intends to appeal against a ruling by a New Jersey districtcourt that opens the door for Apotex to market an authorised

generic of GlaxoSmithKline’s (GSK’s) Paxil CR (paroxetine)controlled-release antidepressant in the US.

Judge Joel Pisano had previously awarded Mylan a temporaryrestraining order (Generics bulletin, 1 October 2010, page 15). Butfollowing a hearing on 18 October, he refused to issue a preliminaryinjunction, allowing Apotex to offer versions of Paxil CR 12.5mg,25mg and 37.5mg through a deal with GSK.

Pisano had brokered a patent-litigation settlement between Mylanand GSK that had allowed the generics firm to launch an exclusivealternative to Paxil CR in May 2008. That agreement – reached inOctober 2007 (Generics bulletin, 2 November 2007, page 16) – hadonly two exceptions in granting patent licences “exclusive (even toGSK) in favour of Mylan for all generic paroxetine products”. Thesewere an authorised generic from GSK “or its affiliate”, or a settlementagreement by GSK with a third party in a patent-infringement action.

Discovered Apotex’ plans from customerMylan – which had only found out about Apotex’ plans from a

customer – claimed neither of the two criteria had been met, not leastbecause Apotex was not an affiliate of GSK. But in its oppositionbrief, GSK argued – apparently successfully – that its agreement withMylan “does not dictate to whom GSK may sell an authorised genericPaxil CR”. The deal gave GSK the right to market an authorisedgeneric two years after Mylan’s launch, the originator insisted.

According to GSK, had it not included a provision for anauthorised generic in the settlement with Mylan, the US Federal TradeCommission (FTC) would have opposed the deal. The brand firmaccused Mylan of trying to “buy time” so it might “cure its deficient”abbreviated new drug application (ANDA) for a 37.5mg strengthpending approval by the US Food and Drug Administration. G

PRODUCT NEWS


ANTIDEPRESSANTS

Mylan plans appealon paroxetine ruling

A bus parked in front of the German parliament, the Bundestag, and posters aroundBerlin’s public-transport network are among the measures Hexal is taking to drawthe attention of German decision-makers to the potential savings offered bybiosimilars. When Hexal commissioned a survey of 49 oncologists and nephrologists,41 representatives of statutory health insurance funds, 27 politicians and 14representatives of doctors’ associations, half of the 131 participants said they hadheard very little or nothing about biosimilars. “Around 40% could not correctlydefine the term,” Hexal noted. And four-fifths felt the savings potential of biosimilarswas, at best, being only partly realised. To highlight potential savings of C8 billion(US$11 billion) by 2020 (Generics bulletin, 16 October 2009, page 1) and meetdecision-makers’ demands for more information, the Sandoz subsidiary has launchedits ‘Biosimilars schaffen Freiräume’ campaign to stress that the savings fromcompetition to original biotech brands would create headroom to fund innovativetreatments. Initiatives within the campaign include a discussion forum and awebsite at www.biosimilars-schaffen-freiraeume.de.

ORCHID has convinced a New Jersey district court to compelWyeth to produce US licensing and settlement agreements made withother companies, as part of the two firms’ patent litigation over thebrand company’s Effexor XR (venlafaxine) extended-releasecapsules. The court granted Orchid’s motion to compel Wyeth todisclose settlements relating to previous litigation over the Effexor XRpatents because these agreements were likely to be relevant whenevaluating Orchid’s invalidity claims or calculating Wyeth’s damagesif Orchid were to launch a generic. Three patents protectingEffexor XR are due to expire on 20 September 2017.

ACTAVIS can expand its range of oncology drugs in Germany afterthe firm received approval for carboplatin 10mg/ml concentrateand gemcitabine 38mg/ml powder for infusion. The company alsosecured clearance for piperacillin/tazobactam 4g/0.5g powder.

MYLAN’S BIONICHE has struck a deal to manufacture and supplyinjectable melphalan to Delcath Systems in the US. The multi-yearagreement gives Delcath an exclusive right of reference to SynerxPharma’s abbreviated new drug application (ANDA) for thechemotherapy product, which is licensed to Bioniche and has beenapproved by the US Food and Drug Administration (FDA). Delcathsaid its right to reference the ANDA would “greatly simplify andenhance” its new drug application (NDA) for a product that usesmelphalan with Delcath’s ChemoSaturation system. The company saidit was currently conducting phase III clinical trials for the product.

HOSPIRA’S abbreviated new drug application (ANDA) for a genericversion of Purdue’s Dilaudid (hydromorphone) in 1mg/ml, 2mg/mland 4mg/ml strengths is the subject of a US patent-infringementlawsuit brought by the brand company in an Illinois District Court.Purdue claims that Hospira’s ANDA infringes US patent 6,589,960,which provides protection for the injectable analgesic brand until9 November 2020.

TEVA CANADA has failed on appeal to secure an order ofconfidentiality for its Notice of Allegation (NOA) challenging Pfizer’sCanadian patents for Lyrica (pregabalin). The generics firm – whichpreviously operated under the Novopharm name – had argued thatwithout an order to prevent disclosure of the NOA, its competitorswould be able to “obtain for free the benefit of the considerableeffort and resources” that the firm had invested in challenging theLyrica patents (Generics bulletin, 7 May 2010, page 17). However,a Federal Court of Appeal in Ontario said Teva had not demonstratedthat disclosing the NOA would cause “irreparable harm” to thecompany’s commercial interest.

WOCKHARDT has reached a settlement agreement with Takeda overUS patent litigation relating to the originator’s Actos (pioglitazone)brand. The Japanese firm has previously reached settlement dealsover the diabetes treatment with Mylan’s Alphapharm, Mylan,Ranbaxy, Sandoz, Torrent, and Watson (Generics bulletin, 7 May2010, page 18). Wockhardt has also received tentative approvalfrom the US Food and Drug Administration (FDA) for a genericversion of Sanofi-Aventis’ Allegra-D 12 Hour (fexofenadine/pseudoephedrine) 60mg/120mg extended-release tablets.

LEHIGH VALLEY TECHNOLOGIES has obtained approval from the USFood and Drug Administration (FDA) for oxycodone 5mg capsulesand 100mg/5ml oral solution as new drug applications (NDAs). Lehighwas among the firms that the FDA last year told to stop marketingunapproved opioid analgesics containing hydromorphone, morphinesulfate or oxycodone (Generics bulletin, 17 April 2009, page 14). G

IN BRIEF

Gen 1_11_10 Pgs.12-17.qxd 28/10/10 07:47 Page 6

Actavis has obtained a marketing authorisation for telmisartan20mg, 40mg and 80mg tablets throughout the European Union

(EU) after the European Commission accepted the positive opinionissued earlier this year by the committee for human medicinalproducts (CHMP) within the European Medicines Agency (EMA).

Telmisartan Actavis, the CHMP advised, had been “shown to havecomparable quality and to be bioequivalent to Micardis”, BoehringerIngelheim’s antihypertensive agent (Generics bulletin, 30 June 2010,page 15). The German brand firm – which has just received EMAclearance for its Twynsta (telmisartan/amlodipine) combination – saidMicardis was its third best-selling brand last year with a global turnoverahead by 14.3% to C1.39 billion (US$1.94 billion). The angiotensin-IIreceptor antagonist is expected to lose patent protection in majorEU markets in 2013. G

PRODUCT NEWS


Reckitt Benckiser has been fined £10.2 million (US$16.1 million)for abusing its dominant UK market position in prescriptions for

alginate and antacid heartburn medicines on the National Health Service(NHS). It has admitted infringing UK and European competition lawby withdrawing and delisting its Gaviscon Original Liquid in 2005,thereby impeding generic competition.

The multinational healthcare, personal care and householdproducts firm had originally insisted that it had competed “fairly andwithin the letter and spirit of the law” (Generics bulletin, 5 March2010, page 16). However, Reckitt subsequently admitted abuse andagreed to cooperate with the UK’s Office of Fair Trading (OFT),thereby reducing its fine from £12 million.

Welcoming the OFT’s decision, Warwick Smith, director of theBritish Generic Manufacturers Association (BGMA), noted that theEuropean Commission had concluded in its sector inquiry thatoriginators’ delaying tactics should be subject to greater scrutiny.

Reckitt withdrew NHS packs of Gaviscon Original Liquid fromthe NHS prescription channel after the product’s patent had expired,but before its generic name had appeared in doctors’ prescribingsoftware. By so doing, the firm attracted more prescriptions for itsalternative product, Gaviscon Advance Liquid, that had been launched in1997, but is patent-protected until 2016. Both Gaviscon Original andAdvance have non-prescription status and are available OTC. G

GASTROINTESTINAL REMEDIES

Reckitt is fined forabusing UK position

ANTIHYPERTENSIVES

Actavis has EU telmisartan

Spain’s Cinfa has extended its Cinfatós range of OTC cold remedieswith the domestic launch of an oral decongestant solution

containing dextromethorphan, pseudoephedrine and triprolidine. Thethree ingredients respectively suppress cough, reduce nasal congestionand relieve runny nose. Cinfa said that Cinfatós Decongestantcontained no alcohol or sucrose, which made it suitable for diabetics.The product is available in 125ml and 200ml bottles, which haveretail prices of C4.75 (US$6.55) and C6.15. G

COUGH/COLD REMEDIES

Cinfa launches decongestant

Gen 1_11_10 Pgs.12-17.qxd 28/10/10 07:47 Page 7

EVENTS


15-16 November

■ Patent Litigation 2010New York, USAThis is a two-day event providing up-to-date information on legal issues anddeveloping litigation strategies and willlook at all stages of a patent lawsuit.

Contact: Practising Law Institute.Tel: +1 212 824 5710.E-mail: [email protected]: www.pli.edu.

16-19 November

■ World Generic MedicinesCongress AmericasWashington DC, USAThis four-day event will providenetworking opportunities and look atissues including biosimilars, emergingmarkets, and lifecyle management.

Contact: Sabrina Khamissa, HNC.Tel: +44 207 608 7055.E-mail: [email protected]: www.healthnetworkcommunications.com/2010/genericsusa.

27 November

■ Challenges in EvaluatingSimilar BiotherapeuticProductsSingaporeJointly organised by the InternationalAssociation for Biologicals (IABS), theInternational Federation of PharmaceuticalManufacturers and Associations (IFPMA)and the European Generic medicinesAssociation (EGA), this one-day workshopwill focus on the World HealthOrganization (WHO) guidelines.

Contact: IFPMA.Tel: +41 22 338 3200E-mail: [email protected]: www.ifpma.org.

6-7 December

■ European Medicines AgencyReview of the Year andOutlook for 2011 and BeyondLondon, UKThis is a two-day meeting jointly organised byTOPRA and the European Medicines Agency.The programme includes sessions on thefuture role of regulatory agencies, clincaltrials and the centralised approval process.

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

24 January

■ 4th EGA PharmacovigilanceDiscussion Forum25-26 January

■ 10th EGA Regulatory &Scientific Affairs ConferenceLondon, UKThe EGA’s Pharmacovigilance Forum,looking at issues including legislation andrisk-management, will precede its two-dayevent on Regulatory and Scientific Affairs.

Contact: Cristina Romagnoli, GPA Conferences.Tel: + 377 93 501 348.E-mail: [email protected] online at www.gpaconferences.com.

14-15 February

■ PharMeetLisbon, PortugalThis 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.

22-25 February

■ World Generic MedicinesCongress EuropeLondon, UKThis four-day event will provide interactivenetworking opportunities and will includeopen discussion sessions. Speakers willinclude Robert Wessman, executivechairman of Alvogen.

Contact: Sabrina Khamissa, HNC.Tel: +44 207 608 7055.E-mail: [email protected]: www.healthnetworkcommunications.com/2010/genericsuk.

28 February – 1 March

■ EuroPLX 45Lisbon, PortugalThis two-day meeting provides a forum

for firms to discuss licensing, marketingand distribution opportunities for patenteddrugs, generics, OTC medicines andnutraceuticals.

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

18 March

■ 7th EGA LegalAffairs ForumBrussels, BelgiumThis is a one-day event organised by theEGA. The meeting will also providenetworking opportunities.


28-30 March

■ DIA 23rd AnnualEuroMeetingGeneva, SwitzerlandLooking at issues including patient safety,counterfeiting, global drug developmentand biologicals, this three-day event willalso provide networking opportunities.There will be speakers from firmsincluding Pfizer, Sanofi-Aventis, andGlaxoSmithKline.

Contact: Drug Information Association (DIA).Tel: +41 61 225 5151.E-mail: [email protected]: www.diahome.org.

14-15 April

■ 9th EGA InternationalSymposium on BiosimilarsLondon, UKThis two-day conference is the ninthannual meeting organised by the EGA.


NOVEMBER 8-10 December

■ 13th IGPA Annual ConferenceMumbai, IndiaThis three-day conference is being organised by the Indian Pharmaceutical Alliance and is theglobal event of the worldwide generics industry. It is the annual joint meeting of the Canadian,European, Indian, Japanese and US generics industry associations, the CGPA, EGA, IPA, JGAand GPhA. Speakers will include Didier Barret, chairman of the EGA and chief executive officerof Mylan Europe, and Paul Bisaro, chairman of the GPhA and Watson’s chief executive officer.

Contact: IPA. Tel: +91 22 2600 0632. E-mail: [email protected] online at www.igpamumbai2010.com.

DECEMBER

JANUARY

FEBRUARY

MARCH

APRIL

Gen 1_11_10 Pg.18.qxd 28/10/10 07:48 Page 2

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


When generic venlafaxine was launched in the UK at the end of2008, Generics bulletin noted the presence of both unbranded

immediate-release tablets and branded extended-release capsules onthe market. Teva was one of the few companies to have both unbrandedtablets in the two lower strengths of 37.5mg and 75mg, as well asRomodel XL 75mg and 150mg capsules. This echoed the Efexor andEfexor XL brand offerings from Wyeth, although not the variety ofpack sizes (Generics bulletin, 16 January 2009, page 19).

Today, the Department of Health has fixed upon 56-count packsof 37.5mg and 75mg tablets in the immediate-release form and 28-capsule packs of 75mg and 150mg “modified-release” venlafaxine forits Drug Tariff of reimbursement prices for pharmacists and dispensingdoctors in England and Wales.

The department has also put venlafaxine tablets into category M,which is based on market prices, and capsules into category C,comprising “drugs which are not readily available as a generic”. As aresult, generic capsule reimbursement prices are based on those forEfexor and are over four-times more expensive for the same 75mgstrength than tablets. Pharmacists were reimbursed £22.50 (US$35.36)for dispensing 28-capsule packs of 75mg modified-release venlafaxinein October, but only £4.71 for larger 56-tablet packs of 75mg tablets,after a 20% reduction on the September reimbursement price of £6.06.

Investigating how the trade prices of venlafaxine in its two forms,three strengths and various pack sizes had fared in almost two yearssince launch, WaveData initially noticed that the price-decay rates ofmodified-release forms of venlafaxine appeared to show slower decayrates than the immediate-release forms. However, when this picturewas compared with what happened to felodipine, which lost its patentprotection in November 2003, WaveData noticed that the release rateappeared not to be an important factor.

“The question ‘why’ necessitated some investigation into whichmanufacturers were making which forms of venlafaxine,” explainedWaveData’s managing director, Charles Joynson. “This revealed therewere a number of listings for ‘Retard’ and modified-release (MR)forms on suppliers’ price lists, which was confusing as no manufacturercurrently makes a venlafaxine Retard or MR product. They are allcalled either immediate-release, SR or XL.”

“In both venlafaxine 75mg and 150mg strengths, the non-existentRetard form is the cheapest – mainly through Strathclyde Wholesale,which is almost certainly confusing pharmacists by calling the XLproduct Retard – with the XL form following a close second (seeFigures 1 and 2),” Joynson said. “With felodipine,” he added, “there islittle difference, although the XL form is marginally cheaper than theothers (see Figures 3 and 4).”

Joynson suggested that Wyeth with Efexor – and other originatorswith felodipine – had attempted to switch prescribing to the XL formto ‘evergreen’ the molecule, thereby retaining market share. “This mightexplain why the XL form makes up more than half of the trade-pricedata for venlafaxine today, and the vast majority of price offers forvenlafaxine capsules,” he said, noting that Wyeth had discontinuedoffering Efexor immediate-release tablets in November 2009. G

Does XL suffix mean slower price decay?

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Figure 2: Price decay since launch of 28-capsule packs of venlafaxine 150mgwith various suffixes as described in trade price lists (Source – WaveData)

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Figure 1: Price decay since launch of 28-capsule packs of venlafaxine 75mg withvarious suffixes as described in trade price lists (Source – WaveData)

Figure 3: Price decay since launch of 28-tablet packs of felodipine 5mg withvarious suffixes as described in trade price lists (Source – WaveData)

Figure 4: Price decay since launch of 28-tablet packs of felodipine 10mg withvarious suffixes as described in trade price lists (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?

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Two years after he was appointed head of Sandozon 20 October 2008, Jeff George has plenty tocelebrate. Having taken charge of a business that

was struggling to register sales growth – and was goingbackwards in its largest single market, the US – Georgeand his team have put Novartis’ generics arm back ontrack to achieve double-digit sales growth this year.

Sandoz’ Project Compete cost-rationalisationprogramme delivered savings of over US$350 millionlast year and is continuing to drive operating marginimprovements. And the company’s strategic focus ondifferentiated products such as biosimilars, oncologyinjectables and respiratory drugs is making solidprogress, not least through its recent acquisitions ofOriel Therapeutics and Ebewe Pharma.

Speaking exclusively to Generics bulletin, Georgerecalled that a year ago he had described 2009 as “aturnaround year” for Sandoz (Generics bulletin, 27November 2009, page 24). “We achieved our targets in2009,” he stated last month, noting that the businesshad achieved a 5% constant-currency sales advanceto US$7.49 billion last year (Generics bulletin, 1February 2010, page 5).

“This year has been about accelerating salesgrowth,” George remarked. And with a 15% increaseto US$6.15 billion in the first nine months of this year,Sandoz appears set to register a double-digit advanceand a turnover of more than US$8 billion in 2010.

George said Sandoz’ strategic priorities hadremained largely the same during his first two years atthe helm. From a growth outlook, these were expandingthe firm’s leading position in differentiated generics;strengthening its presence in emerging markets, includingthe growing Japanese generics sector; and improvingSandoz’ performance in mature markets such as the US.

But while Sandoz’ strategic focus has remainedlargely constant, the team that George has entrusted todeliver that strategy has been transformed. “Two-thirds

of our senior managementteam – 12 out of 18 positions– are new since I took over,”he pointed out. Among those12 newcomers – several ofwhom had moved acrossfrom the Swiss parent group’sNovartis Pharma brands unit– were eight of 10 regionand business-unit heads.

According to George, thispersonnel change had beencrucial to ushering in a newcorporate culture at Sandoz.“A couple of years ago, ourfocus was largely internal.Now we look more closely atwhat our customers need,” heexplained. Moreover, Georgecontinued, following problems

with manufacturing compliance – notably at thefirm’s facility in Wilson, North Carolina – themanagement team had placed great importance onensuring quality, better to conform with increasinglystrict regulatory standards. “With 37 manufacturingsites and 11 global development centres, we undergoaround 100 inspections each year,” he pointed out.

Turning to Sandoz’ strategic focus on differentiatedproducts, George noted that the company’s globalbiosimilar sales had climbed by 73% to US$118 millionlast year (Generics bulletin, 1 February 2010, page 1).“In the first nine months of this year, our biosimilarsturnover is ahead by 59% at constant exchange rates,”he observed. The third-quarter advance was 41%.

“We are the clear biosimilars market leader inregulated markets,” George stressed, highlighting IMSHealth data that showed the firm controlled almost halfof the market with its Omnitrope (somatropin), Binocrit(epoetin alfa) and Zarzio (filgrastim) brands (Genericsbulletin, 17 September 2010, page 24).

“Omnitrope is the world’s best-selling biosimilar,”George remarked, noting that the somatropin brand had“made steady gains against originator growthhormones”. “In the US, the brand has overtaken Teva’sTev-Tropin as the leading follow-on human growthhormone, while more than 30% of naïve patients inEurope are now being treated with Omnitrope,” he said.

Having two years ago introduced Omnitrope asAustralia’s first biosimilar, Sandoz followed up last yearwith pioneering launches in Canada and Japan(Generics bulletin, 16 October 2009, page 1). “TheJapanese market requires patience and commitment,”George maintained. Having put in place a talentedcommercial team, Sandoz was starting to increase patientstarts with the firm’s Somatropin-BS brand, he said.

George said Binocrit and its sister brand Epoetinalfa Hexal were market leaders in Germany. Sandozwas currently rolling out a higher strength version withan oncology indication throughout Europe, he added.

The Zarzio (filgrastim) franchise – including theFilgrastim-Hexal variant – was also producing pleasinggrowth in Europe, according to George. “Unlike withOmnitrope and Binocrit, we were not first to market,”he pointed out. “Nevertheless, we have made significantmarket-share gains.” In the UK, George observed,Zarzio and rival granulocyte-colony stimulating factor(G-CSF) formulations marketed by Ratiopharm andTeva had been adopted as first-line treatments byseveral primary-care trusts. This was significant, heinsisted, because Amgen’s Neupogen had been limitedto second-line use due to its high cost.

Turning to Sandoz’ biosimilars pipeline, Georgesaid the company had invested heavily in developingmonoclonal antibodies. However, noting Pfizer’s recentdeal with Biocon (see page 13), he questioned amove into the insulin market due to the relatively lowreturns on offer. “Insulin is a challenging market,”George believed, contrasting the high manufacturing

BUSINESS STRATEGY


A strategic focus on

biosimilars, injectable

cancer therapies and

respiratory drugs is

paying off for Sandoz,

the company’s global

head Jeff George told

Aidan Fry.

Focus on differentiationaccelerates Sandoz’ rise

EuropeUS$1,009m

-6%

USUS$768m

+78%

Asia, Africa,AustralasiaUS$259m

+26%

Canada and Latin AmericaUS$141m

+1%

Figure 1: Breakdown by region of Sandoz’ turnover ahead by 18%to US$2.18 billion in the third quarter of 2010 (Source – Novartis)

Jeff George

Gen 1_11_10 Pgs.20-21.qxd 28/10/10 07:51 Page 2

costs and capital expenditure needed with the relativelylow prices companies could command in a marketdominated by strong, entrenched players.

Commenting on the plans of biotech and bigpharma companies such as Merck & Co and Pfizer tocompete in the biosimilars arena, George stressedSandoz’ lengthy experience in the field. “We starteddeveloping human growth hormone in 1996 anderythropoietin in 1997,” he pointed out.

Sandoz’ status as part of the broader Novartishealthcare group was a competitive advantage in thebiosimilars sphere, George insisted. “We have a fully-fledged, autonomous unit that is firing on all cylinders,”he said, “but we also have access to Novartis’ clinical andtechnical capabilities, as well as to the capital needed.”George added that developing a biosimilar couldtypically cost up to US$250 million per product.

He maintained that Sandoz’ close relationshipwith Novartis Pharma was also helpful to the genericsdivision’s plans to build an extensive portfolio of genericrespiratory drugs. For example, he noted, both Novartisand Sandoz had alliances with UK-based firm Vectura.

Having limited its deal with Vectura to the EuropeanUnion, Sandoz recently boosted its US respiratorypipeline by paying US$332 million, including milestones,for Oriel (Generics bulletin, 23 April 2010, page 1).

Oriel brings differentiated technology“Oriel was a great bolt-on acquisition that gave us

differentiated technology with its FreePath drug-deliverysystem and the Solis dry-powder inhaler,” Georgecommented. “Demonstrating that a device is identicalis a high bar, but we believe in the potential forsubstitutability of asthma and chronic obstructivepulmonary disease (COPD) therapies in the US,” he said.

Turning to Sandoz’ C925 million (US$1.3 billion)takeover of Austrian injectables specialist Ebewe Pharma,George said a smooth integration had brought “a lot ofenergy and entrepreneurial spirit” into the group. Salesby the former Ebewe operation – now rebranded as partof Sandoz Oncology Injectables (Generics bulletin, 15October 2010, page 2) – had grown by 22% at constantexchange rates in the first nine months of this year.This had been “in line with our expectations”, hestated. “We have invested C30 million in upgradingour injectables plant in Unterach, Austria,” he added.

“Two years ago, we ranked fourth or fifth in termsof global generic injectables sales,” George observed.“Our analysis shows we are currently second behindHospira, but ahead of Fresenius and Teva,” he added,pointing out that this advance was due not just to theEbewe acquisition, but also to launches outside of theoncology category, such as introducing a rival toSanofi-Aventis’ Lovenox (enoxaparin) in the US thissummer (Generics bulletin, 6 August 2010, page 1).

Enoxaparin sales of US$292 million in around 10weeks after market entry – as well as first-to-marketintroductions of lansoprazole, losartan and tacrolimus –were key factors in Sandoz raising its US turnover fromretail generics and biosimilars by 76% in the thirdquarter. As Figure 1 shows, total US sales, includingbulk anti-infectives, rose by 78% to US$768 million.

George said losartan authorised generics hadcontributed US$130 million to US sales. The firm hadshared the generics market equally with Teva beforeadditional competitors entered the arena.

A 6% reportedthird-quarter declineto US$1.01 billionin Europe was duesolely to exchange-rate fluctuations, asthis equated toconstant-currencygrowth of 2%.George said thatwhile tenders bystatutory healthinsurance funds andreference-pricereductions had cut retail generics and biosimilarsturnover in Germany by 15% at constant exchange rates,sales in the rest of western Europe had climbed by 13%despite mandatory price cuts imposed in several markets.

George insisted the German slide should be viewedagainst an overall double-digit decline in the market’svalue. “The policies of the insurers and healthcareadministrators have done a lot of damage to theGerman generics industry,” he asserted.

By contrast, Sandoz had achieved double-digit salesgrowth in Nordic markets and pleasing advances inItaly, Spain and Portugal during the quarter, Georgepointed out. “Sales in Italy were ahead by 45% – andby 66% year-to-date – as our team did a great job inboth the retail and hospital sectors,” he remarked, addingthat Ebewe had boosted Sandoz’ position in Italy, as hada recent acquisition of dermatology and gynaecologyfranchises from Mipharm. “We have rebounded inFrance with a 10% third-quarter rise,” he continued.

Sandoz also enjoyed strong third-quarter gains inseveral emerging markets, as the firm reaped the benefitsof devolving responsibility from its headquarters inHolzkirchen, Germany, to regional units in the Asia-Pacific, Central and Eastern Europe, Latin America andMiddle East, Turkey and Africa regions.

On a constant-currency basis, turnover was aheadby 41% in the Middle East, Turkey and Africa, whilesales advanced by 19% in both the Asia-Pacific andCentral and Eastern Europe regions. And in Japan’semerging generics market, a focus on organic growthhad delivered a 39% sales increase. “Inorganic strategiesare not hugely viable, due to local players’ reticenceto be acquired,” George believed.

Sandoz’ third-quarter constant-currency salesgrowth of 23% to US$2.18 billion equated to an 18%rise as reported in US dollars. A shift in product mixand higher inventory write-offs reduced Sandoz’ third-quarter gross margin by just over three percentagepoints to 46.7%. But “sourcing optimisation inmanufacturing and development” and administrativecost savings – as well as research and developmentspending down by 14% to US$135 million (see Figure2) – enabled Sandoz to raise its operating profit by athird to US$415 million. This improved the firm’soperating margin by 2.2 percentage points to 19.1%.

George acknowledged that additional competitionon some the firm’s first-to-market launches in the US– as well as a four-month contribution from Ebewe lastyear – meant Sandoz’ sales growth could slow in thefourth quarter of 2011. Nevertheless, he insisted, Sandoz’focus on differentiated products had set it up for strongincreases over many years. G

BUSINESS STRATEGY


US$ Change Proportion ofmillions (%) sales (%)

Net sales 2,177 +18 100Gross profit 1,017 +11 47Sales and marketing 344 +10 16Research and development 135 -14 6General and administration 80 -15 4Other costs 43 +19 2Operating profit 415 +33 19

Figure 2: Breakdown of Sandoz’ net sales, profit margins and operatingexpenses in the third quarter of 2010 (Source – Novartis)

“We believe in the

potential for

substitutability of asthma

and chronic obstructive

pulmonary disease

(COPD) therapies

in the US”

Gen 1_11_10 Pgs.20-21.qxd 28/10/10 07:51 Page 3

Teva is strengthening its regulatory team in the US by recruitingGary Buehler – former director of the Office of Generic Drugs

(OGD) within the US Food and Drug Administration (FDA) – asvice-president of regulatory strategic operations.

“We have offered Gary Buehler the position, which he hasaccepted. He is scheduled to start on 1 November,” a Teva spokespersontold Generics bulletin.

Buehler left the OGD earlier this year to become acting deputyfor operations in the agency’s Office of Pharmaceutical Sciences (OPS).The OPS’ deputy director, Dr Keith Webber, took over as acting OGDdirector, thereby inheriting a backlog of around 2,000 abbreviatednew drug applications (ANDAs) awaiting assessment (Genericsbulletin, 26 March 2010, page 26). OPS director Helen Winkle saidBuehler would “play a key role” in the FDA’s negotiations with industryover proposed generic user fees.

Teva is a key member of the Generic Drug User Fee Coalition, alobbying group that includes three other generics firms that are notmembers of the US Generic Pharmaceutical Association (GPhA) –Apotex, Hospira and Perrigo (Generics bulletin, 1 October 2010,page 6). The coalition believes that the OGD’s backlog of ANDAsshould be addressed via “a separate funding model” to user fees andthat any fees for new ANDA filings must be linked to “goals andmetrics that delivery certainty of review times”. G

PEOPLE


APPOINTMENTS

FDA’s Buehler takesposition with Teva

Caraco Pharmaceutical Laboratories has named GP Singh Sachdevaas chief executive officer (CEO) from 1 November. He replaces

Jitendra Doshi, who took on the role of interim chief executive at theUS subsidiary of India’s Sun Pharma last year following the departureof Daniel Movens (Generics bulletin, 1 August 2009, page 27). Caracosaid Doshi – who had resigned for “personal and health-related reasons”– would help Singh settle into the job over the next few weeks.

Singh, 42, has been Caraco’s chief operating officer since July,before which he served as the company’s senior vice-president ofbusiness strategies for three years. Between 2003 and 2007 he wasCaraco’s vice-president of sales and marketing, a position he took afterjoining the company as national sales and marketing manager in 2000.

Significant progress on manufacturing problemsProviding an update on the company’s manufacturing deficiencies

at its Detroit plant (Generics bulletin, 8 July 2009, page 3), Caracosaid it had made “significant progress” towards obtaining US Foodand Drug Administration (FDA) approval under a consent decree toresume manufacturing of two products. The firm said it expected tobegin making these drugs by April 2011, to be followed by a furthertwo or three products by the end of next year. However, the companyadmitted that at best it would take “significant time” before theDetroit facility reached its previous production levels. G

APPOINTMENTS

Caraco names Singhas chief executive

Gen 1_11_10 Pgs.22-23.qxd 28/10/10 07:53 Page 2

Two of Mepha’s most senior managers have quit the Swiss genericsmarket leader following its takeover by Cephalon earlier this year.

Chief executive officer Thomas Villiger has stepped down, while thehead of Mepha International, Martin Berger, is also leaving.

As part of a restructuring exercise, Cephalon has created threecompetence centres at Mepha’s headquarters in Aesch, near Basel. Agenerics centre covering operations in Europe, the Middle East andAfrica is led by Andreas Bosshard, who continues in his role as chiefexecutive officer of the Swiss firm’s domestic operation, Mepha Pharma.Mepha’s international operations outside of Europe, the Middle Eastand Africa have been absorbed into Cephalon’s existing infrastructure.

Mepha’s vice-president of research and development, Dr ViktorBrantl, is responsible for a competence centre for galenic research andnew formulations that will combine Mepha’s existing expertise withCephalon’s DuraSolv, OraSolv, OraVescent and LYOC technologies.

Dr Jürgen Betzing, the Swiss group’s chief operations officer,leads a third centre covering production, distribution and purchasing.

Bosshard, Brantl and Betzing all sit on Cephalon’s Europeanmanagement board, which is headed by the president of CephalonEurope, Alain Aragues.

Mepha – which said it had enjoyed a more than five-fold turnoverrise under Villiger’s 14 years in charge – stressed it would continue toprovide its Swiss customers with generics featuring the firm’s rainbowlogo, augmented by Cephalon brands such as Actiq (fentanyl citrate).

Cephalon – which is currently being led by its chief operatingofficer Kevin Buchi while its chairman and chief executive officerDr Frank Baldino takes a temporary medical leave of absence –completed its SFr662 million (US$680 million) purchase of Mephafrom the Merckle group in April this year. The purchase price was morethan one-and-a-half-times Mepha’s 2009 turnover, which rose by 7.7%to SFr408 million (Generics bulletin, 12 February 2010, page 1). G

PEOPLE


RESIGNATIONS

Mepha managers goafter Cephalon deal

AESEG – Spain’s generics industry association – said it hoped to“maintain cooperation and dialogue” with the country’s ministryof health following the nomination of Leire Pajín to replaceTrinidad Jiménez as minister. G

IN BRIEF

KV Pharmaceutical has poached Mark Hartman, former presidentof Wockhardt’s North American operations, to lead Nesher

Pharmaceuticals, its newly-created generic marketing subsidiary.The US firm had earlier this year said it would close its Ethex

generics unit due to the unit’s tarnished reputation. The firm hadadmitted criminal charges of failing to file ‘field alerts’ fordextroamphetamine and propafenone, which added to the unit’smanufacturing problems (Generics bulletin, 5 March 2010, page 3).Ethex’ president and chief executive officer, Michael Anderson,resigned a few weeks later (Generics bulletin, 28 May 2010, page 30).

“After recently receiving FDA approval to return the first of ourgeneric products to the market,” commented KV’s interim presidentand chief executive officer Greg Divis, “Mark will be spearheadingour ‘go to market’ strategy and subsequent product launch efforts.”The FDA recently told KV it could relaunch its Micro-K (potassiumchloride) 8mEq and 10mEq extended-release capsules (Genericsbulletin, 17 September 2010, page 3).

Having joined Wockhardt a year ago with responsibilities includingthe firm’s Morton Grove liquids business, Hartman spent more thansix years as president of North American generics at Dr Reddy’s. Hehas also held sales and marketing roles at Watson and Alpharma. G

APPOINTMENTS

KV recruits Hartmanto launch new unit

Sandoz is looking for a head of commercial operations in the Asia-Pacific region after Richard Saynor left to join GlaxoSmithKline

(GSK). On an interim basis, Sandoz has given the position to itsAsia-Pacific finance and information technology head, John Rooney.

Saynor has become senior vice-president of GSK’s ClassicBrands operation in Asia and emerging markets. In this role, he isresponsible for the originator’s off-patent brands such as Augmentin(amoxicillin/clavulanic acid), Lamictal (lamotrigine) and Ventolin(salbutamol), as well as branded generics. GSK’s deals with AspenPharmacare and Dr Reddy’s fall under the Classic unit’s remit. G

RESIGNATIONS

GSK snaps up Sandoz’ Saynor

Germany’s cabinet has named Dr Walter Schwerdtfeger aspresident of the country’s federal institute for drugs and medical

devices, BfArM. He will take up the post on 1 November, replacingProfessor Johannes Löwer, who is to retire after three years incharge. Having led the regulatory agency on an interim basis for twoyears, Löwer took full charge of BfArM at the start of this year(Generics bulletin, 15 January 2010, page 23).

Schwerdtfeger – who lectures at the medical faculty of theUniversity of Bonn – currently leads the medicines and pharmaciesdepartment within Germany’s federal ministry of health. In this role,he contributed significantly to restructuring BfArM. He joined theministry in 1992, having previously worked at the Max Planck Institutefor brain research in Frankfurt and the Paul Ehrlich Institute in Langen,which has responsibility in Germany for vaccines and biologics. G

REGULATORY AGENCIES

German agency swaps head

Gen 1_11_10 Pgs.22-23.qxd 28/10/10 07:53 Page 3

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Gen 4-COLOUR House Ad - Jan 2010.qxd:New Gb 4colour Advert 07 11/1/10 10:39 Page 1

lovenox rival brings in us$292mn for sandoz - generics bulletin · 2010. 11. 1. · companynews 2...

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