Gen 2/11/12 Pg.1_Gen 18/11/05 Pg. 1 31/10/2012 20:03 Page 1

2November 2012

COMPANY NEWS 2 Mylan has US$4 billion Sanofi doubles in US on 2 authorised rivals Watson sells stakeinBrazil’sMoksha8 3 Pharmstandardsees no need to change 4 to spend on acquisitions Mylan will buy SMS’ Indian oncologysite 5 Strides submits 28 ANDAs in aquarter 6 Bedfordisshipping limited US supplies 7 ylan has awar-chest of morethan US$4 billion available to fund acquisitions that Bupropion problems cost 8 Mextend its geographic presence or add product categories and technologies, according Impax US$2mn to the US-based group’schief executive officer,Heather Bresch. “Thereare many compelling UK’sAesica aims for£340mn by 2015 9 opportunities out thereand we arelooking at all of them,”she stated, identifying dermatology and topical, injectable and respiratory drugs as areas in which Mylan might strikedeals. MARKET NEWS 10 In recent years, Bresch noted, Mylan had largely been focusing on reducing its debt and maximising the global asset base it had gained by acquiring Merck KGaA’s generics operation Substitution planned this year in Ireland 10 and Indian raw-material specialist Matrix, both in 2007, as well as on building on its purchase of Bioniche to gain entry to the injectables sector. Belgian brand deal is queried 10 Paying offdebt had givenMylan “increased financial flexibility” to pursue acquisitions, by FeBelGen Bresch stated, adding that an annual free cash flowofaround US$700 million had allowed the firm India will onlygrant licences under INNs 12 to reduce its ratio of debt to earnings before interest, tax, depreciation and amortisation (EBITDA) UK refers one moreSPC dispute to ECJ 13 to 2.6-to-1. While senior management wasprepared to exceed the firm’slong-term gearing target Stada and Te va lead SpectrumK contracts13 of 3-to-1, it would aim to return to that levelwithin 18 months of anydeal, she added. Australia will review 14 Acquisitions were just one wayinwhich Mylan would more than double its annual earnings- patent extensions per-share to US$6 by 2018, Bresch insisted. She revealed the firm would soon establish a foothold in Thailand to complementthe commercial unit it recently set up in India. And agenerics PRODUCT NEWS 16 alliance with Pfizer in Japan would come into effect later this year or early in 2013, she added (Generics bulletin,3September 2012, page 1). Watson makes FDAapproveActos rival 16 The first global Phase III clinical trial through Mylan’sbiosimilars partnership with Biocon had begun for arivaltoHerceptin (trastuzumab) in October,Bresch pointed out, while the firm AET aims forHumira via 17 BioXpress deal had recently launched oral contraceptives in Canada and Germanythrough its alliance with India’sFamy Care. Mylan is also investing in the manufacturing network for the Institutional FDAaddsUS$2.7mntotacrolimus trial 17 business unit it set up on the basis of the Bioniche injectables deal (see page 5). G Sandoz enrols forUSstudy on 18 epoetin alfa Te va first in line forEUimatinib approval 21

FEATURES 22 FDA publishes GDUFAfee rates ser fees payablebygenerics firms wishing to submit products for registration in the US Hikma’sInjectables unit 22 Ubetween October 2012 and September 2013 have been published by the US Food and Drug turns gazetowards France – Administration (FDA) in the country’s Federal Register.For an abbreviated newdrug application Hikma believesamix of geographic and (ANDA), the fee is US$51,520, whilst the prior approvalsupplement (PAS) fee is US$25,760. portfolio expansion will drive double-digit The fee payable by owners of drug master files (DMFs) referenced after 1October in generic sales growth by its US$450 million drugsubmissions is US$21,340. Meanwhile,aseparate fee applicable to existing ANDAs Injectables division. Aidan Fry reports. awaiting approvalinthe FDA’sbacklog as of 1October 2012 has been calculated at US$17,434. According to the Generic Drug User Fee Amendments (GDUFA) signed into US lawearlier REGULARS this year (Generics bulletin,13July 2012, page 9), the FDAmay collect US$299 million in generic druguser-fees for the year ending 30 September 2013. The backlog fee –which, Paragraph IV Watch – Ganirelix 20 according to GDUFA, should contribute US$50 million of this total –was calculated based on Events – Our regular listing 22 the FDA’sassertion that there were 2,868 ANDAs in the backlog on 1October. Of the remaining US$249 million, GDUFAspecifies that 24% –orUS$59.8 million –must Price Watch UK – Our in-depth 23 be funded through ANDAand PASfees, and that the PASfee must be equal to half the ANDA look at pricing trends in the UK fee. The ANDAand PASfees were therefore calculated based on the FDA’sestimates that 1,160 People – EU’scommissioner 27 ‘full application equivalents’ (FAEs) and 576 PASs would be receivedduring the first year of Dalli quits after probe the user-fee programme. DMF fees will account for 6% –orUS$14.9 million –ofthe US$249 million, with the final figure based on the FDA’sestimate that 700 DMFs will be referenced. G Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 2

COMPANY NEWS

STRATEGICALLIANCES THIRD-QUARTER RESULTS Mitsubishi Tanabe Sanofi doublesinUS ends Choseido deal on authorised rivals

apanese brand companyMitsubishi Tanabe Pharma and oral-dose arketing authorised generics of its Lovenox (enoxaparin) and Jgenerics specialist Choseido Pharmaceutical have dissolved their MAprovel(irbesartan) helped Sanofitomore than double its US generics strategic alliance after acknowledging that the results of the generics sales at constant exchange rates to C70 million (US$91.1 deal had “not met their initial expectations”. million) in the third quarter of 2012. This helped partially to offset In 2008, Mitsubishi Tanabe agreed to increase its 10% holding declining brand sales in the US, where sales of Lovenox dropped by in Choseido to amajority stakethrough adeal that the originator said almost two-thirds to C55 million and turnoverfrom Aproveland Avalide would help it build aproduct portfolio,sales network and manufacturing (irbesartan/hydrochlorothiazide) plummeted by 83.7% to C16 million. base, supported by Choseido’s“wealth of business experience and solid Sanofi’soverall generics turnoverrose by 14.9% to C479 million base in the generic drug industry” (Generics bulletin,2June 2008, at constant exchange rates, drivenpartly by European sales climbing page 3). The agreement wasaimed at positioning Choseido as a by almost aquarter to C138 million. Meanwhile, in emerging markets – manufacturing companyfor Mitsubishi Tanabe’sgenerics operations. which represented more than half of the brand company’stotal generics Since the deal wasstruck, Mitsubishi Tanabe said it had “taken sales –turnoveredged ahead by just 0.8% to C262 million. Sales in aggressive steps, working to enhance the line-up of generic drugs, the rest of the world contributed C9million after rising by 14.3%. expand the sales system, and establish amanufacturing platform that However, Sanofi’sgroup turnoverslipped by 3.1% to C9.04 billion can accommodate producing alarge variety of goods in small quantities”. as Pharmaceuticals sales declined by 4.3% to C7.04 billion, largely due “Mitsubishi Tanabe Pharma’sholdings of Choseido Pharmaceutical to competition from generics that wiped C448 million offthe originator’s stock have been transferred to Hiasaki Harima, the president and sales. This was“primarily due to generic competition to Eloxatin chief executive officer of Choseido,”the brand companyconfirmed. (oxaliplatin) in the US”, Sanofisaid. Mitsubishi Tanabe’sgenerics subsidiary,Tanabe Seiyaku Hanbai, Sanofi’s“expected loss of market exclusivity” on Eloxatin –after “continues to supply medical institutions with the Choseido the companystruck adeal with several generics firms allowing them Pharmaceutical products at this point”, the originator noted. However, the to launch oxaliplatin under licence from 9August this year (Generics firm and its subsidiary said theywould “rapidly re-evaluate their generic bulletin,9April 2010, page 17) –led US brand sales for the quarter drug business strategies” and create a“newframework”. G to decline by 74.7% to C72 million. G

2 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 3

COMPANY NEWS

MERGERS&ACQUISITIONS DIVESTMENTS Alvogen will acquire Watson sells stake Korean firmKunwha in Brazil’s Moksha8

S-based generics specialist Alvogen has agreed to acquire a atson has sold its stakeinMoksha8 back to the Brazilianbrands Umajority share in South Korean companyKunwha Pharmaceuticals Wand branded generics firm for US$47 million, twoyears after for an undisclosed fee. Alvogen plans to complete the deal through a acquiring the minority share. The move comes as Moksha8 enters combination of buying newshares issued by Kunwha and acquiring into astrategic alliance with Forest Laboratories which will give the existing shares owned by the Korean firm’schairman, Hongsun Chang, originator the option to acquire the Brazilian firm in twoyears. and related parties. At the same time, however, Watson is “expanding its ongoing Alvogen said the transaction represented the next step in its strategy sales and marketing collaboration” with Moksha8 by licensing five “to establish apresence in attractive generic pharmaceutical markets branded generic central nervous system (CNS) treatments to the globally”. The US-based companyintends to use Kunwha as “a centre Braziliancompany. These will be developed for marketing in Brazil of excellence and aplatform for Alvogen’sproducts and support services and Mexico in exchange for royalties and milestone payments. in the Asia-Pacific region as Alvogen enters other regional markets Twoyears ago, Watson paid US$30 million for astakeinMoksha8 in the coming years”. (Generics bulletin,15October 2010, page 3). The deal also included “This transaction is an important step in our strategy to build a an agreement for Watson to manufacture and supply certain products strong regional player in the exciting Asia-Pacific region,”insisted to Moksha8 for the Brazilian and Mexican markets. Alvogen’schairman and chief executive officer,Robert Wessman. Watson’spresident and chief executive officer,Paul Bisaro, said at “Kunwha is along-standing companywith abroad range of marketed the time that the transaction would “transformWatson’scurrent products and an excellent management team and workforce,”he operations in Brazil into alonger-term pan-Latin Americangrowth said. “South Korea provides an opportunity for Alvogen to growits strategy”. However, Watson’spresident of global brands and biosimilars, presence throughout the Asia-Pacific region, where the generic Fred Wilkinson, said the firm wasnow selling its stakeafter “realigning pharmaceutical sector has ahigher growth potential than manyof our corporate structure and ownership of assets in jurisdictions around the mature Western markets.” the world” following its planned acquisitionofActavis. Nevertheless, Wilkinson said Moksha8 had been a“powerful Leverage global supply chain partner in establishing our presence in Latin America”, adding that The Korean firm’srepresentative director,Inwoo Chang, added: Watson would maintain its relationship with the firm “as we pursue “Alvogen’sforay into the Korean market through the acquisitionof additional opportunities to expand Watson’soverall presence in these Kunwha shares is welcome, as it strengthens Kunwha’s markets”. Watson will retain unbranded generic marketing rights competitiveness by leveraging Alvogen’sglobal supply chain and for the CNS productslicensed to Moksha8 under the latest deal. regional sales network. This strategic partnershipfurther enhances Moksha8’sstrategic alliance with Forest will give the Brazilian our ability to continuously provide our customers with high-quality firm an exclusive licence to market the antidepressant brand Viibryd products and services.” (vilazodone) –and “potentially other Forest products” –inLatin Founded in 1958 as an antibioticsspecialist, Kunwha has since America. Forest will provide Moksha8with financing of up to US$125 broadened its portfolio, in part through forming partnerships such as million overthe next twoyears, contingent on the firm “achieving adeal with Switzerland’sSiegfried for antihypertensives. certain business goals”, after which time Forest will have the option The Seoul-based firm has marketing offices throughout its domestic to acquire the Brazilian company. G market and also operates a47,000 sq mmanufacturing facility in Gongju-Si, Korea, that makes both oral-solid and parenteral formulations. Aresearch and development centre in Suwon, Korea, is working on DIVESTMENTS projects including one-a-day pregabalin 300mg and sarpogrelate 300mg tablets, as well as asildenafil 50mg orodispersible film. Watson’s Rugby sold to Major In its most recent financial year,Kunwha increasedits turnover by 6.4% to KRW68.8 billion (US$62.3 million).However,the firm’s atson has sold its Rugby OTCportfolio in the US for US$117 operating profit fell by aquarter to KRW5.03 billion. G Wmillion to Harvard Drug Group subsidiary Major Pharmaceuticals. “I am confident that Major,with its leadership position as a marketer of OTCproducts, will be more strategically positioned to maximise the value of the long-known and respected Rugby name,” MANUFACTURING said Paul Bisaro, Watson’spresident and chief executive officer. Rugby,acquired by Watson in 1998, has an OTCportfolio that Teva opens Hungarian plant includes more than 250 stock-keeping units (SKUs) of treatments for eva says it is equipped to produce up to 200 million injectable units cough and cold, allergy,pain and nausea, as well as nicotine gum, Tper year at the sterile-products plant it has just opened in Gödöllo, vitamins and nutritionalsupplements. Hungary following aHuF22 billion (US$100 million) investment. Watson will retain all rights to manufacture, sell and distribute The 15,000 sq mbuilding houses six individual modules that are store-branded nicotine gum products, as well as other OTCproducts capable of producing six different products simultaneously.Teva plans not sold under the Rugby name. Arelated deal will see Watson make to use the facility to export injectableformulations to more than 70 and supply nicotine gum to be sold under the Rugby and Major labels. countries, including the US and markets in Europe and the FarEast. Terry Haas, Harvard Drug’schief executive officer,said the deal Around athird of the Gödöllo plant’s263 employees would focus would create “supply-chainefficiencies and enhance service levels”. on quality control, the Israelifirm pointed out. G The US Federal Trade Commission (FTC) has cleared the transaction. G

2November 2012 GENERICS bulletin 3 Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 4

COMPANY NEWS

RESULTSFORECAST BUSINESS STRATEGY/NINE-MONTHRESULTS Actavis is poised to Pharmstandardsees pass C2billion mark no need to change

ctavis is likely to achieve arecord turnoverofC2billion (US$2.6 harmstandard believesits long-standingstrategy of developing Abillion) in 2012, according to its chief executive officer,Claudio Pmedicines to meet both regulators’ and patients’ expectations will Albrecht. But before the firm reaches that milestone, it is likely to prove successful amid rapidly changing regulations in Russia. Noting become part of Watson as the US firm’stakeoveriscompleted. that ahost of pricing and tariffamendments were on the cards – “Wetargeted the C2billion figure in our 2012 budget and are while the government planned to invest RUR100 billion (US$3.19 confident of achieving our goal,”stated Albrecht. “With revenues of billion) in ensuring that at least half of local demand wasmet by local C1.6 billion after nine months, we are right on track.” producers by 2020 –the companyforecastedthat “competition on the Total sales this year of just over C2.0 billion would represent an Russian market will be tougher butmore reasonable,and the best increase of atenth overActavis’ 2011 turnoverofaround C1.84 billion and the strongest player will win”. (Generics bulletin,17February 2012, page 28). Referring to government statements,Pharmstandard said plans to Albrecht pointed out that Actavis’ double-digit sales rise compared reimburse essential medicines dispensed through hospitals would favour favourably with single-digitmarket growth in Europe. Quoting IMS generics, especiallythose made locally with provenbioequivalence. Health data, he said the companyhad improvedits European market In the first nine months of 2012, the Russian company–which is share in both 2010 and 2011. set to increase its domestic presence by the end of this year by acquiring “Wealso have excellent growth rates in our US business and in local producer Lekko–reported pharmaceuticals sales ahead by 15.1% emerging markets,”Albrecht continued, noting that the companywould to RUR29.9 billion. Sales of medical equipment 48.1% higher at produce and sell around 24 billion tablets worldwide during 2012. RUR618 million lifted group turnoverby15.6% to RUR30.6 billion. Within the pharmaceuticals total, a29.0% rise to RUR3.56 billion Realised synergies and simplified processes in turnoverfrom Pharmstandard’sprescription drugs wasdue largely to Realising synergies and simplifying “time-consuming administrative stronger sales of branded medicines. Aweak cold and flu season processes” had improvedActavis’ profits, Albrecht said, while the contributed to OTCsales dropping by atenth to RUR10.1 billion. Sales firm had also bolstered its pipeline and divested non-profitable assets. of third-party brands rose by more than athird to RUR15.8 billion, Furthermore, he pointed out, the companyhad also resolved some while turnoverfrom bulk drugs shot up by 60.6% to RUR403 million. G long-standingissues, not least by settling costly US litigation over allegedly misreported average wholesale prices (AWPs) through a US$119 million deal (Generics bulletin,13January 2012, page 9). Actavis’ financial performance in 2012 will determine the extent to which Watson has to next year makeacontingent payment of up to 5.5 million shares. Those 5.5 million shares would be worth around C250 million, based on ashare price of US$60 and aeuro-dollar exchange rate of 1.32. Having taken overActavis “in avery difficult situation” just over twoyears ago, Albrecht said akey factor in turning around the company’ssales and profits “much quicker than expected” had been relocating its corporate headquarters from Iceland to Zug, Switzerland. “The choice of asingle and central global headquarters made it much easier for us to improve communications and steer the company effectively,” he commented. Zug will become the headquarters for Watson’sgenerics business outside of the US once it completes its takeoverofActavis. The Swiss offices will be headed by Lars Ramneborn and will house management for the group’sEuropean and Middle East/Asia-Pacific generics units. Closing of the takeoverisexpected to occur during November after the US Federal Trade Commission (FTC) recently approvedthe deal, contingent on divesting 19 marketed or pipeline drugs (Generics bulletin,19October 2012, page 3). The European Commission had already granted its assent to the deal, which will create acombined entity with an annual turnoverofaround US$8.0 billion (Generics bulletin,4May 2012, page 24). Albrecht, 53, said he and his senior colleagues –such as deputy chief executive Peter Prock –had not yet decided on their next move. “Weare looking forward to an extended winter holiday,” he stated. However, the Austrian national hinted, taking on another turnaroundproject likeActavis could be attractive.“With my people working in finance, information-technology,legal and communications, Iwould at anytime takeonsimilar opportunities anywhere in the world,”Albrecht asserted. G

4 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 5

COMPANY NEWS

THIRD-QUARTER RESULTS MANUFACTURING/THIRD-QUARTER RESULTS US enoxaparin rivals Mylan will buy SMS’ erode Sandoz’ sales Indian oncology site

rapid acceleration in “aggressive competitor pricing” for generic ylan has agreed to pay SMS Pharmaceuticals Rs1.73 billion ALovenox (enoxaparin) following the market entry of Watson/ M(US$32.6million) for an oncology manufacturing facility in Amphastar and Sanofi’sauthorised generic slashed Sandoz’ third-quarter Visakhapatnam, India. Mylan –which expects to close the deal early sales from its version of the anticoagulant by 87%, or US$225 million, next year –said the plant would produce both active pharmaceutical to US$34 million. The lower enoxaparin sales were offset in part by ingredients (APIs) and finished doses for oncology drugs. It plans to around US$100 million of US sales from Sandoz’ authorised generic start commercial production once the US Food and Drug Administration of parent group Novartis’ DiovanHCT (valsartan/hydrochlorothiazide) (FDA) completes asite inspection. combination antihypertensive that the firm launched in late September, Upon FDAapproval, the former SMS site will makecancer thereby splitting the market during Mylan’s180-day exclusivity period drugs for Mylan to supply through the Institutional business unit that (Generics bulletin,1October 2012, page 13). it set up in the US following its acquisition of injectables specialist Sandoz is also poised to offer an authorised generic of Diovan Bioniche twoyears ago (Generics bulletin,6August 2010, page 3). (valsartan) in the US when competitionarrives. However, while The US companyalready has extensive API and finished-dose Ranbaxy believesitremains entitled to 180-day exclusivity (Generics production capacity in India following its 2007 takeoveroflocal firm bulletin,19October 2012, page 14), the US Food and Drug Matrix. Building on Matrix’ strong heritage in the antiretrovirals Administration (FDA) has not yet approvedany generic rivalto sector,Mylan recently set up acommercialoperation in India under Diovan, which achievesUSsales of around US$25 million per week. the Mylan brand name (Generics bulletin,3September 2012, page 23). Sandoz’ total US turnoverfell by 22% to US$628 million, or 31% Higher API and finished-dose antiretroviral sales by Mylan of the generics firm’stotal sales that declined by 13% as reported –and Laboratories in India contributed to Mylan’sGenerics turnoverinthe by 6% on aconstant-currencybasis –toUS$2.04 billion (see Figure 1). Asia-Pacific region increasing by 9% as reported –and by 21% at constant exchange rates –toUS$339 million in the third quarter of Third-quarter sales Reported Constant-currency this year (see Figure 1). Mandatory reimbursement price cuts depleted (US$ millions) change (%) change (%) the turnoverofMylan’sAlphapharm unit in Australia, butthe firm increased its sales in Japan, where its recently-formed generics alliance Europe 1,005 -9 +2 with Pfizer is poised to start operating late this year or early in 2013. US 628 -22 -22 Chief executive officer Heather Bresch said Mylan’stie-up with Asia, Africa, Australasia 258 -4 +1 Pfizer could serveasamodel “in other countries where having troops Canada, Latin America 153 -7 ±0 on the ground and abrand is important”. Sandoz 2,044 -13 -6 Bresch also hailed Mylan’s“return to growth” in the Europe, Middle East and Africa (EMEA) region with a3%constant-currencyGenerics Established markets 1,489 -15 -10 sales rise, although turnoverasreported fell by 7% to US$326 million. Emerging markets 555 -6 +3 In France, recent launches combined with an upturn in generic substitution within the répertoire of eligible prescriptions (Generics Figure1:Breakdown by region and market type of Sandoz’ sales in the third bulletin,19October 2012, page 22) to raise Mylan’sconstant-currency quarter of 2012 (Source –Novartis) sales by 9%. In Italy,launches and higher volumes more than made The constant-currencyslide wasdue to price erosion, as twopercentage- up for price cuts as Mylan’ssales advanced by 17% in constant points of volume decline were offset by the addition of around one currencies. Growth in Spain on the same basis was5%. month’ssales from the US dermatology business Fougera acquired Launching arivaltoNovartis’ DiovanHCT (valsartan/ earlier this year (Generics bulletin,18May 2012, page 1). hydrochlorothiazide) with 180-day exclusivity in the US wasakey factor European sales fell by 9% to US$1.01 billion as reported, butrose in North American Generics sales increasing by 19% to US$831 million. by 2% in constant currencies. Low-price tenders caused a6%constant- The group improvedits operating margin by 1.3 percentage- currencydecrease to US$277 million in Germany. But sales in the points to 18.2% on turnover15% higher at US$1.81 billion. G rest of western Europe rose by 11% on the same basis, “drivenby double-digit growth in France, the UK, Nordic markets and Belgium”. Third-quarter sales Reported Constant-currency In Russia –Sandoz’ third-largest market –the firm increased its (US$ millions) change (%) change (%) turnoverby16% at constant exchange rates. The firm raised its Asian sales by 21% on the same basis, including an 11% rise in Japan and North America 831 +19 +19 double-digit growth in China and the Philippines.“Strong double-digit Asia-Pacific 339 +9 +21 growth” in Argentina, Brazil and Venezuela propelled 17% constant- EMEA 326 -7 +3 currencygrowth in Latin America. Other 7+139 – Despite the DiovanHCT authorised generic in the US and higher- Generics 1,503 +10 +16 margin sales in Russia, Sandoz’ gross margin fell by 1.7 percentage- Specialty 299 +39 +39 points to 42.6% as it spent heavily on addressing quality assurance and manufacturing at three sites in North America that were the subject Corporate/other 8–– of an FDAwarning letter.Sandoz’ operating profit declined by 25% Mylan 1,810 +15 +20 to US$250 million, due in part to US$39 million of integration and other expenses linked to the Fougera deal. This cut the division’s Figure1:Breakdown by business and region of Mylan’s sales in the thirdquarter operating margin by twopercentage-points to 12.2%. G of 2012 (Source –Mylan)

2November 2012 GENERICS bulletin 5 Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 6

COMPANY NEWS

MERGERS&ACQUISITIONS THIRD-QUARTER RESULTS Reddy’smakes move Strides submits 28 for Dutch developer ANDAs in aquarter

rReddy’sintends to buyDutch injectables developer OctoPlus. The trides Arcolab’sAgila Specialities injectables unit submitted 28 Dplanned offer –which has been accepted by amajority of the Dutch Sabbreviated newdrug applications (ANDAs) in the US between July firm’sshareholders–values OctoPlus at C27.4 million (US$35.8 and September this year.Bythe end of the 2012 third quarter,Agila million), a30% premium overOctoPlus’ closing price on 19 October. had filed 189 ANDAs in total, while Strides’ group total –including “Asweglobalise our research and development efforts, we are 43 through its Pharma solid-dose division –was 232 ANDAs. looking forward to building aresearch base in Leiden, the Netherlands. Five ANDAapprovals for Agila during the third quarter –including The acquisition helps us ramp up our technological capabilities in drug for vinorelbine, which it licenses to Pfizer –added to one for the Pharma delivery,” commented GV Prasad, chief executive officer of Dr Reddy’s. division, taking the group total to 102. Among sevenUSlaunches by The deal is expected to close by the end of March 2013. Agila wasits introduction of oxaliplatin under the terms of alitigation Dr Reddy’ssaid it had been attracted by OctoPlus’ expertise in settlement with Sanofi, the owner of the Eloxatin chemotherapy brand. injectable technologies such as liposomes and microspheres that it Agila nowmarkets 50 products in the US, and it has just secured could use to improve the formulations of both existing and newdrugs. ANDAapprovals for the oncology drugs fludarabine and idarubicin. These capabilities, the Indian firm said, would help it to develop its The Indian firm expects to start launching products from its Polish owncomplexgenerics whilst providing services to third parties. steriles facility during the fourth quarter of this year after the US Food and Drug Administration (FDA) audited the site (Generics bulletin, Will be injectables centreofexcellence 1October 2012, page 3). Commenting on the Indian company’smove into contract services, In Canada, Strides’ recently-formed sales and marketing joint OctoPlus’ chief executive officer,Jan Egberts, said: “Dr Reddy’sis venturewith Jamp Pharma launched twoproducts (Generics bulletin, keen to expand into the fee-for-service business. It will retain 3August 2012, page 3). OctoPlus as aspecialiststandalone entity to develop speciality generics Agila doubled its third-quarter earnings before interest, tax, for Dr Reddy’s. OctoPlus will become Dr Reddy’scentre of excellence depreciation and amortisation (EBITDA) to Rs1.35 billion (US$25.1 for complexinjectables.” million) on sales that advanced by 28% to Rs3.71 billion. The injectables The clinically most-advanced product that incorporates OctoPlus’ division’ssales total included Rs990 million of licensing revenues and technology is Locteron (interferon alfa), acontrolled-release version Rs760 million from its operation in Brazil, which made asmall EBITDA of the hepatitis Ctreatment that is undergoing Phase III clinical trials. loss as it washit by delays to US approvals for penem antibiotics made In the first half of 2012, OctoPlus received C1.2 million in Locteron in Brazil and by astrikeatlocal regulatory agencyAnvisa. Agila’s manufacturing revenues from the brand’sowner,Biolex, representing product sales outside of Brazil grewby66% to Rs1.96 billion. aquarter of the Dutch firm’stotal turnoverofC4.84 million. Price erosion on vancomycin capsules in the US due to increased But in July 2012, US-based Biolexfiled avoluntary petition for competition contributed to the Pharma solid-dose division’sturnover liquidation. This led OctoPlus to takeimpairment losses of C1.9 million declining by 13% to Rs2.29 billion. Strides’ profit share from US on receivables outstanding from the US firm and C1.3 million on its vancomycin –for which it claimed to have retained amarket share of minority shareholding in Biolex. As aresult, OctoPlus posted anet more than 30% –plummeted by two-thirds to around Rs80 million. loss of C5.81 million in the first half of 2012. The Pharma unit’sEBITDAshowed asimilar decline to Rs310 million. “The intended public-offer price reflects the value of OctoPlus Excluding the Ascent business in Australia that it sold to Watson after the recent value erosion of Locteron,”acknowledged Egberts. (Generics bulletin,3February 2012, page 1), Strides reported group “Over the last fewmonths, the value of Locteron has significantly turnoverahead by 12% to Rs6.01 billion. Even with acorporate Rs130 eroded due to the ongoing emergence of oral hepatitis Ctreatments, million exchange-rate loss, the Indian firm improvedits EBITDA which ultimately resulted in Biolex’ bankruptcyfiling.” G by 27% to Rs1.54 billion. G

2November 2012 Issue 181 Subscription enquiries: Asubscription to Te rms &Conditions: No partofthis publication may GENERICS bulletin includes the hard-copy be copied, reproduced, stored in aretrieval system, Editor: Aidan Fry newsletter published 20 times ayear –twice distributed or transmitted by anymeans, including Assistant Editor: David Wallace monthlyexcept monthlyinJuly, August, December electronic,mechanical, photocopying or recording, without Assistant Editor: Paul Wolfe and January–and the weeklyelectronic newsflash the prior written permission of the publisher,orunder the Associate Editor: Deborah Wilkes News@Genericsbulletin published 46 times a terms of alicence issued by the Copyright Licensing year.Annual subscriptions in Europe cost £560 Agency (CLA) in London, UK, or rights bodies in other Production Controller: Debi Minal (additional copyatthe same address £345); outside countries that have reciprocal agreements with the CLA. Subscriptions and Europe £590 (£375). Single copies cost £50 each. Marketing Manager: ValDavis Enquiries as left, or [email protected]. Neither maythis publication be exported, distributed or EditorialDirector: MikeRice circulated by anymeans outside the staff who work at the Advertising enquiries: Editorial enquiries: GENERICS bulletin, address to which it is sent by the publisher without the As left, or [email protected] prior written permission of the publisher. 4Poplar Road, Dorridge,Solihull, West Midlands B93 8DB, UK. Printed by Warwick Printing CompanyLimited, While due carehas been taken to ensurethe accuracy of Leamington Spa CV31 1QD, UK. Website: www.generics-bulletin.com information contained in this publication, the publisher Te l: +44 (0)1564 777550 ©OTC Publications Ltd. All rights reserved. makes no claim that it is free of errorand disclaims any Fax: +44 (0)1564 777524 ISSN 1742-0784 liability whatsoeverfor anydecisions or actions taken as a E-mail: [email protected] Companyregistered in England No 2765878. result of its contents.

6 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 7

COMPANY NEWS

RESULTSFORECAST/NINE-MONTHRESULTS MANUFACTURING Olainfarmaims for a Bedford is shipping double-digit decade limited US supplies

lainfarm expects to support adecade of double-digit growth by njectablesspecialistBedford Laboratories is offering “a limited Oexpanding into newmarkets and investing around LVL35 million Isupply” of certain lines after its sister companywithin the Boehringer (US$66 million) in its business overthe next ten years, according to Ingelheim group, Ben Venue, resumed production following avoluntary forecasts by the Latvian firm’schairman, Valerijs Maligins. Even in shutdown due to manufacturing deficiencies. Among the injectable the most “pessimistic scenario”, Maligins stated, the firm expected to products that are nowavailable from sales and marketing firm Bedford achieve annual growth of between 10% and 15%. This figure could even in “limited quantities” are aciclovir,amikacin, bumetanide and diltiazem, reach 20-30%, he added, “if amore favourable scenario develops”. as well as ketamine, ketorolac, leucovorin and midazolam. In the first nine months of 2012, Olainfarm registered sales growth Earlier this year,sterile injectables manufacturer Ben Venue had of almost athird, as advances in Russia, the UK and the firm’sdomestic extended its voluntary suspension of production at its US site, market helped to push total turnoverupby31% to LVL35.1 million. acknowledging that some products might not be available until late- 2012 (Generics bulletin,13January 2012, page 7). Russian sales rose by 30% The Boehringer Ingelheim subsidiary had announced the An increase of 30% in Russia –Olainfarm’slargest market –took manufacturing suspension at the end of 2011 after aUSFood and Drug the country’stotal to around LVL13 million, whilst domestic sales Administration (FDA) audit conducted in May 2011 “indicated that more than quadrupled to LVL6.7 million. This, combined with UK routine preventive maintenance and re-qualification of some turnoverthat doubled to around LVL1.4 million, more than offset manufacturing equipment did not occur at the specified time interval, declines of 7% in Ukraine and 11% in Belarus, which respectively and is overdue” (Generics bulletin,9December 2011, page 3). accounted for afifth and atwentieth of Olainfarm’stotal. Since that time, Ben Venue has brought in external consultants Sales through Olainfarm’spharmacychains reached LVL5.1 and “invested more than US$300 million to upgrade our facilities”. million, following the company’sacquisition of 30 Latvian pharmacies But while the firm anticipates resuming production on additional lines in its domestic market last year by purchasing local firms Ilmas Aptiekas as it makes progress on its remediation plan, it warned that “for most and Juko99(Generics bulletin,18November 2011, page 14) as well of the products we manufacture, supplies will not be available for as four other retailers (Generics bulletin,13January 2012, page 10). G at least several months”. G

2November 2012 GENERICS bulletin 7 Gen 2/11/12 Pgs.2-8_Layout 1 31/10/2012 20:04 Page 8

COMPANY NEWS

SECOND-QUARTERRESULTS THIRD-QUARTER RESULTS Lupin’s sales grow Bupropion problems across all its units cost Impax US$2mn

upin reported double-digit sales advances for all of its operating ithdrawing its Budeprion XL (bupropion) 300mg tablets from the Lregions and divisions in the Indian company’sfinancial second WUS market after theyfailed bioequivalence testing led Impax to quarter ended 30 September 2012. Group net sales that rose by 28.6% register aUS$2.0 million charge in the third quarter of 2012. Marketed to Rs22.4 billion (US$417 million) comprised formulations turnover through Teva,the rivaltoValeant’sWellbutrin XL waswithdrawn after that increased by 30% to Rs20.0 billion and active pharmaceutical the US Food and Drug Administration (FDA) found that the tablets ingredient (API) sales 21% higher at Rs2.39 billion (see Figure 1). “fail to release bupropion into the blood at the same rate and to the same The 30% formulations rise wasdriveninpart by Lupin’ssales in extent” as the brand (Generics bulletin,19October 2012, page 1). Japan leaping up by 85% to Rs3.30 billion after the firm added its Lower turnoverfrom productssold through Impax’ alliance with acquisition of injectables specialist I’rom to its existing Kyowaoperation Teva also contributed to sales for Impax’ Global Pharmaceuticals (Generics bulletin,9December 2011, page 3). The local-currency generics division declining by 12.3% to US$100 million in the three growth in Japan –which contributed 15% of Lupin’sgroup turnover months ended 30 September (see Figure 1). The decline came despite during the quarter –was 55%. Excluding I’rom, Kyowaexpanded its sales by 31% as reported – Division Third-quarter sales Change Operating and by 10% on alocal-currencybasis –toRs2.33 billion. (US$ millions) (%) margin (%) Lupin achievedalmost two-fifths of its total formulations turnover Generics 100.4 -12.3 40.3 in the US, where sales advanced by afifth to Rs7.82 billion. Once Brands 45.2 +751.5 3.5 Second-quarter sales Change Proportion Impax 145.6 +21.5 20.2* (Rs millions) (%) of total (%) *includes US$12.6 million of unallocated general and administrativeexpenses US 7,818 +20 35 Figure1:Breakdown by division of Impax Laboratories’ sales and operating India 6,064 +18 27 margin in the thirdquarter of 2012 (Source –Impax) Japan 3,301 +85 15 a“modest increase” in generics sold under the Global label, according South Africa 810 +19 4 to Impax’ president and chief executive officer,Larry Hsu. Europe 626 +36 3 Impax’ overall turnoverrose by 21.5% to US$146 million, driven Rest of World 1,382 +51 6 largely by US sales of Zomig (zolmitriptan) through alicensing deal Formulations 20,001+30 89 with AstraZeneca. This helped brand sales to advance by more than APIs 2,392 +21 11 8.5-times to US$45.2 million. However, the segment generated an operating profit of just US$1.59 million, giving it amargin of 3.5% Lupin 22,393 +29 100 compared to more than two-fifths for generics. Hsu said Impax wasstill in talks with the FDAoverproblems at Figure1:Breakdown by business and region of Lupin’s sales in its financial the firm’sfacility in Hayward, California, which wasthe subject of second quarter ended 30 September2012 (Source –Lupin) an FDAwarning letter last year (Generics bulletin,30June 2011, adjusted for intellectual-property revenues through adeal with Medicis page 5). Abacklog of generics waswaiting to be approvedonce the in the previous financial year,the Indian companystressed, its US warning letter had been resolved after an FDAre-inspection, Hsu said. sales growth was40%. By the end of November,Hsu said, Impax planned to roll out nine Having receivedUSapprovals during the quarter for three products topical drugs under its deal with Tolmar (Generics bulletin,13July –and filed abbreviated newdrug applications (ANDAs) for two– 2012, page 13). Hsu also noted that Impax had “cash in the bank” and Lupin said it led the market for 19 of the 42 generics that it marketed waslooking to put this to use on the business-development front soon. G in the US. All butfiveofthe 42 drugs ranked among the top-three by market share, it said, adding that the firm ranked fifth by all US generic prescriptions dispensed. Lupin’sformulations turnoverinEurope –where it filed two marketing-authorisation applicationsduring the quarter –increased by just overathird to Rs626 million. And Lupin’sPharma Dynamics unit in South Africa raised its sales by nearly afifth to Rs810 million. The Indian firm’sdomestic formulations turnovergrewby18% to Rs6.06 billion, while sales in the rest of the world –such as Australia and the Philippines –shot up by 51% to Rs1.38 billion. While Lupin’sgroup gross margin declined by more than five percentage-points to 60.3% –and its staffcosts increased by nearly a third –other operating expenses rose more slowly than sales. In particular,lower “legaland professionalcharges” reduced research and development spending by almost athird to Rs935 million. The firm’searnings before interest and tax (EBIT) improvedby 27.7% to Rs4.51 billion, and its EBIT margin slipped down by just 0.1 percentage-points to 20.2%. G

8 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.9-13_Layout 1 31/10/2012 20:07 Page 3

COMPANY NEWS

IN BRIEF BUSINESS STRATEGY PATHEON –the US-based contract-manufacturing group –has agreed to pay Dutch foods group Vion US$255 million for its UK’s Aesica aims for Banner Pharmacaps gelatin capsules business. Banner –which claims to be “the world’ssecond-largest pharmaceutical business focused on delivering proprietary soft-gel formulations” –has four manufacturing facilities in Canada, Mexico, the Netherlands and £340 million by 2015 the US. Patheon said the deal would help it become “the leader in oral-dosage development and manufacturing services” with an ontract development and manufacturing group Aesica believes annual turnoverofmore than US$1 billion. Cacombination of organic and inorganic growth will enable it to reach an annual turnoverof£340 million (US$548 million) by 2015. TORRENT raised its net sales by 14% to Rs7.47billion (US$139 Achieving this goal will require the UK-based companytoalmost million) in the Indian firm’sfinancial second quarter ended 30 double its forecasted sales this year of £180-£190 million. September 2012, following double-digit rises in both its domestic Aesica is barely eight years old, having been formed in 2004 and international sales. US sales that advanced by four-fifths helped through amanagement buyout of aBASF active pharmaceutical to drive the export total up by 15% to Rs4.17 billion, whilst turnover ingredient (API) facility in Cramlington, UK, that wasfunded by in India rose by 12% to Rs3.32 billion. LDC, the private-equity arm of the bank Lloyds TSB. The firm has since acquired several manufacturing plants, includingamulti-purpose ANI PHARMACEUTICALS and BioSante have agreed to merge in site in Queenborough, UK, and three former UCB finished-dose plants aUSdeal that is expected to close in the first quarter of 2013. The in Germanyand Italy for which Aesica has just wonanaward. combined companywill retain ANI’sname and will focus on Outlining the group’splans to Generics bulletin,Simon Clough – manufacturing and marketing branded generics under the leadership who has been managing director of Aesica’sFormulatedProducts of ANI’sexisting management team, headed by chief executive business unit for the past 18 months (Generics bulletin,4March officer and former head of Akorn Arthur Przybyl. 2011, page 12) –pointed out that the companyhad already posted a six-fold sales rise overthe past five years. To continue this momentum, ORION reported Pharmaceuticals sales ahead by 6% to C687 million he said, the UK-based companywas looking to expand both its (US$893 million) in the first nine months of 2012, boosted by geographic presence and its technology base. turnoverfrom off-patent Specialty Products rising by 13% to C270 “The US is akey priority for us,”stated Clough. Aesica has just million after launching generic entacapone at the start of the year. promoted Dr Emma Mickleytothe newly-created position of vice- Along with Diagnostics turnoverthat rose by 12% to C41 million, president of corporate business development. She is based in San Diego, the Finnish firm’ssales advanced by 7% to C726 million. US, and is charged with capturing for the firm aslice of the North America contract development and manufacturing market. UPS has expanded its global healthcaredistribution network by opening facilities in Sydney, Australia, as well as in Hangzhou and EU importservice well received Shanghai, China. The three sites cover5,388 sq m, 22,000 sq mand Clough said Aesica’sEuropean Union (EU) import service had 7,575 sq mrespectively. been “particularly well received” in the US. “ManyUS-based firms are looking to accelerate the speed with which theycan market their GRANULES INDIA doubled its operating profit to Rs153 million products in the EU, and that is where our European infrastructure and (US$2.86million) on turnover8.7% higher at Rs1.75 billion in its understanding of the market has provenanasset. The combination financial second quarter ended 30 September 2012. The Indian of regulatory support, packaging design, European distribution and companyrecently invested Rs1.0 billion in expanding its capacity local qualified-person release appears to be an appealing formula to makepharmaceutical intermediates to 18,000 tons per year for North America,”hecommented. (Generics bulletin,8June 2012, page 10). Aesica wasalso keen to establish amanufacturing base in the Far East –potentiallythrough apartnership or joint venture –tooffer NAVAMEDIC expects “significant sales growth going into 2013”, “western standards at eastern prices” for both exports and local following the Norwegian company’splans to expand its portfolio of consumption, Clough revealed. The companywas keeping an open mind marketed generics with sevenlaunches by the end of 2012. In the on where in Asia to set up abase, he said, adding that Aesica was third quarter of 2012, the firm’sgeneric business –which is “still watching developments in Russia closely as the country’sauthorities in abuild-up phase” –achieved“modest” sales of NOK0.1 million promoted local manufacturing through the ‘Pharma 2020’ plan. (US$17,400), contributing to total companysales that rose by 20.9% Akey consideration while reviewing ahost of finished-dose and to NOK20.6 million. The firm’soverall earnings before interest, tax, API acquisition options that the UK-based group has on the table is depreciation and amortisation (EBITDA) of NOK0.57 million came whether the deal adds to Aesica’sportfolio of development and despite the generics division’sEBITDAloss of NOK2.76 million. manufacturing technologies. “For example,”Clough stated, “we really want to be in aseptic manufacturing.” LITHA HEALTHCARE has advised investors that its has “entered Aesica’sUKproductionsites in Cramlington and Queenborough into negotiations”for adeal that could have “a material effect” on have both been approvedbythe US Food and Drug Administration its share price. The South African firm revealed no further details. (FDA), as have the German finished-dose facilities in Monheim and Zwickau that the firm boughtfrom UCB last year.The companyis UNICHEM LABORATORIES increased its turnoverbyathird to currently expanding its solid-dose capacity at the former Abbott Rs2.64 billion (US$49.2 million) in its financial second quarter site in Queenborough from twotofour billion tablets per year. ended 30 September 2012. The Indian firm’sdomestic sales rose by It is also keen to build on the controlled-substances expertise at almost afifth to Rs1.77 billion, while its international sales shot its API plant in Cramlington –and on astrategic alliance with US up by 73% to Rs871 million. Unichem’spre-tax profit strengthened narcotics specialist Noramco (Generics bulletin,14October 2011, by 78% to Rs462 million. G page 14) –tomove up the value chain to makeopioid tablets at Queenborough and controlled-release capsules at Zwickau. G

2November 2012 GENERICS bulletin 9 Gen 2/11/12 Pgs.9-13_Layout 1 31/10/2012 20:07 Page 4

MARKET NEWS

REGULATORY AFFAIRS LEGISLATION Belgian branddeal is Substitution planned queried by FeBelGen this year in Ireland

deal struck between Belgian originator industry association reland’shealth minister,DrJames Reilly,expects by the end of this APharma.be and the country’shealth ministry must not be allowed Iyear to enact legislation that will introduce both generic substitution to shield branded medicines from healthcare budget measures, and areference-price system. The country’sDepartment of Health according to Belgium’sgenerics industry association, FeBelGen. is also negotiating with local industry body,the Association of Shortly before discussions overBelgium’snational budget began Pharmaceutical Manufacturers in Ireland (APMI), “to deliverfurther in mid-October,Pharma.be agreed a‘stability pact’ with the country’s savings in the cost of generic drugs”. minister for health and social affairs, Laurette Onkelinx. Whilst the Under proposals first published in 2010 (Generics bulletin,30 deal specified that patented medicines should not be the sole target June 2010, page 10), Ireland plans to introduce legislation directing when seeking healthcare savings, FeBelGen said, this did not mean pharmacists to substitute medicines designated as interchangeable that savings should be sought from generics as apriority. within the same reference-pricegroup. Reference prices will be set at the Furthermore, FeBelGen said, Pharma.be’sagreement –which lasts lowest available from all potential suppliers. The Department of Health until 2014 –must not represent an exclusive deal with the government, forecasted that the scheme would generate savings of C30 million and “cannot replace other existing or future consultations”. FeBelGen (US$38.7million) overthe first three years of being introduced would still be consulted on Belgian policymaking, Onkelinx confirmed. (Generics bulletin,13January 2012, page 16). “FeBelGen supports the efforts of the Belgian government to Meanwhile, an agreement that the Department has just struck with encourage and support pharmaceutical research and development in brand industry body,the Irish Pharmaceutical HealthcareAssociation our country,” the generics association insisted. However, it warned that (IPHA), is expected to produce savings of more than C400 million Belgium’slow levelofgeneric utilisation meant that if the “artificially overthe next three years. low” generics prices advocated by Pharma.be were introduced, it could The agreed measures include reducing the wholesale price of contribute to the “total destruction of the market”. brands by 30% upon patent expiry,with afurther cut to 50% of the Joris VanAssche, FeBelGen’smanaging director,said the original price 12 months later.Brands that are already off-patent as association’smember companies needed “reasonable prices” if they of 1November this year will face an immediate 40% reduction, while were to be able to continue investing in developing newgenerics and from 1November 2013 their wholesale price will be half the original biosimilars. Pricing wasparticularly important in Belgium, he noted, level. Up to 400 patented brands will be subject to one-offprice cuts due to the country’slow volume sales and the “strong price cuts” averaging 16% under the terms of the agreement. applied to Belgian generics overthe past fewyears. G An awareness campaign aimed at educating the public about generics has also just been launched in Ireland. The ‘just ask’ campaign – sponsored by Actavis –includes awebsite explaining the nature of generics and their equivalence with brands, as well as the economic REGULATORY AFFAIRS savings theyoffer.Similar data is contained in aleaflet, whilst the campaign EU eases Israeli restrictions also urges people to seek advice and information from pharmacists. G ower prices and awider range of available generics in Europe will Lbe the benefits of atrade deal easing restrictions on pharmaceutical MARKET RESEARCH imports and exports between Israel and the European Union (EU), according to the European Parliament. Under the terms of the agreement on mutual recognition of Portugalsees prices plummet pharmaceutical certificates between the EU and Israel –which was ortugal’saverage price for ageneric medicine hit anew lowin approvedbythe European Parliament by 379 votes to 230, with 41 PAugust, according to data published by the country’smedicines abstentions –“EU-certified pharmaceuticals will be exported to Israel agency, Infarmed. August 2012’saverage figure of C6.57 (US$8.58) and vice-versa without requiring additional certification in the importing wasmore than athird less than the overall 2011 average, whilst certain country”, the Parliament explained. popular molecules suffered even more severe declines. Clopidogrel’s “The EU-Israel agreement on mutual recognition of pharmaceutical August price of C7.61 represented adrop of two-thirds compared to its certificates will remove technical barriers to trade, cut manufacturers’ 2011 average, whilst omeprazole’sfigure fell by 57% to C5.87. costs and enable them to get their products to market faster,” the Despite overall generics volume sales for eight months to August Parliament stated. It added that the Parliament had authorised the deal rising by 18.1% to 39.8 million units, the value figure fell by more “after more than twoyears of extensive debate”, noting that the than afifth to C292 million. This meant generics captured avolume share agreement had been approved“despite reservations that easing trade that rose by 3.3 percentage points to 24.7% of the overall medicines with Israel could send it the wrong political signal at this time”. market –compared to the same period in 2011 –but avalue share All pharmaceuticalsare covered by the deal except “advanced that fell by 1.9 points to 16.7%. G therapyproducts, special medicinal products based on tissues and cells of human origin, and medicinal products that include blood products”. IN BRIEF Mutual recognition agreements had previously been concluded with Australia, Japan, NewZealand and Switzerland, the Parliament SWISSMEDIC –Switzerland’smedicines agency–has revised noted, adding that it wasseeking to negotiate similar deals with its directive on generic marketing-authorisations to clarify its “most Mediterranean countries”, including Algeria, Egypt, Jordan, rules on bioequivalence between different dosage forms. G Lebanon, Morocco and Tunisia. G

10 GENERICS bulletin 2November 2012

Gen 2/11/12 Pgs.9-13_Layout 1 31/10/2012 20:07 Page 6

MARKET NEWS

PRICING&REIMBURSEMENT REGULATORY AFFAIRS Canadian study says India will only grant tendering has risks licences under INNs

ntroducing generic tendering systems in Canada could result in drug ndia’slocal medicines authoritiesshould grant licences and renewals Ishortages and delayed savings, astudy by leading academics has Ionly under generic or international non-proprietary names (INNs), warned. Areport compiled by provincial health ministers recently according to anotice issued by the country’sMinistry of Health and suggested that Canada should initiate a“national competitive bidding Family Welfare. If implemented, the notice could shift India away process” for three to five generics by the end of 2012 to cut prices from apredominantly branded-generics model. from 1April 2013 (Generics bulletin,3September 2012, page 13). In anotice sent to local state authorities, health ministry director The study –which wascommissioned by the Canadian Generic Sanjay Prasad notes that official application forms for obtaining and Pharmaceutical Association (CGPA) –acknowledges that tendering renewing manufacturing and marketing authorisations in India “do systems such as the process employed in NewZealand can produce not require mentioning of anytrade name or brand name”. short-term price cuts for some drugs. However, it stresses, such savings “The grant of drug manufacturing licences under atrade or brand would come at aconsiderable cost in other parts of the system. name is not in accordance with the spirit of the legislation,”Prasad Drug shortages could be triggered by less redundancyinthe supply asserts. “Therefore, amanufacturing licence for the drug formulation chain, it warns. Unsuccessful bidders in tender processes would stop should be granted in the proper or generic name only.” producing and would be unable to fill in gaps in supply,the study argues. Forformulations containing multiple ingredients, Prasad’snotice According to the study,generics firms would also be less likely continues, licences should be granted in line with the product category, to initiate the costly patent litigation that brings generics to market such as ‘multivitamin tablets’. before patent expiry because theywould be unsure of recouping their investment through tender awards. “Necessary” provision Noting that NewZealand’stendering system had been viewed as The notice wasissued under section 33 (P) of India’sDrugs & apotential model for Canada, the study points out that atorvastatin Cosmetics Act, which dictates that “the central government may give generics reached the market in NewZealand in February 2012, almost such directions to anystate government as may appear to the central twoyears later than in Canada, where Apotexprevailed in patent government to be necessary”for implementing anyprovisions of the act. litigation (Generics bulletin,28May 2010, page 1). And NewZealand In July this year,India’sdrugs consultative committee (DCC) had wasalmost four years behind Canada in getting olanzapine and recommended that limiting licences solely by INN or generic name was venlafaxine generics to market. “feasible for single-ingredient drug formulations only”, due to the complexities inherent in labelling combination drugs. Tenders would drive production overseas The DCC also expressed concerns overstate authorities issuing Furthermore, the study says, pricing pressure would likely drive licences for combination drugs without evidence of the products’ safety more generics manufacturing overseas. Almost all drugs supplied and efficacy. To tackle this issue, aseparate annextothe ministry’s through tenders in NewZealand are made outside of the country,it notice insists that state authorities must cancel anylicences for fixed- observes, adding that similar effects have resulted from the introduction dose combinations that have been granted without prior approvalfrom of tenders in Germanyand the Netherlands. the country’sdrugs-controller general, Dr GN Singh. G Meanwhile, Canadian originators have fired the latest verbal volley in the debate overintellectual-property (IP) provisions as negotiations overacomprehensive economic and trade agreement (CETA) between REGULATORY AFFAIRS Canada and the European Union (EU) reach acritical phase. Three reports that brand industry association Rx&D has commissioned from KPMG, RiskAnalytica and Secor claim that EMA expects fewer dossiers “research-based pharmaceutical companies invested more than C$1 he European Medicines Agency(EMA) nowexpects to receive billion (US$1.0 billion) in researchlast year and contributed over Tjust 18 centralised marketing-authorisationapplications for generic C$3 billion to the country’seconomy”. medicines this year,downfrom its initial estimate of 32. The agency According to the reports, “at least 20%” of Canadian originators’ has revised its outlook after a“significant decrease” in the number investment in research and development is not captured by the research of submissions receivedsofar this year.Just 11 generic dossiers were conducted by the country’sPatented Medicines Price ReviewBoard submitted in the first six months of 2012, the EMA said, compared (PMPRB). The CGPAhas repeatedly cited the PMPRB’sreports to show to 21 in the first half of 2011. that Rx&D members have for years failed to deliverontheir pledge to But the EMA has increased its full-year forecast for biosimilar spend 10% of their domestic sales on research and development in applications by three to eight, having receivedsix during the first return for an extension of patent terms in 1987 (Generics bulletin, half of 2012. Twoofthose six dossiers were for the monoclonal 13 July 2012, page 8). antibody infliximab (Generics bulletin,14September 2012, page 21). The CGPArecently issued ajoint statement with the European No biosimilar dossiers were submitted during the first half of 2011. Generic medicines Association (EGA) that said the CETAproposals Due to the anticipated lower number of generic dossiers, the agency “reflect alack of regard for the strength and internationally-competitive believesitwill receive 101 applications in total this year for an initial nature of Canada’sIPregime for pharmaceuticals” and “go farbeyond evaluation of medicinal products. It had originally expected there would the IP standards that the EU itself adheres to” (Generics bulletin, be 112 submissions during 2012. 19 October 2012, page 10). “Current CETAproposals would delay According to the agency’shalf-year report, the proportion of generic entry in Canada by an average of 3.5 years and add C$2.8 applications evaluated within the statutory timeline of 210 days fell billion to the country’sprescription-drugs costs,”theyinsisted. G from 96% as of June 2011 to 91% in the first half of this year. G

12 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.9-13_Layout 1 31/10/2012 20:07 Page 7

MARKET NEWS

PRICING&REIMBURSEMENT INTELLECTUAL PROPERTY Stada and Teva lead UK refers one more SpectrumK contracts SPC dispute to ECJ

tada narrowly headed Teva in terms of the number of contracts KJudge Richard Arnold has for the second time in afew weeks Swoninthe fourth tender round organised by SpectrumK, agroup Ureferred adispute oversupplementaryprotection certificates (SPCs) of 81 German statutory health insurance funds that together covermore to the European Court of Justice (ECJ). The latest dispute referred by than eight million people. Only five of the 16 contracts that Stada Arnold revolves around whether AstraZeneca’sSPC for its Iressa secured under its Aliud and Stadapharm labels were exclusive,but Teva (gefitinib) oncology brand should be based on a2004 Swiss marketing obtained sole-supply status for eight of the 15 products covered by approval–and thus expire on 1March 2019 –orona2009 approvalby its contracts. the European Medicines Agency(EMA), which would stretch SPC From 1January 2013, Stada will be the SpectrumK funds’ sole protection until 22 April 2021. supplier of clonidine capsules and quinapril coated tablets, as well as According to adecision by the UK Intellectual Property Office of carbamazepine delayed-release tablets and of theophylline delayed- (IPO), the duration of the SPC –based on European patent EP0,832,900, release tablets sourced from both Aliud and Stadapharm. which expires on 22 April 2016 –should be calculated on the basis of Teva –via abidding group that includes its AbZ, AWDpharma, the Swiss marketing authorisation, which wasautomatically recognised CT Arzneimittel and Ratiopharm labels –secured exclusive deals for in Liechtenstein in 2004. flutamide tablets, famotidine and ibandronic acid coated tablets, and The IPO said Liechtenstein’srecognition of the approvalconstituted valproic acid as both coated and gastro-resistant tablets. The Israeli an authorisation within the European Economic Area (EEA) –thus firm also captured twoseparate contracts for theophylline delayed- qualifying it for an SPC under the European SPC regulation 469/2009 release capsules, and one for pancreatin gastro-resistant capsules. –eventhough the Swiss approvalwas suspended in 2005 and the EMA Sandoz –through its 1A Pharma and Hexal labels –ranked third did not authorise the product until 2009. with 12 contracts, five of which were exclusive.All sevenofthe awards However, AstraZeneca appealed the IPO’sdecision, claiming that giventoActavis covered molecules for which SpectrumK also Liechtenstein’srecognition of the Swiss authorisation –under the appointed twoother suppliers. Krka’sTad Pharma and Torrent’s customs union between the twocountries –was “not intended to produce Heumann each wonfivecontracts, while Mylan Dura obtained four. anyeffect within the EEA legalorder”. Other exclusive contracts included those awarded to Bluefish for valaciclovir coated tablets, Glenmark for mometasone ointment, Medice Divergence of interpretation for desmopressin tablets and Neuraxpharm for levetiracetam solution. Noting that a“divergence of interpretation” on the matter existed Among the active ingredients for which contracts were giventothree between different national European Union (EU) authorities, Arnold suppliers were atorvastatin coated tablets, candesartan tablets, donepezil said he would ask the ECJ whether aSwiss marketing authorisation orodispersible tablets and timolol/latanoprost eyedrops. that had been automatically recognised by Liechtenstein wascapable In total, SpectrumK awarded contracts in 55 lots for 41 different of constituting the “first authorisation to place the product on the active ingredients. Having receivedbids from 38 companies, the group market” under the SPC regulation. of funds expects to generate annual savings of over C220 million Arnold said he would also ask the ECJ whether its answer to the (US$285 million) from its fourth tender round. first question would change if the Swiss approvalhad been based on During November,SpectrumK intends to launch another tender clinical data that would not satisfy EMA approvalrequirements, and/or round –its fifth in total –covering another 31 active ingredients. Supply had been subsequently suspended and only reinstated after additional contracts for drugs such as anastrozole, exemestane and losartan that data wassubmitted. were granted during its third round beganon1May this year (Generics Furthermore, Arnold said the ECJ would be asked to rule on bulletin,23March 2012, page 11). whether aproduct that had been marketed within the EEA solely on Meanwhile, German generics industry association, Pro Generika, the basis of aSwiss authorisation recognised in Liechtenstein would has criticised the latest tender round for 69 ingredients awarded by the be ineligible for an SPC under the European regulation. Barmer-GEK fund. The seven-week period between the successful In 2005, the ECJ ruled that Liechtenstein’sautomatic recognition bidders being announced and the contracts starting on 1November of Swiss marketing authorisations should be taken into account when wastoo short to ensure that sufficient supplies were produced and deciding the duration of SPCs (Generics bulletin,6May 2005, page provided to pharmacies, the association insisted. G 10). The twocountries changed their bilateral agreement shortly afterwards to incorporate adelay of ayear before Swiss authorisations became valid in Liechtenstein. Arnold also recently asked the ECJ to adjudicate in adispute INTELLECTUAL PROPERTY overthe validity of Sanofi's SPC for its CoAprovel(irbesartan/ hydrochlorothiazide) combination antihypertensive (Generics bulletin, Canada debates CAMR reform 1October 2012, page 17). anada’sparliament on 16 Octoberdebated plannedamendments Meanwhile, adistrict court in The Hague, the Netherlands, has Cto the Canadian Access to MedicinesRegime (CAMR), the also referred five questions on SPCs to the ECJ in adispute between compulsory-licensing legislationthat has beenused just oncesinceit the Dutch patent office and Georgetown University. wasenacted by parliament in 2004. The C-398 private-members’ bill Firstly,the district court asks whether abasic patent that protects sponsored by social-democratic NDPpoliticianHélèneLaverdière several productsiseligible to be used as the basis for separate SPCs would amend CAMR through a“one-licencesolution”that would allow protecting each product individually.Four further questions deal with genericsfirmstoobtainasingle licence per product, rather than require howtointerpret the European SPC regulation if such apatent is eachindividual country to requestacompulsorylicence. G eligible for separate SPCs. G

2November 2012 GENERICS bulletin 13 Gen 2/11/12 Pgs.14-21_Layout 1 31/10/2012 20:09 Page 2

MARKET NEWS

INTELLECTUAL PROPERTY REGULATORY AFFAIRS Australiawill review Amneal challenges patent extensions Suboxonewithdrawal

ustralia’s government is examining whether five-year patent eckitt Benckiser has raised US safety issues around its Suboxone Aextensions strikeaproper balance between fostering innovation R(buprenorphine/naloxone) sublingual tablets “solely to prevent or and allowing timely access to market for low-cost generics. It has delay the final US Food and Drug Administration (FDA) approval commissioned an expert panel to reviewpharmaceutical patents and to of competing generic products”, according to aresponse to Reckitt’s seek public comment before submitting afinal report to the government citizen petition that has been filed by Amneal Pharmaceuticals. in April 2013. Australia’sGeneric Medicines industry Association Amneal argues that the FDAmust denythe petition submitted by (GMiA) has welcomed the reviewas“important and timely”. Reckitt at the end of September.This calls on the agencytorefuse The panel comprises: Tony Harris, former NewSouth Wales approvalfor generic versions of the addictiontreatment until the FDA auditor-general and parliamentary budget officer; Professor Dianne has formallydetermined whether Suboxone tablets were discontinued Nicol, associate dean of research at the University of Tasmania; and for safety reasons. Reckitt’spetition also insists that anybuprenorphine- Dr Nicholas Gruen, chief executive officer of Lateral Economics. It will based abbreviated newdrug application(ANDA) must include an reviewthe system for pharmaceutical patents, particularly the extensions educational programme and child-resistant unit-dose packaging. of up to five years that were introduced in 1998 to compensate for But Amneal –which is among several firms to have filed ANDAs the regulatory-assessmentperiod. for generic versions of Suboxone tablets –insists that the petition is Among the issues that the panel will consider are Australia’s intended to delay ANDAapprovals and fails to demonstrate anysafety obligations under international agreementsand the approaches to issue linked to buprenorphine. In anycase, the US generics firm intellectual-property extensions taken in other countries. G maintains, the FDAlacks the authority to accede to Reckitt’sdemands. In a“textbook case of anti-competitive conduct”, Reckitt is seeking to shift patients away from its off-patent Suboxone tablets and onto the film version that enjoys patent protectionuntil September 2023, PRICING&REIMBURSEMENT alleges Amneal, which filed an ANDAfor buprenorphine/naloxone on 11 May 2010, more than 18 months before the FDAapproveda NAPM counts labelling cost Suboxone risk evaluation and mitigation strategy (REMS). hanges to rules on transparent pricing and labelling in South Africa When the FDAdemanded asingle, shared REMS for Suboxone Cwill create unnecessary costs that will have to be passed on to and proposed generics, Amneal and other ANDAapplicants sought consumers, the country’sNational Association of Pharmaceutical to negotiate with Reckitt, butthe originator “used every opportunity Manufacturers (NAPM) is warning. to delay the process” when the generics were on the cusp of approval While the association broadly supports amendments to South and said it would withdrawSuboxone tablets. Africa’sMedicines and Related Substances Act to tackle bribery and “Reckitt’spetition argues that, after 10 years on the market, Reckitt “unsavoury tactics”inthe medicines market through the threat of has suddenly discovered asafety issue so severe as to require the criminal prosecutions, it is concerned about proposals that government- removalofsuboxone tablets within the next six months, just as the regulated single exit prices (SEPs) be printed on packaging. SEPs REMS process comes to its expected close and the pending ANDAs dictate uniform-transparent prices at which firms must sell products are ripe for approval,”Amneal observes. Giventhat Reckitt has used to private-sector customers. unit-dose or blister packs in Canada and Europe for years, the originator The proposal is “highly impractical”, the NAPM insists, as “every could have addressed the concerns raised in the petition several years time the SEP is adjusted, the packaging would need to be changed”. ago, butrather “continued to sell billions of dollars worth of bulk Firms with the same public- and private-sector packs will suffer,itadds. containers of tablets in the US without apparent concern”. The most recent SEP increase wasa2.14% rise in March (Generics Reckitt Benckiser reported North AmericanSuboxone sales of bulletin,23March 2012, page 14). The maximum SEP rise in 2013 is £587 million (US$943 million) last year,ofwhich the film version expected to be 6% (Generics bulletin,1October 2012, page 12). G made up £249 million, or 42%. But by midway through this year, the film had captured three-fifths of the US market. However, it said “80% of the revenue and profit of the Suboxone tablet business might be lost in the year following the launch of generic INTELLECTUAL PROPERTY/ANTIRETROVIRALS competitors”, while sales of the film would also suffer due to “highly price-sensitive payors”. Indonesia licenses seven drugs According to Amneal, the data presented by Reckitt do not ndonesia has issued a‘government-use decree’, or compulsory licence, substantiate its safety claims. Astudy commissioned by the originator Ifor several antiretroviral drugs to meet “urgent need”. It plans to pay suggested that accidental paediatric exposure wasaround eight-times the patent holders aroyalty of just 0.5% up to the dates of patent expiry. higher for Suboxone tablets than for the film, although “data do not The drugs subject to the decree are Merck &Co’sStocrin isolate the root cause of these findings”. (efavirenz), Bristol-Myers Squibb’sVidex(didanosine), Gilead’sViread Three days after Reckitt filed its citizen petition, Lachman (tenofovir) and GlaxoSmithKline’sZiagen (abacavir), as well as Abbott’s Consultant Services submitted aseparate petition asking the US Kaletra (lopinavir/ritonavir), and Gilead’scombinations Truvada Food and Drug Administration (FDA) to determine whether the brand (tenofovir/emtricitabine) and Atripla (efavirenz/tenofovir/emtricitabine). firm waswithdrawing Suboxonetablets for reasons of safety and Efavirenz is patented until August 2013, whilst abacavir,didanosine, efficacy. Lachman pointed out that the FDA’sdetermination on the lopinavir,ritonavir and tenofovir are protected until 2018. The patent grounds for the tablets’ withdrawalwould affect ANDAs pending for emtricitabine runs until 2024. G approvalthat used Suboxone tablets as the reference drug. G

14 GENERICS bulletin 2November 2012 EUROPEAN GENERIC MEDICINES ASSOCIATION

Forthcoming events | You should not miss them! Register nowfor both the PharmacovigilanceDiscussion Forum &the Regulatory and ScientificAffairs Conferenceand receivea10% discount!

6th EGA PHARMACOVIGILANCE DISCUSSION FORUM 16 January 2013 | London | RADISSON BLU PORTMAN HOTEL

Come and learn directly from the key players about the implementation of the New EU Pharmacovigilance legislation. Our forum, whose main focus is pharmacovigilance for well-established substances, will give you a unique opportunity to get an overview of the implementation tasks and challenges for the various stakeholders. The sessions will focus in particular on: • T he introduction of new pharmacovigilance fees by the EMA • Implementation of the New EU Pharmacovigilance legislation by the The forum is aimedatpersonnel from pharmacovigilanceand European Medicines Agency, the member states and the generic regulatoryaffairs departments of the generic medicines industry pharmaceutical industry andatall those involved in the dailypracticeofpharmacovigilance. • Risk management plans, periodic safety update reports and pharmacovigilance master fi les for generic medicines and inspections in the light of the new legislation

12th EGA REGULATORY AND SCIENTIFIC AFFAIRS CONFERENCE 17 - 18 January 2013 | London | RADISSON BLU PORTMAN HOTEL

Join this unique conference to get an update on recent regulatory developments. Representatives from the authorities together with well-known industry experts will present the latest issues and share their point of view on the following topics:

• Changing the legal and regulatory environment to fulfi l public health needs while managing implementation by stakeholders – how to reach a compromise? • Handling consistency in scientifi c evaluation of generic medicines between similar/identical dossiers authorised via the CP/DCP - EMA/CMDh initiatives • How to implement new elements of the Pharmacovigilance legislation into regulatory practice? • Changes in the regulatory environment - impact on a company’s operational activities

Therewill be twoparallel tracks offered to the delegates:

TRACK I: Regula tory implications of various changes in the legal TRACK II: Electronic submission environment and operational environment. • Submission of information on medicinal products in accordance with Art 57 • Im plementation of the Quality aspects of the Falsifi ed Medicines Directive (FMD) of the New Pharmacovigilance legislation • Pharmaceuticals In the Environment (PIE): how could this emerging issue • Update on recent initiatives to improve the regulatory environment by infl uence the current regulatory framework? eff ective use of electronic tools • Transatlantic dialogue • How to better inform about medicines The conference will close with a special session: Ask your questions to the Regulators. An opportunity to address questions to European Regulators on various regulatory issues

FOR FURTHER INFORMATION &TOREGISTER Visit http://www.gpaconferences.com/phvrac.htm or contactCristina Romagnoli | E: [email protected] | T: +377-93-501348

www.egagenerics.com or www.gpaconferences.com

P-R-S_210x297_2013.indd 1 9/10/12 12:38 Gen 2/11/12 Pgs.14-21_Layout 1 31/10/2012 20:09 Page 4

PRODUCT NEWS

DIABETES DRUGS IN BRIEF MYLAN has launched fenofibrate capsules in 67mg, 134mg and Watson makes FDA 200mg strengths in the US. The product will compete with versions marketed by Impax and Teva.

SANDOZ and Momenta have requested an en banc rehearing of a approve Actos rival US Court of Appeals decision overWatson and Amphastar’s enoxaparin.The appeals court ruled that Amphastar’suse of atson has launched aUSrivaltoTakeda’sActos (pioglitazone) Momenta’spatented method of analysing polysaccharides to provide W15mg, 30mg and 45mg tablets following aColumbia district data quality-control fell within Bolar ‘safe harbour’ provisions court ruling requiring the US Food and Drug Administration (FDA) (Generics bulletin,3September 2012, page 16). But Momenta and to approve the generics firm’sproduct and allowWatson to share the Sandoz argue in their petition that the court’soverly broad interpretation remainder of an exclusivity period that had previously been awarded would expand such provisions into a“safe ocean” and would solely to Mylan. Ranbaxy and Teva also market authorised generics of “essentially render manufacturing patents worthless”. the diabetes treatment, which IMS Health said had branded and generic sales of US$2.7 billion in the US for the year ended August 2012. FDA –the US Food and Drug Administration –has so farbeen In late August,Watson launched alawsuit against the FDA “unable to reach adecision” overacitizen petition submitted by Abbott challenging the agency’sdecision to award Mylan sole exclusivity for asking the agencynot to approve anybiosimilar versions of biologics generic pioglitazone (Generics bulletin,3September 2012, page 1). registered in the US before 23 March 2010. Abbott’spetition –which Watson said it had been afirst filer of paragraph IV challenges to claimed that trade secrets contained in biologic license applications Takeda’sActos patents in 2003. Then, in 2010, the originator settled (BLAs) were unjustlybeing used to help approve the generic versions patent litigation with Mylan and Watson through an agreement that (Generics bulletin,4May 2012, page 14) –“raises complexissues included anon-exclusive licence to several pioglitazone composition requiring extensive reviewand analysis”, the FDAstated. and combination-therapypatents that would be granted to the firms from 17 August 2012 (Generics bulletin,26March 2010, page 15). ADAMED has launched advertising campaigns for twoofits OTC dietary supplement brands in Poland. Television advertising for the Exclusivity decision nine years after filing Polish firm’s Nervomix range of stress-relieving productswill run However, Watson said, the FDAhad waited until August 2012 on national channels until the end of November,whilst aradio to inform the firm of the agency’sdecision to denyshared exclusivity. campaign for the company’s Oeparol Extra food supplement will This came “overnine years after Watson filed its abbreviated new be aired until the end of the year. drug application (ANDA), after numerous assurances that Watson’s ANDAwould be approved, after significant expenditures by Watson ELITE PHARMACEUTICALS has receivedapprovalfrom the US to prepare to launch its product and after supply arrangements for this Food and Drug Administration (FDA) for generic 15mg and 30mg critical diabetes treatment were in place”. phentermine capsules. However, the sole supplier of the active Granting Watson’srequest for summary judgement, the district pharmaceutical ingredient (API) for the appetite suppressant has court directed the FDAimmediately to approve Watson’sANDAfor “restricted the amount of API available to Elite, which will delay the pioglitazone “so that Watson may participate in what remains of the launch of this product” as well as preventing Elite from “meeting shared exclusivity period previously awarded to other generic growing demand for phentermine 37.5mg tablets”.The company manufacturers”. The 180-day exclusivity period beganwhen Mylan hopes to secure an alternativesupplier,but said this could takeat launched its version in mid-August. least 12 months. In responsetothe district court ruling, Mylan filed an expedited motion seeking to stay the court’sorder pendinganappeal. The FDA HOSPIRA has recalledone lot of 1,000ml Lactated Ringer’sand also joined Mylan in its motion. Heather Bresch, Mylan’schief executive 5% Dextrose forinjection in the US. This is due to acustomer report officer,said the firm believedthe court had “erred in its decision by where aleak wasidentified in the primary container between the directlycontravening the Hatch-Waxman Act”. cobra cap and fill-tube seal. Spore-likestructured particulates Insisting that Watson wasnot entitled to share the exclusivity consistent with mould were noted in the solution. The affected lot period, Bresch said Mylan intended to “pursue this case vigorously, has an expiry date of 1December 2013 and wasdistributed between including seeking expedited relief from the appellate court if necessary”. January 2012 and June 2012. However, Mylan’smotion for an emergencystay wasdenied by the Court of Appeals, clearing the wayfor Watson’slaunch. G EMA –the European Medicines Agency–has released adraft quality guideline on transdermalpatches that is open for consultation until 15 March 2013. BIOSIMILARS PERRIGO has receivedtentative approvalfrom the US Food and Drug Fujifilm aims at bevacizumab Administration (FDA) for its abbreviated newdrug application (ANDA) for OTC omeprazole/sodium bicarbonate 20mg/1100mg ujifilm and KyowaHakkoKirin are together planning to develop capsules.Perrigo said it expected to launch the proton-pump Fabiosimilar rivaltoRoche’sAvastin (bevacizumab) through the inhibitor –ageneric version of Merck &Co’sZegerid OTC– joint operation between the twoJapanese companies. Fujifilm Kyowa “when market formation occurs”. Kirin Biologics –the 50-50 joint venture initiated earlierthis year (Generics bulletin,6April 2012, page 18) which is already developing SAGENT has launched a5gpharmacybulk-package version of its aversion of Abbott’sHumira (adalimumab) –plans to develop injectable vancomycin hydrochloride in the US. The company bevacizumab as the second biosimilar in its portfolio. Based on acell said such bulk presentations accounted for around half of the US$186 line already developed by KyowaHakkoKirin, the bevacizumab million annual US sales of the product. G biosimilar is expected to begin clinicaltrials in 2014. G

16 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.14-21_Layout 1 31/10/2012 20:09 Page 5

PRODUCT NEWS

IMMUNOSUPPRESSANTS BIOSIMILARS FDA adds US$2.7mn AET aims for Humira to tacrolimus study via BioXpress deal

study aimed at establishing the bioequivalence of generic versions ET BioTech, the biosimilars affiliate within the German generics Aof Astellas’Prograf (tacrolimus) with the immunosuppressant Adeveloper Alfred ETiefenbacher (AET), has struck adeal with brand will begin in early 2013 after it receivedfunding through a Swiss monoclonal antibodies (mAbs) specialist BioXpress Therapeutics US$2.7 million grant from the US Food and Drug Administration to co-develop arivaltoAbbott’sHumira (adalimumab) blockbuster. (FDA). Professor Rita Alloway, director of transplant clinical research Abbott reported global Humira sales ahead by 14.4% to US$6.59 within the University of Cincinnati’sdepartment of internal medicine, billion in the first nine months of 2012, of which US$2.96billion said the university’sstudy wasintended to address quality and efficacy wasgenerated in the US. concerns of doctors and patients overgeneric immunosuppressants. The twopartners will be jointly responsible for developing the Twoversions of generic tacrolimus will be tested for bioequivalence TNF-inhibitor based on BioXpress’ technology,aswell as for against Prograf as part of asix-way crossoverstudy in 72 kidney- and manufacturing and registering the biosimilar,while AET BioTech will liver-transplant patients. The twogenerics were selected to represent takethe lead role on commercialisation. The twofirms said their the most disparate versions “based on potency, purity and dissolution”. development programme for the rheumatoid arthritis and plaque psoriasis “Currently more than 50% of transplant patients are dispensed treatment took account of “regulatory requirements for marketing in generic tacrolimus,”Allowaystated, adding that “the largest concern countries worldwide”. forclinicians is the switchability between various generics”. Claiming Noting that it would be actively involved in development, AET that patients “could be getting medication from different manufacturers BioTech said it would in particularberesponsible for “providing further each month”, she said the blinded study wastherefore aimed at investment in the biosimilar based on committed long-term financing”. demonstrating “whether even the most disparate generics have the “The BioXpress team has an impressive track record in the same efficacyinhealthypost-transplant patients”. development of the initial originator mAbs, and access to state of the Additionally,Allowaysaid, the study would seek to identify patients art mAbs know-howand technology.The partnershipwill unite our who were genetically inclined to be “poor absorbers” or “high technical and commercial strengths behind the adalimumab biosimilar,” metabolisers” and were therefore at agreater risk of receiving higher commented AET BioTech’smanaging director,DrHarm Peters. “The or lower concentrations of tacrolimus than desired. G cooperation with BioXpress on our initial project is akey step in AET BioTech’smission to bring European-quality biosimilar drugs to markets worldwide at fair prices,”headded. Dr Cori Gorman, chief executive officer of privately-owned BioXpress, described the deal as “an important step in moving one of our biosimilarprojects to the market”. “AET is well known for quality drug-development, executing complexdevelopment and registration strategies and successful commercialisation worldwide,”she noted. “AET BioTech’scommercial contacts, biosimilardevelopment and registration experience,and committedfinancial investment –and our mAb development expertise –will help establish our companies as leaders in the biosimilar space,”Gorman added. BioXpress is also developing biosimilars to Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan/MabThera (rituximab). G

SCHIZOPHRENIADRUGS Par gains quetiapine ANDA ar has bought Handa’sabbreviated newdrug application(ANDA) Pfor ageneric version of AstraZeneca’sSeroquel XR (quetiapine fumarate) extended-release tablets. Handa believesitholds first-to-file status for 50mg, 150mg, 200mg and 300mg strengths, and may be entitled to 180-day generic exclusivity. Having paid an undisclosed fee both for Handa’sANDA–which is pending approval–and for exclusive marketing and distribution rights, Parwill receive ashare of profits on sales. Furthermore, Parhas been assigned the patent-litigation settlement that Handa had previously negotiated with AstraZeneca. This allows the ANDAholder to launch quetiapine extended-release tablets from 1November 2016 (Generics bulletin,6April 2012, page 19). Meanwhile, Par’sAnchen affiliate has secured US approvalfor tretinoin 10mg capsules that are equivalent to Roche’sVesanoid leukaemia drug. Teva holds asimilar ANDAfor tretinoincapsules. G

2November 2012 GENERICS bulletin 17 Gen 2/11/12 Pgs.14-21_Layout 1 31/10/2012 20:09 Page 6

PRODUCT NEWS

CENTRALNERVOUSSYSTEMDRUGS BIOSIMILARS Actavis acts to roll Sandoz enrols for US out riluzole in Europe studyonepoetin alfa

ctavis has launched riluzole film-coated tablets in several European andoz has started patient enrolment for aPhase III clinical trial in Acountries after Sanofi’sRilutek lost patent protection in late Sthe US to compare the safety and efficacyofits HX575 biosimilar October 2012. Citing IMS Health data, Actavis said sales in Europe epoetin alfawith the US-licensed reference drug, Epogen/Procrit of the Rilutek treatment for amyotrophic lateral sclerosis (ALS) –a marketed by Amgen and Johnson &Johnson. form of motor neurone disease –were C77 million (US$99 million) The randomised, double-blind ‘ACCESS’ trial into epoetin alfa in the year ended June 2012. injected subcutaneously will takeasits primary outcome measure the Having already launched the tablets in Denmark, France, Germany, mean absolute changes in haemoglobin levels between abaseline four Hungary,Italy,the Netherlands, Norway,Spain, Sweden and the UK, weeks before the study starts and week 28 of the trial. Sandoz expects Actavis said it would soon introduce its tablets in other markets. G to enrol 360 adult patients with end-stage renal disease and to complete the trial in September 2014. Hospira is currently running acomparative Phase III trial with Epogen for its biosimilar epoetin when administered intravenously. ANTIHYPERTENSIVES Pointing out that it had already generated more than 160,000 patient years of experience with epoetin alfainEurope –where it Heterosettles over nebivolol markets abiosimilar under the Binocrit and other brand names –Sandoz ndia’sHetero Drugs may be able to launch arivaltoForest’sBystolic estimated that more than 600,000 patients in the US were being treated I(nebivolol) antihypertensive tablets in the US before patent expiry for anaemia with epoetin alfaand similar drugs. after the twofirms reached apatent-litigation settlement. The companyiscurrently recruiting patients in Germanyfor an Under the settlement terms, Hyderabad-based Hetero will be able open-label Phase III ‘SENSE’ trial to assess the immunogenicity,safety to launch its generic of Bystolic on the later of twodates –either three and efficacyofHX575 when administered subcutaneously in patients months before Forest’sUSpatent 6,545,040patent expires, or the date suffering from anaemia due to chronic kidneydisease. on which Hetero receivesfinal US approvalfor its abbreviated new Phase III trials are also underway for Sandoz’ biosimilar filgrastim drug application (ANDA). The ‘040 patent expires on 17 December and pegfilgrastim, as well as for its GP2013 rituximab biosimilar to treat 2021 (Generics bulletin,20April 2012, page 18). follicular lymphoma (Generics bulletin,3February 2012, page 17). Forest is continuing to pursue litigation overthe ‘040 patent against Pointing out that the firm wasworking closely on rituximabwith Alkem, Amerigen, Glenmark, Indchemie, Torrent and Watson. G its sister organisation Novartis Oncology, Sandoz’ head JeffGeorge noted reports that several potentialcompetitorshad put Phase III programmesfor biosimilarrituximab on hold. “I think this is going to be more difficult than some players realised when theyfirst got GASTROINTESTINAL DRUGS into it,”hestated, stressing that Sandoz held “first-moveradvantage”, having started developing biosimilar human growth hormone in 1996, Pharmascience loses to AZ followed ayear later by beginning work on epoetin. harmascience has lost its bid to secure anotice of compliance In the third quarter of this year,sales of Sandoz’ three marketed P(NOC), or marketing authorisation, in Canada before AstraZeneca’s biosimilars –Binocrit, Omnitrope (somatropin) and Zarzio (filgrastim) Nexium patent 2,290,531 expires. The ‘531 formulation patent rose by 35% at constantexchange rates to US$82 million. “Zarzio now protects Nexium (esomeprazole) capsules until 18 May 2018. has over20% volume share in Europe in the short-acting granulocyte- Federal Judge John O’Keefe dismissed Pharmascience’sattacks colonystimulating factor (G-CSF) segment, and Omnitrope recently on the grounds of novelty and utility,and also ruled that AstraZeneca became the second-largest human growth hormone in the US with over had disclosed sufficient information for askilled person to makeuse 19% share in amarket with five originators,”the companyclaimed. G of the invention. Prior-art references did not render obvious the ‘531 patent’steachings on release rates and the viscosity of hydroxypropyl methylcellulose (HPMC), O’Keefe decided. G

ONCOLOGY DRUGS Strides gets two US approvals wo injectable oncologydrugs manufactured by Strides Arcolab’s TOnco Therapies division have been approvedbythe US Food and Drug Administration (FDA). The Indian company’sfludarabine comes in 50mg/2ml single-use lyophilised vials, whilst its 1mg/ml idarubicin is packaged in 5ml, 10ml and 20ml single-use vials. Strides said the combined market for the twoproducts wasworth around US$20 million. Other US versions of fludarabine are marketed by Actavis, Fresenius Kabi, Hospira and Teva,whilst Strides will face competition from Bedford Laboratories, Fresenius Kabi, Sandoz and Teva on idarubicin.G

18 GENERICS bulletin 2November 2012 Partnerships Grow Businesses

Showcase your business Aposting on theSourceGenerics websitewill showcase your generics business opportunities to potential partners around theworld (free-of-charge* to Generics bulletin subscribers)

Ta rget the right people Backed by theindustryknowledge of MikeRice,Editorial Directorof Generics bulletin,and Deborah Wilkes, Co-Founder of Generics bulletin, SourceGenerics can help put your message in front of theright people

Drivedecision-makers to your website Abanner advertisement on theSourceGenerics websitecan drive generics business development executives from all around theworld to your website

www.sourcegenerics.com The Resource forBusiness Development

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

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

SourceGenadvert-Oct29.indd 1 29/10/2012 15:02 Gen 2/11/12 Pgs.14-21_Layout 1 31/10/2012 20:09 Page 8

PARAGRAPH IV WATCH Sun faces dual hurdles over ganirelix

spart of the approvalprocess for novelmedicines, newdrug Aapplication (NDA) filers are required to list certain patents in the KEY DETAILS: GANIRELIX US Food and Drug Administration’s(FDA’s) Orange Book if those patents could reasonably be asserted against ageneric version of the Brand: Ganirelix Acetate Injection drug. These listed patents are the basis of the patent-challenge scheme Active ingredient: ganirelix acetate in the Hatch-Waxman legislative framework. Delivery form: 250µg/0.5ml pre-filled syringes Generic applicants must certify to each of the listed patents in order to gain approvalfor their products. Anysuch paragraph IV certification Brand owner: Organon/Merck &Co –indicating the applicant seeks approvalbefore the expiration of the relevant patent on the grounds of non-infringement, invalidity First paragraph IV filing 30 March 2012 or unenforceability –can result in infringement litigation. submitted to FDA: Among the types of patents that must be listed are those covering the drug substance or active ingredient, the drug product or formulation, Known paragraph IV filers: Sun Pharma and methods of approveduse. Other patents that could be infringed Patents at issue – 5,767,082 –16June 2015 by ageneric –such as those covering processes,intermediates and 6,653,286 –16June 2018 packaging –may not be listed in the Orange Book and do not have any bearing on the FDAapprovalprocess. District court locations: NewJersey While non-listed patents cannot block FDAapproval, theycan Litigation references: Merck &CovsSun Pharma be asserted in litigation, and infringement can prove costly to generic 3:12-cv-05374 applicants. As aresult, generic applicants must be aware of all patents that could covertheir target products and not focus solely on those Figure1:Key details of paragraph IV challenges to Organon’s Ganirelix Acetate listed in the Orange Book when theyprepare for litigation. The Injection (ganirelix acetate) fertility drug in the US (Source –Thomson Reuters) Ganirelix Acetate Injection fertility brand that is marketed by Merck &Co’sOrganon illustrates this clearly. Active Brand Earliest ANDA Ganirelix Acetate Injection is approvedtoinhibit premature ingredient name submission date luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation during fertility treatment. According to the Rufinamide Banzel 14 November 2012 product’slabel, it is to be administered after follicle stimulating Tapentadol (tablet/ER tablet) Nucynta/Nucynta ER 20 November 2012 hormone (FSH) therapyhas been initiated. Eltrombopag olamine Promacta 20 November 2012 Fospropofol disodium Lusedra 12 December 2012 Only one unexpired patent in Orange Book The FDA’sOrange Book currently lists only one unexpired patent Plerixafor Mozobil 15 December 2012 covering Organon’sproduct –USPatent 5,767,082, which is entitled Gadofosveset trisodium Ablavar22December 2012 “Nonapeptide and decapeptide analogs of LHRH useful as LHRH Degarelix acetate Firmagon 24 December 2012 antagonists” and expires on 16 June 2015. Organon licenses the ‘082 Milnacipran hydrochloride Savella 14 January 2013 patent on an exclusive basis from Roche. In July 2012, Sun notified Organon and Roche that it had filed an Febuxostat Uloric 13 February 2013 abbreviated newdrug application(ANDA) containing aparagraph IV Everolimus Afinitor/Zortress 30 March 2013 certification for ageneric ganirelix acetate injectabledrug. One might have expected the resulting litigation to include infringement allegations Figure2:Active ingredients subject to new chemical entity (NCE) exclusivities for which abbreviated new drug applications (ANDAs) can be submitted between concerning the Orange Book-listed ‘082 patent. When Merck, Organon November 2012 and March 2013 (Source –Thomson Reuters) and Roche filed asuit in NewJerseydistrict court in August, the complaint did indeed assert the ‘082 patent, butitalso alleged infringement of US companypoints out that although an adverse court decision concerning patent 6,653,286, which expires in 2018 (see Figure 1). the ‘286 patent would not prevent the FDAfrom approving Sun’s The ‘286 method-of-use patent contains claims for administering drug, “it might well keep the product from the market all the same, adaily ganirelix dose of between 0.125 mg and 0.5 mg in conjunction even if Sun were to prevail in its challenge to the ‘082 patent”. with FSH. While the patent is not listed in the FDA’sOrange Book, the Twoother injectable drugs could soon be subject to US patent plaintiffs argue FDA-approveduse of their Ganirelix Acetate Injection challenges. In December,both Eisai’sLusedra (fospropofol) anaesthetic pre-filled syringes is covered by one or more claims. Therefore, they and Genzyme’sMozobil (plerixafor) non-Hodgkin’slymphoma insist, Sun’sproposed product would infringe the ‘286 patent. treatment will enter their fifth year of five-year newchemical entity “It is unclear whether Sun Pharma expected to be sued for (NCE) exclusivity.Under the terms of Hatch-Waxman legislation, infringement of both patents,”comments Thomson Reuters, which the FDAcan accept ANDAs that contain paragraph IV certifications compiles adatabase of paragraph IV certifications and associated to patents listed in its Orange Book one year before the five-year litigation. Noting that the litigation is still in its early stages, the NCE exclusivity for the reference brand expires (see Figure 2). G

Thomson Reuters draws on strategic intelligence and competitive analysis information on the US generics industry to create Newport Premium™,the criticalproduct-targeting and global business-development system from the industry authority on the global generics market. Forfurther details contact Benjamin Burck, Thomson Reuters API Intelligence, 215 Commercial Street, Portland, Maine 04101, USA. Tel: +1 207 871 9700 x35. Fax: +1 207 871 9800. E-mail: [email protected]. Website: scientific.thomsonreuters.com/newport.

20 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.14-21_Layout 1 31/10/2012 20:09 Page 9

PRODUCT NEWS

PRICING&REIMBURSEMENT ONCOLOGY DRUGS Arrowand Apotex Teva first in line for receive NZ listings EU imatinib approval

rrowand Apotexare to have further products listed for eva could soon obtain the first pan-European approvalfor ageneric Areimbursement in NewZealand following approvals from the TrivaltoNovartis’ Glivec(imatinib) leukaemia treatment. The country’spharmaceutical management agency, Pharmac. committee for human medicinal products (CHMP) within the European Arrow’stolterodine 1mg and 2mg tablets will be reimbursed at Medicines Agency(EMA) has recommended that Teva be granted NZ$14.56 (US$11.91) for 56-tablet packs of each strength of the marketing authorisations for both capsules and tablets in 100mg and incontinence treatment. The product will be listed from 1November 400mg strengths. The European Commission typically acts upon the and will have delisting and subsidy protection until 1July 2013. CHMP’sopinions within 67 days. Venlafaxine 225mg extended-release tablets and levonorgestrel Data released by the EMA earlier this month revealed that the 750µg tablets made by Arrowwill be listed from 1January 2013. A CHMP wasreviewing three applications for generic imatinib products. 28-tablet pack of venlafaxine will have areimbursement price of Novartis believesthat Glivecwill benefit from patent protection in NZ$35.12, although this will drop to NZ$27.14 on 1July 2013 and Europe until at least 2016. NZ$19.03 on 1July 2014. Meanwhile, twotablets of Arrow’s At the same time, the CHMP advised –following arbitration ‘Next Choice’ levonorgestrel brand will be listed at NZ$12.50 less procedures in decentralised assessments–that Greece’sAlapis be a“confidential rebate”. denied marketing authorisations for levothyroxine oral drops and Delisting and subsidy protection for venlafaxine will expire on Finland’sVitabalans be refused approvals for furosemide tablets. 1April 2017, whilst Arrow’slevonorgestrel will be protected from Alapis’ chosen reference member state (RMS), the Netherlands, being delisted until 1July 2013. referred adispute to the CHMP after the UK raised concerns over Meanwhile, Apotexhas been granted alisting for its azithromycin the accuracyofthe dose delivered by the generic drug’sdropper 250mg tablets from 1December.A30-tablet pack will be reimbursed device. The EMA committee agreed with the UK’sobjections. at NZ$10.00. Furthermore, restrictions allowing amaximum treatment Estonia acted as the RMS for Vitabalans’ furosemide 40mg length of five days will be applied to all listed versions of the 250mg tablets. But the CHMP agreed with regulators from Lithuania and and 500mg strengths of the antibiotic, although these can be waived Poland that the Finnish firm had not provided sufficient bibliographic for certain uses, such as in patients with cystic fibrosis. G evidence in place of studies to support awell-established use approval. G

ORAL CONTRACEPTIVES Lupintargets Teva’s US pills upin has launched alternatives to twoofTeva’s oral contraceptive Lbrands in the US following approvalfrom the US Food and Drug Administration (FDA). The Indian firm is offering levonorgestrel/ ethinylestradiol 0.15mg/0.03mg tablets as rivals to Teva’s Seasonale brand, and is also marketing an equivalent to Teva’s Nordette (levonorgestrel/ethinylestradiol) 0.15mg/0.03mg tablets under the Kurvelo brand name. While the twoproducts have the same strength, the dosage regimens are different. Sandoz and Watson also market rivals to Seasonale under the Introvale and Quasense brand names respectively.Lupin’sKurvelo will compete against alternativestoNordette that are offered by Glenmark, Sandoz and Watson, as well as Teva’s ownPortia-28 generic. G

ANALGESICS EMA examines diclofenac risk iclofenac appears to showaconsistent butsmall increase in the risk Dof cardiovascular side effects compared with other non-steroidal anti-inflammatory drugs (NSAIDs), said the European Medicines Agency(EMA) after reviewing the latest evidence. The risk wassimilar to that of COX-2 inhibitors, the agencyadded. Current treatment advice for ibuprofen and naproxen, however, adequately reflected the safety and efficacyofthese medicines. All available data on diclofenac would nowbeassessed by its new Pharmacovigilance Risk Assessment Committee (PRAC), the EMA said, to consider the need for updated treatment advice. G

2November 2012 GENERICS bulletin 21 Gen 2/11/12 Pg.22_Layout 1 31/10/2012 20:10 Page 2

EVENTS

NOVEMBER 4-6December 2012 15-16 November ■ 15th IGPAAnnual Conference ■ Getting Approval of Generics Kyoto, Japan in the EU and USA This three-day conference is being organised by the Japanese Generic Medicines Association Vienna, Austria (JGA) and is the global event of the worldwide generics industry.Itisthe annual joint This two-day course discusses the keypoints meeting of the Canadian, European, Indian, Japanese, South African and US generics to consider when applying for marketing industry associations, the CGPA, EGA, IPA, JGA, NAPM and GPhA. Some of the issues authorisations in the European Union and to be covered will include the recent trends of biosimilars, intellectual property rights, the rld Health Organization’s(WHO’s) policies, and bioequivalence requirements. US. Issues to be looked at will include Wo regulatory proceduresand specific dossier Contact:Japan Generic Medicines Association. Tel: +81 35216 5303. requirements.Speakers will also present E-mail: [email protected]. Register onlineatwww.congre.co.jp/igpa2012. case studies and provide information on electronic submissions. Discussion Forum. The conference will includes astrand on developing and Contact:Concept Heidelberg. look at newlegislation, the application of producing biosimilars. Tel: +49 6221 84 44 0. recent rule changes and other developments E-mail: [email protected]. Contact:IBC USA. Website: www.gmp-compliance.org. in the regulatory and scientific environment. Tel: +1 941 554 3500. Both meetings are to be held at the same E-mail: [email protected]. venue in London. Website: www.ibclifesciences.com/BDPWeek. 27 &28-29 November Contact:Cristina Romagnoli, GPAConferences. ■ World Generic Medicines Tel: +377 93 501 348. 26 February–1March Congress Americas E-mail: [email protected]. ■ World Generic Medicines Washington, USA Register onlineatwww.gpaconferences.com. With apre-conference workshop looking at Congress Europe the biosimilars market, this two-day event FEBRUARY London, UK will focus on subjects such as biosimilar This four-day conference will be co-located strategies and lifecycle management. There 12 &13-14 February with the Biosimilar Drug Development will be speakers from firms including World event. Issues covered at these ■ Demonstrate Biosimilarity Actavis, Dr Reddy’sand Pfizer.There will events will include aglobal policyupdate, also be apresentation from Representative WashingtonDC, USA commercial strategies, market share, Henry Waxman, who will give an insight With speakers from the US Food and biosimilarproduct development, and into legislation in the US. Drug Administration (FDA) as well as pharmacovigilance and risk management. companies including Biogen, Sandoz, Contact:Health Network Communications. Contact:Health Network Communications. Tel: +44 207 608 7055. Teva and Wockhardt, this two-day Tel: +44 207 608 7055. E-mail: customerservices@health conference will look at topics including E-mail: customerservices@health networkcommunications.com. the regulatory issues surrounding networkcommunications.com. Website: www.healthnetworkcommunications.com. biosimilars. The event will provide Website: www.healthnetworkcommunications.com. networking opportunities and aone-day pre-conference workshop. JANUARY Contact:Hanson Wade. MARCH Tel: +1 212 537 5898. 16 January 19-20 March E-mail: [email protected]. ■ 6th EGA Pharmacovigilance Website: www.demonstrate-biosimilarity.com. ■ 9th EGA Legal Affairs Forum Discussion Forum Brussels,Belgium London, UK 20-22 February This two-day event organised by the EGA will coverintellectual-property issues and This European Generic medicines ■ GPhA Annual Meeting provide networking opportunities. Association (EGA) event will takethe form Orlando, USA of adiscussion forum and will look at topics Contact:Cristina Romagnoli, GPAConferences. This three-day meeting of the US Generic including the newpharmacovigilance fees Tel: +377 93 501 348. Pharmaceutical Association (GPhA) will introduced by the European Medicines E-mail: [email protected]. look at regulatory issues and the Register onlineatwww.gpaconferences.com. Agency(EMA), the latest legislation, risk challenges and opportunities for the management and inspections. industry.There will also be networking 4-5March Contact:Cristina Romagnoli, GPAConferences. opportunities and social events. Tel: +377 93 501 348. ■ EuroPLX 51 Contact:GPhA. E-mail: [email protected]. Tel: +1 202 249 7100. Limassol, Cyprus Register onlineatwww.gpaconferences.com. E-mail: [email protected]. This two-day meeting will provide aforum Website: www.gphaonline.org. in which companies can discuss licensing, 17-18 January marketing and distribution opportunities for patented medicines, generics, biosimilars, ■ 12th EGA Regulatory& 25 February–1March OTCproducts and nutraceuticals. Scientific Affairs Conference ■ BDP Week Contact:Raucon. London, UK California, USA Tel: +49 6222 9807 0. This two-day conference will followthe This conference covering biopharmaceutical E-mail: [email protected]. EGA’s one-day Pharmacovigilance development and production (BDP) will Website: www.europlx.com.

22 GENERICS bulletin 2November 2012 Gen 2/11/12 Pg.23_Gen 07/10/05 Pg.15 31/10/2012 20:11 Page 3

PRICE WATCH ...... UK CategoryMhas another two members wo recent UK generics-market entrants –candesartan and naratriptan which is based on actual prices in the marketplace –meant a72% T–havebeen added to our list of ‘fast movers’ to mark their transition reduction in the reimbursement price to £2.80 for dispensing candesartan from category Ctocategory Minthe latest Drug Tariffofpharmacy 8mg, and an 82% cut to £4.46 for naratriptan 2.5mg. reimbursement prices. Moxonidine and pravastatin, launched in Pharmacydispensing margins, however, were just 6% on average 2004, have been removedfrom our table to makeway for them. for candesartanand no better than 29% for the lowest price in the The generic launch of candesartan came at the end of April market (see Figure 1). Dispensing margins for naratriptan were (Generics bulletin,4May 2012, page 19), when Takeda’sprotection better at 42% on average, rising to 72% for the best price on offer. for its Amias brand expired, ending brand sales of £87 million (US$140 Candesartanprices suffered from the move to category M, falling million). Patent expiry for Naramig from GlaxoSmithKline wasa by 29% on average for the 8mg strength and by 34% for the 32mg month earlier (Generics bulletin,23March 2012, page 16). format (see Figure 2). Figure 3 confirms whyshortages of temazepam Since launch, both products had been in category Cofthe Drug 10mg and 20mg caused the products –among manyothers –tobe Tariff, meaning theywere reimbursed at the same price as the brand’s givena‘no cheaper stock obtainable’ (NCSO) concession in October, trade price. The move in October from category Ctocategory M– allowing pharmacists to dispense amore expensive alternative. G

BIGGEST FALLERS BIGGEST RISERS Product/Strength/Pack size Lowest Change Average Change Product/Strength/Pack size Lowest Change Average Change price (%) price (%) price (%) price (%) Risperidone tabs 6mg 28 £0.60 ±0 £3.56 -40 Temazepam tabs 10mg 500 £5.90 +9 £23.38 +102 Losartan tabs 12.5mg 28 £0.81 +9 £1.46 -37 Temazepam tabs 10mg 28 £2.28 +57 £4.51 +67 Candesartan tabs 32mg 28 £2.95 -13 £4.24 -34 Temazepam tabs 20mg 28 £1.17 +26 £3.52 +62 Methotrexate tabs 2.5mg 28 £3.44 -3 £8.86 -32 Temazepam tabs 20mg 250 £5.58 ±0 £15.63 +50 Candesartan tabs 16mg 28 £2.47 +3 £3.36 -30 Nifedipine MR tabs 10mg 56 £1.09 ±0 £2.13 +38 Candesartan tabs 4mg 28 £1.10 -50 £2.92 -28 Nifedipine caps 5mg 84 £1.85 +1 £3.73 +35

Figure1(below): Comparison between the periods 1-30 September 2012 and 1-24 September 2012 and 1-24 October 2012 in lowest and average UK trade prices of October 2012 of the lowest and average UK trade prices of fast-moving generics. Each about 748 commonly-dispensed generics. The basket specifically excludes the ‘fast average price was calculated from at least 27 data points. Figure2(above) and movers’ shown below,but includes other presentations of the same products. Each Figure3(above right): Biggest changes recorded between the periods 1-30 average price was calculated from at least 12 data points (Source –WaveData).

FAST MOVERS FAST MOVERS Product/Strength/Pack size Lowest Change Average Change Product/Strength/Pack size Lowest Change Average Change price (%) price (%) price (%) price (%) Alendronate tabs 70mg 4£0.15 -6 £0.22 -1 Nebivolol tabs 5mg 28 £0.89 ±0 £1.47 -6 Alfuzosin tabs 2.5mg 60 £4.49 -6 £5.83 -5 Olanzapine tabs 5mg 28 £0.63 +2 £1.04 -13 Anastrozole tabs 1mg 28 £0.79 +27 £1.62 -8 Perindopril tabs 4mg 30 £0.81 -10 £1.19 -3 Atorvastatin tabs 20mg 28 £0.89 -10 £1.34 -10 Pioglitazone tabs 15mg 28 £1.49 -25 £2.83 -22 Bicalutamide tabs 50mg 28 £1.40 -5 £2.15 -8 Pramipexole tabs 700µg 30 £1.69 -26 £3.94 -9 Candesartan tabs 8mg 28 £1.98 -5 £2.63 -29 Quetiapine tabs 25mg 60 £0.99 ±0 £1.72 -16 Clarithromycin tabs 500mg 14 £1.79 -5 £2.37 ±0 Risedronate sodium tabs 35mg 4£0.42 +2 £0.55 -11 Clopidogrel tabs 75mg 28 £1.04 +2 £1.33 +12 Risperidone tabs 2mg 60 £0.70 +1 £1.12 -1 Donepezil tabs 10mg 28 £0.81 +3 £1.18 -13 Sertraline tabs 50mg 28 £0.39 +22 £0.63 +7 Dorzolamide eyedrops 2% 5ml £1.39 -14 £2.02 -15 Sumatriptan tabs 100mg 6£0.92 ±0 £1.37 -6 Esomeprazole tabs 40mg 28 £6.99 +2 £8.91 -6 Terbinafine cream 1% 15g £0.95 +1 £1.28 -8 Exemestane tabs 25mg 30 £5.99 +33 £7.72 -5 Topiramate tabs 25mg 60 £0.79 -2 £1.57 +1 Finasteride tabs 5mg 28 £0.64 -2 £1.02 +7 Trandolapril caps 2mg 28 £1.13 +3 £1.56 -7 Fosinopril tabs 10mg 28 £5.60 +7 £16.38 +9 Valsartan caps 80mg 28 £1.04 -19 £1.93 -2 Glimepiride tabs 4mg 30 £0.39 ±0 £0.65 -12 Zolmitriptan tabs 2.5mg 6£0.59 ±0 £1.57 -14 Lamotrigine tabs 100mg 56 £1.42 +14 £2.13 -2 Lansoprazole caps 30mg 28 £0.88 -1 £1.06 +2 WANT MORE LIKE THIS? Latanoprost eyedrops .005% 2.5ml £1.49 -1 £2.08 -7 Detailed product price comparisons and other price analyses are Lercanidipine tabs 10mg 28 £0.64 -3 £1.14 -1 available at www.wavedata.net. Letrozole tabs 2.5mg 14 £1.10 -10 £1.60 -18 To find out more about subscribing, please email your contact details to Levetiracetam tabs 500mg 60 £2.39 ±0 £4.55 -9 [email protected] and quote ‘GB online enquiry’ in the title line. Losartan tabs 100mg 28 £0.79 -11 £1.03 -8 ■ Forfurther information see www.wavedata.co.uk. Mirtazapine orodisp. tabs 45mg 30 £1.45 ±0 £1.87 -3 Alternatively,contact Charles Joynson at Mycophenolate tabs 500mg 50 £4.25 -4 £7.52 -5 WaveData Limited, UK. Tel: +44 (0)1702 425125. Naratriptan tabs 2.5mg 6£1.25 ±0 £2.58 -8 E-mail [email protected].

2November 2012 GENERICS bulletin 23 Gen 2/11/12 Pgs.24-25_Layout 1 31/10/2012 20:18 Page 2

BUSINESS STRATEGY Hikma’sInjectables unit turns gazetowards France

Hikma believesamix nasingle deal completed in May last year,Hikma Other US oral-dose Generics Pharmaceuticals doubled the annual sales of its US Injectables US$2.5m of geographic and IInjectables division. By closing its US$112 million US$55.8m, -27.0% US$136.6m, +213.0% portfolio expansion acquisition of Baxter’sMultisource Injectables (MSI) business, the Jordanian companynot only added annual will drivedouble-digit sales of approaching US$200 million, it also doubled its overall turnoverinthe US. sales growth by its Having through MSI become the US’ second- US$450 million largest supplier of generic injectables by volume, Hikma is nowlooking at ways to expand its injectables presence European Injectables Injectables division. in Europe and in the Middle East and Africa (MENA) US$37.0m, region. And in Europe, the companybelievesFrance +1.9% Aidan Fryreports. and Spain in particular,aswell as Belgium, Hungary and Poland, represent “newmarket opportunities”. MENAInjectables MENABranded As can be seen from Figure 1, Europe wasnot only US$51.6m, +42.9% solid-dose the smallest of three geographic regions for Hikma’s US$248.8m, +24.6% Injectables division in the first half of this year,itwas also the weakest in terms of sales growth. However, the Figure1:Breakdown by division and region of Hikma Pharmaceuticals’ group turnover that increased by 34.8% to firm said, the reported 1.9% turnoverrise to US$37.0 US$532 million in the first half of 2012 (Source –Hikma) million equated to aconstant-currencyincrease of a tenth (Generics bulletin,3September 2012, page 7). Acknowledging that fierce competition and pricing At present, Hikma’sInjectablesdivision has adirect pressure meant profit margins were slim for generic sales and marketing presence in the three European injectables in Europe, Hikma said it wasaiming to markets in which it operates manufacturing facilities – improve margins through manufacturing efficiencies – Germany, Italy and Portugal –aswell as in Austria and such as producing larger batch sizes –asitincreased the Netherlands. European countries in which the its sales and geographic footprint in the region. division has an indirect presence through local agents Differentiated products such as lyophilised oncology and distributors include the Baltic States, the Czech drugs produced in Germanyorthe pre-filled syringes Republic, Scandinavia, Switzerland and the UK. that the firm is supplying from aline that it has just In its core European injectables markets, such as commissioned at its facility in Portugal will improve Italy,Hikma intends to adopt a“more aggressive profitability, Hikma believes. And offering contract- pricing” policyintenders whilst adding to its portfolio manufacturing services is ensuring that the firm’s through its ownpipeline and licensing or acquiring drugs. injectables facilities in Germany, Italy and Portugal Forexample, the firm recently acquired three proton- are running at high utilisation rates while the firm pump inhibitors, adeal that allowed it to push into a awaits approvalfor its ownproducts. Greater economies newtherapeutic category. of scale are giving the division more leverage to Hikma’sInjectablesdivision plans to build up its procure active pharmaceutical ingredients(APIs) at market position in those European countries where it has attractive prices, Hikma says. an indirect presence, including Scandinavia and the UK, Meanwhile, the Injectables division is also focusing by expanding its network of third-party collaborations. on improving its levelofvertical integration by “Wehavebeen developing partnerships as avery capitalising on its in-house raw-material capabilities, effective waytogain access to newmarkets. Over time, both through its Hikma Chemicals affiliate in Jordan and once we have built acritical sales mass in these markets, via the partnershipthe firm struck with Chinese oncology we may consider establishing adirect market presence,” APIs producer Hubei Haosun last year (Generics the companystated. bulletin,15July 2011, page 16). Forexample, Hikma This is the stage the division has reached in is preparing to launch in Europe and the US the bone- countries such as France. “Weare developing individual cancer treatment zoledronic acid that is based on an strategies for entering newmarkets directly,” Hikma API that the firm developed itself. revealed. “For example, in France we have identified “Wesee huge opportunities to growour oncology asmall number of products that we think have good business in Europe,”the Jordanian companystated, potential.France is ahighly competitive market, but adding that it wascompiling dossiers for cancer drugs there are opportunities,”the firm maintained. with aviewtomeeting regulatory requirements in France, Hikma observed, ranked second only to Europe, the US and the MENAregion. Germanywithin Europe in terms of the size of its Hikma plans to build on the strong presence it has injectable generics market. Germany, France and Italy established in Germany’sprivate retail oncology market accounted for nearly half of all European sales of following its 2007 purchase from Ratiopharm of the generic injectables, it estimated, while Spain and the sales and marketing unit Ribosepharm (Generics UK also offered sizeable markets. bulletin,2February 2007, page 1). The companyaims

24 GENERICS bulletin 2November 2012 Gen 2/11/12 Pgs.24-25_Layout 1 31/10/2012 20:18 Page 3

BUSINESS STRATEGY

to obtain marketing authorisations and pursue asimilar “Turkey remains on our radar”, stated Darwazah. marketing strategy in those European countries in which However, the multiples that vendors were expecting the Injectables division has adirect presence. for local businesses often did not reflect the country’s Meanwhile, the division is also working on tough pricing environment, he observed. transferring production of Ribosepharm’sportfolio from Insulins presented a“medium- to long-term third parties to the Thymoorgancytotoxics facility that opportunity” for Hikma in the region, he said, while it acquired weeks after the Ribosepharm deal was the firm washelping to shape local biosimilar announced (Generics bulletin,27April 2007, page 5). regulationsasitworked on developing apipeline Developing its oncology business is also akey facet through apartnership with South Korea’sCelltrion of the Injectables division’sstrategy in the MENA (Generics bulletin,9April 2010, page 18). region, along with expanding into newmarkets and Speaking during an investor day held at the Cherry launching value-added products. Hill facility that the companyacquired as part of its The Injectables division’sMENAsales growth of takeoverofBaxter’sMSI business, Darwazah pointed 42.9% to US$51.6 million in the first half of 2012 out that Hikma wasnow the US’ second-largest supplier included aUS$3.6 million contribution from the of injectablegenerics, barely five years after it had Promopharm business that Hikma acquired in Morocco launched its first product in the country.And with the last year (Generics bulletin,14October 2011, page 3). US Food and Drug Administration (FDA) having now “Wehaveonly begun to scratch the surface of our cleared both the Thymoorgancytotoxics plant and potential in the MENAregion,”insisted group chief Hikma’slyophilisation suite in Portugal (Generics executive officer Said Darwazah. “Our regional footprint bulletin,23March 2012, page 5), the firm had the sets us apart from the competition,”hemaintained, capacity and pipeline to expand its position in the US. noting that the Injectables division competed in the Darwazah said the strategic priorities for Hikma’s region not only against local players such as Julphar Injectables unit in the US –where its leading products in the Gulf area and Saudi Arabia’sTabuk, butalso include cefazolin, metoprolol and ondansetron –were multinational originators including Pfizer and Sanofi. to retain market share of high-volume commodity Hikma has along-standing presence in MENA products whilst launching higher-value differentiated injectables markets, having in 1978 struck alicensing drugs and developing noveldelivery systems. The agreement for cephalosporin antibiotics with Fujisawa. division’sstrong compliance track record had enabled Using the experience gained, Hikma became the first it to capture share amid recent market shortages, he companytoset up asterile products facility in Jordan. said, while ongoing investments in capacity were ensuring that it could cling onto the additional business. MENA markets aredisparate Hikma expects to invest US$25 million in capital Hikma’smarketing manager for the MENAregion, projects to support its Injectables unit this year,although Basel Ziyadeh, told investors that the region’s17 it plans to reduce annual spending to around US$10 countries represented acombined pharmaceutical market million overthe next fewyears. AUS$25 million valued at US$12 billion per year.However,hecautioned, renovation of the Cherry Hill plant –which is dedicated regulationsand market conditions were disparate and mostly to large-scale batches of small-volume vials –is were constantly evolving. “Weestimate the MENA expected to be completed by March next year. injectables market, including biologics, to be worth The MSI deal not only almost trebled the Injectables around US$2.3 billion per year,” he said, adding that divison’sroster of products marketed in the US to 56 Algeria and Saudi Arabia were the region’sleaders by and trebled US Injectables sales to US$137 million in value and volume. But while Algeria wasdominated by the first half of 2012, it also gave the firm access to government tenders, Saudi Arabia offered alarge private the controlled-substances market. And Hikma believes market that wassusceptible to salesforce promotions. MSI’sheritage and its greater scale will improve its In most MENAmarkets, Injectables sales were relationships with keyUScustomers such as group growing at double-digit rates, although Hikma’smarket purchasing organisations (GPOs) –which account share varied from 14.0% in Jordan to 0.2% in Tunisia. for 90% of the division’sUSturnover–wholesalersand Outlining the division’sMENApipeline, Ziyadeh integrated hospital networks. said Saudi Arabia and the Gulf Cooperation Council Global Injectables head Riad Mechlaoui said the (GCC) states were “a keyarea of focus for submissions”. US business wasusing several strategies to differentiate Hikma also had an “aggressive pipeline plan” in Egypt, its drugs. Forexample, he said, Hikma had pursued a “Wesee huge where it is looking to buyinjectablemanufacturing paragraph IV patent challenge on argatroban, while it opportunities to assets (Generics bulletin,3September 2012, page 7). had paid GeneraMedixUS$16 million to acquire the Ateam of more than 80 regulatory staff–co-ordinated only generic rivaltoSanofi’sFerrlecit (sodium ferric growour oncology from Jordan –was ensuring that Hikma adapted to gluconate) brand (Generics bulletin,8June 2012, page local requirements in the region, he added. 24). Hybrid 505(b)(2) applications also offered an business in Europe” As in Europe, Hikma is keen to carveout aslice attractive route to market for added-value formulations. of aMENAoncology market valued at around US$1.3 Through adifferentiated pipeline, greater capacity billion per year,including oral therapies. Hikma offers to capitalise on market shortages, better capacity abroad portfolio including carboplatin, epirubicin, utilisation and stronger vertical integration, Hikma imatinib, irniotecan and vinorelbine, butthe market believesitwill be able to achieve its forecasted remains dominated by originals. “Wehavealmost 50 Injectables turnoverofUS$450 million this year with an oncology dossiers pending approvalinMENAmarkets,” adjusted earnings before interest and tax (EBIT) margin Ziyadeh revealed, noting that emerging markets such as of 22%. And the same keyfactors will, it expects, drive Iraq offered attractive opportunitiesinboth the public “double-digit top-line growth” and an improvedadjusted and private sectors. EBIT margin between 2013 and 2016. G

2November 2012 GENERICS bulletin 25

Gen 2/11/12 Pg.27_Layout 1 31/10/2012 20:12 Page 3

PEOPLE

IN BRIEF RESIGNATIONS AMERISOURCEBERGEN has recruited Lawrence Marsh from Barclays’ equity researcharm to serveinthe newly-created role EU’s commissioner of chief strategy officer and senior vice-president of newmarket development for the US wholesaler and healthcare services provider.

AUROBINDO has appointed PV Ramprasad Reddy as executive Dalliquits after probe chairman of the company’sUSsubsidiary following approvalbythe Indian firm’sshareholders(Generics bulletin,1October 2012, page 27). uropean Commissioner for health and consumer policy John Dalli Ehas resigned following an investigation by the European Union’s BASF has named Scott Thomson as senior vice-president of its (EU’s) anti-fraud office, the Office de Lutte Anti-Fraude (OLAF). pharma ingredients and services business unit. The German company European Commission president Jose Manuel Barroso said vice- has just movedthe unit’sheadquarters from Switzerland to NewJersey. president Moros Sefcovic would be responsible for the portfolio that Dalli had held for three years until aMaltese replacement wasnamed. CAPSUGEL has expanded its executive team under president Guido OLAF investigated acomplaint made in May 2012 by tobacco firm Driesen.Appointments include Erasmo Schutzer as chief marketing Swedish Match, which alleged that aMaltese entrepreneur had abused officer, Christopher Game as chief procurement officer and John his connections with Dalli. It claimed the businessman had “sought to Cullivan as senior vice-president of corporate business development gain financial advantages” from the company“in exchange for influence and strategy. Ian Robertson is the capsules specialist’schief overapossible future legislative proposal on tobacco products”. The information officer,while Amit Patel heads Capsugel’snewly-created entrepreneur waslooking to influence an EU export ban on ‘snus’, dosage-formsolutions unit. asnuff-likepowder tobacco manufactured in Sweden and Norway. The Commission has this year been reviewing its tobacco legislation. CMC BIOLOGICS has made Dr Mark Sawicki its vice-president of While the Commission said “the OLAF report did not find any global business development. Sawicki joins the contract manufacturer conclusive evidence of the direct participation of Mr Dalli”, it “did from AlbanyMolecular Research. consider that he wasaware of these events”. Dalli rejected the findings, butchose to resign “in order to be able to defend his reputation and AVISTACAPITAL PARTNERS has welcomed Fougera’sformer that of the Commission”, it added. president and chief executive officer, Brian Markison,toits executive Earlier this year –during the 18th annual conferenceofthe team. As part of his role at the private-equity firm, Markison has European Generic medicines Association (EGA) held in Malta –Dalli joined the board of Lantheus Medical Imaging. pledged that the EU would accept biosimilardossiers that were based on non-EU reference products (Generics bulletin,29June 2012, page 1). WALGREENS has announced senior management changes as it The European Medicines Agency(EMA) recently revealed its plans to develops its strategic partnership with Alliance Boots (Generics act on that pledge (Generics bulletin,19October 2012, page 6). G bulletin,29June 2012, page 3). Former chief strategy officer Robert Zimmerman nowleads the global mergers and acquisition group as senior vice-president of international affairs. Brad Fluegel joins INDUSTRY ASSOCIATIONS thecompanyaschief strategy officer,having previously worked at WellPoint and Aetna. NAPM names chief executive COVINGTON &BURLING has made Dr Witney Schneidman its outh Africa’sNational Association of Pharmaceutical Manufacturers senior international advisor for Africa. The former US state S(NAPM) has made Dr Fathima Docrat its chief executive officer. department official with more than 30 years of experience in Africa Previously medical affairs manager in Africa for Merck &Co, Docrat has joined the lawfirm’sWashington office. has also worked for Novo Nordisk and Pfizer. Docrat said she planned to “raise the awareness and profile of PRAC –the pharmacovigilance risk-assessment committeewithin the NAPM”. The association plans within the next fewmonths to the European Medicines Agency(EMA) –has elected the UK’s hire additional stafftosupport Docrat in tasks that include working June Raine as its chair and Ireland’s Almath Spooner as its vice- with authorities to accelerate generic approvals. chair.Both mandates are for athree-yearperiod. Earlier this year,the NAPM appointed Charles Mothata as chief executive officer (Generics bulletin,23March 2012, page 27). G HOVIONE has named Dr MikeIronside as general manager for its technology-transfer centre in East Windsor,New Jersey. He was most recently with Anacor as vice-president of chemical manufacture APPOINTMENTS and development. The 3,000 sq mcentre includes research and scale-up laboratories, as well as araw-materials pilot plant. Hudson assumes CHMP role OHIM –the European Union’soffice for harmonisation in the internal he UK’s Dr Ian Hudson has been appointed as vice-chairman of market for trademarks and designs –will promote Paul Maier to Tthe committee for human medicinal products (CHMP) within the the director of its observatory from January 2013. He is currently European Medicines Agency(EMA) for athree-year term. Hudson – the president of OHIM’sboards of appeal. who is currently director of licensing at the UK’sMedicines and Healthcare products Regulatory Agency(MHRA) –has been amember NEPHRON PHARMACEUTICALS –the US-based generic respiratory of the CHMP since 2004. specialist –has taken on Jerry Webb as chief scientific officer and He serves alongside the CHMP’schairman, Dr Tomas Salmonson, John Petta as chief operating officer.Webb has worked for Abraxis who recently assumed the role on apermanent basis, having filled and Baxter.Petta’sprevious employers include General Electric. G in on an interim basis after Dr Eric Abadie resigned (Generics bulletin,1October 2012, page 27). G

2November 2012 GENERICS bulletin 27