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20 May2016

COMPANY NEWS 2 Renaissance’s topicals Biosimilars maynot be corefor Allergan 2 Japaneses incentives driveSawai growth 2 Concordia buys as it 3 considers its options topUS$1bn for Mylan McKesson expands its Walmartalliance 3 Oncobiologics cuts the 4 price of its IPO ylan has agreed to pay up to US$1.00 billion to acquirethe “topicals-focused specialty Hypermarcas creates three Pharma units 4 Mand generics business” of privately-held North American firm Renaissance from Hendrickson talks up Perrigo’sgenerics 5 RoundTable HealthcarePartners. The price comprises US$950 million in cash at closing – Reddy’sbiosimilars 5 which is expected by the end of the third quarter of 2016, subject to regulatory approval are‘gaining traction’ and other conditions –along with US$50 million in “additional contingent payments”. Glenmark eyes EU Seretide rival launch 6 Renaissance began life in 2010 when RoundTable acquired contract-development and Krka bolsters base as Russian supplier 7 manufacturing organisations (CDMOs) Confab Laboratories of Montreal, Canada,and DPT Laboratories of Texas in the US. Lots of launches help Impax 7 Renaissance’stopicals business –which had sales of around US$370 million in 2015 and to asales rise employs around 1,200 staff–will “bring Mylan acomplementary portfolio of approximately German growth gives Stada’s 8 25 branded and generic topical products, an active pipeline of approximately 25 products, and sales aboost an established US sales and marketing infrastructure targeting dermatologists”. The business Contraceptives cause Richter’spharma fall 8 also offers “an integrated manufacturing and development platform and aleading topicals- focused CDMO”. In particular,Mylan highlighted “twohigh-quality manufacturing sites with MARKET NEWS 9 capabilities and capacity in creams, ointments, aerosols and foams, gels, suspensions, liquids and suppositories” that were “complementary to Mylan’sexisting capabilities”. Renaissance India seeks stronger domestic 9 will retain its sterilesbusiness and an associatedmanufacturing facility. API source “The dermatology and topicals space has long been an area of focus for Mylan,”outlined Europe reviews plan forsingle SPC study 9 chief executive officer Heather Bresch, “and one that we have targeted for expansion.” GPhA cautions over US 10 Renaissance wasa“strong and growing business in avery attractive category”, she added, Medicarerevamp which was“highly complementary to Mylan’sexisting assets and the pending addition of the Danish agency aims to explain biosimilars 10 Meda dermatology portfolio” (Generics bulletin,19February 2016, page 1). Mylan president RajivMalik said the Renaissance business’ “broad and durable portfolio, PRODUCT NEWS 11 exciting pipeline of topical products, and strong manufacturing and research and development capabilities” would give Mylan “critical mass in the dermatology and topicals area”. “Welook Adamed offers OTCsildenafil in Poland 11 forward to welcoming the business’ talented employees to Mylan upon closing.” G Japanese firms will rival Lilly’sZyprexa 12 Actavis wins appeal over US on-sale bar 13 Pfenex’ teriparatide trial 13 set forthis year Sandoz sued over pegfilgrastim FEATURES 15 mgen has filed aUSpatent-infringement lawsuit against Sandoz and its Slovenian Lek Asubsidiary in aNorthern Californiadistrict court overthe generics firm’splanned rivalto Neulasta (pegfilgrastim) that it had accepted for filing by the US Food and Drug Administration UK needs to share success 15 (FDA) towards the end of last year (Generics bulletin,9December 2015, page 17). The originator cites US patents 8,940,878 and 5,824,784, which expire on 8October 2031 and 20 October 2015 REGULARS respectively.The former relates to “a method of purifying proteins that is used in the manufacture of abiological product” while the latter –which expired after Sandoz filed its biosimilar – Events – Our regular listing 11 claims “a biological product, the use of abiological product, and the manufacture thereof”. Price Watch UK – UK pricing trends 10 Previously,Amgen had sued Sandoz for allegedly failing to followthe patent-dispute People – Epirus’ chief departs as 16 resolution provisions of the US Biologics Price Competition and Innovation Act (BPCIA) in firm changes tack collaboratively identifying Neulasta patents that may be asserted as infringed (Generics bulletin, 18 March 2016, page 11). However, the latest filing states that the twofirms agreed in April that the twopatents should be “properly included in anyimmediate infringement action”, which PUBLISHED WEEKLY has followed within 30 days of the agreement as per the BPCIA’s strictures. Amgen is seeking Next issue –27May 2016 declarations of infringement, damages and an injunction against Sandoz. The litigation is the latest in aseries of biosimilars and BPCIA-related lawsuits between the twofirms. G Gen 20-5-16 Pgs. 2-16_Layout 1 18/05/2016 17:22 Page 2

COMPANY NEWS

BUSINESS STRATEGY/FIRST-QUARTERRESULTS ANNUAL RESULTS/RESULTSFORECAST Biosimilars may not Japanese incentives be corefor Allergan drive Sawai growth

iosimilars might not play amajor part in Allergan’sfuture, the overnment promotionofgenerics in Japan helped to push up Bfirm’spresident and chief executive officer,Brent Saunders,told GSawai’ssales by more than asixth in the firm’sfinancial year investors. “Long term, Idonot think biosimilars will necessarily be ended 31 March 2016, as the country worked towards agoal of 60% acore part of our strategy,” he stated, pledging to devote “the vast volume penetration by generics of the off-patent pharmaceuticals majority of our research and development dollars” to the group’s market by March 2017 (Generics bulletin,5June 2016, page 1). core therapeutic categories. “Demand continued to expand as aresult of the policytopromote “The wayIthink about biosimilars, at least overthe next few the use of generics,”Sawai commented, as its sales climbed by 17.1% years, is that for Allergan, we have made most of the investment already to ¥123 billion (US$1.13 billion). While this fell slightly short of the and we have seen good success with most of the programmes [being firm’sexpected figure of ¥124 billion, the company’soperating profit developed] in collaboration with Amgen,”Saunders explained. sailed past its ¥22.0 billion forecast, growing by 12.1% to ¥23.2 billion “Wemay continue to invest in the partnership with Amgen, “due to underspending on selling, general and administrative expenses”. because it has been agood collaboration,”hecontinued. “Wemay Sawai’soperating margin fell by 0.8 percentage points to 18.8%. look at selective opportunitiestoparticipate on aone-offbasis.” Research and development spending grewbyalmost athird to Noting that Allerganpossessed its ownbiologics development ¥8.02 billion, while advertising costs dropped by 1.5% to ¥2.07 billion. capabilities through the former Eden Biodesign site in Liverpool, UK, Among Sawai’s“core products”, volumes grewby11.0% and Saunders said the firm would “participate in the commercialisation” sales increased in value by 11.4%, with the Japanese firm citing in of the biosimilarcandidates being developed through the oncology particular “steady growth” in volumes from cardiovascular and alliance it formed with Amgen more than four years ago (Generics gastrointestinal drugs that each accounted for around aquarter of sales bulletin,13January 2012, page 21). volumes, as well as central nervous system treatments that made up The partners intend to file for biosimilar Avastin (bevacizumab) in just overatenth of units sold. Europe and the US and to get Phase III data on biosimilar Herceptin “Sales through wholesalers expanded,”Sawai commented, as the (trastuzumab)this year (Generics bulletin,13May 2016, page 13). channel accounted for 56.1% of the firm’stotal sales at ¥69.3 billion. Cetuximab and rituximab are in pre-clinical development. Agencies made up 35.3% of sales with ¥43.6 billion, while the remainder Allergan’sbiosimilars interests do not form part of the Actavis came from marketing alliances and other channels. generics operation that the group expects to divest to Teva for US$40.5 Outlining forecasts for its financial year ending 31 March 2017, billion by the end of June (Generics bulletin,13May 2016, page 1). Sawaisaid it expected sales to growby15.8% to ¥143 billion and Highlighting the recent launches of generic Crestor (rosuvastatin) operating profit that would be ahead by 7.8% to ¥25.0 billion –slightly in the US and pemetrexedininternationalmarkets, Allergansaid the higher than the long-term forecastsitset out last year of sales hitting Actavis business had 92 US first-to-file prospects,including generic ¥134 billion and operating profit reaching ¥23.0 billion in the year Abraxane (protein-bound paclitaxel) and Xifaxan (rifaximin). ending March 2017. In the first quarter of this year,Allerganreported sales by its Research and development spending would decelerate, growing ‘discontinued’ global generics business down by aquarter to US$1.26 by just overafifth –21% –to¥9.70 billion as advertising costs grow billion, while operating profit was30% lower at US$251 million. G by 6.2% to ¥2.20 billion, Sawaipredicted. G

20 May2016 Issue 263 Individual subscriptions Te rms &Conditions: These can be viewedinfull at An annual subscription comprises: www.Generics-bulletin.com/subscribe. Editor: Aidan Fry ■ 46 Generics bulletin online editions No partofthis publication maybecopied, reproduced, Deputy Editor: David Wallace ■ asearchable archiveofmorethan 100 back stored in aretrieval system, distributed or transmitted Assistant Editor: Dean Rudge editions dating back over fiveyears by anymeans, including electronic,mechanical, photocopying or recording, without the prior written ■ 46 optional hard-copyprint editions, delivered Production Controller: Debi Minal permission of the publisher,orunder the terms and by airmail. Production Editor: Jenna Meredith conditions of aGlobal Site Licence or of alicence issued by the Copyright Licensing Agency (CLA) in Director of Subscriptions: ValDavis Choice of formats Group Sales Manager: Rob Coulson London, UK, or rights bodies in other countries that Generics bulletin can be accessed from: have reciprocal agreements with the CLA. Awards Manager: Natalie Cornwell ■ desktop and laptop computers AND Neither maythis publication be exported, distributed Managing Director: MikeRice ■ Apple and Android tablets and smartphones. or circulated by anymeans without the prior written permission of the publisher. Editorial enquiries: GENERICS bulletin, Multiple subscriptions While due carehas been taken to ensurethe accuracy 4Poplar Road, Dorridge,Solihull, Discounts areavailable formulti-user of information contained in this publication, the West Midlands B93 8DB, UK. subscriptions forcolleagues at the same publisher makes no claim that it is free of errorand Website: www.Generics-bulletin.com location. Please ask foraquotation. disclaims anyliability whatsoeverfor anydecisions or Te l: +44 (0)1564 777550 Fax: +44 (0)1564 777524 actions taken as aresult of its contents. E-mail: [email protected] Corporate subscriptions ©OTC Publications Ltd. All rights reserved. Advertising enquiries: Corporate subscriptions provide location-, country- Generics bulletin® is registered as atrademark in As above,[email protected] or company-wide access to Generics bulletin. the European Community. Please ask foraquotation. ISSN 1742-0784. SUBSCRIPTIONS Companyregistered in England No 2765878. Subscription rates arepublished at Subscription enquiries: Printed by Warwick Printing CompanyLimited, www.Generics-bulletin.com/subscribe. Contact [email protected] Leamington Spa CV31 1QD, UK.

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COMPANY NEWS

BUSINESS STRATEGY/FIRST-QUARTERRESULTS STRATEGICALLIANCES Concordia buys as it McKesson expands considers its options its Walmartalliance

oncordia Healthcarehas continued its buying spree as aspecial cKesson and Walmart have taken the “natural next step” in their Ccommittee comprising three independent board members continues Mdecades-long alliance to “lower the cost of pharmaceutical care” to “consider various strategic alternativespotentiallyavailable to the by signing asourcing agreement covering generic pharmaceuticals company” amid rumours of aprivate-equity backed takeoverbid and “an expanded long-term distribution agreement”. (Generics bulletin,29April 2016, page 1). Under the newly-signed agreements, the firms would “collaborate On 12 May,the Canadian companyagreed to acquire global rights on sourcing generic pharmaceuticals for their respective US operations, to four generics for an initial fee of £21 million (US$30 million) plus adding scale and value for both companies”, theysaid. “The new subsequent earn-out payments of up to £7 million due in the first sourcing agreement leverages McKesson’sdemonstrated strength and quarter of next year.Concordia said the deal with an undisclosed expertise in the global pharmaceutical industry and Walmart’sproven vendor represented amultiple of 2.6-times the four products’ pro commitment to delivering leading health and wellness services at an forma 2016 combined sales. everyday lowprice to its customers.” Concordia declined to disclose the molecules involved in the deal Mark Walchirk, president of McKesson’sUSPharmaceutical that is set to close within the next fewweeks, butsaid that the four operation, said the twocompanies had throughout their relationship – niche generics were treatments for anaemia, depression and urticaria which dates back to 1988 –“engaged in an ongoing dialogue about which had potential for volume growth and profit margins broadly in howwecan work together to bring more efficiencyand value to the line with the group’saverage. health care supply chain”. The generic sourcing agreement made John Beighton, president of Concordia’sinternationalAmdipharm “economic and strategic sense” for both wholesaler McKesson and Mercury (AMCo) business, said the four acquired products would retailer Walmart, he added, and would “makeour business stronger predominantlystrengthen the firm’spresence in the UK, althoughthey and create more value for our customers and patients”. were also approvedinIreland. “Wecan relatively easily move them into “The dynamics of health care continue to change, and we are the rest of Europe through the procedures that are available within the changing with it,”commented the president of Walmart’sUSHealth and European Union (EU),”Beighton commented. “Our first port of call Wellness business, George Riedl. will be to look at the markets in which we are present, including Ireland, In recent years, McKesson has extended its long-standing brands the Nordic territories, France and the Netherlands,”heexplained. distribution agreement with US drugstore chain Rite Aid to include Commenting on the special committee, Concordia’schairman and assuming responsibility for sourcing and distributing generics (Generics chief executive officer,Mark Thompson, insisted that “our objective bulletin,7March 2014, page 2), and also extended its US distribution here is to bring the most value to shareholders we can, and part of deal with retailerCVS Caremark (Generics bulletin,8August 2014, that is assessing all of the options that are available to the company, page 10). Both agreementswere signed to run until 2019. G preciselywhat the special committeeisdoing right now”. He declined to reveal whether the group had been approached about atakeover. AMCo, for which Concordia paid private-equity firm Cinven RESULTSFORECAST US$3.3 billion in October last year,contributed sales of US$140 million in the first quarter of 2016 as it launched 10 productsfollowing Hikma sees Roxane benefits the acquisition. The group’sUS$1.2 billion purchase of Covis ayear ago accounted for most of North American turnoverofUS$85.9 million ikma expects to generate full-yearsales of US$2.0-US$2.1 billion that benefited from “the timing of certain orders for Lanoxin (digoxin) Hin 2016, with its US Generics unit contributing US$640-US$670 and higher Plaquenil (hydroxychloroquine) authorised generic revenue”. million “including ten months contribution from Roxane”. The Jordanian Orphan drugs added US$2.67 million to group turnoverofUS$229 firm closed its deal for Boehringer Ingelheim’s US generics business million, as Concordia posted an operating profit of US$59.9 million. G at the end of February (Generics bulletin,4March 2016, page 6). “The integration of Roxane is proceeding swiftly and we are very happywith the progress our teams have made,”Hikma said. “As MANUFACTURING anticipated,”the firm said, divesting “certain legacy products associated with the acquisition of Roxane” had led revenue from the FDA approves Invent’s Inke company’slegacynon-injectable Generics business to decline. “Wecontinue to expect the core Generics operating margin to be nvent Farma’sInkeactive pharmaceutical ingredients(APIs) facility in the lowdouble-digits,”Hikma said, adding that the firm’soverall Inear Barcelona,Spain, has passed agood manufacturing practice results would be “impactedbyanumber of exceptional, non-cash and (GMP) inspection by the US Food and Drug Administration (FDA) other charges, including the amortisation of intangible assets, an with no ‘Form 483’ observations. The US agencyhas nowaudited inventory step-up, the revaluation of the fair value of future royalty the site, which exports 13 APIs to the US, five times since 2002. payments and one-offacquisition costs” totalling US$115 million. At the end of last year,the Spanish group’sgenerics finished-dose Hikma’sInjectablesbusiness was“performing well”, having production arm, Laboratorios Lesvi, also passed an FDAinspection. made “good progress transferring the products acquired from Bedford “Invent Farma has nowbecome one of the fewpharmaceutical groups Laboratories to our manufacturing facilities in NewJersey, Germany in Spain and Europe having passed an FDAinspection for all of its and Portugal”. “Weremain on track to deliverglobal Injectables production process, both APIs and finished dosage forms,”stated the revenue growth in the mid- to high-single-digits in 2016, with group, which has an annual turnoverofaround C100 million (US$113 competition on marketed products being more than offset by new million), including its Qualigen marketing affiliate. G product launches,”the Jordanian group stated. G

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COMPANY NEWS

BUSINESS STRATEGY BUSINESS STRATEGY/FIRST-QUARTERRESULTS Oncobiologics cuts Hypermarcas creates the priceofits IPO three Pharma units

ure-play biosimilars developer Oncobiologics has slashed the razil’sHypermarcas is reorganisng the structure of its Pharma Ppricing of its initial public offering (IPO) on the Nasdaq stock Bdivision. The firm said it would create three ‘strategic business exchange just weeks after its initial proposal. units’ within the operation, including aBranded Generics and Generics The US-based firm nowplans to raise US$35.0 million dollars segment, composed of its Neo Quimica generics line, along with through an offering of just over5.83 million shares priced at US$6.00 Consumer Health and Branded Prescription businesses. each. Meanwhile, the offer’sunderwriters have been granted an option The newbusiness units would be “focused on the strategic and to buyuptoanadditional 875,000 shares at the same price. The closing operational development of each of these segments, aiming at of the offering wasexpected to occur on 18 May,subject to customary continuous improvement in results and value creation”, Hypermarcas conditions, Oncobiologics noted. said, and would be supported by sales, operations, and researchand Several weeks ago, however, the firm had announced it was development areas. “In regard to the research and development area,” looking to raise around US$75 million in total by offering 5.00 million Hypermarcas commented, “the companyhas advanced in its plan for shares priced at US$11.00-US$13.00 –orasmuch as US$65 million – creating anew innovation centre, which should become operational while raising another US$9.75 million through the offer’sunderwriters by the end of 2016.” (Generics bulletin,6May 2016, page 5). In the first quarter of this year,Hypermarcas’ sales increasedby At the beginning of this year,Oncobiologics had put the figure it 12.1% to BRL828 million (US$237 million) as the firm launched a planned to raise at approximately US$115 million (Generics bulletin, generic version of Eli Lilly’sCialis (tadalafil) erectile-dysfunction 29 January 2016, page 3). treatment in March, as well as the antihypertensive olmesartan, “a still Based in NewJerseyand led by former Bristol-Myers Squibb, under-explored product in the generics segment”. Branded generics Genentech and Eli Lilly executive Pankaj Mohan, Oncobiologics is launched during the quarter included Beclonato (betamethasone currently developing biosimilar versions of Avastin (bevacizumab) and dipropionate/betamethasone sodium phosphate) for injection in February. Humira (adalimumab) that are primed for Phase III clinical trials this The Brazilian firm said it had also during the quarter taken year.The firm is also developing biosimilar alternativestoHerceptin “important steps” in its plan to sharpen its Pharma focus, including (trastuzumab)and Prolia/Xgeva (denosumab). divesting for BRL675 million its condoms and sexual health business News of Oncobiologics’ IPO came as another US-based pure-play to Reckitt Benckiser (Generics bulletin,5February 2016, page 4). biosimilars firm, Epirus Biopharmaceuticals,narrowed the focus of Hypermarcas, moreover, agreed to pay BRL60 million for shares in its biosimilars pipeline and cut 40% of its staffamid atop-tier Neolatina, acompanythat owns afacility and land adjacent to management shake-up (see page 16). G Hypermarcas’ production plant in Anapolis, Brazil. Hypermarcas’ earnings before interest, tax, depreciation and amortisation (EBITDA) rose by just overatenth to BRL310 million. Thefirm’sEBITDAmargin dropped from 37.8% to 37.5%. G FIRST-QUARTERRESULTS Remsima delivers for Orion STRATEGICALLIANCES/BUSINESS STRATEGY uadrupling sales of its Remsima (infliximab) biosimilarsold under Qlicence from Celltrion enabled Orion to increase turnoverfrom its off-patent Specialty Products division by 13.1% to C123 million ANI allieswith Aspen in US (US$139 million) in the first quarter of this year. NI Pharmaceuticals has struck an “exclusive distribution and supply The Finnish companysaid the growth in Remsima sales to C12 Aagreement” with Aspen Global Incorporated in the US for million wasdue to having wonseveral tender awards for the biosimilar hydroxyprogesterone caproate 250mg/ml 5ml vials for injection. “Aspen during 2015, including anational contract secured in Denmark midway will be responsible for supplying the finished goods and ANI through last year.“Some of the net sales in the first quarter of 2016 Pharmaceuticals will be responsible for marketing and distribution came from Norway,where Orion did not win the national tendering in the US,”the firm stated. Aspen’svertically-integrated generic of the competition for the 12-month period beginning in March 2016,”the discontinued Delalutinbrand wasapprovedbythe US Food and Drug companycautioned. Administration (FDA) last year,and ANI “intends to commercialise While Orion had last year wonaNorwegian infliximab tender by hydroxyprogesterone caproate for injection in the near term”. offering adeep 72% discount to the original price of Janssen’s “Weare excited to enter into this exclusive strategic distribution Remicade reference brand (Generics bulletin,27February 2015, partnership with Aspen and introduce to the US market aproduct that page 29), Pfizer this year undercut Remsima with its discount for its addresses ahigh-need patient population,”commented ANI’spresident Inflectra biosimilar (Generics bulletin,6May 2016, page 8). and chief executive officer,Arthur Przybyl. “Wehope to build on the Specialty Products sales ahead by 8% to C70 million in Finland launches of hydroxyprogesterone caproate for injection and our more than compensated for Orion’stotal turnoverfrom generic previously-disclosed anti-cancer product,”which is pending FDA entacapone almost halving to C3million. approvalwith atarget action date in June this year,“to strategically The division accounted for nearly half of Orion’sgroup turnover advance aportfolio of oncolytic products in the future.” that edged up by 0.8% to C262 million as turnoverbyits Fermion “Finally,” Przybyl stated, “this launch will also servetoestablish raw-materials division slid by 28.4% to C10.6 million, due mainly to ANI’scommercial presence in the specialtypharmacydistribution “the timing of product deliveries”. The group is investing more than channel, one that we intend to build upon with future product C30 million in aFermion production plant in Hanko, Finland. G introductions from our existing pipeline.” G

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COMPANY NEWS

BUSINESS STRATEGY/FIRST-QUARTERRESULTS ANNUAL RESULTS Hendricksontalks up Reddy’sbiosimilars Perrigo’s generics are‘gaining traction’

ewly-crowned Perrigo chief John Hendrickson says the firm’s rReddy’sLaboratories’ nascent biosimilars presence in emerging NPrescription US generics business is an “important part of our Dmarkets “is gaining traction”, according to the Indian firm. “We diversified, consolidated portfolio”, with a“clear,strategic rationale” have started to receive approvals and build partnerships for our that greatly complements “our core consumer competencies”. products,”Reddy’snoted. Addressing investors just twoweeks after replacing Joe Papa The Indian firm’scomments come after it earlier this year formed as the US store brand specialist’schief executive officer (Generics astrategic alliance with Turkey’s TR-Pharm to market three undisclosed bulletin,29April 2016, page 1) Hendrickson also extolled the biosimilars in the country,which Reddy’sdescribes as “a keyemerging potential of prescription-to-OTC ‘switch’ opportunities. “Takeour market” (Generics bulletin,18March 2016, page 15). Reddy’scurrently topical acne category,” he said. “When acategory likethis begins to markets four follow-on biologics –darbepoetin alfa, filgrastim, switch, we are in aprime position to capitalise on this opportunity.” pegfilgrastimand rituximab–inseveral emerging markets, while it has Hendrickson noted, however, that the Prescription unit wascurrently partneredwith Merck Serono to target biosimilars in advanced markets. suffering from market-wide pricing pressures and erosion stemming Sales in Reddy’semerging markets operation tumbled by aquarter from awaveofrecent approvals for competitors. Growth of 2% as to Rs23.6 billion (US$353 million) in the firm’sfinancial year ended 31 March 2016. This wasinthe wake of Russian turnoverdropping Business First-quarter sales Change Operating by 29% to Rs10.9 billion, along with sales in the firm’sRest of World segment (US$ millions) (%) margin (%) business slipping by 28% to Rs9.4 billion following hyperinflation in Venezuela. During its financial fourth quarter,Reddy’swrote down Consumer Healthcare700.3 +2.2 14.6 outstanding receivables in the country,leading co-chairman and chief Branded Consumer Healthcare317.6 –-152.0 executive officer,GVPrasad, to describe the quarter as “challenging”. Prescription 256.7 +2.0 34.0 Nevertheless, Global Generics turnoverclimbed by 7% to Specialty Sciences 88.0 +7.4 14.7 Rs128 billion after sales in North America,India and Europe all grew Other 20.6 -32.9 26.3 by 19% (see Figure 1). Reporting sales in North America that reached Rs75.4 billion on account of the “sustained performance of the Perrigo 1,383.2*+31.8 -22.0 injectables franchise and market share gains in keymolecules”,Reddy’s *includes first quarter net sales of US$47.4 million from US VMS and India API businesses said it had during the year filed 13 abbreviated newdrug applications (ANDAs) with the US Food and Drug Administration (FDA). This took Figure1:Beakdown by business segment of Perrigo’s sales and operating margin its total ANDAfilings pending US approvalto79, of which 52 contain in its financial first quarter ended 2April 2016 (Source –Perrigo) paragraph IV patent challenges, in addition to three hybrid 505(b)(2) reported to US$257 million (see Figure 1) during Perrigo’sfinancial newdrug applications (NDAs) currently pendingapproval. first quarter ended 2April 2016 “came in belowour expectations”, he In its domestic market, sales climbed to Rs21.3billion, as the said, while market factors had led to “negative organic growth within portfolio of mature dermatology,respiratory and paediatrics brands the segment”. Prescription did deliver“strong margins”, he added. Reddy’slast year picked up from UCB performed “in line with Overall, sales of existing products plummeting by US$50 million expectations”(Generics bulletin,10April 2015, page 2). And turnover almost entirely offset growth of US$46 million from recent product in Europe wasalso just under afifth higher at Rs7.73 billion, “primarily acquisitions and US$11 million from recent product launches. “The drivenbyaripiprazole and pregabalin”. change in the competitive landscape wasmuch more disruptive to With pharmaceutical services and active ingredients (PSAI) sales our plan than had been anticipated and impacted our overall pricing slipping by more than atenth to Rs22.4 billion, Reddy’sgroup sales strategies,”Perrigo acknowledged. growth waslimited to 4%, rising to Rs155 billion. Reddy’soperating During the quarter,Perrigo completed the acquisition of generic profit rose by 13% to Rs29.6 billion, despite higher selling, general forms of Retin-A (tretinoin) acne treatments from MatawanPharma and administrative expenses. G (Generics bulletin,29January 2016, page 11), and later through a partnershipwith Allergan’sActavis introduced a“first-to-market” OTC Annual sales Change Proportion store-brand equivalent to Reckitt Benckiser’sMucinex(guaifenesin) (Rs millions) (%) of total (%) 1,200mg extended-release tablets in the US (Generics bulletin,1 North America 75,445 +19 49 April 2016, page 2). Emerging markets* 23,592 -25 15 This year,Perrigo anticipates full-year Prescription sales of India 21,293+19 14 approximately $1.2 billion. “Within [Prescription], we assume price Europe** 7,732 +19 5 erosion of approximately 6% for the remainder of the calendar year,and nowassume the launch of the generic version of [Teva’s]ProAir HFA Global Generics 128,062 +7 83 (albuterol) in 2017,”Hendrickson stated. Under asettlement deal, Pharma Services/APIs 22,379 -12 14 Perrigo has the right to launch the respiratory drug from December 2016. Proprietary products/other 4,267 +28 3 AUS$318 million contribution from Omega enabled Perrigo to report asales rise of just under athird to US$1.38 billion, as Consumer Dr Reddy’s154,708 +4 100 Healthcare turnoverrose by 2.2% to US$700 million. But an impairment *refers to Russia, other CIS countries, Romania and rest of world markets including Venezuela charge of US$467 million linked to the Omega acquisition –asseen ** includes Germany, the UK and out-licensing sales business in the segment’snegative operating margin –turned aprior-year period Figure1:Breakdown by region and business segment of Dr Reddy’s Laboratories’ US$199 million operating profit to aUS$304 million operating loss. G sales in its financial year ended 31 March 2016 (Source –DrReddy’s)

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COMPANY NEWS

BUSINESS STRATEGY/ANNUAL RESULTS IN BRIEF PODRAVKA said bolstering its business in Russia coupled with the Glenmark eyes EU expansion of its portfolio of heart disease and blood vessel drugs in Bosnia-Herzegovina helped to lift sales of the Croatian firm’sown brand Prescription drugs by 13.1% to CrK127 million (US$19.2 million) in the first quarter of this year.The food and beverages Seretide rival launch specialist noted that it had during that period introduced the cardiovascular agent Lacidipin (lacidipine) and antibiotic Beloxim ndia’sGlenmark could start introducing its generic rivalto (cefuroxime)under its Belupo label, as total Pharmaceuticals sales IGlaxoSmithKline’s(GSK’s) Seretide Accuhaler (fluticasone/ increased by 6.4% to CrK183 million. The segment’searnings before salmeterol) dry-powder inhaler (DPI) in “various” European countries interest, tax, depreciation and amortisation (EBITDA) more than “as early as” during its current financial year ending 31 March 2017, doubled to CrK34.2 million. according to comments made to investors by the company’schairman and managing director,Glenn Saldanha. AMRI’S financial results during the first quarter of this “fell short Last year,Glenmark signed adevelopment and licensing agreement of expectations”, according to the US firm’spresident and chief with Polish firm Celon Pharma covering an alternative to GSK’sbrand executive officer,Bill Marth. The NewYork-based firm posted a in 15 European markets (Generics bulletin,6November 2015, page turnoverthat increased by 29% to US$106 million, following its 17), after launching the product “in anumber of emerging markets”. US$174 million acquisition of Spanish group Gadea Grupo “Wehavealready filed in sevenofthese 15 countries and the remaining Farmacéutico last year (Generics bulletin,7August 2015, page 7), eight we hope to file in the current year,” Saldanha revealed. Launching butanoperating loss of US$4.15 million, down from aprior-year the respiratory drug –which had generic sales in Europe of “about period US$1.23 million operating profit. Lower sales were “largely US$7-US$8 million”, Saldanha said –could be “transformational due to the timing of active pharmaceutical ingredient revenue”, for European operations”, he noted. Marth said, while AMRI had been hurt by increased research and Meanwhile, launching the first generic rivaltoMerck &Co’s development and sales and administrative expenses. “Webelieve Zetia (ezetimibe) together with partner Parwith 180-day market the results are transitory and revenue will build through the year exclusivity later this year would help Glenmark’ssales in its 2017 based on contractualobligations we have in hand,”henoted. financial year “growinexcess of 25%”, Saldanha said. The firm has held final US approvalfor its version of the cholesteroldrug for just SOPHARMA says it expects to introduce “three to five new under ayear (Generics bulletin,10July 2015, page 21). “But the products”bythe end of this year.“Around 10 production processes [US] core business, even keeping ezetimibe aside, should growat and technologies are in the process of transfer,validation and about 15-20%,”Saldanha added. “On the margin front overall if you optimisation,”the Bulgarian firm noted, adding that development takeinto account ezetimibe, our margins will look huge in 2017.” work on “over20” newpharmaceuticals products wasbeing carried In its financial year ended 31 March 2016, US sales that rose by out. In the first quarter of this year,Sopharma’sgroup turnoverrose just under afifth to Rs24.2 billion (US$362 million) helped Glenmark by 2.5% to BGN41.5 million (US$24.0 million),drivenmainly to increase its group turnoverby15.1% to Rs76.5 billion. The firm by sales in its domestic market climbing by 8% to BGN17.6 received24abbreviated newdrug application(ANDA) approvals million, and turnoverfrom its operationsinthe rest of Europe from the US Food and Drug Administration (FDA) –19final and inching ahead by 1% to BGN20.6 million. But the generics and five tentative –“arecord for the company”, according to Saldanha, herbal medicines specialist’soperating profit leapt by almost two- and also filed 12 ANDAs, leaving 59 applications pending. thirds to BGN13.0 million as Sopharma lowered its expenses. Sales were ahead in all of Glenmark’sregions, except for Latin America (see Figure 1), where sales slipped by 1.9% to Rs7.50 billion, MEDREICH –anIndian generics developer and producer that is after Glenmark stopped shipments to Venezuela in November last year. owned by Japan’sMeiji Seika Pharma –has been told by France’s On aconstant-currencybasis, however, Glenmark sawgrowth in Brazil medicines agency, ANSM, that aproposed “comprehensive action” and Mexico. In Glenmark’sdomestic market, its second-largest by plan developed to bring its deficient Unit Vantibiotics site in value, turnoverincreased by afifth to Rs21.1 billion as the firm’s Bollaram, Andhra Pradesh, India, back to compliance is market share increased for cardiovascular and respiratory disease drugs, “acceptable”.Aninspection conducted in May 2014 found 58 as well as diabetes and dermatological drugs. deficiencies, one of which, related to “data falsification”, was Even with higher operating expenses, Glenmark’soperating categorised as “critical”, while 29 were viewed as “major” (Generics profit jumped by 20.6% to Rs11.6 billion, as its operating margin bulletin,16January 2015, page 5). increased by 0.7 percentage points to 15.2%. G RHC HOLDING –the Indian holding companyled by director Region/business Annual sales Change Proportion of Malvinder Mohan Singh, former chairman and chief executive (Rs millions) (%) total (%) officer of Ranbaxy –says it is “exploring further legaloptions” to challenge an award to Daiichi Sankyo of damages relating to the US 24,203 +18.7 32 Japanese firm’sformer stakeinRanbaxy.Anarbitration court in India 21,093 +20.6 28 Singapore recently awarded Daiichi Sankyo damages and fees worth Latin America 7,495 -1.9 10 around ¥56.2 billion (US$525 million) in relation to claims that Europe 7,171 +11.3 9 Ranbaxy shareholders“concealed and misrepresented certain Rest of World 9,033 +11.2 12 critical information concerning US Food and Drug Administration APIs 6,683 +10.4 9 and Department of Justice investigations and the time of Daiichi Licensing/Other 819 –1 Sankyo’spurchase of shares of Ranbaxy in 2008” (Generics bulletin,13May 2016, page 2). “All the parties to the arbitration Glenmark 76,496 +15.1 100 are bound by confidentiality obligations as part of the arbitration Figure1:Breakdown by region and business of Glenmark’s sales in its financial proceedings,”RHC pointed out. G year ended 31 March 2016 (Source –Glenmark)

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COMPANY NEWS

MANUFACTURING/FIRST-QUARTERRESULTS FIRST-QUARTERRESULTS Krka bolstersbase Lots of launches help as Russian supplier Impax to asales rise

lovenia’sKrka says it is “continuously increasing the proportion aunching “more than adozen products overthe past 12 months” Sof products produced in the plant of our subsidiary” in Russia, Lhelped Impax to increase its Generics turnoverbyjust under athird “thereby strengthening our status as adomestic producer”. The firm to US$170 million in the first quarter of this year.Since completing is continuing to invest in its manufacturing base in Russia, where it its US$700 million acquisition of CorePharma in March last year is aiming to increase its ‘Krka-Rus 2’ facility’sproductioncapacity (Generics bulletin,13March 2015, page 7), Impax has obtained US to an eventual 1.8 billion tablets and capsules per year,aspart of what approvals for generics including methyltestosterone capsules, glyburide the companycalls “one of the most important ongoing investments tablets, guanfacine extended-release tablets and dutasteride capsules. in Krka’ssubsidiaries” (Generics bulletin,11March 2016, page 5). Moreover, following approvalinFebruary this year,Impax in In local-currency terms, Krka’sgroup sales in Russia increased April beganshipping its generic rivaltoShire’sAdderall XR by 9% in the first quarter of 2016, althoughthe firm noted that the (amphetaminesalts) extended-release capsules (Generics bulletin, “lower average rouble rate” meant that euro-denominated sales 26 February 2016, page 10) “after selling offour remaining supply of [our] authorisedgeneric version”. Impax had also launched authorised First-quarter sales Change Proportion generic of OxyContin (oxycodone) in “late March,”president and chief executive officer Fred Wilkinson noted. (C millions) (%) of total (%) Wilkinson also reiterated that, following those launches, Impax East Europe 80.1 -2 27 maintained introducing up to 14 products in total this year.Under plans West Europe 80.0 -3 27 laid out earlier in 2016, the US firm plans to takegroup sales to around Central Europe 73.0 +7 24 US$1 billion by improving by “at least 15%” on full-year 2015 sales South-East Europe 37.7 +23 13 of US$860 million (Generics bulletin,26February 2016, page 6). Slovenia 20.2 +5 7 Furthermore, at the end of the quarter,Impax announced it would Overseas Markets 9.9 +33 3 close the manufacturing and packaging facility at its site in Middlesex, NewJersey, which it picked up through CorePharma. “Research and Krka 300.9 +4 100 development activities at Middlesexare not part of this restructuring,” Prescription 243.9 ±0 81 the firm pointed out, “and will continueasakey part of our overall research and development programme.”Annual savings from the Non-prescription 27.4 +1 9 facility closure are estimated at US$23-US$27 million, “of which Animal Health 21.8 +85 7 most will be realised in 2017”. Other 7.9 +11 3 Moreover, in order to tackle the effects of generic price erosion, Figure1:Breakdown by region and product group of Krka’s sales in the first Wilkinson said, Impax had “discontinued products when the market quarter of 2016 (Source –Krka) dynamics are no longer attractive, and then we have re-launched products when theybecome attractive again”. “Additionally, we have were down by 9% to C56.2 million (US$63.7 million) compared to taken steps overthe past year to improve our supply chain, reduce the prior-year period. This contributed to sales in East Europe our cost structure,and remove excess capacity within our company.” falling by 2% to C80.1 million during the quarter (see Figure 1). Quizzed by an investor on possible gains from divestitures stemming Nevertheless, Krka’soverall turnoverincreased by 4% to C301 from Teva’s acquisition of Actavis, Wilkinson said Impax was“obviously million as a12% rise in volumes more than offset the impact of price in the process”. “No one really knows where everybody stands on erosion in manyofthe Slovenian firm’skey markets. this, and [the firms] are not announcing anything till theyare done with “Despite decreasing prices in both the keymarkets of Romania the whole transaction,”hesaid. Teva has just revealed it will divest and Croatia, and in Serbia”, Krka said, sales in South-East Europe global assets worth “approximately US$1.1 billion of net global grewby23% to C37.7 million. Pricing pressures were also experienced revenues” to secure approvalfor the acquisition, which it anticipates in Georgia, Macedonia and Moldova,while negative currencyeffects completing next month (Generics bulletin,13May 2016, page 1). sawsales drop in Kazakhstan and Uzbekistan. Specialty Brands sales that almost quadrupled to US$55.4 million In Central Europe a7%rise to C73.0 million wasdrivenbysales pushed Impax’ group turnoverupby57.6% to US$226 million. Of that increased in all markets “apart from the Czech Republic and Impax’ group turnoverrise, product volumes stemming from the Lithuania”, with the former suffering due to “legislative changes CorePharma acquisition contributed 44 percentage points of growth, exerting pressure to decrease the prices of pharmaceuticals”. and newlaunches 24. This easily outweighed price declines on a“few West Europe sawadrop of 3% to C80.0 million –again cited as high-volume generic products”, “primarily” diclofenacgel and “the result of falling prices of pharmaceuticals” and despite volumes metaxalone, which lowered sales by around 10.5 points. rising “in the majority of markets” –asKrka’s“most important market Impax increased its research and development spending by more in the region”, Germany, enjoyed growth of 13% to C27.5 million. than aquarter to US$19.0 million during the quarter,but those The UK suffered from “severe erosion of prices”, Krka observed, increased sales coupled with lower selling, general and administrative while in Scandinavia “severe price reductions” on duloxetine and expenses helped turn aUS$6.85 million operating loss from the aripiprazole in Sweden and Denmark sawthe region’ssales fall by prior-year quarter into aUS$38.0 million profit. But Impax made a overathird to C6.7 million. US$17.5 million pre-tax loss due to aUS$48.0 million provision for And in Slovenia the firm launched its “first polypill for the receivables related to the Daraprim (pyrimethamine) antiparasitic combined treatment of cholesterol and blood-pressure levels”, Rosmela brand that Impax sold to Turing Pharmaceuticals last year (Generics (amlodipine/rosuvastatin), aiding a5%increase to C20.2 million. G bulletin,1September 2015, page 21). G

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COMPANY NEWS

FIRST-QUARTERRESULTS FIRST-QUARTERRESULTS German growth gives Contraceptives cause Stada’s sales aboost Richter’s pharma fall

nimprovedproduct mix and lower sales deductions linked to harp declines in turnoverfrom oral contraceptivesinEurope and Atenders in Germanyenabled Stada Arzneimittel’sGenerics business Sthe US caused Gedeon Richter’sPharmaceuticals sales to decline by segment to raise its turnoverand to improve its profit margin significantly 2.1% to C239 million (US$272 million) in the first quarter of this year. during the first quarter of this year. Turnoverfrom Richter’srange of oral contraceptivesthat the Sales by the German group’sGenerics segment rose by 2% to companydeveloped itself tumbled by 17%, or by C10.1 million, to C296 million (US$335 million),which Stada said equated to 4% growth C48.3 million. Sales of oral contraceptives acquired from Grünenthal once adjusted for acquisitions and currencyfluctuations. “This in 2010 slipped by around 6% to C11.8 million, offset by Esmya performance wasprimarily aresult of strong sales growth by the (ulipristal acetate) sales up about 50% to C14.4 million. As aresult, German Aliud Pharma subsidiary and asignificant rise in sales in the Richter’sturnoverfrom its Women’sHealthcare franchise sank by Belgian, Italian and Vietnamese markets,”the firm said. almost atenth to C81.9 million, or athird of total Pharmaceuticals sales. As Figure 1shows, German sales ahead by 4% to C82.0 million In the European Union (EU) –excluding the Hungarian group’s accounted for well overaquarter of Stada’stotal Generics turnover. home market –Women’sHealthcare sales stalled at C42.8 million, Excluding exports, German Generics sales advanced by 8% to C75.6 million, aided by astrong performance from Aliud Pharma. First-quarter sales Change Proportion Generics turnoverinStada’sCentral Europe region stalled at C150 (C millions) (%) of total (%) million, even though Belgian sales rose by 9% to C26.9 million amid European Union* 84.8 -0.1 30 “strong demand among consumers”. Italian Generics turnovergrew Russia/CIS 83.9 +3.2 29 by 3% to C38.6 million on “positive volume effects”. Hungary 33.8 -0.9 12 But Generics sales in Spain slipped by 3% to C26.9 million, which China 14.1 +18.5 5 Stada attributed to astrong prior-year quarter during which the local US 6.9 -51.1 2 unit launched several drugs. “Strong price and discountcompetition” Latin America 4.3 -25.9 2 led to a2%dip to C18.8 million in France, while UK Generics Rest of World 10.9 -6.0 4 turnoverhalved to C3.1 million on “a temporarydelivery bottleneck”. Pharmaceutical 238.7 -2.1 83 Stada said its reported 3% Generics growth to C43.4 million in Wholesale &Retail 54.3 +14.3 19 Russia and the Commonwealth of Independent States (CIS) equated to Eliminations/Other -6.7 -4.2 -2 a21% local-currencyadvance. The total included a41% surge to C20.2 million in Russia as Stada increased its share of sales through the DLO Gedeon Richter 286.4 +0.8 100

reimbursement scheme. The Russian rise more than made up for afall *excluding Hungary of athird to C9.0 million in Serbia amid reimbursement-price cuts. The Serbian cuts and stiffdiscount competition in France were Figure1:Breakdown of Gedeon Richter’s sales in the first quarter of 2016 outweighed by “significant growth” in the profitabilityofStada’sAliud (Source –Gedeon Richter) and Stadapharm subsidiaries in Germanyasthe Generics segment around half of Pharmaceuticals sales that stagnated at C84.8 million. improvedits operating margin by 4.1 percentage points to 16.7%. The static EU Pharmaceuticals sales were due in large part to Stada –which will soon vote on replacing three members of its turnoverinGermanysliding by afifth to C13.3 million amid ageneral supervisory board (see page 16) –improvedits group operating margin decline in the local oral contraceptives market. French sales also fell by almost apoint to 11.3% on turnoverthat rose by 2% to C497 million.G by nearly afifth to C4.9 million. Such slides in Western Europe were offset by gains in Central Europe. Polish turnovergrewby10.6% to C20.9 million as sales of Groprinosin (inosine pranobex) benefited from a“strong flu epidemic”. Asia-Pacific/MENA C21.1m, +10% A9.1% gain to C7.2 million in Romania wasdrivenbyaweak prior- Central Europe year quarter and the launch of Restigulin (aripiprazole). C149.6m, ±0% Pharmaceuticals turnoverinthe Hungarian group’sdomestic market –where it is expanding its Debrecen biosimilars plant (Generics Eastern bulletin,18March 2016, page 3) –slipped by 0.9% to C33.8 million, Europe/CIS despite the recent launch of Xilomare (xylometazoline). C43.4m, +3% Sales in Russia and the Commonwealth of Independent States (CIS) grewby3.2% to C83.9 million (see Figure 1). This wasdue largely to a5.5% rise to C59.3 million in Russia on higher volumes, an average 4% price hikeacross the portfolio and a“good sales performance from the range of oral contraceptives”. But US sales more than halved to C6.9 million, caused by a “substantial decrease in revenues from profit-sharing agreements” for Germany oral contraceptives amid “increased generic competition.” C82.0m, +4% The US slide and acurrency-related fall of aquarter in Latin American sales were compensated in part by 18.5% growth to C14.1 Figure1:Breakdown by region of Stada Arzneimittel’s Generics sales that million in China as the group took full control of its Gedeon Richter increased by 2% to C296 million in the first quarter of 2016 (Source –Stada) Rxmidas OTCventure in January this year. G

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MARKET NEWS

INTELLECTUAL PROPERTY REGULATORY AFFAIRS India seeks stronger Europe reviews plan domestic API source for single SPC study

educing the country’sdependence on active pharmaceutical study on supplementary protection certificates (SPCs) planned by the Ringredient (API) imports is among proposals contained in a AEuropean Commission will nowberevised after the Commission’s national intellectual-property (IP) rights policyunveiled by the Indian tender “receivedonly one application”. The study –on‘legalaspects government. But the policymakes no mention of the most controversial of SPCs in the European Union (EU)’ –follows the Commission’s elements of India’sIPframework, such as compulsory licensing and announcement as part of its ‘single market strategy for Europe’ of the Section 3(d) prohibition of patenting “the mere discovery of a plans for a“unitary SPC” to complement the unitary European patent newform of aknown substance” that does not improve efficacy. system (Generics bulletin,6November 2015, page 1). Hailing “the contribution of the Indian pharmaceutical sector in Insisting that aunitary SPC would “enhance the value, transparency enabling access to affordable medicines globally and its transformation and legalcertainty of the protection of medicines”, the Commission to being the pharmacyofthe world”, the policystates that India remains said it would provide a“one-stop shop for the granting of SPCs in committed to the Doha Declaration on protecting public health under Europe”, offering “enhanced certainty to European health authorities, the World Trade Organization’s(WTO’s) agreement on trade-related to patients and to generics companies on the status of aregulated aspects of IP rights (TRIPS). product’sintellectual-property protection”. The Indian government insists it has “created and established a Submissions for the initial tender closed on 4February 2016, TRIPS-compliant, robust, equitable and dynamic IP rights regime”. with aplanned signing date of April. “Wedid not award the tender,” In asection on commercialising IP rights, the government says it aspokesman for the Commission told Generics bulletin.“We are will provide incentivestomanufacture APIs in India and will revitalise working to relaunch the tender as soon as possibleand we are “public-sector undertakings in the healthcare sector”. considering recasting the scope of it.” The same section pledges to “ensure enhanced access to affordable Under the terms of the tender,the study should “evaluate whether medicines and other healthcare solutions by: encouraging cross-sector anew European SPC title, with the current or broader scope, with partnerships between the public sector,private sector,universities and improvedprovisions is required to meet the requirements of current non-governmental organisations (NGOs); promoting novellicensing and expected market developments in the EU”. To this end, the models; and developing noveltechnology platforms”. It also promises document sets out, “the study shall evaluate the current SPC framework to “streamline regulatory processes to ensure timely approvalfor in terms of its legalefficiencyinmeeting its stated objectivesgiven manufacturing and marketing of drugs while maintaining safety and the development of directly affected and related product markets”. It efficacystandards”. must also evaluate “some aspects of the current SPC framework”. Achapter covering enforcementand adjudication promises that “The results could serveasabasis for an impact assessment for India will “takestrong measures against attempts to treat generic drugs afuture proposal by the Commission to create aEuropean SPC title, as spurious or counterfeit”. Objectivesfor India’slegal and legislative and complement with recalibration of the existing EU SPC rules,”the framework include protecting from misappropriation India’s“traditional original tender states (Generics bulletin,29January 2016, page 1). medicinal knowledge”. The tender’sexhaustive specifications required applicants to In asection on generating IP rights, the government outlines plans “provide quantitative and qualitative evidence of the use of SPC to encourage both “publicly-funded research and development protection in selected EU member states”; to “reviewthe economic institutes and industry to develop affordable drugs relating to neglected rationale, value and merits behind SPC protection”; to “provide a diseases” and open-source discovery of drugs for diseases that are comparative inventory of the SPC legalframework in the EU member “life-threatening and have high incidence in India”. G states”; to “analyse and cluster the Court of Justice of the EU’s(CJEU’s) jurisprudence on SPCs”; and to “provide an overviewofthe SPC-type IN BRIEF legalframework in major commercial partners of the EU”. Additionally,the study should “identify and analyse featuresof EMA –the European Medicines Agency–has released forpublic the SPC system/regulations and CJEU’sjurisprudence that might need comment aconcept paper on revising the guideline on “the clarification”; “analyse and compare the procedural aspects of national environmental risk assessment of medicinal products for human SPC systems in the EU”; “identify and discuss legalfeatures of the use”, including considerations for risk-mitigation measures to limit SPC regulations and CJEU’sjurisprudence that are more relevant to their impact on the environment. The consultationisdue to end on encourage innovation”; “discuss the potential of SPC-type protection 31 October.Arelated question-and-answer document on the guideline for newsectors”; “analyse the term of protection”; and “analyse the wasrecently updated, the agencypointed out. introduction of aEuropean SPC title”. According to the timelines set out by the tender specification, an FDA –the US Food and Drug Administration –should use initial “detailed roadmap” must provide a“clear methodology” for the “distinguishable, meaningful suffixes”for biosimilar names, study,while adraft overviewofthe stakeholders to be consulted according to aletter sent by a70-group coalition of healthcare should be made available. This should be delivered within amonth stakeholders to the agency. The letter follows the FDA’s“departure of the contract being signed. from ameaningful to random identifier in the agency’sapproval Subsequently,aninterim report must be delivered to the of the second [US] biosimilar”, Celltrion’sRemsima (infliximab- Commission “no later than four months from the start of the action”, dyyb) earlier this year (Generics bulletin,8April 2016, page 1). including afirst draft of the study,the specification states. Adraft final Sandoz’ Zarxio had previously been approvedasfilgrastim-sndz report should followeight months from the start of the action, with (Generics bulletin,13March 2015, page 1). G afinal version –taking into account Commission feedback –being published within 10 months. G

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MARKET NEWS

PRICING&REIMBURSEMENT REGULATORY AFFAIRS GPhA cautionsover Danish agency aims US Medicarerevamp to explain biosimilars

roposals by the US Centers for Medicare and Medicaid Services nformation for healthcareprofessionals and patients on biosimilars P(CMS) to revamp the wayMedicare Part Bpays for prescription Ihas been published by the Danish Medicines Agencyaspart of its drugs will “erode the economic incentivesthat drive the US healthcare ‘action plan on biological medicines, biosimilars and vaccines for system to lower-cost therapeutic alternatives, particularly in the 2015 and 2016’. biosimilars space”, according to the US Generic Pharmaceutical “A flyer has been distributed to healthcare professionals with Association (GPhA) and its Biosimilars Council. information about the newrules on the recording and reporting of Six alternative models for Part Bdrugs “to improve outcomes and adverse reactions of certain biological medicines, including biosimilars,” align incentivestoimprove quality of care and spend dollars wisely” the agencynoted. This includes details of howtorecord atrade are envisaged by CMS. These include reference-pricing and indications- name and batch number when reporting suspected adverse reactions. based pricing. “With limited exceptions, CMS is proposing to include Earlier this year,the Danish Medicines Agencyupdated its list of all Part Bdrugs and biologicals in this model,”CMS noted. It plans biological and biosimilarmedicines with “stricter reporting to implement the proposals and test the models in twophases –one requirements” for pharmacovigilance(Generics bulletin,12February beginning no earlier than 60 days after the final rule is published, 2016, page 9). This followed an executive order that sawthe agency and one starting “no earlier than January 2017”. “increase focus on the monitoring of adverse reactions from biological While the GPhA and its Biosimilars Council “share CMS’ stated medicinal products, including anyadverse reactions that occur when goal of reducing overall Medicare expenditures”,the industry association switching between biosimilar medicinal products and reference said –with generics and biosimilars “uniquely positioned to help CMS medicinal products” (Generics bulletin,5February 2016, page 9). achieve this goal” –the GPhA has “serious concerns” that the CMS Along with the literature aimed at healthcare professionals, the proposal “risks limiting the savings created through open market agencysaid, “for patients who are to takeabiosimilar medicine, the competition, particularly in the nascent biosimilars market”. agencyand patient organisations have together prepared adossier which “Most importantly”, the GPhA said, “CMS should ensure that answers anumber of questions that patients may have about biosimilars”. Phase II of the proposal does not create an environment where generic This includes information about the nature of biosimilars and regulatory or biosimilarproducts are compared with anything other than their processes governing such medicines,aswell as confirmation that a intended reference product.”“Additionally,GPhA and the Biosimilars biosimilaris“only approvedifithas the same effect, quality and Council also voiced some concern overthe expansive scope of the safety as the original biological drug”. G proposal, and urged CMS to consider amore targeted demonstration that could more effectively measure the effects of anynew value- based proposals,”the association pointed out. PRICE WATCH ...... UK Meanwhile, the GPhA has repeated its opposition to CMS’ coding and payment policyfor non-interchangeable biosimilars Isosorbide sees jump in May (Generics bulletin,1September 2015, page 19). “The current coding and average sales price (ASP) calculation methods are asignificant verage prices for isosorbide mononitrate 10mg and 40mg tablets departure from previous CMS policyand unfairly disadvantage Aincreased threefold in early May,according to the latest UK non-interchangeable biosimilars.” figures provided by WaveData. In its letter to CMS, the GPhA insists that the “percentageadd-on Comparing UK trade prices between the periods 1-30 April calculated from the ASP should be based on the ASP of the reference 2016 and 1-16 May 2016, the average trade price for a56-tablet product, as is done under current payment policy”, to “maintain pack of the higher strength rose by 312% to £6.10 (US$8.83), Congressional intent” for the overall biosimilars payment policy. G despite the lowest available offer falling by almost 9% to £0.54, based on averages calculated from at least 36 data points. Meanwhile, the lower 10mg strength sawanaverage rise of REGULATORY AFFAIRS 283% to £4.61 for 56-tablet pack, as the lowest available offer increased by just overtwo-fifths to £0.77. EMA seeks dissolution input Gliclazide 30mg modified-release tablets in 56-count packs saw their average price quadruple to £6.42 as the cheapest price remained omments are being sought by the European MedicinesAgency just £0.82. And the price for apack of 30 cimetidine 800mg tablets C(EMA) on adraft reflection paper that the regulator has published leapt by 292% to £7.26 –again, despite the lowest offer remaining on “the dissolution specification for generic oral immediate-release stable at £0.99 –reversing atrend seen in March (Generics bulletin, products”. The deadline for comments is 13 August. 1April 2016, page 11). “During the last fewyears, the suitability of dissolution The steepest average price declines were experienced by specifications has been discussed in marketing authorisation procedures,” trospium chloride 20mg tablets in 60-count packs –which sawa the EMA explains. “A decision tree is proposed to makethe evaluation fall of 46% to £5.33 –and packs of 21 metronidazole 200mg tablets, process more transparent.” the average price of which dropped by 38% to £0.60. G However, the agencyacknowledges, “there may be some drugs Up to the minute live retail market pricing is available with very narrowtherapeutic ranges or products where there is prior for the UK and Eire on Wavedata Live at wavedata.net. knowledge of critical dissolution behaviour –such as sublingual or Alternatively,contact Charles Joynson at WaveData Limited, orodispersible tablets with some buccal absorption –which still have UK.Tel: +44 (0)1702 425125. E-mail: [email protected]. to be evaluated on acase-by-case basis”. G

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PRODUCT NEWS

EVENTS – June ERECTILEDYSFUNCTIONDRUGS

8-10 June ■ Joint MfE and IGBA Annual Conference Adamed offers OTC Dubrovnik, Croatia For2016, Medicines for Europe (MfE) and the International Generic and Biosimilar Medicines Association (IGBA) will join sildenafilinPoland forces for their annual conferences. Contact:Lucia Romagnoli. Tel: +44 7562 876 873. en in Poland will be the first in the world to be able to buythe E-mail: [email protected]. Merectile-dysfunction drug sildenafil without aprescription and Register onlineatwww.egaevents.org/ega16. without anyintervention from apharmacist. Aspokesperson for Polish firm Adamed said the country’s 13-14 June regulator had approvedinApril its prescription-to-OTC switch ■ EuroPLX 61 application for sildenafil 25mg under the brand name MaxOn Active Valetta,Malta and that the product wasnow shipping to pharmacies. The switch had been granted, the spokesperson explained, thanks This meeting provides an opportunity to discuss and negotiate to aquestionnairethat wasincluded in every pack. This allowed the agreements, in-licensing and marketing and distribution. user to “makeasafe decision” educating him about sildenafil and Contact:Raucon. Tel: +49 6221 426296 0. contraindications. To support the switch application, Adamed had, E-mail: [email protected]. Website: europlx.com. the spokesperson said, carried out an observational clinical study to 13-14 June prove the effectiveness of the questionnaire. 7th Annual Summit on Biosimilars “Wewill educate pharmacists about the product and the ■ questionnaire,”the spokesperson pointed out, “so theyfeel comfortable New Yo rk,USA explaining to customers howtouse the product safely.” Issues to be discussed at this event include interchangeability and Adamed intends to launch atelevision and digital marketing labelling as well as litigation strategies, naming and substitution. campaign for MaxOn Active at the end of May,along with a Contact:American ConferenceInstitute.Tel:+1212 352 3220. comprehensive pharmacist-training programme. E-mail: [email protected]. Poland is the first country in the world to approve a‘true’ Website: americanconference.com. prescription-to-OTC switch of sildenafil. Pfizer tried and failed to switch the ingredient –which is the basis for its blockbuster drug Viagra –in August &September a50mg formulation through Europe’scentralised procedure in 2008. NewZealand has come closest to granting OTCstatus to the 2-5August drug, butsildenafil remains in the country a“prescription medicine; ■ 3rd PharmaCon, Pharmaceutical Congress Asia except when supplied by apharmacist who has successfully completed Singapore the approvedtraining programme for the treatment of erectile This is atwo-day conference with pre- and post-conference workshops. dysfunction in males aged 35 to 70 years”. G There are four events hosted at the same location: Pharmaceutical Regulatory Affairs Asia, Market Access Asia, Pharmaceutical Compliance Asia and Clinical Trials Asia. BIOLOGICALDRUGS Contact:IBC Asia.Tel:+65 6508 2401. E-mail: [email protected]. Website: pharmaconasia.com. FDA plans abiosimilars unit

7-8 September he US Food and Drug Administration (FDA) is proposing to T“establish adedicated biosimilars unit” as part of its discussions with ■ GPhA BiosimilarsCouncil Conference industry on reauthorising the Biosimilar User Fee Act (BsUFA) for the Maryland, USA agency’sfiscal years running from October 2017 to September 2022. This is atwo-day interactive conference looking at topics including According to the agency, adedicated unit for biosimilars would access, regulatory issues, reimbursement and legalaffairs. “provide amore focused and better resourced capacity to coordinate Contact:GPhA. Tel: +1 202 249 7100. keyscientific, regulatory and policyfunctions” by acting as a“central E-mail: [email protected]. Website: gphaonline.org. point” to manage issues such as operations management,training and external outreach. 29-30 September During arecent BsUFAsteering committee meeting with industry ■ Biosimilars Europe stakeholders, the FDAdiscussed howthe unit “would address several London, UK enhancement proposals raised by industry targeted towards improving This two-day conference will look at developments in the consistency, transparencyand communication during the reviewof biosimilarguideline framework and legislation in both Europe and biosimilarapplications”. Industry was“supportive of the FDA’s the US. Patent litigation, market access, pricing and proposal” and both parties pledged to “have related commitment-letter reimbursement and emerging markets will also be covered. language drafted” for discussion at afuture meeting. The FDAhas already provided industry with draft commitment- Contact:SMi.Tel:+44 207 827 6000. letter language on abiosimilars reviewmodel similar to the programme E-mail: [email protected]: smi-online.co.uk. for newdrugs under the PrescriptionDrug User Fee Act (PDUFA). But SAVE THE DATE... while companyrepresentativessaid theywould consider the language, 4October 2016, Barcelona, Spain the agencyacknowledged that “industry expressed concerns about the Contact: [email protected] lack of data to showthat the programme would be as successful for BsUFAasithas been for PDUFA”. G

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PRODUCT NEWS

ANTIPSYCHOTIC DRUGS IN BRIEF ACTAVIS has settled its dispute with Supernus overUSpatents Japanese firms will 8,821,930 and 9,119,791 that protect the originator’s Oxtellar XR (oxcarbazepine)extended-release tablets until 13 April 2027. The twofirms have also agreed to drop their respective appeals against aNew Jerseydistrict court’srecent ruling that US patent 8,617,600 rival Lilly’s Zyprexa wasvalid butnot infringed by Actavis’ proposed generic version of the epilepsy drug (Generics bulletin,12February 2016, page ivals to Eli Lilly’sZyprexa (olanzapine)are set to hit the Japanese 13). Actavis will proceed with its appeal against the district court’s Rmarket next month, according to local firms Sawaiand Towa, finding that twoother Oxtellar XR patents that run until 13 April which both plan to launch their versions of the antipsychotic in June. 2027 were infringed by its generic version. Supernusreported The originator brand had annual sales in Japan of around ¥57.3 Oxtellar XR sales up by athird last year to US$33.2 million. billion (US$526 million),according to 2015 data cited by Towa. Sawaisaid it also planned to launch three orodispersible tablets EMA –the European Medicines Agency–was, as of 10 May, in June. ArivaltoTaiho Pharmaceutical’sTS-1 (tegafur/gimeracil/ considering three centralised marketing authorisation applications oteracil potassium) anti-metabolic agent; aversion of AstraZeneca’s each for emtricitabine/tenofovir disoproxil, ivabradine and Casodex(bicalutamide) prostate-cancer treatment; and arivalto pegfilgrastim.The agencyisalso evaluating twodossiers each for Mitsubishi Tanabe’sCeredist OD (taltirelin) anti-spinocerebellar generic or biosimilar adalimumab, bortezomib, enoxaparin and degeneration agent. G fluticasone/salmeterol,aswell as twoapplications each for methotrexate, pemetrexed, sildenafil, tenofovir disoproxil and teriparatide.Single biosimilar dossiers are pending assessment BIOLOGICALDRUGS for etanercept, insulin glargine and rituximab. TELIGENT has receivedUSapprovalfor triamcinolone acetonide Coherus secures Humira IPR 0.1% ointment. The US firm plans to launch the topical corticosteroid iosimilars developer Coherus BioSciences has persuaded the US in tubes and jars by the end of June. Noting that it had filed its dossier BPatent and Trademark Office (USPTO) to institute an inter partes for the ointment in January 2013, Teligent said triamcinolone was reviewofAbbVie’sUSpatent 8,889,135, which covers adosing regimen its “fourth prescription topical abbreviated newdrug application in which 40mg of Humira (adalimumab) is administered subcutaneously (ANDA) approvedbythe US Food and Drug Administration (FDA) every 13 to 15 days as atreatment for rheumatoid arthritis. Boehringer so farthis year”. Ingelheim currently has twosimilar petitions on the patent pending before the USPTO’sPatent Trial and Appeal Board (PTAB). MYLAN has introduced frovatriptan succinate 2.5mg tablets in the Explaining its decision to conduct areviewofclaims 1to5of US as ageneric alternative to Endo’s Frova migraine treatment, the ‘135 patent, the PTAB said the mention of “a method for treating which lost US patent protection last year.Citing IMS Health data rheumatoidarthritis” in the preamble to the five claims did not “require for the 12 months ended March 2016, Mylan said frovatriptan 25mg aparticular levelofefficacy”. had annual US sales of US$88.3 million. Glenmark secured asimilar Treating rheumatoid arthritis, the board added, meant reducing approvalearlier this year. the signs, symptoms and/or progression of the condition. There wasa“reasonablelikelihood”, the PTAB decided, that SUNSHINE BIOPHARMA says it has “signed across-referencing Coherus would prevail in proving that claims 1to5were obvious in agreement with amajor pharmaceutical companyfor anastrozole”. light of twoprior-art references published in journals during 1999, The Canadian companyiscurrently seeking adrug identification ‘Kempeni’ and ‘van de Putte’. number (DIN) and adrug establishment license (DEL) from local Coherus has also petitioned the USPTOtoconduct areviewof regulatory agency, Health Canada, before launching the breast-cancer 18 keyclaims contained in US Humira patent 9,114,116 that was drug under its ownSBI-Anastrozole label. issued to AbbVie in August last year. ZYDUS CADILA has obtained final approvalfrom the US Food and Claim is overbroad and unpatentable Drug Administration (FDA) for glyburide 1.25mg, 2.5mg and In its petition,Coherus claims that claim 1ofthe ‘116 is overbroad 5mg tablets. The Indian firm will makethe diabetes drug at its and unpatentable in that it covers astable, isotonic, subcutaneousliquid formulationsfacility in Baddi, India. formulation of an anti-tumour necrosis factor (anti-TNF) antibody, abuffer system and apHrange between 4.0 and 8.0. “The breadth BIOINTEGRATOR –amember of Russia’sChemRar group –has of this claim is remarkable as it recitesnothing more than adesired launched its Nescler (fingolimod)0.56mg oral formulation in Belarus. outcome –astable formulation –that would essentially coverany The firm initially registered the rivaltoNovartis’ Gilenya pH-buffered liquid subcutaneous formulation covering 50mg/ml of (fingolimod)multiple-sclerosistreatment in Russia twoyears ago. the IgG1 antibody D2E7,”the biosimilars specialist maintains, adding that such attributes were “conventional” as of the patent’s APOTEX faces alawsuit in aDelaware district court overits 16 August 2002 priority date. paragraph IV challenge to US patent 6,417,175 that protects Allergan’s Arguing obviousness, Coherus contends that the vandePutte Teflaro (ceftaroline fosamil)until April 2022. Allergansaid it had abstract showed that D2E7 wasasafe and effective treatment for sued for infringement within the 45-day windowthat made it eligible rheumatoid arthritis, while a‘Relton’ patent describedhow to make for a30-month stay on approvalofApotex’ abbreviated newdrug D2E7 formulations. Askilled person, it argues, would have been application (ANDA) until 8September 2018. Aseparate 30-month motivated to combine the twoprior-art references and “arrive at the stay in litigation overthe antibiotic that Allergan’sForest and its claimed formulation of the ‘166 patent”. partner Takeda had brought previously against Apotexand Sandoz Coherus is also seeking reviews of twoother US Humira patents – runs until 29 April 2018. G 9,017,680 and 9,073,987. G

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PRODUCT NEWS

ORAL CONTRACEPTIVES OSTEOPOROSIS DRUGS Actavis wins appeal Pfenex’teriparatide over US on-sale bar trial set for this year

ctavis’ Watson has successfully appealed against aDelaware district fenexanticipatesbythe end of this year initiating a“clinical Acourt’sruling to uphold akey claim in US patent 6,441,168which Pprogramme”for its 505(b)(2) hybrid version of Eli Lilly’sForteo protects Bayer’sSafyral and Beyaz (drospirenone/ethinylestradiol/ (teriparatide) blockbuster after reporting “top-line data” in a levomefolate calcium) oral contraceptivesuntil 17 April 2020. bioequivalence study involving its PF708 teriparatide candidate. Delaware District Judge Richard Andrews had found that the key Claiming that the planned programme would “satisfythe 505(b)(2) claim 4ofthe ‘168 patent –covering acrystalline calcium salt of a filing requirements” with the US Food and Drug Administration tetrahydrofolic acid (MTHF) –was not rendered invalid under the US (FDA), Bert Liang, the US biosimilars developer’schief executive on-sale bar (Generics bulletin,11September 2015, page 20). This officer,said it would include an immunogenicity/pharmacokinetic study bars inventors from obtaining apatent more than one year after offering in patients with osteoporosis. “Webelieve that the clinical programme the claimed invention for commercial sale. But the US Court of in the US can be leveraged for regulatory filings in other geographies,” Appeals overturned Andrews’ verdict following an appeal broughtby Liang commented. Additional updates “will be provided overthe Watson, which had filed aparagraph IV challenge to the ‘168 patent. course of 2016”, he remarked. Noting that its focus was“on whether there wasaninvalidating Lilly’sForteo had global sales of US$1.35 billion last year,of commercial offer to sell the product prior to the critical date, 17 April which US$612 million stemmed from the US. The brand is currently 1999”, the Court of Appeals noted that on 9September 1998, Roland protected by sevenpatents in that market, that are listed in the Martin –amanager at Bayer’spartner,Merck KGaA –had signed a FDA’sOrange Book patent database. Of the sevenpatents protecting faxinwhich he promised to “arrange everything” for the sale of 2kg Forteo, six have expiry dates ranging from December 2018 to August of MTHF to supplements firm Weider. 2019, and the seventh shields the product until 25 March 2025. “Martin’sdetailed fax–providing essential price, delivery and Meanwhile, Pfenexexpects its partner Pfizer to also this year payment terms –contained all the required elements to qualify as a begin a“pivotal” clinical comparator trial for the firms’ PF582 commercial offer for sale,”the Court of Appeals stated. “Anoffer to biosimilarversion of Roche’sLucentis (ranibizumab). The firms are sell is sufficient to raise the on-sale bar,regardless of whether that developing the ophthalmic biosimilar together under the terms of a sale is ever consummated.” G tie-up Pfenexreached with Hospira prior to its takeoverbythe US originator last year (Generics bulletin,27February 2015, page 23). And during the second half of 2016, Pfenexexpects to begin a Get Generics bulletin on your pharmacokinetic/pharmacodynamic study and immunogenicity trial concerning Bayer’sBetaseron (interferon beta 1-b). The proposed tablet and smartphone development comes after the biosimilars firm last year completed a Phase Iclinical trial for its PF530 version of the multiple sclerosis Make the most of your subscription – brand that involved 12 “healthysubjects”. G get FREE accessto HEPATITIS CDRUGS Download the FREE Generics bulletin-i App for optimised viewing India grants sofosbuvir patent on your Apple and/or ndia’spatent office has granted Gilead apatent covering its Sovaldi Android tablet and I(sofosbuvir) hepatitis Ctreatment. The country’s deputy controller smartphone. of patents and designs, Rajesh Dixit, dismissed pre-grant oppositions brought by several parties, includingBDR Pharmaceuticals, Optimus Use the links below Pharma and the Initiative for Medicines,Access &Knowledge (I-MAK). to login with your In rejecting the pre-grant oppositions, Dixit noted that arguments subscriber personal presented during oral hearings on 23-29 February this year had focused on alack of novelty and inventive step, as well as that Gilead’sclaimed account* details. invention wasnot patentable under the Indian Patent Act’ssection 3(d), which prohibits patenting “the mere discovery of anew form of a known substance” that does not improve efficacy. Dixit dismissed novelty arguments against the patent’seight claims http://tinyurl.com/ov7uleq http://tinyurl.com/krxxrfl based on the prior-art filing WO 2002/057425. And acombination of patents and other literatures failed to convince the Gilead’spatent Each Friday you will receive the latest issue – lacked inventive step. wherever you are worldwide Turing to Section 3(d), Dixit found that “the compounds argued to be known substances for this case are hypothetical in nature”. The * Please contact [email protected] if you have forgotten opponents had not shown howaskilled person could makesuch your personal login details.Please also contact us if you do not have hypothetical compounds from the teachings of cited prior-art patents, a subscriber personal account, possibly because your company has a Corporate subscription. he said, adding that Gilead’sclaimed compound had an “added layer of enhanced efficacy”. G

20 May2016 GENERICS bulletin 13 GGB 2016 Full Pg 9-5-16 V2_Layout 1 12/05/2016 16:42 Page 1

Recognising the best in the global generics and biosimilars industries Presented by Generics bulletin in association with IMS Health CocktailCocktail Reception Reception & & AwAwardsards Presentation Presentation TuTuesdaesday4Oy4Octoberctober 2016 2016 Hotel PortaFira,The Gran Via complex, Barcelona, Spain

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INDUSTRYASSOCIATIONS UK needs to sharesuccess

Incentivising healthcare hen the British Generic Manufacturers chief pharmaceutical officer,Keith Ridge. “Weare trying stakeholders in the WAssociation (BGMA) launched adedicated to develop amore consensus-drivenapproach,”henoted. biosimilars sector group under the banner of “The national meetings are areally important UK by enabling them the British Biosimilars Association (BBA) in April, forum,”deGavre said, calling them “a wonderful its intention wasclear: the BBAwas announced as example of industry collaboration, butalso collaboration to shareinthe benefits having “the sole focus of increasing the understanding across all of the individual stakeholders in the UK health of biosimilars will be and use of biosimilar medicines in the UK” (Generics economy”. “Wehaveall of the keystakeholders at the bulletin,22April 2016, page 8). table,”heobserved, including the NHS and the National key to promote uptake. And speaking in an exclusive interviewwith Institute of Health and Care Excellence (NICE). Generics bulletin,BBA chair TimdeGavre is equally “NICE has been very supportive,” he said, referring Tim de Gavre, chair of clear on the challenges faced on UK biosimilars uptake, in particular to guidance published by the national the British Biosimilars and howtoaddress them. Healthcarestakeholders in reimbursement body last year that drewonexperiences the UK, he insists, must be incentivised by being at NHS trusts in London and Southampton to create Association, gives allowed to share in the benefits of biosimilars, adoption advice for biosimilar infliximab (Generics David Wallace his views. including –but not limited to –the financial rewards. bulletin,1September 2015, page 27). “The major barrier right nowinthe UK is that “Theyreally laid out aplaybook on howto you’ve basically got athousand different National Health implement infliximab,”deGavre stated, also praising Services (NHSs),”deGavre explained, referring to the NICE guidance from last year that recommended using hundreds of separate clinical commissioning groups the least expensive version of infliximab to treat (CCGs) responsible for providing NHS services in ankylosing spondylitis (Generics bulletin,11September England. “You have different approaches in different 2015, page 20). “That wasbecause biosimilars firms regions,”henoted, leading to a“lack of clarity and were able to submit data that showed asubstantial lack of consistencyinimplementation”. difference in price, and use that to change treatment Investment in extra resources –including healthcare guidelines,”hecommented. professionals such as nurses –was essential, de Gavre Nevertheless, de Gavre maintained,promoting said. “You really have to invest to get the change.”But biosimilars through formal guidance was“an area where in general, he observed, “there is not awillingness NICE can do more”. “If NICE could change their to share and to invest”. guidelines to reflectthe impact of biosimilars and This wasbecause there wasadesire on the part broaden patient access, that would do alot to convince of CCGs to retain the savings theygenerated, rather physicians and patients that biosimilars are not just TimdeGavre than seeing them as part of awider process in which about cost,”heurged. economies from one group of products allowed for Multiple technology appraisals (MTAs) could investment in the next. “Providers need to look at how be made “less onerous”, he suggested. While such to maximise the benefits from the savings,”deGavre assessments were carried out overafive-year period, said. “And when you do that, then you increase access he observed, approaching them on amore ongoing for patients.”Without using biosimilars, future savings basis would enable the impact of biosimilarmarket could not be generated, he pointed out, emphasising entry to be more quickly incorporated into NICE’s that “100% of nothing is nothing”. economic modelling. Noting that it had been savings on statins –driven Educating stakeholders wasalso an essential area by generic competition –that had previously allowed of focus, de Gavre acknowledged. “I think we have to the NHS to invest in asubsequent wave of biological educate physicians,”heinsisted, adding that the BBA medicines, de Gavre suggested it wassavings from had held events such as workshopsand lectures. biosimilarcompetition that would in turn unlock funds However, de Gavre conceded, “industry cannot do to invest in treatments such as newhepatitis Cdrugs. it on its own”. “Wehavetocollaboratewith the NHS,” “The CCGs are the ones paying for these products,” he explained. While messages from industry could be he acknowledged. “And theyfeel ownership overthat.” perceivedascarrying vested interests, he said, “if “What we need within CCGs –and across the entire something comes from acolleague, someone part of your system –isaconstant cycle of saving, which ensures organisation, someone you respect, you have alot better reinvestment in high-quality treatments, working chance of that being implemented and accepted”. together across CCGs. This will provide the highest The BBAwas nowlooking at developing the next quality and most advanced medicines to patients. For step from its workshopstodrive further educationon manyparts of the NHS, this is amissed opportunity biosimilars, de Gavre said. in atime of austerity.” And for the end users of biosimilars, de Gavre said, Moreover, de Gavre said, the incentivesfor doctors it was“really important that we develop some material and pharmacists needed to go beyond the mere financial for patients that explains things in away that theycan benefits of biosimilars. “Unless you’re incentivising understand”. Such information “must be unbiased, but physicians by making them feel that they’re providing must also ensure that we do not concern the patient”. better patient care, they’re not going to do it.” The BBA“would love to work with NHS, patient The BBAwas helping to spread the positive groups and industry bodies to develop those materials”, message about biosimilars, de Gavre outlined, through de Gavre concluded. “Wereally have to have aco- national meetings with healthcare stakeholders from ordinated, multi-stakeholder approach to make across the industry that were chaired by NHS England’s biosimilars successful in the UK.” G

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PEOPLE

RESHUFFLES/BUSINESSSTRATEGY Epirus’ chief departs as firmchanges tack

ure-play biosimilars developer Epirus Biopharmaceuticals has and “associated markets”. Livzon wasa“principal investor” in the US$36 Punveiled wholesale changes to its senior management team after million private-financing round that Epirus closed in April 2014 prior to suspending development on lead biosimilar candidate infliximab in becoming apublic company(Generics bulletin,2May 2014, page 2). order to “focus exclusively” on rare disease treatments. Following the suspension of its BOW015 infliximab candidate, Following four years at the helm, president and chief executive Epirus announced it wasworking to “further evaluate strategic options” officer Amit Munshi has left the companywith immediate effect. for the biosimilar version of Janssen’sRemicade brand, including Board member Scott Rocklage has taken on the role of chief executive, partnerships, divestiture or “other value-generating alternatives”. The while Michael Wyand has stepped up to the position of president and suspension was, moreover, “based on cost-savings, not technical reasons, chief operating officer.Former chief technology officer Wyand was and the programme remains ready to commence its planned global a“keyforce in building the rare disease pipeline”, Epirus noted. Phase III clinical study”, Epirus insisted. Shortly after his departure from Epirus, Munshi wasannounced As afurther cost-cutting initiative,Epirus will also slash up to 40% as president and chief executive officer of US biopharmaceutical of its total workforce, which stood at 73 as of the end of March this originator Arena Pharmaceuticals. year.“The focus on high-value biosimilars that treat rare diseases Under its newinitiative,Epirus will focus solely on developing necessitates arestructuring of operations,”Epirus explained. The firm its biosimilar versions of Alexion’sSoliris (eculizumab) and Roche’s added that the action wasalso in response “to the evolving biosimilar Actemra (tocilizumab). The former,developed under the name competitive and business landscape”, and would allowEpirus to “focus BOW080, wasamong abundle of three biosimilarcandidates, including on markets that are more targeted and may yield marketed products Janssen’sStelara (ustekinumab) and Simponi (golimumab), gained through amore capital-efficient development pathway”. when Epirus bought Dutch monoclonal antibody developer Bioceros With total net losses of US$155 million since its foundation in last year (Generics bulletin,2October 2015, page 23). January 2011, “as well as negative cash flows from operating activities”, Epirus, meanwhile, has marketing tie-ups for its BOW070 Epirus revealed that it currently “does not have sufficient cash resources tocilizumab candidate, including with Poland’sPolpharma in certain to meet its cash requirements for the 12 months following 31 March European Union (EU) markets, Turkey,Russia and the Commonwealth 2016”. “Management is in the process of evaluating various financial of Independent States (CIS), and with China’sLivzon for its domestic alternativesfor operations,”noted the firm. G

PROMOTIONS MANAGEMENT RESHUFFLES Perrigo’s Brown expands role Investor urges Stada changes errigo has expanded the responsibilities of its chief financial officer, tada should replace three of its nine supervisory board members, PJudy Brown,toalso include executive vice-president of the US Saccording to aproposal put forward by Active Ownership Capital, store brands specialist’sbusiness operations. “In this role, Judy will which owns ashare of more than 5% in the German group. Mooted have leadership of our global product portfolio and global shared replacementsinclude Active foundingpartner Klaus Röhrig. services platform,”commented Perrigo’spresident and chief executive “Stada has evolved from agenerics manufacturer operating in officer, John Hendrickson,“complementing her responsibilities for Germany,”Active states, “to aglobal pharmaceutical companywith an corporate development, finance, strategy,and communications.” international client base, without adapting the competencies of its Former WhirlpoolCorporation executive Brown has been with supervisory board accordingly.” Perrigo since September 2004, joining the firm as its corporate Stada has allowed the motion to be tabled for its annual general controller before being promoted to chief financial officer just under meeting on 9June “in order to avoid the substantial costs that would twoyears later.The latest addition to her duties comes in the wake of have been incurred in the case of legalaction” stemming from Hendrickson replacing Joe Papa after he left to lead Canada’sValeant. G refusing the request, and “to ensure aquick decision in this matter”. G

16 GENERICS bulletin 20 May2016