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Bulletin Publishing Group is a division of OTC Publications Ltd Registered Office: 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. Registered in England No 2765878 Gen 5-9-14 Pg. 1_Gen 18/11/05 Pg. 1 02/09/2014 17:47 Page 1
5September 2014
COMPANY NEWS 2 Global industrydemands Biocon begins filing forANDAs in the US 2 Bidvest mulls owning majority of Adcock 3 Amerigen teams up with China’sMenovo 4 Sawai is to develop for 5 full position within ICH selling overseas US injectables spikecarries Hikma to rise 6 Actavis sees plenty of targets to develop 7 he global generics industry should have equal status with the originator industry within Tthe International Conference on Harmonization (ICH) that develops global quality, Impax invigorated by authorised Renvela 8 safety and efficacy standards, according to aletter sent to the ICH’ssteering committee Vensun and ScieGen strike 9 by the International Generic Pharmaceutical Alliance (IGPA). 23 ANDAdeal Noting that the steering committee had at arecent meeting proposed limiting full participation Hungary’sRichter is hurtbyCIS troubles 10 to regulators and originator industry representativesfrom the European Union, Japan and US – Excelvision deal adds to Akorn’scapacity11 together with regulators from Canada and Switzerland – the IGPAsaid limiting its role to an Sterile products givePar growth injection 12 ‘ICH party’ would exclude it from decision-making processes within the steering committee, which could override recommendations of other ICH committees in which generics companies MARKET NEWS 13 could be represented. Giventhat generics suppliers nowaccounted for more than half of all prescriptions worldwide Belgian sales fall as prices suffer decline 13 – and 84% of prescriptions in the US –“the originator industry nowrepresents only aminority Romania’sAPMGR warns 14 of global pharmaceutical production”, the IGPApoints out in its letter. over clawback Recognising the ICH’sachievements and mission in harmonising drug quality,safety and efficacystandards, the body – representing the generics industry in Australia, Brazil, Canada, Judges assess around 100 awards entries 15 Europe, Japan, Jordan, Mexico, South Africa, Taiwan and the US – warns in the letter that FDAmeeting will coverGDUFAguides 16 “ifIGPAisnot included as asteering committee member,then we will be required to evaluate our continued relationship with, and involvement in, ICH”. G PRODUCT NEWS 17
Celltrion aims to lead 17 US monoclonal rivals Alvogen will buy Korea’s Dream Sandoz’ topical hits Germanyand Sweden 18 Hospira takes action over Precedex rivals 19 lvogen says it will create “one of South Korea’slargest generic pharmaceutical companies” Coherus and Daiichi begin Japanese trial 20 Aby acquiring Dream Pharma in an US$187 million cash deal that is scheduled for completion Mundipharma strikes EU 22 by the end of this year.The acquired firm will be combined with local player Kunwha that deal on infliximab Alvogen bought around 18 months ago (Generics bulletin,2November 2012, page 3), “adding Actavis falls shortinGralise attack in US 23 acomplementary portfolio of over100 products”. “Dream currently has an impressive 35% market share in obesity products in Korea, with FEATURES 26 no overlap with Kunwha’scurrent portfolio in the market,”Alvogen commented. “The consolidated business creates astrong platform for exports and abasis upon which to introduce Alvogenaims forUS$1bn 26 the Korean portfolio in other Asia-Pacific markets.” as it invests in biosimilars Observing that the Asia-Pacific pharma market remained highly fragmented, Alvogen Combining strong organic growth with pledged to “play aleading role in further industry consolidation, with afocus on building a acquisitions in the Asia-Pacific region will selective,high-quality product portfolio in markets such as Korea, Taiwan, Thailand, China, carry Alvogen’sgroup sales past US$1 Japan and Vietnam”. billion by 2017, chairmanand chief “Dream is an excellent business, and we are looking forward to collaborating with its high- executive Robert Wessman told Aidan Fry. calibre team as we work to fuel regional growth and to gain scale in the Korean market with a broader product offering,”stated Alvogen’spresident and chief executive officer,Robert Wessman. REGULARS Seoul-based Dream has built aleading position in Korea’sobesity treatments market through brands such as Panbesy (phentermine) 30mg sustained-release tablets. The firm’sbroad Events – Our regular listing 24 prescription and OTCportfolio – produced at its factory in Hyangnam, Korea – includes Estina Price Watch UK – Our in-depth 25 (ebastine) and Spasmex(trospium chloride). look at pricing trends in the UK Having recently merged its Asian operations into Lotus, the Taiwanese companyinwhich People – Desai succeeds Kay 31 it has taken a67% stake, Alvogen is working towards becoming “one of the top-fiveplayers as chief at Apotex in the Asia-Pacific market”. In 2017, the region is forecasted to makeupalmost aquarter of the company’sUS$1 billion turnover(see page 26). G Gen 5-9-14 Pgs. 2-12_Layout 1 02/09/2014 17:48 Page 2
COMPANY NEWS
BUSINESS STRATEGY/FIRST-HALF RESULTS BUSINESS STRATEGY/FIRST-QUARTERRESULTS Alkaloid establishes Biocon begins filing Slovenian laboratory for ANDAs in the US
acedonia’sAlkaloid has strengthened its ability to export to iocon has started filing abbreviated newdrug applications (ANDAs) MEuropean Union (EU) markets by registering atesting laboratory Bin the US, having submitted “several” during its financial first in Ljubljana, Slovenia, under name of Alka-Lab. quarter ended 30 June 2014. “Wehavebegun our foray into the US The Skopje-based companysaid it had invested around C0.6 million generics space,”stated managing director Kiran Mazumdar-Shaw, adding (US$0.8 million) in the wholly-owned laboratory,which would test that the Indian firm wasaiming to “move up the pharma value chain”. finished-product batches prior to their release for marketing in the EU. Furthermore, the Indian group intends to file its basal and Alkaloid’ssales in EU member states climbed by overafifth to recombinant human insulins in the US through the hybrid 505(b)(2) C3.54 million in the first half of this year,helping the group to increase route. And aPhase III clinical trial for the insulin glargine that Biocon its Pharma turnoverby9.0% to C50.9 million. is developing under apartnership with Mylan is scheduled to start later In the firm’slargest sales region, South-East Europe, Pharma this year,while construction continues of an insulins facility in Malaysia. turnovergrewby11.2% to C22.2 million, while sales in Russia and the Commonwealth of the Independent States rose by 5.7% to C3.57 million. Overcame Middle East turbulence The Macedonian company’sdomestic Pharma sales –which First-quarter group turnoverincreased by 3% to Rs7.42 billion accounted for overathird of its total turnover–advanced by 5.7% to (US$123 million), due mainly to a12% rise to Rs1.72 billion in C21.4 million. Including C9.52 million from non-Pharma business, revenues by the firm’sResearch Services division. Indian Branded Alkaloid increased its group turnoverby8.8% to C60.4 million. Formulations sales ahead by atenth to Rs1.11 billion more than With sales ahead by 22.7% to C9.96 million, OTCproducts made up for a1%dip to Rs4.36 billion in Biopharma turnoverthat accounted for almost afifth of Pharma turnover, as did cardiovascular Biocon attributed to “politicalturbulence” in the Middle East and drugs, which experienced a10.7% sales rise to C10.0 million. lower supplies of bulk fidaxomicin to Cubist Pharmaceuticals. Antibiotics and central nervous system drugs each made up a “Our statins business has been stable, while immunosuppressants sixth of the Pharma total. and specialty active pharmaceutical ingredient (API) manufacturing With the group’sgross margin 2.2 percentage points lower at continue to provide upsides,”Mazumdar-Shawcommented. 47.5%, its operating profit edged ahead by 1.7% to C5.34 million. G Biocon improvedits pre-tax profit by atenth to Rs1.38 billion. G
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2 GENERICS bulletin 5September 2014 Gen 5-9-14 Pgs. 2-12_Layout 1 02/09/2014 17:48 Page 3
COMPANY NEWS
BUSINESS STRATEGY/FIRST-QUARTERRESULTS MERGERS&ACQUISITIONS/NINE-MONTHRESULTS Ciplaisrolling out Bidvest mullsowning respiratoryinEurope majority of Adcock
ipla says its respiratory launch plans in Europe are “on track” as ncertaintyconcerning Adcock Ingram’s“current trading Cit rolls out an ipratropium metered-dose inhaler in the UK and Uperformance” is causing the South African firm’slargest amometasone nasal spray in the Netherlands. shareholder,Bidvest, to hold offincreasing its stakeinAdcock to “These are twoproducts where there are already several players,” above 35%, after Bidvest’sapplication to do so wasapprovedbySouth acknowledged investor relations head Anant Atal, adding that the Indian Africa’sCompetition Tribunal. “[Bidvest] continues to evaluate its firm would look to “get areasonable share” of the market for each position, buthas not determined whether to makeageneral offer to respiratory drug. Mometasoneapprovals would followin“select Adcock’sshareholders,”stated the conglomerate. European markets”, he added. Increasing its staketo34.5% earlierthis year (Generics bulletin, During the second half of this year,Atal noted, Cipla would unveil 14 February 2014, page 3) wassufficient to block CFR’sbid to take combination inhaler products. In Germany, the firm has just got clearance control of Adcock, after the Chilean firm had its offer of around US$1.3 for its Serroflo (salmeterol/fluticasone) 25µg/125µg and 25µg/250µg billion accepted by the South African firm. Adcock investors such as metered-dose inhalers. Cipla markets asimilar inhaler under the Duohal South Africa’sPublic Investment Corporation (PIC) also opposed the brand name in Croatia, where the firm at the end of last year boughtout deal. Since CFR’sfailed bid, Adcock has replaced both its chairman its local distributor,Celeris (Generics bulletin,10January 2014, page 2). and chief executive officer with senior Bidvest staff–Brian Joffe Atal said the deal Cipla had recently struck to market BioQuiddity’s and Kevin Wakeford respectively. pre-filled OneDose ReadyfusOR ropivacaine infusion system in countries including Germanywould give the Indian firm afoothold Impairments lead to large operating loss in Europe’shospital and critical-caresectors (Generics bulletin,8 Announcing an operating loss of ZAR975 million (US$91.7 August 2014, page 23). million) –due largely to asset impairments –onastatic turnoverof Chief financial officer Rajesh Garginsisted the firm’sacquisition ZAR3.62 billion in the nine months ended 30 June 2014, Wakeford of the 75% stakeinmonoclonal antibodies developer Mabpharm it warned he could not “promise areturn to profitability in the short term”. did not already ownwould allowCipla “to start to put in place our In abid to reverse the firm’s“dramaticreversal of fortunes” as its biological strategy” (Generics bulletin,8August 2014, page 3). management was“substantially pre-occupied with the CFR merger Having recently bought marketing platforms in Sri Lanka and proposal”, the newteam is restructuring Adcock into four divisions: Yemen (Generics bulletin,11July 2014, page 2), Cipla is assessing Consumer,OTC, Prescription and Critical Care. “opportunities to build front-ends in selected international markets”. A“particularly poor performance” by the South African group’s Early next year,the companyintends to launch its ownsales domestic OTCbusiness sawsales fall by 16.4% to ZAR1.14 billion as organisation in the US, where only around 40 of the 90 abbreviated total domestic turnoverdropped by 3.7% to ZAR3.25billion. Prescription newdrug applications (ANDAs) for which the firm holds final approval sales rose by 5.9% to ZAR1.39 billion despite “disappointing” generics are currently marketed by local partners. Cipla is currently building sales, and hospital turnoverincreased by 3.2% to ZAR721 million. up launch inventories, setting up supply-chain systems and ensuring Adcock’sturnoverinits Rest of Africa region climbed by 43.0% it has all the necessary state licences. to ZAR206 million, while Indian sales totalled ZAR178 million as Strong sales of asthma therapies, allergy remedies and antiretrovirals the firm’sCosme operation failed to meet the group’sexpectations. G –aswell as tender wins in South Africa for cardiovascular,mental health and women’shealth drugs –helped to lift Cipla’sformulations exports turnoverby12.7% to Rs12.2 billion (US$200 million) in the LITIGATION/MANUFACTURING company’sfinancial first quarter ended 30 June 2014. Total exports increased by 10.5% to Rs13.6 billion as active pharmaceutical ingredient Apotex loses NAFTAdispute (API) sales outside of India dipped by 5.4% to Rs1.40billion. With Indian sales 17.0% higher at Rs12.9 billion on growth in nimport alert issued by the US Food and Drug Administration respiratory,anti-infective and cardiovascular therapies, group turnover A(FDA) against Apotex’ twoOntario plants in Etobicokeand Signet advanced by 13.6% to Rs26.5 billion (see Figure 1). Drive,North York from 2009 to 2011 waslawful and did not violate But Cipla’spre-tax profit declined by athird to Rs4.23 billion, US obligations under the North America Free Trade Agreement due in part to a45.8% increaseinemployee-benefits expenses. G (NAFTA), athree-member NAFTAtribunal has determined.The Canadian firm –which had sought up to US$1.5 billion in damages – First-quarter sales* Change Proportion also lost its claim that the import alert wasissued by the FDA“without (Rs millions) (%) of total (%) due process” and “in violation of the customary international law minimum standard of treatment”. Formulations 12,180 +12.7 46 Having had the alert lifted three years ago, Apotexin2012 brought APIs 1,400 -5.4 5 arbitration against the US under NAFTA(Generics bulletin,23March Exports 13,580 +10.5 51 2012, page 3). However, the tribunal ruled that the FDAhad acted India 12,890 +17.0 49 lawfully,and ordered Apotextopay all of the agency’slegal fees, as Cipla 26,470 +13.6 100 well as 75% of arbitration costs. Arguing that the import alert had “effectively removedApotex *rounded to nearest Rs10 million from the US solid-dose drug market for almost twoyears”, the Canadian Figure1:Breakdown of Cipla’s sales in its financial first quarter ended 30 June firm’snewly-appointed head, Jeremy Desai (see page 31), said Apotex 2014 (Source –Cipla) remained “strongly committed to the US market”. G
5September 2014 GENERICS bulletin 3 Gen 5-9-14 Pgs. 2-12_Layout 1 02/09/2014 17:48 Page 4
COMPANY NEWS
STRATEGICALLIANCES FIRST-QUARTERRESULTS Amerigen teams up US import block hits with China’s Menovo sales by Wockhardt
merigen Pharmaceuticals has teamed up with China’sNingbo slump of more than three-fifths in Wockhardt’sUSsales has led the AMenovo to develop generics, primarily for the US market. Menovo AIndian firm to report aturnoverthat fell by more than aquarter will be responsible for manufacturing the active pharmaceutical –27.0% –toRs9.91 billion (US$163 million) in its financial first ingredients (APIs) and the finished products, whereas Amerigen will quarter ended 30 June 2014. Earnings before interest,tax, depreciation takecharge of clinical,regulatory and US commercial activities. and amortisation (EBITDA) plummeted by 85.5% to Rs610 million. Furthermore, the US firm –which focuses on oral-dose products – The decline followed US Food and Drug Administration (FDA) import will help Menovo to obtain US Food and Drug Administration (FDA) alerts for the firm’sIndian facilities in Chikalthana and Waluj. approvalfor its finished-dose facility in Daxie, China. “The status on the import alerts on the Chikalthana and Waluj “Our first product opportunity leverages formulation work already facilities remains unchanged,”Wockhardt confirmed. undertaken by Amerigen at its Suzhou facility and Menovo’s leading Sales in the US fell by 60.3% to Rs2.87 billion (see Figure 1) as position with the corresponding API,”revealed the US company’s the firm filed 13 abbreviated newdrug applications (ANDAs) during president and chief executive officer,John Lowry. G the quarter.Wockhardt also received‘Form 483’ observations relating to quality controls and procedures at its US Morton Grove facility. In Europe, turnovergrowth in France of more than two-thirds to FIRST-QUARTERRESULTS Rs470 million more than offset sales in the rest of the region that slid by 0.6% to Rs2.97 billion, providing aEuropean total of Rs3.44 billion.
US grows Cadilabyaquarter Region First-quarter sales Change Proportion lmost doubling its formulation exports to the US enabled Zydus (Rs millions*) (%) of total (%) ACadila to report group gross turnoverahead by aquarter to Rs20.6 India/Emerging 3,610 +16.5 36 billion (US$336 million) in its financial first quarter ended 30 June 2014. Four launches contributed to an 87.6% leap to Rs7.17 billion US 2,870 -60.3 29 in the US, where the firm filed 26 abbreviated newdrug applications UK 2,370 ±0 24 (ANDAs) during the quarter. Ireland 440 +13.1 4 European Formulations turnoverrose by 9.1% to Rs1.01 billion, France 470 +68.9 5 while Latin American sales contributed Rs544 million, and other Other 160 –2 markets Rs1.05 billion, to total Formulations Exports that advanced Europe 3,440 ~+5.3 35 by 55.8% to Rs9.77 billion. Exports of active pharmaceutical ingredients (APIs) strengthened by asixth to Rs767 million, while animal-health Wockhardt 9,910 -27.0 100 and other products added another Rs132 million. *rounded to the nearest Rs10 million The Indian firm’sdomestic formulations turnoverincreased by 8.0% to Rs6.75 billion, aided by 19 launches, while other operations Figure1:Breakdown by region of Wockhardt’s sales in its financial first quarter in India contributed Rs1.96 billion. G ended 30 June 2014 (Source –Wockhardt)
5September 2014 Issue 217 published 20 times ayear – twice monthly, except and areprotected by copyright, trademark and other laws. monthlyinJuly, August, December and January, and Editor: Aidan Fry Subscription enquiries: As left, or delivered by air mail – and afreeweeklyemail [email protected] Deputy Editor: David Wallace newsflash News@Genericsbulletin published 46 Assistant Editor: Liudmila Kotko times ayear.Individual annual subscriptions in Europe Te rms &Conditions: No partofthis publication maybe copied, reproduced, stored in aretrieval system, distributed cost £620 (additional copies at the same address Business Reporter: Dean Rudge or transmitted by anymeans, including electronic,mechanical, Production Controller: Debi Minal £395); outside Europe £650 (£425). photocopying or recording, without the prior written Production Editor: Jenna Meredith The 20 Generics bulletin newsletters arenow available permission of the publisher,orunder the terms and conditions as adigital edition, Generics bulletin-i,for either of aGlobal Site Licence or of alicence issued by the Copyright Director of Subscriptions: ValDavis Licensing Agency (CLA) in London, UK, or rights bodies in Apple or Android mobile devices at acost of £895. Group Sales Manager: Anisa Shan other countries that have reciprocal agreements with the CLA. This subscription includes News@Genericsbulletin. Awards Manager: Natalie Cornwell Neither maythis publication be exported, distributed or Managing Director: MikeRice Acombined annual subscription to Generics bulletin circulated by anymeans outside the staff who work at the (hard-copynewsletter plus weekly email newsflash)and address to which it is sent by the publisher without the prior written permission of the publisher. Editorial enquiries: GENERICS bulletin, Generics bulletin-i (digital edition)costs £1,095. 4Poplar Road, Dorridge,Solihull, While due carehas been taken to ensurethe accuracy of Single hard-copynewsletters cost £50 each. Subscription information contained in this publication, the publisher makes West Midlands B93 8DB, UK. rates maybeadjusted to coverany period and can be no claim that it is free of errorand disclaims anyliability Website: www.generics-bulletin.com backdated. Subscriptions mayonlybecancelled at expiry. whatsoeverfor anydecisions or actions taken as aresult Te l: +44 (0)1564 777550 Fax: +44 (0)1564 777524 of its contents. Corporate subscriptions: Global Site Licences are E-mail: [email protected] ® available to companies.These provide in-house electronic ©OTC Publications Ltd.All rights reserved. Generics bulletin Advertising enquiries: is registered as atrademark in the European Community. access forstaff to Generics bulletin or Generics As above,[email protected] bulletin-i and [email protected] ask for ISSN 1742-0784. SUBSCRIPTIONS aquotation. Such licences aresupplied strictlyonthe Companyregistered in England No 2765878. Individual subscriptions: A GENERICS bulletin condition that both publications arethe intellectual Printed by Warwick Printing CompanyLimited, annual subscription includes this hard-copynewsletter property of the copyright holder,OTC Publications Ltd, Leamington Spa CV31 1QD, UK.
4 GENERICS bulletin 5September 2014 Gen 5-9-14 Pgs. 2-12_Layout 1 02/09/2014 17:48 Page 5
COMPANY NEWS
BUSINESS STRATEGY/FIRST-QUARTERRESULTS BUSINESS STRATEGY/SECOND-QUARTERRESULTS Sawai is to develop European OTC option for selling overseas gets Mylan attention
research and development centre that SawaiPharmaceutical is ylan intends to explore opportunitiestobuild up an OTCoperation Asetting up in Suita City near Osaka, Japan, is being built to conform Min Europe to complement the US company’spending US$5.3 to US and European, as well as local, good manufacturing practice billion purchase from Abbott of aroster of more than 100 mature brands (GMP) standards, enabling the Japanese generics specialist to develop and branded generics in developed markets. drugs for overseas markets. “Weplan to invest atotal of ¥6 billion “Wethink OTCisaninteresting channel, in some respects outside (US$58 million) in this facility,which is scheduled to open by October the US more than inside the US,”chief executive officer Heather 2015,”the companyrevealed. Bresch told investors. Observing that pharmacists were independent While expanding beyond Japan remained astrategic goal and in much of Europe, Bresch identified an opportunity for Mylan to “source of future growth” for Sawai, president Mitsuo Sawaiadmitted “build abrand presence” behind and in front of the pharmacycounter. that overseas markets were “unlikely to contribute to short-term financial “The Abbott transaction certainly givesusabeginning foothold performance”. Nevertheless, he said, the Japanese companywas “making on OTC,”Bresch stated. “Wehavegot real opportunitiestolook at preparations” to move into other countries as it worked on establishing some of these brands that we are nowacquiring, as well as perhaps itself as Japan’s“number one” generics supplier. to add some products that would be very strategic and would allow During its recent reviewofmedical-service fees, the Japanese us to build upon the Mylan equity through all channels in Europe.” government –which in 2013 set atarget of 60% generic penetration Positive currencyshifts accounted for half of areported 10% uplift of the off-patent market –amended generic dispensing premiums to US$396 million in Mylan’sEuropean Generics sales in the second intended to encourage pharmacists to dispense generics, and also quarter of 2014. The US-based firm –which will switch its tax domicile introduced ageneric drug indextoencourage hospitals operating under to the Netherlands via the Abbott deal –said its European growth the diagnosis procedure combination (DPC) system to use generics. was“primarily the result of increasedvolumes in Italy and France”. Meanwhile, asales-tax increase heightened patients’ cost-awareness. Mylan’sglobal Generics sales rose by 5% to US$1.53 billion (see Figure 1), as North American Generics turnoveradvanced by 3% to Demand to reach 73 billion tablets in 2018 US$737 million, aided by sales from acquired businesses such as the “These measures are expected to result in dramaticgrowth in the Agila injectables unit. quantities of generic drugs sold,”Sawai stated. “Our forecasts indicate Generics sales in the rest of the world grewby6%toUS$396 that sales of generic drugs in our domestic market will increase by 30 million –orby11% on aconstant-currencybasis –fuelled by strong billion tablets overthe next five years, from 43 billion tablets per year antiretroviral sales and “double-digit growth” on higher volumes and in 2013 to 73 billion in 2018.” product launches in Japan, where apartnership with Pfizer wasexceeding But the Japanese firm observed that higher volumes would come the firm’sexpectations.Mylan said its Australiansales fell due to at reduced prices, as the government had approvedpricing reforms lower volumes and a“significant government-imposed pricing reform”. that would introduce cuts for existing products based on the rates of At the end of the quarter,Mylan paid US$50 million for “certain generic penetration, set aceiling of 60% of the brand price for new product rights and other intangible assets” in Australia,New Zealand generics, and group reimbursed generics into three brands. “These and Brazil. Acompanyspokesperson declined to divulge further details. changes to the drug-pricing system represent an extremely serious Group turnoverahead by 8% to US$1.84 billion included Specialty challenge for the generic-drug industry and will create amuch harsher sales that rose by 22% to US$288 million on higher prices and market business environment,”Sawai warned. expansion for EpiPen (epinephrine). But adirect-to-consumer marketing Pledging to “avoid simple price wars”, Sawaisaid it would focus campaign for EpiPen combined with higher legaland marketing costs on its strengths in development capabilities, areliable supply chain to support generic launches in North America, legal-settlement fees and areputation for quality. and research and development investment in biosimilar and respiratory Having launched 11 products based on six active ingredients in projects to cut the group’soperating profit by 27% to US$226 million. June 2014, Sawaisaid it would increase its researchand development Forecasting full-year group sales of US$7.8-US$8.0 billion, Bresch investment in its current financial year by more than afifth to ¥6.3 said she anticipated US launches of generic Copaxone (glatiramer billion. The firm is aiming to differentiate itself on commodity generics acetate) and Celebrex(celecoxib) by the end of this year. G such as valsartan, such as by laser-printing information about the products directly onto tablets. To ensure it can meet the anticipated rise in demand, Sawaiis Business Second-quarter sales Reported Constant-currency segment (US$ millions) change(%) change (%) expanding its Kanto facility to make3.5 billion tablets per year,taking the group’sannual capacityto10billion tablets. North America 737 +3 +3 Currently in the final 12 months of athree-yearbusiness plan, Europe 396 +10 +5 Sawainow expects to increase its turnoverbyaround 18% to ¥106 Rest of World 396 +6 +11 billion in the year ending March 2015, exceeding the plan’sinitial Generics 1,529 +5 +6 target of ¥104 billion. The firm anticipates hitting its earnings goal of an operating profit of ¥21.0 billion. Specialty 288 +22 +22 Lower gross margins following National Health Insurance (NHI) Other 21 +46 – price cuts contributed to Sawai’soperating profit falling by 13.8% to Mylan 1,837 +8 +8 ¥5.03 billion in the firm’sfinancial first quarter ended 30 June 2014. The profit slide came despite a14.7% turnoverrise to ¥25.1 billion Figure1:Breakdown by business segment and region of Mylan’s sales in the on “soaring demand for low-price products”. G second quarter of 2014 (Source –Mylan)
5September 2014 GENERICS bulletin 5 Gen 5-9-14 Pgs. 2-12_Layout 1 02/09/2014 17:48 Page 6
COMPANY NEWS
ANNUAL RESULTS FIRST-HALF RESULTS Perrigo Prescription US Injectables spike unit nears US$1bn carries Hikma to rise
ntegrating several acquisitions enabled Perrigo to increase the turnover SInjectablesturnoverjumping by overthree-fifths to US$268 Iof its Prescription Pharmaceuticals division by 31% to US$927 Umillion wasalmost entirely behind Hikma’s16% group sales rise million in its financial year ended 28 June 2014. This wasahead of to US$738 million in the first half of 2014. the growth of 25% to 29% that the Ireland-based firm had forecasted US sales made up overthree-quarters of global Injectables turnover last year (Generics bulletin,6September 2013, page 7). that increased by 41% to US$346 million (see Figure 1). Lower sales A£180 million (US$297 million) move for UK-based liquids in Algeria caused Middle East and North African (MENA) turnover specialist Rosemont and Perrigo’sUS$129 million purchase of nine to stall at US$40 million, while a“reduction in contract-manufacturing ophthalmic generics from Fera (Generics bulletin,28June 2013, page services” in Europe –caused by reallocating capacity to enhance US 21) contributed US$83.7 million of the total US$218 million increase production –offset “double-digit” growth of Hikma’sown products, in Prescription sales. Another US$106 million came from products as European Injectables turnoverslid by 7% to US$38 million. introduced during the 12-month period such as fluocinonide cream Having launched 12 injectables across the globe in the first half and its at-risk launch of ageneric rivaltoMeda’sAstepro (azelastine) of this year –and received46regulatory approvals combined in MENA 0.15% nasal spray (Generics bulletin,16May 2014, page 25). and Europe –the Jordanian firm took steps to further expand its Rosemont and Fera, as well as favourable pricing, lifted the injectables portfolio and pipeline by acquiring Bedford Laboratories, Prescription unit’sgross margin by 1.8 percentagepoints to 52.8%, while the generic sales and marketing division of Boehringer Ingelheim’s its operating margin improvedby0.6 points to 37.7% (see Figure 1). Ben Venue subsidiary,inadeal worth US$300 million (Generics But the group’soperating margin weakened by 5.2 points to bulletin,6June 2014, page 3). Soon after,Hikma exercised an option 14.0% as it wasdented by restructuring and intangible amortisation to buy“substantially all of the assets” of Ben Venue’sproduction site (Generics bulletin,8August 2014, page 3). Business Annual sales Change Operating Said Darwazah, Hikma’schief executive officer,told investors segment (US$ millions) (%) margin (%) that the firm did not currently have plans to reactivate operations at Ben Venue, which were discontinued in December 2013. “For the time Consumer Healthcare2,219 +6 16.6 being, we don’tfeel we need the capacity,” he commented, adding Prescription Pharma 927 +31 37.7 that the firm wastransferring equipmenttoUSand European sites. Nutritionals 552 +9 7.3 Furthermore, Hikma has just submitted its first pre-filled syringe Specialty Sciences 147 –-46.7 to the US Food and Drug Administration (FDA), having installeda API 138 -14 33.5 pre-filled syringe line at its US Cherry Hill site in order to capitalise Other 79 +7 5.2 on its 2013 supply agreement with US drug-delivery specialist Unilife. Just over17% of group turnovercame from the Jordanian firm’s Perrigo 4,060 +15 14.0* US solid-dose Generics segment, where sales dipped by 3% to US$128 *includes US$173 million of unallocated expenses million. Hikma has re-introduced 10 generics during the first half of this year,having in the period receivedaclose-out letter from the FDA Figure1:Breakdown by business segment of Perrigo’s sales and operating margin in its financial year ended 29 June 2014 (Source –Perrigo) for its solid-dose facility in Eatontown, NewJersey, that lifted awarning letter receivedin2012 (Generics bulletin,18April 2014, page 7). charges at the loss-making Specialty Sciences division, which covers Meanwhile, “strong” growth in Egypt and Saudi Arabia helped to the rights to the Tysabri (natalizumab) multiple-sclerosis drug that offset the effect of “politicaldisruptions” in Iraq, Libya and Sudan, as Perrigo gained through its US$8.6 billion takeoverofElan. the firm’sBranded Generics sales rose by 1% to US$259 million. IncludingElan, group turnoverrose by 15% to US$4.06 billion. Boosted by strong Injectables and Generics margins, Hikma’s Perrigo said this represented organic sales growth of 7%. That rise was operating profit increasedbyalmost two-thirds to US$236 million. G achieveddespite a14% decline to US$138 million in active pharmaceutical ingredient (API) sales as supplying temozolomide for Business First-halfsales Change Operating Teva to market in the US failed to offset pressure on other bulk drugs. segment (US$ millions) (%) margin (%) With 31 abbreviated newdrug applications (ANDAs) pending approval–including five Perrigo said were confirmed first-to-file US 268 +62 – opportunities, plus twodate-certain first-to-file launches –Perrigo MENA40±0– insists it has the strongest Prescription pipeline in its history.The five Europe 38 -7 – first-to-file opportunities include ageneric version of Androgel Injectables 346 +41 40.5 (testosterone) 1.62% gel, which will join the 1.0% strength for which Branded 259 +1 18.9 the firm has just secured an ‘AB’ substitutable rating. As well as Androgel 1.62%, Perrigo is also embroiled in Generics 128 -3 60.9 paragraph IV patent litigation overAxiron (testosterone) 2% topical Others 5+67 –* solution and Topicort (desoximetasone) 0.25% spray. Hikma 738 +16 32.0** In its current financial year ending June 2015, Perrigo expects a generic of Clobex(clobetasol) spray as well as at least eight undisclosed *operating loss of US$3 million products to contribute to Prescription sales growth of 5% to 9%, which ** includes unallocated corporate expenses of US$28 million should takethe division’sturnovertoaround US$1.0 billion. The firm Figure1:Breakdown by business segment of Hikma Pharmaceutcals’ sales and is forecasting a7%to11% increaseingroup turnover. G operating margin in the first half of 2014 (Source –Hikma)
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COMPANY NEWS
BUSINESS STRATEGY/FIRST-QUARTERRESULTS BUSINESS STRATEGY/SECOND-QUARTERRESULTS Aurobindo will halve Actavis sees plenty loss on Actavis deal of targets to develop
urobindo Pharma is confident that it will during its current financial ctavis has “ample” generic development projects, both in the US Ayear more than halvethe operating loss of the former Actavis Aand in other countries, according to the group’sexecutive chairman, operations in western Europe that the Indian group acquired on 1April. Paul Bisaro. “Despite concerns otherwise, there is no shortage of Noting that the operations in sevencountries had been making an opportunities for generic development in the US market,”Bisaro told annual loss of C23 million (US$18 million) at earnings before interest, investors. “In the first half of this year,wehaveidentified 41 new tax, depreciation and amortisation (EBITDA) levelupon acquisition, products for development,”hesaid, noting that these included 23 Aurobindo’schief executive officer,Arvind Vasudeva,said the Indian first-to-file and 10 first-to-market opportunities. Among 24 abbreviated firm would cut the loss to around C10 million by March 2015. newdrug applications (ANDAs) submitted during the first six months Noting that the acquired business wasgrowing at ahigh single-digit of 2014 were 11 potential first-to-file products. rate, Vasudeva said Aurobindo wasfocusing on more profitable “Outside the US,”Bisaro continued, “we continue to see ample products in Europe and on procuring products for tenders at lower cost development opportunities as Actavis and [third-party dossier supplier] Medis have filed close to 1,000 marketing authorisations in the first Business First-quarter sales Change Proportion of half of the year.” He anticipated that 362 submissions made using segment (Rs millions) (%) total (%) neworexisting dossiers outside of the US would result in just over 700 marketing authorisations, while Medis’ 125 filings would yield US 11,157 +78.6 38 288 national authorisations. Europe 7,982 +359.0 27 Launching OTCproducts in Finland and Switzerland contributed Rest of world 1,369 +24.5 5 to International sales by Actavis Pharma outside of North America Antiretrovirals 2,242 +16.9 8 edging ahead by 0.4% to US$622 million in the second quarter of Formulations 22,750+106.7 78 this year.The negative effect of divesting operations in sevenwestern Semi-synthetic penicillins 2,385 +7.3 8 European countries to Aurobindo on 1April were offset by strong Cephalosporins 2,120 -2.0 7 performances from Actavis’ remaining operations in Ireland, the UK, Non-betalactam 2,198 +5.5 8 Nordic countries and several other markets. “Weare nowthe second- Active Ingredients 6,703 +3.6 23 largest generics companyinIreland,”Bisaro proclaimed. Dossier income 18 -40.0 – Expanding its OTCportfolio washelping Actavis to outperform the local market in Russia and the Commonwealth of Independent Eliminations -360 –-1 States, Bisaro observed, while acquiring Silom Medical in April had Aurobindo 29,111 +69.7 100 made the group the fourth-largest generics player in Thailand and givenitabase from which to expand in south-east Asia (Generics Figure1:Breakdown by business segment of Aurobindo Pharma’s sales in its bulletin,18April 2014, page 3). And Actavis had been first-to-market financial first quarter ended 30 June 2014 (Source –Aurobindo) in Indonesia with aripiprazole tablets, oral solution and injectable forms. of goods, butbringing production in-housethrough facility transfers “In Canada,”Bisaro continued, “we became the fifth-largest could take18to24months. Launching Aurobindo’sown portfolio of generics company.”Afurther sevenproduct launches were scheduled injectables in Europe would start in around 18 months’ time, he added. in Canada this year,herevealed. The acquired operations in Belgium, France, Germany, Italy,the Weaker than anticipated competition to the firm’sUSgeneric Netherlands, Portugal and Spain –which Aurobindo expects to break versions of Cymbalta (duloxetine) and Lidoderm (lidocaine)helped to even at EBITDAlevel in its 2015-2016financial year –contributed raise North American Generics sales by 9% to US$1.03billion (see Rs6.24 billion (US$103 million) to total European Formulationssales Figure 1), even though Actavis faced additional competition to its that increased more than four-fold to Rs7.98 billion in the firm’s authorised generic of Janssen’sConcerta (methylphenidate). financial first quarter ended 30 June 2014. Vasudeva said Aurobindo’s IncludingUS$587 million from North American Brands, global legacy operation in France had benefitted from launching moxifloxacin. generics and brands turnoverbythe Actavis Pharma division climbed Europe accounted for just overathird of Aurobindo’stotal by 31% to US$2.24 billion. The firm’sAnda Distribution unit added Formulations turnoverthat more than doubled to Rs22.8 billion (see US$427 million to group turnoverthat rose by 34% to US$2.67 Figure 1). Half of that total wasachievedinthe US, where sales rose billion. The group posted an operating profit of US$206 million. G by 78.6% to Rs11.2 billion, aided by introducing generic Adderall (amphetamine salts). Atotal of 40 abbreviated newdrug application Second-quarter sales Change Proportion (ANDA) submissionsduring the quarter ahead of increased stability (US$ millions) (%) of total (%) requirements took the company’stotal ANDAfilings by June 2014 North American Generics 1,031 +9 39 to 376, of which 168 had receivedfinal approval. North American Brands 587 +306 22 Formulations turnoverinthe Indian group’sRest of the World region rose by aquarter to Rs1.37 billion, while its global sales of International 622 ±0 23 finished-dose antiretrovirals climbed by 16.9% to Rs2.24 billion. Actavis Pharma 2,240 +31 84 Group turnoveradvanced by 69.7% to Rs29.1 billion as total Anda Distribution 427 +55 16 Active Ingredients sales grewby3.6% to Rs6.70 billion on higher sales Actavis 2,667 +34 100 of semi-synthetic penicillins and non-betalactam bulk drugs. Aurobindo expects early next year to conclude validation of 1,100 cubic metres Figure1:Breakdown by business unit of Actavis’ sales in the second quarter of of extra capacity at its Unit 11 bulk-drugs facility in Vizag, India.G 2014 (Source –Actavis)
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COMPANY NEWS
THIRD-QUARTER RESULTS SECOND-QUARTERRESULTS Oxycodone advance Impax invigorated by assists Mallinckrodt authorised Renvela
rebling its sales of methylphenidate extended-release tablets and ntroducing an authorised generic of Sanofi’sRenvela (sevelamer Tsubstantially increasing its turnoverofbulk and finished-dose Icarbonate) tablets in the US helped Impax Laboratories’ Global oxycodone helped Mallinckrodt to raise its total sales of generics and Pharmaceuticals generics turnovertosoar by 87.7% to US$176 million active pharmaceutical ingredients (APIs) by 29.8% to US$329 million in the second quarter of this year.The agreement for the kidney-disease in the US firm’sfinancial third quarter ended 27 June 2014. treatment –struck early in the quarter (Generics bulletin,2May Group turnover, including brands and medical-imaging agents, 2014, page 14) –covered a“specified number of bottles”, which advanced by 14.6% to US$653 million (see Figure 1). Global Pharmaceuticals head Carole Ben-Maimon noted would “sell Mallinckrodt said it had benefitted from “positive sales trends” as through to mid-September”. its methylphenidate sales shot up by 214% to US$54.7 million. “Strategic However, Impax’ pursuit to market its owngeneric sevelamer – pricing initiatives” helped to lift turnoverfrom oxycodone –inboth along with several other abbreviated newdrug applications (ANDAs), tablet and bulk forms –by50.3% to US$53.8 million, and also lifted and its novelParkinson’sdisease treatment Rytary (carbidopa/levodopa) sales of other controlled substances by afifth to US$154 million. –continues to be hindered by quality issues at its manufacturing These gains more than compensated for a30.1% decline to US$25.3 facility in Hayward, California. The US firm receivedafurther million in sales of hydrocodone tablets and API. setback when arecent US Food and Drug Administration (FDA) Afirst-time contribution of US$53.2 million from the Ofirmev inspection of the plant concluded with sevenForm 483 observations, (acetaminophen) injectable brand acquired in March this year lifted twoofwhich were repeat observations (Generics bulletin,8August Brands sales by 54.6% to US$84.9 million 2014, page 3). Aseparate inspection of Impax’ facility in Taiwan also Amortisation and patent-litigation charges linked to Ofirmev– highlighted quality deficiencies, triggering class-action lawsuits. along with US$16.6 million of transaction costs as part of the firm’s “The observations were of things that should neverhappen here,” US$5.8 billion takeoverofActhar Gel (corticotropin) owner Questcor Impax’ president and chief executive officer,Fred Wilkinson, told that closed in mid-August –were largely responsible for Mallinckrodt investors of the manufacturing issues at Hayward as he celebrated his recording an operating loss of US$4.4 million. G 100th day in charge (Generics bulletin,2May 2014, page 27). However, he stressed: “I think the nature of these observations are all answerable.” Third-quarter sales Change Proportion Along with sevelamer –which Impax could have launched on (US$ millions) (%) of total (%) 16 March this year had it obtained approvalintime –the US firm is also awaiting FDAapprovalfor arivaltoJanssen’sConcerta Methylphenidate ER 54.7 +214.4 8 (methylphenidate) extended-release tablets, as well as for ageneric Oxycodone 53.8 +50.3 8 version of Daiichi Sankyo and Sanofi’sWelchol (colesevelam) tablets Hydrocodone 25.3 -30.1 4 (Generics bulletin,15July 2011, page 15). “[Sevelamer] is avery Other controlled substances 154.4 +20.5 24 challenging product,”Ben-Maimon acknowledged, adding that the Others41.2 +13.8 6 firm would continue to “pursue its ANDAs”. Generics &APIs 329.4 +29.8 50 With the uncertainty surrounding approvals, Impax’ generics arm washanded aboost when Actavis wasmade to divest to the US firm its Brands 84.9 +54.6 13 ursodiol tablets –which Impax launched immediately –and lamotrigine Medical Imaging 227.1 -8.4 35 orally-disintegrating tablets, which Impax said it would introduce “by the end of the year”, to complete Actavis’ US$25 billion move for Other 11.7 -13.3 2 Forest Laboratories(Generics bulletin,11July 2014, page 3). Mallinckrodt 653.1 +14.6 100 Those increased generics sales more than helped offset the continued deterioration of the US firm’sbrands business –inwhich Figure1:Breakdown of Mallinckrodt’s sales in its financial thirdquarter ended 27 fierce generic competition to Zomig (zolmitriptan) tablets caused June 2014 (Source –Mallinckrodt) branded sales to plummet by more than two-thirds to US$11.7 million – as group turnoverrose by 45.1% to US$188 million (see Figure 1). Coupled with lower patent-litigation and selling, general and THIRD-QUARTER RESULTS administrative expenses, the much-improvedgenerics sales saw Impax report an operating profit of US$53.9million –compared to Orchid’s sales grow by 11% US$5.77 million in the second quarter of 2013 –giving it an operating rchid Chemicals &Pharmaceuticals reported turnoverahead by margin that leapt by 24.3 percentage points to 28.7%. G O11% to Rs2.85 billion (US$47.2 million) in its financial third quarter ended 30 June 2014. But the Indian firm posted apre-tax loss Division Second-quarter sales Change Gross of Rs778 million, due in large part to interestexpenses. (US$ millions) (%) margin (%) Having recently restructured its debt and completed the sale of its penicillin and penem active pharmaceutical ingredient (API) business Generics 176.4 +87.7 60.4 and manufacturing facility located in Aurangabad, India –along Brands 11.7 -67.1 27.7 with aChennai development centre –toHospira nearly twoyears Impax 188.1 +45.1 58.4 after the deal wasfirst announced (Generics bulletin,11July 2014, page 8), the Indian firm was, its managing director KRaghavendra Figure1:Breakdown by division of Impax Laboratories’ sales and gross margin in Rao insisted, “on track to regain its position in the market”. G the second quarter of 2014 (Source –Impax)
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COMPANY NEWS
FIRST-QUARTERRESULTS STRATEGICALLIANCES Japan’s Towa grows Vensun and ScieGen ahead of rise in tax strike 23 ANDA deal
owasaid atemporary increase in demand ahead of arise in sales S-based generics players Vensun Pharmaceuticals and ScieGen Ttaxes waspartly responsible for the Japanese company’ssales UPharmaceuticals have struck adeal to develop and market 23 jumping by 12.9% to ¥16.5 billion (US$161 million) in its financial abbreviated newdrug applications (ANDAs). first quarter ended 30 June 2014. “Sales in April exceeded the plan, and Under the terms of the agreement –for which financial terms sales in the other months are in line with the plan,”Towaobserved, were not disclosed –the prescription generics will upon final US referring to the firm’starget of achieving full-year sales of ¥72.0 billion. Food and Drug Administration (FDA) approvalbemanufactured by Moreover, the firm said its rise in turnoverhad also been driven ScieGen –asubsidiary of food supplement companyBactolac by asales bump ahead of price changes due to Japanese regulations Pharmaceuticals –atits 10,900 sq msolid-dose facility in Long that will see generics grouped into three separate price bands. Island, NewYork, which is capable of making both immediate- and extended-release tablets and capsules. The drugs will then be supplied Operating margin rose by half apoint to Vensun, which will be responsible for marketing and distribution. Despite research and development costs for the quarter increasing Noting that twoofthe ANDAs had already receivedfinal US by athird to ¥1.30 billion –aspart of plans to spend ¥6.7 billion across approval, privately-owned Vensun –which is developing a“unique the entire financial year –Towawas nevertheless able to raise its portfolio of complexgenerics” and already has apipeline of 20 filed operating profit by 17.5% to ¥2.10 billion, and its operating margin ANDAs –said the launch of the first product “was under way”, with by half apercentage point to 12.7%. This wasdue to the firm’scost several more launches scheduled by the end of this year.According to of goods rising by just 7.3% to ¥8.31 billion –or50.4% of sales IMS Health data, the 23 molecules covered by the deal have combined compared to 53.0% last year –asaresult of cheaper outsourced annual US sales of approximately US$6 billion. manufacturing and afall in depreciation costs. “With the combination of our internal product-development Towa also maintained its trend of increasing the proportion of programme and pipeline of ScieGen products, we will be offering a its sales that were made directly –rather than through sales agents broad and attractiveportfolio of generic drugs to our customers,” –with the figure rising by three percentage points to 58.2% as the commented Hem Pandya, president and chief executive officer of firm opened newsales offices. G Vensun, which wasset up three years ago in Yardley, Pennsylvania. G
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COMPANY NEWS
FIRST-QUARTERRESULTS FIRST-HALF RESULTS Sun grows ahead of Hungary’s Richter is closing Ranbaxy deal hurtbyCIS troubles
ouble-digit growth in Formulations sales enabled Sun Pharma to harmaceutical sales in Russia and the Commonwealthof Dincrease its group gross sales by 13.0% to Rs39.8 billion (US$655 PIndependent States (CIS) sliding by almost afifth to C199 million million) in the Indian firm’sfinancial first quarter ended 30 June 2014. (US$265 million) were largely behind Gedeon Richter’stotal pharma At constant exchange rates, group turnoveradvanced by 7% as Sun sales falling by 6.7% to C491 million (see Figure 1) in the first half awaits clearance from antitrust authorities in India and the US for its of this year.Double-digit declines in Russia and Ukraine more than planned US$4.0 billion acquisition of Ranbaxy (see page 12). cancelled out “notable sales growth” of 17.0% to C41.3 million in Managing director Dilip Shanghvi said Sun’srecent acquisitions other CIS countries, such as Belarus and Uzbekistan. of dermatology specialist Dusa and URL’s generics portfolio in the In Russia, currencydeflation and the continued fallout resulting US were “doing better that we had originally expected”. from destocking in the fourth quarter of last year –which Richter said “Wecontinued to enjoythe benefits of lowcompetition for certain had led to “increased competition at both wholesaler and pharmacy generic products in the US,”Shanghvi stated, noting that the firm level” –caused turnovertofall by aquarter to C130 million. Likewise, remained the country’s sole supplier of generic liposomal doxorubicin. the Hungarian group pointed to “strict receivables control and voluntary In Sun’sfinancial first quarter,USFormulations sales advanced shipment restrictions” in Ukraine owing to political unrest as the by 14.4% to Rs23.2 billion, which Shanghvi said amounted to alocal- reason behind respective sales dropping by 22.6% to C27.7 million. currencyrise of 7% to US$389 million, achievedinspite of a15% Turnoverinthe European Union (EU) –excluding Hungary – turnoverdecline to US$130 million by Taro, in which Sun holds a movedahead by 4.8% to C162 million, buoyed by increased sales of controlling stake. Taro’sturnoverwas hit by “charges taken to meet contractual obligations associated with price adjustments” that First-half sales Change Proportion of totalled US$79 million. (C millions) (%) total (%) Russia/CIS 199.2 -18.9 35 Filed 14 ANDAs during quarter European Union* 161.6 +4.8 28 During the quarter,the firm filed 14 abbreviated newdrug Hungary 59.0 +1.5 10 applications (ANDAs) in the US, and receivedsix approvals. This left China 21.8 -12.8 4 140 ANDAs awaiting final approval, including 12 tentative approvals. US 20.3 +12.2 4 Sun’sglobal Formulations turnovermovedahead by 14.3% to Latin America 8.3 +50.9 1 Rs38.1 billion (see Figure 1), as the Indian firm reported domestic Formulations sales 16.9% higher at Rs9.92billion. Formulations Rest of World 20.4 +4.6 4 turnoverinthe rest of the world increased by 9.0% to Rs4.91billion Pharmaceutical 490.6 -6.7 86 despite “temporarysupply issues”. Shanghvi said the companywas Wholesale &Retail 92.4 +5.6 16 assessing options for its respiratory portfolio in Europe. Eliminations/Other -13.6 –2 Global Bulk-Drug sales slipped by almost atenth to Rs1.74 billion as the group stepped up its ownsupplies for vertical integration. Gedeon Richter 569.4 -5.3 100 With research and development spending up by aquarter to Rs2.57 *excluding Hungary billion, Sun improvedits pre-tax profit by 12.2% to Rs16.9 billion, excluding an exceptional prior-year charge of Rs25.2 billion to settle Figure1:Breakdown of Gedeon Richter’s sales in the first half of 2014 (Source – damages for an at-risk US launch of generic Protonix (pantoprazole). Gedeon Richter) After the quarter ended, Sun acquired Pharmalucence, aUS the contraceptive Esmya (ulipristal acetate) in France. However, sales producer of generic contrast media, for an undisclosed sum (Generics in Poland fell by aquarter to C29.6 million –due in part to price erosion bulletin,8August 2014, page 2). “This acquisition givesusaccess for generics –while Romanian sales dropped by 2.5% to C15.5 million. to sterile injectables capacity in the US, supported by strong research In the Hungarian firm’sdomestic market –where Richter has and development capabilities,”Shanghvi commented. “Welook at just launched the allergy remedy Lordestin (desloratadine) and the this as asite which can takeadditional injectable products to be antidepressant Scippa (escitalopram) –turnoverrose by 1.5% to filed for the US.” G C59.0 million, or by 5.4% to HuF18.1 billion in local-currencyterms. Meanwhile, Richter’sLatin American sales continued to progress, First-quarter sales Change Proportion leaping by half to C8.3 million as the companyfocused on promoting (Rs millions) (%) of total (%) its female healthcare products in the region. Richter earlier this year US 23.234 +14.4 58 acquired amajority stakeinCuraçao-based distributor Mediplus India 9,923 +16.9 25 (Generics bulletin,6June 2014, page 9), alongside deals for women’s health firms in Brazil and Mexico. The Hungarian firm also prospered Rest of World 4,913 +9.0 12 from increased sales of the contraceptivePlan BOne-Step Formulations 38,071 +14.3 96 (levonorgestrel) in the US, where sales rose by 12.2% to C20.3 million. Bulk Drugs 1,744 -9.6 4 Destocking caused Richter’sChinese turnovertofall by more than Other 33 -3.0 – atenth to C21.8 million, butsales in the firm’sRest of the World pharma business rose by 4.6% to C20.4 million. Sun Pharma 39,848 +13.0 100 With group turnoverdownby5.3% to C569 million, aweaker Figure1:Breakdown by region and business of Sun Pharma’s gross sales in its gross margin contributed to Richter’soperating profit falling by financial first quarter ended 30 June 2014 (Source –Sun Pharma) almost two-fifths to C62.0 million. G
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COMPANY NEWS
FIRST-HALF RESULTS MERGERS&ACQUISITIONS/SECOND-QUARTERRESULTS Russia and Germany Excelvision deal adds rock Stada’s results to Akorn’s capacity
ouble-digit sales declines in Russia and Germanycaused total korn is set to bolster its manufacturing capacity and capabilities DturnoverbyStada Arzneimittel’sGenerics business segment to fall Aafter agreeing to acquire ophthalmics specialist Excelvision –the by 2% to C599 million (US$799 million) in the first half of this year. Swiss operation of French contract-manufacturing group Fareva –for Russian Generics sales tumbled by 27% to C55.6 million, SFr21.7 million (US$23.9 million). Based in Hettlingen, Switzerland, representingathird of Stada’stotal turnoverinthe country that declined Excelvision has aUSFood and Drug Administration (FDA) approved by 16% to C164 million. Pointing out that the constant-currencyfall manufacturing facility that Akorn noted would add around 30-35 million had been just 2%, the German group said it had suffered from the rouble’s units –including solutions, ointments, gels and suspensions –tothe devaluation and lower demand from wholesalers. US firm’smanufacturing output. The group’stotal generics turnoverinits Commonwealth of Akorn’schief executive officer,Raj Rai, said the US firm planned Independent States (CIS) and Eastern Europe region tumbled by 14% to “transfer anumber of approvedophthalmic products in the coming to C119 million amid local currencydevaluations. The fall came despite months from our sites in the US” to the facility to expand Akorn’s an 8% increase to C36.5 million in Serbian Generics sales as Stada capacities in the US. The deal for Excelvision –which currently overcame ashift towards national tenders and deferred wholesaler manufactures Akorn’sZioptan (tafluprost) ophthalmic solution –is purchasing pending price cuts. set to close in the first quarter of 2015. Sales declines of 12% and 28% respectively for the Aliud and Rai added that Akorn had responded to Form 483 observations Stadapharm sales units led the group’sGerman Generics turnover and submitted acorrective action plan following an FDAinspection to decrease by 11% to C147 million. Sales by the firm’sCellpharm nephrology and oncology unit slipped by 6% to C16.3 million, while Second-quarter sales Change Gross exports contributed around C17 million. (US$ millions) (%) margin (%) Generics sales in Italy increased by 6% to C78.4 million, while Prescription Pharma 136.2 +102 49.9 volume growth drove a3%Generics turnoverrise to C69.3 million Consumer Health 14.5 +50 59.6 in Belgium (see Figure 1). Stada blamed a7%Generics sales slide to C38.0 million in France in part on “price competition” and said its local Akorn150.7 +96 50.9 operation had initiated“counter-measures” to stabilise its market share. However, the French fall wasmore than offset by 8% growth to Figure1:Breakdown by business segment of Akorn’s sales and gross margin in C50.6 million in Spain as the companybenefitted from strong local the second quarter of 2014 (Source –Akorn) demand. In the UK, Generics sales almost doubled to C8.3 million. of one of the US firm’sfour Indian facilities “late in the second quarter”. Consolidating the group’sStada Beijing operation in China and The inspection had been triggered by Akorn’sfiling of anew drug acquiring control of ajoint venture in Vietnam resulted in Stada’s application (NDA) from the facility earlier this year (Generics bulletin, generics sales in its Asia-Pacific region jumping by 70% to C26.6 million. 21 March 2014, page 10), and Rai noted that the US firm anticipated The German group’sturnoveradvanced by 4% to C1.00 billion as filing three ANDAs from the facilities by the end of 2014. “Asaresult sales by the firm’sBranded Products segment increased by 14% to C382 of continued filings, we expect [the FDA] to re-inspect[the site] in million following several acquisitions. On an organic basis, group early 2015 to verify our commitments and corrective actions,”hestated. turnoverfell by 1% as Stada’sCommercial unit contributed C22.5 million. Furthermore, Rai said Akorn wasplanning to utilise its Indian Lower Branded Products earnings reduced Stada’soperating profit facilities to increase global filings, having made over20registrations by 6% to C121 million, cutting the group’soperating margin by 1.3 in the Asia-Pacific and Africa regions during the first half of this year. percentage points to 12.1%. G The US firm has also taken steps to wind down “the majority” of its contract-manufacturing business in India. Asia-Pacific In the second quarter of this year,Akorn’sturnoveralmost doubled C26.6m, +70% to US$151 million thanks to aUS$51.5 million contribution to sales Germany from its US$640 million acquisitionofHi-Tech Pharmacal, as well Others C147.2m, -11% C96.5m as sales of three ophthalmic brands the US firm boughtfrom Merck late last year.Akorn is also anticipating an additional US$90-US$100 million in annual sales from its US$440 million acquisition of US dermatology player VersaPharm, which has just closed (Generics Serbia bulletin,16May 2014, page 1). C36.5m, +8% As can be seen from Figure 1, turnoverbyAkorn’sPrescription Pharmaceuticals division –comprising hospital drugs, injectables, France Hi-Tech’sgenerics segment and some of Akorn’sophthalmics –saw Italy C38.0m, -7% C78.4m, +6% sales ahead by 102% to US$136 million. Consumer Health turnover– including OTCophthalmics, Hi-Tech’sOTC drugs and animal-health Spain products –rose by ahalf to US$14.5 million. The figures exclude the C50.6m, +8% recently-divested ECR unit (Generics bulletin,11July 2014, page 4). Russia Belgium Incurring US$3.6 million in amortisationcosts following the step-up C55.6m, -27% C69.3m, +3% of Hi-Tech’sacquired inventory brought Akorn’sgross margin down Figure1:Breakdown by countryof Stada’s Generics sales that fell by 2% to by 3.8 percentage points to 50.9%. And US$20.8 million of acquisition- C599 million in the first half of 2014 (Source –Stada) related costs cut its operating profit by 26.9% to US$16.3million. G
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COMPANY NEWS
SECOND-QUARTERRESULTS IN BRIEF SUN PHARMA AND RANBAXY must by mid-September publish Sterile products give details of their proposed US$4 billion merger,the Competition Commission of India (CCI) has directed under the country’srules on business combinations that are “likely to have an appreciable adverse effect on competition”. The US Federal Trade Commission Par growth injection (FTC) has also yet to clear the deal.
US$35.5 million contribution from the range of sterile injectable ALEMBIC increased its turnoverby16% to Rs4.96 billion Aand ophthalmic products that it gained by acquiring JHP in February (US$81.9million) in its financial first quarter ended 30 June 2014 this year enabled ParPharmaceutical to report total generics sales as International Formulations sales rose by 36% to Rs1.36billion. ahead by 29.6% to US$279 million in the second quarter of this year. Indian Formulations sales advanced by 14% to Rs2.49billion, Group turnoverincreased by 26.4% to US$295 million as sales by the while global turnoverfrom active pharmaceutical ingredients firm’sStrativa brands division fell by just overatenth to US$16.6 (APIs) decreased by 1% to Rs1.06billion. The Indian firm million on lower volumes for Megace ES (megestrol acetate). improvedits pre-tax profit by 40% to Rs849 million. Drugs such as Adrenalin (epinephrine) and Aplisol (tuberculin) acquired through the US$488 million acquisition of JHP contributed SANOFI has changed the name of its generics operation in Germany 12% of group turnover. from Winthrop Arzneimittel to Zentiva Pharma.The French group Par’ssales of bupropion extended-release tablets climbed by 59.3% has gradually been phasing out the Winthrop label in favour of Zentiva to US$18.4 million as competitors were unable to supply rivals to overthe past three years (Generics bulletin,4March 2011, page 4). GlaxoSmithKline’sWellbutrin XL antidepressant. These gains offset a 15.0% slide to US$38.3 million in turnoverfrom the firm’sauthorised DR REDDY’S has distanced itself from US Consumer Product Safety generic version of AstraZeneca’sEntecort EC (budesonide) amid Commission (CPSC) allegations that products the Indian firm sold “price declines resulting from competition”. from 2008 to 2012 violated child-resistant packaging regulations. Turnoverfrom generic propafenone fell by 11.9% to US$15.3 Reddy’s–which is also facing asimilar investigation by the US million despite Parremaining the sole supplier of an alternative to Department of Justice –acknowledged that “an unfavourable GlaxoSmithKline’sRythmol SR arrhythmia treatment. But sales of outcome in these matterscould result in significant liabilities”. Par’srivaltoAbbVie’sDepakote (divalproex) benefitted from a competitor’smarket exit in June 2013 as sales totalled US$15.5 million. CELESIO has bought the remaining 40% of Brazilian specialty Par’sunique generic rivaltoConcordia’sKapvay ER (clonidine), pharmaceutical distributor Oncoprod that it did not previously own launched in October last year,contributed US$11.3 million (see Figure for an undisclosed sum. The German group acquired its initial 60% 1). Competition hit pricing and volumes on metoprolol succinate ER, stakethree years ago (Generics bulletin,18November 2011, page 14). sales of which slipped by just overatenth to US$12.1 million. And the firm’sturnoverfrom its authorisedgeneric of Maxalt (rizatriptan) JUBILANT LIFE SCIENCES’ Pharmaceutical sales declining by fell sharply to US$1.60million as competitors streamed into the 7% to Rs6.04 billion (US$99.7 million) were more than offset by a market in July 2013. spikeinLife Sciences Ingredients turnoveras group sales rose by Adding JHP’ssterile products and launching clonidine and 8%toRs14.7 billion during the company’sfinancial first quarter dexmethylphenidate in the fourth quarter of 2013 –along with higher ended 30 June 2014. Almost three-quarters –orRs10.5 billion – profits from divalproexand market shortages of bupropion –lifted the of group sales came outside of the Indian group’sdomestic market. gross margin of Par’sgenerics division by 8.6 percentage points to 30.1%. Jubilant recently consolidated its Pharmaceutical business under a But higher researchand development costs and increased operating subsidiary in Singapore. expenses combined with aUS$35.9 million intangible-asset impairment charge –linked largely to six products that Parnolonger expected to PSC BIOTECH –aCalifornia-based service provider to life-sciences reach forecasted results –toproduce agroup operating loss of US$17.5 firms –has through its PSC Investments subsidiary acquired ahigh- million. The generics business contributed around half of that loss. G potency sterile injectable facility in Madison, Wisconsin, to form the basis of acontract-manufacturing operation named BioTechnique. Second-quarter sales Change Proportion of The US firm said operationsfrom the site –which will be able to (US$ millions) (%) total (%) provide specialised filling services for cytotoxic, high-potency, biologic, and other sterile injectablecompounds –would be “customer Budesonide 38.3 -15.0 13 ready for sterile liquid and lyophilisation fill-finish production in 2015”. Sterile products 35.5 –12 Bupropion ER 18.4 +59.3 6 OLAINFARM has receivedaC14 million (US$18 million) loan Divalproex15.5 –6 from Latvian bank SEB Banka to further expand its operations. The PropafenoneER15.3 -11.9 5 Latvian firm said it intended to use the funds to develop its product Metoprolol ER 12.1 -10.6 4 portfolio, upgrade its capacities and enter newexport markets. Clonidine ER 11.3 –4 Lamotrigine ER 10.3 -2.6 3 HYPERMARCAS’total pharmaceutical sales that rose by 7.4% to Rizatriptan 1.6 -53.9 1 R$646 million (US$289 million) amounted to around three-fifths of Other 120.6 -0.6 41 group turnoverahead by 6% to R$1.13 billion in the second quarter Generics 278.8 +29.6 94 of this year.The Brazilianplayer noted it had bolstered its generics portfolio during the quarter by introducing through its Neo Química Strativa 16.6 -10.7 6 generic and branded generics arm products including the Par295.4 +26.4 100 antihypertensive valsartan, the antibiotic azithromycin and the osteoporosis treatment alendronate sodium. G Figure1:Par Pharmaceutical’s sales in the second quarter of 2014 (Source –Par)
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MARKET NEWS
PRICING&REIMBURSEMENT REGULATORY AFFAIRS Belgian sales fallas FDA gives guidance prices suffer decline for biological dates
alling ex-factory prices in Belgium contributed to the total combined raft guidance explaining howthe US Food and Drug Administration Fsales for member companies of local generics industry association D(FDA) determines the “date of first licensure” for abiological FeBelGen declining by 2.4% to C277 million (US$369 million) in reference product –and thus the dates on which an application for a 2013, according to IMS data cited by the association. According to biosimilarrivalmay be submitted and approved–has been published FeBelGen, local ex-factory prices for generics have fallen by 18% over by the agency. Interested parties have 60 days to submit comments. the past three years, drivenbyprice cuts such as the 2.5% reduction Noting that adecision on the date of first licensure for areference that wasimplemented from the start of this year (Generics bulletin, product is “in effect, adecision on eligibility for reference-product 10 January 2014, page 9). exclusivity and on the date on which such exclusivity begins to run”, Belgium’sfalling generics sales came despite the arrivalof14new the guidance notes that abiosimilar 351(k) application can be submitted generics on the market in 2013. This, along with the falling generics four years after this date, and approved12years after first licensure. prices, helped local health insurer INAMI to reduce its spending on “In most instances, the date of first licensure will be the initial date the medicines by 2.37% –or C97 million –to C4.01 billion in 2013, particularproduct at issue waslicensed in the US,”the guidance states. FeBelGen indicated. However, anew date is not created for supplements for the Meanwhile, the association has renewed its call for Belgium’s biological reference product, or subsequent applications filed for a government to introducemeasures to promote the use of biosimilars, change that results in “a newindication, route of administration, dosing in the wake of areport commissioned by the European Generic schedule, dosage form, delivery system, delivery device or strength”. medicines Association’s(EGA’s)European Biosimilars Group advising The date also does not change as aresult of an application for “a on asustainable framework for biosimilars in Europe (Generics modification to the structure of the biological product that does not bulletin, 20June 2014, page 1). result in achange in safety, purity or potency”. The EGA’s report had reached similar conclusions to areport on “Congress did not intend for every biological product licensed barrierstobiosimilar market access published by state body the Belgian under section 351(a) of the Public Health Service Act to be eligible for Health Care Knowledge Centre (KCE) last year,FeBelGen noted. The aseparate period of reference product exclusivity,” the guidance points KCE report had urged introducing hospital quotas for biosimilars as out. Therefore, it adds, the “FDAmust makeadetermination regarding well as providing better information on comparability, safety and the date of first licensure” for each reference biologic. efficacytodoctors (Generics bulletin, 19April 2013, page 9). As well as advising on what information should be provided to “In Belgium, the use of biosimilars constrasts strongly with their the FDAbyreference-product sponsors, the guidance says the agency development in numerous other European countries,”FeBelGen is “reviewing options for making information publicly available observed, with virtuallynouptakeinBelgium compared to avolume regarding reference-product exclusivity and dates of first licensure”.G share of around 45% in Germany. Noting that the top eight branded biologics represented annual spending of around C400 million in Belgium, FeBelGen’smanaging REGULATORY AFFAIRS director Joris VanAssche insisted that the country “cannot miss the opportunity” to save healthcarecosts that wasbeing provided by EU leads regulatorycoalition biosimilarmedicines. “It is for this reason,”Van Assche said, “that FeBelGen is urging the next government to establish areal plan for he European Medicines Agency(EMA) says its decentralised biosimilars for the next five years.” G Tmarketing-authorisation procedure “is being used as amodel to accelerate the assessment of applications of generic medicines” as part of the International Generic Drug Regulators Pilot (IGDRP) programme TRADE AGREEMENTS that also involves Australia, Canada, Chinese Taipei and Switzerland. Sharing assessment reports with partner authorities should, the EMA Text for CETAdeal is finalised said, “enable medicines to be authorised in different territories in a coordinated wayatapproximately the same time”. anada and the European Union (EU) have finalised the text of their “Other members of the IGDRP may decide to takepart in the pilot CComprehensive Economic and Trade Agreement (CETA), having programme at alater stage,”the EMA said, noting that these included reached an agreement in-principle in October last year.Translations Brazil, China, Japan, Korea and Mexico, as well as NewZealand, and afinal legalrevieware underway of the text, which will bring to Russia, Singapore and South Africa. The European Directorate for the an end dual litigation in pharmaceutical patent cases, provide two- Quality of Medicines and healthcare (EDQM) and the World Health year patent-term extensions and allowgeneric manufacturing for Organization (WHO) participate as observers. export during anypatent-extension period (Generics bulletin, 1 Other areas of IGDRP co-operation in which the EMA is involved November 2013, page 1). include work-sharing for active substance master files, inspections of “The Canadian Generic Pharmaceutical Association (CGPA) sites conducting bioequivalence and bio-analytical studies, and welcomes the Government of Canada’scommitment to reduce the information-sharing on quality issues. burden on the courts, bring earlier finality to pharmaceutical patent The IGDRP said the use of the decentralised procedure as amodel disputes and delivergreater business certainty for generic pharmaceutical for information-sharing was“one of the most significant developments” companies in Canada. CGPAcommends the Government of Canada in its efforts to increase the efficiencyof, and to strengthen, regulatory for recognisingthe importance of generic pharmaceutical manufacturing reviewprocesses, as well as to ensure an “appropriate levelofglobal to the domestic economy,” commented CGPApresident Jim Keon. G regulatory oversight through information-exchangeand co-ordination”. G
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MARKET NEWS
PRICING&REIMBURSEMENT REGULATORY AFFAIRS New Zealand tenders Romania’sAPMGR reach ‘recordlevels’ warns overclawback
enders run by NewZealand’spharmaceutical management agency, omania must immediately implement amodified clawback tax TPharmac, reached “record levels” in the year ended 30 June as Rto ensure the survivaloflocal generics manufacturers, according the agencyreceived“nearly 3,500 offers to supply pharmaceuticals to the country’sindustry association APMGR. Noting that the calculation from 54 companies”. Noting that 73% of all medicines used in New of the clawback wasunfair to generics firms –because it was“applied Zealand were generics –and observing that “only Germanyand the in the same waytogeneric and innovative medicine producers, despite UK have higher rates of generics use” –Pharmac said that this was its different impact on manufacturers’ margins and sales price” – largely due to the tender system, adding that the country’suse of APMGR said the Romanian government should introduce a generic medicines was“likely to growfurther”. “differentiated calculation”, based on local requirements that ageneric “Pharmac has nowawarded 246 contracts from this tender process, must not cost more than 65% of the equivalent originator price. likely to produce savings of approximately NZ$38 million (US$32 Citing the “devastating impact on the generics industry” caused million) across hospital and community medicines overthree years,” by the clawback –which has increasedbyafifth in each of the past the agencystated. three quarters –APMGR’sexecutive director Laurentiu Mihai said Sarah Fitt, Pharmac’sdirector of operations, said savings from that most generics firms had “re-evaluated their local production, the tender were “important for Pharmac, and servetwo purposes”, limited their portfolios and delayed investments”. allowing the agencytoboth fund existing medicines and invest in new Moreover, APMGR warned, includingnew molecules from brand treatments. She added that the agency’sannual tender “actively seeks companies on Romania’slist of reimbursed medicines from the end of bids for medicines coming off-patent, and promotes competition this year would raise clawback costs even further.“Basically,”Mihai between suppliers”. said, “we end up paying each quarter an increasingly higher clawback “NewZealanders are nowfamiliar with generic medicines, and tax for the growing costs of treatments with innovative medicines.” G are used to changing between brands of medicine from time to time,” Fitt said, insisting that the Pharmac tender had “helped with acceptance of generics”.People also had agreater understanding that generics REGULATORY AFFAIRS went through the same quality, safety and efficacychecks as other medicines, Fitt claimed. “Significant decisions from the current tender include newcontracts India has inspections guide for different presentations of the painkiller paracetamol,New Zealand’s acility inspections conducted by Indian authorities should last most prescibed medicine,”Pharmac said, predicting that this would Fbetween twoand five days, depending on the size of the plant, as save “more than NZ$2 million overthree years”. well as the number and complexity of products it produces, according to Sole-supply deals for quetiapine and olanzapine would save around guidelines issued by the country’sdrugs-controller general, GN Singh. NZ$6 million and NZ$2 million respectively overthe three-year period, Recommending a“risk-based approach”, the guidelines state that the agencyforecasted. Meanwhile, deals for other products –including inspectors should “focus on product development, product-quality paclitaxel, rizatriptan and tramadol –would each produce savings attributes and stability studies conducted to establish shelf-life in Indian of at least NZ$1 million. G climatic conditions”, as well as on “process validation, complaints and recalls, handlingofout-of-specification [results], deviations, change- control procedures, aseptic processing and sterilisation”. REGULATORY AFFAIRS/BIOLOGICALDRUGS An “exit meeting” should be held with the facility owner at the end of the audit to reviewthe inspectors’observations, the guideline US doctorsseek unique INNs states, while anyobservations that have a“direct impact on the quality, safety and efficacy” of the produced drugs should be finalised iosimilars should have “distinguishable non-proprietary names”, immediately upon the end of the inspection. Bagroup of doctors’ organisations and individual physicians – Calling on state drug-control authoritiestoprovide training, Singh including originator-backed body Alliance for Patient Access –has says that inspectors should conduct “a minimum of five good insisted in aletter sent to US Food and Drug Administration (FDA) manufacturing practice (GMP) inspections in one year to sustain CommissionerMargaret Hamburg. their performance”. G Such unique names, theyargue, would “help prevent inappropriate pooling of adverse events by clearly identifying which product apatient wasprescribed”. The National Drug Code (NDC) that could PRICING&REIMBURSEMENT identify individual products is “not readily available to the treating physician”, the letter claims. Swedish body urges efficiency Furthermore, as asurvey conducted by the Amgen-backed Alliance for Safe Biologic Medicines (ASBM) had found 61% of European ore efficient communication between regulators overgeneric prescribers believedtwo products with the same international non- Msubstitution could generate significant savings in Sweden, proprietaryname (INN) would have the same indications (Generics according to local industry association FGL. Making decisions on bulletin,6December 2013, page 20), “the FDA’sdecision on interchangeability at the same time as marketing authorisations were interchangeability between indications may largely be rendered moot granted, argued FGL’s president, Kenneth Nyblom, would lead to once biosimilars enter the US marketplace, ifthe biosimilar shares more effective competition and greater savings for the country’s anon-proprietary name with the reference product”. G healthcaresystem. G
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MARKET NEWS
AWARDS Judgesassess around 100 awardsentries
xpert judges including the former global heads of Actavis, Ranbaxy Eand Ratiopharm are currently assessing almost 100 nominations API Supplier of the Year – Nominations for the Global Generics &Biosimilars Awards 2014. ● Dr Reddy’s ● Medichem ● Neuland ● Perrigo Winners in 11 categories (see below) will receive their awards Scinopharm ● Teva ● Unichem during acocktail reception at the Sheraton Paris Airport Hotel on 7 ● October.The reception will be co-hosted by Generics bulletin and Sponsored by Ark Patent Intelligence, and will be presented by Medicines Patent Pool executive-director GregPerry. Individual awards sponsors include Ark Patent Intelligence, Acquisition of the Year – Nominations Honeywell, Lotus Labs, Panacea, Pharmacloud and Thomson Reuters. G ● Actavis/Forest ● Alvogen/Lotus ● Aurobindo/Actavis
● Cipla/Medpro ● Endo/Boca ● Hikma/Bedford ● Lupin/Grin Company of the Year – Nominations ● Lupin/Nanomi ● Mylan/Agila ● Sun/Ranbaxy ● Alvogen ● Amgen ● Amneal ● Aspen ● Aurobindo ● Cipla ● Dr Reddy’s ● Hikma Business Development of the Year – Nominations ● Julphar ● Lupin ● Sandoz ● Sun Pharma ● Torrent ● Xellia Sponsored by ● AET BioTechnologie ● Alvogen –Inflectra ● Fresenius –Binnopharm ● Fresenius –PTSoho Company of the Year,Americas – Nominations ● Lupin –Yoshindo ● Medis ● Mylan –Prosonix
● Alvogen ● Akorn ● Amneal ● Endo ● Mallinckrodt ● Sagent ● Sandoz Patent Litigation of the Year – Nominations
● Accord –quetiapine SR ● Actavis –pemetrexed
Company of the Year,Asia-Pacific – Nominations ● Hospira –trastuzumab ● Krka –esomeprazole
● Aurobindo ● Cipla ● Dr Reddy’s ● Lupin ● Lupin –Trizivir ● Natco –oseltamivir
● Sawai ● Sun Pharma ● Torrent ● TWi –megestrol Sponsored by Sponsored by
Company of the Year,EMEA – Nominations EXPERTJUDGES ● Acino ● AMCo ● Aspen ● Hikma Claudio Albrecht, Peter Ballard, David Barker,Peter Billev, ● Julphar ● Krka ● Stada ● Xellia Andrew Bourgoin, Benjamin Burck, Duncan Bucknell, Sponsored by Frances Cloud, Duncan Curley,Tommy Erdei, Ronny Gal, Leader of the Year – Nominations Leighton Howard, Charles Joynson, Ewald Kreid, Kate Kuhrt, Doug Long, Shibani Malhotra, Paul Mendelsohn, ● Amneal –Patel ● Aspen –Saad ● Aurobindo –Govindarajan Skhumbuzo Ngozwana, TimOldham, Christian Pawlu, ● Dr Reddy’s–Reddy ● Hikma –Darwazah ● Lupin –Gupta NorbertRau, Howard Rosenberg, Malcolm Ross, Alan Sheppard, ● Sun Pharma –Shanghvi Warwick Smith, Brian Tempest, James Vane-Tempest. ● Therapeutic Proteins –Niazi Sponsored by
Innovation of the Year – Nominations
● Pensa –omeprazole ● Proveca –captopril
● Sandoz –AirFluSal ● Sun –repaglinide
● Teva –DuoResp
● Therapeutic Proteins Sponsored by
Biosimilar Initiative of the Year – Nominations
● Actavis/Amgen ● Alvogen –Inflectra Cocktail Reception &Awards Presentation
● Alvotech ● Hetero –Pipeline ● Hospira –Inflectra Sheraton Paris AirportHotel &Conference Centre Tuesday 7October 2014 ● Lupin –Yoshindo ● Sandoz –USfilgrastim Forinformation on attending the invitation-only Awards Presentation, ● Therapeutic Proteins contact Natalie Cornwell at [email protected].
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MARKET NEWS
REGULATORY AFFAIRS IN BRIEF CARIBBEAN COUNTRIES are discussing howtocreate a unified FDA meeting will registration process for generic medicines in the region that would “improve availability, quality and access to essential medicines”. Apilot project to be co-ordinated in part by the PanAmerican Health Organization (PAHO) and the World Health Organization (WHO) cover GDUFAguides will focus initially on the WHO’slist of essential medicines, and will be aimed at examining product-authorisationcriteria, supporting the ublic comments on five draft guidances issued by the US Food training of technical personnel and improving post-marketing Pand Drug Administration (FDA) to facilitate implementation of the surveillance. According to PAHO, fewer than half of Caribbean 2012 Generic Drug User Fee Amendments (GDUFA) will be invited countries currently have anational process for registering medicines. at afull-day public hearing the agencyishosting on 17 September in Hyattsville, Maryland. Requests to makeoral presentations had to be NPS MEDICINEWISE –the independent medicines advice body submitted by 3September, but comments after the meeting will be funded by the Australian government –has launched an e-learning accepted until 13 October under the docket reference FDA-2014-N-1168. programme called ‘Demystifying bioequivalence’.Itisaimed The five guidance documents on which the FDAisseeking at giving health professionals “a greater levelofconfidence and comments cover: the content and format of abbreviated newdrug understanding” of howgeneric drugs are approved. applications (ANDAs); refusal to receive for lack of proper justification of impurity limits; amendments and easily correctable deficiencies; US CORPORATE TAXRULES put local companies at a “significant prior-approvalsupplements; and controlledcorrespondence related competitive disadvantage” and endanger US jobs, according to to generic-drug development. an opinion piece by Mylan’sexecutive chairman, Robert Coury, During the meeting, the FDAwill also seek to establish whether published in the newspaper USA Today.Reacting to criticism of there are other topics related to implementing GDUFAordeveloping Mylan’splan to perform a‘tax inversion’ through its purchase of generics that ought to be covered by guidance documents. In particular, Abbott’soff-patent portfolio,Coury stated: “All of our major the agencyplans to solicit feedback on howtimings of ANDAapprovals competitors were either founded outside of the US or have recently affect eligibility for 180-day generic market exclusivity. inverted, and benefit from more attractive tax structures.”The tax Furthermore, the FDAisinviting input on what constitutes ANDAs disparity, hewarned, “potentially makes us an easier acquisition for “first generic productsfor which there are no blocking patents or target, which could result in the downsizing or elimination of our exclusivities on the reference-listed drug”, as outlined in aGDUFA US facilities and workforce”. commitment letter accompanying the legislation. The meeting comes shortly after the FDA’sOffice of Generic Drugs CGPA –the Canadian Generic Pharmaceutical Association –isamong (OGD) issued manual of policies and procedures (MAPP) documents several industry bodies that have been givenleave to intervene in on criteria and procedures for both managing and prioritising reviews aSupreme Court of Canada hearing of a dispute between Apotex of original ANDAs, amendments and supplements. G and Sanofi overthe validity and infringement of apatent protecting Plavix (clopidogrel). The court is expected to give alandmark ruling on the promise of utility in patents. REGULATORY AFFAIRS APPG –the UK’sAll-Party PharmacyGroup –has highlighted “growing problems in the supply of generic medicines”.Laying Brazil fines Merck over block the blame in part on globalisation, the politicians called for erck has been fined R$4.30 million (US$1.87 million) by Brazil’s “collaboration, data-sharing and more pre-emptive action to maintain MAdministrative Council for Economic Defense (CADE) “for cartel sufficient supplies”. formation to prevent the sales of generic medicines”. The originator had “united with the country’slarger pharmaceutical laboratories”, US ORIGINATORS can be held legally accountable forside- CADE found, with the goal of “preventing distributors of medicines effects resulting from patients taking generic versions of their from working with generic medicinal products”. This agreement could brands, the Alabama Supreme Court has ruled. “hamper the entry of generic medicines in Brazil”, CADE concluded. “The anti-competitive effects in practice are clear,” CADE said, INDIAN FORMULATORS can now export to Argentina under a “since the non-entry or delay in the entry of generic products in the decree published in Argentina’s Official Bulletin on 8August. India market, even for ashort period, would avoid the loss of profits.” joins Australia, Brazil, Chile, China, Cuba, Mexico and New Generics represented “a cheaper option, and possibly better and more Zealand –aswell as several European countries –onthe list of accessible to the population”, CADE observed. G nations permitted to export finished drugs to Argentina.
FDA –the US Food and Drug Administration –received 635 REGULATORY AFFAIRS abbreviated new drug application (ANDA) submissions in June as increased stability requirements of three batches per strength and EGA queries stability guide six-months of accelerated stability data came into effect on 20 June. Just four dossiers were submitted in July.The FDAhas also released raft guidance published by the European Medicines Agency(EMA) bioequivalence recommendations for 41 products. Don stabilitytesting for variations to marketing authorisations would “create massive delays” in the process, according to comments submitted MHRA –the UK’sMedicines and Healthcare products Regulatory by the European Generic medicinesAssociation (EGA). However, the Agency–has launched aconsultation on which prescription drugs EMA rejected the EGA’s suggestions that submitting three months should be exempt from anti-counterfeiting safety features required of stabilitydata should be enough to support certain type II variations. under the European Union’s Falsified Medicines Directive. G This was“not sufficient in manycases”, the agencyfound. G
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PRODUCT NEWS
CHOLESTEROL-LOWERINGDRUGS BIOLOGICALDRUGS Crestor ruling stands Celltrion aims to lead on Australian appeal US monoclonal rivals
panel of five Australian Federal Court judges has dismissed elltrion believesits Remsima (infliximab) will be the first biosimilar AAstraZeneca’sappeal against an earlierruling that last year found Cmonoclonal antibody (mAb) to be accepted for filing by the US twopatents protecting the originator’sCrestor (rosuvastatin) cholesterol- Food and Drug Administration (FDA), following the South Korean lowering drug to be invalid and not infringed by generic versions company’sinitiation of the filing process –ahead of acceptance– marketed by Actavis and Apotex. for its rivaltoJanssen’sRemicade brand. Revocation of the twopatents at issue –the low-dose patent “This marks the first 351(k) biosimilar mAb applicationtobe AU2000,23,051 and the cation composition patent AU2000,51,842 filed in the US,”Celltrion noted, adding that it wasalso only the second –had been stayed pending resolution of AstraZeneca’sappeal. application for abiosimilar to be filed under the US biosimilars pathway Last year,Federal Judge Jayne Jagot ruled that claims of the ‘051 created by the country’sBiologics Price Competition and Innovation “low-dose” patent were invalid in light of aprior-art European patent Act (BPCIA). Sandoz recently became the first firm to have afiling application, while the ‘842 “cation” patent lacked novelty in light of accepted through the BPCIA pathway, for the company’sfilgrastim prior art that included Australian patent 2000,51,841, describing tribasic (Generics bulletin, 8 August 2014, page 1). phosphates (Generics bulletin, 22March 2013, page 15). “After prior consultation with the FDA, Celltrion conducted Dismissing AstraZeneca’sappeal, the judging panel also required additional clinical trials –starting in October 2013 and lasting six the originator to pay 80% of the generics firms’ costs. However, the months –todetermine the bioequivalencyofthe originator products panel queried certaindetails of Jagot’sapproach to evaluating the lack with Remsima,”the South Korean firm explained. Celltrion said it had of inventive step for the ‘842 patent. Regarding knowledge of “tested for pharmacokinetic and pharmacodynamic equivalencyand rosuvastatin and its properties as “a given” at the earliestofpriority safety equivalencyfor three distinct products: the originator products dates –eventhough it wasnot “common general knowledge” –was sold in the US, the originator products sold in Europe, and Remsima”. not a“permissible approach to take”, the panel stated. These additional clinical trial data were submitted to the FDAwith In the second quarter of 2014, AstraZeneca reported Crestor sales Celltrion’sestablished global clinical-trialdata as part of its application. outside the US that declined by 5% to US$679 million “reflecting the Celltrion said it expected to obtain FDAapprovalfor Remsima impact of generic competition in Australia”. During the same period, within ayear,“barring anysetbacks”. While the firm acknowledged US sales advanced by 1% to US$771 million. G that Remicade wasprotected by US patents running until 2018, it pointed out that it wascurrently seeking adeclaratory ruling in a Massachusetts district court that Janssen’sremaining patents for the brand were invalid and unenforceable (Generics bulletin, 18April 2014, page 19).
Remicade patents should have ended “Under law, Janssen’speriod of permissible patent protection should have already ended,”Celltrion insists in its filing. According to the South Korean firm, Janssen has tried to “improperly extend its monopoly after its initial patents expired”, having engaged in “manipulative and deceptive practicesbefore the US Patent and Trademark Office”. While an at-risk launch of Remsima could create “serious risks and exposure for Celltrion”, adecision to delay launching its infliximab rivalwould also be harmful to the company, it maintains. “Because Celltrion expects to face patent-infringement allegations from Janssen, Celltrion wants to start the adjudicative process,”the South Korean firm states in its filing, recognising that it is on an “inevitable collision course” with the originator. However, Janssen has responded by claiming that Celltrion filed the suit “prematurely”, before filing its biosimilar application. “There is no justification for permitting Celltrion to avail itself of the biosimilar approvalpathway in the BPCIA while at the same time skirting the patent-resolution procedures,”the originator insists. Having receivedapprovaltomarket Remsima in South Korea almost twoyears ago (Generics bulletin,3September 2012, page 16), Celltrion has since receivedapprovals in Europe (Generics bulletin, 20 September 2013, page 17) and Canada (Generics bulletin, 3 February 2014, page 13), as well as Japan and Turkey (Generics bulletin, 8 August 2014, page 19). Noting that its infliximab was“the world’sfirst and only biosimilar mAb” to be approvedinEurope, Japan and Canada, the firm stated that “this FDAfiling will mark the final step for Celltrion’sgoal of obtaining global approvalfor Remsima”. G
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PRODUCT NEWS
LITIGATION UROLOGY DRUGS Eisai sues FDA over Sandoz’ topical hits fears of early entries Germany and Sweden
isai has filed alawsuit against the US Food and Drug Administration andoz has launched Vitaros (alprostadil), apatent-protected topical E(FDA) claiming that generic rivals to twoofits brands –the weight- Stherapyfor erectile dysfunction, in Germanyand Sweden. The management treatment Belviq (lorcaserin) and the anti-epileptic firm has licensed rights to the alprostadil cream from its developer, Fycompa (perampanel) –will reach the US market early, based on Apricus Biosciences, in Germanyand Sweden as well as nine other what the Japanese originator believesisthe US agency’serroneous western European countries. determination of the drugs’ exclusivity dates. “Vitaros is the first topical erectile-dysfunction therapytobemade Belviq receivedfinal FDAapprovalon27June 2012, while available to patients in Europe, and the first novelerectile-dysfunction Fycompa wasapprovedsome four months later on 22 October.As treatment in nearly adecade,”pointed out Nick Haggar,Sandoz’ head controlled substances, it wasalso necessary for both drugs to receive of Western Europe, Middle East and Africa. approvalfrom the US Drug EnforcementAgency(DEA) before they Noting that the treatment wascharacterised by its “ease of use, could be marketed. Despite DEA assessment not occurring until around rapid onset and high tolerability”, Haggar said the launches in Germany ayear later for Belviq –and some fourteen months later for Fycompa – and Sweden “demonstrate Sandoz’ commitment to finding novel the FDAdetermined the brands’ exclusivity periods as beginning on and innovative ways to meet patient need across awide range of the day of final FDAapproval. therapeutic areas”. “The FDA’sdecision regarding when the five-year market exclusivity Citing IMS data, Sandoz said the European erectile-dysfunction periods for Belviq and Fycompa were triggeredisarbitrary, capricious, market wasworth more than US$1.3 billion as of December 2013 an abuse of discretion, or otherwise not in accordance with law,”the based on prescription sales, with Germany’smarket alone accounting Japanese originator complained in aColumbia district court. for more than US$150 million of this value. Requesting that the FDAmove the exclusivity dates to match the Meanwhile, Sandoz has receivedits first Latin American approvalfor dates of DEA approval–7June 2013 for Belviq and 2January 2014 its AirFluSal Forspiro (fluticasone/salmeterol) rivaltoGlaxoSmithKline’s for Fycompa –Eisai said it had “no adequate remedy at law” and would Seretide brand after Mexico’sCofepris medicines agencyapproved “suffer substantial and irreparable harm in the form of alost statutory the respiratory drug in 50µg/100µg, 50µg/250µg and 50µg/500µg right unless this court issues declaratory and injunctive relief”. G presentations. The product will be sold as IrFlosol Forspiro. G
WEIGHT-LOSSTREATMENTS Par holds up TWi’s megestrol ar Pharmaceutical has obtained an injunction preventing TWi PPharmaceuticals from marketing or selling ageneric version of Par’sMegace ES (megestrol acetate) brand in the US until an appeal has been resolved. Parisappealing against aMaryland district court’s finding earlierthis year that US patent 7,101,576 –which protects the weight-loss treatment until April 2024 –was invalid due to obviousness (Generics bulletin,2March 2014, page 16). Taiwan’sTWi has just obtained US approvalwith 180-day generic market exclusivity for its megestrol 125mg/ml oral suspension, and intends to launch if it can dissolvethe injunction. Requiring Partopost abond of US$10 million and to move to expedite its appeal to aFederal Circuit court, Maryland District Judge Catherine Blakesaid the court’sobviousness finding had been “a close call”. While Parhad not presented astrong likelihood of success with its argument that the court had erred on motivations to combine prior art, it had “made ashowing of asubstantialcase”, she decided. Blakestated: “The court finds it likely that, should TWilaunch its product, [Par’sbrands division] Strativa would quickly lose an essential part of its funding and likely be forced to close. This kind of harm is irreparable.”Bycontrast, she said, an injunction would merely postpone TWi’sexclusivity, should it ultimately prevail in the case. G IN BRIEF GREEN CROSS has obtained approvalinSouth Korea for Neulapeg (pegteograstim)onthe basis of non-inferiority studies to pegfilgrastim. Alaunch is planned early next year. G
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PRODUCT NEWS
OPHTHALMICS SEDATIVES Apotex beats bar on Hospira takes action Canadian travoprost over Precedex rivals
potexhas defeated an attempt by Alcon to bar competition to the ospira has succeeded in convincing aMaryland district court to ANovartis subsidiary’sTravatan Z(travoprost) in Canada until 2027. Hissue atemporary restraining order suspending adecision by the Denying Alcon’srequest to prohibit Apotexreceiving anotice of US Food and Drug Administration (FDA) to approve US rivals to compliance (NOC), or marketing authorisation, for its Apo-Travoprost Z Precedex(dexmedetomidine) based on alabelling ‘carve-out’. product until Canadian patent 2,606,370 expired on 20 September 2027, The FDAhad approvedgeneric 200µg/2ml versions that were Judge Catherine Kane said Apotex’ allegation that the ‘370 patent launched immediately by Mylan and Parafter the agencydetermined wasobvious wasjustified. However, Kane rejected the generics firm’s that it should be able to approve abbreviated newdrug applications argument that the patent wasinvalid for lack of utility.Acknowledging (ANDAs) that containeda‘section viii’ statement and omitted labelling that the determination had been made confidentially,Kane said the disclosing amethod of use that wasprotected by Hospira’sUSpatent ruling would be made public “with necessary redactions”. 6,716,867 covering intensive-care unit sedation.But after attacking Meanwhile, in an associated ruling, Kane also found that Alcon’s the agency’sdecision, Hospira convinced the court that the FDA’s Canadian Travatan Zpatent 2,129,287 –which expired on 2August actions appeared to be “at odds with relevant authority”. this year –was obvious and anticipated. “FDA’sclear policyand practice for years has been that it would “There wasmotive for inventors to find asolution to the side- not approve an ANDAthat relies on asection viii statement if that effects concerns of the use of prostaglandins,”Kane found, adding that statement overlaps in anyway with the brand’suse code as published prior art disclosed asolution and latanoprost wasalready in clinical trials in the Orange Book,”Hospira observed. “Therefore, when –ashere – when travoprost wasdeveloped. However, she again rejected Apotex’ the newdrug applicationholder’suse-code statement asserts that its allegations of lack of demonstrated or soundly predicted utility. G method-of-use patent overlaps with all approvedindications, FDA must reject an ANDAapplication based upon asection viii statement and require the ANDAapplicant to proceed according to the standard HORMONE THERAPIES/PARKINSON’S DISEASEDRUGS paragraph IV patent certification and notice procedure.” Arestraining order wasneeded, Hospira argued, to protect the Lannett purchases two ANDAs firm from “irreparable injury”. Otherwise, the companysaid, generics would “flood the market, and Hospira will be without afull and annett has agreed to buyabbreviated newdrug applications adequate remedy even if it prevails on the merits of this action”. Generic L(ANDAs) for estradiol 0.5mg, 1mg and 2mg tablets as well as for challengers would offer prices up to 45% lower than Precedex, Hospira selegiline 5mg capsules. The deal –for which the US companyhas claimed, predicting that a“prematuregeneric launch” would cost disclosed neither the price nor the vendor –will be completed following Hospira “tens of millions of dollars, if not more than US$100 million”. “a successful technical transfer”. “Giventhe importance of Precedex”, Hospira said a“premature Within the next fewmonths, Lannett expects to launch its generic entry” would force it to “terminate its US brand drug sales force alternative to Teva’s estradiol hormone tablets, while the firm’s of approximately 130 persons”, as well as reducing or reorganising introduction of arivaltoMylan affiliate Somerset’sEldepryl (selegiline) corporate staff. Furthermore, the firm pointed out, “Hospira will have no Parkinson’s disease drug will follow“sometime thereafter”. The two means to recoverits losses because FDA’ssovereign immunity would drugs had annual US sales at average wholesale prices (AWPs) of preclude Hospira from recovering moneydamages”. US$31.0 million and US$8.5 million respectively,Lannett noted. Considering Hospira’smotion for an injunction, Judge George At present, Actavis, Mylan, USL Pharma and Teva hold US Food Jarrod Hazel concluded that “to nowpermit FDAtoapprove generic and Drug Administration (FDA) approvals for estradiol tablets, while versions of Precedexonthe basis that it can approve ANDAs for broad, similar approvals for selegiline capsules are held by AAI Pharma, general indications that overlap with aprotected method of use would Apotex, Endo’sDavaand Somerset. be tantamount to achange of the rules”. Noting that “the court cannot Separately,Lannett has secured FDAapprovalfor oxycodone 5mg find FDA’sinterpretation to be reasonable”, Hazel concluded that capsules and has stated that it does not expect its sales of digoxin – Hospira had “demonstrated its likelihood of success on the merits”. which account for less than atenth of its group turnover–tobe While the temporary restraining order –which runs until mid- “significantly impacted” by an abstract published in the Journal of September –had initially required the FDAtorescind the generic the American College of Cardiology (JACC) that suggested apotential approvals and recall anyproduct sold or distributed under such an increased risk of mortality in atrial-fibrillation patients. G approval, Mylan wasable to convince the court to stay these parts of the order while the generics firm filed an appeal. It argued that these actions would “impact immediateand irreparable harm on Mylan and others in the supply chain”. Moreover, Mylan said, no mechanism existed for ONCOLOGY DRUGS such arecall. Acourt filing by Hospira claims Par“flooded wholesalers with an approximate six-week supply of its generic Precedex”. Venus has Swiss gemcitabine Sandoz previously reached asettlement agreement with Hospira enus Remedies says it has “achievedanother landmark” by obtaining that would allowthe Novartis subsidiary to launch aUSrivalto Vits first marketing authorisationinSwitzerland. The Indian company Precedex–which Hospira markets under licence from Orion –from expects to “capture asignificant share” of the Swiss gemcitabine 26 December this year (Generics bulletin, 10January 2014, page 23). market when it launches its 200mg and 1,000mg rivals to Lilly’sGemzar Earlier this year, the FDAhad invited comments from oncology drug through local marketing partner Swiss Pharma dexmedetomidine ANDAfilers overHospira changing the use code for towards the end of this year. G the ‘867 patent (Generics bulletin,3February 2014, page 17). G
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PRODUCT NEWS
BIOLOGICALDRUGS IN BRIEF AKORN has agreed to sell its tuberculosistreatment rifampin to Coherus and Daiichi Actavis as acondition of securing US Federal Trade Commission (FTC) clearance for its US$440 million acquisitionofVersaPharm. Noting that Akorn’sabbreviated newdrug application(ANDA) for rifampin wascurrently pending approval, the FTC said VersaPharm begin Japanese trial wasone of only three firms –along with Mylan’sAgila and Bedford –that currentlyheld US approvaltomarket the injectable drug. Phase III trial for aplanned biosimilar rivaltoAmgen’sEnbrel A(etanercept) in rheumatoid arthritis patients has been initiated in LUPIN is aiming to compete for astakeinIndia’sRs2.19 billion Japan by US-based biosimilars developer Coherus Biosciences and (US$35.7million) insulin glargine market after striking an local partner Daiichi Sankyo. The Japanese firm said it wasdeveloping agreement with South Korean biopharmaceutical firm LG Life the ‘CHS-0214’ candidate in Japan “with the intention to enter the Sciences to distribute the diabetes treatment in India. Under the biosimilarmarket in the near future”. agreement, the Indian firm will be responsible for sales and marketing “The trial is arandomised, double-blind, active-control, parallel- of insulin glargine, which Lupin noted would be sold under the group, multi-centre global study,” Daiichi Sankyo explained, adding Basugine name. No financial terms were disclosed. that it wasaimed at “comparing the efficacyand safety of CHS-0214 with Enbrel in subjects with active rheumatoid arthritis who have FRESENIUS KABI will be able to launch ageneric rivaltothe demonstrated an inadequate response to methotrexate”. The primary Ofirmev (acetaminophen)injectable drug in the US on 6December endpoint is a20% improvement at 24 weeks according to American 2020 under the terms of apatent-litigation settlement reached with College of Rheumatology criteria. the analgesic brand’sowner,Mallinckrodt’sCadence subsidiary. Coherus recently announced aPhase III trial for CHS-0214 in Twopatents are listed against Ofirmevinthe Orange Book partnershipwith Baxter BioScience for chronic plaque psoriasis maintained by the US Food and Drug Administration (FDA). The (Generics bulletin, 8 August 2014, page 25). Baxter is also first expires on 5August 2017, and the second on 6June 2021. collaborating with Coherus on aPhase III trial for rheumatoid arthritis (Generics bulletin, 11July 2014, page 20). TEVA has expanded its range of cardiovascular drugs in the UK by Meanwhile, Coherus has just announced that its planned biosimilar introducing eplerenone 25mg and 50mg tablets. The tablets are rivaltoAbbVie’sHumira (adalimumab) had “met the primary endpoint generic rivals to Pfizer’s Inspra treatment for chronic heart failure. in apivotal pharmacokinetic similarity study”. “The parallel-group, single-dose study met the criteria for pharmacokinetic similarity on all MYLAN has launched equivalents to Genentech’s Xeloda three required, prospectively defined, pharmacokinetic endpoints,”Coherus (capecitabine)150mg and 500mg tablets in the US. Teva holds the stated. These were maximum serum concentration; area under the time- only other generic approvalfor the oncology drug, having entered concentration curvefrom first to last time-point;and area under the the US market earlier this year under the terms of apatent-litigation time-concentration curvefrom first time-point, extrapolatedtoinfinity. settlement (Generics bulletin, 21March 2014, page 17). All three geometric ratios for the ‘CHS-1420’ candidate were “fully within the 90% confidence interval from 80% to 125%”, Coherus HOSPIRA has claimed the first Japanese launch of generic oxaliplatin said, adding that “both agents were well-tolerated and there were no for infusion in 50mg/10ml and 100mg/20ml presentations. Meanwhile, differential safety findings observed between the twoagents”. the injectables specialist –which has apartnership deal with Japan’s Noting that the study was“an essential global regulatory Mochida to co-promote oncology generics –has also introduced requirement”, Coherus’chief medical officer,Barbara Finck, said the locally generic paclitaxel 30mg/5ml and 100mg/16.7ml for infusion. “robust results” represented a“significant reduction in development- programme risk”. DennyLanfear, the company’spresident and chief AMNEAL says it is entering acombined US market worth around executive officer, said the “clinical milestone” for such acomplex US$900 million through four launches aimed at “extending our molecule “further validates Coherus’ development platform and generic offerings across all dosage forms”. ArivaltoValeant’s demonstrates our ability to advance biosimilars across our portfolio”. G Zovirax (acyclovir)5%ointment will be available in a30g tube, while Amneal’sversion of GlaxoSmithKline’s Mepron (atovaquone) 750mg/5ml oral suspension is supplied in a210ml bottle. Meanwhile, ANTIHYPERTENSIVES oxycodone tablets in five strengths –equivalent to Mallinckrodt’s Roxicodone –havealso been launched, at the same time as a US courtbars Apotex’ patent cherry-flavoured rivaltoPfizer’s Cleocin Pediatric (clindamycin) 75mg/5ml oral solution. Florida district court wascorrect to find aUSpatent Apotexhad Agained for aprocess for making moexipril drugs wasunenforceable AMERIGEN says its Chinese subsidiary,Suzhou, has launched due to inequitableconduct, the US Court of Appeals has stated. mecobalamin 0.5mg tablets in China after receiving approvalfrom Apotexhad sued UCB’sKremers Urban, claiming its Univasc the Chinese Food and Drug Administration (CFDA). Manufactured and Uniretic brands infringed US patent 6,767,556, which discloses at the CFDAand US Food and Drug Administration (FDA) certified aprocess of reacting moexipril with an alkaline magnesium compound. plant in Suzhou, China, the drug will be distributed through a But the Court of Appeals affirmed the Florida court’sfinding that the partnershipdeal with local firm Sinochem. ‘556 patent’sinventor –Apotex’ founder and chairman, Barry Sherman – had “engaged in material misconduct”and had “affirmatively and SANOFI has launched an authorised generic version of its Eloxatin knowingly misrepresented material facts regarding the prior art”. (oxaliplatin)injectable through its Winthrop subsidiary in the US. “The district court did not clearly err in finding that Dr Sherman Several generics firms hold approvals for rivals to the colorectal knew, or at least had astrong suspicion, that he wasseeking to patent cancer treatment, the authorised version of which will be available the very same process used to obtain an already existing and widely in the same 50mg and 100mg vial presentations as the brand. G available drug,”the Court of Appeals stated. G
20 GENERICS bulletin 5September 2014 Partnerships Grow Businesses
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PRODUCT NEWS
MULTIPLE SCLEROSISDRUGS BIOLOGICALDRUGS Copaxone challenged Mundipharma strikes over higher strength EU deal on infliximab
eva’s 40mg/ml formulation of its Copaxone (glatiramer acetate)has undipharma has struck adeal with Celltrion that will give it Tbeen challenged by Dr Reddy’safter the Indian firm sent the Israeli M“exclusive rights” to distribute the South Korean firm’sRemsima companyaparagraph IV notification alleging that patents protecting (infliximab)biosimilar in Belgium, Germany, Italy,Luxembourg, the the multiple sclerosis drug were invalid or not infringed by Dr Reddy’s Netherlands and the UK. The firm will begin marketing Remsima abbreviated newdrug application(ANDA). “following expiry of the relevant patents and supplementaryprotection “Teva will continue to vigorously defend its Copaxone intellectual certificates (SPCs)” for Janssen’sRemicade brand. property rights against infringement wherevertheyare challenged,” Celltrion’sRemsima wasapprovedbythe European Commission Teva said, adding that it planned to sue Dr Reddy’swithin 45 days, almost ayear ago, at the same time as development partner Hospira’s triggering a30-month stay of final US Food and Drug Administration Inflectra version (Generics bulletin, 20September 2013, page 17). (FDA) approvalfor the ANDA. “Copaxone 40mg/ml is protected AntonyMattessich, Mundipharma’smanaging director, said the by twoOrange Book patents that expire in 2030,”Teva noted. deal reflected “our aim to work in partnershipwith companies that Meanwhile, Sandoz and development partner Momenta have also share our high standards to delivereffective treatment options which had aparagraph IV ANDAaccepted for reviewbythe FDA. Noting meet the needs of both patients and payers”. Celltrion’sproduct would that it believeditcould qualify for 180-day exclusivity,Momenta benefit from Mundipharma’s“European reach, strong commercial said the product “could be on the market as early as the first quarter focus and expertise”,Mattessich indicated. G of 2017, assuming the paragraph IV challenge is successful”. Mylan’s version has also been accepted for filing by the FDA. Copaxone’s40mg/ml strength wasapprovedbythe FDAearlier DIABETES DRUGS this year (Generics bulletin, 14February 2014, page 15). The higher- dose, three-times-a-week injectablewas made available alongside the daily 20mg/ml strength, which wasopened up to generic competition FDA clears follow-on insulin from May by an appeals court ruling last year that found akey patent li Lilly and Boehringer Ingelheim have secured tentative approval protecting the brand to be invalid (Generics bulletin, 9 August 2013, Efrom the US Food and Drug Administration (FDA) for their page 1). However, no generic rivals have yet receivedFDA approval Basaglar (insulin glargine) rivaltoSanofi’sLantus treatment for and the Supreme Court is reviewing the appeals court’sdecision. G type-2 diabetes. But theywill have to wait until mid-2016 to gain final approvalunless acourt ruling in their favour ends a30-month stay that Sanofihad obtained by suing for infringement of sevenUSpatents INTELLECTUAL PROPERTY with expiry dates running between December 2023 and March 2028 (Generics bulletin, 14February 2014, page 14). Bulgaria rejects Atripla SPC The twofirms applied for approvalofthe basal insulin –delivered in the KwikPen pre-filled dosing device –via the FDA’shybrid ulgaria’sSupreme Administrative Court has rejectedasinvalid 505(b)(2) pathway, which allowed them to reference Sanofi’ssafety BMerck &Co’ssupplementaryprotection certificate (SPC) for and efficacydata for Lantus (Generics bulletin, 10January 2014, its Atripla (efavirenz/emtricitabine/tenofovir) triple-combination HIV page 19). Their submission also included “results from pharmacokinetic therapy, following the reasoning of the European Court of Justice’s and pharmacodynamic studies, as well as Phase III studies in people Medeva decision (Generics bulletin 9December 2011, page 15). with type-1 and type-2 diabetes”. Initially, the country’spatent office had refused to grant Merck’s While the European Medicines Agency(EMA) recently adopted SPC in September 2011. However, an administrative court reversed apositive opinion on the firm’sbiosimilar application for insulin this decision and granted the SPC for Atripla in October 2013. glargine under the trade name Abasria (Generics bulletin, 11July On appeal, the Supreme Court found that Atripla’scombination 2014, page 1), the same name had “not necessarily been approved of three ingredientswas not sufficiently covered by the BG62,612 in other countries”. Therefore, theywere “targetting aglobal trade basic patent. The court noted that the ‘612 patent specified only two name outside of the US for the alliance’s insulin glargine product, of the ingredients in Atripla, butdid not disclose tenofovir. G which will be announced at alater date”. G
BIOLOGICALDRUGS ONCOLOGY DRUGS Twomake biosimilars pledge Sandoz Brazil rivals Velcade mgen and Novartis have become the first twosignatories to aset andoz Brazil has claimed the launch of the country’sfirst generic Aof common principles around biosimilar lobbying, patient safety Sversion of Janssen-Cilag’sVelcade (bortezomib) in 3.5mg lyophilised and business partnerships created by acoalition of 19 institutional powder vials. “Sandoz will distribute and promote bortezomibinBrazil investors. The coalition –led by the United Automobile Workers (UAW) based on an agreement with Accord Pharmaceuticals,”the firm said, Retiree Medical Benefits Trust –has invited 25 pharma companies adding that the drug would be “the first Sandoz medicine marketed to ensure investments in political lobbying are aligned with shareholders’ in Brazil for treatment of haematologic –asopposed to solid –tumours”. interests, information provided to policymakers on patient safety is Bortezomib, the firm noted, wasnot fully reimbursed by Brazil’s balanced, and disclosure of major business partnerships is transparent. G government, so the generic would help to increase patient access.G
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PRODUCT NEWS
IN BRIEF ANALGESICS MYLAN has begun shipping the first generic versions of Upsher- Smith’s Klor-Con (potassium chloride)8mEq and 10mEq Actavis fallsshortin extended-release tablets in the US. The generics firm said the hypokalaemia treatment had annual US sales of US$135 million.
APOTEX has recalledabatch of mycophenolic acid 360mg tablets Gralise attackinUS in Canada following an error in French-language labelling for the immunosuppressant. “The French statement on the outer carton nabbreviated newdrug application(ANDA) filed by Actavis for indicates that each tablet contains 180mg of the medicine,”Apotex Aan alternative to Depomed’sGralise (gabapentin) tablets infringes stated, noting that the tablets themselves contained the correct all sevenUSpatents protecting the post-herpetic neuralgia treatment, strength. Although the risk of apatient taking ahigher dose was NewJerseyDistrict Judge Joel Pisano has ruled. The latest-expiring “unlikely”, the firm said, the oversuppression of the immune system of the sevenpatents expires on 26 February 2024. could lead to a“serious or fatal” increased risk of infection. As Generics bulletin went to press, Pisano’sruling wasunder seal to protect confidential information. His decision came around DEA –the US Drug Enforcement Administration –has published amonth after he had temporarily enjoined Actavis from marketing afinal rule imposing more stringent restrictions on hydrocodone its 300mg and 600mg gabapentin tablets pending acourt ruling combination products in the country’s Federal Register.Moving (Generics bulletin, 8 August 2014, page 23). combinations of hydrocodone with other substances such as Actavis’ Watson and Impax had previously withdrawn ANDAs for acetaminophen or aspirin into Schedule II –which contains substances generic versions of Gralise, while Parhad abandoned its paragraph IV with accepted medical uses that have the highest potential for harm patent challenge. Earlier this year,Depomed reached patent-litigation and abuse –will come into effect 45 days after publication. While settlements with Incepta and Zydus Cadila that allowthe twogenerics hydrocodone by itself is already in Schedule II, combination products firms to launch from 1January 2024. The originator is also suing the are currently in the less restrictive Schedule III. US Food and Drug Administration (FDA) in abid to obtain seven-year orphan-drug exclusivity for the extended-release brand. PHARMAC –New Zealand’sPharmaceutical Management Agency– Depomed reported US Gralise sales ahead by 77% to US$26.0 is seeking feedback from pharmaceutical suppliers and interested million in the first half of this year. parties on proposals for sole-supply tenders and draft processes for Meanwhile, Actavis has launched paragraph IV challenges to the agency’s2014/15 tender.Pharmac said it wasalso seeking Acorda Therapeutics’Ampyra (dalfampridine) 10mg extended-release feedback on “commercial proposals as an alternative to tendering”. tablets and UCB’sNeupro (rotigotine) extended-release transdermal film in six strengths. In both cases, the generics firm believesitmay ZYDUS CADILA has receivedfinal US Food and Drug Administration be eligible for 180-day exclusivity as first to file an ANDA. Both (FDA) approvalfor aciclovir 400mg and 800mg tablets. The Indian originatorshavesued Actavis, triggering 30-month stays of approval. firm said it would enter aUSmarket worth US$55.8million annually. Ampyra and Neupro had annual US sales of US$231 million and US$85 million respectively according to IMS. MACLEODS PHARMACEUTICALS has receivedtentative US Food Actavis has also been sued by Supernus Pharmaceuticals overa and Drug Administration (FDA) approvalfor its fixed-dose paragraph IV challenge to Trokendi XR (topiramate) extended-release combination of efavirenz, lamivudine and tenofovir 600mg/300mg/ capsules, which are protected by FDAOrange Book patents until 2027. 300mg as well as its tenofovir 300mg tablets under the US President’s Separately,Actavis is also facing alawsuit from Canadian women’s EmergencyPlan ForAIDS Relief (PEPFAR). The Indian firm has also health specialist Duchesnay in aDelaware district court overwhat receivedfinal FDAapprovalfor olanzapine tablets in six strengths. Actavis believesisafirst-to-file paragraph IV challenge to Diclegis (doxylamine succinate/pyridoxine) 10mg/10mg delayed-release tablets. HEALTH CANADA has implemented labelling changes for controlled- The Orange Book currently lists twopatents against the treatment release opioids “to enhance their safe and appropriate use”. The for morning sickness in pregnant women –USpatents 7,560,122 regulator said the changes “provide standardised wording that more and 6,340,695–which expire on 25 January 2019 and 21 June 2021 clearly outlines the risks and safety concerns associated with controlled- respectively, while newproduct exclusivity (NPE) for Diclegis release opioids”. Updated guidance also “encourages more appropriate expires on 8April 2016. G patient selection and monitoring”.
ANI PHARMACEUTICALS has paid US$11 million to acquire the GASTROINTESTINAL DRUG US rights for Vancocin (vancomycin)125mg and 250mg capsules from Shire. The deal also givesANI access to abbreviated newdrug Novel gets first Metozolvrival applications (ANDAs) for “currently non-marketed products” including injectable forms of vancomycin in 500mg, 1g and 10g ovelLaboratories has become the first companytosecure US Food strengths as well as 250mg and 500mg oral solution presentations. Nand Drug Administration (FDA) approvalfor ageneric alternative ANI said it planned to launch Vancocin capsules under its own to Salix’ Metozolv ODT (metoclopramide) orally-disintegrating tablets. label during the fourth quarter of 2014. Granting Novelapprovalfor 5mg and 10mg orally-disintegrating tablets, the FDAnoted that Salix no longer marketed the higher strength. ACTAVIS says it has achieved“positive topline results” in Phase III However, the agencysaid, the 10mg strength had not been withdrawn studies evaluating the potential for the “investigational antibiotic” for reasons of safety or efficacy, so approvalofageneric version ceftazidime-avibactam as atreatment for hospitalised adult patients waspermissible. with complicated intra-abdominal infections. The compound was Furthermore, the agencyobserved, Salix had not sued Novelover being developed to treat a“broad range” of infections that were US patent 6,413,549 –which expires on 11 July 2017 –within the “becoming resistant to antibiotics”, Actavis said. G 45-day windowthat would have triggered a30-month stay on final approvalfor the generic version of the heartburn treatment. G
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EVENTS
SEPTEMBER 19-21 November 2014 17 &18-19 September ■ 17th IGPAAnnual Conference ■ BiosimilarsGlobal Miami,USA Congress 2014 Europe This three-day event is being organised by the US Generic Pharmaceutical Association (GPhA) and is the global event of the worldwide generics industry.Itisthe London, UK annual joint meeting of the Canadian, European, Japanese, South African and US Preceded by aworkshop covering regulatory generics industry associations, the CGPA, EGA, JGA, NAPM and GPhA. Topics covered guidelines and clinical development, this will include market trends, regulatory developments and intellectual property.There will two-day event will look at issues be speakers from companies such as Actavis, Hospira, Mylan, Sandoz and Teva,along including patient access, manufacturing, with opportunities to network. interchangeability,and emerging markets. Contact:Jennifer Nguyen, GPhA.Tel:+1202 249 7127. Contact:Paradigm Global Events. E-mail: [email protected]. Website: www.gphaonline.org. Tel: +44 207 193 3485. E-mail: [email protected]. Website: www.paradigmglobalevents.com. manufacturing and clinical trials. The and their impact on the generics industry. conference will include case studies Contact:GPhA. 25-26 September looking at clinical trials as well as Tel: +1 202 249 7127. ■ GMP Meets presentations on scale-up processes and E-mail: [email protected]. RegulatoryAffairs demonstrating biosimilarity. Website: www.gphaonline.org. Budapest, Hungary Contact:OxfordGlobal. Tel: +65 657 02208. NOVEMBER This event looks at applying for and E-mail: [email protected]. maintaining marketing authorisations in Website: www.biosimilarsasia-congress1.com. ICH countries and will coverissues 4-7November including the required documentation and ■ 9th Generics Asia the structure of the dossier,input from OCTOBER Singapore GMP regulatory departments and drug This is afour-day conference which will look approvalinEurope, the US and Japan. 6&7-9October at topics including strategic partnerships, Contact:Concept Heidelberg. ■ CPhI Pre-Connect Conference marketing, the challenges of biosimilars Tel: +49 6221 84 44 0. &CPhI Worldwide and opportunities in supergenerics. Quote E-mail: [email protected]. code P46253GB for a15% discount on Paris,France Website: www.gmp-compliance.org. registration rates. CPhI Worldwide is an exhibition and Contact:IBC Asia. networking opportunity which will also 25-26 September Tel: +65 6508 2401. include the co-located events iCSE, P-MEC ■ 2nd Annual Biosimilars E-mail: [email protected]. and Innopack. The event will be preceded Website: www.generics-asia.com. Asia Congress by the Pre-Connect Conference taking Singapore place in the same location. 11-12 November This two-day meeting will discuss topics Contact:UBM Information. including access to emerging markets, Tel: +44 207 921 8039. ■ 3rdAnnual World Biosimilar strategies for commercialising biosimilars, E-mail: [email protected]. Congress Europe Website: www.cphi.com. Geneva, Switzerland Covering the latest developments in the 13-15 October biosimilarsmarket, this two-day event will ■ 11th TOPRA Annual include keynote presentations as well as case Symposium studies and interactive discussion formats. Brussels,Belgium Contact:Terrapinn. Tel: +44 207 092 1000. Cocktail Reception & Arranged by The Organisation for Awards Presentation E-mail: [email protected]. Professionals in Regulatory Affairs Website: www.terrapinn.com. Tu esday7th October 2014 (TOPRA) in conjunction with Belgium’s Federal Agencyfor Medicines and Health 17-18 November Sheraton Paris Airport Products (FAMHP), this event will cover Hotel &Conference Centre current and forthcoming regulatory issues. ■ EuroPLX 56 Contact:TOPRA. Nice,France Sponsor,Attend Tel: +44 207 510 2560. This meeting provides aforum for E-mail: [email protected]. business-development decision makers to Website: www.topra.org. discuss and negotiate collaborative Find out moreat agreements, in-licensing, marketing and www.generics-bulletin.com 27-29 October distribution of patented medicines, ■ GPhA Fall Technical generics, biosimilars, OTCproducts, Alternatively, contact medical devices and food supplements. [email protected] Conference Contact:Raucon. or [email protected] Maryland, USA Tel: +49 6222 9807 0. or call +44 (0)1564 777550 This three-day GPhA conference will look at E-mail: [email protected]. the current regulatory and technical issues Website: www.europlx.com.
24 GENERICS bulletin 5September 2014 Gen 5-9-14 Pg. 25_Layout 1 02/09/2014 17:51 Page 3
PRICE WATCH ...... UK Newer products experience aquiet August ugust sawanumber of price offers withdrawn for recently-launched Department of Health’sAugust price concessions, allowing pharmacists Aproducts, although average prices remained relatively stable. Neither to claim more than the Drug Tariffreimbursement price for dispensing average rises nor falls got into double-digit territory (see Figure 1). them. The concessionary price for the 80mg strength was£11.15, giving Memantine bucked the trend, as the lowest price for 28-packs of pharmacists an average dispensing margin of about 6%. memantine 10mg fell by 23% to £1.80 (US$2.98). Meanwhile, the same Valsartan’sprice seems to have peaked as it wasnot among the product’saverage price slid back by 9% to £5.54.Elsewhere though, ‘biggest risers’ in Figure 3. Fenofibrate 200mg capsules sawthe biggest price offers were withdrawn for candesartan 8mg and rabeprazole price hiketo£12.26, which wasless than the Department’sconcessionary 10mg, causing their lowest prices to growbyabout aquarter.Naratriptan price of £14.23. Naftidrofuryl 100mg capsules were also givenaprice and rizatriptan also sawtheir lowest prices rise markedly. concession, as were tamoxifen 20mg tablets, even though the 10mg The biggest change, however, wasfor 28-capsule packs of valsartan strength in Figure 3appeared more of aproblem. Price fallers shown 80mg. The rise in its lowest price belatedly caught up with the average in Figure 4, such as pramipexole 350µg, were generally after recent rises. price increasesthat have been affecting the antihypertensive in recent As in July,the products exciting most interest in the marketplace, months (Generics bulletin,8August 2014, page 27). according to the number of price offers made for them, were omeprazole, All three strengths of valsartan capsules were included in the lansoprazole and simvastatin (see Figure 2). G
RECENT LAUNCHES FAST MOVERS Product/Strength/Pack size Lowest Change Average Change Price offers price (%) price (%) Product/Strength/Pack size June July August Amorolfine lacquer 5% 5ml £4.24 -5 £7.11 +1 Omeprazole caps 20mg 28 145 155 120 Atorvastatin tabs 20mg 28 £0.54 -2 £0.92 +4 Lansoprazole caps 30mg 28 125 139 107 Candesartan tabs 8mg 28 £0.49 +26 £0.98 ±0 Simvastatin tabs 40mg 28 125 128 100 Cilostazol tabs 100mg 56 £12.10 -1 £20.59 -4 Warfarin tabs 1mg 28 97 101 93 Cyclizine tabs 50mg 100 £8.35 +5 £11.28 +5 Citalopram tabs 20mg 28 106 110 91 Desloratadine tabs 5mg 30 £0.48 +7 £0.91 +2 Ramipril caps 2.5mg 28 99 106 86 Desogestrel tabs 75µg 84 £1.90 -7 £2.83 -6 Gabapentin caps 300mg 100 100 94 84 Donepezil tabs 10mg 28 £0.69 ±0 £1.36 +1 Alendronate tabs 70mg 4109 108 83 Entacapone tabs 200mg 30 £5.19 -4 £5.69 -3 Bendroflumethiazide tabs 2.5mg 28 113 114 83 Hydroxychloroquine tabs 200mg 60£3.40 -2 £4.22 -2 Fluoxetine caps 20mg 30 96 99 83 Irbesartan tabs 75mg 28 £0.49 -8 £0.78 -4 Latanoprost eyedrops .005% 2.5ml £0.99 +4 £1.80 +7 Memantine tabs 10mg 28 £1.80 -23 £5.54 -9 BIGGEST RISERS Montelukast tabs 10mg 28 £1.10 ±0 £1.58 -3 Product/Strength/Pack size Lowest Change Average Change Naratriptan tabs 2.5mg 6£0.99 +19 £1.42 +4 price (%) price (%) Quetiapine tabs 25mg 60 £0.48 -2 £1.06 ±0 Fenofibrate caps 200mg 28 £1.54 +19 £12.26 +418 Rabeprazole tabs 10mg 28 £1.34 +25 £1.85 -1 Allopurinol tabs 300mg 28 £0.35 +21 £1.22 +98 Raloxifene tabs 60mg 28 £4.70 -18 £8.35 -8 Tamoxifen tabs 10mg 30 £2.31 +46 £12.82 +85 Riluzole tabs 50mg 56 £18.90 -5 £32.11 -5 Aciclovir cream 5% 10g £0.59 ±0 £2.62 +72 Rizatriptan tabs 10mg 3£1.15 +16 £3.03 +7 Allopurinol tabs 100mg 28 £0.36 ±0 £0.91 +45 Sildenafil tabs 100mg 4£0.38 -7 £0.69 ±0 Naftidrofuryl caps 100mg 84 £5.85 +2 £16.79 +31 Telmisartan tabs 80mg 28 £0.95 -11 £1.79 -6 Tolterodine tabs 2mg 56 £1.54 -17 £2.60 -3 Valsartan caps 80mg 28 £7.99 +263 £10.43 +3 BIGGEST FALLERS Zolmitriptan tabs 2.5mg 6£0.42 -5 £0.91 +3 Product/Strength/Pack size Lowest Change Average Change price (%) price (%) Figure1(above): Comparison between the periods 1-31 July and 1-26 August 2014 of UK trade prices of the most recently-launched generics listed in categoryMof Pramipexole tabs 350µg 100 £1.95 +11 £15.24 -48 the Drug Tariffofpharmacy-reimbursement prices. Averages calculated from at Senna tabs 7.5mg 60 £1.50 -2 £3.78 -42 least 30 data points. Figure2(top right): Ranking of fastest-moving products subject to the most price offers made to independent UK pharmacists (one strength per Glimepiride tabs 3mg 30 £0.24 -25 £0.91 -38 ingredient; offers recorded by 26 August). Figure3(centreright) and Figure4(bottom Zolmitriptan tabs 5mg 6£0.65 ±0 £2.22 -32 right): Biggest average trade-price changes between 1-31 July and 1-26 August 2014. Averages calculated from at least 22 data points. Data for Figures 2, 3and 4from Nystatin suspension 100,000iu 30ml £0.66 -53 £2.39 -28 abasket of about 750 commonly-dispensed generics. Recently-launched products Pramipexole tabs 350µg 30 £0.95 -8 £8.06 -28 in Figure1excluded from Figures 3and 4(Source –WaveData).
WANT MORE LIKE THIS? Detailed product price comparisons and other price analyses are available at www.wavedata.net. To find out more about subscribing, please email your contact details to [email protected] and quote ‘GB online enquiry’ in the title line. ■ Forfurther information see www.wavedata.co.uk.Alternatively,contact Charles Joynson at WaveData Limited, UK. Tel: +44 (0)1702 425125.E-mail [email protected].
5September 2014 GENERICS bulletin 25 Gen 5-9-14 Pgs. 26-29_Layout 1 02/09/2014 17:51 Page 2
BUSINESS STRATEGY Alvogen aims forUS$1bn as it invests in biosimilars
Combining strong ithin the next three years or so, Alvogen in this rapid expansion, he brought in an experienced intends to achieve an annual turnoverof team drawn in large part from his former colleagues organic growth with WUS$1 billion. And after the “next-generation at Actavis (see box entitled ‘The Alvogen team’). acquisitions in the pharmaceutical company” achievesthat milestone in Includingcontract manufacturing under the 2017, it has ambitious goals for further growth, fuelled Norwich Pharmaceuticals banner,the US accounts for Asia-Pacific region will in part by aroster of biosimilarmonoclonal antibodies around half of Alvogen’sturnover. Other keymarkets (mAbs) to be producedatafacility that sister company include Romania, Hungary,South Korea, Taiwan, carryAlvogen’sgroup Alvotech is building next to the University of Iceland Bulgaria, Russia, China and Thailand. sales past US$1 billion in Reykjavik. Alvogen plans to invest overUS$500 While the companyoffers abroad range of solid- million in the newplant and development, including dose, semi-solidand injectable drugs with prescription- by 2017, chairman clinical studies, of its biosimilars pipeline. only and OTClegal status, one of the ways it is seeking Speaking exclusively to Generics bulletin just to challenge “traditional generics models” is through and chief executive ahead of his five-year anniversary with the company, extensive use of strategic partnerships and outsourcing, RobertWessman told chairman and chief executive officer Robert Wessman capitalising on an increasing willingness in the industry recalled that, when he joined in September 2009, the to collaborate and share costs. Forexample, the firm Aidan Fry. firm wasaUS-focused contract manufacturer operating has adeal with 3M to develop and produce aportfolio from afacility in Norwich, NewYork. of transdermal patches, while an alliance with Hospira Having switched the company’sname from has enabled Alvogen to introduce biosimilarepoetin Norwich Pharmaceuticals to Alvogen –derivedfrom zeta and filgrastim –aswell as, most recently,infliximab ‘alvo’ meaning target or goal, and ‘gen’ to suggest the –incentral and eastern Europe. firm’snext-generation strategy –former Actavis chief Wessman and his management team set about creating Annual sales near US$400 million an international generics business. Having generated contract-manufacturing revenues “Back then, the companydid not have its own of US$37 million in 2009, Alvogen last year achieved label or anymarketed products,”Wessman remarked aturnoverofalmost US$400 million on aproforma (Generics bulletin,4September 2009, page 30). “But basis, including afull-year impact from acquiring the we had aclear viewofwhere we were heading and which Naprelan (naproxen) analgesic brand from Shionogi in products and regions we wanted to focus on, bearing the US (Generics bulletin,15November 2013, page 20). in mind the industry’sdynamics and growth drivers.” The companyisforecasting sales of more than “Despite the intense competition in commodity US$550 million this year,rising to overUS$800 RobertWessman generics, we sawour biggest market as being the US,” million in 2015 as it consolidates the pending he explained. “We also selected emerging markets in acquisitions of Lotus Pharmaceuticals in Taiwan and central and eastern Europe as well as in the Asia-Pacific Dream Pharma in South Korea (see front cover). And region, which is growing proportionally faster than any the Lotus and Dream deals, combined with astrong other region of the world and has seen little of the launch roster,should give the group 2015 earnings consolidation that has taken place elsewhere.”Ineach before interest,tax, depreciation and amortisation of these three regions, Alvogen has created local (EBITDA) exceeding US$200 million. development and manufacturing hubs. “When we started back in 2009 with US$37 Growing to its current size of around 2,500 million, the target wastoget to acritical mass of employees across 34 countries had, Wessman pointed US$1 billion, target fast-growth emerging markets and out, entailed setting up alocal country operation at a be very strategic in our portfolio selection.Itseemed a rate faster than one every other month. To support him long wayaway, butitispretty realistic now,” Wessman remarked. Whereas the US –including contract manufacturing –accounted for almost half The Alvogen team of group sales in 2013, Central and Eastern Europe a Robert Wessman Chairman and chief executive officer third and Asia-Pacific afifth (see Figure 1), by the William Hill Americas commercial operations time Alvogen hits its US$1 billion milestone in 2017, Petar VazharovCentral and Eastern Europe commercial operations the Asia-Pacific and Central and Eastern Europe Peter Keil Asia-Pacific commercial operations regions should each contribute just under aquarter of GeorgIngram Business development the total (see Figure 2). Astrong pipeline of first-to- Lisa GraverStrategic development file and first-to-market opportunities is set to drive Kevin Bain Chief financial officer significant growth in the firm’sUSgenerics business, Arni Hardarson Chief legalcounsel keeping it at almost half of the group total sales. SvafaGronfeldt Organisationaldevelopment Wessman waskeen to highlight that the 78% Chris Young Supply chain compound annual growth rate (CAGR) in turnover Fjalar Kristjansson Quality achievedbythe companybetween 2009 and 2013 had Thor Kristjansson Mergers and acquisitions been achievedlargely through establishing greenfield operations, rather than through acquisitions. “Our organic
26 GENERICS bulletin 5September 2014 Gen 5-9-14 Pgs. 26-29_Layout 1 02/09/2014 17:51 Page 3
BUSINESS STRATEGY
growth in this period was59% ayear,” he pointed out. partnershipwith India’sNatco Norwich Contract Outlining Alvogen’slofty ambitions from his office (Generics bulletin,4March 2011, Manufacturing 12% in Iceland’stallest building, Wessman acknowledged page 22). Earlier this year,the Asia-Pacific the firm’spublicly-stated goal of becoming atop-10 partners receivedakey US Court 20% global generics player.Based on our latest rankings, of Appeal ruling that appears to that currently implies annual generics sales of around pave the waytoanearly market US$2 billion (Generics bulletin,20June 2014, page 26). entry of generic oseltamivir in the While atop-10 ranking remained abroad target, US (Generics bulletin,2May Wessman said the firm’s“ultimate goal” wastoachieve 2014, page 17). critical mass in its fast-growing target markets and “We felt that we had aunique to build up asolid pipeline. “We are well positioned approach to the intellectual property with strong management talent and asolid balance around oseltamivir,” Wessman stated, sheet to pursue acquisition targets that would bolster describing the court ruling as US Central and our organic growth,”he maintained. “precedent-setting”. 36% Supporting Alvogen in its growth ambitions will Wessman also highlighted Eastern Europe be Pamplona Capital Management, the private-equity Alvogen’spartnership with 32% fund that took amajority stake inthe companyearlier Switzerland’sAcino for ageneric this year.Atthe time, Wessman said the fund’sresources of Novartis’ Exelon (rivastigmine) Norwich Contract Manufacturing would give Alvogen “further firepower” to make patch. Recently the company Asia-Pacific 6% acquisitions as it pursued aplace in the industry’stop- secured afinal judgement of non- 24% 10 players (Generics bulletin,18April 2014, page 3). infringement on twostrengths, “Pamplona will, for sure, change our scope to do and obtained acovenant not to sue things,”Wessman confirmed. “It is alarge fund, so if on athird strength. we want to do acquisitions, it will help us.” However, he added, pushing “Theyinvested in our vision, our strategic plan, into the US injectables arena wasnot our team and our pipeline,”he continued, adding that attractive giventhe stiffcompetition, the fund had made “a long-term investment” and had limited margins and high production- “longer than afive-year vision”. compliance costs it would entail. Discussing Alvogen’sfuture under Pamplona’s Explaining the rationale behind majority ownership, Wessman stated: “We will continue Alvogen’sacquisition last year of US Central and US to growthe business to to explore attractive growth rights to Shionogi’sNaprelan Eastern Europe 46% opportunities. We are well funded for further growth, (naproxen sodium) controlled-release 24% butlooking abit more longer term, apublic listing for tablets (Generics bulletin,15 Alvogen may be an attractive option to support our November 2013, page 20), Wessman Figure1(top): Breakdown by region of Alvogen’s growth.”The company’slegal domicile in Luxembourg said the analgesic would complement proforma sales of almost US$400 million in 2013 gave it atax rate below20%, meaning it did not need the firm’sroster of controlled-release Figure2:Breakdown by region of Alvogen’s forecasted sales totallingUS$1.01 billion in 2017 to followUSrivals in seeking a‘tax inversion’ through products. “It wasopportunistic rather an overseas merger or via an acquisition, he added. than an attempt to build aspecialty business,”he With US generics sales last year –excluding said, highlighting the complexity of the formulation. proceeds from contract-manufacturing –inexcess of Controlled-release substances, such as analgesics, US$250 million, Alvogen claims to be one of the are manufactured at Alvogen’s37,000 sq mfacility in country’sfastest-growing generics players. About half Norwich, NewYork, which is currentlyequipped to of its business is with retail chains, and 30% with produce around 3.5 billion solid doses per year.However, wholesalers and distributors, with hospitals and clinics Wessman said it could be fitted out to make around accounting for atenth. The other 10% comes from double that volume. Over the past twotothree years, mail-order and government business. the firm has built 14 pilot scale-up rooms at Norwich. “A public listing for Furthermore, he added, by retaining contract- Partnership forpatches manufacturing at the site, Alvogen had been able to Alvogen may bean The firm already markets twotransdermal patches, achieve unit costs close to Indian producers and to ensure and it has another six patches awaiting approvalorunder regular third-party audits that had kept the plant free from attractiveoption to development through partnerships with companies major Form 483 observations for more than 20 years. supportour growth” including 3M. In total, the companyhas around 60 “In the US, we deliverwithin 48 hours and we abbreviated newdrug applications (ANDAs) filed or have not once been out of stock,”Wessman in development, of which it believes28are first-to-file proclaimed. These exemplary service levels had been or first-to-market opportunities. Products already filed recognised by the entire trade in giving the company have combined annual brand sales of US$7 billion, Healthcare Distribution Management Association Alvogen estimates, while the equivalent value of (HDMA) awards in both 2013 and 2014, he pointed ANDAs in development is US$17 billion. out, adding that these awards demonstrated Alvogen’s AUSresearch and development centre that Alvogen ability to compete as apreferred supplier as customer set up in Pine Brook, NewJersey, four years ago focuses consolidation continued. on first-to-file and first-to-market opportunities, as well By contrast, Wessman observed, the Asia-Pacific as niche developments such as controlled-release and region remained highly fragmented and localised. “It is controlled-substance formulations. lacking aregional leader with access to alarge portfolio, Among the first-to-file opportunities that Alvogen an international supply chain and lower costs than is pursuing in the US is ageneric version of Roche’s standalone companies, manyofwhich are family- Tamiflu (oseltamivir) antiviral agent through a owned,”he said. Alvogen intends to “play aleading
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BUSINESS STRATEGY
role in industry consolidation, with afocus on building products for Japan, where we don’tcurrently have a aselective,high-quality product portfolio in markets such presence. The plan is to increase that to four or five as Korea, Taiwan, Thailand, China, Japan and Vietnam”. products per year,” he continued. Wessman said Alvogen By agreeing to acquire amajority stake inSouth would retain Lotus’ model of licensing marketing rights Korea’sKunwha twoyears ago (Generics bulletin, to top-five generics players in Japan, rather than looking 2November 2012, page 3), Alvogen established alocal to establish its ownfront-end operation. development, manufacturing and marketing platform Noting that the hospital-based Taiwanese pharma from which to expand throughout the Asia-Pacific region. market wasvalued at US$6 billion, Wessman said Lotus Tworecently-announced acquisitions aim to build also had aportfolio of pending filings for prescription up the Kunwha platform.AUS$200 million deal for a drugs in China. Givenapprovaltimelines of up to five 67% stake inTaiwan’sLotus Pharmaceuticals (Generics years for such drugs, Alvogen had to date focused on “Wewill use Dream bulletin,3February 2014, page 5) –into which Alvogen OTCproducts for infants and women’shealth in China. Pharma to supply obesity merged its Asian operations –has just been followed Combining Dream Pharma with Kunwha would, by the group’sUS$187 million move to buyKorea’s Wessman remarked, create “one of South Korea’slargest drugs across Asia, and Dream Pharma from Hanwha Chemical. generic pharmaceutical companies”.“Dream currently By merging its Asian operations with publicly- has an impressive 35% market share in anti-obesity potentially for Europe” listed Lotus, Alvogen expects to broaden its local products in Korea,”he said, adding that the firm’s marketing network and portfolio, including by gaining overlap with Kunwha’sportfolio of cardiovascular, access to the Taiwanese firm’shigh-potencyand central nervous system, oncology and OTCdrugs cytotoxic oral formulations. And through Alvogen’s wasjust one product. global reach, Lotus will be able to export difficult- “We will use Dream to supply anti-obesity drugs to-produce generics from its facility that has been across Asia, and potentially for Europe,”Wessman stated. approvedbythe US Food and Drug Administration In central and eastern Europe, Alvogen acquired (FDA). “We have selected ahandful of Lotus products Hungarian firm Kéri Pharma at the end of 2010, and that have good prospects in central and eastern Europe, soon after established astring of sales offices to support and perhaps in western Europe,”Wessman revealed. launches throughoutthe region. “Lotus has also been developing one or two Twoyears ago, the firm established aregional Building on an established biosimilars base romAlvogen’sinception in 2009, biosimilars have been central to the company’sstrategy.The firm will invest around US$500 million in Fbiosimilarinitiativesthrough its sister company, Alvotech, overthe next three years. This investment includes building avertically-integrated facility and creating apipeline of monoclonal antibodies (mAbs) that will be launched towards the end of this decade, both under the Alvogen label and out-licensed to third parties. To gain experience and abrand presence in the biosimilars arena, Alvogen in 2011 struck adeal to market Hospira’sbiosimilar epoetin zeta and filgrastim in central and eastern Europe. And through the deal, it gained co-marketing rights in Bulgaria, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland and Romania to Hospira’sInflectra(infliximab) brand (Generics bulletin,7March 2014, page 23). “In some countries, we have a40% market share. We lead in Hungary,Croatia and some other markets on filgrastim and epoetin,”Alvogen’s chairman and chief executive officer,Robert Wessman, told Generics bulletin.“It is going as Iexpected,”he said, noting that the company hadadopted ahybrid marketing model of generic-style bidding for tenders butthen using brand equity to convince doctors to use biosimilars that were preferred in tender processes. “We have already wonkey tenders for infliximab in Hungary and Poland, and we see very good uptake innon-tender-drivenmarkets like Bulgaria, Croatia and Romania,”Wessman revealed. “Our experience has been that doctors are happytouse biosimilars for patients starting therapy, and we are already seeing pretty decent patient recruitment,”he said, adding that physicians had not, to date, raised any concerns about Inflectra’sclinical programme or extrapolated indications. There wasgood potential in central and eastern Europe for biosimilarinfliximabtowiden patient access to anti-tumour necrosis factor (anti-TNF) treatments if payers preferred the biosimilarthrough mechanismssuch as tenders or favourable reimbursement, Wessman believed. “We expect going forward to eat into the other TNF products,”he said. Having enjoyed success with biosimilars licensed from Hospira, the company–through Alvotech –isnow developing its ownpipeline of mAbs. Alvogen will have global marketing rights to products developed by Alvotech, and has struck deals with partners for several markets in which it does not operate. Twoofthe five undisclosed mAbs in Alvotech’spipeline are being developed using third-party cell lines, butthe companyiscreating its ownmammalian cell lines at the 11,800 sq mfacility it started constructing late last year next to the University of Iceland in Reykjavik (Generics bulletin,6December 2013, page 27). When it comes online in early 2016, the facility will have an annual capacity of filling 3million vials or syringes per year,and a12,000-litre active pharmaceutical ingredient (API) capacity. Wessman said the companyhad formed an alliance with the university to build up biotech expertise in the country that could provide well- qualified stafffor the facility.Iceland offered the advantage of having fewlocally-filed patents, which would allowcommercialstockpiling ahead of patent expiries in other countries,he pointed out. The plant, Wessman continued, had been designed to maximise yields whilst minimising changeoverand cleaning-validation times through the use of disposable bags. While Alvotech’sapproach to clinical trials and extrapolation of indications wasconfidential, Wessman said the companyhad learnt from costly mistakes made by firms that developed the first wave of biosimilars. “We will start Phase Iclinical trials for our first candidate within the next fewmonths,”he proclaimed. “We believe we will be among the first wave for biological products coming offpatent between 2018 and 2020.” “For one of the products, we are looking at afour-tofive-player market when we launch into aUS$12 to US$15 billion market,”Wessman forecasted. And with development work scheduled to start for further mAbs in the near future, the companywas already preparing to meet demand by applying for aplot to expand the facility in Reykjavik. G
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BUSINESS STRATEGY
packaging centre in Serbia that splits up bulk shipments Alvogen’sactivities in western Europe would be and tailors labelling for specific markets, according to limited to opportunistic deals for third parties to market demand and inventory levels. And at around the same specific products, such as transdermal patches, Wessman time, Alvogen struck abiosimilars deal with Hospira stated. And while Latin America remained an interesting that sawitmarket the US injectables specialist’sepoetin proposition, competing in the region’slargest market, zeta and filgrastim products in the region (see box Brazil, would require taking on powerful local players entitled ‘Building on an established biosimilars base’). that had large saleforces and local manufacturing. And then at the start of 2013, Alvogen announced As the group expanded globally,Alvogen’s adeal to buyRomania’sLabormed from Advent for an management had been focusing intensively on ensuring undisclosed fee. Labormed not only gave the group that the integration process made the acquired firms’ cardiovascular,central nervous system and OTC employees feel part of one companywith shared portfolios to add to its local range of oncology and standards, goals and ambitions, Wessman outlined. hospital products, it also provided Alvogen with “a Handled sensitively and pragmatically –such as by not manufacturing, research and development, and sales looking to abandon local brands and labels overnight – and marketing base for the entire region” (Generics the integration process could invigorate staffthrough bulletin,15February 2013, page 3). Labormed’s the opportunities brought by being part of agroup with facility in Bucharest, Romania, has an annual capacity global supply-chain, business-development and of 1.5 billion units. regulatory and quality affairs, as well as abroader portfolio, he said. Diverse portfolio is crucial in Europe Citing acouple of examples of howsmall changes Acknowledging the pressure on profits applied could makeabig difference, he said Alvogen had by cost-cutting measures such as mandatory clawbacks improvedthe staffcafeteria at the Norwich site and in Hungary and Romania, tender-like pricing movedKunwha into amodern office building. “These programmesinHungary and international reference- were not huge initiatives, buttheymade people see that pricing employed by several countries, Wessman said Alvogen cares for its employees,”he explained. An offering adiverse portfolio in central and eastern annual ‘Alvogen’sGot Talent’ competition helped to Europe wascrucial to protecting margins. Alvogen’s foster asense of one global company, he noted, while country managers were, he said, free to select products various other cultural activities formed part of efforts from the group’sbroad prescriptionand OTCportfolio – to integrate newbusinesses and instil aperformance- with around 1,400 marketing authorisations granted drivenculture throughout the group. in the region between 2010 and 2013 –tosuit demand Part of Alvogen’snext-generation model was in their local market. making extensive use of online tools for internal “We have most of the keyoncology products communication and training. “With around 2,500 available in the region,”Wessman stated. And in the employees, we do not have manylayers of bureaucracy,” respiratory field, Alvogen had secured deals for some he said. “We empower managers to propose ideas and of the more interesting combination products. “We felt take decisions more quickly than in larger companies.” we were too late to build our ownfacility,sowe have Manyofthe larger generics players were looking licensed some respiratory drugs for launch on an to reinvent themselves, as pipelines of small-molecule “In the Asia-Pacific opportunistic basis,”he explained. opportunitieswould be insufficient to offset continuing “I am happywith our scale in Hungary and price erosion, Wessman observed. Pushing into the OTC region, we believewe Romania,”Wessman declared. “We have grown in arena wasone option, butrequired major investments Bulgaria to adecent size, with sales of US$15-US$17 in brand-building before making areturn, he said. And can continue to gather million this year,and we have become pretty sizeable in buying mature products being sold offbyoriginators speed through our chosen areas of oncology and biosimilars in Poland”. could temporarily lift profit margins, butultimately “We have manyfilings in Kazakhstan, and we sales and profits from such tail products would decline. consolidation” have been investing in the Balkan region since 2010, Giventhat eight of the world’s10best-selling such as in Albania, Bosnia, Macedonia, Montenegro pharmaceuticals were nowbiological, investing in and Serbia,”he continued. biosimilars wascrucial, Wessman believed. But with “In Russia, where we are still building acritical manyofthe most establishedbiosimilar developers mass, we are largely taking an OTCapproach. By the already locked into alliances or going it alone, catching end of this year we will have around 15 OTCbrands, up would be difficult. “When we come to the market as well as five to six prescription products approved,” around 2018 to 2020, we envisage perhaps five rather he said, adding that the firm waslooking to expand than 10 competitors,”he forecasted. its local salesforce beyond its current size of around Alvogen’ssmaller size had necessitated afocused 60 people. Giventhe high multiplesbeing sought for approach, centred on organic growth in North America Russian companies that often offered minimal product and central and eastern Europe, bolstered by business- pipelines, building up aquality label using Alvogen’s development deals, Wessman said. “But in the Asia- ownportfolio appeared preferable, he said. Pacific region, we believe we can continue to gather “Ukraine is another market where we would like speed through consolidation, with twoacquisitions to build further scale,”Wessman continued. “Ukraine is underway at present and most likely another couple undergoing turbulence at present, butifyou are mindful within the next 24 months.” on collecting receivables, there are solid opportunities.” “This pace is not for everyone, so having manyof But he wasless keen on Alvogen building up a my former team around me that Ihave worked with for presence in Turkey,because seemingly attractive market adecade or so has been critical,”Wessman concluded. data did not reveal the huge demand for free goods and “With all the old guys around, it has been alot more fun the need to maintain ahuge salesforce. than Ithought it would be to do it again.” G
5September 2014 GENERICS bulletin 29 Generics Awards Ad 5-9-14_Layout 122/08/2014 10:49 Page 1 Gen 5-9-14 Pg. 31_Layout 1 02/09/2014 17:53 Page 3
PEOPLE
RESHUFFLES APPOINTMENTS Walgreens Boots to Desai succeeds Kay be led from the US as chief at Apotex
algreens’ chief executive officer, Greg Wasson,will soon head potexhas selected its president and chief operating officer, Jeremy Waglobal business with an annual turnoverof around US$130 ADesai,toreplace Jack Kay as the Canadian company’schief billion after the US drugstore chain chose to exercise its option to executive officer.Kay has become vice-chairman of Apotex’ board. acquire the 55% of UK-based wholesaler and retailer Alliance Boots Born in London, UK, Desai –who has retained the title of president that it does not already own. The deal –which will see Walgreens pay in his newrole –holds apharmacydecree and doctorate, along with a US$5.3 billion in cash plus just over144 million shares that are master’sdegree in business administration (MBA). He joined Apotex currently worth around US$8.8 billion –isscheduled to close in the from nowTeva subsidiary Ivax 11 years ago as senior vice-president first quarter of 2015, creating agroup with more than 11,000stores of research and development, before rising to become the Canadian across 10 countries and 180,000 pharmacycustomers. firm’sglobal research head three years later.Hetook on his most recent Wasson will be president and chief executive officer of Walgreens responsibilities as chief operating officer in 2011. Boots Alliance, aholding companythat –eschewing the recent trend Commenting on the change in leadership, privately-owned Apotex toward tax-inversion movesabroad by US companies –will have its noted that “a great time of change in the industry” –coupled with a tax domicile in the US and its headquarters in Chicago, US. “challenging and evolving global regulatory environment” –had put the Stefano Pessina,currently executive chairman of Alliance Boots, company’sfocus on “leadership and keystrategic planning to succeed”. G will report to Wasson as executive vice-chairman with responsibility for strategy,including mergers and acquisitions. The group will have four divisions:Walgreen US drugstores headed RESIGNATIONS by Alex Gourlay;the Boots retail chain in the UK and Ireland led by Simon Roberts;Pharmaceutical Wholesale and International Retail AET’s von Gersdorff departs under the leadershipof Ornella Barra;and Global Brands sold through third parties, which will be overseen by KenMurphy. Jeff Berkowitz ifferences over“leadership principles” and future strategy have will be the group’spresident of pharma and global market access, Dled Carol vonGersdorff to leave German generics developer while TimMcLevish will serveaschief financial officer.The post of and bulk-drugs agent Alfred ETiefenbacher (AET), where he had chief legaland administrative officer will be filled by TomSabatino, served as joint managing director for the past 12 years. He will become while TimTheriault will be the group’schief information officer, the chief executive officer of Carela, aprivate-equity companythat and Kathleen Wilson-Thompson will lead human resources. G invests in, and consults on, life sciences. “I am looking forward to bringing my long-term experience in the industry to create sustainable organisations and to help investors, as well as pharma companies, makeuse of the momentum in the RESIGNATIONS international market,”von Gersdorff stated. Following the departure of vonGersdorff–who wasalso Lynch leaves Australia’s GMiA chairman of the group’sAET Biotech division, and on the board of ate Lynch is stepping down as chief executive officer of Australia’s Cyprus’ Aegis Pharmaceuticals – Dieter Schönfeld and former Stada KGeneric Medicines industry Association (GMiA) after nearly six executive Hans-Martin Schwarm remain joint managing directors years in the role. She will be replaced on an acting basis “for the of Hamburg-based AET.Schönfeld also holds the title of group chief remainder of 2014” by the association’spolicydirector, Belinda Wood, executive officer,and has become chairman of AET Biotech. G while the GMiA searches for apermanent head. “Since her appointment in 2008,”the association commented, “Kate has steered the GMiA through significant changes in medicines APPOINTMENTS policyand overseen the growth of the organisation.” G Weininger takes Fair-Medpost ormer Dexcel Pharma executive Oren Weininger has become chief REGULATORY AGENCIES Fexecutive officer of Switzerland-based Fair-Med Healthcare. Twoagencies appoint heads Building on his experience at Dexcel –where he held senior business-development and sales and marketing roles (Generics bulletin, rance’sANSM medicines agencyand Germany’sfederal institute 6September 2013, page 21) –and as executive vice-president of Ffor drugs and medical devices, BfArM, have named newleaders. Kamedis Bio-Skincare, Weininger intends to pursue an aggressive Dominique Martin has replaced Dominique Maraninchi as the international expansion strategy for the generics specialist. director-general of the ANSM from 1September.Adoctor,Martin Fair-Med’sGerman affiliate has just secured approvals to expand waspreviously professional-risk director at French national health its OTCportfolio with products including ambroxol, bisacodyl and insurance fund CNAMTS. dimenhydrinate, as well as its first insurance-fund tender wins for Karl Broich –honorary professor of the medical faculty of prescription drugs. Weininger told Generics bulletin the company Friedrich-Wilhelms University in Bonn, Germany–has become waslooking for partnerships in Europe and the Commonwealthof president of BfArM since the end of July,replacing Walter Independent States (CIS), as well as in the Middle East and North Schwerdtfeger,who has retired. Aneurologist, Broich has been with Africa (MENA) region and in Australia, where the Swiss firm is BfArM since 2000, including as vice-president for the past five years. G active through Melbourne-based Eris Pharma. G
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