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Darren Alkins www.generics-bulletin.com Bulletin Publishing Group 4 Poplar Road, Dorridge, Solihull B93 8DB, UK Tel: +44 (0)1564 777550 Fax: +44 (0)1564 777524 E-mail: [email protected] COPYRIGHT NOTICE This publication must not be forwarded, exported, distributed or circulated by any means or in any format to persons including clients outside the direct employment of your Company. You may distribute the publication internally, but you may incorporate only insubstantial extracts, abstractsbulletin or summaries into presentations, providing Generics is identified as the source of the information. bulletin bulletin The publication/s, Generics and/or News@Generics , in PDF and/or HTML format, are supplied to you strictly under the terms and conditions of the Global Licence agreement between your Company and OTC Publications Ltd, the copyright holder of the publications. The publication/s are the intellectual property of the Publisher, OTC Publications Ltd and are protected by English copyright, trademark and other laws. 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 1/11/13 Pg. 1_Gen 18/11/05 Pg. 1 30/10/2013 19:41 Page 1 1November 2013 COMPANY NEWS 2 Levinsteps down from Wockhardt loses UK GMP certifications 2 McKesson movesfor Celesio in Europe 3 Actavis has deadline forEuropean decision 3 PharmstandardOTC grows 4 leadership role at Teva ahead of spin Te va cuts portfolio in Japan by 81 drugs 5 Ranbaxy’sfortunes varyacross Europe 5 eva’spresident and chief executive officer,Jeremy Levin, has stepped down from the Trole with immediate effect, the Israeli company has announced. “The board has named Sandoz outstrips global markets growth 6 Eyal Desheh, Teva’s executive vice-president and chief financial officer,tofill the role of Biocon awaits Indian 8 president and chief executive officer on an interim basis,”Tevanoted, adding that the firm trastuzumab approval had “formed acommittee that will promptly begin to search forapermanent successor”. Phillip Frost, chairman of Teva’s board, acknowledged that Levin and the board had been MARKET NEWS 9 “truly aligned” on the firm’sstrategy,but had “different views” overhow best to pursue it. These differences revolved around “nuances” and “subtleties”, Frost said, butwere not able to Industryurges WHO to use 9 be resolved. He said the firm’smanagement team was“fully committed to the implementation common INNs of Teva’s strategy,including the development of newcompounds, making strategic acquisitions, Canada’sCGPAhas mixed viewonCETA 9 forming joint ventures and the planned acceleration of the company’scost-reduction programme”. UK seeks clarity over 10 The Israeli firm recently announced plans to slash around 5,000 jobs –more than atenth widening SPC scope of its global workforce –bythe end of next year in abid to produce annual cost savings of REMS sample case will continue in US 11 US$2.0 billion by 2017 (Generics bulletin,18October 2013, page 1). This formed part of a German companies arehurtbyrebates 11 global restructuring programme outlined by Levin at the end of last year (Generics bulletin, 11 January 2013, page 24). PRODUCT NEWS 12 Since then, the firm has announced the creation of aGlobal Specialty Medicines group to encompass the group’sproprietary brands (Generics bulletin,3May 2013, page 26) and has FDAfinds fault with second 12 cancelled abiosimilars joint venture with Lonza (Generics bulletin,9August 2013, page 5). Teva US bupropion also recently suffered alegal setback that could see US rivals to its Copaxone (glatiramer acetate) blockbuster launch as early as May next year (Generics bulletin,9August 2013, page 1). Stada will license Apotex’ EU filgrastim 14 “It is obvious that Teva is going through atransition period,”Desheh stated, adding that Arrowtakes aim at eight French targets 14 he had “full confidence in the ability of Teva’s management and employees to achieve our Te va drops dossier 15 goals and execute the strategy laid out for the company”. G forUSlipegfilgrastim Stada buys Russian Aqualor sea sprays 15 Te va Canada loses on zoledronic acid 17 Canadagets two-year extensions FEATURES 20 wo-year patent-term extensions for Canadian pharmaceutical patents have been agreed by TCanada and the European Union (EU) as part of acomprehensive economic and trade Stada sets great storeby20agreement (CETA). The agreement also includes aBolar-type provision that will allowCanadian lureofeastern promise generics firms to manufacture products for export during anypatent-term extension period, as European companyStada is looking well as measures aimed at ending the possibility of generics firms being sued more than once eastwards towards Asia and the by originatorsoverthe same brand patents. Aspokesperson for the Canadian Generic Commonwealth of Independent States Pharmaceutical Association (CGPA) told Generics bulletin that the association knewof (CIS) for growth. Aidan Fry reports. “no CETAprovisions regarding pharmaceutical intellectual property that apply to the EU”. Noting that the deal constituted an “agreement in principle”, the CGPAsaid that it could REGULARS takeuptothree months before the full text of the deal waspublished. Canada and the EU must then conduct alegal reviewofthe document before it can be signed and ratified. Paragraph IV Watch – Savella 16 Jim Keon, president of the CGPA, said the association was“disappointed by the inclusion Events – Our regular listing 18 of apatent-term extension in CETA, butwelcomes the government of Canada’scommitment Price Watch UK – Our in-depth 19 to cap the maximum length of extension at twoyears and include other essential safeguards”. look at pricing trends in the UK Meanwhile, Keon said the CGPAwas pleased that the government had committed to “additional safeguards and reforms to Canada’spharmaceutical intellectual-property regime” that would People – Polpharma’sGlinka 23 “provide greater business certainty” for local generics manufacturers. “The specific implementation leads Mylan Europe details will be crucial to the success of these critical reforms,” Keon stated. G Forfurther details of the CGPA’sreaction to CETA, turntopage 9. Gen 1/11/13 Pgs. 2-8_Layout 1 30/10/2013 19:42 Page 2 COMPANY NEWS MANUFACTURING/SECOND-QUARTERRESULTS Wockhardt loses UK GMP certifications he UK’sMedicines and Healthcare products Regulatory Agency Region Second-quarter sales Change Proportion T(MHRA) has withdrawn good manufacturing practice (GMP) (Rs millions*) (%) of total (%) certificates it had previously issued for Wockhardt’sIndian solid-dose facilities in Chikalthana and Kadaiya. Forboth plants, the UK regulator US 5,220 -19 43 has issued restricted certificates that permit production only of ‘critical’ India/Emerging 3,440 -7 29 drugs that are at risk of market shortage. Furthermore, the MHRA ordered Wockhardt to recall from UK 2,390 +5 20 pharmacies, clinics and wholesalersfivenon-critical, prescription- Ireland 340 -37 3 only drugs made at the Chikalthana site. The recalleddrugs –all in France 290 -18 2 tablet form –are amiloride 5mg, clarithromycin 250mg and 500mg, Other 290 –2 gliclazide 80mg, quinine sulphate 300mg and tamsulosin pinexel400µg. Europe 3,310 ±0 28 The firm also voluntarily recalled several own-label OTCpainkillers. Wockhardt 11,970 -11 100 Wockhardt estimated that the effect of the MHRA’s actions over the Chikalthana plant would reduce its turnoverby£9million (US$15 *rounded to the nearest Rs10 million million) on an annualised basis. Figure1:Breakdown by region of Wockhardt’s sales in its financial second Citing “concerns overthe continuity of supply”, the MHRA said quarter ended 30 September 2013 (Source –Wockhardt) it wasallowing Wockhardt to continue to provide UK patients with 10 prescription-only medicines made at the Chikalthana site. plant. Audits of Indian plants in Baddi, Bhimpore and Shendra had Wockhardt has not learned which critical drugs the UK regulator produced only minor observations, as had separate MHRA and FDA will permit it to makeatthe Kadaiya plant following an inspection inspections of the firm’ssite in Wrexham, UK. in September this year.“The impact on existing business will only be The US import alert on the Waluj facility contributed to a19% known once the companyreceivesfurther communication from the local sales fall to Rs5.22 billion (US$87 million), equivalent to a MHRA,”stated Wockhardt, which added that the total annual value 26% dollar slide. Lower metoprolol prices were also afactor.Of53 of exports from Kadaiya to the UK was£18 million. abbreviated newdrug applications (ANDAs) pendingapproval, 43 had In July,the MHRA recalled16drugs made at Wockhardt’s been filed from either the Chikalthana or Waluj site, the firm noted. manufacturing site in Waluj, India, due in part to arisk of cross- Wockhardt’sreported 5% sales rise to Rs2.39 billion in the UK contamination (Generics bulletin,9August 2013, page 3). The same equated to a2%local-currencydecline due to product recalls and just site is the subject of aUSFood and Drug Administration (FDA) import one launch during the quarter.The Indian firm said its turnoverinIreland alert. Wockhardt said it had enlisted the consultant Lachman, which had plummeted by 37% to Rs340 million on lower prices as the country had completed a“baseline assessment”atWaluj, trained staffonGMP transitioned from abrand-led to asubstitution-drivenmarket. French requirementsand data integrity,and wasoverseeing remediation plans. sales tumbled
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