Copyright Notice
Total Page：16
File Type：pdf, Size：1020Kb
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 21/3/14 Pg. 1_Gen 18/11/05 Pg. 1 17/03/2014 19:47 Page 1 21 March 2014 COMPANY NEWS 2 Council fits missing part Alvotech finesses its biotech production 2 Sun facility suffers an FDAimportalert 3 Lannett pursues buys as sales shoot ahead 4 Hikma commits to its US Generics unit 5 into patent courtpuzzle Aspen wants partner to push into Japan 6 legal compromise reached by the Council of the European Union (EU) is “the last ScinoPharm benefits from 7 focus on Japan Amissing part forthe establishment of Europe-wide patent protection” through aUnified Patent Court, the European Commissionhas claimed. Council ministers have endorsed a Endo to acquire‘twoorthree’ during 2014 8 compromise agreement on the Commission’sproposals forupdating existing rules on the Siegfried is seeking moretargets to buy 9 jurisdictionofcourts and recognition of judgements. “By making changes to the rules on Rising’sUSlaunches driveAceto’sgrowth 10 recognition of judgements, we aretaking afurther step on the way to the new Unified Patent Court beginning its work,”claimed EU Commissioners Michel Barnier and Viviane Reding. MARKET NEWS 11 The European Parliament nowneeds to vote in favour during aplenary session, “which is expected at the latest in April”, according to the Commission. Meanwhile, the Commission FDAasks forinput on research priorities 11 is encouraging participating EU member states to ratify the Unified Patent Court Agreement Patent reviewstudy shelved 12 “as quickly as possible” and to complete preparatory work for the court to start operating. in Australia At present, 25 EU member states have signed up to aunitary patent package that will allow FDAlabel rule hit by broad-based attack 13 parties to obtain European patents that can be litigated through the Unified Patent Court. Italy India issues guidance on 15 and Spain opted out, while Croatia has yet to opt in following its EU accession last year. patent exclusions Aimed at creating aunified court to decide patent disputes throughout the EU, the agreement relies on the EU’sBrussels IRegulation to determine the court’sinternationaljurisdiction. PRODUCT NEWS 16 Therefore, the Commission proposed amending the Brussels IRegulation to clarifyrelations between the court, member states and litigating parties. TWi defeats Par on US megestrol patent 16 Apreparatory committee charged with bringing the court into being sees early 2015 as “a realistic target date” for operations to start with adequate facilities, trained judges and an Te va offers US rivals to 17 electronic filing and case-management system. Patent holders will be able to opt out in favour Xeloda and Evista of national patent litigation. A16th version of draft rules of procedure for the court has just Patadaypatent falls to Canada’sCobalt 18 been unveiled by the preparatory committee. Among several alterations,this clarifies Firms finish US fight on 19 procedures for opting out of hearings before the unified court. G Tracleer samples Natco claims victory 21 on Indian Copaxone US Celebrex ruling opens door FEATURES 24 keyUSpatent protecting Pfizer’sCelebrex(celecoxib) blockbuster until December next Communication is keyto24 Ayear is invalid, aVirginia district court judge has ruled. The summary judgement opens the deliver on GDUFAgoals wayfor generics firms to secure approvalfor,and to launch, the arthritis drug once six-month More efficient communication between the paediatricextensions to twoother patents expire in May this year.Pfizer –which reported US US Food and Drug Administration (FDA) Celebrexsales ahead by 11% to US$1.93 billion last year –said it would appeal. and industry,aswell as within the regulator Judge Arenda Wright Allen granted summary judgement to Actavis, Apotex, Lupin, Mylan itself, will be crucial to fulfilling the promise and Teva,declaring that Pfizer’sreissued US method-of-use patent RE44,048 wasinvalid. Pfizer, of the country’sgenerics user-fee programme. she said, “could not use the reissue process to correct its failure to file adivisional application”. David Wallace reports. Furthermore, Allen added, Pfizer had deliberately filed acontinuation-in-part, not adivisional application, of an earlier patent to maximise its exclusivity for Celebrex. “Because intentional REGULARS acts are not correctable via reissue, the court finds that the ‘048 patent violates the reissue statute as amatter of law, and is invalid.”And as the ‘048 patent could not be considered divisional, Pipeline Watch – Relenza and Reyataz 20 it wasalso invalid due to obviousness-type double patenting in light of earlier patents. Events – Our regular listing 22 The ruling comes 12 months after the US Patent and Trademark Office (PTO) reissued Price Watch UK – Our in-depth 23 the ‘048 patent, and Pfizer sued the generics firms for alleged infringement. look at pricing trends in the UK Actavis said it “may be entitled to 180 days of generic market exclusivity,orshared People – Parpicks Coughlin 27 exclusivity” pending final approvalfor its 50mg, 100mg, 200mg and 400mg capsules, which the for operations post firm expects upon expiry of paediatric extensions to US patents 5,466,823 and 5,563,165 on 30 May this year.Mylan expects to share exclusivity on the three highest strengths. G Gen 21/3/14 Pgs. 2-10_Layout 1 17/03/2014 19:48 Page 2 COMPANY NEWS STRATEGICALLIANCES MANUFACTURING/BIOLOGICALDRUGS Amneal partners on Alvotech finesses its developing its APIs biotech production mneal has formed an alliance with Intrexon, asynthetic biology lvogen’snewly-formed biosimilars affiliate, Alvotech, has formed Aspecialist based in Maryland, US, to “develop an improved Aamanufacturing partnership with California-based Finesse production process for acomplexactive pharmaceutical ingredient Solutions. The deal will give Alvotech access to “world-class, scalable, (API)”. The agreement between the twofirms will leverage Intrexon’s flexible and cost-efficient manufacturing and laboratory technology proprietary UltraVector development platform –aswell as the firm’s through Finesse’sturnkey SmartFactory good manufacturing practice suite of other synthetic biology technologies –with the aim of reducing (GMP) manufacturing platform suite”. the cost of producing the API. “This partnership allows us to leverage Finesse’ssingle-use bio- “Intrexon has an impressive track record of developing the full manufacturing automation platform, combining best-of-breed bioprocess potential of synthetic biology.This is an exciting newpropositionfor equipment from upstream through downstream,”commented Alvotech’s the expansion of our generic pharmaceutical development capabilities,” chief executive officer,Andreas Herrmann. The deal gave Alvotech said Amneal’schairman and co-chief executive officer,Chintu Patel. “much-needed additional manufacturing capacity and scale-up The twofirms would look to explore similar opportunitiesinthe capabilities”, he said, adding that the first manufacturing suite would future, noted Intrexon, which said the alliance could “drive acomplex, be “in place by the end of 2015”. multistep chemical process towards anew era of more affordable Alvotech recently started building abiologics development and drugs produced through biology-enabled production methods”. manufacturing centre in Reykjavik, Iceland, that it plans to open in early In amove that expands its presence in Europe, Intrexon has just 2016. The firm is investing US$250 million in developing aportfolio of acquired laboratories located in Budapest, Hungary,from biocatalysts monoclonal antibodies (Generics bulletin,6December 2013, page 27). G specialist Codexis. “The acquisition will expand Intrexon’sstrain- and protein-development capabilities, as well as strengthen fermentation- IN BRIEF process optimisation and scale-up,”commented the US-based company. Robert Walsh, president of Intrexon’sIndustrial Products division, UNILIFE –the US-based injectabledelivery systems specialist –has said incorporating the Budapest team would “afford Intrexon greater secured a US$60 million loan from investment firm OrbiMed. G flexibility in existing collaborations, including with Amneal”. G 2 GENERICS bulletin 21 March 2014 Gen 21/3/14 Pgs. 2-10_Layout 1 17/03/2014 19:49 Page 3 COMPANY NEWS BUSINESS STRATEGY MANUFACTURING Japan’s Nichi-Iko is Sun facility suffers seeking aUSpartner an FDA importalert apanese generics player Nichi-IkoPharmaceutical