Gen 6-11-15 Pg. 1_Gen 18/11/05 Pg. 1 04/11/2015 17:37 Page 1 6November 2015 COMPANY NEWS 2 EU proposal will allow Concordia completes acquisition of AMCo 2 Walgreens’ Rite Aid bid worthUS$17bn 3 NewZealand’sAFT weighs initial listing 4 Perrigounveils plan to 5 production during SPC contest Mylan bid Reddy’ssees Russia as biosimilars target 6 Indian warning mars 7 “targeted supplementary protection certificate (SPC) waiverfor export purposes” Sandoz’ performance Awill allowEuropean Union (EU) manufacturers of generics and biosimilars to “compete Kabi “fullyontrack” forcost-cutting plan 8 on equal footing with competitors from non-EU countries”, under proposals that have Authorised launches aid Sanofi Generics 10 just been published by the European Commission. Aworking document entitled ‘A single IGI changes identity to 11 market strategy forEurope –analysis and evidence’ sets out the Commission’splans become Te ligent to implement “a recalibration of the patent and SPC regulatory framework in the EU”. Lupin upbeat that US approvals 12 Having long campaigned for a‘Bolar’ style manufacturing exemption during the SPC will return period, the European Generic and Biosimilarmedicines Association (EGA) welcomed the Commission’sstrategy proposals. “Europe needs to rapidly introduce atargeted SPC waiver MARKET NEWS 13 to capitalise on this tremendous opportunity for pharmaceutical manufacturing in the EU,” said EGA director general Adrian vanden Hoven. “The European generic and biosimilar France saves C1.7bn as 13 medicines industry is on the cusp of creating manymore jobs as it expands access to high substitution rises quality medicines for patients.” FTC slams FDAoverbiologicals 14 “Under the current system,”the EGA noted, “European manufacturersare required to suffix plans outsource production to supply countries without SPCs, or where SPCs expire earlier than in Swedish prescribing must aid substitution 15 Europe, and to stimulate competition as soon as SPCs expire in Europe.” Observing that “global spending is expected to shift toward generic medicines”,the Commission stated that generics and biosimilars“could represent 80% of the volume of medicines PRODUCT NEWS 16 by 2020”. “AnSPC manufacturing waiver for export purposes to non-EU countries with no Unipharm has remedy 16 SPC protection could allowthe EU generics and biosimilars industries both to create thousands over Sanofi’sPlavix of high-tech jobs in the EU and start manynew companies,”the Commission recognised. Glenmark teams up forEU 17 Moreover, the Commission also plans to introduce a“unitary SPC” to complement the Seretide rival unitary European patent system. This would “enhance the value, transparencyand legalcertainty Pfizer must respond on US Retacrit letter 18 of the protection of medicines”,providing a“one-stop shop for the granting of SPCs in Europe” and giving “enhanced certainty to European health authorities, to patients and to generics Te va defeats AZ in Dutch DuoResp duel 19 companies on the status of aregulated product’sintellectual-property protection”. G Celltrion has success 21 switching infliximab FEATURES 24 Mylan set to file Advair ANDA Sawai sets sights on US and 24 plans fordomestic demand ylan expects to file an abbreviated newdrug application(ANDA) in the US for a Japan’sSawai Pharmaceutical is filing Msubstitutable generic version of GlaxoSmithKline'sAdvair Diskus (fluticasone/salmeterol) products in the US as it scales up its blockbuster inhaler within the next fewweeks. The generics firm recently conducted a production capacitytosatisfy an “collaborative”pre-ANDAmeeting with the US Food and Drug Administration (FDA) and anticipated increase in domestic believesits formulation, “developed to be qualitatively and quantitatively the same” as the demand. Aidan Fry reports. reference brand, meets all the criteria for an AB-substitution rating that are laid out in the agency’sdraft guidance (Generics bulletin,20Sept 2013, page 1). REGULARS RajivMalik, Mylan’spresident, said the companywas currently completing the third of three pharmacokinetic (PK) studies to support the ANDAsubmission, having already finished Paragraph IV Watch – Xarelto 20 aclinical endpointstudy.Furthermore, human-factor and device-robustness studies had, he said, Events – Our regular listing 22 demonstrated that Mylan’sdry-powder inhaler could “be used as successfully with newpatients as those trained on Advair Diskus”. Price Watch UK – UK pricing trends 23 Malik said Mylan and its partner Prosonix were “making good progress” on developing a People – Lupin appoints heads 27 generic rivaltoFlovent (fluticasone) for the US, having completed pilot PK studies. Meanwhile, for twoofits regions an equivalent project for generic Flixotide in the European Union was“on track to be approved in the first quarter of 2016”, Malik noted. G Gen 6-11-15 Pgs. 2-12_Layout 1 04/11/2015 17:39 Page 2 COMPANY NEWS MANUFACTURING MERGERS&ACQUISITIONS Krka facility boosts Concordia completes vertical integration acquisition of AMCo rka says it expects to gain a“keystrategic advantage” by opening oncordia Healthcaresays it possesses “a powerful global platform Kamanufacturing facility for active pharmaceutical ingredients Cfor our continued organic growth” after completing its US$3.5 (APIs) in Krško, Slovenia. billion takeoverofUK-based Amdipharm Mercury (AMCo) from The Sinteza 1plant, into which the companyhas invested C85 vendors including Cinven(Generics bulletin,2October 2015, page 5). million (US$94 million), “givesKrka newcapacities for maintaining Mark Thompson, Concordia’sfounder,chairman and chief the entire process from development to production of rawmaterials executive officer,noted that the acquisition had “transformed us from and finished products”. apredominantly US business to aleading international pharmaceutical According to the Slovenian group, the 5,529 sq mplant will company” that generated around two-fifths of its turnoverinthe US. support its business model that already sees more than 70% of the firm’s Concordia insists it is “competitively positioned with AMCo’s portfolio vertically integrated from API through to finished doses. attractive,international portfolio that focuses on products with high “Krka’sown production of most of its keyAPIs enables the barrierstoentry,such as difficult manufacturing processes, technical companytoplan and manage the entire vertically-integrated business barriersand complexregulatory hurdles”. The vast majority of AMCo’s process, which results in high-quality, effective and safe APIs,”the top-20 products by value currently had twoorfewer competing drugs. companyclaimed. “This allows Krka to be the first to launch its With AMCo on board from 21 October this year,Concordia generic products to selected keymarkets and to have the necessary anticipates its 2016 full-year turnovertopping US$1 billion. Group speed and flexibility to react to regulatory and market changes, as sales of US$1.02-US$1.06 billion should generate adjusted earnings well as to better handle business risks.” before interest,tax, depreciation and amortisation (EBITDA) of Having acquired a16.6 hectare plot in Krško, north-east of its US$610-US$640 million. By the end of 2016, the firm anticipates Novo Mesto headquarters, Krka intends to build further raw-material having anet debt no more than 5.5-times its EBITDA. capacity at the site. Over the “next fewyears”, the companyalso intends “Management expects high single-digitrevenue growth of the to increase its annual finished-dose output from nearly 13 billion tablets combined business overthe next three years, drivenprimarily by and capsules to more than 17 billion. The group expects to make expected organic volume growth through continued promotion of its capital investments this year of around C165 million. G legacy products and up to 60 product launches,”Concordia stated. G BARCELONA · BASILEA BUDAPEST · DUBAI MADRID · MONTEVIDEO SÃO PAULO · VALENCIA ANYTHING International distribution:Collections and deliveries to any place,standard or urgent ANYWHERE service,refrigerated,own DGR transportation, oversized transportation,customs, freight ANYTIME forwarding… Local and national deliveries within 24 hours. We offer logistics and distribution services that satisfy the specific needs of the SPECIALISTS INTRANSPORTING PHARMA AND CHEMICALS pharmaceutical industry, as well as the www.airpharmlogistics.com chemical and veterinary. 2 GENERICS bulletin 6November 2015 Gen 6-11-15 Pgs. 2-12_Layout 1 04/11/2015 17:39 Page 3 COMPANY NEWS BUSINESS STRATEGY/THIRD-QUARTER RESULTS MERGERS&ACQUISITIONS Teva stillsearching Walgreens’ Rite Aid for biosimilars deal bid worth US$17bn eva is continuing to search for apartnership to strengthen its position algreens Boots Alliance (WBA) has agreed to acquire US Tin the biosimilars market, according to the head of the company’s Wdrugstore rivalRite Aid in atransaction valued at around US$17.2 Global Generic Medicines business segment, Siggi Olafsson. “Time billion, including acquired debt. The US$9.00 per share all-cash is ticking on us, butwereally will be aplayer in this space,”hesaid, deal –which has been approvedbyboth firms’ board of directors, Noting that the group currently generated annual sales of around butissubject to approvalbyRite Aid shareholders and antitrust US$350 million from its ‘waveone’ biosimilars and proprietary Granix clearances –isscheduled to close in the second half of next year.WBA (tbo-filgrastim) brand, Olafsson acknowledged that Teva had “walked said the deal represented a48%