29 April 2016 Sanofi sells its stake in Japan’s Nichi-Iko 3 Biocon eyes Lantus filings 3 by next March China’sYabao allies with US player Salus 4 Alembic venture will focus 4 on dermatology Sandoz to file Humira 5 and Rituxan rivals MARKET NEWS 6 Costs guide Canada on biological drugs 6 RCEP’s terms concern MSF 6 Portugal’s Infarmed backs biosimilar use 7 Commission must act on EU’s 7 SPC waiver MfE takes issue with 8 EU biosimilars study GPhA lauds bill that limits 8 FDA label rule PRODUCT NEWS 9 Nichi-Iko acquires rights to rituximab 9 Sandoz’ Zarxio saves millions 9 from US cost Firms appeal CMA fines over paroxetine 10 France adds to its répertoire 10 Mylan’s Cialis appeal is rejected 11 in Canada Lannett and YiChang 11 strike US insulin deal Patent Pool strikes deal on tuberculosis 13 FEATURES 14 Better communication key 14 to delivering GDUFA goals REGULARS Events – Our regular listing 10 Price Watch UK – UK pricing trends 12 People – Känd takes lead as 16 Acino chief executive COMPANY NEWS 3 C oncordia Healthcare has formed a ‘special committee’ “to consider various strategic alternatives potentially available to the company” amid rumours of a private-equity backed takeover. Revealing that the committee was composed of independent members of its board of directors, the Canadian firm noted that it had “had discussions” concerning strategic alternatives. “However, there can be no assurance that any transaction will occur,” Concordia said. “Concordia does not intend to make any additional comments at this time regarding various strategic alternatives potentially available to the company,” the firm stated. Through two acquisitions last year – a basket of 18 branded and authorised generic drugs from Covis Pharma for US$1.2 billion in April (Generics bulletin, 13 March 2015, page 10) and its US$3.5 billion takeover of Amdipharm Mercury (AMCo) in October (Generics bulletin, 11 September 2015, page 1) – Concordia’s 2015 group turnover almost quadrupled to US$394 million.“We began [2015] as a company selling six products into one main jurisdiction, the US. With acquisitions of Covis and AMCo we exited 2015 with more than 200 high-margin products in 100 countries,” Concordia’s chairman and chief executive officer, MarkThompson, summarised (Generics bulletin, 1 April 2016, page 4). G Concordia weighs its options P U B L I S H E D W E E K L Y Next issue – 6 May 2016 P errigo’s chairman and chief executive officer, Joe Papa, has left the company to take up the equivalent role at Valeant Pharmaceuticals. He will be succeeded at Perrigo by John Hendrickson as chief executive officer and Laurie Brias as chairman. Valeant recently began searching for a new chief executive after admitting that “improper conduct” by senior executives had caused the Canadian firm to misstate financial results (Generics bulletin, 25 March 2016, page 3). Mike Pearson is continuing to serve in the role until Papa takes up the post of chairman and chief executive officer and joins the firm’s board of directors, which Valeant expects to happen “by early May”. Pearson recently acknowledged several “controversies that have adversely impacted our business over the past several months”. These included claims of improper conduct on the part of former chief financial officer Howard Schiller, resulting in “the provision of incorrect information” to the firm’s ad hoc committee investigating allegations about the firm. This “contributed to the misstatement” of results for 2014 and early 2015, in turn leading to the firm failing to file its 10-K annual report on time. Schiller denies the accusations. Meanwhile, Pearson is facing contempt proceedings from the US Senate after failing to attend a deposition in early April (Generics bulletin, 15 April 2016, page 2). “Fostering an ethical culture and creating opportunities for professional development have always been high priorities for Joe,” emphasisedValeant chairman Robert Ingram. Papa, 60, said Valeant had “an opportunity to move forward with a renewed focus on operating with integrity across all areas of their business”. “I am excited to take on the challenge of leading Valeant and helping the company chart a new course,” he commented. Perrigo said its former US Consumer Healthcare head and current company president Hendrickson was an “exceptional leader” who was “uniquely qualified to successfully lead Perrigo into the future”. Meanwhile, the firm has withdrawn Marc Coucke’s nomination for re-election to the board at Perrigo’s forthcoming annual shareholders meeting. Coucke founded and was chief executive officer of Belgium’s Omega Pharma, which Perrigo acquired for C3.8 billion (US$4.3 million) last year (Generics bulletin, 10 April 2015, page 7). G Papa leaves Perrigo to take lead with Valeant
Transcript
29 April 2016
Sanofi sells its stake in Japan’s Nichi-Iko 3Biocon eyes Lantus filings 3by next MarchChina’s Yabao allies with US player Salus 4Alembic venture will focus 4on dermatologySandoz to file Humira 5and Rituxan rivals
MARKET NEWS 6
Costs guide Canada on biological drugs 6RCEP’s terms concern MSF 6Portugal’s Infarmed backs biosimilar use 7Commission must act on EU’s 7SPC waiverMfE takes issue with 8EU biosimilars studyGPhA lauds bill that limits 8FDA label rule
PRODUCT NEWS 9
Nichi-Iko acquires rights to rituximab 9Sandoz’ Zarxio saves millions 9from US costFirms appeal CMA fines over paroxetine10France adds to its répertoire 10Mylan’s Cialis appeal is rejected 11in CanadaLannett andYiChang 11strike US insulin dealPatent Pool strikes deal on tuberculosis 13
FEATURES 14
Better communication key 14to delivering GDUFA goals
REGULARS
Events – Our regular listing 10Price Watch UK – UK pricing trends 12People – Känd takes lead as 16Acino chief executive
COMPANY NEWS 3
Concordia Healthcare has formed a ‘special committee’ “to consider various strategicalternatives potentially available to the company” amid rumours of a private-equity backed
takeover. Revealing that the committee was composed of independent members of its boardof directors, the Canadian firm noted that it had “had discussions” concerning strategicalternatives. “However, there can be no assurance that any transaction will occur,” Concordiasaid. “Concordia does not intend to make any additional comments at this time regardingvarious strategic alternatives potentially available to the company,” the firm stated.
Through two acquisitions last year – a basket of 18 branded and authorised generic drugsfrom Covis Pharma for US$1.2 billion in April (Generics bulletin, 13 March 2015, page 10)and its US$3.5 billion takeover of Amdipharm Mercury (AMCo) in October (Generics bulletin,11 September 2015, page 1) – Concordia’s 2015 group turnover almost quadrupled to US$394million.“We began [2015] as a company selling six products into one main jurisdiction, theUS. With acquisitions of Covis and AMCo we exited 2015 with more than 200 high-marginproducts in 100 countries,” Concordia’s chairman and chief executive officer, Mark Thompson,summarised (Generics bulletin, 1 April 2016, page 4). G
Concordia weighs its options
PUBLISHED WEEKLYNext issue – 6 May 2016
Perrigo’s chairman and chief executive officer, Joe Papa, has left the company to takeup the equivalent role at Valeant Pharmaceuticals. He will be succeeded at Perrigo
by John Hendrickson as chief executive officer and Laurie Brias as chairman.Valeant recently began searching for a new chief executive after admitting that “improper
conduct” by senior executives had caused the Canadian firm to misstate financial results(Generics bulletin, 25 March 2016, page 3). Mike Pearson is continuing to serve in the roleuntil Papa takes up the post of chairman and chief executive officer and joins the firm’s boardof directors, which Valeant expects to happen “by early May”.
Pearson recently acknowledged several “controversies that have adversely impacted ourbusiness over the past several months”. These included claims of improper conduct on the partof former chief financial officer Howard Schiller, resulting in “the provision of incorrectinformation” to the firm’s ad hoc committee investigating allegations about the firm. This“contributed to the misstatement” of results for 2014 and early 2015, in turn leading to the firmfailing to file its 10-K annual report on time. Schiller denies the accusations. Meanwhile, Pearsonis facing contempt proceedings from the US Senate after failing to attend a deposition inearly April (Generics bulletin, 15 April 2016, page 2).
“Fostering an ethical culture and creating opportunities for professional development havealways been high priorities for Joe,” emphasised Valeant chairman Robert Ingram. Papa, 60,said Valeant had “an opportunity to move forward with a renewed focus on operating withintegrity across all areas of their business”. “I am excited to take on the challenge of leadingValeant and helping the company chart a new course,” he commented.
Perrigo said its former US Consumer Healthcare head and current company presidentHendrickson was an “exceptional leader” who was “uniquely qualified to successfully leadPerrigo into the future”. Meanwhile, the firm has withdrawn Marc Coucke’s nomination forre-election to the board at Perrigo’s forthcoming annual shareholders meeting. Coucke foundedand was chief executive officer of Belgium’s Omega Pharma, which Perrigo acquired forC3.8 billion (US$4.3 million) last year (Generics bulletin, 10 April 2015, page 7). G
Sanofi has offloaded its minority stake in Nichi-Iko Pharmaceuticalback to the Japanese generics player, but the sale will not affect
the firms’ existing partnership co-promoting generic products in Japan,the French originator says. According to Nichi-Iko, Sanofi has sold allof its 2.85 million shares – which had represented a 4.76% shareholdingin the Japanese group – in exchange for approximately ¥7.0 billion(US$63.3 million). The transaction was “strategic” and would“optimise cash flow”, a Sanofi spokesperson told Generics bulletin.
The two firms had struck a deal to develop a Japanese genericsbusiness around six years ago. At the time the agreement was reached,Sanofi held a 51% stake in in the joint venture after paying ¥4.41billion for more than 1.5 million of Nichi-Iko’s shares (Genericsbulletin, 18 June 2010, page 7).
Having immediately taken over Japanese marketing rights toSanofi’s Amoban (zopiclone), the venture was later broadened to includesome of Nichi-Iko’s generics, including donepezil and edaravone, aswell as an authorised generic of Sanofi’s Allegra (fexofenadine) inMay 2013. Last year, the venture introduced an authorised generic ofthe French firm’s Plavix (clopidogrel), in response to multiple genericentrants in Japan (Generics bulletin, 7 August 2015, page 10). G
COMPANY NEWS
3GENERICS bulletin29 April 2016
BUSINESS STRATEGY
Sanofi sells its stakein Japan’s Nichi-Iko
Abbott head Miles White says that acquiring further assets forthe company’s Established Pharmaceuticals branded generics
division has been put “partly on the back burner” as the US originatorlooks to “put our emphasis and focus” toward its larger devices anddiagnostics businesses.
Acknowledging that “there are properties out there [within theEstablished Pharmaceuticals division]”, chairman and chief executiveofficer White observed Abbott was wary of “heavy currency headwinds”in developing countries, along with significant earnings before interest,tax, depreciation and amortisation (EBITDA) multiples necessaryto acquire such assets.
Following Abbott’s acquisitions of CFR in Latin America andVeropharm in Russia, White said that the Established division was,“post-shaping of the Europe business and so forth, a pretty good gem”.“I think we can be selective about given markets [we target],” Whitesaid. “We want to be prudent, [and ensure] that we earn the return.”
In the first quarter of this year, foreign exchange losses wiped12 percentage points of growth from the operation. Reporting totalEstablished Pharmaceuticals sales that fell by 1.0% to US$888million, the US firm said this, however, represented growth of11.0% on an ‘operational’ constant-currency basis.
Almost three-quarters of turnover – or US$634 million – camefrom the division’s ‘Key Emerging Markets’, representing operationalgrowth of 11.9%, but a reported decline of 3.2%. “Operational salesgrowth in Key Emerging Markets – comprising countries includingIndia, Russia, Brazil and China – was led by continued double-digitgrowth in India,” Abbott commented, adding that it had also “achievedabove-market growth” in China and several countries in Latin America.
The remaining US$254 million of sales came from ‘other’emerging markets, representing operational and reported growth of8.6% and 4.9% respectively. G
BUSINESS STRATEGY/FIRST-QUARTER RESULTS
Abbott’s eye not on generics
Biocon is “on track” to submit regulatory filings for its biosimilarinsulin glargine candidate in the European Union (EU) and the
US by March next year, after it “crossed key interim milestones” inglobal phase III trials for its rival to Sanofi’s Lantus blockbuster.
Just over a month ago, the Indian firm secured approval fromJapan’s Ministry of Health, Labour and Welfare (MHLW) for thebiosimilar (Generics bulletin, 1 April 2016, page 11), shortly afterforming an agreement with Mexico’s Laboratorios Pisa to developand commercialise recombinant human insulin (rh-insulin) for theUS market (Generics bulletin, 25 March 2016, page 11).
“Insulin aspart and insulin lispro [biosimilar rivals to NovoNordisk’s Novolog and Eli Lilly’s Humalog respectively] collaborationprogrammes are progressing as per plan,” Biocon also revealed, “andare expected to cross critical pre-clinical milestones [during ourfinancial year ending March 2017].” The firm says its existing portfolioof insulins is registered in “over 65 markets, which represents 40%of the global diabetes population”.
During the same timeframe, Biocon says, regulatory submissionsremain “on track” in Europe and the US for “some” of the firm’sbiosimilar candidates that it is developing with partner Mylan. Thisincludes adalimumab, bevacizumab and trastuzumab, which are“making good [clinical development] progress”, as well aspegfilgrastim, for which a global phase III study “has been completed”.
Moreover, the firm has consolidated “all of its biosimilar assets”into a new legal entity, Biocon Biologics Limited, which is incorporatedin the UK. “We believe this restructuring will enable us to unlock greatervalue from our business segments at an opportune time,” Biocon said.
In its 2016 financial year, Biocon’s group turnover increased by14% to Rs35.7 billion (US$537 million), fuelled by strong growth inits contract research services division (see Figure 1), and Biopharmasales rising by 8% to Rs19.5 billion. Biocon recently secured Europeanapproval for rivals to AstraZeneca’s Crestor (rosuvastatin) cholesterol-lowering agent (Generics bulletin, 19 February 2016, page 11), thefirm’s first approval for a generic finished-dose formulation in highly-regulated markets, providing access “to over 15 European countries”.
Meanwhile, Biocon’s NeoBiocon operation in Gulf CooperationCouncil (GCC) markets also prospered, “driven by branded generics”.At the end of last year, NeoBiocon reached an agreement with Novartisto market the originator’s Jalra (vildagliptin) and Jalra-M (vildagliptin/metformin) diabetes brands in the United Arab Emirates.
Despite ramping up research and development spending by almosttwo-thirds to Rs2.75 billion, Biocon’s earnings before interest, tax,depreciation and amortisation (EBITDA) rose by more than a fifthto Rs9.03 billion. Pre-tax profit doubled to Rs12.3 billion. G
BUSINESS STRATEGY/ANNUAL RESULTS
Biocon eyes Lantusfilings by next March
Business Annual sales* Change Proportionsegment (Rs millions) (%) of total (%)
Figure 1: Breakdown by business segment of Biocon’s sales in its financial yearended 31 March 2016 (Source – Biocon)
Gen 29-4-16 Pgs. 2-16_Layout 1 27/04/2016 17:16 Page 3
Alembic Pharmaceuticals is partnering with fellow Indian firmOrbicular Pharmaceutical Technologies to establish Aleor
Dermaceuticals, a joint venture majority-owned by Alembic thatwill develop, manufacture and market dermatology products forglobal markets. No financial details were disclosed.
Privately-owned Orbicular, which was co-founded and is headed byformer Ranbaxy, Dr Reddy’s and Strides Arcolab executive M S Mohan,“has capabilities in developing dermatology products with a fully-equipped and staffed research laboratory” at its base in Hyderabad. The1,100 sq m research and development centre is capable of formulatingoral dosages, injectables, ophthalmics, otics, as well as semi-soliddosage forms, including ointment, creams and gels.
Moreover, Alembic noted, Orbicular also had a “pipeline ofproducts under various stages of development”.
Under the firms’ agreement, Alembic will own a 60% stake, whileOrbicular will hold the remaining 40% of the Aleor venture.“Worldwide registrations” for products would be filed from a dedicatedAleor Dermaceuticals manufacturing facility, Alembic said. G
COMPANY NEWS
4 GENERICS bulletin 29 April 2016
29 April 2016 Issue 260
Editor: Aidan FryDeputy Editor: DavidWallaceBusiness Reporter: Dean RudgeProduction Controller: Debi MinalProduction Editor: Jenna MeredithDirector of Subscriptions: Val DavisGroup Sales Manager: Rob CoulsonAwards Manager: Natalie CornwellManaging Director: Mike Rice
China’s Yabao Pharmaceutical has formed a strategic partnershipwith US firm Salus Pharma to co-develop, manufacture and market
generics with high technical barriers worldwide.Under its agreement with privately-owned Salus, which specialises
in controlled-release formulations, the Chinese firm will “exclusivelyown rights to commercialise certain Salus-developed products outsidethe US and to manufacture for worldwide markets”. The US firm, inreturn, will retain US marketing rights. G
STRATEGIC ALLIANCES
China’s Yabao allieswith US player Salus
JOHNSON & JOHNSON has reached an agreement to divest itscontrolled-substances raw materials and active pharmaceuticalingredient (API) business. The originator expects to complete adeal for the operation, which had a turnover of around US$250million last year, “towards the middle of 2016”. Johnson &Johnson’s Noramco controlled-substances business was formed in1979 to supply raw codeine for the group’s Tylenol analgesics.The business later acquired the Tasmanian Alkaloids narcotic rawmaterials operation in Westbury, Australia, and added a USfacility in Athens, Georgia, to its site in Wilmington, Delaware.Other affiliate sites are located in Belgium and Switzerland. G
IN BRIEF
Incomplete data, failure to “exercise appropriate controls” overcomputer systems to ensure quality data, and lack of documented
procedures to guarantee drug quality were among “significant violationsof current good manufacturing practice (cGMP) regulations” that haveled the US Food and Drug Administration (FDA) to issue a warningletter against a site belonging to India’s Sri Krishna Pharmaceuticals.
The warning letter, which followed a four-day inspection inDecember 2014, concerns the firm’s local Unit II bulk granulesmanufacturing facility in Nacharam, Andhra Pradesh. Last year, the sitewas subjected to an FDA import alert (Generics bulletin, 2 October2015, page 8), while months earlier Italy’s medicines agency said thefacility did not comply with GMP standards after discovering “10 majordeviations from EU GMP” (Generics bulletin, 16 January 2015, page 5).
Within the warning letter, the US agency said Sri Krishna’sresponse “lacks sufficient corrective actions”. “We observed similarissues at your facility in 2007,” the FDA commented. “At that time,we found you had improperly integrated high performance liquidchromatography (HPLC) peaks and had not identified and investigatedout-of-specification test results.” G
MANUFACTURING
FDA warns Sri Krishna site
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Sandoz intends to make regulatory filings for adalimumab andrituximab in both the European Union (EU) and the US before
the end of next year. Novartis’ generics division also plans tosubmit a dossier to the US Food and Drug Administration (FDA)this year for epoetin alfa as a biosimilar alternative to Epogen andProcrit anaemia treatments marketed by Amgen and Janssen.
As Figure 1 shows, Sandoz has scheduled a filing with the FDAfor a biosimilar rival to AbbVie’s Humira (adalimumab) blockbusterthis year, to be followed next year by a submission in the EU. Thesequence will be reversed for a biosimilar version of Genentech’sRituxan (rituximab) oncology drug, with a dossier submitted to theEuropean Medicines Agency (EMA) this year ahead of a similarfiling with the FDA during 2017.
Sandoz says it in February 2015 completed recruitment for aPhase III clinical trial in psoriasis patients for its GP2017 adalimumabcandidate. In March this year, Sandoz completed recruitment for aPhase III rheumatoid arthritis trial for its GP2013 rituximab project.
The five scheduled submissions in the EU and US will completethe 10 planned biosimilar filings in major markets that Sandoz hascommitted to making between 2015 and 2017.
The division recently marked its fifth submission in that sequencewhen the EMA accepted its filing for its LA-EP2006 biosimilar ofAmgen’s Neulasta (pegfilgrastim) neutropenia drug (Generics bulletin,19 February 2016, page 13). The FDA had accepted LA-EP2006 forfiling towards the end of last year, at around the time that both theUS agency and the EMA accepted Sandoz’ submission for its GP2015etanercept candidate (Generics bulletin, 8 January 2016, page 9).
Recruited for infliximab trialSandoz has, it says, fully recruited a Phase III trial for the GP1111
infliximab candidate to which it earlier this year acquired rights fromPfizer in the European Economic Area (EEA). No filing schedule hasbeen announced as yet.
Explaining the rationale for acquiring the infliximab rights fromPfizer (Generics bulletin, 19 February 2016, page 1), Sandoz’ globalhead, Richard Francis, told investors it was part of a plan to have “theright molecules at the right time in the right markets”. “With infliximab,”he explained, “we saw an opportunity to leverage what was happeningwith Pfizer, and we took that opportunity to make sure we were wellplaced for entering into the market in a timely fashion.”
Sales of Sandoz’ three marketed biosimilars – Binocrit (epoetinalfa), for which the division recently secured EU approval forsubcutaneous application in nephrology indications; Omnitrope(somatropin); and Zarzio (filgrastim) – contributed to 50% constant-currency growth to US$214 million in the division’s Biopharmaceuticalsturnover in the first quarter of this year. While Sandoz introduced itsZarxio (filgrastim-sndz) biosimilar in the US in September last year,parent group Novartis said the driver of Biopharmaceuticals growth
was “mainly Glatopa”, the generic rival to Teva’s Copaxone (glatirameracetate) blockbuster that Sandoz launched in June 2015 (Genericsbulletin, 26 June 2015, page 1).
Sandoz’Anti-Infectives sales dipped by 3% at constant exchangerates to US$360 million, “reflecting the weak flu season”.
The division reported total constant-currency turnover ahead by4% as 11 percentage points of volume growth more than offset sevenpoints of price erosion. A four-point currency effect ensured reportedsales stalled at US$2.45 billion, once restated to include 19 matureproducts transferred from sister division Novartis Pharma, such as fourformer GlaxoSmithKline oncology drugs, with combined annual saleslast year of US$913 million (Generics bulletin, 8 April 2016, page 4).
On a regional basis, constant-currency turnover increased by 2%to US$865 million in the US following the launches of Glatopa andZarxio last year (see Figure 1).
Total constant-currency turnover in Europe ahead by 3% toUS$1.08 billion included growth of 3% to US$714 million in WesternEurope and a 1% rise to US$287 million in Sandoz’ Central andEastern Europe region amid a “weak macroeconomic environment”.
Turnover up by 5% to US$353 million in the Asia, Africa andAustralasia region included growth of a tenth in the Middle East andAfrica, while Asia-Pacific sales improved by 4% to US$182 million inconstant currencies as Sandoz withdrew from “low-margin businesses”.
A 15% constant-currency turnover rise to US$151 million in Canadaand Latin America was attributable largely to 19% growth to US$80million in Latin America, “driven by double-digit growth in Brazil”.
With both sales and marketing and research and developmentexpenses largely static at US$410 million and US$195 millionrespectively, Sandoz increased its operating profit by 2% as reported,and by 9% on a constant-currency basis, to US$346 million. Thisimproved Sandoz’ operating margin by 0.3 percentage points to 14.2%,aided by contribution of the mature products and “ongoingproductivity improvements”. G
Europe 1,076 -1 +3US 865 +2 +2Asia, Africa, Australasia 353 ±0 +5Canada, Latin America 151 -4 +15
Sandoz 2,445 ±0 +4
Established Markets 1,805 +2 +3Emerging Markets 640 -4 +5
Figure 2: Breakdown by region of Sandoz’ sales in the first quarter of 2016.First-quarter 2015 computors have been restated to include mature brandstransferred from Novartis Pharma (Source – Novartis)
Molecule Sandoz Main indication Originator brand Agency Expectedproject filing
Epoetin alfa HX575 Aneamia Epogen, Procrit FDA 2016
Adalimumab GP2017 Rheumatoid arthritis Humira FDA 2016
Rituximab GP2013 Non-Hodgkin’s lymphoma Rituxan EMA 2016
Adalimumab GP2017 Rheumatoid arthritis Humira EMA 2017
Rituximab GP2013 Non-Hodgkin’s lymphona Rituxan FDA 2017
Figure 1: The five regulatory submissions for biosimilars that Sandoz has scheduled in major developed markets before the end of 2017 (Source – Novartis)
BUSINESS STRATEGY/FIRST-QUARTER RESULTS
Sandoz to file Humira and Rituxan rivals
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Subsequent entry biologics (SEBs) introduced in Canada “mustprovide a reduction in the drug’s transparent price to benefit all
Canadians”, according to a first principles document published bythe pan-Canadian Pharmaceutical Alliance (pCPA) that brings togethersourcing practices for all 13 of the country’s provinces and territories.
“Consistent with its mandate that includes increasing patient accessto clinically- and cost-effective drug treatment options,” the documentstates, “the pCPA will encourage a competitive environment thatincludes SEB market growth and is conducive to long-term costreductions and sustainability for public drug plans.”
The sourcing alliance says its pricing and reimbursementdeliberations will be shaped by “Health Canada’s regulatorydeterminations that SEB products are safe and efficacious with noclinically meaningful differences with the comparator reference drugs”.Health technology assessment (HTA) recommendations and otherevidence will also be taken into account, it notes.
Proposals to supply both SEBs and reference biologics will “onlybe considered through the national pCPA negotiation process”, ratherthan by individual or groups of jurisdictions on a local level.
Earlier this year, Canada’s federal drug plans operated by thenational government started participating in the pCPA, joining forceswith regional funds (Generics bulletin, 29 January 2016, page 7). Acentral office located in Toronto, Ontario, is co-ordinating operations,while a team drawn from Ontario, Nova Scotia and Saskatchewanis leading the development of guiding principles.
According to the SEB first principles document, proposals frombiologic originators will only be considered if they “provide at leastsimilar overall value compared to the SEB”. Offers for referencebiologics must “include similar or better transparent price reductionsif equivalent listing status is sought”. Furthermore, they must provide“overall national value to public drug plans” while avoiding incrementalcosts to the provinces and territories.
“These first principles are a starting point and are expected toevolve through the pCPA’s engagement with stakeholders, includingthe pharmaceutical industry, to develop a more comprehensive SEBpolicy framework,” the alliance concludes. G
MARKET NEWS
6 GENERICS bulletin 29 April 2016
PRICING & REIMBURSEMENT
Costs guide Canadaon biological drugs
Access to generics for millions of people throughout the Asia-Pacificregion could be “severely restricted” by provisions contained in
a draft Regional Comprehensive Economic Partnership (RCEP) tradedeal, according to humanitarian group Médecins Sans Frontières (MSF).
With a draft intellectual-property chapter having been leaked asthe next round of RCEP negotiations started in Perth, Australia, MSFvoiced particular concerns over plans to include at least five years ofdata exclusivity and patent-term extensions to compensate for regulatoryreview periods.
The leaked chapter, MSF alleged, showed that Japan and SouthKorea were pushing for measures that went beyond international traderules, mirroring terms of the Trans-Pacific Partnership (TPP) tradeagreement. “Countries that did not join the TPP – particularly India andkey members of the Association of Southeast Asian Nations (ASEAN) –will be pushed to adopt similar standards in the RCEP negotiations.” G
TRADE AGREEMENTS
RCEP’s terms concern MSF
US LEGISLATION on trade secrets has moved closer to becominglaw after the House of Representatives’ judiciary committee approvedby voice vote the text of the S.1890 Defend Trade Secrets Act.The next step for the legislation, which would create a federal civilremedy for stealing trade secrets, is being passed by the full House.The European Parliament recently approved a directive that obligesmember states to ensure victims of misuse of trade secrets can defendtheir rights in court and seek compensation (Generics bulletin,22 April 2016, page 6).
ALMOST 20 CIVIL SOCIETY GROUPS have urged EuropeanUnion (EU) member states to support the Dutch EU Presidency’svision of access to affordable medicines and curbs on the misuseof intellectual property. In its submission to the United Nations (UN)high-level panel on access to medicines, the Dutch governmentrecommended developing “a wider variety of innovation-financingmodels that do not rely on creating additional market exclusivities”as well as “encouraging voluntary and non-voluntary licensing ofpatents and test data”. Groups including the European Public HealthAlliance, Health Action International and Médecins Sans Frontièresinsisted that “additional market exclusivity, data exclusivity andsupplementary protection certificates (SPCs) that add to theinternationally-agreed 20-year period of patent protection delayprice-lowering generic competition”.
FDA – the US Food and Drug Administration – has released forcomment a draft guidance on comparability protocols for humandrugs and biologics. The Chemistry, Manufacturing and Controls(CMC) guide is to replace existing advice from 2003. It givesrecommendations on the content of post-approval comparabilityprotocols as well as on how to modify approved protocols. The FDAwill also on 19 May hold a public workshop on ‘oral absorptionmodelling and simulation for formulation development andbioequivalence evaluation’.
ADVERTISEMENTS TO RECRUIT JUDGES for the plannedEuropean Unified Patent Court (UPC) will begin during Mayafter the UPC’s preparatory committee agreed a recruitment package.The committee expects to agree a draft code of conduct forpractitioners during its next meeting to be held in Germany on 26May. It also welcomed news that Bulgaria was poised to becomethe 10th signatory state to ratify the UPC agreement.
THE BIOSIMILARS COUNCIL – a division of the US GenericPharmaceutical association (GPhA) – will on 7-8 September holda two-day conference in North Bethesda, Maryland. It will coverthe regulatory, reimbursement, political and policy environmentssurrounding biosimilars.
MEDICINES FOR EUROPE welcomed more than 100 participantsto its third annual ‘Universal Access to Health’ Forum held inBrussels, Belgium. “Cooperation among stakeholders is key toimprove access to healthcare in Europe,” insisted the industryassociation’s director general, Adrian van den Hoven.
USPTO – the US Patent and Trademark Office – has grantedRanbaxy’s petition to institute an inter partes review of US patent8,772,306 protecting Jazz Pharma’s Xyrem (sodium oxybate) untilMarch 2033. The patent office found that the Sun affiliate had “showna reasonable likelihood it would prevail with respect to some, butnot all, of the challenged claims”. Thus, the review will be limitedto claims 19 to 34 of the ‘306 patent. Par had a similar petitiondenied, while Amneal has one pending. G
IN BRIEF
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A“formal legal proposal” must be made by the EuropeanCommission “without delay” to implement a waiver that will allow
European generics firms to manufacture during the supplementaryprotection certificate (SPC) period, according to Adrian van den Hoven,director general of European generics industry association Medicinesfor Europe (MfE).
Noting that the European Parliament’s committee on internalmarket and consumer protection had adopted its report on the ‘singlemarket strategy’ – which included a proposal to introduce a targetedSPC waiver for export purposes when it was published last year(Generics bulletin, 6 November 2015, page 1) – MfE said this would“stimulate manufacturing and early export of generic and biosimilarmedicines to countries where no patent or SPCs exist”.
“The Parliament has once again voted for more manufacturingjobs in Europe,” declared van den Hoven, urging the Commission to“deliver on this tremendous development opportunity for the Europeanpharmaceutical manufacturing industry”.
Stimulates industry investmentMfE said the SPC manufacturing waiver would “allow the
European Union (EU) generic and biosimilar medicines industries tocreate up to 64,000 hi-tech jobs in the EU and dozens of new firms,with a C3.3 billion (US$3.72 billion) business value”. The measurewould also “bring pharmaceutical research and development back toEurope, as research and development and manufacturing are oftenconducted on the same site for pharmaceuticals”, MfE said.
“The export of generic and biosimilar medicines to non-EUcountries during the SPC period will increase access to high-qualitymedicines in third countries without changing the equilibrium betweenthe originator and the generic and biosimilar medicines industries inthe EU,” the generics industry association concluded.
The single market strategy adopted by the European Parliamentalso includes provisions for the possible creation of a unitary SPC,to accompany the unitary patent mechanism that is currently in theprocess of being introduced in Europe.
Amendments proposed to the single market strategy ahead ofthe vote included a passage urging the Commission to “introduceand implement before 2019” the SPC manufacturing waiver. Aseparate amendment calls on the Commission to “put forward withoutdelay a targeted legislative proposal” to allow European companiesto manufacture during the SPC period, which will “create a levelplaying field between European companies and their competitorsfrom third countries”. G
MARKET NEWS
7GENERICS bulletin29 April 2016
REGULATORY AFFAIRS
Commission must acton EU’s SPC waiver
Atotal of 348 final and 92 tentative approvals for abbreviated newdrug applications (ANDAs) were approved by the US Office of
Generic Drugs (OGD) in the first half of its financial year runningfrom October 2015 to September 2016. The US Food and DrugAdministration (FDA) office also issued 690 complete responses, withand without an inspection.
The half-year total of 440 final and tentative approvals comparesfavourably with the 612 – 492 final and 120 tentative – awarded duringthe entire 2015 fiscal year that ended in September 2015 (see page 14).
During the 2015-2016 half year, the OGD set a record inDecember 2015 with 99 final and tentative approvals, followed inMarch 2016 by 70, the second-highest number ever granted.
Final approvals granted by the OGD during the first three monthsof calendar 2016 included Amneal’s desipramine tablets and diclofenacgel, Teligent’s desoximetasone ointment and Apotex’ fluticasonenasal spray, as well as Novast’s levonorgestrel tablets and Invatech’ssodium polystyrene powder. G
REGULATORY AFFAIRS
OGD achieves record rates
Portuguese patients prescribed with biologics should be “treated withbiosimilars whenever possible”, according to guidance published
by the country’s national pharmaceutics and therapeutics commission(CNFT) within local medicines agency Infarmed. Guidelines set outby the CNFT recommend that patients initiating treatment should begiven the “most accessible” biological medicine, “in all indicationsfor which it is approved”.
When switching patients from one version of a biologic drugto a biosimilar equivalent, patients should be treated for a minimumperiod of at least six months on a given drug to “safeguard traceability”.All switches should respect the ‘principle of precaution’ and shouldbe carried out in accordance with a drug’s therapeutic indications, theguidance notes. For pharmacovigilance purposes, the CNFT’s guidancestates, brand names should be noted to ensure traceability.
The CNFT emphasises as part of its guidelines that “biosimilardrugs have been shown to have safety, efficacy and quality similar tothe reference biological product”. The main advantage provided bybiosimilars was to “increase access to treatment for a large number ofpatients”, the regulator said, which would contribute to the sustainabilityof Portuguese national health service SNS. Currently, 19 biosimilarsare marketed in Portugal, according to the CNFT.
National medicines formulary FNM sets out specific provisionswith respect to switching between biologics and biosimilars, the CNFTpointed out, adding that this should only take place following theadvice of a qualified health professional and in accordance with theregulatory body’s latest guidelines. G
REGULATORY AFFAIRS
Portugal’s Infarmedbacks biosimilar use
Medicines with an active ingredient “of vegetable or mineralorigin” can now be included in France’s répertoire of generic
equivalents, following a rule published in the country’s OfficialJournal. The legislation enacts provisions originally outlined in thecountry’s social security financing law for 2015.
Listings in France’s répertoire allow groups of generic productsto be recognised as equivalent to a common reference brand, makingthem eligible for substitution. G
REGULATORY AFFAIRS
France expands listing scope
APMGR – Romania’s generics industry association – has urgedthe country’s authorities to address fraud worth over RON9.4million (US$2.4 million) identified by auditors in the use of fundsallocated to Romania’s national health insurance. G
IN BRIEF
Gen 29-4-16 Pgs. 2-16_Layout 1 27/04/2016 17:16 Page 7
Astudy on biosimilar labelling carried out by European brandindustry biologics body EuropaBio “attempts to create an
unnecessary differentiation between biosimilar medicines and theirreference products”, according to Europe’s generics and biosimilarsindustry association Medicines for Europe (MfE).
Published in the journal Regulatory Toxicology and Pharmacology,the study surveyed 210 physicians across seven European countries –France, Germany, Italy, Poland, Spain, Sweden and the UK – askingthem to compare “excerpts from the label of an authorised biosimilarand modified texts with additional information”.
The survey used the summary of product characteristics (SmPC)for Sandoz’ Binocrit (epoetin alfa) rival to Janssen’s Eprex brand, withthe first label excerpt being “identical to the current biosimilar label”,while the second excerpt presented to doctors comprised “text samplesthat included additional information and referred to the respectiveproducts used for generation of the included data”.
Of the 210 doctors surveyed, four-fifths preferred the sampleswith additional information. “This survey shows that the label is anappropriate vehicle for providing physicians with information aboutbiologics and that physicians prefer more product-specific informationin the biosimilar label,” the industry-funded study concluded.
But MfE insisted that the study “fails to acknowledge somefundamental elements”. Healthcare professionals had been voicinggeneral concerns with SmPCs and patient information leaflets “foryears”, the association noted. “The study should therefore have analysedthese information tools for all medicines, instead of focusing exclusivelyon biosimilar medicines,” MfE suggested.
MfE also pointed out that the content of an SmPC was definedby law, with biosimilar labels obliged to be “almost identical to thelabel of the reference product”. This was because biosimilars were“only approved when the applicant has demonstrated that the biosimilarand the reference product have comparable safety and efficacy profilesand the biosimilar is authorised to be used in the same way as thereference product”. For this reason, the US Food and DrugAdministration (FDA) had recently published draft labelling guidanceessentially confirming the ‘same label’ approach as “the way forward”for biosimilars, MfE noted (Generics bulletin, 8 April 2016, page 5).
“The main healthcare professional and patient community concernsappear to be the accessibility of information – where can it be found? –and the suitability of the information – is it understandable?”, MfEobserved. “The availability of unbiased information from regulatoryagencies is typically not an issue,” MfE insisted, thanks to “transparentpolicies” by regulators such as the European Medicines Agency, whichallowed access to documents such as the European Public AssessmentReport for any centrally authorised medicine.
MfE emphasised that the association’s Biosimilar MedicinesGroup was “engaged in many multi-stakeholder platforms to facilitatethe accessibility and understanding of the information”.
Separately, MfE welcomed a section of the survey that revealedthat 88.6% of the doctors “were aware of the regulatory definition ofa biosimilar before they read about it in the introduction part of thesurvey”, while 59.0% had prescribed biosimilar medicines. This “clearlydemonstrates the increased trust and acceptance by the medicalcommunity of biologics, including biosimilar medicines”, MfE said.
Calling these results “a major step forward compared to surveysof just two years ago”, MfE said the survey “proves the robustnessof the European Union regulatory framework”. G
MARKET NEWS
8 GENERICS bulletin 29 April 2016
REGULATORY AFFAIRS
MfE takes issue withEU biosimilars study
An agriculture appropriations funding bill that would “stop theUS Food and Drug Administration (FDA) from using federal
funds to finalise or implement its proposed rule to update genericdrug labelling requirements” has been welcomed by the US GenericPharmaceutical Association (GPhA). Approved by the Houseappropriations committee, the rule covers the US financial year endingSeptember 2017.
Under the proposed FDA rule, which is set to be published inJuly, generics firms would be required to update safety informationusing the same ‘changes being effected’ (CBE) process as originators.This would require generic manufacturers “to update labels basedon incomplete information without first receiving FDA approval”,according to the GPhA, despite the agency being “the only entity withall of the data needed to recommend a safety information change”(Generics bulletin, 8 January 2016, page 7).
Recently, a group of 15 healthcare stakeholders – including theAmerican Pharmacists Association and the Pharmaceutical CareManagement Association – wrote to the agency to oppose the change,urging the FDA “to serve as the centralised authority for labellingchanges” (Generics bulletin, 22 April 2016, page 5).
“The GPhA is pleased that House appropriators recognise the needto avoid the vast unintended consequences that would arise shouldthe FDA finalise this proposed rule as written,” said the association’spresident and chief executive officer, Chip Davis. The association saidit “appreciates the committee’s longstanding interest in its proposedrule and its concerns regarding the proposal’s substance and process”.
“GPhA strongly supports Section 747 of this funding bill,” thegenerics association said, “which specifies that in order to receive thenecessary funding, the agency must first approve of a label change andalso ensure an identical change is made to the reference brand product.”
Instead, the GPhA said it “continues to urge the FDA to considerthe brand and generic drug industry supported Expedited AgencyReview (EAR), a solution that accomplishes the FDA stated objectiveswithout putting safety or savings at risk”. The EAR proposal would“create a system where the FDA would have final authority over allpotential label changes” and meet shared public health objectives“without compromising patient safety or access”, according to Davis(Generics bulletin, 10 April 2015, page 9).
Proposals set out for the EAR scheme include establishing “definedtime parameters for the FDA to take action on a label change”, theGPhA said, suggesting a deadline of 45 to 60 days for the FDA tomake a decision on the appropriateness of a change. The EAR schemewould also call for the adoption of e-labelling technology “to makenew information available in real time”.
According to a study by Matrix Global Advisors, the GPhA said,the FDA’s proposed labelling rule would increase generic drug costsby US$4 billion per year.
“The proposed rule contradicts and undermines precedent set bythe Hatch-Waxman Act, the foundation of the generic drug industry,”Davis concluded. “In addition to substantially driving up health costs,allowing a scenario where the same medicines could have conflictinglabel information would cause confusion and poses risks to patients.We look forward to continuing to work with Congress, the FDA andothers to ensure that any changes made to the generic drug labellingprocess prioritise patient safety and avoid unravelling the regulatoryfabric responsible for decades of patient access and trillions ofdollars in patient and health system savings.” G
REGULATORY AFFAIRS
GPhA lauds bill thatlimits FDA label rule
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Japanese generics company Nichi-Iko Pharmaceutical has acquiredglobal rights to market a biosimilar alternative to Rituxan (rituximab)
that is being developed by its long-term partner, South Korea’sAprogen, under the AP056 code name.
Aprogen said it was working with its Japanese partner andminority shareholder on “preparing an investigational new drug (IND)application for a Phase I clinical trial in the US no later than 2017”.
Rituxan is marketed in Japan jointly by Chugai and ZenyakuKogyu. The brand’s owner, Roche, reported Rituxan/MabThera salesin Japan ahead by 11% last year to SFr230 million (US$236 million).
Having in October 2010 struck a biosimilars alliance with Aprogen,Nichi-Iko has already secured global distribution rights to biosimilarinfliximab and trastuzumab. The firms filed for approval of Aprogen’sGS071 infliximab in Japan last year, and the Korean firm said it waspreparing an IND for a Phase III trial in the US. A Phase I trial forits AP063 trastuzumab in the US is scheduled to start this year.
An affiliate of Schnell Biopharmaceuticals, Aprogen is alsodeveloping biosimilar adalimumab, bevacizumab, cetuximab andetanercept candidates. Schnell holds marketing rights in Korea.
Towards the end of last year, Nichi-Iko announced it was sellingits entire 12.6% stake – around 3.88 million shares – in its Koreanbiosimilar manufacturing partner Binex. However, the Japanese firmstressed, their contract-manufacturing alliance would continue. G
PRODUCT NEWS
9GENERICS bulletin29 April 2016
Brand new portfolio extensionready end of 2016
Neogen N.V. expects to have 8 new dossiers ready for licensing out andsubmission by clients in 2016.
Following dossiers amongst others:
❖ Folic acid 0.4/1/5mg tablets
❖ ASA 50/75/100/160mg enteric coated tablets
❖ Methadon 2.5/5/10/20/40mg tablets
❖ Sodium valproate solution for infusion 100mg/ml (3ml/4ml/10ml)
Sandoz’ introduction of a US biosimilar rival to Amgen’s Neupogen(filgrastim) enabled the US to save more than US$72 million from
its annual spending on prescription medicines in 2015, according todata published by the IMS Institute for Healthcare Informatics.
In its report entitled ‘Medicines Use and Spending in the US –A Review of 2015 and Outlook to 2020’ (Generics bulletin, 22 April2016, page 14), the market researcher said that Sandoz’ Zarxio(filgrastim-sndz) biosimilar – which is currently the only biosimilarlaunched under the US pathway – had captured 5% of filgrastim salesafter five months on the market. The biosimilar was launched in earlySeptember 2015 (Generics bulletin, 11 September 2015, page 19).
“Significant advances occurred in 2015 for biosimilars,” IMSobserved, including not only Sandoz obtaining the first approval underthe biosimilar abbreviated pathway, but also the submission to the USFood and Drug Administration (FDA) of seven biosimilar applications,and a “growing number of biosimilar products advancing throughclinical development”.
According to IMS data on the US biosimilar pipeline for biologicswith the greatest number of biosimilar candidates, there were as ofthe end of last year 15 adalimumab candidates in various stages ofdevelopment, and 11 candidates for rituximab. Bevacizumab, etanerceptand trastuzumab each had eight candidates in development, whilepegfilgrastim had seven, infliximab had six and filgrastim had three. G
BIOLOGICAL DRUGS
Sandoz’ Zarxio savesmillions from US cost
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Actavis, Mylan and GlaxoSmithKline have lodged appeals againstthe varying fines imposed by the UK’s Competition and Markets
Authority (CMA) earlier this year over UK ‘pay-for-delay’ patentlitigation settlements GSK reached more than a decade ago with thegenerics firm’s predecessor companies.
The CMA’s action concerned the firms’ conduct over GSK’sSeroxat (paroxetine) between 2001 and 2004. According to theauthority, Actavis’Alpharma and Mylan’s Generics UK “accepted valuetransfers” from GSK in return for delaying generic competition to theantidepressant brand (Generics bulletin, 19 February 2016, page11). Once generic competition arrived at the end of 2003, the CMAnoted, “average paroxetine prices dropped by over 70% in two years”.
Fines totalling approximately £47.7 million (US$68.6 million)were levied against the firms, the majority of which – £37.6 million –was imposed on GSK. The CMA fined Generics UK £5.84 million,for which its former owner Merck KGaA was fully liable, whileMylan’s Generics UK was jointly liable for £2.73 million. ActavisUK, Xellia Pharmaceuticals and Alpharma were jointly liable for atotal penalty of £1.54 million.
GSK has appealed the CMA’s fine on six primary grounds,including that the Authority “erred in finding that GSK held a dominantposition because it incorrectly defined the relevant product market asthe market in a single molecule”. The originator also contends thatthe CMA has not established that GSK’s agreements with Alpharmaand Generics UK “had the effect of restricting competition”.
“Without prejudice to GSK’s primary grounds of appeal, GSKcontends that the CMA erred in imposing any fine,” the firm asserted.“In the alternative, GSK submits that any fine imposed on GSK shouldhave been substantially smaller.”
The CMA, which has the authority to fine firms up to 10% of theirglobal turnover for anticompetitive conduct, is also investigating Pfizerand Flynn Pharma for “excessive and unfair pricing” for phenytoinsodium capsules, and earlier this month fined the US originator£10,000 for failing to comply with an information request as part ofits investigation (Generics bulletin, 22 April 2016, page 10). G
PRODUCT NEWS
10 GENERICS bulletin 29 April 2016
17-18 May
■ GPhA CMC WorkshopMaryland, USAThis interactive workshop will provide up-to-date informationregarding CMC regulatory requirements and the challenges of approval.
■ World Biosimilar Congress USASan Diego, USATopics looked at during this two-day conference will include competingin the biosimilars market, development costs and clinical trials.
■ 7th Annual Summit on BiosimilarsNew York, USAIssues to be discussed at this event include interchangeability andlabelling as well as litigation strategies, naming and substitution.
Contact: American Conference Institute. Tel: +1 212 352 3220.E-mail: [email protected]: americanconference.com.
29-30 September
■ Biosimilars EuropeLondon, UKThis two-day conference will look at developments in thebiosimilar guideline framework and legisation in both Europe andthe US. Patent litigation, market access, pricing andreimbursement and emerging markets will also be covered.
Contact: American Conference Institute. Tel: +1 212 352 3220.E-mail: [email protected]: americanconference.com.
EVENTS – May & June
8-10 June
■ Joint MfE and IGBA Annual ConferenceDubrovnik, CroatiaFor 2016, Medicines for Europe (MfE) – formerly the EuropeanGeneric and Biosimilar medicines Association – and theInternational Generic and Biosimilar Medicines Association(IGBA) will join forces for their annual conferences.Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected] online at www.egaevents.org/ega16.
Sandoz’ generic rival to AstraZeneca’s Rhinocort (budesonide) 64µgnasal spray has been added to France’s répertoire of substitutable
generic equivalents under the name Desonair. Mylan’s brinzolamide10mg/ml eye drops have also been listed, against Alcon’s Azopt.
Claris Lifesciences and Panpharma’s adenosine 30mg/10mlsolution has been listed in the répertoire as equivalent to Sanofi’sAdenoscan, while the French originator has also added authorisedgenerics of its own Tranxene (clorazepate) 5mg, 10mg and 20mgcapsules under the Zentiva label.
Bluefish has seen listed its miglustat 100mg capsules as a rival toActelion’s Zavesca brand, while Biogaran has had its formoterol 12µgpowder for inhalation in a capsule listed as equivalent to Novartis’Foradil. The French generics firm recently advertised its version asthe country’s only generic alternative to the asthma treatment, notingthat its formulation used the same key excipient, lactose, as theoriginal (Generics bulletin, 8 April 2016, page 8). G
RESPIRATORY DRUGS
France adds to its répertoire
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Lannett is looking to further diversify its portfolio and claim a stakein the multi-billion dollar US insulin market by striking an agreement
to co-develop an undisclosed generic insulin product with its partnerin China, HEC Group’s YiChang HEC ChangJiang Pharmaceutical.No financial details were disclosed.
Noting that the product was “currently in late-stage development”,the US generics player said it would “manage the remaining clinicaland regulatory steps” toward gaining US Food and Drug Administration(FDA) approval, on top of enjoying exclusive US marketing rights.
Describing YiChang as a company with “substantial drugdevelopment and manufacturing expertise”, Lannett’s chief executiveofficer, Arthur Bedrosian, said the Chinese firm had “developed aproprietary process for manufacturing the insulin protein”. YiChangalso planned to “build a dedicated facility for the manufacture of theinsulin product for multiple markets around the world”, he added.
Lannett already has an alliance with another HEC affiliate, itsSunshine Lake US subsidiary, having two years ago entered into abroad distribution and contract-manufacturing agreement with thefirm (Generics bulletin, 16 May 2014, page 5). “We are currentlycollaborating with HEC on five projects,” Bedrosian said.
The US firm has taken steps to diversify its portfolio beyondoral-solid dosage formulations, including buying US liquids genericsspecialist Silarx Pharmaceuticals last year, and more recently bypartnering with US intranasal specialist Summit Biosciences over thefirst US generic version of GlaxoSmithKline’s Imitrex (sumatriptan)nasal spray (Generics bulletin, 4 March 2016, page 11).
Meanwhile, Lannett’s strategy to push into the US generic insulinsarena comes as the market remains nascent. At the end of last year, theFDA approved the first “follow-on insulin glargine treatment”, Eli Lillyand Boehringer Ingelheim’s Basaglar (insulin glargine) 505(b)(2)hybrid, which rivals Sanofi’s Lantus SoloStar diabetes blockbuster(Generics bulletin, 8 January 2016, page 14). Under a settlementagreement reached several months earlier, Lilly and Boehringerobtained the right to introduce Basaglar in December this year. G
PRODUCT NEWS
11GENERICS bulletin29 April 2016
DIABETES DRUGS
Lannett and YiChangstrike US insulin deal
Canada’s Federal Court of Appeal has rejected Mylan’s appealagainst a lower court’s ruling that barred the US firm from
obtaining a Notice of Compliance (NOC), or marketing authorisation,for a local rival to Eli Lilly’s Cialis (tadalafil) brand until patent expiry.
At the beginning of last year, Federal Court Judge Yves deMontigny described as “unjustified” Mylan’s claims that Canadianpatent 2,226,784, which protects the erectile dysfunction treatmentuntil July this year, was invalid due to lack of utility and obviousness-type double patenting (Generics bulletin, 6 February 2015, page 19).
The appeals court found in relation to obvious-type doublepatenting that de Montigny “did not commit a palpable andoverriding error” in concluding that the ‘784 patent was “patentablydistinct” over prior-art Canadian patent 2,181,377.
On the issue of lack of utility, the appeals court again sided withLilly, affirming de Montigny’s judgment that “in light of theexperiments taught in the [‘784] patent’s disclosure, the commongeneral knowledge and the disclosure of the ‘377 patent, there was aprima facie reasonable inference of utility for the claimed compounds”.
“A skilled person would be able to infer the oral administrationof both compounds [claimed in the ‘784 patent] – tadalafil and 3-methyl tadalafil – to treat erectile dysfunction,” the appeals courtfound. “There was no guarantee of success, but the doctrine of soundprediction does not require guarantees.” G
ERECTILE-DYSFUNCTION DRUGS
Mylan’s Cialis appealis rejected in Canada
Reducing reference prices in Germany for product groups includingrespiratory treatments will harm access by forcing patients to
make co-payments, the country’s generics and biosimilars industryassociation, Pro Generika, has warned.
In response to plans unveiled by the umbrella organisation ofstatutory health insurance funds, GKV-Spitzenverband, to cut referenceprices for 11 product groups “due to market dynamics”, Pro Generikasaid planned reimbursement cuts would reduce from five to none thenumber of beta-2-sympathomimetics for complaints such as asthmathat are free from patient co-payments.
Companies can exempt their products from patient co-paymentsby pricing them at least 30% below the relevant reference price.
Pro Generika pointed out that insurance fund members were oftenunaware that the co-payments they had to contribute were often severaltimes higher than the dispensed drug’s ex-factory list price.
Revised reference prices for 14 molecules including buprenorphine,ciclosporin, clopidogrel and gabapentin came into effect on 1 April. G
RESPIRATORY DRUGS
German groups hurt patients
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PRICE WATCH ............ UK
12 GENERICS bulletin 29 April 2016
Up to the minute live retail market pricing isavailable for the UK and Eire on Wavedata Liveat wavedata.net.
Launching true generic pregabalin products may prompt moves tocategory M of the Drug Tariff of pharmacy reimbursement
prices, Justice Richard Arnold commented last autumn in a 174-pageruling on claims contained in the UK part of Pfizer’s European method-of-use patent 0,934,061 (Generics bulletin, 2 October 2015, page 27).
But, six months later, despite Arnold ruling that only prescriptionsfor pregabalin to treat peripheral neuropathic pain should carry Pfizer’sLyrica brand name – but all other uses of the painkiller, such asfibromyalgia, should be generic – not much has changed.
When Sandoz and Teva launched unbranded pregabalin genericslast July, they effectively released the pregabalin market from thestranglehold put on it earlier by Arnold when he ordered the NationalHealth Service (NHS) to issue guidance that pregabalin should onlybe prescribed for neuropathic pain under Pfizer’s Lyrica brand name(Generics bulletin, 13 March 2015, page 19).
Starting in July, average generic pregabalin prices started to decayfaster. But a glance at the Drug Tariff for April 2016 shows thatpregabalin capsules in eight strengths from 25mg to 300mg are stillin category C and should still all be reimbursed at the trade price ofthe equivalent Lyrica strength. For pharmacists, this means dispensingprofit margins of between 90% and 98%, given that average priceshave fallen to 10% of the brand’s official trade price and lowestprices barely reach 2%.
Official dispensing data shows that when three branded genericswere launched in February 2015 – Actavis’ Lecaent, Consilient’sRewisca and Dr Reddy’s Alzain – they immediately replaced Lyrica aspharmacists’ products of choice, cutting brand sales down to almostzero (see Figure 1).
However, Arnold insisting that the NHS should issue guidance –“the most efficacious, dissuasive and cheapest solution” to Pfizer’sfears that pharmacists would dispense generics for what was then thefull patented indication – allowed Pfizer’s Lyrica back into the market.So-called ‘brand equalisation’ measures, comments WaveData’smanaging Director Charles Joynson, also contributed to Lyrica’s“fight back” as Pfizer equalised its prices with those of the generics.He adds that dispensing doctors were even more affected by the NHSguidance than pharmacists. Only 4% of generic pregabalin was handedout by dispensing doctors in the period between March and December2015, with pharmacists responsible for the remaining 96%.
Market prices for pregabalin – however it was labelled andmarketed – held remarkably steady during the months followinggeneric launch in February 2015. Even after the entry of unbrandedgenerics in July, market prices for Lyrica, as well as parallel importsof Lyrica, followed those of the generics downwards (Genericsbulletin, 23 October 2015, page 31).
Today, however, pregabalin acts like a category M generic – withits reimbursement price dictated by actual market prices – despiteits category C status. Figures 2, 3 and 4 all show the early slow pricedecline and the more rapid fall from last July. They also illustrateaverage generic prices today of £6.00 to £7.00 (US$8.60 to US$10.00)and lowest prices under £2.00. G
Figure 1: Monthly quantities of pregabalin dispensed in England and Wales, showingthe distinct change on generic launch in February 2015 (Source – WaveData)
Figure 4: Lowest and average trade, and Drug Tariff prices for pregabalin 150mgcapsules after generic launch (Source – WaveData)
Pregabalin fails to heed judge’s forecast
Figure 3: Lowest and average trade, and Drug Tariff prices for pregabalin 75mgcapsules after generic launch (Source – WaveData)
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PRODUCT NEWS
13GENERICS bulletin29 April 2016
An agreement outlining a “multi-pronged collaboration to encouragethe development of new tuberculosis (TB) regimens and ensure
their availability in low- and middle-income countries” has been struckby the Medicines Patent Pool (MPP) with the non-profit TB Alliance.
Under the terms of the memorandum of understanding signedby the two organisations – which is effective for five years, and can befurther renewed – the MPP and TB Alliance will “work together ona range of initiatives, with a focus on public health-oriented licensingstrategies and the sharing of intellectual property to spur research anddevelopment of affordable new TB treatments”.
The MPP and TB Alliance plan to “collaborate on developinglicensing strategies for future TB drug regimens developed by theTB Alliance, and to ensure that those regimens are available,affordable and adopted in high TB burden countries”. Moreover, thetwo organisations envision further collaborating on a “comprehensivereview of promising TB compounds in development for potentiallicensing opportunities”.
Also part of the memorandum of understanding are plans towork on “improving access to correctly-dosed, properly-formulatedTB medicines for children”. “The MPP, as a founding member of thePaediatric HIV Treatment Initiative, is working on similar issues inregard to HIV medicines,” the document points out, stating that theorganisations will “explore potential avenues of collaboration” as partof a shared commitment to making essential TB medicines “widelyavailable, affordable, and adopted to the benefit of all children in need”.
“Finally, the parties will share patent status, sales data,epidemiological and other information and work in consultation withother public health organisations to develop TB drug market forecastsand intelligence,” according to the agreement.
Within a month of signing the deal, the memorandum ofunderstanding says, the MPP and TB Alliance will “agree on an annualcommunication and stakeholder outreach plan that will specifyexpectations regarding jointly-organised symposia, website contentsetc” as part of a plan that will be “adjusted as needed”.
The deal comes five months after UNITAID – which funds theMPP – approved the Patent Pool’s expansion into the new areas ofTB and hepatitis C (Generics bulletin, 20 November 2015, page 16).
Greg Perry, executive director of the MPP, said the organisationwas “thrilled to work with the TB Alliance” and would “benefit fromits significant expertise in the area of TB drug research anddevelopment”. The memorandum of understanding “provides anexcellent opportunity to bolster both organisations’ efforts, achievesignificant global health benefits in the research and developmentand manufacturing of new anti-TB drugs and facilitate greater andbetter sharing of intellectual property for that purpose”.
The TB Alliance’s president and chief executive officer, MelSpigelman, said that with the MPP’s “strong track record in negotiatingvoluntary licences for HIV treatments, we believe the MPP cancontribute significantly toward improving the international responseto combating TB in low- and middle-income countries”.
Meanwhile, Viiv Healthcare has extended its licensing deal with theMPP for dolutegravir to cover “all remaining lower middle-incomecountries”. The firm’s previous agreement allowed generics firms toproduce adult and paediatric forms for “countries with the highest HIVburden” (Generics bulletin, 18 April 2014, page 16). With the additionof Armenia, Moldova, Morocco and Ukraine, the MPP licence for adultdolutegravir formulations now covers 92 developing countries. G
TUBERCULOSIS DRUGS
Patent Pool strikesdeal on tuberculosis
JOHNSON & JOHNSON does not expect to see US biosimilarcompetition to its Remicade (infliximab) and Procrit (epoetin alfa)brands this year. Chief financial officer Dominic Caruso said the recentUS approval of Celltrion’s Inflectra (infliximab), which will bemarketed by Pfizer’s Hospira, had not changed the originator’soutlook. “We have several patents that we intend to defend,” Carusostated, highlighting US antibody patent 6,284,471 that expires on4 September 2018, as well as cell-growth media patent 7,598,083that runs until February 2027. Celltrion and Hospira recently denied aspart of litigation in a Massachusetts district court that that they couldnot launch until early October this year, six months after providing180 days’ notice of commercial marketing following approval on5 April. Rather, the partners said, they could come to market “asearly as 30 June 2016” (Generics bulletin, 22 April 2016, page 1).
QUANTUM PHARMA has been cleared to introduce ergocalciferol50,000 IU capsules in the UK under the Colonis Pharma label. TheUK-based company said the addition to its vitamin D product linemeant that equivalent unlicensed ‘specials’ could no longer besupplied. Quantum now holds UK marketing authorisations forseven vitamin D products across four strengths.
DR REDDY’S has obtained US approval for a generic version ofHelsinn’s Aloxi (palonosetron) 0.075mg/1.5ml and 0.25mg/5mlinjectable with shared 180-day exclusivity. Under the terms of a patentlitigation settlement reached last October, the Indian firm can launchthe intravenous antiemetic from 30 September 2018. Sandoz reacheda similar settlement, but Teva last year failed to convince a NewJersey district court that four formulation patents protecting Aloxiuntil 30 July 2024 were invalid and not infringed by its generic(Generics bulletin, 9 December 2015, page 20). Reddy’s has alsolaunched its recently approved Zembrace SymTouch (sumatriptan)3mg auto-injector for migraine relief in the US.
XBRANE BIOPHARMA has moved closer to launching its Xlucane(ranibizumab) biosimilar in Iran through its local partner, HelveticBiopharma. Having transferred production technology to Helvetic,Sweden’s Xbrane said the partners would scale up production aheadof a planned launch next year.
MACLEODS PHARMA has secured clearance in Germany tointroduce clopidogrel, memantine, sildenafil and valsartan film-coated tablets. Through its UK affiliate, the Indian company has alsoobtained a German authorisation to launch pantoprazole enteric-coated tablets.
AUROBINDO has secured final US approval for four strengths ofamlodipine/valsartan tablets equivalent to Novartis’ Exforgeantihypertensive. A launch will follow before the end of June. TheIndian company has also gained US clearance to introduce genericsof AstraZeneca’s Nexium (esomeprazole) 20mg and 40mg delayed-release capsules. The launch is based on a settlement of litigationwith AstraZeneca over the gastrointestinal remedy.
CHEMWERTH is offering heparin sodium as its 59th drug masterfile (DMF) available for reference. The generic active pharmaceuticalingredient (API) supplier said its version of the anticoagulant was“high-quality, reliable and traceable”, with full tracking to “theinitial source”.
FRESENIUS KABI has introduced in the US an alternative to Pfizer’sZyvox (linezolid) antibiotic in 600mg/300ml Freeflex bags that featurea foil overwrap with differentiated colour labelling on both sides. G
IN BRIEF
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As industry negotiates with the US Food and DrugAdministration (FDA) over the second iterationof the Generic Drug User Fee Amendments
(GDUFA), companies are only beginning to see thefruits from the first five-year round that came into effectin October 2012.
Despite pouring more than US$300 million peryear into the FDA’s coffers – US$299 million annuallyplus an inflation factor – industry has continued tostruggle with a huge backlog of pending abbreviatednew drug applications (ANDAs) and supplements. Andto add to that frustration, the agency has for much ofthe past three-and-a-half years been reluctant to sharemuch information of the progress of those pendingdossiers through its review process.
But in recent months, the FDA’s stance has changedmarkedly. Companies that previously had been in thedark on their pending ANDAs started to receive targetor goal dates for action on their applications. And theagency has increasingly been active in highlightingits progress in meeting the commitments it made inagreeing the first GDUFA scheme. As part of thatpublic transparency, the FDA’s Office of GenericDrugs (OGD) has just released its first annual report.
Introducing the report covering calendar 2015, theOGD’s director, Kathleen Uhl, insisted the agency wasmeeting all of its GDUFA commitments, and in manyinstances was “going above and beyond thosecommitments”. A key part of that, she stressed, was a“significant and sustained increase in communications”.
“The OGD spent 2015 continuing to increasecommunications with industry, putting out a recordamount of formal correspondence to industry onapplication-specific issues, closing out controlledcorrespondence and providing target action dates(TADs),” Uhl outlined.
A crucial vehicle for delivering improved
communication with industry has been the unifiedinformation-technology platform created to enable thevarious disciplines within the OGD to share informationduring the review process. The agency has also usedthe fees paid by firms to hire the extra reviewers andsupport staff it needs to clear its backlog and worktowards a goal of reviewing 90% of original ANDAswithin 10 months during its 2017 fiscal year startingin October 2016 (see Figure 1).
“We built the machine, now we are cranking itup!” Uhl proclaimed during a Generic Drugs Forumthat the agency hosted earlier this month.
Respond to controlled correspondenceAs one of the commitments it made in 2012 ahead
of GDUFA coming into effect, the FDA pledged torespond to 70% of controlled correspondence – requestsfor information on a specific element of genericdevelopment – within two months of submission. Thattarget will rise to 90% in the final year of theprogramme, ending September 2017. Timelines willbe extended by a month if input is needed from theOGD’s clinical division.
“FDA had a backlog of controlled correspondencesubmitted before October 2014, when GDUFA goaldates started. FDA has essentially eliminated thatbacklog,” the OGD stated in its annual report, pointingout that it closed out a record 2,065 controlled responsesto industry last year.
As can be seen from Figure 2, the agency has allbut cleared a backlog of around 1,300 correspondencessubmitted before October 2014, with just 26 to be dealtwith by the end of 2015. For most of 2015, the FDAdealt with controlled correspondence within its goalin at least 95% of instances.
Under GDUFA, the number of such requests fromindustry has risen rapidly, from 953 in the agency’s2013 fiscal year to 1,519 in the 12 months endedSeptember 2015. In particular, the OGD’s Offices ofGeneric Drug Policy, Pharmaceutical Quality andResearch & Standards – as well as the clinical divisionwithin its Office of Bioequivalence – have been calledupon to provide advice.
During calendar 2015, the agency communicatedwith industry almost 6,000 times in total overinformation requests and easily correctable deficiencies.
“Improved communication and increasedproductivity are the direct result of our improvedinformation-technology system for the generic drugprogramme,” Uhl explained. That “single, integratedsystem” – launched on 1 October 2014 – links OGDfunctions such as controlled correspondence, ANDAreviews, facility inspections and user-fee checks, andalso helps the agency to prioritise reviewing first genericalternatives to original brands.
Major brands for which the OGD approvedgenerics last year (see Figure 3) included Abilify(aripiprazole), Copaxone (glatiramer acetate), Fusilev
REGULATORY AFFAIRS
14 GENERICS bulletin 29 April 2016
As the US Food and
Drug Administration
(FDA) negotiates
renewing the Generic
Drug User Fee
Amendments (GDUFA)
programme, the agency
is stressing how it
has improved
communications
with industry.
Aidan Fry reports.
Better communication keyto delivering GDUFA goals
Goals Review time 2015 (%) 2016 (%) 2017 (%)
Original ANDA submission 15 months 60 75 90*Tier 1 first major amendment 10 months 60 75 90Tier 1 minor amendments (1st-3rd) 3 months** 60 75 90Tier 1 minor amendments (4th-5th) 6 months** 60 75 90Tier 2 amendment 12 months 60 75 90Prior approval supplements 6 months** 60 75 90ANDA teleconference requests 10 business days 200 250 300Controlled correspondence+ 2 months 70^ 70 90ANDAs, amendments and PASs inbacklog on 1 October 2012
* 10 months** 10 months if inspection required+ If no input required from clinical division^ 4 months
Figure 1: Major performance goals and commitments by fiscal year made by the US Food and DrugAdministration (FDA) under the Generic Drug User Fee Amendments (GDUFA) scheme (Source – FDA)
Act on 90% by end of 2017
Gen 29-4-16 Pgs. 2-16_Layout 1 27/04/2016 17:16 Page 14
(levoleucovorin), Integrelin (eptifibatide), Norvir(ritonavir), Tygacil (tigecycline) and Zyvox (linezolid).
Also in 2014, the OGD “enacted a criticalimprovement” by assigning a regulatory project managerto each ANDA, thereby providing companies with“a central point of contract” for each review process.
A public meeting the FDA will hold on 20 Maywill gather feedback on the OGD’s regulatory scienceinitiatives, while the agency has just followed up onthe 124 new and 48 revised individual productbioequivalence guidelines that it issued during 2015by publishing another 38 new, and six revised,recommendations for industry (Generics bulletin,22 April 2016, page 8).
Broader guidelines released last year by the OGDcovered refuse-to-receive standards, the size and shapeof tablets and capsules and controlled correspondence(Generics bulletin, 23 October 2015, page 14). Manualsof policies and procedures (MAPPs) published lastyear included guidance on consolidation of ANDAs(Generics bulletin, 6 November 2015, page 15).
Within its expanded scope as an FDA ‘super office’,the OGD last year hired around 125 new employeesto help it deliver on its commitments and goals.
“2015 marked the highest number of generic finaland tentative approvals ever awarded by the FDA – morethan 700 in all,” Uhl pointed out. The 580 final ANDAapprovals last year included 79 in December, and 20tentative approvals during that record month took theannual total to 146 (see Figure 4).
More ANDAs received than expectedThe record approval rate went some way to
addressing the disparity between industry’s desire tosubmit ANDAs and the OGD’s ability to review them.“The FDA received approximately five-and-a-half yearsof projected ANDA receipts in four years,” Uhlacknowledged. Indeed, the 1,473 ANDAs submittedin the agency’s fiscal year to September 2014 wasalmost double its 750 projection, although fiscal 2015redressed that in part with just 539 filings.
“Another major commitment of GDUFA,” Uhlrecognised, “was to take a first action, by 2017, on 90%of the backlog of those applications pending prior toGDUFA as of 1 October 2012. We had 2,866 abbreviatednew drug applications (ANDAs) and 1,873 priorapproval supplements (PASs) in the backlog, but by theend of 2015, we completed first actions on 84% of
ANDAs and 88% of PASs – already close to the 90%goals set for 2017.”
As Figure 5 shows, the OGD took a first actionon more than 2,400 ANDAs between 1 October2012 and 31 December 2015.
But while the FDA may insist the ANDA filingbacklog has “essentially been eliminated”, industryis still waiting for many of those applications to securefinal approval. Uhl pledged to work with industry toraise the proportion of ANDAs approved during theirfirst review cycle above the current rate of 14%.
The interdependence of industry’s ability to makehigh-quality submissions and the FDA’s capacity tocovert such filings into approved generics is likely to becentral to ongoing negotiations about reauthorising theGDUFA programme when the initial five-year term runsout in September 2017. Legislation requires the agencyto submit a package to Congress by 15 January 2017. G
Figure 3: Selected first-time generics approved by the US Food and Drug Administration (FDA)during 2015 (Source – FDA)
1,400
1,200
1,000
800
600
400
200
0
Con
trol
led
corr
espo
nden
ceba
cklo
g
Initialbacklog
Sep
14
Oct
14
Nov
14
Dec
14
Jan
15
Feb
15
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15
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15
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15
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Jul1
5
Aug
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Sep
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Dec
15
1,299
871
704
579512
468 429 411363 328
274 241 230 198141
7826
Figure 2: Controlled correspondence backlog at the Office of Generic Drugs (OGD)by month (Source – FDA)
100
90
80
70
60
50
40
30
20
10
0
Num
ber
ofap
prov
als
Approvals Tentative approvals
January
February
Marc
hApril
May Ju
neJu
ly
August
Septem
ber
October
Novem
ber
Decem
ber
Figure 4: The number of final and tentative approvals for abbreviated new drugapplications (ANDAs) each month in 2015 (Source – FDA)
2527
19
49 4757
4758
61
50
61
79
513
6
1913
10
12
6
14
226
20
Actions ANDAs PASs
Final approval 609 959
Tentative approval 151 4
Complete response with an inspection 1,384 465
Refuse to receive 69 2
Withdrawn application 201 236
Percentage complete 84% 88%
Number with first action 2,414 1,666
Figure 5: The number and proportion of backlog applicationswith a first action by 31 December 2015 (Source – FDA)
Gen 29-4-16 Pgs. 2-16_Layout 1 27/04/2016 17:16 Page 15
Lupin’s managing director, Nilesh Gupta, has been named aspresident of the Indian Pharmaceutical Alliance (IPA) until the
end of September 2017. Gupta, the Indian firm’s managing directorsince September 2013, was previously the IPA’s vice-president.That role, meanwhile, has been handed to Glenmark’s chairman andmanaging director, Glenn Saldanha.
Gupta replaces Dr Reddy’s chairman Satish Reddy, while DilipShah, chief executive officer of Vision Consulting Group, continuesas secretary general. Past presidents of the India-based alliance includeUnichem’s Prakash Mody, Zydus Cadila’s Pankaj Patel (Genericsbulletin, 16 October 2009, page 23), Torrent’s Sudhir Mehta andSun’s Dilip Shanghvi.
Formed more than 16 years ago by eight national companies, theIPA now boasts 20 “research-based” Indian firms. These includeAlembic, Alkem, Cadila Pharmaceuticals, Cipla, Dr Reddy’s, Glenmark,Intas, Ipca, and JB Chemicals & Pharmaceuticals. Lupin, Mylan Labs,Micro Labs, Natco, Panacea, Sun, Torrent, Unichem, USV, Wockhardtand Zydus Cadila complete the alliance’s membership.
“Collectively, the IPA members account for almost 85% of theprivate-sector investment in pharmaceutical research and development,contribute 60% of the country’s exports of drugs and pharmaceuticals,service over 40% of the domestic market, and account for 43% oftotal sales of essential medicines,” the IPA observed. G
PEOPLE
16 GENERICS bulletin 29 April 2016
INDUSTRY ASSOCIATIONS
Lupin’s Nilesh Guptanamed IPA president
Switzerland’s Acino has appointed Kalle Känd as group chiefexecutive officer after Jostein Davidsen decided to step down.
Davidsen had served in the role since May 2014, having succeededPeter Burema (Generics bulletin, 7 March 2014, page 30).
Känd had joined the executive committee of Acino in May 2014as chief commercial officer (Generics bulletin, 6 June 2014, page 26),and subsequently “redeveloped the commercial strategy of the companyfrom scratch”, Acino said. “He is a proven leader with remarkableexperience in Acino’s key growth markets,” the firm pointed out, “whocarried out important strategic projects such as the set-up of thecompany’s regional offices with solid sales organisations and performingleadership teams, resulting in the turnaround of commercial operationsperformance and a company sales increase of 18% in 2015.”
“The appointment of Kalle Känd ensures the continuity of Acino’sgrowth strategy focusing on its key markets in the Middle East, Africa,Latin America and the Commonwealth of Independent States (CIS),”the firm said, “where the company markets Swiss-quality medicinesunder the brand ‘Acino Switzerland’.”
Prior to joining Acino, Känd served as vice-president of strategicplanning and business support for emerging markets at Takeda, beforewhich he held strategic roles at Nycomed covering Russia, the CISand Baltic states. He has also held country management roles inEstonia for Berlin-Chemie Menarini and TopMed.
Känd will preside over a management team that includes GeirMyklebust as chief financial officer and Konstantin Bakaykin ashead of corporate business development. Christina Peusch servesas chief legal and compliance officer, while Barthold Pieningcompletes the management team as chief operations officer.
The firm’s seven-strong board is chaired by Hakan Björklund,alongside vice-chairman Toni Weitzberg. Five other members –Jonas Agnblad, Tom Dean, Per Edelmann, Kunal Pandit andThomas Vetander – complete the board.
Thanking outgoing chief executive Davidsen for his “significantcontribution to Acino”, Björklund said that under his leadership thefirm “went through a significant transformation process, implementeda successful growth strategy, and became a mid-size internationalpharmaceutical company with focus on selected emerging markets”.“With the build-up of a new management team,” Björklund added,“Acino is well prepared for future growth.” G
APPOINTMENTS
Känd takes lead asAcino chief executive
Vivimed has appointed Pavan Kumar as chief executive officerof the Indian firm. “Kumar has over three decades of managerial
experience working for multinational and Indian organisations indiverse sectors such as consumer and industrial goods, agribusinessand chemicals, in functions such as marketing, operations, projectsand general management, leading and building competitivebusinesses,” Vivimed noted.
Meanwhile, Ramesh Challa has been appointed as Vivimed’s chieffinancial officer. Incumbent Amarjit Singh Bhatia “will be transitioninginto an advisory position for Vivimed group”, the firm noted. G
APPOINTMENTS
Vivimed makes Kumar chief
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