company news whosetsoutplansfor innbiologicalqualifier · gen29-1-16pg.1_gen18/11/05pg.1 27/01/2016...

29 January 201629 January 2016

Sandoz’ Lek boosts biosimilar capacity 2Richter fully controls its Chinese venture 2Oncobiologics files for US$115mn IPO 3Poland flags up faults at 3Mylan Agila siteAlembic names five strategies for growth 4Formulations carry Unichem up a tenth 4Biocon works toward 520-25 ANDA filingsConcordia not eyeing another 6sizeable dealSandoz has deal with Kyowa Hakko Kirin 6

MARKET NEWS 7

Finland acts to ratify 7Unified Patent CourtCanada government links with provinces 7Originators hit back on REMS legislation 8

PRODUCT NEWS 9

Four ink agreements for BMS’ daclatasvir 9India denies licence to 9saxagliptin patentSandoz has extension 10in US filgrastim fightGermany overturns patent 11on tiotropiumBiocad’s trastuzumab is approved 13in RussiaDutch agency must use carve-out labels 13

FEATURES 14

Aurobindo looks to expand 14beyond base in EU and US

REGULARS

Events – Our regular listing 10Pipeline Watch – Linezolid 12People – Von Rohr appointed 16AMRI’s API leader

COMPANY NEWS 2

Afinal proposal setting out plans for a ‘biological qualifier’ code to be applied to allbiological substances with international non-proprietary names (INNs) has been

published by the World Health Organization (WHO). The biological qualifier will consistof “a code formed of four random consonants in two two-letter blocks, separated by a two-digit checksum”. While it will apply prospectively, the WHO indicated that “mechanismsto allow retrospective application are being investigated”.

Insisting that “some drug regulatory authorities have requested the INN programme todevelop and administer a voluntary and global complementary nomenclature scheme”, the WHOdescribes the qualifier as “an additional and independent element used in conjunction with theINN to uniquely identify a biological substance to aid in the prescription and dispensing ofmedicines”. A single code “applies for global use”, for a “substance made in all manufacturingsites demonstrated to be of a similar standard of quality”.

Once assigned, the biological qualifier may take three forms, the WHO noted: either fourletters; four letters followed by the checksum; or two letters, two digits, and two letters “thusmimicking car registration plates to be more memorable”. As a fictional example, the WHO saidthe same qualifier code could be represented as either ‘bxsh’, bxsh08’ or ‘bx08sh’. The checksum“gives the ability to detect errors in transcription”, the WHO stated.

“It is acknowledged that the biological qualifier will only be as useful as the breadth withwhich it is taken up globally,” the WHO said. The European Commission has already indicatedthat “biosimilars should be closely aligned with their reference products” and a qualifier codewould run “contrary to such alignment” (Generics bulletin, 20 November 2015, page 19).

The European Generic and Biosimilar medicines Association (EGA) has urged discussionof the biological qualifier proposals to be put on hold “until further clarity becomes available”from international regulators on the scheme, insisting that “drug substances from differentmanufacturers should be entitled to get the same INN if the substances are found to becomparable or highly similar” (Generics bulletin, 23 October 2015, page 16). G

WHO sets out plans forINN biological qualifier

Alegal study that has been put out to tender by the European Commission is to serve as thebasis for “an overall evaluation of the supplementary protection certificate (SPC) system

in the European Union (EU)”. The study will “inform the decision on whether to come forwardwith a new SPC title at European level and whether to revise the existing SPC legislation”.

“The study shall evaluate whether a new European SPC title, in its current scope, orbroadened with improved provisions, is required to meet the requirements of current and expectedinnovative market developments in the EU,” the Commission’s directorate-general for internalmarket and industry states. It wants the study’s authors to evaluate the “legal efficiency” of thecurrent SPC framework for affected product markets, to “evaluate some economic aspects of thecurrent SPC framework” and to “suggest whether the existing SPC rules need to be recalibrated”.

Noting that Europe’s planned unitary patent package “does not create a unitary SPC”, theCommission acknowledges “a significant degree of legal uncertainty” following myriad EU courtrulings. Procedures for granting SPCs vary across EU member states, it observes, adding that moredrugs might “deserve additional short-term SPC extensions” like the six-month paediatric term.

Parties interested in conducting the study have until 4 February to submit bids. TheCommission estimates the study’s value at C200,000 (US$216,850) before value-added tax(VAT) and expects it will take 10 months to complete. G

EU plans study to review SPCs

NOW PUBLISHED WEEKLYNext issue – 5 February 2016

Gen 29-1-16 Pg. 1_Gen 18/11/05 Pg. 1 27/01/2016 16:56

Hungary’s Gedeon Richter has taken full control of its femalehealthcare and OTC focused joint venture with long-term Chinese

marketing partner Rxmidas Pharmaceuticals by acquiring the remaining50% stake in the operation that it did not previously own. No financialdetails of the transaction were disclosed.

Having first partnered in 1998 by signing a co-operation agreementcovering the distribution, marketing and promotion of Richter’sproducts in China, the two firms two years later established their 50/50joint venture, with the Hungarian firm making an initial RMB18 million(US$2.75 million) investment (Generics bulletin, 14 January 2011,page 10). This extended their partnership into female healthcare.

Controls contraceptives and OTC businessDescribing the acquisition of the remaining stake as an “important

step to underline its commitment to expand its business in China”,Richter affirmed it was now “in full charge of its contraceptive and OTCbusiness in China”. Richter’s sales in China jumped by three-fifths toC51.6 million in the first nine months of 2015, amounting to around 6%of group turnover (Generics bulletin, 20 November 2015, page 10).

Around three years ago, Richter strengthened its presence in Chinaby taking a 51% majority stake in a separate joint venture with theChinese firm that covered prescription brands, including those licensedfrom third parties (Generics bulletin, 22 March 2013, page 6). G

COMPANY NEWS

2 GENERICS bulletin 29 January 2016

MERGERS & ACQUISITIONS/STRATEGIC ALLIANCES

Richter fully controlsits Chinese venture

Sandoz’ Lek has opened laboratories at its Slovenian facility forbiosimilars development, quality control and biopharmaceutical

technical development. The laboratories – in which Lek has investedover C10 million (US$11 million) – give the firm’s BiopharmaceuticalsMengeš facility, where biosimilar active ingredients are alreadymanufactured, an “additional development role”. The investment isin line with Sandoz’ commitment “to make 10 biosimilar regulatorysubmissions between 2015 and 2017”.

The creation of the “development field and laboratory facility” hasadded 100 jobs to the site, in which a total of more than C64 millionhas been invested in development and production by Sandoz’ parentcompany, Novartis. The centre employs over 350 staff and is part of “asupply centre for the markets of central and eastern Europe, south-east Europe and the Commonwealth of Independent States”.

Sandoz’ global head of biopharmaceuticals and oncologyinjectables, Carol Lynch, noted “the addition of development of finaldosage forms for biosimilars further reinforces Mengeš’ role as animportant centre of biotechnology for Sandoz and Novartis”.

The Mengeš site’s head, Matjaž Oven, commented that with theincreasing need for biologics, Lek has “vast potential for furtherdevelopment in the biopharma business”. Sandoz currently marketsthree biosimilars – somatropin, erythropoietin alpha and filgrastim –all of which are available in Europe, including in Slovenia. G

MANUFACTURING

Sandoz’ Lek boostsbiosimilar capacity

Gen 29-1-16 Pgs. 2-16_Layout 1 27/01/2016 16:57

Deficiencies that “pose a risk of microbial and particulatecontamination” at Mylan’s Agila Specialties injectables facility in

Warsaw, Poland, have led the local pharmaceutical inspectorate, GIF,to suspend manufacturing activities at the site. Mylan had already toldGIF that it had suspended production of all ampoules, vials andpre-filled syringes that were linked to modifying and qualifying theplant’s heating, ventilation and air-conditioning (HVAC) system.

“Since October 2015, manufacturing has not been performed,but all corrective actions have not been done,” states an entry intoEurope’s EudraGMP database made by the Polish authorities. OnceMylan has addressed the deficiencies identified by the inspection,the authorities say they will re-inspect the facility.

An inspection conducted by GIF in July last year discovered 29major deficiencies at the site that Mylan acquired as part of its takeoverof Strides Arcolab’s Agila injectables business at the end of 2013.According to the inspectorate, most of the deficiencies related to thedesign and qualification of the HVAC and air-flow systems, as wellas to cleaning and maintenance of clean areas, change control andmanufacturing and batch releases not complying with requirementsof good manufacturing practice (GMP).

In December 2014, the EudraGMP entry notes, Mylan madesignificant modifications to its HVAC system covering vial and pre-filled syringe lines at the Agila facility. After these changes, it says,the firm made 49 batches without qualification between Januaryand July 2015.

Specifically, inspectors found insufficient pressure differencesbetween grades of clean area, a laminar air-flow system that did notmeet guideline requirements, particle tests performed incorrectly anda “lack of proper and regular maintenance” of clean areas andequipment. Other faults included a contaminated filling machine forpre-filled syringes as well as “crumbling insulation of pipes, peelingTeflon on the ports of tanks and pumps, lack of labelling and mixedclean and dirty equipment”.

Noting that Mylan had performed a risk assessment of theampoules and pre-filled syringes manufactured between 6 Januaryand 23 September 2015 – after modifying its HVAC system – GIFsaid it had not issued any product recalls. “Each involved nationalcompetent authority should evaluate, following an assessment conductedin conjunction with marketing authorisation holders, if a recall ofmedicinal products is needed,” the EudraGMP entry states.

Strides recently revealed that Mylan was looking to recoup someof the US$1.65 billion it had paid for Agila. The Indian firm said ithad “received notification of claims from Mylan ... in relation to certainprovisions contained in the sales and purchase agreement [for Agila]and in relation to certain regulatory concerns” (Generics bulletin,8 January 2016, page 4). Three Agila sites in India were cited in awarning letter that the US Food and Drug Administration (FDA) sentto Mylan last year (Generics bulletin, 1 September 2015, page 2).

Another EudraGMP entry reveals that Czech inspectors discovered24 deficiencies, 10 of which they categorised as major, during anOctober 2015 inspection of Hubei Hongyuan’s plant in Huanggang,China, that was linked to a certificate of suitability (CEP) formetronidazole. The CEP has been suspended after a nearby intermediatesite mentioned in the CEP was found “in a devastated state” with “hugelayers of dust”, little labelling and no evidence of batch documentation.

Romanian authorities have suspended a manufacturing authorisationfor local firm Ircon after finding four critical and 10 major deficiencies.G

COMPANY NEWS

3GENERICS bulletin29 January 2016

MANUFACTURING

Poland flags up faultsat Mylan Agila site

Pure-play biosimilars developer Oncobiologics is looking to raiseUS$115 million through an initial public offering (IPO) on the

Nasdaq stock exchange.The US-based company said it intended to use proceeds to fund

into clinical development its “most advanced” biosimilar candidates,which consist of the firm’s ONS-3010 adalimumab programme thata year ago met primary and secondary endpoints in a Phase I clinicalstudy (Generics bulletin, 27 February 2015, page 24), and its ONS-1045bevacizumab candidate that later in 2015 reached a similar milestone(Generics bulletin, 7 August 2015, page 7). Both biosimilars areanticipated to advance to Phase III clinical trials this year.

In addition, Oncobiologics has six early-stage biosimilarcandidates, including its ONS-1050 trastuzumab biosimilar that isscheduled to undergo a Phase I clinical trial this year. Meanwhile, thefirm has completed developing cell lines “with clone sectionscompleted” for its potential denosumab and cetuximab biosimilars,while tocilizumab, golimumab and ustekinumab biosimilar programmesare in early-stage development.

Proceeds of the IPO would also be used to expand the firm’sresearch and development facility, Oncobiologics noted, as well as to“fund other research and development activities”, and for “workingcapital and general corporate purposes”. “We may also use a portionof the net proceeds to acquire complementary businesses, products ortechnologies, although, we have no present commitments or agreementsfor any specific acquisitions,” Oncobiologics noted.

The firm revealed that it had during December and January raisedfurther net proceeds of approximately US$16.6 million from sellingjust fewer than two million shares to 19 investors, adding to theUS$89.4 million in aggregate net proceeds the firm said it had obtainedup to the end of its financial year ended September 2015. In addition,the firm said it had received US$23 million under collaboration andlicensing agreements in China, India and Mexico.

Led and founded by former Bristol-Myers Squibb, Genentech andEli Lilly executive Pankaj Mohan, Oncobiologics disclosed that it hadUS$9.07 million in cash and an “accumulated deficit” of US$94.1million as of its 2015 financial year. Operating expenses of US$51.8million on collaboration revenues of US$5.22 million during theyear left the firm with a US$46.6 million operating loss. G

BUSINESS STRATEGY

Oncobiologics filesfor US$115mn IPO

Strides Arcolab’s purchase from Sun of its Ranbaxy affiliate’s Solusand Solus Care central nervous system marketing units has been

approved by the Competition Commission of India (CCI). The Rs1.65billion (US$25.1 million) transaction – which includes employees fromthe two divisions – was agreed between the two companies last year,and has now obtained “all necessary regulatory approvals” (Genericsbulletin, 2 October 2015, page 9).

The two divisions had combined sales of Rs920 million for the12 months ended July 2015. Strides previously called the acquisitionof Solus and Solus Care “of strategic significance to the growth ofour branded business in India”. Abhay Gandhi, chief executive officerof Sun’s Indian operation, said the deal was in line with Sun’s strategy“to firmly consolidate our CNS business in India”. G

MERGERS & ACQUISITIONS

Strides gets nod for Sun deal

Gen 29-1-16 Pgs. 2-16_Layout 1 27/01/2016 16:57

Launching between seven and nine products in the US “every yearfor the next three years” is amongst five key strategies going forward

for Alembic. Following two abbreviated new drug application (ANDA)approvals, and having filed three ANDAs with the US Food and DrugAdministration (FDA), during its financial third quarter ended 31December 2015, Alembic boasts 45 ANDA approvals, includingthree tentative approvals, and a further 29 ANDAs pending approval.

On top of those launches, the firm also wishes to have a greaterfront-end presence in the US. A third strategic goal will be to submitfilings in a more diverse array of international markets, including

Australia, Brazil, Canada, Europe and South Africa. Alembic plansto fuel these filings through “aggressive investments in research anddevelopment activities”, with the aim of “building a robust pipelineof products for regulated markets”.

A fifth strategic pillar will see the Indian firm focus its domesticBranded Formulations business on “progressive therapies forsustainable growth and increased market share”.

In its financial third quarter ended 31 December 2015, Alembic’sgroup sales leapt by four-fifths to Rs9.31 billion (US$137 million).The firm’s US business “outperformed” in the wake of launchingrivals to Otsuka’s Abilify (aripiprazole) last year, causing InternationalFormulations sales to soar by 248% to Rs5.21 billion (see Figure 1). G

COMPANY NEWS


29 January 2016 Issue 247

Editor: Aidan FryDeputy Editor: DavidWallaceBusiness Reporter: Dean RudgeBusiness Reporter: Jake NinanProduction Controller: Debi MinalProduction Editor: Jenna MeredithDirector of Subscriptions: Val DavisGroup Sales Manager: Rob CoulsonAwards Manager: Natalie CornwellManaging Director: Mike Rice

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BUSINESS STRATEGY/THIRD-QUARTER RESULTS

Alembic names fivestrategies for growth

Third-quarter sales Change Proportion of(Rs millions) (%) total (%)

Intl. formulations 5,211 +248 56Indian formulations 3,083 +9 33APIs 1,012 +24 11

Alembic 9,307 +81 100

Figure 1: Breakdown by region and business of Alembic’s sales in its financialthird quarter ended 31 December 2015 (Source – Alembic)

Low- and mid-teen growth in its Domestic Formulations andInternational Formulations businesses helped India’s Unichem

Laboratories to overcome tumbling active pharmaceutical ingredient(API) turnover as the firm’s group sales rose by a tenth to Rs9.21billion (US$136 million) in the nine months ended 31 December 2015.

Unichem’s domestic finished-dose turnover increased by 13% toRs5.72 billion, more than offsetting Indian API sales that dropped by3% to Rs179 million. International Formulations turnover, meanwhile,advanced by 16% to Rs2.67 billion, helping to outweigh API salesthat slumped by a quarter to Rs554 million.

Within its International business, Unichem reported “healthy[sales] growth” of 39% to US$24.1 million and pre-tax profit ofUS$1.47 million from its wholly-owned US subsidiary.

In Brazil, Unichem’s sales rose by just under two-fifths to BRL1.65million (US$0.40 million). But the firm’s Niche Generics UK divisionsuffered a sales slide of around a fifth to £5.87 million (US$8.37million). Unichem’s nine-month sales in South Africa total ZAR2.8million (US$0.2 million). G

NINE-MONTH RESULTS

Formulations carryUnichem up a tenth

Nine-month sales Change Proportion of(Rs millions) (%) total (%)

India 5,717 +13 62International 2,673 +16 29Formulations 8,390 +14 91

India 179 -3 2International 554 -24 6APIs 732 -20 8

Other 87 ±0 1

Unichem Labs 9,209 +10 100

Figure 1: Breakdown of Unichem Laboratories’ sales in the nine months ended31 December 2015 (Source – Unichem)

Gen 29-1-16 Pgs. 2-16_Layout 1 27/01/2016 16:57

Biocon says that development work for active pharmaceuticalingredients (APIs) supporting abbreviated new drug application

(ANDA) submissions is “gaining traction”, putting the Indiandeveloper “on track to file 20-25 dossiers over the next few years”.At the same time, Biocon has just commenced building its potentoral-solid dosage formulations manufacturing facility in Bangalore,India, which the firm says “further supports” its strategy to verticallyintegrate ANDA filings.

Confirming previous comments, Biocon noted that its “mostadvanced” biosimilar and follow-on insulin programmes – adalimumab,pegfilgrastim, trastuzumab, and insulin glargine – being developed

under a partnership with Mylan were “continuing to cross criticalclinical milestones and are on track” for US and European regulatoryfilings during the course of 2016.

Mylan has recently signed a development agreement withMomenta covering six ‘next wave’ biosimilars (Generics bulletin, 15January 2016, page 1), although the latter firm insists there is nocrossover with Mylan’s partnership with Biocon.

Having last year announced that it was pursuing licensingopportunities in emerging markets for its trastuzumab biosimilar,along with its insulin glargine (Generics bulletin, 6 November 2015,page 8), Biocon said it had made “good progress” in finding a partnerfor the biosimilar and seeking approval “in some of the emergingmarkets”. The firm has also begun process qualification at its insulinmanufacturing facility in Malaysia, ahead of planned filings.

In its financial third quarter ended 31 December 2015, Bioconincreased its group sales by a tenth to Rs8.57 billion (US$126 million),driven mainly by turnover through its contract research servicesdivision rising by almost a quarter to Rs2.70 billion, alongsideBiopharma sales that moved forward by 4% to Rs4.54 billion (seeFigure 1). Through its Biopharma business, Biocon said it was seeingan “increasing contribution from immunosuppressants and genericinsulins in the emerging markets”. The firm reported Rs320 million inbiosimilar licensing income through the Biopharma unit. BrandedFormulations turnover in India stalled at Rs1.04 billion.

Despite increasing its research and development spending by 45%to Rs679 million, Biocon’s earnings before interest, tax, depreciationand amortisation advanced by almost a quarter to Rs2.09 billion. G

COMPANY NEWS


THIRD-QUARTER RESULTS

Biocon works toward20-25 ANDA filings

Business Third-quarter sales Change Proportionsegment (Rs millions) (%) of total (%)

Biopharma 4,536 +4 53

Branded Formulations 1,045 ±0 12

Contract Research 2,701 +23 32

Other 289 +60 3

Biocon 8,571 +10 100

Figure 1: Breakdown by business segment of Biocon’s sales in its third quarterended 31 December 2015 (Source – Biocon)

MAPI PHARMA – the Israeli active pharmaceutical ingredient (API)producer – has launched an initial public offering (IPO) of 3.125million shares priced at between US$15.00 and US$17.00. If theoffer’s underwriters take up an additional allocation of 468,750shares, Mapi expects to raise US$52.1 million and have just over12.2 million shares outstanding. Zhejiang Jingxin Pharmaceuticalhas agreed through a separate private placement to buy US$10million of shares at the IPO price. The extended-release specialist isdeveloping bulk drugs including rivals to Teva’s Copaxone (glatirameracetate), Pfizer’s Lyrica (pregabalin) and Johnson & Johnson’sRisperdal Consta (risperidone), but does not currently have anyproducts approved for sale.

SEQUENT SCIENTIFIC is paying Rs68.5 million (US$1.01 million)for a majority 51% stake in Indo Phyto Chemicals (IPC), a femalehealthcare specialist based in New Delhi, India, with productionfacilities in Uttarakhand. “IPC is a fully integrated firm with a portfolioof steroids and hormonal active pharmaceutical ingredients (APIs),”SeQuent noted, adding that the firm’s expertise in fermentation andchemical synthesis gave it “a unique ability to produce APIs from thebasic starting materials that are extracted from plants”. IPC currentlyproduces 14 APIs, generating an annual turnover of Rs675 million,and has another 20 bulk drugs under development.

OLAINFARM increased its group turnover by 5% to C98.1 million(US$106 million) last year, just shy of its C100 million target,according to preliminary figures. The Latvian company pointed outthat it had doubled its turnover in the Netherlands to around C6 millionin 2015, helping to offset a slight dip in Russia, which accounts fora third of group turnover. The firm’s domestic turnover ahead by11% to around C24 million made up nearly a quarter of the total,compensating for downturns in Ukraine and Belarus.

KMART – the US retail chain – is offering 10 commonly-usedgenerics for US$3.00 per pack for cash customers who sign up toits Pharmacy Savings Plus initiative. Consumers who pay US$10per year for an individual membership, or US$15 for their household,will qualify for discounted rates on amlodipine, amoxicillin,fluoxetine, fluticasone and ibuprofen, as well as hydrochlorothiazide,lisinopril, meloxicam, metformin and simvastatin.

VALEANT is not a “hedge fund”, it is a multinational pharmaceuticalcompany that “invests heavily in research and development”, thegroup’s interim chief executive officer Howard Schiller and interimchairman Robert Ingram have insisted following criticism of theCanadian firm’s business model. “We have been attacked by short-sellers, criticised by many peers in our own industry and subjectedto intense public scrutiny,” they observed, adding that Valeant’sshare price had plummeted by 70% “before partially recovering”.Schiller – who is leading Valeant while Mike Pearson is on sick leave(see page 16) – said the company was changing how it operated,such as by striking a price-cutting deal for off-patent brands withWalgreens (Generics bulletin, 8 January 2016, page 5).

CELLTRION has adopted Medidata’s ‘clinical cloud’ technologyplatform in order to “enhance the speed, efficiency and accuracy of itsclinical trials”. The South Korean biosimilars developer gains accessto Medidata’s cloud-based technology for electronic data capture andmanagement, medical coding and trial-supply management.

CFDA – the Chinese Food and Drug Administration – has ordered 14domestic companies to both stop selling and immediately recall 16different drugs. The recalls cover capsules, granules and tablets. G

IN BRIEF

CIPLA has had its A1+ debt rating affirmed by Credit Analysis andResearch (CARE), India’s second-largest credit rating agency. G

IN BRIEF

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Failing to test finished batches and to ensure the identity of drugcomponents have led the US Food and Drug Administration

(FDA) to issue a warning letter to Hong Kong-based manufacturerChan Yat Hing.

Other deficiencies identified during an inspection of the firm’sfacility in Kowloon conducted in July 2015 a lack of stability data andwritten procedures for quality control. “Your quality unit releasedmultiple batches of drug product for distribution, despite these andother violations,” the FDA pointed out.

“We have not received a response from your firm for correctiveactions to the violations identified during the inspection,” the FDAstated, adding that this had led the agency to place the company onan import alert.

The US agency has also just issued an import alert against ZhejiangHisoar’s plant in Taizhou City, China, due to good manufacturingpractice (GMP) deficiencies. G

COMPANY NEWS


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MANUFACTURING

FDA warns Hong Kong firm

Sandoz has struck an “exclusive licensing agreement” with KyowaHakko Kirin for the Japanese biopharmaceuticals specialist to

distribute and promote the generics firm’s biosimilar rituximabcandidate in Japan. Under the terms of the deal, Sandoz will beresponsible for obtaining a marketing authorisation and manufacturingthe biosimilar, while Kyowa Hakko Kirin will handle “all sales,marketing and promotion activities in Japan”.

Kyowa Hakko Kirin will pay Sandoz an upfront fee, along withsubsequent payments for regulatory filing, approval and “success-basedmilestones”. The deal – financial details of which were not disclosed –also sets out “royalties and a defined supply price for every order”.

“Since the biosimilars market is expected to expand more thanever in Japan, biosimilars are becoming important for pharmaceuticalbusiness,” commented Masashi Miyamoto, Kyowa Hakko Kirin’sdirector of strategic product portfolio. “Sandoz is the pioneer in thebiosimilars market”. The Japanese firm is expecting full-year salesfor 2015 of around ¥360 billion (US$3.04 billion).

Carol Lynch, Sandoz’ global head of biopharmaceutical andoncology injectables, said the deal with Kyowa Hakko Kirin“demonstrates our commitment to expanding patient access across theworld”. If approved, Lynch said, “biosimilar rituximab means thathealthcare professionals in Japan will have more choice in what theyprescribe to their patients with haematological cancers”. G

STRATEGIC ALLIANCES

Sandoz has deal withKyowa Hakko Kirin

Concordia Healthcare is “not in a position from a capital stand point”to carry out a further large transaction in the wake of its US$3.5

billion acquisition of Amdipharm Mercury (AMCo), but the firm iscurrently “working on” multiple smaller ‘tuck-in’ type acquisitions,according to chairman and chief executive officer Mark Thompson.

“I think we are a growing engine, we do not have to do mergersand acquisitions, but if there are good tuck-ins, we will do them,” hetold investors at a recent Canadian Imperial Bank of Commerce (CIBC)conference. Potential new deals had also sprung from meetings thathad taken place at the 2016 JP Morgan Healthcare Conference heldearlier this month, he added.

Concordia’s priority, however, would be to reduce borrowingsfollowing the AMCo transaction (Generics bulletin, 11 September2015, page 1), Thompson noted, pointing out that by the end of 2016the firm anticipated having a net debt no more than 5.5-times itsearnings before interest, tax depreciation and amortisation (EBITDA).“We are going to have to spend some time over the coming monthsto pay down our debt”, he admitted.

Following the completion of the AMCo deal, Concordia isforecasting 2016 full-year turnover of US$1.02-US$1.06 billion, andadjusted EBITDA of US$610-US$640 million (Generics bulletin,6 November 2015, page 2). And Concordia now expected around 60“nice” launches over the next 3-4 years, Thompson said, with eachproduct targeting a market worth around US$1-US$10 million. Thetransaction had taken Concordia’s existing portfolio to over 200products that were sold in over 100 countries, he reiterated.

Meanwhile, AMCo’s ‘centre of excellence’ in India was somethingConcordia was “very excited about”, Thompson insisted, noting thatthe firm was in the process of expanding. “We are moving everythingwe have outsourced into India, our regulatory filings in the US are goinginto India. This gives us a very strong competitive advantage,” he said.

Thompson also believes there is “most definitely” an opportunityto take products from AMCo’s majority UK-based portfolio into theUS, “and that is something we are working on now”, he revealed.“But these things take time,” he conceded. G

BUSINESS STRATEGY

Concordia not eyeinganother sizeable deal

Gen 29-1-16 Pgs. 2-16_Layout 1 27/01/2016 16:57

Federal drug plans operated by Canada’s national government areto link up with the pan-Canadian Pharmaceutical Alliance (pCPA)

that negotiates generic and branded drug prices on behalf of thecountry’s provinces and territories.

“Combining the negotiating power of federal, provincial andterritorial governments achieves greater savings for all publicly-fundeddrug programmes, increases access to clinically effective drug-treatmentoptions and improves consistency of pricing and coverage criteriaacross Canada,” the national government maintained.

Through federal health plans, the Canadian government providesbenefits to First Nations and Inuit, the Royal Canadian Mounted Police(RCMP), the armed forces, veterans, inmates and refugee-protectionclaimants. In 2014, drug-related spending on these groups totalledC$630 million (US$446 million).

These plans will join Alberta, British Columbia, Manitoba, NewBrunswick, Newfoundland and Labrador, as well as Nova Scotia,Ontario, Quebec, Prince Edward Island, Saskatchewan and the Yukonas participating members of the pCPA.

To date, the pCPA has negotiated price reductions for 14 genericdrugs. Amlodipine, atorvastatin, omeprazole, rabeprazole, ramipriland venlafaxine had their prices limited to 18% of the equivalentbrand price from 1 April 2013 (Generics bulletin, 1 February 2013,page 1). The same limit was applied to citalopram, pantoprazole,rosuvastatin and simvastatin from 1 April 2014 (Generics bulletin,4 April 2014, page 7). And from April 2015, solid-dose clopidogrel,gabapentin, metformin and olanzapine have also been subjected to the18% limit, with more molecules set to follow in April this year.Combined with around 90 negotiations on branded medicines, thesecuts have resulted in total savings of more than C$490 million per year.

The Canadian Generic Pharmaceutical Association (CGPA) hascalculated, using IMS data, that the 18% generic price reductions willsave all payers about C$1.6 billion over the full term of the agreement,which is set to expire on 31 March 2017.

Nova Scotia is currently co-leading with Saskatchewan on thegenerics initiative and is working with Ontario on the branded side.Toronto, Ontario, hosts the pCPA’s central office from which thealliance’s senior manager and senior negotiator operate.

“I am impressed and encouraged by the cost savings that the pCPAhas achieved to date and I am looking forward to working togetherto negotiate better prices for prescription drugs,” commented FederalMinister of Health, Jane Philpott. Participating in the alliance formspart of moves by the new national Liberal government led byPrime Minister Justin Trudeau to develop a new health accord.

Praising the Trudeau government for joining with the provincesand territories in controlling healthcare costs, the Canadian MedicalAssociation (CMA) called for private health insurance plans thataccounted for around 36% of prescription drug spending to also jointhe pCPA. “The bigger bulk-buying muscle the alliance has, the better,”the doctors’ association stated. G

MARKET NEWS


PRICING & REIMBURSEMENT

Canada governmentlinks with provinces

Finland has become the latest country to ratify the agreement for aEuropean Unified Patent Court (UPC). The European Council said

Finland’s parliament had passed legislation that “applies provisionallythe article 1, 2, 4, 5, 6(1), 7, 10-19, 35(1, 3 and 4), 36-41 and 71(3) ofthe Agreement on a UPC and article 1-6, 7(1 and 5), 9-18, 20(1),22-28, 30, 32 and 33 of the Statute of the UPC”. Formal notificationof ratification was given on 19 January.

Nine member states – Austria, Belgium, Denmark, Finland, France,Luxembourg, Malta, Portugal and Sweden – have now ratified theUPC agreement. It will enter into force when 13 states – which mustinclude France, Germany and the UK – have completed ratification.

Draft statutory instruments have just been introduced in the UKto allow the ratification of the UPC and unitary European patents,following a technical review of the agreement.

An explanatory note to the draft instruments clarifies that oncethe UK part of a European patent has “unitary patent protection, thatpatent no longer has effect in the UK as a national patent and is tobe treated as never having had the effect as a national patent”. Thisclarification is aimed at prohibiting double patenting.

UK legislation addresses SPCsSpecific sections tackle provisions on compulsory licences and

jurisdiction over supplementary protection certificates (SPCs), whichwill be granted nationally by the UK’s Intellectual Property Office(IPO) on the basis of unitary patents. The UK government expects theUPC to begin operating in early 2017.

Luxembourg’s government on 15 January passed draft legislationto enact a UPC protocol signed in the country on 1 October last year.This will see certain parts of the UPC agreement enacted early andwill pave the way for the UPC’s Court of Appeal to be in Luxembourg.Alexander Ramsay, vice-chairman of the UPC preparatory committee,believes preparatory work can be completed later this year. G

INTELLECTUAL PROPERTY

Finland acts to ratifyUnified Patent Court

Re-introducing price differentiation between generics and off-patentbrands is essential to stimulate competition in Spain’s

pharmaceuticals market, representatives from the European Genericand Biosimilar medicines Association (EGA) and local industryassociation Aeseg stressed during a joint executive meeting.

“Our industry is ready to work with the Spanish authorities toremove barriers to competition and increase the cost-effectiveness oftherapies to ensure better access to high-quality medicines,” stated EGAdirector-general Adrian van den Hoven during the meeting in Barcelona.

Other issues addressed included negative consequences broughtabout by the current tender procurement system in Andalusia and theproposed European waiver for manufacturing for export duringsupplementary protection certificates (SPC) terms (Generics bulletin,6 November 2015, page 1).

“The European Commission proposal for an SPC manufacturingwaiver is essential to create new manufacturing and job opportunitiesin Spain,” argued Aeseg’s director-general, Angel Luis Rodriguezde la Cuerda. “We call on the Spanish government to strongly supportthis job-creating measure in the European Union.” G

PRICING & REIMBURSEMENT

Price gap essential in Spain

INTER PARTES REVIEWS of US patents are unconstitutionalbecause they are conducted by a tribunal that lacks authority,according to a certiorari petition filed with the US Supreme Courtby patent holder Carl Cooper. G

IN BRIEF

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MARKET NEWS


Brand lobbyists have clashed with the US Generic PharmaceuticalAssociation (GPhA) over legislation to improve access to brand

samples for bioequivalence testing that is currently being consideredby Congress. The Alliance for the Adoption of Innovations in Medicine(Aimed) believes that the proposed Fair Access to Safe and Timely(FAST) Generics Act will “gut existing safety measures” by forcingsales to generics firms. This view is opposed by the GPhA, which hasrepeatedly called on Congress to pass the FAST Generics Act tostreamline the Risk Evaluation and Mitigation Strategies (REMS)process (Generics bulletin, 6 November 2015, page 13).

In a report published in the Journal of Pharmaceutical Policy andPractice, the lobbyists urge policy makers to reject the FAST legislation,warning it will weaken the US Food and Drug Administration’s(FDA’s) safety procedures. Focusing specifically on the FDA’sREMS programme that requires companies to manage drugs withpotential serious risks, Aimed asserts that policy makers need to“closely guard” the safety process.

Dismissing claims made by the GPhA, Aimed argues thatoriginators do not use REMS to limit generic manufacturers’ accessto brand samples (Generics bulletin, 8 August 2014, page 15),although it acknowledges that restricted distribution systems havemade it “more difficult for generic manufacturers to obtain” brandeddrugs. However, generics companies have the ability to gain accessto brand samples in the REMS programme through an approved FDApathway, according to Aimed, which noted: “Through this processnearly a dozen medicines subject to REMS have gone generic.”

Aimed also refutes the GPhA’s contention that 40% of brandeddrugs have authorised unique REMS programmes, claiming the figureis “6% – or 73 of the 1,161 FDA-approved brand drugs”. The reportattempts to analyse the GPhA’s allegation that REMS abuse costs theUS healthcare system US$5.4 billion, rejecting the GPhA’s figureand labelling it “conjecture and based on questionable methodology”.

Problems are also apparent in the FAST legislation, Aimed argues,with a “broad and ambiguous” definition of an ‘eligible productdeveloper’. The group believes “any individual or business could claimto be an eligible product developer, including an entity with a historyof failing to follow safety protocols or producing counterfeit oradulterated medicines”. Wholesalers “will feel free to do business withany party that offers adequate consideration for drug samples underthe guise of an eligible product developer”, Aimed insisted.

Brand companies would also be forced, under the FAST Act, tosell REMS-protected products to wholesalers and provide productsamples for bioequivalence testing due to new powers granted to theFDA, Aimed claims. However, if the FDA did not authorise the “forcedsale” within 60 days, authorisation would be automatic. In addition,the wholesaler does not have to reveal the identity of the purchaserto the brand owner, meaning “samples could get into the hands of abad actor, yet neither the FDA nor the brand manufacturer wouldhave any knowledge of the transfer”.

Aimed argues that “guarding patient safety and increasing genericdrug development are mutually exclusive” and goes on to exhort policymakers to create polices “that make it easier for brand manufacturersto negotiate with generic companies”. It also warns the FAST Actwould create “a chilling effect on the development and marketing ofnew drugs subject to REMS restrictions in the future”. The paperconcludes by calling for generics manufacturers “to be held to thesame REMS safety standards as brand manufacturers”. G

SOUTH AFRICAN FIRMS have been granted a maximum 4.80%increase in the Single Exit Price (SEP) that they charge for anygiven medicine to all private purchasers. Companies have until 11March to apply for price increases.

FDA – the US Food and Drug Administration – has pledged tocontinue negotiating with industry over generics user fees for smallbusinesses. A small-business working group formed as part of theprocess to reauthorise the generic drug user fee amendments(GDUFA) scheme is discussing Congress’ request to consider reducedfees for smaller companies. The agency has also launched twoweb-based tutorials on current GDUFA processes and requirements.

EMA – the European Medicines Agency – recommended 93medicines for marketing authorisations last year. That total included39 new active substances, a third of which were for treating cancer.Among the 93 recommendations, 18 had an orphan designation.European Union (EU) conducted over 2,590 good manufacturingpractice (GMP) and more than 270 good clinical practice (GCP)inspections during 2015, with GCP inspections leading to thewithdrawal of three marketing-authorisation applications –Aripiprazole Mylan, Duloxetine Sandoz and VeraSeal (fibrinogen/thrombin) – before the EMA’s committee for human medicinalproducts (CHMP) had given an opinion.

CANADA’S PRIVATE DRUG PLANS would have seen prescription-drug savings of up to 5.7% in 2013 had oral solid-dose brandsbeen reimbursed at generics price levels, according to a reportreleased by the country’s patented medicine prices review board(PMPRB). By 2013, the report says, generics cost on average 42%of the cost of the reference brand and accounted for 55% ofprescriptions reimbursed by Canada’s private drug plans.

THE UNITED NATIONS has called for stakeholder contributionsto its secretary-general’s high-level panel on access to medicines.The panel wants to “address the policy incoherence in relation tothe rights of inventors, international human-rights law, trade rulesand public-health objectives, including access to medicines, vaccines,diagnostics and medical devices”. Interested parties have until 18February to respond ahead of hearings to be held in March.

GAO – the US Government Accountability Office – believes theUS Food and Drug Administration (FDA) should improve its oversightof post-approval safety data. In a report prepared for a Housesub-committee, the GAO notes that about a quarter of applicationsapproved by the FDA’s Center for Drug Evaluation and Research(CDER) between October 2006 and December 2014 “used at leastone expedited programme”. “FDA lacks reliable, readily accessibledata on tracked safety issues and post-market studies,” it says.

THE NETHERLANDS will seek to “strengthen voluntary cooperationamong member states on medicines pricing issues” and to aid“access to innovative, affordable medicines” during its presidencyof the European Union (EU) Council in the first half of 2016.

PARAGRAPH IV PATENT CERTIFICATIONS and 180-dayexclusivity are among the generics-related industry guidancesthat the Center for Drug Evaluation and Research (CDER) withinthe US Food and Drug Administration (FDA) intends to release thisyear. The agency will also advise on whether to submit applicationsvia the 505(b)(2) hybrid or 505(j) generic pathways, and will giveguidance on specific products including topical patches andabuse-deterrent oral opioids. G

IN BRIEFREGULATORY AFFAIRS

Originators hit backon REMS legislation

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Indian generics players Cipla, Emcure, Hetero and Natco haveobtained sub-licences from the Medicines Patent Pool (MPP) to

produce versions of Bristol-Myers Squibb’s Daklinza (daclatasvir)hepatitis C treatment, along with “fixed-dose daclatasvir combinationsthat offer the potential to treat all of the six major genotypes ofhepatitis C”, in 112 low- and middle-income countries.

The sub-licences follow the MPP reaching a non-exclusive,royalty-free licensing agreement with the originator at the end of lastyear (Generics bulletin, 9 December 2015, page 18), allowinggenerics manufacturers to “develop fixed-dose combinations with otherdirect-acting antivirals to create powerful pan-genotypic regimens thatoffer the potential to treat all of the six major genotypes of hepatitis C”.

Under that deal, Bristol-Myers Squibb agreed to provide a“technology-transfer package and information needed for themanufacture and registration of the product”.

Greg Perry, the MPP’s executive director, commented that the Poolhad “worked quickly to forge agreements with generic companies”. “Wewelcome Natco, a new collaborator, to the MPP and hope to have othercompanies on board as well,” he said, noting that the MPP was“assessing applications from several other companies”. Cipla holdsseveral MPP sub-licenses for antiretrovirals including dolutegravirand tenofovir alafenamide, while Emcure was “one of the first genericcompanies to sign a licence with MPP for antiretrovirals in 2012”. G

PRODUCT NEWS


HEPATITIS C DRUGS

Four ink agreementsfor BMS’ daclatasvir

Indian intermediates and active pharmaceutical ingredients (APIs)developer Lee Pharma has seen its application for a compulsory

licence relating to a patent protecting AstraZeneca’s saxagliptin-baseddiabetes treatment brands rejected by India’s controller of patents. Theoriginator’s Indian compound patent 206,543 protects both its Onglyza(saxagliptin) brand and the saxagliptin/metformin combinationmarketed under the Kombiglyze XR name.

According to Section 84(1) of the Indian Patent Act, an applicationmay be made for a compulsory licence on a patent three years after itis granted on any of three grounds; that the “reasonable requirements”of the public are not satisfied; that the patented invention is “notavailable to the public at a reasonably affordable price”; and that thepatented invention is “not worked in the territory of India”.

Lee – which had submitted its application for a compulsory licencemid-way through last year (Generics bulletin, 10 July 2015, page 18),but was initially found to have not presented a prima facie case on anyof those three bases (Generics bulletin, 1 September 2015, page 29) –had subsequently insisted to India’s controller of patents that allthree grounds were applicable with respect to the ‘543 patent.

The Indian firm alleged that there was, according to its ownestimates, “more than a 99% shortage of saxagliptin in the Indianmarket” in 2013, while the cost of one saxagliptin tablet was more thanan entire day’s earnings in some of the more impoverished parts ofIndia. Moreover, Lee argued, AstraZeneca had “not taken adequatesteps to manufacture saxagliptin in India and make full use of theinvention…to an adequate extent”.

“[The] applicant has failed to provide evidence along with itsapplication or during hearing by supplementary submission and failedto satisfy the controller regarding any of the grounds as specified inSection 84(1) of the Act,” India’s patent controller commented, ultimatelyfinding again that a “prima facie case has not been made out”. G

DIABETES DRUGS

India denies licenceto saxagliptin patent

Teva has settled its pending US patent litigation versus UnitedTherapeutics over Remodulin (treprostinil). The originator has

granted Teva a non-exclusive licence to market a generic version ofthe injectable treatment for pulmonary arterial hypertension from23 December 2018, or earlier “under certain circumstances”.

United had in 2014 sued Teva in a New Jersey district court foralleged infringement of five Remodulin patents, one of which expiresnext year, three in 2028 and one in 2029. A trial had been scheduledto take place this year.

Through a similar litigation settlement, Sandoz last year securedrights to launch its generic rival to Remodulin on 26 June 2018(Generics bulletin, 23 October 2015, page 27). The New Jersey districtcourt had found that US patent 6,765,117 expiring on 24 October 2017was valid and infringed, while US patent 7,999,007 expiring on 29March 2029 was valid but not infringed by the abbreviated new drugapplication (ANDA) that Sandoz had submitted (Generics bulletin,19 September 2014, page 19).

United – which reported Remodulin sales 4% higher at US$432million in the first nine months of 2015 – stressed that the settlementsdid not cover its other treprostinil-based formulations and brands. G

CARDIOVASCULAR DRUGS

Teva settles over treprostinil

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Sandoz has obtained an extension until 16 February to appeal to theUS Supreme Court against an appeals ruling that it had to await

final US Food and Drug Administration (FDA) approval before giving180-day notice of launching its Zarxio (filgrastim-sndz) biosimilar.

Last year the US Court of Appeals issued a fractured ruling inSandoz’ dispute with Amgen that the biosimilar developer could notgive 180-day notice of commercial marketing to the originator beforeit had obtained approval from the FDA (Generics bulletin, 7 August2015, page 1). The appeals court however backed Sandoz’ argumentthat the firm need not disclose details of its dossier and manufacturingprocess to the reference drug’s owner.

Both Amgen and Sandoz later filed en banc petitions against theappeals court ruling, with Amgen appealing the decision not to disclosethe dossier and Sandoz challenging the 180-day ruling. Both petitions,however, were refused (Generics bulletin, 23 October 2015, page 25).While Sandoz has obtained an extension to petition for a certiorarireview of the appeals court ruling, Amgen allowed the deadline forit to file a certiorari petition to pass.

Amgen’s belief that a firm must disclose its dossier andmanufacturing process to the originator may still yet be examined bythe Supreme Court, according to US law firm Patterson BelknapWebb & Tyler, if Amgen files a conditional cross-petition to the SupremeCourt. In this case, the court could re-examine both issues. G

PRODUCT NEWS


22-24 February

■ GPhA 2016 Annual MeetingFlorida, USAThis meeting, organised by the US Generic Pharmaceutical Association,will look at regulatory issues and opportunities within the industry.

Contact: GPhA. Tel: +1 202 249 7100.E-mail: [email protected]. Website: gphaonline.org.

3-4 March

■ Business Development & InnovationOpportunities in Consumer Healthcare/OTCLondon, UKOrganised jointly by the Pharmaceutical Licensing Group andOTCToolbox, this event will focus exclusively on businessdevelopment and innovation in the consumer healthcare/OTC market.Contact: OTCToolbox. Tel: +44 121 314 8757.E-mail: [email protected]: plg-group.com/events/bdconsumerhealthcareotc/

6-7 March

■ EuroPLX 60Barcelona, SpainThis meeting provides an opportunity to discuss and negotiateagreements, in-licensing and marketing and distribution.

Contact: Raucon. Tel: +49 6221 426296 0.E-mail: [email protected]. Website: europlx.com.

8-9 March

■ 12th EGA Legal Affairs ConferenceBrussels, BelgiumThis conference will cover issues including the latest legal andintellectual-property developments regarding generics and biosimilars.

Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected] online at www.egaevents.org/laf/egalaf2016reg.htm.

18-19 April

■ 4th Annual Biosimilars & Biobetters CongressLondon, UKTopics including market access and opportunities and commercialchallenges will be addressed at this two-day event.

Contact: Oxford Global Conferences. Tel: +44 1865 248455.E-mail: [email protected]. Website: oxfordglobal.co.uk.

28-29 April

■ 14th EBG Biosimilars ConferenceLondon, UKThis conference will cover issues including market access, regulatoryissues, the evolving landscape and scientific developments.

Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.egaevents.org/bios/egabios2016reg.htm.

EVENTS – February, March & April

8-10 June

■ Joint EGA and IGBA Annual ConferenceDubrovnik, CroatiaFor 2016, the European Generic and Biosimilar medicines Association(EGA) and the International Generic and Biosimilar MedicinesAssociation (IGBA) will join forces for their annual conferences.

Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.egagenerics.com or www.egaevents.org.

BIOLOGICAL DRUGS

Sandoz has extensionin US filgrastim fight

More than 80 generics, originator, biotechnology and diagnosticscompanies, as well as their key industry associations, have

joined forces to call on government and industry to take comprehensiveaction against drug-resistant infections or ‘superbugs’.

A ‘declaration on combating antimicrobial resistance’ has beendrafted and signed by 85 companies and nine industry associationsacross 18 countries. Launched at the World Economic Forum inDavos, Switzerland, the declaration – which will be updated everytwo years – is intended to reduce drug resistance, improve accessto antibiotics and encourage research and development that meetsglobal public-health priorities.

Among the measures proposed in the declaration are: funding“transformational commercial models” that will create sustainable andpredictable markets; removing financial incentives for healthcareprofessionals to prescribe and dispense antibiotics in high volumes;delinking sales and usage volumes; and making prompt, value-basedreimbursement decisions.

Acknowledging that “traditional research and developmentapproaches have largely failed”, the declaration says “companies andprivate and public funders have invested billions of dollars over the last20 years to discover new antibacterials, yet no new class of antibioticfor gram-negative infections has reached approval in over 40 years”.

“The rational use of medicines through good prescription practiceand better health literacy to ensure patient compliance with antibioticmedicines is crucial to maintain the effectiveness and availability ofthese life-saving treatments,” commented Adrian van den Hoven,director-general of the European Generic and Biosimilar medicinesAssociation (EGA). G

ANTIBIOTICS

Industry aligns on resistance

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PRODUCT NEWS


The German part of Boehringer Ingelheim’s European patentEP1,379,220 protecting its Spiriva (tiotropium) respiratory brand

is invalid in its entirety, Germany’s federal court of justice, theBundesgerichtshof, has ruled in an oral judgement. The country’s federalpatent court, the Bundespatentgericht, had previously upheld the‘220 patent in an amended form.

No written reasoning for the court of justice’s invalidity findinghad been released as Generics bulletin went to press. According to lawfirm Gleiss Lutz, the court indicated during proceedings that prior-art references provided sufficient motivation for a skilled person toformulate the inhalation capsules described in the ‘220 patent.

Patent court had upheld some claimsIn November 2013, the Bundespatentgericht had found certain

claims in the ‘220 patent to be invalid, but had allowed other claimsto survive following amendments made by Boehringer Ingelheim.

Teva recently convinced the UK Patents Court that two key claimsof the ‘220 patent were invalid due to lack of inventive step (Genericsbulletin, 9 December 2015, page 21). Justice Paul Morgan noted inthat trial that Spiriva was also protected by a UK supplementaryprotection certificate (SPC) linked to European patent EP0,418,716that expires on 11 March this year. G

SANDOZ is set to have the efficacy of its salbutamol 100µg perdose aerosol inhaler reviewed at a European level. The DutchMedicines Evaluation Board (MEB) is seeking the review due toindications from the Lareb pharmacovigilance centre that the asthmatreatment’s efficacy may have been reduced following reformulation.Sandoz’ inhaler had been on the Dutch market since autumn 2014and was widely used, including by children, the MEB noted.

AMNEAL has secured tentative approvals from the US Food andDrug Administration (FDA) for saxagliptin 2.5mg and 5mg tabletsand for saxagliptin/metformin extended-release tablets in 2.5mg/1,000mg, 5mg/500mg and 5mg/1,000mg strengths. Final approvalis being held up by ongoing litigation over AstraZeneca’s Onglyzaand Kombiglyze brands in a Delaware district court. Both casescover reissued patent RE44,186 that expires on 31 July 2023, whilethe Onglyza dispute involves US patent 7,951,400 and the Kombiglyzesuit relates to US patent 8,628,799.

PERRIGO has completed its acquisition of generic forms of Retin-A(tretinoin) acne treatments from Matawan Pharma. The store-brandspecialist acted as the authorised generic distributor of the topicalgenerics previously (Generics bulletin, 8 January 2016, page 11).

HIKMA has obtained clearance to market bendamustine 2.5mg/mlpowder for infusion in Germany under the Ribosepharm label.Accord, Medac, Omnicare and Onkovis have secured similarapprovals for vials in the same strength.

MYLAN now holds final approval for a generic rival to Pernix’ Silenor(doxepin hydrochloride) 3mg and 6mg tablets in the US. Actaviscurrently holds the only other approval for the sleeping aid. Mylanhas also launched in the US its rival to Meda’s Felbatol (felbamate)400mg and 600mg tablets. The seizure therapy had US sales ofUS$53 million in the year ended 30 November 2015, according toIMS Health. Amneal offers both strengths, while Impax’ Corepharmaholds similar approvals.

HOSPIRA has been admonished by the US Food and DrugAdministration (FDA) for a YouTube video promoting its Precedex(dexmedetomidine) anaesthetic. “The video is false and misleadingbecause it omits risks and material facts associated with Precedex,”the agency objected in an untitled letter.

APOTEX has seen dismissed its application to appeal to theSupreme Court of Canada against an Ontario Court of Appeal rulingthat the generics firm was not entitled to a share of Eli Lilly’s profitsfrom selling Strattera (atomoxetine). The Canadian firm had soughta share of the profits that Lilly made during a two-year period inwhich the generic firm was kept out of the market by litigation overCanadian patent 2,209,735, which was subsequently found to beinvalid (Generics bulletin, 22 May 2015, page 20).

BIOINTEGRATOR says it has launched the first generic versionof Novartis’ Gilenya (fingolimod) in Russia and several Eurasiancountries under the Neskler brand name. According to the Moscow-based ChemRar affiliate, the Russian launch followed a lengthylegal battle against Novartis over the multiple-sclerosis treatment.

GLENMARK has received US approval for a generic version ofAllergan’s Loestrin 21 (norethindrone/ethinylestradiol) 1mg/0.02mgtablets. The oral contraceptive had US sales of US$56.8 million forthe year ended November 2015. Glenmark has also obtained approvalfor potassium chloride 10 mEq extended-release capsules. G

IN BRIEF RESPIRATORY DRUGS

Germany overturnspatent on tiotropium

Fresenius Kabi’s Canadian operation can secure a notice ofcompliance (NOC), or marketing authorisation, for injectable

moxifloxacin hydrochloride before Bayer’s CA2,378,424 patent expireson 25 July 2020, the country’s Federal Court of Appeal has ruled.

A panel of three appeal judges found no error in a lower courtruling that a proposed generic of Bayer’s Avelox IV from Kabi’sCanadian PPC unit would not induce infringement of the ‘424patent, which covers aqueous formulations containingmoxifloxacin and sodium chloride in specified concentrations.

Federal Court Judge Cecily Strickland had ruled last year that“merely stating that the [generic] product is compatible with 0.9%sodium chloride is not sufficient to establish that PPC is knowinglyinducing healthcare practitioners to breach the ‘424 patent”.

The appeals panel agreed. The proposed generic productmonograph “does not instruct or direct that Fresenius’ product is to beco-administered with 0.9% sodium chloride”, the judges said, addingthat the monograph’s “general reference” to sodium chloride was“obligatory and fell short of inducement”. G

ANTIBIOTICS

Kabi Canada clear on Avelox

Granules USA has strengthened its OTC store-brand offering bystriking a marketing deal with Endo’s Par. The Granules India

subsidiary will market Par’s generic version of Merck’s ZegeridOTC (omeprazole/sodium bicarbonate) upon US approval, whichthe Indian firm expects Par to obtain in July this year. G

GASTROINTESTINAL DRUGS

Granules partners with Par

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PIPELINE WATCH


Pfizer’s Zyvox (linezolid) antibiotic faces widespread competitionafter supplementary protection certificates (SPCs) expired in early

January in Europe’s largest markets. SPCs based on the Europeanlinezolid molecule patent EP0,717,738 expired in Austria, Denmark,France, Germany, Greece, Ireland and Italy, as well as in theNetherlands, Portugal, Slovenia, Spain, Sweden and the UK.

Accord Healthcare was among the vanguard to capitalise onZyvox’ loss of exclusivity. The Intas affiliate announced day-onelaunches of 10-count packs of linezolid 600mg film-coated tabletson 5 January in the UK and Ireland, and on 6 January in Spain.

Actavis was also among the day-one entrants with 600mg tabletsin the UK. Furthermore, Actavis recently obtained a UK marketingauthorisation for linezolid 2mg/ml solution for infusion, as didMylan’s Generics UK and Greece’s Pharmathen.

In Germany, competition on both the solid-dose and solutionforms of the pneumonia treatment looks set to be fierce. Around 10companies have secured clearance to introduce 600mg film-coatedtablets, including leading players such as Sandoz’ 1A Pharma andHexal, Stada’s Aliud, Dr Reddy’s Betapharm, Mylan Dura, Aurobindo’sPuren Pharma and Teva’s Ratiopharm. Several of the same firms,along with hospital specialists such as Fresenius Kabi, are offeringthe 2mg/ml solution for infusion.

Following opposition filed by Sandoz’ Hexal, the EuropeanPatent Office (EPO) revoked Pfizer’s linezolid tablet formulationpatent EP1,265,608 in 2011.

Another of Pfizer’s antibiotics, Vfend (voriconazole), has lostSPC protection in Norway and Switzerland. However, notes Ark PatentIntelligence, SPCs in most major European countries have beenextended by six months through paediatric exclusivity. For example,in the UK the SPC GB02/031 linked to European patent EP0,440,372

has been extended by six months to 23 July 2016.In the first nine months of 2015, Pfizer reported Vfend sales in

its ‘Developed Europe’ region that were almost flat on an operational,constant-currency basis, but that slid down by 15% as reported toUS$191 million. Nine-month Zyvox sales in the region fell by 11%to US$227 million, although the originator said this equated tooperational growth of 7%.

Over the same period, Pfizer’s global Zyvox sales declined byalmost a third to US$696 million as turnover more than halved toUS$234 million in the US due to generic competition.

Having in early 2015 introduced a linezolid 600mg/300mlsolution for infusion into the US market under the terms of apatent-litigation settlement, Teva followed up midway through lastyear by introducing its generic rival to Zyvox 600mg film-coatedtablets with 180-day generic market exclusivity (Generics bulletin,5 June 2015, page 22).

Several solution formulations of linezolid are now available,while Amneal, Glenmark and Mylan, as well as Alembic, Alkemand Hetero, were among the firms that recently secured US approvalsfor 600mg tablets after Teva’s 180-day exclusivity ended (Genericsbulletin, 22 January 2016, page 10).

Looking at data exclusivity, Ark Patent Intelligence observes thatan eight-year European data exclusivity term for Celgene’s Abraxane(albumin-bound paclitaxel) cancer drug has come to an end, to befollowed by a two-year market exclusivity period. A year ago, theEuropean Commission approved Abraxane as a first-line treatmentfor patients with non-small-cell lung cancer.

In the US, Takeda’s alogliptin tablets with metformin orpioglitazone – the Kazano and Oseni diabetes brands respectively –have seen expire three-year exclusivity terms for new combinations. G

This monthly update of key patent, SPC and data exclusivity data is extracted from Ark Patent Intelligence Expiry Database. Coveringover 50 countries and 2,200 INNs, Ark Expiry Database contains watertight data teamed with the ultimatein generic launch analysis.

For further information, visit www.arkpatentintelligence.comor e-mail: [email protected].

INN Country

Clostridium botulinum France, Germany, Italy, Spain, UKtype B

Efavirenz/emtricitabine/ Bulgariatenofovir

Emtricitabine Austria, Belgium, Denmark, France,Germany, Hungary, Italy, Luxembourg,Netherlands, Norway, Romania, Spain,Sweden, Switzerland, UK

Levocetirizine Greece, Italy, Portugal, Spain

Linezolid Austria, Denmark, France, Germany,Greece, Ireland, Italy, Netherlands, Portugal,Slovenia, Spain, Sweden, UK

Memantine Portugal

Rasagiline Czech Republic, Slovakia

Tegaserod Czech Republic

Voriconazole Norway, Switzerland

Figure 1: Molecules for which supplementary protection certificates (SPCs) expire incertain markets in January 2016 (Source – Ark Patent Intelligence)

SPC expiries in JanuaryINN Country/Region

Alogliptin/metformin USAlogliptin/pioglitazone USBesilesomab TurkeyCorifollitropin alfa TurkeyDaptomycin European UnionFosaprepitant European Union **Gadoxetic acid Canada*Galsulfase European UnionImmune globulin human European UnionInfluenza virus H5N1 South KoreaIoflupane USPaclitaxel (albumin-bound) European Union **Spinosad USTetanus toxoid, pertussis toxoid, diphtheria South Koreatoxoid, fimbria type 2, fimbria type 3 vaccineVilazodone US* This will be followed by a no-marketing period of two years duringwhich a notice of compliance will not be granted to a generic manufacturer.

** This will be followed by two years of market exclusivity, where a genericwill not be placed on the market.

Data exclusivity expiries in January

Figure 2: Molecules for which data exclusivity expires in certain markets duringJanuary 2016 (Source – Ark Patent Intelligence)

Linezolid SPCs reach the end of the line

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Biocad has received approval from Russia’s Ministry of Healthfor its alternative to Roche’s Herceptin (trastuzumab) brand,

taking its portfolio of biosimilar monoclonal antibodies (mAbs)approved in the country to three.

Having begun development on its Herticad biosimilar version oftrastuzumab six years ago, Biocad said its approval had followed “theresults of a randomised, multi-centre clinical study comparing thepharmacokinetics, immunogenicity, safety and efficacy” of Biocad’sBCD-022 trastuzumab candidate against Herceptin. In 2014, Russia’sgovernment had spent “over RUB5 billion (US$63 million)” onHerceptin, and there remained “uncovered medical needs of Russianpatients [with] trastuzumab”, Biocad noted.

The Russian firm received its first biosimilar approval – for itsversion of Roche’s MabThera (rituximab) – in 2014, introducing itthe same year under the AcellBia name (Generics bulletin, 6 June2014, page 21). An approval for Biocad’s rival to Avastin (bevacizumab)followed last year, with the firm scheduled to launch during the currentquarter (Generics bulletin, 8 January 2016, page 10).

All three biosimilars are manufactured in Biocad’s “new, ultra-modern Neudorf facility set in a special economic district outsideSt Petersburg”. The Russian firm last year said it anticipated launchinga rival to Janssen’s Remicade (infliximab) brand in Russia next year(Generics bulletin, 13 March 2015, page 21). G

PRODUCT NEWS


BIOLOGICAL DRUGS

Biocad’s trastuzumabis approved in Russia

Pfizer has forced the Dutch Medicines Evaluation Board (MEB)to remove from its website full-label summaries of product

characteristics (SmPCs) and package inserts for generic pregabalinproducts. The originator obtained from a district court in The Haguean order commanding the MEB to instead publish generic SmPCs andinserts that carve out Pfizer’s patented neuropathic pain indication.

Noting that the Dutch part of Pfizer’s European second-medical-use pain patent EP0,934,061 was in force until 17 July 2017, the Haguecourt observed that generics companies were free to market genericversions of Pfizer’s Lyrica (pregabalin) brand for the off-patentindications of treating epilepsy and general anxiety disorder.

The court said Accord, Aurobindo and Sandoz had to date launchedgeneric pregabalin in the Netherlands. But while Aurobindo had carvedout pain usage from its label, the MEB had included the patentedindication in the full-label SmPC and insert for the Indian firm’sgeneric, along with similar versions for marketing authorisations heldby Krka, Ranbaxy and Teva.

Pfizer promptly asked the agency to use the carved-out labelling,and prompted Aurobindo to do likewise. But the MEB refused onthe grounds of public safety.

Dismissing any question of the MEB having indirectly infringedthe ‘061 patent, the Hague court gave the agency four weeks to replacethe full-label SmPCs and inserts with the carve-out versions. G

ANALGESICS

Dutch agency mustuse carve-out labels

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Aurobindo Pharma prides itself on being “amongthe top-five listed pharmaceutical companiesfrom India by sales and market capitalisation”.

Having established itself as one of the country’s “leadingsuppliers” of active pharmaceutical ingredients (APIs),the company says it is also ranked by IMS data as theeighth-largest supplier in the US by the volume ofprescriptions dispensed.

And through a 2014 deal that saw it pay C30million (US$32 million) for Actavis’ generics operationsin Belgium, France, Germany, Italy, the Netherlands,Portugal and Spain (Generics bulletin, 3 February 2014,page 1), the firm has recently gained an “expandedpresence” in the European Union (EU).

However, the next steps in Aurobindo’s journey,according to the Indian firm, will take it into newterritory, in both geographical and technological terms.

Presenting its plans for future growth at therecent 2016 JP Morgan Healthcare Conference inSan Francisco, US, Aurobindo said it planned a“continued focus on the base business while capitalisingon complex molecules, differentiated technologyplatforms and specialty products”, as well asexpansion into several key emerging markets.

Currently, Aurobindo’s formulations in the USaccount for over two-fifths of the firm’s overallturnover, with its global APIs business representingaround a fifth (see Figure 1). Meanwhile the firmsays it is still “consolidating our presence in the EU”,which generated almost a quarter of total sales in itsfinancial second quarter ended 30 September 2015that rose by 16% to Rs33.3 billion (US$491 million).Around half of Aurobindo’s European turnover comesfrom retail generics with the remainder comingthrough tenders, the hospital channel, brands and OTCdrugs (see Figure 2).

While the firm plans to continue consolidating itspresence in the US and EU – with a steady stream ofabbreviated new drug application (ANDA) approvals inthe US (Generics bulletin, 22 January 2016, page 11)and “future growth potential” in the EU coming from

low-penetration markets such as France, Italy and Spain– Aurobindo says it is also looking further afield toemerging markets to build a foundation for future growth.

Aurobindo’s strategy in emerging marketscomprises three key goals: to “build a branded genericspresence”; to “enhance penetration in selected emergingmarkets through local manufacturing units”; and to“expand presence within therapeutic areas like oncologyand specialty injectables”.

Brazil and South AfricaThe company plans to “focus on the major markets

of Brazil, South Africa, Ukraine and Mexico”, whilein the EU the company intends to “augment our positionthrough new product launches and extension toselected Eastern Europe markets”, such as Poland andthe Czech Republic.

At the same time, Aurobindo plans to expand into“selective markets in the Asia-Pacific, Africa andMiddle-East regions”. The firm has just revealed plansto build an oral-solid dose manufacturing plant in SaudiArabia (Generics bulletin, 22 January 2016, page 3)as part of its strategy to “leverage the opportunity ofemerging markets through local manufacturing unitsin selected geographies”.

Aurobindo board member Madan Mohan Reddycalled the Saudi site “a major turning point for ourcompany” that had come “in response to rising demandfor our products in the Arabian Gulf”, where the firm saidthere was potential for growth in the generics market.

As well as geographic expansion, the company hasidentified certain “new business and technologyinitiatives to support growth”. Peptides being developedby Aurobindo include two drug master files (DMFs) thathave already been filed, with a further filing to followby the end of March. Citing an “addressable market ofUS$3 billion” for the microspheres it is working on, thefirm said its “highly experienced team of scientists”had developed technologies for more than 10 products.

A second initiative concerns oncolytics and

BUSINESS STRATEGY


As Aurobindo

continues to enjoy

growth in the US and

consolidates its

European operations,

the Indian company

is preparing to move

forward by exploring

new geographies and

technologies.

David Wallace reports.

Aurobindo looks to expandbeyond base in EU and US

Business Second-quarter sales Change Proportion ofsegment (Rs millions) (%) total (%)

US 14,775 +26 44Europe 7,643 ±0 23Rest of world 1,680 +7 5Antiretrovirals 2,708 +95 8Formulations 26,806 +20 80

Cephalosporins 2,294 -2 7Semi-synthetic penicillins 1,981 -8 6Others 2,636 +12 8Active Ingredients 6,911 +1 21

Eliminations -382 – -1

Aurobindo 33,335 +16 100

Figure 1: Breakdown by business segment of Aurobindo Pharma’s sales in its financial second quarterended 30 September 2015 (Source – Aurobindo)

RetailGenerics

48%

Prescription brands9%

Hospitaldrugs25%

OTC2%

Tenders16%

Figure 2: Breakdown by sales channel of Aurobindo’s EuropeanUnion business (Souce – Aurobindo)

Gen 29-1-16 Pgs. 2-16_Layout 1 27/01/2016 16:58

hormones, for which Aurobindo has set up a dedicatedresearch and development centre for both solid andparenteral dosage forms. Having completed its firstexhibit batches for three hormone products – with filingsexpected by the end of March – the company is alsoworking on 15 oncolytics and is planning to prepareexhibit batches for injectables by the same date. Thefirm has commissioned a dedicated ‘Eugia’ facilityfor hormones and oncology drugs as part of its plansfor manufacturing expansion.

Enzymes are the third major area that Aurobindohas identified as a new technology initiative, while thefirm also noted that it was “working on differentiatedtechnology platforms” including depot injections,inhalers, patches and films.

Investing in manufacturingTo support its overall expansion plans, Aurobindo

says that “key investments for future growth” willinclude a new dedicated block for lyophilised vials atits Unit IV general injectables facility, which is linkedto almost 50 ANDAs that are currently under review inthe US (see Figure 3).

Of 387 ANDAs filed in the US, Aurobindo hadreceived either final or tentative approval for 228applications as of 31 December 2015, with 159 stillunder review. The majority of the firm’s approvedANDAs have been filed from the Unit III oralformulations plant. The firm’s AuroNext peneminjectables facility has yet to secure an ANDA approval.

Aurobindo’s investments will also include newfinished-dosage formulations blocks at its Unit VIIplant – from which nearly 90 ANDAs are currentlypending, representing more than half of those currentlyunder review (see Figure 4) – along with new APIblocks at the firm’s Unit XI plant and “substantialcapacity expansion” at its US AuroLife unit.

The company is also planning to construct an oralsolid-dose facility in Naidupet, India; a finished-dosageformulations plant for European markets at its Vizagsite; a new campus in the US with a “central automatedwarehouse, OTC liquids and packaging facility”; anda new formulations development centre in the US.

Meanwhile, Aurobindo has identified dolutegraviras “the next growth driver” for its antiretroviralsbusiness. “Aurobindo is the first generic company to signa licence with Viiv Healthcare for the next-generationintegrase inhibitor”, the Indian company noted, having

filed an ANDA application for a 50mg strength in theUS under the President’s Emergency Plans for AIDSRelief (PEPFAR) programme (Generics bulletin, 5June 2015, page 25).

“The World Health Organization (WHO)announced this drug as a first-line reserve drug in its2015 HIV treatment guidelines,” Aurobindo pointedout, adding that it was developing a triple-combinationdrug containing dolutegravir.

To further develop its antiretrovirals business,Aurobindo says it is focusing on global tenders by“multi-lateral organisations” such as the Global Fund,PEPFAR, and country-specific tenders, giving thecompany potential access to 2.2 million patients. TheIndian firm has “filed over 1,100 antiretroviraldossiers for registrations across the globe”. G

BUSINESS STRATEGY


Site Filed Approved Under review

Unit III – Oral Formulations 119 112 7Unit IV – Injectables and Ophthalmics 67 21 46Unit VIB – Cephalosphorins Oral 11 11 0Unit VII – Oral Formulations 143 55 88Unit XII – Penicillin Oral and Injectables 19 19 0AuroLife USA – Oral Formulations 26 10 16AuroNext – Penem Injectables 2 0 2

Total 387 228 159

Figure 3: Breakdown by manufacturing site of Aurobindo’s filed and approved ANDAs as of 31December 2015 (Source – Aurobindo)

400

350

300

250

200

150

100

50

0

Num

ber

offi

lings

Final approval Tentative approval* Under review

2012 2013 2014 2015 31 Dec 2015

* Tentative approvals include 21 ANDAs approved underPEPFAR which are not for commercialisation in the US market

9288

145183

159

119155 165 166

19828

26 26 27

30

Figure 4: Aurobindo’s cumulative ANDA filings and approvals as of the financial years ended 31 March2012 to 31 March 2015, and 31 December 2015 (Source – Aurobindo)

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Mallinckrodt’s general manager of global active ingredients (APIs),Dawn Von Rohr, has joined AMRI as senior-vice president of

its API division. AMRI’s API business unit is the US-based contractresearch and manufacturing organisation’s largest division.

Reporting to chief operating officer George Svokos, Von Rohrwill in her new role have responsibility for “setting and implementingthe strategic direction for AMRI’s growing API business unit, andfor achieving financial results”. She will also join AMRI’s executivemanagement team, headed up by president and chief executiveofficer Bill Marth.

Having joined Mallinckrodt in 1993, Von Rohr took on roles ofincreasing responsibility before being appointed global director ofAPI marketing for Mallinckrodt’s former parent group Covidien inJune 2007. She served in this position for four years, before takingon her most recent and final role, in which she “led an approximateUS$400 million global API business” and formed part of the leadershipteam that “set the direction and executed the successful spin-out ofMallinckrodt from Covidien” in June 2013.

Pricing and product strategyCommenting on Von Rohr’s appointment, AMRI observed that

she had in her final role with Mallinckrodt “successfully led a businessthat met and exceeded profit targets each year”, and would bring tothe company the benefits of “strategic pricing, productrationalisation and business building experience”.

AMRI has recently taken several steps to expand its API business,including in July last year acquiring Spain’s Gadea Grupo Farmacéutico,which operates a complex API business, Crystal Pharma. Shortly after,AMRI signed an agreement to collaborate with Slovakian firm SanecaPharmaceuticals to “develop, manufacture and market a portfolio ofopium-derived APIs” (Generics bulletin, 11 September 2015, page 2).

“We are confident that Dawn brings the expertise and dynamicleadership to define and drive the next phase of growth for the APIbusiness,” commented Svokos, who was promoted to his current role inSeptember last year (Generics bulletin, 2 October 2015, page 35). G

PEOPLE


APPOINTMENTS

Von Rohr appointedAMRI’s API leader

Valeant’s chief executive officer, Mike Pearson, says he is “on theroad to recovery” and looks forward to returning to work following

an absence since late December due to severe pneumonia. “Someunexpected complications resulted in a longer hospital stay thananticipated,” Pearson stated in a memo to employees sent while onmedical leave, “and although the timing of my return remains uncertain,I look forward to being back at work when able.”

In Pearson’s absence, Valeant board member and former chieffinancial officer Howard Schiller has been appointed as the Canadianfirm’s interim chief executive officer, while lead independent directorRobert Ingram has taken on Pearson’s responsibilities as chairmanof the board (Generics bulletin, 8 January 2016, page 16). “I specificallywant to thank Howard for stepping in as interim chief executiveofficer and to all the members of the management team for theleadership that they have shown,” Pearson commented, adding thatthe company’s “future remains bright”. G

INTERIM APPOINTMENTS

Pearson plans Valeant return

AFFIMED has appointed Joerg Windisch as chief operating officerof the clinical-stage biopharmaceutical specialist. After a 20-yearcareer with Sandoz, Windisch last year joined Poland’s Polpharmaas head of the firm’s Biologics biotech division (Generics bulletin,2 October 2015, page 35). “As chief operating officer, Dr Windischwill provide his broad expertise in pharmaceutical regulatory affairs,quality control and project management to support the company’sexpanding clinical pipeline,” Affimed said. “We will greatly benefitfrom Joerg’s operational leadership.” At the same time, BernhardEhmer has joined the Dutch oncology specialist’s board.

RECIPHARM has recruited Anke Mollowitz as key account directorof the contract-development and manufacturing organisation. “Ankehas joined the business management team and is responsible forco-ordinating customer management and commercial aspects, aswell as developing relationships with a selected number of customersin Europe,” the firm noted. Meanwhile, the company has alsoappointed Yves Buelens as general manager of its wholly-ownedsubsidiary Kaysersberg Pharmaceuticals, having been plant managerfor Recipharm’s facility in Kaysersberg, France, since 2014.

AKORN has named Gregory Lawless to become the firm’s chiefhuman resources officer. “Greg is an accomplished executive withover 25 years of experiences in human resources at Fortune 500companies,” said chief executive officer Raj Rai. Lawless joinsthe US generics specialist from Kraft Heinz.

KANTAR HEALTH has promoted Michel Murino to European chiefexecutive officer of the healthcare consultant and market researcher.Murino will “lead the organisation’s European business, strengtheningits solutions and allowing the company to more synergisticallyaddress its clients’ country-specific business issues in marketinginsights, commercial effectiveness, real-world research and marketaccess”. He previously headed the firm in Southern Europe.

TEVA’s former chief financial officer for its Generics businessand former Pliva chairman and chief executive officer, TihomirOreskovic, has become prime minister of Croatia.

RENTSCHLER BIOTECHNOLOGIE has appointed Frank Mathiasto become chief executive officer of the German biopharmaceuticalcontract-manufacturer from 1 April 2016. Incumbent NikolausRentschler is moving to the supervisory board “to concentrate onthe further expansion of the Rentschler group”. G

IN BRIEF

Amgen’s application for a US biosimilar rival to AbbVie’s Humira(adalimumab) has been accepted for review by the US Food and

Drug Administration. A Biosimilar User Fee Act (BsUFA) targetaction date of 25 September this year has been set by the agency forthe firm’s ABP-501 candidate.

Following the positive results in November of a Phase IIIclinical trial comparing the safety, efficacy and immunogenicity ofABP-501 against Humira in patients with moderate-to-severerheumatoid arthritis, Amgen submitted what it claimed was thefirst biosimilar adalimumab application in the US (Genericsbulletin, 9 December 2015, page 15). Around the same time, thefirm claimed the first biosimilar adalimumab application to theEuropean Medicines Agency (EMA). G

STOP PRESS

Amgen’s adalimumab is accepted

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