COMPANY NEWS Global industryg iven seatatt able with ICH · 2018-11-20 · FDAu nveils raft of development guides 6 EU industrya pplauds 7 biosimilars workshop GPhA supports bill

24 June 2016

Sanofi sees a future in 2value-added drugsPolpharma to acquire Epirus Netherlands 2Hovione expands in Japan and in the US 3Teva agrees to divest to Sagent 3and ZydusMylan completes on Renaissance topicals 4

MARKET NEWS 5

One month remains for 5entries to AwardsEU Council supports industry incentives 5India plans increase 6for API import feesFDA unveils raft of development guides 6EU industry applauds 7biosimilars workshopGPhA supports bill to 7curb REMS abuse

PRODUCT NEWS 8

Australia identifies key 8awareness pointsAmneal collaborates over generic inhaler 8Zydus and Eczacibasi strike 9deal in TurkeyAstraZeneca seeks bar on Crestor rivals 9German court sends back Alimta ruling 10Sandoz plans for five bio 11launches by 2020

FEATURES 14

Global generics market will 14grow by 6.9% up to 2019

REGULARS

Price Watch UK – UK pricing trends 8Events – Our regular listing 10Pipeline Watch – Aranesp 12People – Johnston is charged 16over insider trading

COMPANY NEWS 2

PUBLISHED WEEKLYNext issue – 1 July 2016

Global industry representative the International Generic and Biosimilar MedicinesAssociation (IGBA) has been accepted as an assembly member of the International

Council for Harmonisation (ICH), following a positive vote by the general assembly.Calling the recognition “a historical moment for our industry”, the IGBA said the decision“reflects the evolution of the generic and biosimilar pharmaceutical industries”.

IGBA chair Vivian Frittelli said the association was “very much looking forward to playinga constructive role in the ICH, engaging actively in the ICH processes through the representationof our members across the five continents”. Frittelli had recently told the joint conference ofEuropean group Medicines for Europe (MfE) and the IGBA held in Dubrovnik, Croatia, earlierthis month, that the IGBA expected imminently to be admitted as a member of the ICH (Genericsbulletin, 17 June 2016, page 7), where IGBA members have already participated in working groups.

“We strongly believe that, having contributed to the ICH work as an interested party duringthe last 20 years, we can now open a new chapter of engaging fully in the ICH activities ofdeveloping the international standards applied to the pharma industry, including generic andbiosimilar manufacturers,” Frittelli stated. “These industries are now global, with generic medicinesaccounting for the overwhelming majority of prescriptions filled globally, while the developmentand approval of biosimilars and other complex-to-manufacture medicines continue to expand.”

“IGBA is well-positioned to continue contributing to the development of the ICH, incollaboration with all members,” the global industry association insisted. Frittelli hadpreviously commented that the “ultimate goal” of joining the ICH management committee couldonly be reached after two years as a member of the assembly.

Meanwhile, MfE director-general Adrian van den Hoven recently noted that Frittelli wasplanning to lead a mission to Geneva, Switzerland, “in a couple of months” to explore options forstrengthening the IGBA’s presence in the region. The association would be “reaching out toother groups there”, van den Hoven said, to “forge co-operation and make alliances”. G

Global industry givenseat at table with ICH

Impax has agreed to pay Teva US$586 million for a US basket of approved generics andpipeline assets, in the largest divestiture agreed yet by the Israeli firm as it aims to secure

US Federal Trade Commission (FTC) approval for its US$40.5 billion takeover of Actavis.Upon completion of the deal – which is contingent on Teva closing its Actavis acquisition,

scheduled for the end of the month, and FTC approval – Impax will add to its US portfolio15 currently-marketed generics, which last year had sales of around US$150 million andgenerated approximately US$100 million worth of gross profit.

Impax will also obtain one approved generic and two approved strengths of a marketedproduct which have not yet been launched; one generic and a strength of an approved productpending US Food and Drug Administration (FDA) approval; and one in-development generic.The acquired portfolio includes oral-solid, inhalable, injectable and topical dosage forms.

The US player will moreover pick up full commercial rights to its own pending abbreviatednew drug application (ANDA) for a rival to Janssen’s Concerta (methylphenidate), whichhad previously been shared with Teva (Generics bulletin, 1 October 2012, page 16).

Impax expects the marketed products to add around US$80 million to its second-half sales,and approximately US$50 million to annual earnings before interest, tax, depreciation andamortisation (EBITDA). Sagent and Zydus have also made deals with Teva (see page 3). G

Impax buys assets from Teva

Gen 24-6-16 Pg. 1_Gen 18/11/05 Pg. 1 22/06/2016 17:20 Page 1

Poland’s Polpharma is set to augment its biosimilar developmentcapabilities after agreeing to pay US$3.5 million for Epirus

Biopharmaceuticals’ Netherlands-based technical cell-line generationand process development site.

Through the transaction, which the two firms have agreed to close“no later than 24 June”, the Polish firm will pick up a proprietarycell-line platform and “all related intellectual property rights”, a “fully-equipped laboratory”, and “bioreactor capabilities designed for thedevelopment of monoclonal antibodies (mAbs) and protein therapeutics”.

Epirus had acquired the business, which formerly operatedunder the name Bioceros, as part of a US$14.1 million deal lessthan a year ago (Generics bulletin, 2 October 2015, page 23).

Through the deal, Epirus picked up three pre-clinical biosimilarassets covering proposed versions of Alexion’s Soliris (eculizumab)and Janssen’s Stelara (ustekinumab) and Simponi (golimumab). Epirusnoted that it would retain exclusive rights to develop its BOW080eculizumab candidate.

The US developer will also retain rights to develop its BOW070tocilizumab candidate. The rival to Roche’s Actemra was one of severalbiosimilars for which Epirus and Polpharma last year struck adevelopment and marketing agreement covering certain EuropeanUnion (EU) markets, Turkey, Russia and the Commonwealth ofIndependent States (Generics bulletin, 7 August 2015, page 19).

Moreover, the agreement comes only a month after Epirus tookaction to “focus exclusively” on the BOW070 and BOW080 raredisease treatments after suspending development on its lead biosimilarcandidate infliximab, as part of a broader restructuring initiative(Generics bulletin, 20 May 2016, page 16).

“With this sale of Epirus Netherlands,” Epirus noted, “thecompany will continue to pursue its restructuring efforts, includingthe possible creation of a separate company focused on rare-diseasebiological product opportunities.” G

COMPANY NEWS

2 GENERICS bulletin 24 June 2016

24 June 2016 Issue 268

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

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MERGERS & ACQUISITIONS

Polpharma to acquireEpirus Netherlands

Sanofi’s interest in the generics sector is focused on strengtheningthe group’s existing presence in emerging markets and on offering

value-added formulations.Speaking at the first joint conference of Medicines for Europe

and the International Generic and Biosimilar Medicines Association(IGBA) in Dubrovnik, Croatia, the head of Sanofi’s Generics operation,Jean-Marie Arnault, said that the French group had “no standalonegenerics strategy”. Sanofi is currently considering whether to divest itsEuropean generics business that contributed around C1 billion of thegroup’s global Generics turnover that totalled C1.92 billion (US$2.17billion) last year (Generics bulletin, 12 February 2016, page 6).

Rather, he said, generics fitted into Sanofi’s broader aim to bea leader in emerging markets and adding value to known molecules.

Outlining Sanofi’s generics operations and prospects during thesame conference, the company’s head of generics portfolio andprogramme management, Martin Albert, said the group was a majorplayer in several regions under labels including Zentiva and Winthropin Europe, Medley and Genfar in Latin America and Globalpharmain the Middle East. “Our focus is on branded markets,” he noted.

To develop differentiated products, Albert said Sanofi had recentlyset up a value-added medicines innovation centre that brought togetherclinical and development skills from across the organisation and wouldalso handle lifecycle management of the group’s established brands.

As examples of Sanofi’s progress to date in adding value to knownmolecules, Albert cited the PulmoJet dry powder inhalers that the firmacquired from Siegfried six years ago. Using this delivery device, thecompany is currently rolling out fluticasone/salmeterol in Europe.

Registering fixed-dose combinations through hybrid registrationpathways also formed a key part of Sanofi’s strategy, Albert explained.As examples, he highlighted the Zenon (rosuvastatin/ezetimibe)cholesterol-lowering combination and the Caramlo (candesartan/amlodipine) antihypertensive in Central and Eastern Europe. G

BUSINESS STRATEGY

Sanofi sees a futurein value-added drugs

Gen 24-6-16 Pgs. 2-16_Layout 1 22/06/2016 17:20 Page 2

Teva has agreed to divest products in the US to Sagent and ZydusCadila as it continues to shed assets as a condition of obtaining US

Federal Trade Commission (FTC) clearance for its takeover of Actavis.Earlier this month, the Israeli group struck its first proposed

divestment in relation to the Actavis deal, agreeing to sell to Dr Reddy’sa basket of eight abbreviated new drug applications (ANDAs) forUS$350 million in cash (Generics bulletin, 17 June 2016, page 1).Teva – which has also just agreed to divest assets to Impax (see frontpage) expects to close its US$40.5 billion acquisition of Allergan’sActavis business later in June.

In the first of Teva’s latest divestments, which are both subjectto the Teva-Actavis deal closing, as well as to FTC approval, Tevahas agreed to sell to Sagent a basket of five generic injectableformulations for US$40.0 million.

According to the US injectables specialist, the portfolio is expectedto “generate US$40-US$50 million in revenue on an annualisedbasis”, and includes Teva’s propofol 1% emulsion for injection thatSagent has previously distributed for the Israeli group.

“The distribution agreement with Teva for propofol was set toexpire in the second quarter of 2018,” Sagent noted, adding that itscurrent US market share for the anaesthetic was approximately 12%.

A spokesperson for Sagent informed Generics bulletin that threeof the injectables were currently marketed in the US, while theremaining ANDAs were “filed and anticipated to be approved in thenext 12-18 months”.

ANDA market size worth US$340 million“Total market sales for the five ANDAs are US$340 million on

a trailing twelve-month basis, [according to] IMS Health [data],”Sagent added. Further details of the products were not disclosed.

Allan Oberman, Sagent’s chief executive officer, noted that thefirm had “built a strong collaborative partnership with Teva over thepast several years, and we are pleased to secure these significantproducts for the future”. Furthermore, he pointed out propofol “wasour second largest selling product by revenue in 2015”.

“We are excited to add these margin-enhancing assets to ourrobust portfolio,” Oberman added.

Last month, Oberman told investors that he would be “disappointed”if Sagent did not complete “at least one product acquisition orcommercial product in-licensing transaction each quarter” during theremainder of this year (Generics bulletin, 13 May 2016, page 5).

Meanwhile, Zydus has also bolstered its US portfolio byagreeing to pick up two ANDAs from Teva for an undisclosed sum.

The deal included one already marketed US product and “onepipeline ANDA which is a transdermal patch”, the Indian firm stated,adding that the “estimated market size of the two ANDAs” was“nearly US$200 million”.

Pankaj Patel, Zydus’ chairman and managing director, noted thatthe acquisition would strengthen the firm’s pipeline of complex genericproducts. “Zydus has made significant investments in transdermalmanufacturing technology,” he commented, pointing out that the firmhad in the last few years “acquired a transdermal manufacturingfacility in the US”.

“Zydus is upbeat about the growth potential in the US, and willcontinue to pursue more inorganic opportunities,” he said.

The firm recently announced that its US turnover “crossed theUS$600 million sales mark” during its last financial year. G

COMPANY NEWS

3GENERICS bulletin24 June 2016

DIVESTMENTS

Teva agrees to divestto Sagent and Zydus

Active pharmaceutical ingredient (API) manufacturer Hovione hasopened a new sales and customer support office in Japan as well

as announced plans to expand its New Jersey, US, facility.Calling Japan a “strategic market” for Hovione, the Portuguese

company plans to grow both its off-patent API and contract-manufacturing businesses through its new office located in Osaka,Japan. The office will “support customer relations and help in thedevelopment of new business within Japan, whilst reinforcing Hovione’sglobal position”, the company said.

Yasushi Usuda will lead the Osaka office. Roger Viney, Hovione’ssenior director for off-patent APIs, said “we are fortunate to haveUsada leading our office as he is a Japanese national with 20 years’international business experience. He will help us develop our businesseven further.” The firm’s vice-president of marketing and sales, KristineSenft, said Hovione’s “advanced technologies and focus on qualitygives us an excellent fit with the Japanese market”.

Separately, Hovione has announced plans to expand its New Jerseyfacility in East Windsor, US, as part of the company’s overall strategyto “increase its global development and commercial capacity”. Theexpansion – which will add an additional 2,840 sq m to the existing2,210 sq m facility – will “introduce a new commercial spray-dryerunit to complement the existing pilot unit”, Hovione said, addingthat “this installation will be specifically designed to handle potentdrug substance APIs”.

The New Jersey facility would “more than double its capacityto manufacture drug substances”, adding around 60 new jobs to thecurrent workforce over the next three years, Hovione predicted.

“This is an important step to strengthen our continued commitmentto the pharmaceutical industry and patients by offering innovativetechnologies and services,” commented Hovione’s general managerin New Jersey, Marco Gil. “The site will be unique in offering at asingle location drug-substance, spray-drying, hot-melt extrusion anddrug-product manufacturing services using innovative continuousmanufacturing technology.”

The operation is expected to start up in April 2017 for the drug-substance and spray-drying services, whilst the continuous drug-productmanufacturing is planned for the end of next year. G

BUSINESS STRATEGY

Hovione expands inJapan and in the US

Beximco Pharma says it has become the first Bangladeshi companyto launch pharmaceuticals “in any Gulf member country under the

Gulf Cooperation Council (GCC)” after commencing exports to Kuwait.Following a launch ceremony at its local headquarters in Dhaka,

Beximco has begun shipping to Kuwait its Azmasol (salbutamol)and Bexitrol-F (salmeterol/fluticasone) metered-dose inhalers, aswell as its amlodipine antihypertensive that the firm markets underthe Amdocal name. “The company expects to launch additionalproducts in Kuwait later this year,” Beximco commented.

“The Gulf market is an important market for us,” the firmadded, “and the launch of our products in Kuwait will open up newopportunities in the region.” Beximco said it estimated thet combinedGulf market to be worth US$9 billion, of which Kuwait representeda US$1.5 billion opportunity. G

BUSINESS STRATEGY

Beximco exports to Kuwait


Mylan has completed its acquisition of Renaissance’s “leadingtopicals-focused specialty and generics business” from

RoundTable Healthcare Partners for US$950 million “plus additionalcontingent payments of up to US$50 million”. This follows Mylan’sannouncement in May of plans to pay up to US$1.00 billion to acquirethe topicals business of the North American company from the private-equity firm (Generics bulletin, 20 May 2016, page 1).

Renaissance’s topicals business – which had sales of aroundUS$370 million in 2015 and employs around 1,200 staff – will “bringMylan a complementary portfolio of approximately 25 branded andgeneric topical products, an active pipeline of approximately 25products, and a leading topicals-focused contract-development andmanufacturing organisation (CDMO)”. According to Mylan, thebusiness will also offer the company an “established US sales andmarketing infrastructure targeting dermatologists and a high-quality,integrated manufacturing and development platform”.

Mylan’s chief executive officer, Heather Bresch, stated: “Bybringing together the Renaissance topicals business with Mylan’s existingassets and the pending addition of Meda and its dermatology portfolio,we will become a leader in this very attractive category.” She foresees“significant opportunities” in this area as Mylan “maximises ourcombined assets across customer channels and geographies”. “Weexpect dermatology and topicals to be another key global franchise”.

Meanwhile, Mylan has announced that its offer to acquireSweden’s Meda for SEK83.6 billion (US$10.0 billion) – announcedearlier this year (Generics bulletin, 19 February 2016, page 1) – willrun from 17 June to 29 July, with settlement “expected to commencearound 10 August 2016”. The offer has been approved by the SwedishFinancial Supervisory Authority.

“Mylan reserves the right to extend the acceptance period and,to the extent necessary and permissible, will do so in order for theacceptance period to cover applicable decision-making procedures atrelevant authorities,” the firm said, adding that it also “reserves theright to postpone the settlement date”. The company was recentlygiven a provisional deadline of 6 July by the European Commission’scompetition authority on the proposed merger (Generics bulletin,10 June 2016, page 3). G

COMPANY NEWS


MERGERS & ACQUISITIONS

Mylan completes onRenaissance topicals

CHEMWERTH – the US-based active pharmaceutical ingredient(API) supplier – insists that the US Food and Drug Administration(FDA) should publish data and test results used to ensure thequality, safety and efficacy of new drug applications (NDAs). Atpresent, the firm claims in an open letter to Congressman GusBilirakis, generics developers are “being stonewalled” in their attemptsto demonstrate bioequivalence, particularly where risk evaluation andmitigation strategies (REMS) restrict access to the reference drug.

LANNETT has repurchased the remaining US$200 million of its12% senior note bonds that are due in 2023. The US genericsspecialist funded the purchase by amending its existing creditagreement and raising a US$150 million term loan. Chief executiveofficer Arthur Bedrosian said the move would save the firm around“US$170 million in cash interest over the life of the loans”.

CONCORDIA HEALTHCARE has agreed to pay US$12.5 million tosettle an arbitration claim made by a former financial advisor tothe company that claimed it was owed US$38.3 million plus interest.

AUSTIN BIOTECHNOLOGY has received a warning letter fromthe US Food and Drug Administration (FDA). An inspection of thefirm’s finished-dose facility in Taipei, Taiwan, identified deficienciesincluding a failure to establish a quality-control unit, a lack of writtenprocedures for validation protocols and expiration dates that werenot supported by appropriate stability testing.

SORRENTO THERAPEUTICS – the US-based biosimilars developer –has raised US$150 million through a private share placement.

CONSORT MEDICAL says its Bespak affiliate has constructed a5,500 sq m facility and clean room in King’s Lynn, UK, to “producethe expected volumes” of its DEV610 dry powder inhaler for usein Mylan’s generic version of Advair (fluticasone/salmeterol). TheUS Food and Drug Administration (FDA) has set Mylan apotential Generic Drug User Fee Act (GDUFA) approval date of28 March 2017 (Generics bulletin, 26 February 2016, page 1).

AMNEAL has received a distribution industry award for notableachievements in healthcare (DIANA) for generic manufacturers withsales over US$100 million from the US Healthcare DistributionAlliance (HDA). Citing IMS Health data, Amneal said it was theseventh-largest generics company measured by US prescriptionsfilled, with 115 molecules approved and around 170 in development.

AUROBINDO has updated its US website at www.aurobindousa.comas part of a rebranding exercise. The site includes a searchableproduct catalogue and a portal for employment opportunities.

PHARMACEUTICS INTERNATIONAL’S US facilities in Cockeysvilleand Hunt Valley do not meet good manufacturing practice (GMP)standards, according to entries made by the UK’s Medicines andHealthcare products Regulatory Agency (MHRA) in Europe’sEudraGMP database. Inspections discovered a risk of cross-contamination and failing quality systems. The MHRA isrecommending a recall of both sterile and non-sterile products. In aseparate EudraGMP entry, the MHRA has added India’s Akums Drugsas a manufacturing site to a marketing authorisation for NordicPharma’s Gestone (progesterone) ampoules that has been put on hold.

SARTORIUS STEDIM BIOTECH has launched an updated websitefor its BioOutsource subsidiary to highlight the firm’s cell-lineand upstream-process development services. G

IN BRIEF

Perrigo is set to realise plans to divest its US vitamins, minerals andsupplements (VMS) business after reaching an agreement with

US-based International Vitamin Corporation (IVC).Subject to customary closing conditions, the transaction is

“expected to close by early August”. No financial details were disclosed.The US store-brands specialist had proposed divesting VMS last

year as part of a broader wave of cost-cutting measures designed tocombat Mylan’s hostile takeover attempt (Generics bulletin, 6November 2015, page 5). The sale would help to improve Perrigo’soperating margin, the firm noted at the time.

John Hendrickson, Perrigo’s chief executive officer, commentedthat the divestment of the VMS business was “part of our ongoingportfolio assessment and ensures that we remain focused on ourmost profitable and strategic businesses”. G

DIVESTMENTS

Perrigo agrees to divest VMS


Companies and individuals involved in the generics and biosimilarsindustries have until Friday 15 July to submit their entries to the

Global Generics & Biosimilars Awards 2016. Entrants for the 14awards – which will be judged by expert panels – can e-mail theirentries to [email protected] along with evidence of upto 500 words to support their proposals.

Now in their third year, the Awards – which are free to enter andattend – will be presented on Tuesday 4 October 2016 at the HotelPorta Fira at the Gran Via Complex in Barcelona, Spain.

Awards have so far been sponsored by firms including co-hostsIMS Health, along with International Health Partners, Pharmacloud,Pharmawise, Samarind and Thomson Reuters. Still available forsponsorship are awards for Company of the Year for the Americas,Asia-Pacific and EMEA regions; Innovation of the Year; BusinessDevelopment of the Year; Biosimilar Initiative of the Year; and IndustryPartner of the Year.■ To request tickets to attend the awards, and for any further details, please [email protected].

MARKET NEWS


INDUSTRY AWARDS

One month remainsfor entries to Awards

More than C4 billion (US$4.5 billion) could be saved by Germanstatutory health insurance funds over the next five years by

maximising the use of cost-effective biosimilars, according to one ofthe country’s leading funds. Industry association Pro Biosimilarswelcomed the “clear and positive statement” made by the Barmer-GEKfund in its 2016 medicines report and called on associations of statutorydoctors to inform their members about biosimilars.

According to Barmer-GEK, biosimilars offer on average a 25%discount to their reference brands, with biosimilar filgrastim costingaround 30% less (see Figure 1). Calling on doctors to prescribe onboth medical and economic grounds, the fund said its spending onbiologic drugs had grown by more than 40% since 2010 to C1.2 billionlast year, representing 21.3% of its drugs bill.

With an annual cost of almost C128 million, AbbVie’s Humira(adalimumab) rheumatoid arthritis treatment was the drug on whichBarmer-GEK spent most in 2015.

Barmer-GEK described as “alarming” that only a quarter of thesavings potential of biosimilars was currently being realised. To achievethe targeted C4.2 billion saving over five years, doctors should followthe example of regions achieving over 50% biosimilar penetration. G

PRICING & REIMBURSEMENT

German fund backs biosimilars

Molecule Biosimilar Saving per Untapped savingvolume share (%) DDD (%) potential (C)

Infliximab 11.6 21.0 9,601,843Somatropin 12.4 21.6 4,754,198Filgrastim 74.1 29.5 748,432Erythropoetin 72.9 10.6 482,204

Total – – 15,586,676

Figure 1: Untapped savings potential for four biosimilars prescribed throughGermany’s Barmer-GEK fund in 2015, based on biosimilar market share anddiscount to the reference brand per defined daily dose (Source – Barmer-GEK)

European Union (EU) member states should co-operate to “contributeto higher affordability and better access to medicinal products”,

including by revising incentives for industry development, accordingto European Council conclusions on “strengthening the balance inthe pharmaceutical systems in the EU and its member states”.

Inviting the European Commission to “streamline theimplementation of the current legislation on orphan medicinal products”,the Council suggests preparing “an overview of the current EUlegislative instruments and related incentives that aim to facilitateinvestment”, including the European supplementary protectioncertificate (SPC) Regulation 469/2009.

An “evidence-based analysis of the impact of the incentives” isneeded, the Council recommends, as well as a review of “accessibilityof medicinal products”, including “availability of generic medicinalproducts”. Among the incentives examined, “particular attention shouldbe given to the purpose of SPCs as defined in the relevant EU legislativeinstrument and the use of the ‘Bolar’ patent exemption, data exclusivityfor medicinal products and market exclusivity for orphan products”.

The European Commission recently published a revised tenderfor a proposed study on SPCs in the EU’s Official Journal (Genericsbulletin, 17 June 2016, page 5), having received only one, unsatisfactoryoffer in response to its initial tender, which was wider in scope(Generics bulletin, 20 May 2016, page 9).

Furthermore, the Commission should prepare “by the end of 2016”a report on recent competition cases, merger enforcement, potentialcases of market abuse and excessive pricing, as well as other marketrestrictions, the Council recommends.

Medicines for Europe said it would “engage rapidly with healthministers across Europe” to implement the Council conclusions, which“underline the importance of the timely availability of generics andbiosimilar medicines to improve patient access to therapy and to ensurethe sustainability of national health systems”. Value-added medicinesshould be included in this process, the association insists, as they “cancontribute significantly to the efficiency of health systems whilestimulating more competition”.

Director-general Adrian van den Hoven said member states “nowunderstood the importance of stimulating competition in pharmaceuticalsafter patent expiry to help rebalance a market heavily impacted by theintroduction of new highly-priced patent-protected medicines”. “Ourmembers are ready to drive this agenda forward to ensure better accessfor better health.”

Meanwhile, according to the Council, EU member states should“consider further development” of “voluntary co-operation betweenrelevant authorities and payers from member states, including co-operation within groups of member states, that share common interestsin relation to pricing and reimbursement of medicinal products.”“Where relevant and appropriate, groups of member states that wouldlike to explore co-operation on a voluntary basis may also make useof international expertise,” the Council recommends.

This co-operation could include “assessment of future introductionof new medicinal products with a possibly significant financial impacton health systems at an early state through so-called ‘joint horizonscanning’, which entails a forward-looking scan of emerging trends andfuture developments”, the Council suggests. It also moots “pro-activeexchange of information between member states, such as nationalpricing and reimbursement authorities”, as well as “exploring possiblestrategies on voluntary joint price negotiations”. G

REGULATORY AFFAIRS

EU Council supportsindustry incentives


India’s government is soliciting feedback from state drug controllersover plans to alter the country’s Drugs and Cosmetics Act to raise

fees for “various categories of licences and permissions” relating topharmaceuticals, including in particular fees for registration andimport licences for active pharmaceutical ingredients (APIs).

At a meeting of the Central Drugs Standard Control Organisation’s(CDSCO’s) technical advisory board in May, the board noted thatincreasing fees was “considered necessary” as current fee levelswere established at least 13 years ago, in 2003 and 2001. This was“despite the fact that the cost index in the country has increasedmanifold” over the past decade, the board stated.

Draft rules to implement the increase, published by India’s Ministryof Health and Welfare, proposed fees that were “roughly six times theexisting fee structure”, the board said, except where very low feeswere specified for “minor activities” such as granting test licences.

Citing the need to explore “more avenues for revenuegeneration” as the CDSCO was restructured and strengthened, theadvisory board observed that “the cost of registration in India isextremely low compared to other countries”.

In particular, the board said, “concerns have been expressed overthe import of APIs from China”, which made up “over 60% of thetotal API requirement of the country”.

“In India, registration per product costs about US$1,000, whilesimilar registration costs about US$35,000 per product in China,” theboard noted. “This is having an impact on the Indian bulk-drugindustry.” After “deliberations”, the board said it had “agreed that inprinciple the fees are required to be raised for providing services underthe rules”. The rate of increase would however be “decided by thegovernment in consultation with stakeholders”. G

MARKET NEWS


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REGULATORY AFFAIRS

India plans increasefor API import fees

The latest tranche of draft product-specific development guidelinesfor generics has been issued by the US Food and Drug

Administration (FDA), including both new and revisedrecommendations. Covering active ingredients in generic drug productsand appropriate methodologies for development, the agency’s latestguidelines comprise 19 new product recommendations and 19 revisionsto existing guidance documents. The agency is seeking feedback onthese recommendations.

When selecting methodology used to demonstrate bioequivalence,“applicants must conduct testing using the most accurate, sensitive andreproducible approach available”, the FDA reiterates.

Among the 19 newly-added guidance documents are amcinonidelotion, erythromycin granules and prednicarbate as an ointment.Guidelines have also been issued for fluocinonide in both gel andointment form, while pseudoephedrine and tacrolimus are both thesubject of new development guides for extended-release tablets.

Updates to existing guidelines cover azelastine in metered-dosespray form, as well as methylphenidate extended-release film andlansoprazole as a delayed-release, orally-disintegrating tablet. Guidelinesfor mesalamine have been revised, covering dosage forms includingdelayed-release capsules and delayed-release tablets. Also among the19 newly-revised bioequivalence recommendations are dexamethasoneand loteprednol suspensions and benzoyl peroxide gel. G

REGULATORY AFFAIRS

FDA unveils raft ofdevelopment guides

Communication with applicants on abbreviated new drug application(ANDA) reviews and review goals were among the topics discussed

by industry representatives with the US Food and Drug Administration(FDA) at the latest meeting held to discuss reauthorisation of the USgeneric drug user fee amendments (GDUFA). The meeting – whichtook place in mid-May – “continued discussions from earlier negotiationmeetings on issues pertaining to ANDAs and drug master files(DMFs)”, according to the latest minutes published by the agency.

Covering review goals, review-related communications, facilityevaluations and a pre-ANDA process – including pre-ANDA meetings,product-specific guidance and controlled correspondence – the meetingwas attended by representatives from the US Generic PharmaceuticalAssociation (GPhA), as well as members of the Pharma and BiopharmaOutsourcing Association (PBOA) and the Bulk PharmaceuticalsTask Force (BPTF). “FDA and industry discussed resource needs,user-fee concepts and fee-structure considerations for GDUFA II,”the agency stated.

Last month, minutes from a separate meeting with non-industrystakeholders indicated that industry was close to reaching a finalagreement with the FDA on GDUFA renewal (Generics bulletin,10 June 2016, page 7). The second five-year phase of GDUFA isdue to begin in October 2017. G

REGULATORY AFFAIRS

Industry consults on GDUFA


MARKET NEWS


FDA – the US Food and Drug Administration – has released draftguidance for industry on “quality attribute considerations for chewabletablets”. A review of applications for chewable drugs had revealedthat “in certain cases critical quality attributes such as hardness,disintegration and dissolution were not given as much considerationas may have been warranted”, the agency noted.

EMA – the European Medicines Agency – adopted a multi-annualwork plan to 2020 at its management meeting this month. Anoverarching framework for stakeholder relations management wasalso outlined, in addition to a positive assessment of the firm’soperations last year and an update on the EudraVigilance system.

CFDA – the Chinese Food and Drug Administration – has beguna pilot programme for a “drug marketing authorisation holdersystem”, as agreed by the state council. The trial system aims to“encourage pharmaceutical innovation and improve the quality ofmedicines” as the CFDA strengthens supervision and inspection.

THE EUROPEAN COMMISSION has opened a public consultationon “risk-proportionate approaches in clinical trials” that will rununtil 31 August. The directorate general for health and food safety,DG Sante, “intends to seek the views of stakeholders and otherinterested parties” and will “highlight areas identified in the clinicaltrials regulation which support and facilitate adaptations”. G

IN BRIEF

Draft US legislation aimed at curbing the abuse of Risk Evaluationand Mitigation Strategies (REMS) by originators has been

welcomed by the US Generic Pharmaceutical Association (GPhA)and several healthcare stakeholder groups.

The Creating and Restoring Equal Access to Equivalent Samples(CREATES) Act will “improve patient access to safe and affordablemedicines by taking steps to curb abuses of REMS withoutcompromising patient safety”, according to the GPhA.

Describing REMS as US Food and Drug Administration (FDA)programmes that are “designed to protect patient safety”, the GPhAcontends that “certain brand drug companies misuse them to blockcompetition from generic medicines”.

The bill – which cites the US policy to “promote competition inthe market for drugs and biological product by facilitating the timelyentry of lower-cost generic and biosimilar versions” – refers to “certainlicense holders preventing generic product developers from obtainingquantities of the covered product necessary for them to support anapplication for approval by the FDA”. This, the draft legislationstates, includes “testing to show bioequivalence, biosimilarity, orinterchangeability to the covered product, in some instances based onthe justification that the covered product is subject to a REMS withelements to assure safe use (ETASU)”.

According to the GPhA, the bill targets “two forms of anti-competitive behaviour used by certain brand manufacturers to stiflegeneric and biosimilar entry: refusal to provide adequate samples togain approval, and denying generic and biosimilar access into anFDA-approved single-shared REMS programme”.

As a result of the CREATES Act, a generic drug manufacturerfacing one of these tactics will be able to bring an action in federalcourt for relief, such as obtaining a required sample or entering court-supervised negotiations for a shared safety protocol. In addition, thebill also authorises a judge to award damages to deter future delays.

According to a Matrix Global Advisors study cited by the GPhA,“abuse of programmes like REMS cost the healthcare system US$5.4billion annually” (Generics bulletin, 8 August 2014, page 15). Moreover,the GPhA says, if this expands to biosimilars as they begin to enter theUS healthcare system, it “could result in around US$140 million inadditional lost savings for every US$1 billion in biologics sales”.

A group of 15 major healthcare stakeholders has composed a letterto the senate judiciary committee welcoming the act, referring to itas a “common sense solution” that will “prevent such abuses andfurther patient access to safe, effective and affordable medications”.

An estimation from the Congressional Budget Office calculatesthat such legislation would “save the government over US$2 billionover 10 years”, also suggesting that the “savings to consumers andprivate insurance companies would likely be far greater”.

GPhA president and chief executive officer Chip Davis concededthat it was “worth noting and recognising recent efforts by representativesin the branded industry to highlight the valuable role generic medicinesplay in driving healthcare system savings, including their support forreducing the backlog of pending abbreviated new drug applications(ANDAs), at the FDA”.

However, he insisted, “continued use of these anti-competitivepractices by certain manufacturers drives the exact opposite outcome;delaying or eliminating alternative treatment options to advance patientoutcomes while continuing to increase healthcare costs. It is timeto put a stop to these anti-competitive manoeuvres.” G

REGULATORY AFFAIRS

GPhA supports billto curb REMS abuse

Aworkshop set up by the European Commission on access tobiosimilar medicines has been welcomed by local generics and

biosimilars industry association Medicines for Europe (MfE), as wellas brand bodies the European Federation of Pharmaceutical Industriesand Associations (EFPIA) and the European Association forBioindustries (EuropaBio). Patients, doctors, pharmacists, press andindustry gathered at the workshop to share biosimilar experiences.

Organised by the directorate-general for the internal market,industry, entrepreneurship, and small- and medium-sized enterprises(DG Grow), the workshop – which forms part of DG Grow’s ‘processon corporate responsibility in the field of pharmaceuticals’ – aimsto “facilitate discussions on ethics and transparency, and on non-regulatory conditions for better access to medicines after they havebeen granted a marketing authorisation”.

An updated IMS report on ‘the impact of biosimilar competition’highlighted “key aspects such as price competition and the significantincrease in access resulting from the introduction of biosimilarmedicines, especially in countries where there has been an unmetmedical need, such as in Romania, Bulgaria, Slovakia and Poland”.

The initial results of a “patient-friendly question-and-answer onbiosimilar medicines” were presented during the workshop.

Within the project, MfE presented a survey to identify goodpractices and obstacles to the uptake of biosimilar medicines in theEuropean Union (EU) and countries in the European Economic Area(EEA), noting that it “demonstrated the need for clear unbiasedinformation from an independent source”. This information “shouldtarget all stakeholders on the scientific concept of biosimilars, theirapproval process and their safety and efficacy”. G

REGULATORY AFFAIRS

EU industry applaudsbiosimilars workshop


Amneal is partnering with Swedish dry-powder inhaler specialistIconovo to develop a “generic inhalation product to treat asthma

and chronic obstructive pulmonary disease” (COPD)”.“This collaboration will complement Amneal’s current pipeline

of inhalation products in markets outside the US,” the US-basedgenerics company commented. Amneal’s operations currently spanmarkets in Asia, Australia and Europe, as well as in North America.

Under the firms’ exclusive development and license agreement,Amneal will leverage Iconovo’s ICOres reservoir multi-dose dry-powder inhaler platform and dry-powder formulation to develop theundisclosed generic respiratory product.

“Amneal expects to manufacture these products in its Cashel,Ireland, facility in the future,” the firm noted, referring to the formerJohnson & Johnson plant that it bought from Singapore-based SolidusPrivate Equity last year (Generics bulletin, 1 September 2015, page 5).At that time, Amneal said it expected to split the site equally betweenbiosimilars and metered-dose or dry-powder inhalers.

“Additionally, Amneal continues to develop inhalation products forthe US markets through its internal research and development, withseveral products in advanced stages of development,” the New Jersey-based firm said. Last year, Amneal entered the US generic inhalationsolutions market with a rival to Novartis’ Tobi (tobramycin) 300mg/5mlsingle-use ampoules (Generics bulletin, 7 August 2015, page 25). G

PRODUCT NEWS


PRICE WATCH ....... UK

Up to the minute live retail market pricing is availablefor the UK and Eire on Wavedata Live at wavedata.net.Alternatively, contact Charles Joynson at WaveData Limited,UK.Tel: +44 (0)1702 425125. E-mail: [email protected].

Ropinirole registers risesAverage prices for ropinirole tablets in several different

presentations shot up in mid-June, according to the latest figuresprovided by WaveData.

Comparing UK trade prices between the periods 1-31 May2016 and 1-21 June 2016, the average trade price for 5mg tabletsin 84-count packs increased sixfold to £31.53 (US$46.30) as thelowest offer rose by around a tenth to just £3.49.

Similarly, the 2mg strength in the same pack size registereda similar increase in its average price to £19.30, despite a lowestavailable price that rose by just 10% to £1.95, based on averagescalculated from at least 20 data points.

Other strengths of the Parkinson's disease and restless legssyndrome treatment saw rises, albeit less pronounced. The averageprice for packs of 84 tablets in the 1mg strength rose by more thanfive times to £11.16 despite no change in the lowest price of £1.35,while 28-count packs of 0.5mg tablets and 12-tablet packs in the0.25mg strength saw averages that more than doubled to £4.23 and£2.05 respectively. And prolonged-release ropinirole 4mg tabletsin 28-tablet packs saw their average more than quintuple to £29.64.

Meanwhile, price concessions on isosorbide 10mg and 20mgtablets continued to be granted to UK pharmacists by the country’sDepartment of Health (DoH) as average and lowest availableprices shot up for both strengths. G

RESPIRATORY DRUGS

Amneal collaboratesover generic inhaler

Key points underpinning a ‘biosimilars awareness initiative’ forAustralia have been identified in meetings of the initiative’s reference

group. The Australian government last year pledged to contribute to a“A$20 million (US$15 million) awareness campaign to support theincreased use of biosimilar medicines by patients, pharmacists andspecialists” as part of a wider ‘strategic agreement’ with the country’sGeneric and Biosimilar Medicines Association (GBMA) running forfive years (Generics bulletin, 5 June 2015, page 14).

At its first meeting, the reference group sought to “engage keyrepresentative groups in the development of effective and targetedcommunications” to support the initiative. The meeting included theGBMA and brand industry association Medicines Australia, as wellas several patient, doctor and pharmacy groups and the country’sPharmaceutical Benefits Advisory Committee (PBAC).

“Members committed to ensuring that messages coming from theinitiative are consistent and targeted,” the reference group stated, withmembers agreeing that the group would “provide advice and supportto the steering committee on the identification and engagement ofrelevant target groups in order to raise awareness of biosimilars”.

Key priorities of the initiative were identified as: engaging with“a broad range of stakeholders”, including those outside the referencegroup; conducting market research to support the initiative; developing,testing and disseminating “communication and education materialsto support understanding and use of biological and biosimilarmedicines”; gathering information on international policies andexperience relating to the uptake of biosimilars; and establishing“current data-collection capabilities and requirements”.

At a subsequent meeting, market researcher ORC Internationalpresented a study to the reference group that provided “valuableinsights into the identification of key target groups, and the reassurancethat these groups are seeking with respect to biosimilars”. Thegovernment was seen as a “credible source of independent information”,ORC found, identifying a “need for the government to provide simpleinformation, available in plain English”, such as through a brochure.

“Members discussed the importance of developing consistentmessages to be delivered to all stakeholders,” the group stated. “It washighlighted during discussions that despite messages to variousstakeholders needing to be of differing levels of complexity, theunderlying message must remain consistent if there are to be significantgains in the understanding of biosimilars.”

Therefore, the group said, it was agreed that “important key pointsneed to be highlighted throughout the awareness initiative”. Thesewere patient and prescriber choice; how biosimilars can benefit thesustainability of the healthcare system; the message that “lower-costmedicines do not equate to inferior products”; a reiteration of the quality,safety and efficacy of biosimilars; and the idea that “more affordablebiosimilars may lead to an increase in treatment options availablethrough the Pharmaceutical Benefits Scheme (PBS)”.

“The strategy will also need to consider the levels of generalhealth literacy needed to support the understanding of the biosimilarsmessage,” the group concluded, such as information on the PBS andhow it works, including costs of medicines. “It was seen as importantthat prescribers and dispensers are made aware of the financial impactthat their choices may have on the healthcare system over time.”

Furthermore, the group said, healthcare professionals wereidentified as “the key group for targeted communications, due to theirrole in clinical decision-making and patient education”. G

BIOLOGICAL DRUGS

Australia identifieskey awareness points


Apetition submitted in the US by AstraZeneca is urging the USFood and Drug Administration (FDA) to deny final approvals for

rivals to the originator’s Crestor (rosuvastatin). Generic versions ofthe antihypertensive should not be approved, AstraZeneca argues, untilorphan drug exclusivity expires for the use of Crestor to treat paediatricpatients aged between seven and 17 for homozygous familialhypercholesterolaemia (HoFH). Rivals should either include theHoFH indication, data, and prescribing information, or should not beapproved until after 27 May 2023, the petition requests.

“Carving out AstraZeneca’s protected paediatric HoFH labellingfrom the labelling of a product marketed under an abbreviated newdrug application (ANDA) or section 505(b)(2) new drug applicationwould present substantial safety and efficacy risks,” the brand companyclaims in its petition. “Although the FDA may in some instancesapprove ANDAs that omit protected paediatric labelling, the FDAhas made clear that a carve-out is inappropriate when, as here, theprotected paediatric labelling is necessary for the safe use of the drug.”

Moreover, the petition insists, “irrespective of whether a carve-out would present a safety risk, FDA lacks legal authority to carve outpaediatric labelling protected by orphan drug exclusivity”. Together,AstraZeneca argues, “the Hatch-Waxman Act’s same-labellingrequirement and FDA’s paediatric-labelling regulations impose acategorical rule: paediatric-labelling information subject to orphandrug exclusivity may not be omitted from generic-drug labelling”.

Actavis has already launched, in May, the first generic versionsof rosuvastatin in the US (Generics bulletin, 6 May 2016, page 11),under the terms of a settlement agreement that the firm’s Watsonaffiliate had reached with the UK originator three years ago (Genericsbulletin, 5 April 2013, page 15). This gave Actavis the right to launchits generics, developed with Egis, just over two months beforeAstraZeneca’s US molecule patent RE37,314 expires – including sixmonths of paediatric exclusivity – on 8 July.

Tentative FDA approvals are currently held for rosuvastatin tabletsby Alkem, Apotex, Aurobindo, Glenmark, Mylan and Par, as well asSandoz, Sun, Teva and Torrent. Crestor was, by value, the fourth-largestselling drug in the US for the year ended September 2015, accordingto IMS Health data. Sales grew by 7.8% to US$6.25 billion (Genericsbulletin, 11 March 2016, page 12). G

PRODUCT NEWS


ANTIHYPERTENSIVES

AstraZeneca seeksbar on Crestor rivals

Zydus Cadila and Turkish healthcare company Eczacibasi havesigned a strategic collaboration agreement to market biotech

products, including biosimilars, in Turkey. The deal involves importingbiosimilars which are currently unavailable in Turkey, particularlycancer treatments. This deal, according to Zydus, will in turn “pavethe way for a long-term strategic collaboration to produce and launchnew products in the market”.

Chairman and managing director of the Zydus group, PankajPatel, said “the long-term agreement between both partners to enrichthis collaboration through the introduction of new products will augurwell for healthcare access beyond geographies”.

Meanwhile, Bülent Eczacibasi, chairman of the Turkish company,emphasised the importance of new collaborations to the firm’sdomestic market to “enable innovation and add value in the field ofhealthcare”. “Our target,” he said, “is to ensure that the importantworldwide advances in the field of biotech products are simultaneouslyreflected and reach more people in our country.”

The agreement with Zydus follows a deal struck by Eczacibasiearlier this year with Baxalta, through which the two firms establisheda 50-50 biotech joint venture to “increase the treatment options andstandards for patients in Turkey with a portfolio of new and advancedtherapies in the areas of haematology and immunology”. The jointventure also aims to offer a portfolio of innovative oncology products. G

BIOLOGICAL DRUGS

Zydus and Eczacibasistrike deal in Turkey

HyClone Laboratories, the US-based company that supplied cell-culture media for Celltrion and Hospira’s biosimilar version of

Remicade (infliximab), infringes Janssen’s US cell-culture media patent7,598,083, according to a lawsuit that the Johnson & Johnson subsidiaryhas filed in a Utah district court.

In the complaint, Janssen says that, since it filed a lawsuit in aMassachusetts court alleging technical infringement by Celltrion andHospira for failure to provide required manufacturing information, itreceived information that cell-culture media made by HyClone at itssite in Logan, Utah, and supplied to Celltrion, infringed the ‘083 patentthat expires on 7 February 2027. Janssen has also just sued Celltrionand Hospira in the Massachusetts court for actual infringement ofthe ‘083 patent by using the media supplied by HyClone. G

BIOLOGICAL DRUGS

Celltrion’s cell supplier sued


Germany’s federal supreme court, the Bundesgerichtshof, has vacatedan appeals court’s finding last year that Actavis’ generic version

of Eli Lilly’s Alimta (pemetrexed disodium) did not infringe theoriginator’s vitamin regimen patent (Generics bulletin, 13 March 2015,page 17). The supreme court has ordered the Düsseldorf appeals courtto reconsider whether Actavis’ proposed dipotassium salt form ofpemetrexed would infringe Lilly’s EP1,313,508 vitamin regimen patentthat runs until June 2021.

Actavis sought to market the dipotassium salt of the chemotherapydrug after Lilly’s German molecule patent for pemetrexed expired inDecember last year. The appeals court had in March 2015 overturned aDüsseldorf regional court’s previous infringement decision. But theBundesgerichtshof – which had not published its reasoning as Genericsbulletin went to press – vacated and remanded the appeals court’s ruling.

Lilly – which reported global Alimta sales last year down by 11%to US$2.49 billion, of which US$1.33 billion was achieved outsideof the US – said the German supreme court’s decision would not affecta separate infringement proceeding and validity challenge with Sandoz’Hexal. A preliminary injunction against Hexal’s generic pemetrexeddisodium salt that Lilly had obtained in December last year and upheldin late May 2016 would “stay in force pending further appeal by Hexaland the outcome of the cases on the merits,” the originator pointed out.

Separate infringement proceedings in Germany against Teva’sRatiopharm affiliate – which is appealing against a preliminaryinjunction – would “take this ruling into account”, Lilly added.

While several generics firms last year dropped their appeals againstthe European Patent Office’s (EPO’s) decision to uphold the ‘508patent, Actavis in February this year convinced the UK High Courtthat its pemetrexed trometamol vials with instructions to dilute only withdextrose solution would not infringe the ‘508 patent in France, Italy,Spain and the UK (Generics bulletin, 19 February 2016, page 13).

In the US, where Lilly’s vitamin regimen patent has paediatricexclusivity until 2022, the originator anticipates receiving a ruling onan appeal brought by Teva and Fresenius Kabi’s APP later this year. Adecision by the US Patent and Trademark Office (USPTO) onwhether to institute inter partes reviews of the vitamin patent thatare being sought by Neptune Generics and Sandoz is imminent.

Although several generic versions of Alimta were approved inJapan in February this year, potential competitors agreed not to proceedto pricing approval, and Lilly does not expect generics firms to launchahead of a ruling on an appeal brought by Sawai and three other firmsin invalidity proceedings over two vitamin regimen patents. G

PRODUCT NEWS


2-5 August

■ 3rd PharmaCon,Pharmaceutical Congress AsiaSingaporeThis is a two-day conference with pre- and post-conference workshops.There are four events hosted at the same location: PharmaceuticalRegulatory Affairs Asia, Market Access Asia, PharmaceuticalCompliance Asia and Clinical Trials Asia.

Contact: IBC Asia. Tel: +65 6508 2401.E-mail: [email protected]. Website: pharmaconasia.com.

7-8 September

■ GPhA Biosimilars Council ConferenceMaryland, USAThis is a two-day interactive conference looking at topics includingaccess, regulatory issues, reimbursement, interchangeability andthe legal landscape.

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

29-30 September

■ Biosimilars EuropeLondon, UKThis two-day conference will look at developments in thebiosimilar guideline framework and legislation in both Europe andthe US. Patent litigation, market access, pricing andreimbursement and emerging markets will also be covered.

Contact: SMi. Tel: +44 207 827 6000.E-mail: [email protected]. Website: smi-online.co.uk.

3 & 4-6 October

■ CPhI WorldwideBarcelona, SpainCPhI Worldwide is an exhibition and networking opportunity whichwill include the co-located events iCSE, P-MEC and Innopack.The event will be preceded by the Pre-Connect Congress whichwill look at the latest developments in the pharma industry.

Contact: UBM Information. Tel: +31 207 081 637.E-mail: [email protected]. Website: cphi.com

24-26 October

■ GPhA Fall Technical ConferenceMaryland, USAThis is a three-day event organised by the Generic PharmaceuticalAssociation (GPhA). There will be speakers from the industry andthe US Food and Drug Administration (FDA). Topics covered willinclude regulatory and technical issues affecting the industry.There will be a variety of networking opportunities available.

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

Cocktail Reception and Awards PresentationCocktail Reception and Awards Presentation4 October 20164 October 2016

Hotel Porta Fira, The Gran Via complex, Barcelona, SpainHotel Porta Fira, The Gran Via complex, Barcelona, SpainContact: [email protected]: [email protected]

EVENTS – August, September & October

SAVE THEDATE...

ONCOLOGY DRUGS

German court sendsback Alimta ruling

The US Supreme Court has invited the US solicitor general to filebriefs “expressing the views of the US” in the dispute between

Sandoz and Amgen over notice of commercial marketing and accessto abbreviated biologic license application (aBLA) submissions.

Sandoz is asking the Supreme Court to hear its appeal against aUS Court of Appeals’ finding that aBLA filers can only provide thestatutory 180-day notice of commercial marketing after biosimilarapproval. Amgen is querying whether providing manufacturing anddossier details is optional (Generics bulletin, 3 June 2016, page 9). G

BIOLOGICAL DRUGS

US seeks solicitor’s bio briefs


Sandoz intends to make “five major global biosimilar launches by2020”. The Novartis division is targeting approvals and launches for

rivals to Enbrel (etanercept), Humira (adalimumab), Neulasta(pegfilgrastim), Remicade (infliximab) and Rituxan (rituximab). And itsearly-stage biosimilar development pipeline includes at least fiveoncology drugs and three projects in immunology or other specialty areas.

When the European Medicines Agency (EMA) in May this yearaccepted for filing Sandoz’ submission for a biosimilar version ofRituxan, it marked the sixth of 11 filings in Europe and the US thatthe firm intends to make between 2015 and 2017. Having already maderegulatory submissions for both biosimilar Enbrel and Neulasta lastyear – and secured EMA approval for subcutaneous epoetin alfa –Sandoz plans during the remainder of this year to file for both epoetinalfa and adalimumab with the US Food and Drug Administration (FDA).

Next year, the division expects to make submissions with the EMAfor biosimilar Humira and Remicade – the latter having been acquiredfrom Pfizer – and with the FDA for biosimilar Rituxan (Genericsbulletin, 3 June 2016, page 13).

To support its commercial plans to bring more biosimilars to themarket, Sandoz has earmarked more than US$1 billion for capitalexpenditure on its biomanufacturing facilities in Schaftenau and Kundl,Austria, between 2010 and 2020.

Speaking during a media day held at the Schaftenau plant, Sandoz’global head of biopharmaceuticals, Carol Lynch, forecasted that theglobal biosimilars market would grow by around 62% per year toexpand from around US$1 billion last year to US$14 billion in 2020.Combined sales of Enbrel, Humira, Neulasta, Remicade and Rituxanwere US$43.6 billion last year, she noted.

Biosimilar rituximab and pegfilgrastim would fit neatly withNovartis Pharma’s portfolio of oncology brands such as Afinitor(everolimus), Lynch pointed out, while adalimumab, etanercept,infliximab and rituximab offered synergies with immunology brandsincluding Cosentyx (secukinumab).

Sales in 2015 by Sandoz’ biopharmaceuticals business – whichincludes its Omnitrope (somatropin), Binocrit (epoetin alfa) and Zarxio(filgrastim) marketed biosimilars, its Glatopa (glatiramer acetate)alternative to Teva’s Copaxone multiple-sclerosis blockbuster in theUS and contract-manufacturing revenues – reached US$772 million. G

PRODUCT NEWS


BIOLOGICAL DRUGS

Sandoz plans for fivebio launches by 2020

PERRIGO has obtained final US Food and Drug Administration(FDA) approval for its generic version of Mallinckrodt’s Ofirmev(acetaminophen) injectable. Under the terms of a settlement reachedwith Mallinckrodt’s Cadence affiliate at the end of 2012, the USstore brands specialist is able to launch its rival to the analgesicinjectable from 6 December 2020 (Generics bulletin, 14 December2012, page 23). Perrigo also secured the right to be the sole authorisedgeneric distributor if Mallinckrodt launches such a product.

VANC PHARMACEUTICALS has signed an agreement with anundisclosed manufacturer to file on the manufacturer’s behalf twoabbreviated new drug submissions (ANDS) in its native Canada.Vanc will hold “exclusive marketing rights” in the country. “Oneof these molecules ranks among the top three in the Canadian genericsmarket in 2015, with a market size of approximately US$150 million[according to IMS Health data],” Vanc noted, “[and] the other productwill become off-patent in 2017.”

BIOCAD has sued Roche in a New York district court for allegedlydesigning and implementing a “scheme” to stymie Biocad’s plansto introduce in the US its biosimilar versions of the Swiss originator’sAvastin (bevacizumab), Herceptin (trastuzumab) and Rituxan(rituximab) monoclonal antibody brands upon patent expiry. “Thescheme involved an astonishing array of illegal conduct thatdeliberately targeted, and severely burdened [Biocad],” the Russianfirm claims. “While Roche keeps raising prices in the US, it engagesin predatory pricing in Russia,” Biocad also alleges.

ONCOBIOLOGICS has received “the first of its European Unionclinical trial authorisation approvals” for the biosimilarity studyportion of the US firm’s Phase III clinical programme concerningits ONS-3010 biosimilar version of AbbVie’s Humira (adalimumab).Countries covered by approvals include Germany, Spain and theUK. “The Phase III programme will be conducted in patients withmoderate-to-severe plaque psoriasis and is anticipated to begindosing patients later in 2016,” Oncobiologics commented.

LUPIN has obtained final approval from the US Food and DrugAdministration (FDA) for its generic voriconazole 50mg and 250mgtablets, as well as the 40mg/ml oral suspension formulation of theIndian firm’s alternative to Pfizer’s Vfend antifungal.

JULPHAR has introduced in its native United Arab Emirates (UAE)a tablet formulation of its Pantonix (pantoprazole) alternative toPfizer’s Protonix proton-pump inhibitor (PPI) brand. “Following thegreat success of our Pantonix vials – now the highest selling injectablePPI in the UAE – we noted that there was a need in the market for[an] oral form”, commented Julphar’s marketing director, Hosam Badr.

AMGEN has initiated a trial for a biosimilar version of AlexionPharma’s Soliris (eculizumab). The US originator has registeredthe trial for its ABP-959 candidate with the Australian New ZealandClinical Trials Registry (ANZCTR). The randomised, double-blind,single-dose, three-arm, parallel group study will determine thepharmacokinetic similarity of Amgen’s ABP-959 candidate againstthe Soliris brand in healthy male subjects.

CHMP – the committee for medicinal products for human use withinthe European Medicines Agency (EMA) – has received and isevaluating three new generic centralised marketing authorisationapplications, according to the committee’s June report. These includefor proposed rivals to Recordati’s Carbaglu (carglumic acid),Takeda’s Uloric (febuxostat) and Pfizer’s Lyrica (pregabalin).G

IN BRIEF

Accord Healthcare’s rival to Astellas Pharma’s Levact (bendamustine)2.5mg/ml powder for solution for perfusion has been added to

France’s répertoire of generic equivalents in a newly-created referencegroup. At the same time, the Intas affiliate saw its cisatracurium besylate5mg/ml injectable added to the répertoire, along with propranolol40mg tablets and Intas’ quetiapine 50mg prolonged-release tablets.

Other generics recently listed include Cipla’s version ofGlaxoSmithKline’s Avodart (dutasteride) 0.5mg soft capsules, as well asZydus Cadila’s rival to Daiichi Sankyo’s Olmetec (medoxomil) 10mg,20mg and 40mg tablet. Aguettant’s oxycodone 10mg/ml and 50mg/mlinjectables have been added to groups with Mundipharma’s Oxynormas the reference brand, while Biogaran has seen listed its rivals toAstraZeneca’s Crestor (rosuvastatin) in 5mg, 10mg and 20mg tablets. G

ONCOLOGY DRUGS

France adds to its répertoire


PIPELINE WATCH


Mid-June brought the expiry in most Western European countriesof supplementary protection certificates (SPCs) protecting

Amgen’s Arenesp (darbepoetin alfa) anaemia treatment. The SPCsthat have just expired in Austria, Belgium, Denmark, France, Finland,Germany, Greece, Hungary and Ireland, as well as in Italy, Luxembourg,the Netherlands, Norway, Portugal, Slovenia, Spain, Sweden and theUK (see Figure 1) were based on Kirin-Amgen’s European patentEP0,640,619 that covered ‘erythropoietin analogs with additionalglycosylation sites’ until it expired in August 2014.

IMS Health’s Ark Patent Intelligence service notes that, whileSPCs for Aranesp have now expired throughout the European Union(EU), local protection for the brand in Switzerland will continue throughto August next year.

At present, Aranesp is the only medicine containing darbepoetinalfa to have been approved by the European Medicines Agency (EMA).As of 9 June, the EMA said it was not assessing any applications forbiosimilar darbepoetin alfa.

Last year, Amgen reported Aranesp sales ahead by 1% to US$1.95billion as 13% growth to US$900 million in the US on higher volumes –including a shift from the firm’s own Epogen (epoetin alfa) brand –more than compensated for a 7% fall to US$1.05 billion in the rest ofthe world that reflected “a decrease in net selling price” and competitionfrom biosimilar rivals to Epogen.

The trend continued into the first quarter of this year, with a 7%slide in the firm’s rest of the world region being outweighed by a 38%leap in the US to give 11% global growth to US$532 million. Amgenexpects Aranesp to enjoy US patent protection until May 2024.

June also brought the expiry in Norway and Switzerland ofSPCs for Novartis’ Glivec (imatinib) oncology blockbuster. The SPCs

were linked to the European patent EP0,564,409 that describes‘pyrimidin derivatives and process for their preparation’.

Having initially been granted a European orphan drug designationfor Glivec, Novartis voluntarily surrendered that status, seemingly toqualify for SPCs that could be extended by six-month paediatricexclusivity until December 2016 in several EU member states.

Earlier this year (Generics bulletin, 15 April 2016, page 11), adistrict court in the Hague, the Netherlands, ruled that Teva’s plannedimatinib would infringe Novartis Dutch SPC that is based on theEuropean ‘409 patent and runs until 20 December this year, includinga six-month paediatric extension. The court found that Novartis wasnot precluded from obtaining a paediatric extension by virtue of havingheld orphan-drug status. Teva, Accord, Actavis and Medac all holdcentralised EMA approvals for generic imatinib tablets or capsules.

Glivec/Gleevec remained Novartis’ best-selling pharma brandin the first quarter of this year despite a 22% decline to US$834million. That fall was due to a 40% tumble to US$319 million inthe US, where the treatment for chronic myeloid leukaemia hassince 1 February this year faced competition from the genericversion that Sun Pharma introduced under the terms of a patent-litigation settlement (Generics bulletin, 5 February 2016, page 11).

Looking at data exclusivity, Ark notes that 10-year protection inthe EU for Bristol-Myers Squibb’s Baraclude (entecavir) hepatitis Btreatment ends during June. However, it points out, paediatric extensionsto SPCs that are linked to the European entecavir molecule patentEP0,481,754 extend protection in key European markets until April2017. “Generic competition may be delayed in certain markets beyondthe expiry of patent and SPC protection, as generics companies awaitmarketing approval from regulatory authorities,” Ark comments. 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

Capecitabine Estonia

Darbepoetin alfa Austria, Belgium, Denmark, France,Finland, Germany, Greece, Hungary,Ireland, Italy, Luxembourg, Netherlands,Norway, Portugal, Slovenia, Spain,Sweden, UK

Etanercept Cyprus

Imatinib Norway, Switzerland

Ioflupane Switzerland

Metaflumizone France, Italy, Spain, UK

Methyl aminolevulinic acid Austria, Belgium, Czech Republic, France,Hungary, Ireland, Italy, Luxembourg,Netherlands, Norway, Portugal, Spain, UK

Rupatadine Austria, Czech Republic, France, Germany,Ireland, Italy, Netherlands, Slovakia

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

SPC expiries in June

INN Country/Region

Cannabidiol/Tetrahydracannabinol UK

Cefovecin European Union

Clodronic acid Australia

Clorazepate dipotassium Canada*

Dexmedetomidine South Korea

Entecavir European Union

Lapatinib European Union**

Natalizumab European Union

Retigabine US

Rimonabant European Union

Risedronic acid South Korea

Ticagrelor Australia

* This will be followed by a no-marketing period of two years during which a notice ofcompliance will not be granted to a generic manufacturer.

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

Data exclusivity expiries in June

Figure 2: Molecules for which data exclusivity expires in certain markets in June2016 (Source – Ark Patent Intelligence)

European certificates end for Aranesp


GGBawards entry deadline ad FV_Layout 1 13/06/2016 14:39 Page 1

Even within the expanding global pharmaceuticalsmarket, generics have been enjoying a golden age.Buoyed by a wave of patent expiries that have

consistently produced double-digit sales increases,worldwide sales of prescription generics achieved acompound annual growth rate (CAGR) of 11.1% in thesix-year period between 2009 and 2015, according tomarket researcher IMS Health (see Figure 1).

Driven by strong rises particularly in the US and‘pharmerging’ countries, the global generics marketexceeded US$200 billion last year at ex-factory listprices before undisclosed rebates and discounts. Involume terms, the global generics market passed 1.4trillion standard units last year, with a CAGR of 7.5%over the past few years covering a period in whichvolume growth has halved from more than 10% in2010 to around 5% in 2015, as Figure 1 shows.

Presenting data at the first joint annual conferenceof Medicines for Europe and the InternationalGeneric and Biosimilar Medicines Association (IGBA)held in Dubrovnik, Croatia, earlier this month, DougLong – vice-president of industry relations at IMSHealth – noted that generics growth in pharmergingmarkets had slowed amid economic weakness incountries including Brazil and Russia.

US market to top US$90 billionNevertheless, he forecasted that the global generics

market by value would achieve a CAGR of 6.9% upto 2019, as sales in the US rose by about US$20 billionto more than US$90 billion and turnover in the top-fiveEuropean Union (EU) countries surpassed US$30 billionin 2019 (see Figure 2).

Long also predicted market expansion in Japanas the country’s government worked towards achieving

its ambitious goals for generic penetration of the localoff-patent market. During the decade up to 2015, henoted, generics’ value share of Japan’s retail pharmamarket had increased from 4% to 10%, but stilllanguished far behind the 19% share that generics heldin the US and the quarter of the market captured bygenerics in Europe.

Retail value shares for generics were 27% in Asiaand Australasia, 28% in Canada, 39% in Africa andthe Middle East, and 57% in Latin America.

Measured by volume, generics accounted for 26%of Japan’s pharma retail market in 2015, a mere fractionof the 82% recorded in the US, 73% in Canada, 71% inLatin America and 56% in Europe, with the latter figurelimited by the enduring popularity of non-protectedbrands in parts of the continent.

As Figure 3 shows, Japan’s US$6.2 billion genericsmarket is dominated by unbranded generics thatproduced all value growth in the market between 2009and 2015. Similarly, in France, Germany, Spain andthe UK, as well as in Canada and the US, unbrandedgenerics make up about four-fifths of the local market.By contrast, in pharmerging countries such as China,Mexico and South Korea branded generics predominate.

“Generally speaking, the unbranded sector isgrowing more strongly than the branded business,”Long observed.

Looking at a similar breakdown by countrybetween branded and unbranded generics in volumeterms (see Figure 4), Long said generics usage instandard units was reaching levels in some countriesfrom which further growth was starting to look difficult.“That would be the case particularly in the US because85% of prescriptions are already filled generically. Forthat figure to grow would suggest a stagnant pharma

MARKET RESEARCH


Continued growth

in the US, Japan and

the top-five European

countries will ensure

the global generics

industry keeps

expanding up to 2019.

Aidan Fry analyses the

latest data presented

by IMS Health.

Global generics market willgrow by 6.9% up to 2019

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Pharma growth

Figure 1: Breakdown by region of global prescription generics market growth by value and volume between 2009 and 2015 (Source – IMS)

CAGR+11.1%

CAGR+7.5%

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market due to a lack of innovation,” he remarked, addingthat the past five years had been “probably the mostinnovative time in the history of the pharmaceuticalindustry” in therapeutic areas such as oncology,hepatitis C and autoimmune diseases.

Turning to the top-10 players by value in thegenerics industry (see Figure 5), Long noted that Tevawas about to extend its global leadership through itsUS$40.5 billion takeover of Allergan’s Actavis genericsoperation. In the US, he said, the enlarged Teva groupwould account for around one fifth of all generics salesby both value and prescriptions filled.

Indian players enjoy large volumesMeasured by standard units, he continued,

GlaxoSmithKline’s alliance with South Africa’s Aspenranked the UK-based originator third behind Teva andNovartis’ Sandoz division. Much of the rest of the top-10by volume was filled by Indian players and the localchampion in Latin America, Hypermarcas, he added.

Nevertheless, Long pointed out, the continuousindustry consolidation had not resulted in a lessfragmented market. “The top-10 players now representless of the market volume than they did five years ago,”he said, highlighting that other players made up 71%of the market by volume in 2015, up four percentagepoints from 67% in 2010 (see Figure 6).

“There is more globalisation of generics companiesthan in the past,” Long acknowledged. However, henoted, the leading companies still had particularstrengths and weaknesses in certain areas, with noleading players having a large-scale presence in Japan.

Charting the wave of patent expiries that had fuelledgenerics industry growth since Prozac (fluoxetine) lostprotection in the US in 2001, Long stated: “We arestarting to run out of small-molecule opportunities from2018.” However, he commented, “biosimilaropportunities are just beginning to present themselves”.G

MARKET RESEARCH


Value CAGR 2009-2015Generics sales Branded Unbranded Branded Unbranded(US$ billions) (%) (%) (%) (%)

US 71.9 15 85 7 13China* 26.7 69 31 13 20Brazil 11.7 54 46 26 34Germany 7.1 25 75 5 5UK 6.5 18 82 8 9France 6.2 17 83 2 7Japan 6.2 21 79 0 22Canada 4.3 18 82 10 1Korea 3.8 89 11 3 1Italy 3.7 40 60 3 14Spain 3.1 28 72 0 10Mexico 1.9 78 22 4 18* China excludes traditional Chinese medicines – unbrandedgenerics includes unbranded and company branded generics

Figure 3: Breakdown by country of the value shares and compound annual growth rate of theprescription generics market enjoyed by branded and unbranded generics in 2015 (Source – IMS)

Volume CAGR 2009-2015Generics sales Branded Unbranded Branded Unbranded(Units billions) (%) (%) (%) (%)

US 196.8 5 95 -3 5Brazil 110.4 63 37 30 34China* 86.0 40 60 18 21Japan 52.6 40 60 1 25UK 45.5 14 86 3 6Germany 42.9 16 84 1 4France 27.8 21 79 -1 6Spain 21.1 27 73 -1 13Korea 20.3 88 12 5 3Canada 19.5 17 83 4 4Mexico 7.4 51 49 -2 18Italy 3.7 48 52 0 12* China excludes traditional Chinese medicines – unbrandedgenerics includes unbranded and company branded generics

Figure 4: Breakdown by country of the volume shares and compound annual growth rate of theprescription generics market enjoyed by branded and unbranded generics in 2015 (Source – IMS)

US

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Figure 2: Breakdown by region of actual and forecastedprescription generics market growth by value between 2009and 2019 (Source – IMS)

Rank Company Annual sales 2009-2015 Market share (%)(US$ billions) change (%) 2009 2015

1 Teva 16.73 +3 12 82 Sandoz 12.27 +12 5 63 Mylan 9.90 +39 4 44 Allergan/Actavis 8.24 +62 3 45 Pfizer/Hospira 5.87 +29 3 36 Sanofi/Zentiva 5.13 +38 2 27 Sun 3.56 +33 2 28 Dr Reddy’s 2.74 +137 1 19 Apotex 2.71 +71 1 110 Stada 2.71 +37 1 1

Figure 5: Top ten global generics suppliers by value share of the prescriptiongenerics market in 2015 (Source – IMS)

Rank Company Annual sales 2009-2015 Market share (%)(Units billions) change (%) 2009 2015

1 Teva 68.3 -4 7 52 Sandoz 67.0 +7 6 53 GlaxoSmithKline 43.3 +34 3 34 Cipla 41.9 +37 3 35 Sanofi/Zentiva 39.5 +33 3 36 Hypermarcas 36.7 +187 1 37 Mylan 35.8 +3 3 28 Sun 32.0 +36 2 29 Allergan/Actavis 28.9 +7 3 210 Lupin 22.6 +81 1 2

Figure 6: Top ten global generics suppliers by volume share of the prescriptiongenerics market in 2015 (Source – IMS)


Former US Generic Pharmaceutical Association (GPhA) vice-president of regulatory affairs, Gordon Johnston, is facing insider

trading charges from the US Securities and Exchange Commission(SEC) after being accused of “deceptively obtaining confidentialinformation from the US Food and Drug Administration (FDA)” andpassing this information on to hedge fund managers.

“The SEC alleges that Sanjay Valvani reaped unlawful profitsof nearly US$32 million for hedge funds investing in healthcaresecurities by insider trading on tips he received from Gordon Johnston,”the SEC stated. It added in its explanation of the charges that Johnstonhad “worked at the FDA for a dozen years and remained in closecontact with former colleagues while working for a trade associationrepresenting generic drug manufacturers and distributors”.

Johnston was made vice-president of regulatory affairs for theGPhA in April 2003, before retiring from the position eight years later(Generics bulletin, 8 April 2011, page 30). As Generics bulletin wentto press, the association had not responded to requests for comment.

“Johnston concealed his separate role as a hedge fund consultantand obtained confidential information about anticipated FDA approvalsfor companies to produce enoxaparin,” the SEC alleges. Furthermore,it claims, “Johnston allegedly funneled to Valvani the details of hisconversations with FDA personnel, including a close friend he mentoredduring his time at the agency”.

Subsequently, according to the financial regulator, Valvani“traded in advance of public announcements concerning FDAapprovals for such companies as Momenta, Watson and Amphastar”.

“We allege that Valvani’s formula for trading success was tappingJohnston to abuse his position of trust as a generic industryrepresentative to the FDA and underhandedly obtain confidentialinformation from his friends and former colleagues at the FDA,”said Andrew Ceresney, director of the SEC’s enforcement division.“Valvani and his hedge funds made millions by trading on non-publicFDA drug approval information not available to the rest of the stockmarket,” Ceresney concluded.

The SEC’s complaints, in a Manhattan federal court, seek“disgorgement of ill-gotten gains plus interest and penalties”, as wellas “permanent injunctions against future violations”. Meanwhileparallel criminal charges have been brought by the US attorney’soffice for the southern district of New York. G

PEOPLE


INDUSTRY ASSOCIATIONS

Johnston is chargedover insider trading

Former Pliva chief Kurt Orlofski has taken on the newly-created roleof president of generics with current employer G&W Laboratories

under a management reshuffle initiated by the privately-held US player.In his new role, Orlofski will “lead sales, marketing and

commercialisation of current and near-term generic products”, whichG&W claim is a “foundation for the company’s long-term growth”.Since 2009 he had been the firm’s group president, having previouslyserved as president and chief of Wockhardt’s US business and, priorto its takeover by the Indian firm, of Morton Grove. Industry veteranOrlofski was Pliva’s president and chief between April 2004 andDecember 2006, two years before Teva acquired the Croatian player.

Replacing Orlofski as company president is Merck executiveJay Galeota, who has also been appointed as G&W’s chief operatingofficer. Galeota – who was most recently the US originator’s chiefstrategy and business development officer, and president of Merck’semerging business operation – in the operating role replaces RobertoDarienzo, who has been named as G&W’s head of global supply. G

RESHUFFLES

G&W Labs’ Orlofskinamed generics head

Former president of Actavis’ US Anda generics distribution operation,Albert Paonessa, and co-founders of fellow US distributor The

Harvard Drug Group, Randy Friedman and Jay Levine, are to“re-enter the generic drug distribution business” after Friedman’sFriedman Capital private-equity firm partnered to acquire Ohio-basedgenerics distributor KeySource Medical.

Paonessa was president of Anda – the US’ “largest generic drugdistributor by volume” – for around ten years before stepping downin January last year. Friedman and Levine, meanwhile, founded TheHarvard Drug Group in 1988, before it was sold to private-equityfirm Court Square Capital Partners six years ago (Generics bulletin,7 May 2010, page 9). Cardinal Health then paid US$1.25 billionfor the business in July last year.

Friedman Capital’s allies in the transaction include KeySource’sco-founder and former chief executive, Stephanie Ring, and Jonathanand Edward Cohen and their Seal Rock private-equity firm. G

BUSINESS STRATEGY

Firms ally to buy KeySource


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