COMPANY NEWS Pfizer to delayI nflectra launch untilS eptember · 07.06.2016 · Japanesefirms...

17 June 2016

Apotex can afford to 2take long-term viewTwo players in Japan form 2biosimilars pactAlvotech opens plant for mAbs in Iceland 3Aspen strikes a deal for 3AZ’s anaestheticsValeant’s guidance is cut for a second time 4Hikma launches an Egypt oncology unit 4

MARKET NEWS 5

Supreme Court seeks 5solicitor-general viewCommission reduces SPC report’s scope 5Regulators see hope in TTIP negotiations 6Global industry will speak with one voice 7Producers and payers vary 7on key priorities

PRODUCT NEWS 8

Spanish court stops sustained Seroquel 8Actavis dismisses its 9USVascepa appealHospira defeats UK daptomycin patents 9Amgen’s US Humira rival 10gets review dateUS court ruling takes 11out Suboxone patentMayne gets FDA nod for first 11Tikosyn rivalUS court rules valid fourTreanda patents 12Inflectra indications are added in Canada 12

FEATURES 15

Europe leads on biosimilars 14

REGULARS

Events – Our regular listing 10Price Watch UK – UK pricing trends 14People – Mylan’s Coury is to 16become board chair

COMPANY NEWS 2

PUBLISHED WEEKLYNext issue – 24 June 2016

Pfizer’s Hospira has agreed not to launch its Inflectra (infliximab-dyyb) biosimilarversion of Janssen’s Remicade (infliximab) in the US before 15 September this year,

barring certain conditions, under the terms of a stipulation that has been filed in aMassachusetts district court.

Shortly after Inflectra was approved earlier this year, Hospira and development partnerCelltrion revealed they intended to market the biosimilar “as early as 30 June 2016” (Genericsbulletin, 22 April 2016, page 1), reserving the right not to supply to Janssen a 180-day noticeof commercial marketing following Inflectra’s approval on 5 April. This period, in effect,would run until 2 October.

Janssen is, however, again seeking to obtain a 180-day marketing notice injunction againstHospira and Celltrion, declaring in litigation that it intends to file its renewed motion once averdict is reached in Apotex’ ongoing biosimilar marketing-notice dispute with Amgen. A USCourt of Appeals is currently reviewing a district court injunction requiring Apotex to provideAmgen with 180-day marketing notice for its rival to the originator’s Neulasta (pegfilgrastim)biologic brand (Generics bulletin, 15 April 2016, page 9).

Hospira could nevertheless bring Inflectra to market earlier than 15 September if certainconditions listed in the firms’ stipulation are met. This includes an agreement between Hospira,Celltrion and Janssen that an appeals court decision in the Apotex case ahead of this datewould moot Janssen’s renewed attempts to obtain a 180-day marketing notice injunction.

Moreover, the stipulation decrees, an earlier launch would be possible should Hospira andCelltrion obtain a “court order denying Janssen’s renewed 180-day preliminary injunctionmotion”, or by them obtaining a “court order authorising an earlier launch date”.

Inflectra – for which Pfizer obtained exclusive US marketing rights following its takeoverof Hospira in September last year – is the first and only biosimilar monoclonal antibody(mAb) to have received final US Food and Drug Administration (FDA) approval (Genericsbulletin, 8 April 2016, page 1). G

Pfizer to delay Inflectralaunch until September

Dr Reddy’s is set to bolster its US offering after agreeing to pay US$350 million in cashfor a portfolio of eight abbreviated new drug applications (ANDAs) from Teva.The proposed transaction represents the first US divestment agreed by the Israeli firm as

a condition of securing US Federal Trade Commission (FTC) approval for its US$40.5 billiontakeover of Allergan’s Actavis generics business (Generics bulletin, 7 August 2015, page 1).Thus, Dr Reddy’s acquisition is subject to the Teva-Actavis deal closing, and the FTC approvingDr Reddy’s as a buyer. Teva expects the deal to close this month.

The Indian firm noted that the portfolio was “a mix of filed ANDAs pending approval andan approved ANDA,” and comprised “complex” generic products “across diverse dosageforms”. A Dr Reddy’s spokesperson disclosed to Generics bulletin that these dosage formsincluded sublingual films, intravenous therapies, inhalation respules, topical creams and oralsolids. “We are unable to comment on specifics of the therapy indications at this point,” he added.

Alok Sonig, Dr Reddy’s executive vice-president and North American head, pointed out thatDr Reddy’s currently had “over 79 filed ANDAs, of which we believe 18 have first-to-file status”.Branded sales of the products within the basket, meanwhile, had sales of US$3.5 billion forthe 12 months ending April 2016, according to IMS Health data. G

Reddy’s buys basket from Teva

Gen 17-6-16 Pg. 1_Gen 18/11/05 Pg. 1 15/06/2016 17:12

Japanese firms Nippon Kayaku and Mitsubishi Gas Chemical haveannounced the formation of a local joint venture to contract

manufacture monoclonal antibodies (mAbs), “including biosimilars”.Mitsubishi will own a 55% stake, while Nippon will have the

remaining 45%, of the venture that is based at Mitsubishi’s localheadquarters in Chiyoda, Tokyo, and operate under name Cultivecs.Noting that the venture would use Mitsubishi’s local manufacturingfacilities in Niigata, the firms said Cultivecs aimed to begin production“within two years”.

Headed up by Mitsubishi’s Masashi Fujii in the role of president,the venture would combine the “experience and knowledge of bothfirms”, Nippon and Mitsubishi noted, and would help to “strengthenthe capability of local production [of mAbs and biosimilars], upgradeskills, and contribute to the prevalence of biosimilars”.

Nippon’s previous experience with biosimilars in Japan includesits marketing since May 2013 of Teva’s biosimilar filgrastim througha partnership with the Israeli firm (Generics bulletin, 17 May 2013,page 16), which had received local approval from Japan’s Ministryof Health, Labour and Welfare (MHLW) earlier that year.

Moreover, Nippon has since November 2014 marketed Celltrion’sRemsima (infliximab) in Japan, following approval for the biosimilarfrom the MHLW just under two years ago (Generics bulletin, 8 August2014, page 19). The two firms – which had struck a co-development andmarketing agreement for the rival to Janssen’s Remicade (infliximab)in 2010 – have also since last year been developing jointly a biosimilarrival to Roche’s Herceptin (trastuzumab) for the Japanese market.

Mitsubishi, meanwhile, noted that it had “long-time experience”with cell cultivation involved in the mAb production process, and,furthermore, had struck a mAb technology transfer agreement withTaiwan’s GlycoNex two years ago. To “expand business” and developmAbs, the firm noted that it had established a dedicated MitsubishiPharma affiliate in 2014. G

COMPANY NEWS

2 GENERICS bulletin 17 June 2016

17 June 2016 Issue 267

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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STRATEGIC ALLIANCES

Two players in Japanform biosimilars pact

Apotex’ privately-owned status gives it greater freedom to pursuelong-term strategies in a climate of rapid industry consolidation,

according to the Canadian firm’s chief executive officer, Jeremy Desai.Addressing the joint conference of European generics industry

association Medicines for Europe and the International Generic andBiosimilar Medicines Association (IGBA) held in Dubrovnik, Croatia,earlier this month, Desai insisted that “big doesn’t necessarily meanbetter”. Apotex was aiming to be “the best” firm among its peers, Desaiclaimed, even if he conceded that “we may not be there with everyday-one launch”. And amid customer consolidation, such as amongdistributors, Desai said there was still room for Apotex among its largerpeers. “They do not want to put all their eggs in one basket,” he said.

There were still high-value opportunities for the firm to explorein small molecules, particularly with complex generics, Desai stated.Furthermore, he predicted, the biosimilars market would become moreaccessible in the coming years as development and production costsfell – partly as a result of less onerous regulatory requirements, andpartly due to technology improvements – and market access waseased through education and communication efforts.

Moreover, Apotex would continue to counter brand strategies suchas those seen in recent litigation over the US biosimilars pathway,Desai insisted. “We will litigate if appropriate,” he emphasised. G

AMCO has reacted to an article in the UK’s The Times newspaperaccusing the firm of profiteering from huge price increases in theUK by stressing that the average weighted selling price of its drugsis just £5.94 (US$8.41). Concordia affiliate AMCo said prices formany of its drugs were “significantly lower” than the NationalHealth Service (NHS) reimbursement price. G

IN BRIEF

BUSINESS STRATEGY

Apotex can afford totake long-term view

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

South Africa’s Aspen Pharmacare is looking to further bolster itspresence overseas after reaching an agreement worth up to US$770

million for the global commercialisation rights outside of the US toAstraZeneca’s anaesthetics portfolio.

Scheduled to close by the end of September, subject to customaryclosing conditions, the transaction comprises seven mature brands,including the Diprivan (propofol) general anaesthetic and Emla(lidocaine/prilocaine) topical cream or patch, along with Xylocaine(lidocaine), Marcaine (bupivacaine), Naropin (ropivacaine), Carbocaine(mepivacaine) and Citanest (prilocaine).

Aspen noted that the basket had sales of US$592 million during2015, while it would have generated around US$100 million ofpre-tax profit for the South African firm during that 12-month period.Aspen currently operates under a July-June financial calendar.

“The products in the portfolio are sold in more than 100 countriesworldwide,” Aspen said, “including China, Japan, Australia and Brazil.”Stephen Saad, Aspen’s chief executive officer, observed that theportfolio would help the firm to “build critical mass in Japan and China”,and overall had a “a strong presence” in the Asia-Pacific region.

Aspen began trading in Japan from 1 July last year after earlierforming a joint-venture with GlaxoSmithKline, while Saad told investorsearlier this year that establishing a dedicated affiliate in China was“under consideration” (Generics bulletin, 25 March 2015, page 15).

“The key territories in which the portfolio is sold represent anexcellent fit with Aspen’s existing operational geographic footprint andthose markets on which its future strategy is focused,” theJohannesburg-based firm summarised.

US$520 million payment upfrontUnder the terms of its agreement, Aspen will pay the UK originator

US$520 million upfront, along with “double-digit percentage royaltieson sales of portfolio”. Furthermore, Aspen will make sales-basedpayments of up to US$250 million “based on sales in the 24 monthsfollowing completion”.

AstraZeneca, meanwhile, has agreed to supply the portfolio toAspen for an initial 10-year period, and to transition “commercialactivities” to Aspen in the “short-to-medium” term, providing the SouthAfrican firm with commercialisation services during this period.

Commenting further on the transaction, Aspen said that “as acategory of pharmaceuticals that primarily involves sterile manufacturingand that is dispensed largely in hospitals and clinics”, anaestheticspresented an “opportunity to leverage both Aspen’s existing hospital-focused salesforce that is currently promoting anticoagulants and,potentially in due course, sterile manufacturing capabilities”.

Aspen’s anticoagulants portfolio includes the Arixtra(fondaparinux) and Fraxiparine (nadroparin) brands that it picked upfrom GlaxoSmithKline three years ago, the Orgaran (danaparoid)fractionated heparin brand it bought from Merck, and the Mono-Embolex (certoparin sodium) injectable it obtained from Novartis.

Anaesthetics, moreover, were a therapeutic category that presentedan opportunity to “add significant value” to Aspen, the firm noted, andtied in with the firm’s inorganic strategy of acquiring niche products.

Acknowledging that the US$770 million deal was “very large”,Saad said its price would, however, “not preclude future opportunities”after the firm’s parent company, Aspen Holdings, secured C3.00 billionof equivalent loan arrangements. “Aspen’s debt facilities have beenenhanced,” he noted. G

COMPANY NEWS

3GENERICS bulletin17 June 2016

MERGERS & ACQUISITIONS

Aspen strikes a dealfor AZ’s anaesthetics

Alvotech has officially opened a facility in Iceland for developingand making biosimilar monoclonal antibodies (mAbs) that will

be marketed by its sister company, Alvogen.Located on the science park of the University of Iceland in

Reykjavik, the 13,000 sq m plant – designed and built according toUS Food and Drug Administration (FDA) and European MedicinesAgency (EMA) requirements – uses disposable, single-use 1,000-litreand 2,000-litre reactors, giving a total capacity of 16,000 litres. Thesite includes around 2,500 sq m of office space as well as severallaboratories and filling lines for vials and pre-filled syringes.

“The new facility will significantly increase Alvotech’s productioncapacity, enabling the group to produce higher yields at lower costs,”the company maintained, adding that Iceland offered “a favourableoperating environment, with a strong regulatory system and convenientgeographical location”.

Having just bolstered its cell-line development and early-stagecapabilities by acquiring Baliopharm’s German operations (Genericsbulletin, 27 May 2016, page 1), Alvotech – which has a pipeline ofsix mAbs – is close to completing a deal for Hannover-based proteincharacterisation and analytics specialist Glycothera. G

MANUFACTURING

Alvotech opens plantfor mAbs in Iceland

Necessary injectable medicines will continue to be supplied fromSandoz Canada’s facility in Boucherville, Quebec, the firm has

insisted, despite strike action in early June by unionised employees.In May, over 250 members of the Teamsters union had voted

91.5% in favour of a strike following their last collective agreementexpiring on 31 December 2015. Michel Robidoux, president and generalmanager of Sandoz Canada, noted that the company had been innegotiations with the union since October, adding that “during thisdifficult time, our priority is to ensure that customers and patients donot experience any difficulty in receiving medicines”.

To allow for a “fair distribution” of medicines, Robidoux explainedthat a “proactive allocation system” had been put into place to help“preserve and manage the right inventory levels and respond to patientand customer needs”.

According to the Teamsters union, following the 24-hour strikethere was a “lockout” as workers were turned away upon arrival of amorning shift. Subsequently, however, a six-year collective agreementbetween Sandoz Canada and 267 Teamsters members has beenannounced. As a result the temporary allocation system at the plantwill be lifted in “the coming days”.

Robidoux described the new agreement as “good news for allparties concerned, as well as for the Canadian healthcare system, as wehave one of the biggest injectable manufacturing plants in Canada,producing high-quality life-saving products”. G

INTELLIPHARMACEUTICS has raised net proceeds of aroundUS$4.6 million through a public offering of its shares on theNasdaq stock exchange. G

IN BRIEF

MANUFACTURING

Sandoz Canada settles strike

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

Valeant has slashed its full-year financial forecast for 2016 for thesecond time in three months, after announcing that it was selling

some products through its pricing and distribution agreement withWalgreens at a loss.

Full-year sales are now set to be in the range of US$9.9-US$10.1billion, down from the US$11.0-US$11.2 billion Valeant projectedwhen it revised its guidance for the first time in March (Genericsbulletin, 18 March 2016, page 3). The Canadian group had initiallyforecasted a full-year turnover of US$12.5-US$12.7 billion last year.

“We have to be realistic,” chief executive officer Joe Papa said,in light of the “significant challenges” Valeant had faced for itsdermatology business, as well as its Salix gastrointestinal affiliate thatwas “currently running below original expectations”.

Addressing investors less than five weeks after replacing MikePearson as Valeant’s chief, Papa explained that the firm’s agreementwith Walgreens – which was struck at the end of last year (Genericsbulletin, 8 January 2016, page 5) – had both prior authorisation andaverage selling price issues.

“There’s a percentage of the business where the average sellingprice is significantly below what we had previously expected, as weput the programme together,” Papa revealed. “And in fact, in someplaces, the average selling price is negative.”

And that means, every time a prescription goes out the door, weare taping dollar bills to that prescription. That is something that wehave to get fixed,” he insisted.

Papa ultimately described Valeant as a “distracted organisation”,noting that “negative external attention” was continuing to “adverselyimpact the business and our reputation”.

The embattled firm earlier this month received further notices ofdefault on its bonds due its ongoing failure to make mandatory financialfilings on time (Generics bulletin, 10 June 2016, page 4), havingearlier admitted that “improper conduct” by senior executives hadcaused the firm to misstate prior financial results.

But in response Papa has announced a four-point ‘stabilisationplan’, which he said would take three-to-six months to implement,including plans to refocus “research and development dollars intoinvestment for core assets” and to sell off “non-core assets” to reducecomplexity and pay down debt. This would be “followed by aturnaround stage and ultimately a transformation stage”, he said.

In the first quarter of this year, Valeant reported group sales thatwere 9% higher at US$2.37 billion, “primarily due to the effect ofacquisitions”, and including ‘Neuro & Other/Generics’ turnover thatinched ahead by 1% to US$545 million. At the end of last month, thehead of Valeant’s neurology, dentistry and generics operation, BrianStolz, stepped down “to pursue other opportunities” (Genericsbulletin, 3 June 2016, page 20).

“Our generics portfolio grew 14%,” chief financial officer RobertRosiello revealed to investors, as Papa commented that Valeant’sgenerics operation in its Asia operation had been “steady”.

In the US, Valeant noted that it had six active generic programmes,comprising four late-stage and two early-stage candidates.

However, Valeant noted, on an organic basis total sales had“declined US$289 million in the first quarter of 2016 from theremainder of the existing business”. And considerably higher operatingexpenses – including selling, general and administrative costs andamortisation and impairment charges – caused Valeant’s operatingprofit to plummet by 88% to US$66.2 million. G

COMPANY NEWS


RESULTS FORECAST/FIRST-QUARTER RESULTS

Valeant’s guidance iscut for a second time

Launching an oncology business unit in Egypt will enable Hikmato “focus on high-need areas” and “provide access to affordable

high-tech therapies to patients”, according to the Jordanian company.Named “Hikma Specialized Egypt”, the business unit aims to “improvethe company’s ability to meet the unique and urgent needs of cancerpatients and healthcare providers in Egypt”.

Despite “progress made in the fight against cancer”, HikmaSpecialized director Tareq Darwazah contended there were “seriousunmet needs persisting across many forms of the disease”. “HikmaSpecialized brings with it a deep understanding of this fast-changingtherapeutic area and applies scientific rigour and resources,” he said.

Describing the unit’s business model as “agile”, Darwazah statedthe “strategic move” will enable the company to “quickly meet thediverse needs of cancer patients, healthcare providers and systems inEgypt”, which in turn will “bring the next generation of cancertreatments to patients at affordable prices”.

Highlighting plans to expand its presence in the Middle East andNorth Africa (MENA) region, Hikma last year agreed to acquire a98.09% stake in Egyptian oncology specialist EIMC UnitedPharmaceuticals (EUP) for an undisclosed sum (Generics bulletin,2 October 2015, page 3). Hikma’s acquisition of EUP “strengthened”the company’s ability to bring “high-tech locally manufactured oraland injectable oncology products onto the Egyptian market”.

Managing director of Hikma Egypt, Hassan Shafick, stated thatwith a “more robust local manufacturing capability” and “globalnetwork and resources” provided by Hikma internationally, the companywas “optimally positioned to leverage all tools at our disposal toquickly acquire and locally produce compounds for cancer patientsin Egypt and the MENA region at large”. G

MERGERS & ACQUISITIONS

Hikma launches anEgypt oncology unit

Granules India has acquired exclusive rights to market and distributefour products in the US from USpharma Windlas. The deal was

struck through the Indian company’s wholly-owned US subsidiaryGranules Pharmaceuticals. “Product in-licensing is a strategicmanoeuvre to accelerate our business expansion plans in the US byfostering long-term partnerships,” Granules stated.

Through its subsidiaries, USpharma Windlas holds abbreviatednew drug applications (ANDAs) for fingolimod, prasugrel, dronedaroneand lurasidone, and believes three of these ANDAs contain first-to-file paragraph IV certifications. Annual US sales for these four productsare approximately US$4.4 billion, according to IMS Health data.

USpharma will receive milestone payments and a share of profitsfrom sales and Granules Pharmaceuticals will be responsible formarketing and distributing the products in the US. G

BUSINESS STRATEGY

Granules licenses in the US

STRIDES has obtained an establishment inspection report (EIR)from the US Food and Drug Administration (FDA) for its KRSGardens oral-dosage facility in Bangalore, India, closing the FDA’sinspection of the site in February this year. G

IN BRIEF

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

The US Supreme Court has invited the country’s solicitor-generalto file a brief “expressing the views of the US” in a ‘reverse-

payment’ dispute between GlaxoSmithKline (GSK) and King Drugover a patent-litigation settlement on Lamictal (lamotrigine).

Having opened a docket on the case in February this year, theSupreme Court has since accepted amicus curiae filings from partiesincluding the US Generic Pharmaceutical Association (GPhA) and thePharmaceutical Research and Manufacturers of America (PhRMA).

Court of Appeals found transfer of valueAt the end of June last year, the US Court of Appeals for the Third

Circuit ruled that an agreement not to launch an authorised genericthat was included in GSK’s Lamictal settlement with Teva could“represent an unusual, unexplained reverse transfer of considerablevalue from the patentee to the alleged infringer” (Generics bulletin,10 July 2015, page 13). The appeals court denied a petition for arehearing in September last year. G

MARKET NEWS


LITIGATION SETTLEMENTS

Supreme Court seekssolicitor-general view

Atotal of 190 complete responses on abbreviated new drugapplications (ANDAs) issued by the US Food and Drug

Administration (FDA) in April 2016 was the highest number since thegeneric drug use fee amendments (GDUFA) began in October 2012.The agency issues such responses to indicate that applications are notapprovable in their current form.

During the first eight months of its fiscal year running untilSeptember 2016, the FDA issued 1,030 complete responses, not farshort of the 1,180 total for the entire previous fiscal year.

April 2016 saw 53 final ANDA approvals – just shy of the 56ANDAs submitted – plus another 16 tentative approvals. The FDArefused to receive 31 ANDAs, while 20 were withdrawn.

Initial data for May 2016 shows that 58 ANDAs were submitted,as the FDA granted 54 final approvals and 20 tentative approvals.The agency issued 151 complete responses. G

REGULATORY AFFAIRS

FDA sets rejections record

Just over half of global doctors do not feel they have enougheducational information to prescribe biosimilars to their patients,

according to a recent poll by physicians’ social network Sermo.The poll found that 47% of 3,849 doctors from 28 countries who

were surveyed anonymously believed biosimilars would prove safe andeffective enough to prescribe, 43% said they needed more informationbefore prescribing biosimilars and 10% refused to prescribe biosimilars,regardless of having information on their safety and efficacy.

Sermo said several physicians were concerned about “the speedwith which these products are going to market, and the lack of testingthey face before being given to patients”. Anecdotal accounts gatheredfrom doctors around the world revealed widespread ignorance andmisconceptions of biosimilar assessment principles. G

MARKET RESEARCH

Global poll divides doctors

The European Commission has narrowed the scope of a study onsupplementary protection certificates (SPCs) that it has put out for

tender. Having received only one, unsatisfactory offer to conduct thestudy, in its initial tender (Generics bulletin, 20 May 2016, page 9),the Commission’s directorate-general for internal market, industry,entrepreneurship and small and medium-sized enterprises (DG GROW)on 9 June published a revised tender in the European Union’s (EU’s)Official Journal.

With a maximum value of C185,000 (US$208,500) and an eight-month duration, the legal study is “to be used for an overall evaluationof the SPC system in the EU, and to inform the decision on whetherto come forward with a new SPC title at European level and whetherto revise the existing SPC legislation”. Interested parties have until27 July to submit bids, with offers to be opened on 29 July and acontract to be signed in September this year.

A Commission spokesperson told Generics bulletin that thesubjects omitted in the narrower tender – predominantly issues beyondthe pharma sector and economic analyses – would be covered by aseparate, economics-focused tender that would be launched withinthe next few weeks.

The study – which “could serve as a basis for an impact assessmentfor a future proposal by the Commission to recalibrate the existingEU SPC rules” – is intended to look particularly at the “legal efficiency”of the existing system in “meeting its stated objectives given thedevelopment of directly affected and related product markets”.

Among the issues and challenges relating to the current systemfor extending EU monopolies for up to five-and-a-half years that theCommission highlights in the tender’s technical specifications are:“legal uncertainty or ambiguity in the current text of the SPC regulationsand jurisprudence”; the need for “additional harmonisation andtransparency” on national procedures; and industry evolution,including on biologics, combination drugs and second medical uses.

Applicants will be expected to compile “a solid evidence base”,including by analysing rulings by the Court of Justice for the EU(CJEU) and by providing an outline of patent-term extensionmechanisms in Japan and the US. Conclusions and recommendationsin the English-language report should include the impact of changesto SPC protection. G

INTELLECTUAL PROPERTY

Commission reducesSPC report’s scope

Adeadline to comment on draft US Food and Drug Administration(FDA) draft guidance on biosimilar labelling has been extended

to 2 August. “A 60-day extension will allow adequate time forinterested persons to submit comments without compromising timelypublication of the final guidance,” stated the FDA, which unveiledits draft in early April (Generics bulletin, 8 April 2016, page 5).

As Generics bulletin went to press, the docket for writtencomments on the guidance – FDA-2016-D-0643 – contained 34submissions. The International Generic and Biosimilar MedicinesAssociation (IGBA) described as “coherent” proposals to duplicate thereference product’s label, allowing for carved-out indications. But theBiotechnology Innovation Organization (BIO) said the FDA’s approachwas “flawed” in failing to detail clinical studies for the biosimilar. G

REGULATORY AFFAIRS

FDA extends labels deadline

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Value-added medicines that innovate around an existing molecule– offering improvements over existing treatments – will enable

Europe to preserve access to medicines despite economic constraints,according to Teva’s Christoph Stoller, who is also chair of the ValueAdded Medicines Group within European generics and biosimilarsindustry association Medicines for Europe (MfE).

Addressing the first joint conference of MfE and the InternationalGeneric and Biosimilar Medicines Association (IGBA) held inDubrovnik, Croatia, earlier this month, Stoller insisted: “The statusquo is no longer an option.”

Short-term efforts over the past decade had concentrated oncutting healthcare costs, particularly on medicines, he observed. Butthe latest white paper released with the support of MfE had urged aregulatory overhaul to recognise the additional benefits providedby value-added drugs (Generics bulletin, 10 June 2016, page 9).

“It is clear that the time has come for Europe’s healthcare systemto change if we want to preserve access to medicines,” Stoller said.But this “cannot be done by any single player”. Instead, he suggested,it would require collaboration between industry and a range ofstakeholders including policy-makers, payers and patients. G

MEDICINES FOR EUROPE


INDUSTRY ASSOCIATIONS

Added value will widen access

COORDINATED ACTION is needed on European patents andsupplementary protection certificates (SPCs), according to EuropeanCommissioner for Health, Vytenis Andriukaitis. “Fragmentation acrossEurope not only leads to legal uncertainty in the pharmaceuticalsystem and the internal market, it also undermines pharmaceuticalinnovators’ investments, dissuades generics manufacturers and hasadverse effects for national health authorities and patients’ access toinnovative and affordable medicines,” he said. Pointing out that theCommission was working with member states to improve existingregulatory frameworks, Andriukaitis also suggested that it could be tothe pharma industry’s advantage to provide greater transparency onpricing to “provide better access to quality healthcare and sustainability”.

MOPI – the Malaysian Organisation of Pharmaceutical Industries –has joined the International Generic and Biosimilar medicinesAssociation (IGBA) as an associate member. Generics associationsfrom Australia, Brazil and Mexico also hold associate membership,while full members comprise bodies from Canada, Europe, Japan,Jordan, South Africa, Taiwan and the US.

FORTUNES IN THE US will “make or break” the biosimilarsindustry, according to McKinsey’s Simon Goeller. Pointing outthat the US accounted for around half of global biological drugssales, Goeller said the evolution of the US market would “definehow we think about biosimilars five years from now”. Experiencesin the small-molecules generics market suggested that biosimilarprices would decline sharply once more than four players hadentered the market, he added.

PRODUCT DONATIONS should not necessarily be viewed through aprism of sustainability, stressed Alex Harris, chief executive officer ofEurope-based charity International Health Partners (IHP). Highlightingthe acute need for medicines as part of disaster responses in regionssuch as Lebanon and Northern Iraq, Harris urged manufacturers toadopt a proactive approach to product donations that included “plannedinterventions and multi-year commitments” to help through the charity’sonline Eurmed platform that “matches supply with demand”.

IRAN is forecasted to offer a pharmaceutical market valued at morethan US$4 billion by 2019, noted Dunja Siuc Valkovic from Croatia’sJGL. Observing that per capita drug spending was rising rapidlyamong a youthful population of over 79 million people, Valkovicsaid Iran’s health policy to 2020 promised universal insurancecoverage and increasing pharma market liberalisation. She suggestedthat European manufacturers could capitalise on a strong localperception of quality, but cautioned that Iran’s drug-registrationprocess was “not transparent” and approval timelines varied.

JAPANESE GENERICS COMPANIES are investing heavily toexpand capacity as they strive to produce the 100 billion tabletsper year needed to achieve the government’s target of 80% genericpenetration of the country’s off-patent pharma market by 2020,commented Itsuro Yoshida, president of the Japan Generic medicinesAssociation (JGA). The latest data from December 2015 showedgenerics volume penetration of 56.1%, he noted.

CANADIAN COMPANIES expect within the next two months toconclude the latest generics pricing negotiations with the federalnegotiating team representing provincial payers. Apotex’ GlobalGenerics head Jeff Watson noted that the current agreement – wherebyprices for 18 commonly-used molecules are set at 18% of the referencedrugs’ prices – would end in April next year. Tendering systemsremained under discussion, he added. G

IN BRIEF

Discussions around greater regulatory convergence for biosimilarsand complex generics, as well as for facility inspections, during

negotiations over a Trans-Atlantic Trade and Investment Partnership(TTIP) trade agreement have “helped to achieve momentum in severalareas”, according to Emer Cooke, head of international affairs forthe European Medicines Agency (EMA).

Speaking at the first joint conference of Medicines for Europeand the International Generic and Biosimilar Medicines Association(IGBA), Cooke said regulators hoped that the TTIP negotiationswould succeed in producing a ratified agreement. But if they didnot, she added, the “valuable process” could still lead to significantregulatory improvements.

“The European Union (EU) is pushing convergence on biosimilarsand complex generics,” Cooke pointed out in reference to letters sentby the European Commission to US authorities (Generics bulletin,5 February 2016, page 1). Furthermore, she added, there had been“significant progress” on mutual recognition of inspections.

On biosimilars, Cooke said a cluster of regulators from the EU,US, Canada and Japan was working to harmonise guidelines and createdata requirements “acceptable to all agencies”. Furthermore, abiosimilars working group within the International PharmaceuticalRegulators Forum (IPRF) was drawing up a reflection paper onextrapolation of indications, a concept that engendered “inherentdistrust” among healthcare professionals and patients. Assessor trainingon biosimilars for both EU and non-EU regulators was scheduled totake place by the end of 2016, she added.

Apotex’ chief executive officer, Jeremy Desai, applaudedseveral of the regulators’ initiatives, but stressed that convergencehad “not yet translated to the point where we can say it is workingfor us”. “We are still decades away from one global scientificreview,” he suggested. G

REGULATORY AFFAIRS

Regulators see hopein TTIP negotiations

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

Collaboration between the European and global generics associationswill ultimately lead to industry speaking with a unified voice on

an international level, according to representatives from Europeangroup Medicines for Europe (MfE) and the International Generic andBiosimilar Medicines Association (IGBA).

Speaking at the first joint conference of MfE and the IGBA heldin Dubrovnik, Croatia, earlier this month – which also functioned asthe 22nd MfE annual conference and the 19th annual conference forthe IGBA – the global association’s chair, Vivian Frittelli, said that theIGBA expected imminently to be admitted as a full member of theInternational Council for Harmonisation (ICH), where the IGBA’scompany members have already participated in working groups.

Having submitted an application two months ago, the IGBA hadbeen asked to attend as observers to the ICH general assembly laterthis month, Frittelli noted. “We need a place there,” he insisted, whileMfE president Jacek Glinka agreed that a presence as an ICH memberwas “essential”. Frittelli added that the “ultimate goal” of joining theICH management committee could only be reached after two yearsas a member of the assembly.

Responding to queries over whether the IGBA would set up apermanent presence for lobbying purposes, Frittelli commented thatthe association was exploring funding models to work towards thateventual goal. “At the moment, we’re focusing more on gainingmembership,” he observed, adding that the Costa Rican genericsassociation had recently applied to join.

MfE director-general Adrian van den Hoven nevertheless notedthat Frittelli was planning to lead a mission on behalf of the IGBAto Geneva, Switzerland, “in a couple of months”. The associationwould be “reaching out to other groups there”, van den Hoven said,to “forge co-operation and make alliances”.

Frittelli added that a key aim was to obtain recognition from otherGeneva-based organisations such as the World Health Organization(WHO) and World Trade Organization (WTO). Having last year agreeda set of key IGBA principles for global trade agreements (Genericsbulletin, 5 December 2014, page 20) – which were being disseminatedthrough training workshops – Fritelli acknowledged that the associationwould “have to shout loud” to have its views on pharmaceuticals heardin the larger context of such international trade deals.

Meanwhile, Glinka noted that the recent rebranding of the formerEuropean Generic and Biosimilar medicines Association (EGA) underthe MfE banner earlier this year (Generics bulletin, 18 March 2016,page 7) had come as a result of “rethinking whether our brandcommunicates our scope and message”. The rebranded organisationcovers three sector groups: one each for generic medicines, biosimilarmedicines and value-added medicines.

In the face of persistent barriers to uptake – such as patent-linkageregimes, ineffective pricing and reimbursement mechanisms, andregulatory inefficiency – Glinka said “we are ready to do more, andwe will do more, as an industry”. But industry alone was “not strongenough”, he cautioned, urging partnership and collaboration with abroad spectrum of stakeholders, including payers, prescribers, patientsand other associations such as European brand body EFPIA. “Workingtogether, we can do a lot more,” he insisted.

Addressing the conference, US Generic PharmaceuticalAssociation (GPhA) chair Heather Bresch observed the US associationhad reacted so positively to MfE’s rebranding exercise that the GPhAwas “undergoing a similar effort”. G

MEDICINES FOR EUROPE



Global industry willspeak with one voice

Biosimilar manufacturers and payers each appreciate the need fora sustainable market, but they differ on how to achieve that goal,

according to the preliminary findings of a study commissioned byMedicines for Europe (MfE).

Outlining the findings during the first joint annual conference ofMfE and the International Generic and Biosimilar MedicinesAssociation (IGBA) held in Dubrovnik, Croatia, Simon Kucher &Partners’ Michael Dilger said the consultancy had to date analysedthe sustainability of national pricing and market-access policies forbiosimilars in seven European countries – France, Germany, Italy,Norway, Poland, Spain and the UK. The main focus had been onmanufacturers, payers and policy-makers, he said, although patientsand physicians had been considered indirectly.

When presented with nine criteria defining a sustainable biosimilarsmarket, manufacturers and payers were quite closely aligned on six.But manufacturers felt three criteria – a fair price level, commercialattractiveness and acknowledgement of biosimilar complexity in pricingand market-access processes – to be considerably more important thatpayers considered them to be.

While producers felt processes such as single-winner tendersimmediately sought high discounts, payers claimed companies werevoluntarily slashing prices. Payers also complained that they lacked thereal cost information to judge the validity of manufacturers’ argumentson the need for commercial attractiveness to recoup investments. Andcounter to industry’s beliefs, payers generally believed their policiesalready reflected the complexity of bringing biosimilars to market.

Outlining five principles for sustainability, Dilger said pricingand market-access policies should ensure: investments are “balancedby a reasonable income”; “healthy competition” among severalmanufacturers is maintained; lower biosimilar prices are accompaniedby guidance on use and prescribing incentives; long-term commercialattractiveness generates savings; and benefits are “gain-shared”between payers, decision-makers and prescribers. G

MARKET RESEARCH

Producers and payersvary on key priorities

Inadvertent alignment of tenders, tight lead-times, unfavourablecontract lengths and disproportionate penalties for failure to supply

are among the supply-chain challenges faced by industry, accordingto Derek Brown, director of Actavis UK’s hospital business.

Addressing the joint conference of Medicines for Europe and theInternational Generic and Biosimilar Medicines Association (IGBA),Brown observed that many tenders ran from the first day of January,which caused “congestion impacts on manufacturing, capacity, activepharmaceutical ingredient (API) availability and the supply chain”,and also had an effect on product shelf-life. “In England, there is aproposal to align all hospital-only contracts away from a rollingregional tender framework,” he noted.

Meanwhile, tender operators often gave suppliers little timebetween submissions to tenders, award dates, the start date of contractsand the time to first supply. This “creates a huge workload, congestedactivity, and demands products within timeframes which are not alwayscredible or sustainable”, he said, urging “ideally four to six monthslead-time to start of supply”. G

MANUFACTURING

Supply chain sees challenges

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

The US Food and Drug Administration (FDA) has again rejectedAdamis Pharmaceuticals’ application for its epinephrine pre-filled

syringes, requesting that further studies be completed before it willapprove the US firm’s alternative to Mylan’s EpiPen (epinephrine).

Adamis has received a second complete response letter (CRL) fromthe agency, in which the FDA states that Adamis “must expand its humanfactors study [for patient usability] and reliability study [for productstress testing]” in order to advance its new drug application (NDA).

The FDA’s initial CRL for Adamis’ hybrid 505(b)(2) epinephrine0.3mg pre-filled syringes, which the firm received in March last year,raised questions pertaining to “chemistry, manufacturing and controls(CMC) relating to the volume of dose delivered by the syringe”.

“The company believes that it can finalise the study protocols withthe FDA and complete the additional testing within a relatively shortperiod of time at an immaterial cost,” Adamis noted, adding that it wouldsubmit data back to the agency “sometime in the second half of 2016”.

Adamis joins Teva in facing a setback to introducing anepinephrine alternative in the US. The FDA earlier this year “identifiedcertain major deficiencies” in the Israeli firm’s abbreviated new drugapplication (ANDA), leading the Israeli firm to announce that anyproposed launch would not take place “before 2017” (Genericsbulletin, 4 March 2016, page 1).

Adamis last month struck a licensing and marketing agreementwith Allergan’s Actavis for its epinephrine candidate, with up toUS$32.5 million in upfront and milestone payments available to theUS firm, on top of “double-digit” sales-based royalty payments(Generics bulletin, 13 May 2016, page 13). G

PRODUCT NEWS


ANAPHYLAXIS DRUGS

Adamis’ epinephrine rejected

Asustained-release patent protecting AstraZeneca’s Seroquel Prolong(quetiapine) sustained-release tablets is invalid, Spain’s supreme

court, the Tribunal Supremo, has confirmed. The opinion, which cannotbe appealed, upholds a Barcelona Court of Appeal’s finding of invalidityfor lack of inventive step that was handed down in late October 2013(Generics bulletin, 15 November 2013, page 23).

Ruling in favour of Accord Healthcare and Sandoz, the TribunalSupremo decided that the Barcelona court had correctly and logicallyapplied a “problem-solution approach” in finding that Spanish patentES2,182,079 – the local counterpart to AstraZeneca’s Europeansustained-release patent EP0,907,364 – lacked an inventive step.

The Barcelona Court of Appeal had overturned a lower court’sruling in favour of AstraZeneca, having accepted arguments broughtby Accord and Sandoz that it would have been obvious to a skilledperson, in light of prior-art references, to develop a sustained-releaseformulation as described in the Spanish ‘079 patent.

AstraZeneca reported European sales of Seroquel XR/Prolongdown by 41% to US$35 million in the first quarter of this year asgeneric competition hit. The originator in January this year settled itsdispute with Accord in France over the ‘364 patent, shortly after aninjunction on Mylan’s launch was lifted. In Germany, AstraZenecafaces damages claims from generics firms over an injunction itsecured in April 2012 ahead of an invalidity finding later that year(Generics bulletin, 23 November 2012, page 1). G

ANTIDEPRESSANTS

Spanish court stopssustained Seroquel

STRIDES SHASUN has received its “first product approval underthe US Generic Drug User Fee Amendments (GDUFA)”, formetronidazole 250mg and 500mg tablets. Citing IMS data, theIndian company said the US market for the two presentations wasworth around US$50 million. Meanwhile, Strides Shasun has alsoreceived a tentative approval for a rival to Bristol-Myers Squibb’sSustiva (efavirenz) 600mg tablets, which have a US market worthUS$150 million. “The final approval will be received after patentexpiry in August 2018,” Strides said. And the firm has just secured atentative approval for its roflumilast 500µg tablets, the US marketfor which is worth US$174 million, according to IMS. The Indianfirm is currently engaged in paragraph IV litigation over theproduct, believing itself to be one of the first generic challengers.All of these products will be manufactured at the company’s oraldosage facility at Bangalore, India, that has just received USapproval (see page 4).

MEDICINES FOR EUROPE director-general Adrian van den Hovenhas highlighted that the association’s Biosimilar Medicines Group(BMG) is “engaging actively to reduce the information gap as anessential means to improving stakeholder trust, understanding andacceptance of biosimilar medicines”. Speaking as Medicines forEurope held a symposium on extrapolation and interchangeability(Generics bulletin, 3 June 2016, page 6) at the annual congress ofthe European League Against Rheumatism (EULAR) in London,UK, the BMG said physicians needed “a clear understanding ofthe underlying scientific principles of the biosimilarity concept”.

AJANTA PHARMA has been granted final approval for voriconazole50mg and 200mg tablets by the US Food and Drug Administration(FDA). The nod for the triazole antifungal represents the tenth finalabbreviated new drug application (ANDA) approval for Ajanta, whichalso has two tentative ANDA approvals. A further 14 ANDAs arestill under review by the agency. Meanwhile, Ajanta has just launchedmemantine 5mg and 10mg tablets in the US.

MERCK, SHARP & DOHME has revealed data indicating that itsMK-1293 insulin glargine candidate has met its primary andsecondary endpoints in two Phase III studies, “showing non-inferiority” when compared with Sanofi’s Lantus version. Thebiosimilar candidate – developed in collaboration with SamsungBioepis – was tested in patients with type 1 and type 2 diabetes.

HIKMA has received US Food and Drug Administration (FDA)approval for a generic rival to GlaxoSmithKline’s Flonase(fluticasone) 50µg spray. “Combined generic and branded sales forthe twelve months ended May 2016 were US$343 million,” theJordanian firm observed. Hikma has partnered with Perrigo for thelaunch, which expects to “begin customer shipments immediately”.

TEVA has announced a “positive conclusion for the Europeandecentralised procedure” for its Braltus (tiotropium bromide)bronchodilator. “Braltus contains a new dry-powder formulationof tiotropium bromide, delivered through a new capsule-based inhaler,the Zonda inhaler,” the Israeli firm noted.

US STATE LEGISLATION has been enacted in Missouri for thesubstitution of interchangeable biologics after governor Jay Nixonsigned into law Senate Bill 875. While the US Food and DrugAdministration (FDA) oversees approval of biologic medicines anddesignation of interchangeability – and has not yet publishedguidelines on the subject – policies governing substitution arecovered by state law. G

IN BRIEF

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

PRODUCT NEWS


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Allergan’s Actavis has filed a motion with the US Court of Appealsto shelve patent-litigation proceedings concerning its proposed US

generic version of Amarin Pharma’s Vascepa (icosapent ethyl) afterthe cholesterol-lowering agent was handed additional exclusivity.

At the beginning of this year, New Jersey District Judge MaryCooper granted Amarin’s motion to dismiss litigation against Actavis,as well as Apotex, Dr Reddy’s, Hikma’s Roxane and Teva, in light of aseparate US ruling that saw the US Food and Drug Administration(FDA) suspend review of the firms’ generic filings (Generics bulletin5 February 2016, page 13).

The latter court ruling had vacated and remanded for a newdetermination an FDA decision that Vascepa was eligible for threeyears of exclusivity, instead of the five years that is handed out tooriginators for a new chemical entity (NCE).

But the FDA has decided, at the end of May, to award Vascepafive years of new chemical entity exclusivity, leading to Actavis’motion to terminate litigation. “Once the Court of Appeals grants[Actavis’] unopposed motion to dismiss the appeal, there will be nopending litigation related to Vascepa,” Amarin noted.

Separately, Actavis has received a mixed ‘Markman’ claim-construction ruling in patent-litigation proceedings over Orexigen’sContrave (naltrexone/bupropion) extended-release tablets, the weight-loss treatment for obese adults distributed by Takeda in the US. G

CHOLESTEROL-LOWERING DRUGS/WEIGHT-LOSS DRUGS

Actavis dismisses itsUS Vascepa appeal

Pfizer’s Hospira has convinced UK patents judge Henry Carr torevoke three patents protecting Cubist’s Cubicin (daptomycin)

antibiotic. One of the patents covers a dosage regimen, while theother two cover purification methods.

Addressing the UK part of European patent EP1,115,417, Carrfound that all of the ‘417 patent’s claims lacked an inventive step over apress release that Cubist had issued in March 1999 to detail clinicaltrials for once-a-day daptomycin. Dosages of 4mg/kg to 6mg/kg every24 hours disclosed in the press release fell within the ‘417 patent’sclaimed 3mg to 10mg per kg per day range, he stated in finding that askilled team would have had a fair expectation of success indemonstrating efficacy at such doses.

Furthermore, Carr decided, claims 1-7 of the ‘417 patent wereobvious in light of the prior art Woodworth paper from 1992 that“explicitly discloses once-daily doses at 4-6mg/kg”.

Prior art invalidates purity patentTurning to the EP1,252,179 purification method patent, Carr

said all of the patent’s independent claims were obvious against USpatent 4,874,843. A skilled team, when reading the ‘843 patent, wouldhave been motivated to improve the purity of daptomycin beyond 93%,including by choosing the “routine option” of ion-exchangechromatography and employing the “standard practice” of using buffers.Claim 1 of the ‘179 patent was also obvious over “common generalknowledge”, Carr added.

Cubicin’s purity patent EP2,264,047 was held to be obvious in lightof a prior-art Lin & Jiang article from 1997 on purifying biosurfactants.

In reaching his decision, Carr acknowledged that the EuropeanPatent Office’s (EPO’s) Opposition Division had found that the ‘417patent lacked an inventive step, although that finding was currentlyunder appeal. The US equivalent of the ‘417 patent had been held tobe anticipated and obvious in light of prior art, while US purity patentswere also invalid (Generics bulletin, 20 November 2015, page 20). G

ANTIBIOTICS

Hospira defeats UKdaptomycin patents

Chemo Group is collaborating with non-profit organisations theDrugs for Neglected Diseases initiative (DNDi) and Mundo Sano

to register benznidazole in the US and Latin America. The trio isaiming to “overturn a situation where less than 1% of people withChagas disease have access to treatment”.

Chemo Group and its corporate social responsibility partner MundoSano are working to register adult 100mg and paediatric 12.5mgbenznidazole for Chagas treatment with the US Food and DrugAdministration (FDA), as well as in Mexico, Colombia and otherendemic countries in Latin America.

According to Spain’s Chemo – which is seeking an FDA priorityreview voucher – DNDi will support this move by sharing “technicaland scientific expertise”, and “providing data gathered with partnersfrom previous clinical trials for adult and paediatric forms”.

Ensuring benznidazole is made available to the public sector inChagas-endemic countries on an affordable basis is Chemo Group’saim. “Our goal is to ensure its widespread use and equitable access forall patients,” said Leandro Sigman, the company’s managing director. G

CHAGAS DISEASE DRUGS

Three ally over benznidazole

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

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...

Adate of 12 July has been set for the US Food and DrugAdministration’s (FDA’s) Arthritis Advisory Committee to meet

to review Amgen’s biologics license application (BLA) for its ABP-501adalimumab candidate.

The US originator said the committee would “review analytical,clinical and pharmacokinetic data from studies” supporting Amgen’sapplication, which was accepted for review by the FDA at the beginningof this year (Generics bulletin, 29 January 2016, page 16).

This study data included results from two Phase III comparativeefficacy and safety studies conducted against AbbVie’s Humira(adalimumab) brand in both moderate-to-severe plaque psoriasis andmoderate-to-severe rheumatoid arthritis, Amgen noted, along with“data to support the transition of adalimumab patients to ABP-501”.

The agency has set a Biosimilar User Fee Act (BsUFA) targetaction date for Amgen’s application of 25 September 2016.

Separately, Coherus BioSciences has successfully petitioned theUS Patent and Trademark Office (USPTO) to conduct inter partesreviews of Humira dosing regimen patents 9,017,680 and 9,073,987.The USPTO had only last month granted the US developer’s requestfor an inter partes review of US Humira patent 8,889,135 (Genericsbulletin, 20 May 2016, page 12), as part of Coherus’ attempts tolaunch its CHS-1420 biosimilar adalimumab in 2018. G

BIOLOGICAL DRUGS

Amgen’s US Humirarival gets review date

Biosimilars developers have presented data on their monoclonalantibody (mAb) candidates and marketed biosimilars at the

European League Against Rheumatism’s (EULAR) 2016 annualcongress, which was held in London, UK, earlier this month.

Samsung Bioepis, the South Korea-based joint venture of SamsungBiologics and Biogen, said switching data from Phase III trialsinvolving its Benepali (etanercept), Flixabi (infliximab) and SB5adalimumab candidate demonstrated “sustained comparable efficacyand safety profiles” against their respective reference brands.

This included “long-term data” for Benepali and Flixabi, whichrival Amgen’s Enbrel and Janssen’s Remicade respectively, withcomparable efficacy and safety profiles “up to week 100 and week 78”in the biosimilars’ related Phase III clinical trials respectively. SB5,an alternative to AbbVie’s Humira, had shown similar data from itsone-year Phase III study, Samsung added.

Momenta and Coherus offer dataMomenta and Coherus BioSciences also presented data on their

M923 adalimumab and CHS-0214 etanercept candidates respectively.The former’s presentation included key data from a pharmacokineticand safety study for its biosimilar Humira that it is developing withShire’s Baxalta, and followed the announcement of the M923 candidatemeeting the primary endpoints of a pharmacokinetic study at the endof last year (Generics bulletin, 8 January 2016, page 12).

Coherus, meanwhile, released study data “demonstrating theequivalence” of its etanercept candidate against Amgen’s Enbrel original.The US pure-play developer noted that, at the outcome of the study,“there were no clinically meaningful differences between CHS-0214and etanercept with regard to safety and immunogenicity”. G

BIOLOGICAL DRUGS

Firms present biosimilar data

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

Allergan’s Actavis and Endo’s Par have together received a mixedverdict in US patent-litigation proceedings concerning their

attempts to introduce the first generic versions of Invidor’s Suboxone(buprenorphine/naloxone) sublingual film formulation in the US.

Delaware District Judge Richard Andrews has ruled that allasserted claims of the opioid dependence treatment’s latest-expiringUS patent – 8,475,832, which shields Suboxone until 26 March 2030 –were invalid due to obviousness, while other claims were indefinite.Moreover, he found, the generics firms’ proposed rivals did not infringecertain claims of the patent, although other claims of the ‘832 patentwould be infringed, were they valid.

However, asserted claims within US patents 8,017,150 and8,603,514, which expire on 13 February 2023 and 3 April 2024respectively, were found to be valid by Andrews. The ‘514 patent claimsare also infringed by Actavis and Par’s abbreviated new drug application(ANDA) products, according to Andrews’ judgement, although the‘150 patent claims are not.

These are the only patents listed against Suboxone film in theUS Food and Drug Administration’s (FDA’s) Orange Book.

Although the ruling was, according to the former Reckitt Benckiserunit, a “very important milestone” for Invidor, the UK firm warnedinvestors to be “mindful that the company has ongoing litigation againstfour other ANDA filers”. A trial against Teva is scheduled to start inNovember this year, while lawsuits involving Alvogen, and Mylan andSandoz together (Generics bulletin, 23 October 2015, page 23), wereprojected to begin in April and September next year respectively.

Moreover, in February this year, Teva also sent Invidor aparagraph IV patent challenge concerning the Israeli firm’s hybrid505(b)(2) 16mg/4mg version of Suboxone. The brand, which had a 59%share of the US buprenorphine/naloxone sublingual film market lastyear, is currently available in four strengths: 2mg/0.5mg, 4mg/1mg,8mg/2mg and 12mg/3mg. G

PRODUCT NEWS


OPIOID DEPENDENCE DRUGS

US court ruling takesout Suboxone patent

Sandoz’ proposed US rival to Amgen’s Enbrel (etanercept) will bediscussed by the US Food and Drug Administration’s (FDA’s)

Arthritis Advisory Committee at a public meeting on 13 July. Similarmeetings have preceded FDA approval for Sandoz’ filgrastim andCelltrion’s infliximab biosimilars. Sandoz’ etanercept filing was acceptedby the FDA in October (Generics bulletin, 23 October 2015, page 21).

The announcement of the meeting date came as Sandoz revealedthat its rivals to Enbrel and Rituxan/MabThera (rituximab) had metprimary endpoints in separate “key” bioequivalence studies.

A Phase I trial for the Novartis affiliate’s rival to Enbrel“demonstrated pharmacokinetic (PK) bioequivalence and no clinicallymeaningful differences in safety, tolerability and immunogenicity”between itself and the brand.

Meanwhile, Sandoz’ rituximab candidate, which was accepted forevaluation by the European Medicines Agency (EMA) several weeksago (Generics bulletin, 3 June 2016, page 12), also demonstratedPK bioequivalence “and similar pharmacodynamic safety, efficacyand immunogenicity” to Roche’s original in a Phase II study. Sandoz’US filing for rituximab is scheduled for next year. G

BIOLOGICAL DRUGS

Sandoz gets etanercept date

Mayne Pharma has launched the first generic version of Tikosyn(dofetilide) in the US after its abbreviated new drug application

(ANDA) was approved by the US Food and Drug Administration(FDA) with 180 days of generic market exclusivity.

The launch follows a settlement agreement reached in Februarylast year whereby Pfizer dropped litigation concerning US patent6,124,363 that protects Tikosyn until 9 October 2018 (Genericsbulletin, 13 March 2015, page 18).

According to IMS Health, annual sales of Tikosyn in the US wereapproximately US$200 million for the 12 months ended April 2016.Available as 0.125mg, 0.25mg and 0.5mg capsules, the antiarrhythmicagent is used to prevent irregular heartbeats such as atrial fibrillationand atrial flutter.

Mayne’s chief executive officer, Scott Richards, describeddofetilide’s launch as a “significant milestone” for the company, astheir first generic product to receive 180-day market exclusivity inthe US. “We are proud to be the first generic drug alternative to Tikosynin the US, bringing significant cost savings to patients requiring thislife-saving drug,” he commented. “This approval accelerates ourgrowth and underscores our investment and commitment to bringingcomplex generic products to the marketplace.”

Mayne – which has two product development and manufacturingfacilities based in Salisbury, Australia and Greenville, US – has anagreement with long-time partner Johnson Matthey, the activepharmaceutical ingredient (API) supplier for dofetilide, to “equallyshare the profits from the sale of this product”.

The timing of Mayne’s market approval coincided with the FDA’swithdrawal of the Tikosyn risk evaluation and mitigation strategies(REMS) programme, which “limited the drug’s availability anddispensation to certified prescribers, pharmacies and wholesalers”,according to Mayne. The removal means Mayne’s dofetilide capsulescan be “more readily stocked by pharmacies nationwide”. G

CARDIOVASCULAR DRUGS

Mayne gets FDA nodfor first Tikosyn rival

In a bid to develop its domestic Global Consumer Healthcare (GCH)business, India’s Sun Pharma says it is focusing on dermatology as

the “fourth engine of growth” for its over-the-counter (OTC) business.The Indian GCH business markets dietary supplements, analgesicsand antacids, and its entry into dermatology offers Sun a “largerplay into the fast-moving consumer goods category”.

Subodh Marwah, business head of GCH, said the company’s forayinto dermatology was “an indicator of the focus and importance SunPharma assigns to grow the consumer healthcare business”. A sunscreenproduct, Suncros, is the company’s first dermatology product to berolled out through the GCH business.

Sun entered the consumer healthcare and OTC business as a resultof its US$4 billion merger with Ranbaxy in March last year (Genericsbulletin, 13 March 2015, page 3). Outlining one of the key benefitsof the merger to be the “combined firm’s increased ability to invest inresearch and development”, Sun’s managing director, Dilip Shanghvi,said the GCH business would be “used as a ‘nucleus’ to develop thebusiness in other markets in which the firm did not have a significantpresence” (Generics bulletin, 10 April 2015, page 24). G

DERMATOLOGY DRUGS

Sun adds derma to local OTC

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

PRODUCT NEWS


Four US composition patents protecting Teva’s Treanda(bendamustine hydrochloride) 25mg and 100mg vials are not invalid

due to obviousness, a US district court has decided, quashing argumentsbrought by five abbreviated new drug application (ANDA) filers.

Accord, Hetero, Hospira, InnoPharma and Sagent had already,in November last year, stipulated to infringement of the patent claimsasserted by Teva’s Cephalon affiliate in the consolidated ruling.

The firms however argued before Delaware District JudgeGregory Sleet that claims of US patents 8,609,863, 8,791,270 and8,895,756, which all expire on 12 July 2026, and US patent 8,436,190 –which shields the chronic lymphocytic leukaemia treatment until26 April 2031 – were obvious in light of prior art.

But Sleet was not convinced, ruling that a skilled person wouldnot have been motivated to start with the process of lyophilisation, asCephalon had done, to improve Astellas Pharma’s prior bendamustinehydrochloride formulation, Ribomustin. “This decreases the likelihoodof the court finding the final lyophilised product is obvious,” he noted.

This led Sleet to find that a skilled person would not have arrivedat the claimed limitations “through routine experimentation”, as thegenerics firms had argued. “Although this [lyophilisation] process maybe routine, the court is not convinced that it is as straightforward asdefendants profess,” he said. “A person of skill would not have startedwith lyophilisation precisely because of its complexity.”

Sleet also ruled that certain claims of the ‘270 patent were neitherinvalid due to anticipation nor rendered invalid under the US on-salebar. However, the firms convinced the district court that three claimsof that patent had been derived from Astellas’ erstwhile Fujisawaaffiliate, and were therefore invalid.

Patents expire from 2026 to 2029Treanda is in total shielded by seven US patents, according to the

US Food and Drug Administration’s (FDA’s) Orange Book. Theremaining three patents have expiry dates ranging from 2026 to 2029.

Earlier this year, Glenmark obtained final approval for bothstrengths of its generic version of Treanda (Generics bulletin, 1 April2016, page 9), having earlier struck a patent-litigation settlementagreement that entitles it to launch from 1 November 2019. Both Hospiraand InnoPharma – which have become affiliates of Pfizer since litigationproceedings began – also hold final ANDA approvals, as well as Accord.

However, Teva expects, in the words of Teva Oncology generalmanager Paul Rittman, to eventually “replace Treanda with Bendeka”,a rapid-infusion formulation of bendamustine that it launched in theUS with developer Eagle Pharmaceuticals at the beginning of thisyear (Generics bulletin, 5 February 2016, page 15). Teva acquiredthe US marketing rights for Bendeka in a US$120 million deal lastyear, but recently saw the FDA decide not to award seven years oforphan-drug exclusivity (ODE) for the product (Generics bulletin,8 April 2016, page 8).

Separately, Teva has voluntarily suspended sales, marketing anddistribution of its Zecuity (sumatriptan) transdermal patch in the USfollowing reports that patients using the migraine treatment had suffered“reactions described as burns and scars”. Teva said it had initiated a“pharmacy-level recall of the product”.

Teva has also just obtained an advisory committee recommendationfor final FDA approval for its hydrocodone bitartrate extended-releasetablets that feature the Israeli firm’s proprietary abuse-deterrencetechnology, under the name Vantrela ER. G

ONCOLOGY DRUGS

US court rules validfour Treanda patents

LIPIDOR and Cadila Pharmaceuticals have struck a deal tocollaborate on marketing “a sprayable anti-psoriatic product consistingof the generic vitamin D analogue, calcipotriol”. The product wouldbe “formulated with Lipidor’s patented lipid-based drug-deliverytechnology, Akvano”, the firms stated. As part of the agreement,Cadila will conduct a Phase III programme in India starting this year.

AMGEN has filed a notice of appeal over a US Delaware DistrictCourt order denying Amgen’s request to compel Hospira to producemanufacturing information relating to the Pfizer unit’s proposedepoetin alfa biosimilar.

ZYDUS CADILA has received final US Food and Drug Administration(FDA) approval to market amantadine 100mg capsules in the US.Citing IMS data, the Indian company said the market for the drugwas worth around US$40 million.

PERRIGO has filed a paragraph IV challenge to Leo Pharma’sPicato (ingenol mebutate) 0.015% and 0.05% gel. “Perrigo believesit is a first filer for this opportunity, making it eligible for 180 daysof generic exclusivity,” the firm stated. G

IN BRIEF

Health Canada has approved additional indications for Hospira’sInflectra (infliximab) biosimilar covering Crohn’s disease, fistulising

Crohn’s disease and ulcerative colitis. The Canadian regulator had in2014 approved the biosimilar infliximab developed with Celltrion forsome – but not all – of the indications approved for the referenceproduct, Janssen’s Remicade, despite this having been requested byCelltrion (Generics bulletin, 3 February 2014, page 13).

At the time, Health Canada said that while it had grantedindications for rheumatoid arthritis, ankylosing spondylitis, psoriaticarthritis and plaque psoriasis, “extrapolation to indications and usespertaining to Crohn’s disease and ulcerative colitis could not berecommended due to differences between Inflectra and the referenceproduct that could have an impact on the clinical safety and efficacyof these products in these indications”.

Hospira’s parent company Pfizer said the additional indicationshad now been “granted on the basis of similarity between Inflectraand the reference product, Remicade, in product quality, mechanismof action, disease pathophysiology, safety profile, dosage regimen andon clinical experience with the reference product”. An updated productmonograph issued on 10 June includes the newly-added indications.

“Pfizer will now work with provincial drug programmes, privatepayers and other stakeholders to ensure Crohn’s disease and ulcerativecolitis are part of the indications approved for reimbursement,” theUS originator stated.

Health Canada’s decision follows Celltrion’s successful rebuttalof Janssen in litigation over Canadian patent CA2,261,630. Janssen wasseeking a prohibition order relating to Celltrion’s 2015 supplementarynew drug submission (SNDS) applying for approval for the additionalindications. Ultimately, ruled a Toronto federal court, the ‘630 patentdid not refer to the inflammatory bowel disease indications “on a plainreading of the claims”. “There is simply no evidence of infringementbefore the court on this motion.” G

BIOLOGICAL DRUGS

Inflectra indicationsare added in Canada

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

PRICE WATCH .............UK


April sales offers by suppliers of celecoxib 200mg and duloxetine30mg capsules were withdrawn in May, apparently as other

suppliers were responding to their initiatives.Eclipse was quoting £0.40 (US$0.58) for 30-capsule packs of

celecoxib 200mg in April. This was the lowest recorded by WaveData,but Eclipse doubled its price to £0.80 in May, which was more thanthe £0.75 on offer elsewhere. The resulting 88% increase in the lowestprice was in sharp contrast to a 3% average price fall in the rest ofthe market for the COX-2 painkiller (see Figure 1).

Similarly, Forte Direct was advertising 28-capsule packs ofduloxetine 30mg at £1.35 in April, but this offer was not repeatedlast month. Nevertheless, the average price of the antidepressantstill fell by 20% to £3.49 in May, even as the lowest price availablerose by 30% to £1.75.

Prices for escitalopram 10mg tablets followed the same trend.

A double-digit increase to the admittedly still low price of £0.23 wasaccompanied by an average price fall of 16% to £0.74 for 28-tabletpacks of the antidepressant.

Irbesartan 75mg tablets in 28-count packs were 10% cheaper onaverage in the trade last month than they had been in April, while theirlowest price fell faster by 12% to £0.30. Aripiprazole 10mg continuedits steep price decline, with both its average and lowest prices droppingby 22%, while rabeprazole could be obtained last month for a 25%discount on its April price, taking its May average down as well.

Meanwhile, prices for 56-tablet packs of isosorbide 10mg, 20mgand 40mg went through the roof (see Figure 2), far outweighing theprice falls in Figure 3. Most UK suppliers continued to ensure thatthe proton-pump inhibitors lansoprazole and omeprazole, as well asthe statins atorvastatin and simvastatin, were ever-presents on theirprice lists (see Figure 4). G

Figure 1 (above): Comparison between the periods 1-30 April 2016 and 1-31 May2016 of UK trade prices of the most recently-launched generics listed in categoryM of the Drug Tariff of pharmacy-reimbursement prices. Averages calculated from atleast 25 data points. Figure 2 (top right) and Figure 3 (centre right): Biggest averagetrade-price changes between 1-30 April 2016 and 1-31 May 2016. Averagescalculated from at least 24 data points. Figure 4 (bottom right): Ranking of fastest-moving products subject to the most price offers made to independent UKpharmacists (one strength per ingredient; offers recorded by 31 May). Data forFigures 2, 3 and 4 from a basket of about 750 commonly-dispensed generics. Recently-launched products in Figure 1 excluded from Figures 2 and 3 (Source – WaveData).

WANT MORE LIKE THIS?

RECENT LAUNCHES

Product/Strength/Pack size Lowest Change Average Changeprice (%) price (%)

Aripiprazole tabs 10mg 28 £1.05 -22 £2.28 -22

Atorvastatin tabs 20mg 28 £0.40 ±0 £0.71 -4Benzydamine 0.15% 300ml £4.85 ±0 £5.79 ±0Carbimazole tabs 5mg 100 £66.29 -2 £77.93 -5Celecoxib caps 200mg 30 £0.75 +88 £1.48 -3Cilostazol tabs 100mg 56 £2.09 -9 £3.95 -4Cyclizine tabs 50mg 100 £5.49 -11 £8.05 -5Desogestrel tabs 75µg 84 £1.21 -4 £2.09 +1Duloxetine caps 30mg 28 £1.75 +30 £3.49 -20Entacapone tabs 200mg 30 £3.69 +6 £5.08 -3Eplerenone tabs 25mg 28 £3.66 -3 £7.50 -12Escitalopram tabs 10mg 28 £0.23 +21 £0.74 -16Irbesartan tabs 75mg 28 £0.30 -12 £0.60 -10Memantine tabs 10mg 28 £0.42 ±0 £0.95 -2Montelukast tabs 10mg 28 £1.40 -8 £1.90 -2Nortriptyline tabs 10mg 100 £37.98 -7 £52.17 -5Oxcarbazepine tabs 300mg 50 £4.85 -1 £6.69 +3Rabeprazole tabs 10mg 28 £0.69 -25 £1.36 -7Raloxifene tabs 60mg 28 £2.65 -2 £3.79 -3Riluzole tabs 50mg 56 £11.25 -5 £18.31 -4Rizatriptan tabs 10mg 3 £0.80 +5 £1.51 -12Sevelamer tabs 800mg 180 £59.70 -12 £87.43 -7Sildenafil tabs 100mg 4 £0.23 -8 £0.49 -14Telmisartan tabs 80mg 28 £0.74 -3 £1.38 -1Tolterodine tabs 2mg 56 £1.25 +12 £1.85 -5

FAST MOVERS

Price offers as at 31 May 2016Product/Strength/Pack size March April May

Omeprazole caps 20mg 28 118 129 123

Lansoprazole caps 30mg 28 108 105 103

Atorvastatin tabs 10mg 28 83 89 100

Simvastatin tabs 40mg 28 101 94 96

Hydrocortisone tabs 10mg 30 74 75 93

Ramipril caps 10mg 28 91 77 91

Bisoprolol tabs 2.5mg 28 90 90 90

Gabapentin caps 300mg 100 85 90 89

Sertraline tabs 50mg 28 91 113 87

Bendroflumethiazide tabs 2.5mg 28 93 87 87

BIGGEST FALLERSProduct/Strength/Pack size Lowest Change Average Change

price (%) price (%)

Trospium chloride tabs 20mg 60 £4.49 ±0 £5.30 -46

Pioglitazone tabs 30mg 28 £6.50 -28 £16.18 -35

Duloxetine caps 20mg 28 £1.95 -24 £4.08 -27

Co-amoxiclav susp. 250mg/62mg £1.71 -20 £2.14 -27

Pioglitazone tabs 45mg 28 £7.49 -17 £20.93 -27

Digoxin tabs 125µg 28 £1.64 -15 £2.29 -25

BIGGEST RISERSProduct/Strength/Pack size Lowest Change Average Change

price (%) price (%)

Isosorbide tabs 10mg 56 £0.77 +43 £6.18 +415

Isosorbide tabs 40mg 56 £0.54 -8 £5.91 +299

Isosorbide tabs 20mg 56 £0.40 ±0 £2.13 +145

Naproxen tabs 500mg 28 £0.52 ±0 £1.72 +91

Amiodarone tabs 200mg 28 £0.88 ±0 £2.45 +47Losartan tabs 12.5mg 28 £0.62 +5 £2.95 +45

May brings an end to April sales offers

Up to the minute live retail market pricing is available for 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].

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

MARKET RESEARCH


To mark the first joint annual conference ofMedicines for Europe and the InternationalGeneric and Biosimilar Medicines Association

(IGBA), the two bodies teamed up with Genericsbulletin to conduct a unique survey of the status andprospects for the global generics and biosimilarsindustries. A total of 12 questions were devised, oneeach to correspond with a session of the conferencethat took place this month in Dubrovnik, Croatia.

Two of the questions answered anonymously onlineby almost 100 leading industry executives sought todiscover which regions would offer the most competitivemanufacturing for both small-molecule generics andbiosimilars over the next five years.

For small-molecule generics, India dominated,capturing 41.1% of all votes cast (see Figure 1). Europeranked second with 26.0%, narrowly ahead of Chinaon 23.3%, with North and South America far behind.

But when asked the same question aboutbiosimilars, the picture was very different. Europecaptured just over two-fifths of the votes, while SouthKorea – perhaps reflecting the recent approvals formonoclonal antibodies achieved by Celltrion andSamsung Bioepis – was chosen by nearly a quarter ofrespondents (see Figure 2). India and North Americatied third with 13.5% each.

When asked about the greatest barriers to uptakeof biosimilars, industry executives identified two keyissues: misleading information creating confusion andmistrust among patients and physicians; and regulatorycomplexity causing development inefficiencies.

Industry key to co-operationDirect industry involvement and multilateral or

plurilateral initiatives were deemed the best way topromote regulatory co-operation that could facilitateoperations for industry. Increasing patient awarenessand closing illegal websites while supporting legalonline pharmacies were the best ways to combatcounterfeit drugs, executives felt. The overwhelmingfavourite path to strengthening the international supplychain was held to be harmonising regulatory standards.

Price, quality and reliability of delivery, in that

order, were viewed as the most important award criteriaused in medicines procurement procedures. Nearlyhalf of participants expected oncology medicines tofuel generics market growth over the next five years,well ahead of respiratory therapies in second anddiabetes drugs in third.

Just under half of respondents believed that patientempowerment through digital communications wouldhave the greatest impact on industry. And nearly two-thirds of executives anticipated patients’ importance forpharma companies increasing over the next fiveyears, a similar proportion to those who expectedpayers’ relevance to rise.

But when questioned about the key challenges tofurther growth in emerging markets, executives were farless united. As Figure 3 shows, sub-optimal healthcareinfrastructure was narrowly the leading answer, favouredby a fifth of respondents.

Another question asked: “What is the mostimportant healthcare inefficiency that could be addressedby value-added medicines?” Unmet patient needs wasfavoured by slightly over two-fifths of executives (seeFigure 4), with insufficient focus on healthcare outcomesranking second, just ahead of a lack of patient adherenceto, or concordance with, treatment. G

Senior generics and

biosimilars executives

expect India to lead

production of small-

molecule generics over

the next five years. But

Europe will spearhead

the next wave of

biosimilars production,

according to a major

industry survey.

Europe leads on biosimilars

NorthAmerica

4.1%

SouthAmerica

1.4%

India41.1%

China23.3%

Europe26.0%

Other4.1%

NorthAmerica13.5%

India13.5%

China6.8%

South Korea23.0%

Europe41.9%

Other1.4%

Figure 1 (left): Which region will be the most competitive manufacturer of generic medicines overthe next five years? Figure 2 (right): Which region will be the most competitive manufacturer ofbiosimilar medicines over the next five years?

Lack of patient adherence/concordance to treatment

23.7%

Not enough focuson health outcomes

in healthcare26.3%Medical errors when preparing medicines

for patients (e.g. clinical setting)6.6%

Unmet patient needs43.4%

Figure 4: What is the most important healthcare inefficiencythat could be addressed by value-added medicines?

Suboptimal healthcareinfrastructure

20.3%

Lack ofreimbursement and

policy funding10.1%

Supply chain anddistribution issues

5.8%Lack of market

transparency(e.g. tenders)

10.1%

Talent issues(e.g. recruitment,

development, retention)5.8%

Price pressure13.0%

Lengthy productregistration

process10.1%

Lack of regulatoryconvergence

18.8%

Capacity and oversight building foreffective regulatory and inspection systems

5.8%

Figure 3: What are the key challenges to further growth inpharma emerging markets? Please select one of nineoptions presented.

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

Mylan’s executive chairman and former chief executive officer,Robert Coury, will be appointed to chair the firm’s board as

a ‘non-employee director’ following Mylan’s annual general meetinglater this month. The US firm commented that Coury, who has agreedto serve in the new role “for at least the next five years”, would“continue to be directly involved on behalf of the board” in “mattersconsidered significant by the board”. This includes “any materialtransactions”, “providing guidance to the senior management team”,and “interactions with shareholders”.

Executive chairman since 2012Coury has served as Mylan’s executive chairman since the

beginning of 2012, when the firm initiated a major top-tier reshuffle(Generics bulletin, 18 November 2011, page 31). This included Couryhanding over the position of chief executive officer, which he had heldsince September 2002, to then president, Heather Bresch.

Mylan added that Coury would in his new role “focus moreintently, with the board and in collaboration with the senior executivemanagement team, on the strategy for Mylan for the next decade andbeyond”. The US firm will hold its annual general meeting on 24 June.G

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APPOINTMENTS

Mylan’s Coury is tobecome board chair

Dr Reddy’s Laboratories executive Kedar Upadhye will join rivalIndian firm Cipla “on or before 16 August” as its new global chief

financial officer, following approval from Cipla’s board of directors.Upadhye has been with Dr Reddy’s for more than a decade, and

currently serves as the firm’s vice-president of global generics financeand head of investor relations. The qualified accountant has alsoheld positions at Pepsi India and Thermax.

Upon joining Cipla, he will take the finance head position fromUmang Vohra, who took up that role, as well as that of chief operatingofficer, when he, also, left Dr Reddy’s to join Cipla last year (Genericsbulletin, 11 September 2015, page 27).

Vohra would retain the chief operating officer role uponUpadhye’s appointment, Cipla noted. G

RESHUFFLES

Cipla appoints a finance head

Walgreens Boots Alliance (WBA) has named two chief operatingofficers as it shakes up its senior management team following

18 months spent integrating Alliance Boots and Walgreens. The chiefoperating officer role will be split between current president ofWalgreens, Alex Gourlay, and the firm’s president and chief executiveofficer of global wholesale and international retail, Ornella Barra.

Gourlay will now oversee the Walgreens business in the US andBoots in the UK. In addition to her current role, Barra will also beresponsible for global brands, human resources and other functions.

Commenting on the move, Stefano Pessina, WBA’s executivevice-chairman and chief executive officer, said both Barra and Gourlaywould be “instrumental in driving the operations of the company inthe next phase of its evolution”. “I will now be able to further focuson driving the growth strategy and development of WBA,” he added.

Reporting to Barra will be Ken Murphy – who has been namedchief commercial officer and president of global brands – and KathleenWilson-Thompson, the firm’s global human resources officer.

Simon Roberts, president of Boots UK, will leave the companyin July, while Elizabeth Fagan, currently managing director ofinternational retail, has been named managing director of Boots. G

RESHUFFLES

Walgreens Boots hastwo operating heads

The US Generic Pharmaceutical Association (GPhA) hasstrengthened its position on Capitol Hill by hiring Kathryn

Anderson as vice-president of federal government affairs.Offering “decades of issue and cause-advocacy expertise”,

Anderson was most recently senior managing director for global lawand public-affairs firm Dentons. She has also handled in-housegovernment affairs for major health and life insurance companies, andwas also a special assistant to the general counsel for the Clinton-GoreUS presidential election campaign.

Anderson joins a federal affairs team at GPhA that includes seniordirector Michael Brzica, director Heidi Wilson and senior managerChristian Cruz. “Kathryn is a well-respected advocate on CapitolHill for the depth of her policy knowledge,” the GPhA insisted. G


GPhA adds Anderson to team

GEN 17-6-16 Pgs. 2-16_Layout 1 15/06/2016 17:11

COMPANY NEWS Pfizer to delayI nflectra launch untilS eptember · 07.06.2016 · Japanesefirms...

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Transcript of COMPANY NEWS Pfizer to delayI nflectra launch untilS eptember · 07.06.2016 · Japanesefirms...