Lupin makesm ove into Russiat hrough Biocom · agents and central nervous system treatments, as...

10 July 201510 July 2015

Pharmascience puts resources 2into plantsHospira’s Vizag site 3obtains FDA approvalActavis plans to shut its facility in Iceland 3McKesson eyes US biosimilars sector 4Sandoz places focus on Brazil and China 5Johnson Matthey is aiding ANDA filings 6Slovakia’s Saneca sets sights on Suir 7Lupin clears path to raise over US$1bn 8

MARKET NEWS 9

Central procurements poses 9English threatIndustry warns over global risks of TPP 10GPhA renews call for 11shared biologic nameQuestions remain on 12biologic INN qualifierCanada takes action to combat shortages13US reverse payments may go 13beyond cash

PRODUCT NEWS 14

Italian court voids Seroquel RP patent 14UK court reverses Actavis’ Alimta win 15Angiomax patents are invalidated in US 18Australia court rules Abilify 19patent invalidTeva falls to Novartis on Exjade in Canada 20Hospira defeats UK patent 21on HerceptinNovartis sued on US Gleevec settlement 23

FEATURES 26

Europe must respond to 26narrowing opportunities

Africa may be last frontier 30

REGULARS

PipelineWatch – Insulin 22Events – Our regular listing 24PriceWatch UK – UK pricing trends 25People – France’s Gemme has 31Teva’s Roche as lead

COMPANY NEWS 2

Lupin is making its first “foray into the Russian pharmaceutical market” by acquiringlocal generics player Biocom for an undisclosed fee, subject to certain closing

conditions. The acquired company generated a turnover last year of RUB861 million(US$15.2 million) through sales of drugs such as systemic antibiotics, cardiovascularagents and central nervous system treatments, as well as through its activities in contractmanufacturing and secondary packaging.

“Biocom operates a modern European good manufacturing practice (GMP) compliantplant and was also one of the first Russian pharmaceutical manufacturing companies toreceive an approved manufacturer status from the World Health Organization (WHO) in2013,” Lupin pointed out. The Russian company says its 2,000 sq m solid-dose facility hasa capacity to make 540 million tablets and 200 million capsules per year, while an automaticblister packaging line can complete 24 million packs annually.

“We are excited about our entry into the Russian market through Biocom,” stated theIndian group’s chief executive officer, Vinita Gupta. “Russia is an attractive market, and thisacquisition will also enable our expansion into neighbouring markets, as well as otherEastern European markets, in the future.”

Russia’s pharma market had “recorded double-digit growth” over the past decade toreach RUB765 billion last year, Lupin observed, while market researcher IMS Health said itwould be among the world’s eight largest markets by 2018.

“The acquisition provides us with a strong platform to grow into the Russian marketand has a lot of synergy with Lupin’s global research, technology, manufacturing andcommercial expertise not to mention our global high quality product pipeline, all of whichwe shall leverage to grow Biocom into a market leader in the years to come,” commentedMaurice Chagnaud, Lupin’s president of Europe and head of inhalation strategy.

Lupin’s deal for Biocom comes a few weeks after the Indian firm entered the Brazilianmarket with a move for local player Medquímica (Generics bulletin, 22 May 2015, page 1).

For further details of Lupin’s strategy, turn to page 8.

Lupin makes move intoRussia through Biocom

France expects to save C38.8 million (US$42.6 million) in 2016 by supporting the uptakeof generics through hospital prescriptions, according to local health insurer CNAMTS. The

cost-cutting plans – revealed as part of a broader package of measures put forward by thenational health insurance body at the start of July – follow a “national plan of action topromote generic medicines” that was announced by France’s health ministry earlier this year(Generics bulletin, 10 April 2015, page 1).

Having adopted the latest proposals – which foresee overall savings of more than C3 billionover the next three years, with C715 million of these coming in 2016 – the board of CNAMTSacknowledged that questions had been raised by affiliate organisations over the means by whichthe goals could be achieved, as well as the perceived lack of “structural impact” of its proposals.

The health ministry’s earlier plan of action includes taking steps to raise levels of genericprescribing within hospitals and maintaining the use of generics in the transition to outpatientcare. It calculated that around C350 million could be saved by 2017 through increasing by fivepercentage points the rate of prescribing within the country’s répertoire of generic equivalents.A public communication campaign to build trust in generics is also planned. G

France unveils savings proposal

Gen 10-7-15 Pg. 1_Gen 18/11/05 Pg. 1 08/07/2015 17:57

Marksans Pharma has acquired US solid-dose manufacturerTime-Cap Laboratories for an undisclosed sum. The deal includes

a facility in Farmingdale, New York, that has been approved by theUS Food and Drug Administration (FDA) for making genericprescription drugs, OTC medicines and nutritional supplements.

Founded in 1979, Time-Cap produces more than 50 differentproducts in tablet, caplet, capsule and pellet form. India’s Marksans saidthe debt-free acquired firm had an average annual turnover “in excess ofUS$30 million”, producing annual adjusted earnings before interest, tax,depreciation and amortisation (EBITDA) of around US$4 million.

“Time-Cap has developed differentiated manufacturing expertise,resulting in a key competitive advantage in the marketplace forextended- and delayed-release products, and for coating services,”Marksans commented. “Its capabilities with respect to extended-release products offer opportunities to pursue abbreviated new drugapplications (ANDAs) for high-margin products.”

“This strategic acquisition helps Marksans to expand itsmanufacturing capabilities, along with its product portfolio andpenetration, in the US,” stated the Indian firm’s managing directorand chief executive officer, Mark Saldanha.

North American Formulations sales ahead by almost two-thirds inMarksans’ financial year ended 31 March 2015 made up a fifth of groupturnover that grew by 26.5% to Rs7.97 billion (US$121 million). G

COMPANY NEWS

2 GENERICS bulletin 10 July 2015

MERGERS & ACQUISITIONS

Marksans buys USproducer Time-Cap

Canada’s Pharmascience intends to invest C$55.7 million (US$44.9million) by the end of 2016 in modernising its research and

development facilities and increasing production capacities at its plantlocated near Montreal.

Of that total – which includes C$4.8 million from governmentincentive schemes run by the Québec province – C$47.5 million will bededicated to improving production, packaging and quality-managementsystems. The remaining C$8.2 million will go “towards themodernisation of the company’s research and development facilities tofacilitate the development of new products for international markets”.

Privately-owned Pharmascience – which claims to be Canada’sthird-largest retail generics manufacturer – intends to “pursue adiversification strategy, based on the development of new products andan increased international profile”. The firm’s International divisionsupplies drugs to more than 60 countries, in part through local alliancessuch as a partnership with Kolmar in South Korea struck at the startof 2013 (Generics bulletin, 11 January 2013, page 3).

Having almost a year ago acquired fellow Canadian firm UmanPharma, Pharmascience is also building an injectables presence.

In Canada, Pharmascience operates under its own name in thegenerics arena, while OTC and prescription brands are marketedthrough its Pendopharm division, which recently secured OTC marketingrights in Canada to Sanofi’s Nasacort Allergy 24HR (triamcinolone).G

BUSINESS STRATEGY

Pharmascience putsresources into plants

Gen 10-7-15 Pgs. 2-8_Layout 1 08/07/2015 17:57

Allergan’s Actavis generics unit is to close its production facility inHafnarfjördur, Iceland by mid-2017, shedding around 300 jobs.

The group intends to retain its other operations in Iceland, includingits Medis third-party licensing business.

Actavis said it would from the the third quarter of 2016 start totransfer production from the Icelandic site to other units to ensurethe firm’s portfolio remained cost-competitive “in the global genericsmarketplace”. Manufacturing operations are scheduled to cease bythe end of the second quarter of 2017.

Robert Stewart, Allergan’s president of Generics and GlobalOperations, said the team in Iceland had delivered “exceptionalachievements in recent years”, with an enhanced level of quality,safety and customer service. However, an audit of the group’ssupply-chain capabilities following its takeover of Allergan hadsuggested that other facilities had unused capacity that could producethe products currently made in Iceland, thereby increasing efficiency.

“I want to stress that Actavis is not leaving Iceland,” Stewart said.Around 400 staff working on product development, regulatoryaffairs, quality control, finance and sales and marketing wouldremain in the country, which would continue to serve as theheadquarters for the Medis dossiers licensing business.

At the start of 2011, Actavis – before its merger with US genericsplayer Watson – opened “the world’s only pharmaceuticalmanufacturing facility completely powered by renewable energy” inHafnarfjördur following an C8 million (US$9 million) expansionproject (Generics bulletin, 1 February 2011, page 3).

Generics bulletin understands that Alvogen – which is headed byformer Actavis chief executive officer Robert Wessman – made anoffer to acquire both the plant and Actavis’ operations in Iceland, but theoffer was rejected. A spokesperson for Alvogen declined to comment. G

COMPANY NEWS

3GENERICS bulletin10 July 2015

MANUFACTURING

Actavis plans to shutits facility in Iceland

Hospira says it has begun “limited commercial production” at its100,000 sq m injectables facility in Vizag, India, after the US firm

received “official notification from the US Food and Drug Administration(FDA) that the inspection of the [site] was deemed acceptable for themanufacture of finished-dose drugs”. “As a result of this action, thecompany may receive US product approvals from this facility in thefuture,” Hospira stated.

Having broken ground at the site four years ago, Hospira hadpreviously been frustrated in its attempts to get operations at Vizagunderway. In March last year, the FDA issued the US firm with a‘Form 483’ containing 10 observations following a pre-approvalinspection at the plant. Subsequently, Hospira received a letter fromthe FDA requesting additional information regarding Hospira’s plansto address those deficiencies, after the agency took issue with two of thefirm’s corrective actions (Generics bulletin, 8 August 2014, page 5).

After receiving Hospira’s responses to the corrective actions, theFDA revisited the facility in February this year and issued a further14 observations (Generics bulletin, 13 March 2015, page 2). But theUS injectables specialist noted that responses and additional supportdocumentation it had submitted in March and May this year were“found to be acceptable” following review by the FDA.

Earlier this year, the Vizag site was identified by Pfizer – whichis attempting to close a US$17 billion takeover of Hospira (Genericsbulletin, 27 February 2015, page 1) – as an “important component forfuture growth and cost reduction when it comes on line”. The facility –which is expected to provide Hospira with “various tax benefits”,having been built in a “special economic zone” – represents a capitalinvestment by Hospira of around US$450 million. As of 31 Marchthis year, the US firm – which is closing an injectables productionsite in Clayton, North Carolina, later this year – said it had spentUS$357 million on the site.

Meanwhile, Pfizer’s takeover move for Hospira has taken astep closer after the two firms received approval from the CompetitionCommission of India (CCI) for their proposed merger.

The CCI noted that both companies operated in India, Pfizerthrough sales of finished-dose formulations and Hospira activepharmaceutical ingredients (APIs), as well as through its Zydus HospiraOncology Private Limited (ZHOPL) joint-venture with Zydus Cadilato manufacture and market oncology drugs. “There is no horizontaloverlap between Pfizer and Hospira, as in India Pfizer is not presentin the market for APIs, whereas Hospira is not present in the marketfor formulations,” the Indian watchdog observed.

At a molecule level, the CCI commented, there was only a“limited overlap” between Pfizer and ZHOPL for formulations thatare based on epirubicin, amounting to an “incremental market share”of less than 1%-5%.

Moreover, the CCI noted, the merger “would not likely result inany vertical foreclosure” of the Indian market for tadalafil API – theonly bulk drug Hospira manufactures in India that could potentially besupplied to Pfizer for producing finished-dose formulations. Nor didthe oral cephalosporin formulations that Hospira made on a contract-manufacturing basis for an Indian company conflict with Pfizer’s statusas “an insignificant player” in the cephalosporins formulations market.

“Considering the facts on record…and the assessment of thecombination after considering relevant factors…the commission is of theopinion that the proposed combination is not likely to have anyappreciable adverse effect on competition in India,” the CCI concluded.G

MANUFACTURING

Hospira’s Vizag siteobtains FDA approval

Indian contract research organisation (CRO) Quest Life Scienceshas been issued with a ‘notice of concern’ by the World Health

Organization (WHO), following an inspection by the global body.The inspection – conducted in October 2014 – “revealed critical andmajor deviations from the WHO good clinical practices and goodlaboratory practices standards as published in WHO publications”,the organisation stated.

Inspectors had focused on a study of lamivudine, nevirapine andzidovudine tablets from Micro Labs. They found data integrity failuresfor clinical trial records, such as duplicate electrocardiograms (ECG)on which subject details and dates had been changed to make themappear to be from different subjects, including nine times for the sameECG in one case. “As inspectors entered the bioanalytical laboratory,staff were seen in the process of completing records, some of themback-dated,” the WHO observed, adding: “An apparent attempt wasmade to hide documents from inspectors.”

Despite having received a “partial response” to the inspectionreport from Quest, the WHO said it recommended rejecting the studyand issuing a ‘notice of concern’. “The nature of the observations wassuch that retrospective corrective action was not considered to bepossible for the study,” the WHO stated. G

QUALITY

WHO queries Quest’s results

Gen 10-7-15 Pgs. 2-8_Layout 1 08/07/2015 17:57

Companies distributing in Canada drugs containing activepharmaceutical ingredients (APIs) manufactured or tested by India’s

Polydrug Laboratories at its local facility in Ambarnath, Maharashtra,have been requested by Health Canada to voluntarily quarantine thosebulk drugs following concerns over data integrity at the site.

“Health Canada is taking this interim precautionary measure tohelp mitigate any potential risk in light of recent findings from trustedregulatory partners that raised concerns about the reliability of datagenerated at this site,” the agency said, underlining that it was “notrequesting a recall of any products with API from Polydrug Laboratoriescurrently on the Canadian market”.

The European Directorate for the Quality of Medicines (EDQM)has suspended Polydrug’s certificates of suitability (CEPs) forchlorobutanol hemihydrate, ferrous fumarate and fluconazole, as wellas for metoprolol succinate and metoprolol tartrate. Meanwhile, theUS Food and Drug Administrtion (FDA) included Polydrug on a recentlist of companies that were in arrears on paying generics facility fees. G

COMPANY NEWS


10 July 2015 Issue 235

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

Editorial enquiries: GENERICS bulletin,4 Poplar Road, Dorridge, Solihull,West Midlands B93 8DB, UK.Website: www.Generics-bulletin.comTel: +44 (0)1564 777550 Fax: +44 (0)1564 777524E-mail: [email protected] enquiries:As above, or [email protected]

SUBSCRIPTIONSSubscription rates are published atwww.Generics-bulletin.com/subscribe.

Individual subscriptionsAn annual subscription comprises:■ 20 Generics bulletin newsletters;■ AND at least 46 weekly News@Genericsbulletinelectronic newsflashes containing the week’s topnews stories (currently delivered by email).

Choice of formatsThe 20 Generics bulletin newsletters are available:■ EITHER as the digital Generics bulletin-i foronline access by desktop, and tablet and smartphone.Mobile devices can have Apple or Androidoperating systems.■ OR in traditional hard-copy print format,delivered by airmail.

Corporate and multiple subscriptionsGlobal Site Licences are available to companies.These provide in-house electronic access for staff toGenerics bulletin and [email protected] ask for a quotation.

Discounted multiple subscriptions are available toGenerics bulletin-i at the same location.

Subscription enquiries:Contact [email protected]

Terms & Conditions:These can be viewed in full atwww.Generics-bulletin.com/subscribe.No part of this publication may be copied, reproduced,stored in a retrieval system, distributed or transmittedby any means, including electronic, mechanical,photocopying or recording, without the prior writtenpermission of the publisher, or under the terms andconditions of a Global Site Licence or of a licenceissued by the Copyright Licensing Agency (CLA) inLondon, UK, or rights bodies in other countries thathave reciprocal agreements with the CLA.Neither may this publication be exported, distributedor circulated by any means without the prior writtenpermission of the publisher.While due care has been taken to ensure the accuracyof information contained in this publication, thepublisher makes no claim that it is free of error anddisclaims any liability whatsoever for any decisions oractions taken as a result of its contents.© OTC Publications Ltd.All rights reserved.Generics bulletin® is registered as a trademark inthe European Community.ISSN 1742-0784.Company registered in England No 2765878.Printed byWarwick Printing Company Limited,Leamington Spa CV31 1QD, UK.

MANUFACTURING

Health Canada wantsbar on Polydrug APIs

Launching a non-reimbursable Amofin (amorolfine) 50mg/mlantifungal nail lacquer in its domestic market helped Croatia’s

Podravka to increase its Pharmaceuticals sales by 0.6% to CrK172million (US$25.1 million) in the first quarter of this year.

Volume growth of 3.1% more than offset the effect ofreimbursement price cuts in Croatia last year as well as a CrK5.3million negative exchange-rate effect. Sales of non-prescription drugsclimbed by 14.0% to CrK21.7 million. On a constant-currency basis,Podravka said its Pharmaceuticals turnover rose by 3.7%.Pharmaceuticals made up 21.9% of the Croatian group’s turnover. G

FIRST-QUARTER RESULTS

Amorolfine boosts Podravka

McKesson is “positioned for success with biosimilars” in NorthAmerica through a “comprehensive platform” to help industry

achieve uptake, according to the distribution and retail group’spresident of Specialty Health, Nick Loporcaro.

Loporcaro said McKesson could offer a multi-channel presencewith “access via network and group purchasing organisations (GPOs)”to over 3,000 oncologists and more than 4,500 other specialists. “Strongpartnerships with manufacturers” would, he said, be based on thegroup’s expertise in distribution, patient care and services.

Factors that would affect the uptake of biosimilars in the US,Loporcaro outlined, included the ability to substitute, physicians’ viewson quality and efficacy, and delivery channels.

McKesson says turnover through its OneStop generics programmefor multiple and independent pharmacies in the US has grown by anaverage of a fifth over the past five years, while its Health Martfranchise – which buys generics through the OneStop scheme – nowcovers more than 4,000 independent pharmacies, making it the largestsuch network in the US.

Group president of Distribution Solutions, Paul Julien, noted that,following McKesson’s takeover of Germany’s Celesio in December2014, the company had set up a global procurement and sourcing officein London, UK. Based in the London office are president of globalprocurement Jack Fragie and president of global sourcing Saul Factor.

In its truncated three-month ‘financial year’ ended 31 March 2015,Celesio increased its turnover by 5.6% to C5.27 billion (US$5.76billion). This was driven in part by a 13.1% leap to C979 million in salesthrough its Consumer Solutions pharmacy retail business on stronggrowth in the UK, aided by exchange-rate fluctuations. Turnover by thePharmacy Solutions wholesaling division rose by 4.0% to C4.29 billion.

However, the Germany-based company reported earnings beforeinterest and tax (EBIT) down by 31.6% to C62.2 million. Celesio blamed“the impact of state-imposed price reductions in the UK, weak marketconditions in France and the loss of a hospital contract in Norway”. G

BUSINESS STRATEGY

McKesson eyes USbiosimilars sector

Gen 10-7-15 Pgs. 2-8_Layout 1 08/07/2015 17:57

European Union (EU) competition regulators will decide by 29 Julythe conditions under which Mylan’s takeover bid for Perrigo should

be allowed to go ahead. Both Mylan and Perrigo are domiciled in theEU, the former in the Netherlands and the latter in Ireland.

The European Commission’s directorate-general for competitionnoted that Mylan had requested EU clearance on 23 June for itsproposed acquisition of the US store-brand specialist.

Last month, Abbott stated its intention to use its 14.5% stakein Mylan to support the Dutch group’s planned bid for Perrigo(Generics bulletin, 26 June 2015, page 3).

In a proxy statement filed by Mylan ahead of a planned shareholdervote on the proposed deal, the Netherlands-domiciled group committedto pay US$75.00 in cash plus 2.3 Mylan shares for each Perrigo share.No date for the meeting has been determined as yet.

“Mylan’s offer reflects an effective implied value of US$232.23per Perrigo ordinary share, based on the closing price of a Mylanordinary share of US$68.36 on 8 April 2015, the first day of marketreaction to Mylan’s initial proposal to acquire Perrigo,” the statementnotes, adding that if Mylan acquires at least 80% of Perrigo’soutstanding shares, it will apply under Irish law to make compulsorypurchases of the remainder on the same terms.

Perrigo is ‘right next strategic transaction’Writing to shareholders, Mylan’s executive chairman, Robert

Coury and chief executive officer Heather Bresch described Perrigoas “an exceptional company and the right next strategic transactionfor Mylan”. “The combination of Mylan and Perrigo demonstratesclear and compelling industrial logic and we expect this combinationto result in a combined company that has complementary businessesand cultures, unmatched scale in its operations and ability to deliverproducts and services, one of the industry’s broadest and mostdiversified portfolios, and immense reach across distribution channelsaround the world.”

In particular, Coury and Bresch believe combining with OTCspecialist Perrigo would allow Mylan to capitalise on “theunprecedented number of transfers of proven prescription drugs tonon-prescription status”.

According to Mylan – which has for the second time been pulledup by the Irish Takeover Panel for mentioning a 2018 earnings targetduring the bidding process – a combined entity would have a pro forma2014 turnover of US$15.3 billion. Mylan anticipates at least US$800million of annual pre-tax operational synergies within four years ofclosing a transaction.

Any deal would be conditional upon Perrigo – which has beenlinked in media speculation to a bid for Boehringer Ingelheim’sRoxane US generics business – making no acquisitions or disposals.

However, Coury and Bresch acknowledge in the letter toshareholders, despite initial talks, “in recent weeks Mylan has repeatedlyoffered to have constructive discussions with Perrigo regarding itscurrent offer, but Perrigo has refused to engage in discussions”.

“Mylan continues to hope that it is possible to reach a consensualtransaction with Perrigo,” they say. “However, given the compellingnature of this transaction and Mylan’s commitment to making thiscombination a reality, Mylan is moving forward to complete thetransaction as quickly as possible.”

Perrigo insists that the offer from Mylan – which is, itself, subjectto a hostile takeover bid by Teva – undervalues the company. G

COMPANY NEWS



EU regulators weighMylan’s Perrigo bid

Brazil and China are among the “priority growth markets” in whichSandoz expects “to see significant absolute growth on the top and

bottom line”, according to an investor presentation delivered by thebusiness’ head, Richard Francis. Key “priority focus markets” that willremain major pillars for the company include Germany and the US.

In the first quarter of this year, Sandoz achieved 42% local-currencysales growth in Brazil, and a 28% rise in China. In Germany – wherethe firm is consulting on closing sites in Gerlingen and Frankfurt –constant-currency growth was 10% (Generics bulletin, 8 May 2015,page 6). The company expects its Neva production plant in Russia –where first-quarter sales rose by 13% at constant exchange rates – tostart operating in 2017.

In the US, Sandoz is looking to build on a 13% first-quarter salesadvance by launching a generic rival to Teva’s Copaxone (glatirameracetate) 20mg blockbuster. Citing IMS Health data for the 12 monthsended March 2015, Francis said Sandoz had outperformed its US peersby achieving 16.9% total prescription growth, raising its volume shareof the US generics market to 7.2%, behind only Teva and Mylan.

Geographic focus was one of six priorities that Francis said woulddrive performance. The others were: portfolio priorities; biosimilars;technical operations and quality; development, registration, businessdevelopment and licensing; and patients, people and collaboration.

Among portfolio priorities were “regional growth drivers” suchas Sandoz’ Fougera dermatology and Falcon ophthalmics brands in theUS, as well as pain therapies in markets including Germany. He alsohighlighted the company’s US$1.5 billion retail and bulk anti-infectivesoperation that he said was the global generics market leader by volume.

With a US$514 million turnover last year from three marketedmolecules, Sandoz’ biosimilars business was also the global leader.Five biosimilar molecules – adalimumab, epoetin alfa, etanercept,pegfilgrastim and rituximab – were currently at the Phase III clinicalor registration stage, Francis pointed out. G

BUSINESS STRATEGY

Sandoz places focuson Brazil and China

Two manufacturing facilities belonging to active pharmaceuticalingredient (API) specialist Medichem have passed US Food and

Drug Administration (FDA) inspections without any observationsof current good manufacturing practice (cGMP) deficiencies, theSpanish firm has revealed.

An inspection by the agency of Medichem’s Spanish facility inCelrà, Girona, at the end of April marked the “sixth consecutive time”it had passed with no observations, following the site’s first FDAinspection 16 years ago.

Meanwhile, for the second consecutive time following its initialinspection in 2012, the Spanish firm’s plant in Hal Far, Malta, was inFebruary found to merit no ‘Form 483’ observations. “The inspectionsof Medichem’s plants carried out by FDA officers covered GMPsystems, as well as several APIs exported to the US,” Medichem noted.

Just over a third of Barcelona-based Medichem’s sales areachieved in the US and Canada, while slightly over a quarter aregenerated in Europe. The rest of the world accounts for the other 37%.The API producer is currently in the process of integrating more closelywith its finished-dose sister company, Combino Pharm. G

MANUFACTURING

FDA inspects Medichem sites

Gen 10-7-15 Pgs. 2-8_Layout 1 08/07/2015 17:57

Bulk-drugs producer Johnson Matthey says it is “focusing oncomplex, typically smaller-volume active pharmaceutical

ingredients (APIs)” and is working with several customers to formulateand develop generics for the US market. “To date,” the UK-basedcompany stated, “this work has generated a number of abbreviatednew drug applications (ANDAs) that have received, or are awaiting,US Food and Drug Administration (FDA) approval.”

Building on its strength in developing APIs, particularly forcontrolled substances including analgesics, Johnson Matthey wants itsFine Chemicals division to “extend its position in generics by movingfurther up the pharmaceutical value chain, increasing access to a high-growth market segment through co-investing in and co-developingformulated drug products”.

Chief executive officer Robert MacLeod said the company wasinvesting in developing complex APIs that went beyond the group’shistorical strength in controlled substances.

In Europe, the group is currently refurbishing a 109,000 sq mformer GlaxoSmithKline API production plant in Annan, south-westScotland, that it acquired in November 2014, with a view to bringingthe site into regulatory compliance midway through next year. “Thisplant offers further opportunities to optimise efficiencies,” JohnsonMatthey said, adding that the additional capacity would support thegrowth of its API business, especially in Europe.

Strong demand for custom services helped the group to increasesales by its API Manufacturing unit by 3% to £216 million (US$336million) in its financial year ended 31 March 2015. “Sales from APIsfor treatment of attention deficit hyperactivity disorder (ADHD) werebroadly in line with last year, although sales of bulk opiates in Europewere down this year as one of our customers relocated production outsideof the controlled UK market in which we operate,” the firm commented.

APIs made up two-thirds of Fine Chemicals unitAPI Manufacturing made up two-thirds of Johnson Matthey’s

Fine Chemicals division that saw its turnover rise by 1% as reported –and by 3% on a constant-currency basis – to £327 million (see Figure1). The firm is looking to “leverage synergies” between APIManufacturing and its Catalyst and Chiral Technologies unit that makesproducts that increased its sales by 4% to £34 million.

Johnson Matthey has just agreed to divest its Alfa Aesar ResearchChemicals unit – which suffered a 3% sales slide to £77 million –to Thermo Fisher for £256 million.

“Process-efficiency improvements” in its API unit were largelyresponsible for the Fine Chemicals division improving its operatingprofit by 6% to £88.8 million. The precious metals and emissions-control technologies specialist raised its operating profit by 19% to £533million despite its turnover dropping by a tenth to £10.1 billion. G

COMPANY NEWS


BUSINESS STRATEGY/ANNUAL RESULTS

Johnson Matthey isaiding ANDA filings

Annual sales Reported Constant-currency(£ millions) change (%) change (%)

API Manufacturing 216 +3 +3Research Chemicals 77 -3 -1Catalysis and Chiral 34 +4 +7

Fine Chemicals 327 +1 +3

Figure 1: Breakdown by business unit of sales by Johnson Matthey’s Fine Chemicalsdivision in its financial year ended 31 March 2015 (Source – Johnson Matthey)

Quality controls in Zhuhai United Laboratories’ Chinese Guangdongplant are “weak and inappropriately-implemented”, according

to an inspection conducted by Romania’s medicines agency. As aresult, the active pharmaceutical ingredient (API) supplier’s existinggood manufacturing practice (GMP) certificate will be “reissued toinclude only non-sterile products”, with a restricted GMP certificateissued for “sterile critical medicinal products for Romania, France andthe UK”, covering amoxicillin sodium and potassium clavulanate.

“The company was not operating its aseptic manufacture operationsin compliance with European Union (EU) GMP,” according to theEudraGMDP database. “This was evident from the high number ofobservations regarding the aseptic manufacturing facilities design,equipment, operations, environment-monitoring, and media-fillvalidation.” The firm’s quality-assurance systems “failed to notice theseproblems”, the database notes. Relevant CEPs have been suspended.G

MANUFACTURING

China’s Zhuhai losesGMP status in EU

Beximco says it has become “the first Bangladeshi company toreceive US Food and Drug Administration (FDA) accreditation”,

after the agency approved the firm’s oral solid-dosage facility in Tongifollowing an inspection in January 2015. Following the “comprehensiveaudit”, Beximco noted, there had been “no ‘Form 483’ observationsissued by the FDA”. Nazmul Hassan, Beximco’s managing director,cited the approval as a “major milestone” for the company.

Noting that it had “already submitted several abbreviated new drugapplications (ANDAs) to the FDA, which are currently under review”,Beximco said it would begin exports to the US market upon approval. G

MANUFACTURING

Beximco gains FDA approval

Jubilant Life Sciences’ sterile manufacturing facility in Spokane,Washington, US, has been upgraded to voluntary action indicated

(VAI) status by the US Food and Drug Administration (FDA) followingthe “successful conclusion” of inspections at the plant last year.

Having been issued with a warning letter by FDA at the end of2013 for current good manufacturing practice (cGMP) violations relatedto aseptic procedures (Generics bulletin, 10 January 2014, page 6),the facility had formerly operated under the official action indicated(OAI) status. “We consider this development as another step towardsbuilding a reliable and sustainable pharma business,” the firm said.G

MANUFACTURING

US upgrades Jubilant plant

SAMSUNG BIOEPIS is reported to be considering an initial publicoffering (IPO) on the Nasdaq stock exchange. The South Koreanventure between Samsung Bioepis and Biogen earlier this year filedits SB2 biosimilar rival to Remicade (infliximab) with the EuropeanMedicines Agency (EMA), having a few weeks earlier had its SB4etanercept submission accepted for review by the agency. G

IN BRIEF

Gen 10-7-15 Pgs. 2-8_Layout 1 08/07/2015 17:57

Irish contract-manufacturing organisation (CMO) Suir Pharma Irelandwill be acquired in full by privately-owned Slovakian formulations

and active pharmaceutical ingredient (API) producer SanecaPharmaceuticals under the terms of a definitive agreement that hasjust been struck between Saneca and Suir’s current owner, Germany’sMutares. Financial terms were not disclosed.

“Saneca is confident that this strategic acquisition will addsignificantly to the services that the Saneca group can offer to itscustomers, and we look forward to the combined entity continuingto grow its presence in the CMO, API and licensing business into thefuture,” the Slovakian firm said. Suir currently produced finished-dosage formulations “across a broad range of therapeutic areas forvarious customers worldwide”, Saneca noted, adding that former Stadaunit Suir also “operates the only independent Food and DrugAdministration (FDA) approved betalactam facility in Europe”.

“We see the combined entity providing significantly enhancedpharmaceutical-development capacity and tech-transfer capabilitiesacross a range of forms,” Saneca stated, “which will provide easieraccess to various markets for our worldwide customer base.”

Suir boasts that it is “equipped to deal with all areas of soliddosage-form manufacturing”. Saneca currently produces dosage formsincluding oral-solid tablets, liquids, soft-gel capsules and creams, aswell as a portfolio of APIs. G

COMPANY NEWS


Fall Technical2015

ConferenceBethesda NorthMarriott Hotel and Conference Center - North Bethesda, MD - November 2-4, 2015

Register Today!Join us starting Monday afternoon to kick off the conference with the new agenda format.Each year, more than 700 generic industry professionals attend this unique educational

conference. Hear presentations from experts from the FDA, industry and academia as theyaddress key regulatory and technical issues impacting the generic industry.

Register online at www.gphaonline.org.

Sponsorship OpportunitiesRaise your company profile by sponsoring at this prestigious event.

Opportunities include logo placement, company recognition and much more!

Formore information, contact Jennifer Nguyen at [email protected] or +1(202) 249-7127

REGISTER

TODAY

20151 Fall Technical5

ConferenceFall Technical

REGIS

el and

eerono

tth Marriott HorBethesda No

tions frtaesen. Hear preencre than 700 generh

nffeEachE

c, morearr, mory

uJoinJ ty afondating Mus star

er - North Bethesda, MD - November 2-4, 2015tenCecenrefonCel and

Conference

om the FDts frxperom etions fressionaoffessionals ay pric industre than 700 gener

eonffeick off the co knoon tertday!oer TToegistR

er - North Bethesda, MD - November 2-4, 2015

ia as theya

Conference

y and academia as theyucational

A, industrom the FDend this unique educaa

ndada fttessionals ae with the new agenda fencer

as theeyy

.tionalall

mm ttmaore with the new agenda f

STER

T

tunities includttOpporrrorompanRR

non

our caise yR

egistaa

Rtegulaess key raddrtions free taesen. Hear preencernffec

ontace information, cor moreFFor mor

y rompan, ctementunities include logo placing ay sponsorofile by prompantunitiesorpponsorship OpSSp

.gphaoww.wt wer online aegistechnical issues impacy and tort

om the FDts frxperom etions fr

en@gphaonlineen at jnguyennifer Nguyt Jontac

nitionnition and much moranand much more!d much morogg

a

..ec

ty r

e tenenious evevvestig

.

t this pring atunities

.g.orrg.gphaonlineyyic industra as they

ting the generechnical issues impacy and academia as theyA, industrom the FD

g or +1(202) 249-7127.orrg or +1(202) 249-7127en@gphaonline

aas theey

e!

y

g or +1(202) 249-7127

TODAY


Slovakia’s Sanecasets sights on Suir

Dr Reddy’s Laboratories has chosen purple as its new corporatecolour, and will operate under the slogan ‘Good Health Can’t

Wait’, following a rebranding exercise. Unveiling a new visual andcorporate brand identity with an accompanying heart-shaped logo, theIndian firm said purple was “associated with creativity and wisdom”.

Reddy’s said the re-branding would be executed in two stages:firstly transitioning to the new corporate identity and secondlyincorporating it onto product packaging. “The existing logo and brandidentity will remain in place and valid until changes that are pertinent

to legal processes, documentation and other regulatory or statutorychanges are complete,” the Indian group explained.

“Over 31 years,” commented the Indian firm’s chairman, SatishReddy, “Dr Reddy’s has grown from a manufacturer of activepharmaceutical ingredients (APIs) into a multinational pharmaceuticalbrand of repute, with operations in over 25 countries.” “Our belief‘Good Health Can’t Wait’ lends new meaning to our core purpose ofaccelerating access to affordable and innovative medicines,” he added.G

BUSINESS STRATEGY

Reddy’s picks purplefor corporate colour

Gen 10-7-15 Pgs. 2-8_Layout 1 08/07/2015 17:57

Lupin’s board has approved raising up to Rs75.0 billion (US$1.18billion) by issuing shares, bonds or other financial instruments. The

Indian company will seek shareholder approval at its annual generalmeeting to be held on 23 July.

While Lupin did not disclose its plans for the funds in an officialnotification to the Bombay Stock Exchange, the Indian firm has of latebeen engaged in a wave of geographic expansion, having just followedup its entry into Brazil by taking over local player Medquímica bymaking its first foray into Russia through a deal for Biocom.

Writing in the group’s recently released annual report, chiefexecutive officer Vinita Gupta and managing director Nilesh Guptastated: “Going forward, meaningful acquisitions are going to be vitalto our growth strategy and we are targeting geographies, complementaryproduct portfolios and therapies that we feel are missing from ourcurrent portfolio.”

In the report, Lupin highlights its “growing presence and leadershipcredentials in markets like Japan, South Africa and Mexico”. Thesemoves – “coupled with our efforts to enter new markets with meaningfulacquisitions” – are key to the firm’s strategy for tapping into growthin emerging markets. In Japan, Lupin intends to set up a manufacturingsite for oral solids and to install an injectables line at Kyowa CritiCare(KCC), which previously operated under the I’rom name. The firmexpects a dedicated block for Japan at its plant in Goa, India, to startoperating in its next financial year.

“We are breaking new ground to ensure that we become the firstIndian company to launch biosimilars in markets such as Japan,” thecompany stated. Lupin says it has “successfully completed a Phase Iclinical trial in Japan” for biosimilar etanercept, while its Lupifil(filgrastim) and Lupifil-P (pegfilgrastim) biosimilars are “ready tolaunch in India”.

The Indian group has strengthened its presence in South Africaby taking full control of local subsidiary Pharma Dynamics (Genericsbulletin, 27 March 2015, page 5), while it says it has “completed theintegration” of Laboratorios Grin, Mexico’s fourth-largestophthalmics player (Generics bulletin, 4 April 2014, page 3).

“New beginnings for Lupin in Europe” include establishing aregional headquarters in Zug, Switzerland, and ramping up its localmanagement team in areas such as regulatory affairs and supply chain.

In the US – where Lupin claims to rank sixth by volume in thecountry’s unbranded generics market (see Figure 1) – the companyis interested in “making strategic brand acquisitions”. G

COMPANY NEWS


BUSINESS STRATEGY

Lupin clears path toraise over US$1bn

Annual sales Change Proportion of(millions of prescriptions) (%) total (%)

Teva 458 -3.2 12.8Mylan 327 -6.9 9.1Sandoz 257 +14.8 7.2Actavis 233 -5.2 6.5Endo 208 +1.9 5.8Lupin 198 +8.7 5.5Others 1,911 – 53.2

US market 3,592 +4.5 100.0

Figure 1: Breakdown by leading companies of the US unbranded generics marketin the 12 months ended April 2015, measured by prescriptions dispensed(Source – Lupin/IMS Health)

ACETO pointed to price increases for certain products, and theaddition of sales from its Pack Pharmaceuticals affiliate, as theunderlying reasons for its Human Health sales rising by two-thirdsto US$56.3 million in the US firm’s financial third quarter ended31 March 2015. Coupled with a double-digit rise in the company’sPerformance Chemicals sales, those Human Health sales morethan offset a 15.2% dip to US$40.5 million in Aceto’s PharmaceuticalIngredients turnover as group sales rose by 16.8% to US$146 million.Meanwhile, with corporate expenses only marginally higher, thecompany’s operating profit more than doubled to US$15.4 million.

HOVIONE – the Portuguese active pharmaceutical ingredient (API)and intermediates specialist – has improved its ability to handlehigh-potency APIs after installing a new large-scale spray-dryingunit at its site in Loures, Portugal, which is slated to be fullyoperational by March next year. “This additional commercial unitis the first phase of a broad expansion programme designed toincrease the scope of offering and expand capacity,” the firm noted.

TEVA has agreed to pay the US and certain states participating inthe Medicaid Drug Rebate programme a total of US$7.5 million,plus interest, to resolve allegations that its Cephalon unit “knowinglyunderpaid rebates” into the programme. The settlement – announcedby the US Department of Justice – consists of a US$4.3 millionfederal payment and US$3.2 million to affected states to resolveallegations over brands such as Provigil (modafinil) and Nuvigil(armodafinil). In a similar settlement, AstraZeneca has agreed topay a total of US$46.5 million to federal and state authorities.

ATTIX PHARMACEUTICALS – a Canadian firm that specialisesin the repackaging of active pharmaceutical ingredients (APIs) – hasreceived a warning letter from the US Food and DrugAdministration (FDA) for “significant deviations from current goodmanufacturing practice (cGMP)” related to cross-contaminationrisks at its local facility in Toronto, Ontario. During the Novemberinspection, the agency said, Attix had failed to use separate facilitiesor dedicated equipment to manufacture penicillins and other APIs,and had also allowed “personnel and materials to move freely betweenbetalactam and non-betalactam manufacturing areas”.

IGI LABORATORIES says it now has 27 abbreviated new drugapplications (ANDAs) pending approval with the US Food and DrugAdministration (FDA) after submitting its fifth generic filing ofcalendar 2015. The US firm’s president and chief executive officer,Jason Grenfell-Gardner, said the company expected to submit atotal of 20 ANDAs this year.

MICRO-MACINAZIONE – a Swiss-based company specialisingin the micronisation of active pharmaceutical ingredients (APIs) –says it is investing SFr3 million (US$3.2 million) in a “newbanding system, and in constructing new production units for themicronisation of highly potent substances and cytotoxic products”used in oncology drugs. Moreover, the Swiss firm is building anew storage facility – providing an extra 500 sq m of storagecapacity for non-micronised and micronised materials – at its sitein Molinazzo di Monteggio, Switzerland.

CARDINAL HEALTH – the US health services provider – has quicklycompleted its all-cash US$1.15 billion acquisition of privately-heldgenerics distributer The Harvard Drug Group from Court SquareCapital Partners. The transaction agreement – which covers twodistribution facilities and 450 employees – was only struck lastmonth (Generics bulletin, 26 June 2015, page 2). G

IN BRIEF

Gen 10-7-15 Pgs. 2-8_Layout 1 08/07/2015 17:57

Aprovision of the US’ proposed 21st Century Cures Act that wouldextend by six months market exclusivity periods for “certain

branded drugs” that receive a new indication for the treatment ofrare diseases would increase US government spending on prescriptiondrugs through mandatory health programmes by US$869 millionbetween 2016 and 2025, according to estimates in a report by theUS Congressional Budget Office (CBO).

According to the CBO’s report, around 15% of currently-approvedbrand name drugs that are expected to face generic competition before2025 would be eligible to receive the additional exclusivity. “Beyond2025, the potential for the legislation to delay the entry of genericdrugs or biosimilars is greater and the federal budgetary effect wouldincrease in later years,” the CBO noted.

Meanwhile, the office’s report notes that state spending underthe Medicaid social-welfare programme for prescription drugs overthe same period would increase by US$50 million due to delayedmarket entry for some generics. And for generics manufacturers thatwould not be able to compete due to the extended exclusivity period,the CBO said that “based on information about the sales of drugs thatcould be affected in the first five years that the mandate is in effect”, thecost to manufacturers from loss of income “would amount to aboutUS$50 million or less in each of those years”.

Earlier this year, US lobbying group the National Health Council(NHC) noted that the Dormant Therapies provision of the Cures Act –which offered 15-year protection for drugs addressing “unmet medicalneeds” – had been dropped from the latest version of the bill, a movewelcomed by the US Generic Pharmaceutical Association (GPhA) as“recognising the balance between pharmaceutical competition andinnovation” (Generics bulletin, 5 June 2015, page 14). G

MARKET NEWS


REGULATORY AFFAIRS

US counts cost ofadditional exclusivity

Centralised procurement of primary-care generics in England wouldthreaten effective supply and pharmacy reimbursement

arrangements under the current market-driven Drug Tariff system,according to speakers at a business day hosted by the British GenericManufacturers Association (BGMA).

BGMA vice-chairman Peter Ballard argued that the Drug Tariff’sCategory M – which lists pharmacy reimbursement prices for readily-available drugs, based on adding an agreed margin to ex-factory pricesreported by manufacturers – ensured effective competition whilstremunerating pharmacists for dispensing. “We could shorten the timelag [on price adjustments], but the system generally works well.”

“We need to get decision-makers to understand how good thesystem is,” agreed Sue Sharpe, chief executive officer of thePharmaceutical Services Negotiating Committee (PNSC) that representsaround 11,500 independent and multiple pharmacies in Drug Tariffnegotiations with the National Health Service (NHS) England.

Sharpe pointed out that generics were responsible for all of the£800 million (US$1.25 billion) retained margin on medicines to whichcommunity pharmacists were entitled under a total £2.8 billion pharmacyfunding package agreed with NHS England (Generics bulletin, 3October 2014, page 9). This was because pharmacists typically lostaround £100 million per year by dispensing branded originals.

But increasingly powerful local authorities and ClinicalCommissioning Groups (CCGs) – such as through the ‘Devo Manc’initiative to consolidate health and social care services in GreaterManchester – could endanger this equilibrium, Sharpe feared. Therewas a “not negligible risk” that such authorities would look to carveoff some of the £800 million pharmacy margin though centralised,tender-like drug procurement programmes, she warned.

While NHS executives were “determined to do the impossible” bypredicting pricing trends rather than adjusting Drug Tariff marginsretroactively, Sharpe said pharmacists were also being squeezed byreimbursement prices for branded generics. She proposed a singlereimbursement price for each off-patent molecule, whether branded ornot. This point found agreement from Martin Sawer, executivedirector of the British Association of Pharmaceutical Wholesalers.

Sharpe acknowledged that the Drug Tariff could be improved,not least by better reflecting multiple pharmacies’ drug-acquisitioncosts and by reacting more quickly to pricing fluctuations.

BGMA director-general Warwick Smith said: “It is important thatthe finely honed mechanisms designed to ensure that the NHS receivesvalue for money are not disrupted by the introduction of different localor regional procurement or reimbursement procedures which wouldinevitably end up costing the NHS overall more money.”

Smith pointed out that while price rises, as well as falls, wereinherent in a market-driven system, this did not necessarily indicatesupply problems. Genuine shortages of getting medicines to patientswere rare and were usually caused by problems with the activepharmaceutical ingredient (API) or a “perfect storm” of events. G

PRICING & REIMBURSEMENT

Central procurementposes English threat

Canada has amended its Patented Medicine Notice of Compliance(PM-NOC) Regulations to clarify issues relating to combination

drugs. The country’s Department of Industry had previously proposedthe changes to the Regulations to “clarify ambiguities regarding thelisting requirements as they relate to patents containing a claim for themedicinal ingredient and combination drugs” (Generics bulletin,22 May 2015, page 13). This followed Federal Court decisions thatinterpreted the PM-NOC Regulations in a manner “inconsistent withthe policy intent” by finding that a patent that does not explicitly claimall of the ingredients contained in a drug cannot be listed against thatdrug (Generics bulletin, 8 May 2015, page 18).

The revision adds text to the Regulations specifying that “a patentthat contains a claim for the medicinal ingredient is eligible even ifthe submission includes, in addition to the medicinal ingredient claimedin the patent, other medicinal ingredients”.

The amendments also state that a patent containing a claim forthe formulation is eligible for listing if it includes the non-medicinalingredients specified in the claim – “even if the submission containsany additional non-medicinal ingredients” – while a patent containinga claim for the use of a medicinal ingredient may contain otheringredients, additional uses, or a requirement to use the medicinalingredient in combination with another drug. G

REGULATORY AFFAIRS

Canada has combination rule

ICH – the International Conference on Harmonisation – has publisheda new question-and-answer guideline on active pharmaceuticalingredients (APIs) “to clarify uncertainties due to differentinterpretations of requirements laid down in the ICH Q7 guideline”. G

IN BRIEF

Gen 10-7-15 Pgs. 9-13_Layout 1 08/07/2015 17:58 Page 3

Negotiators for the Trans-Pacific Partnership (TPP) internationaltrade deal should adopt a “more balanced approach, promoting

both competition and innovation” and must not “abandon the needsof millions of the world’s citizens for access to affordable medicines”,the International Generic Pharmaceutical Alliance (IGPA) has urged,as the TPP negotiation process “enters its final phase”.

“IGPA supports trade agreements which promote the distributionof safe and affordable medicines and contribute to the sustainabilityof healthcare systems globally,” the association said. “Unfortunately,based on available information, TPP will threaten the right of ‘accessto medicines for all’ enshrined in the 2001 World Trade Organization(WTO) Doha Declaration and recognised by all 12 TPP countries.”

Citing leaked TPP draft documents, the Politico website recentlyclaimed that the deal’s chapter on intellectual property (IP) would“give US pharmaceutical firms unprecedented protections againstcompetition from cheaper generic drugs, possibly transcending thepatent protections in US law”. On “every issue” related to IP for drugs,Politico claimed, “the US sided with drug companies in favour ofstricter IP protections”. This included making patent linkage mandatoryfor all TPP nations, the website reported, including for biologics.

“While IGPA supports balanced policies to promote IP rights,”the association said, “TPP, as currently drafted, protects the interestsof brand medicine manufacturers at the expense of public health. Thisone-sided approach to IP protection would undermine the efforts ofTPP countries to increase utilisation of safe and affordable genericand biosimilar medicines.”

Developments in global IP and foreign market access will beamong the subjects discussed at this year’s 18th annual IGPAconference, being held in Toronto, Canada, on 16-19 September. G

MARKET NEWS


Executives in sevenof the world’s top 10generics and biosimilarscompanies are alreadybenefitting from aCorporate Subscription toGenerics bulletin.

ContactVal Davis,Subscriptions Director,at [email protected] telephone +44 (0) 1564 777 550

Make sure your colleaguesare as well informed as you

Make sure your fellow directors andexecutives get the latest generic medicinesand biosimilars news and exclusive insightsfrom Generics bulletin. Empower them tomake informed decisions and take decisiveactions to keep your business ahead of itscompetitors. Make sure your company hasa Corporate Subscription.

Business benefits

❖ Generics bulletin is available electronically worldwide toall company executives

❖ Keeps your business up-to-date with industry news andexclusive insights

❖ A fully-searchable archive offers in-house research facilities❖ Flexible formats – desktop,mobile and print options available❖ Flexible access – online or via company intranet❖ Modest cost – available for a fraction of the price of

multiple, individual subscriptions

TRADE AGREEMENTS

Industry warns overglobal risks of TPP

Prices to the UK National Health Service (NHS) of medicines costingmore than £20 (US$31) will be printed on packs from next year,

under plans unveiled by Secretary of State for Health, Jeremy Hunt.Affected packs will also bear a statement “funded by the UK taxpayer”.Hunt said the UK spends “£300 million a year on wasted medicine”.

“This will not just reduce waste by reminding people of the cost ofmedicine, but also improve patient care by boosting adherence to drugregimes,” Hunt claimed. “I will start the processes to make this happenthis year, with an aim to implement it next year.”

At present, the practical and regulatory changes required toimplement such a scheme are not clear.

Warwick Smith, director-general of the British GenericManufacturers Association (BGMA), commented: “We look forwardto hearing more information about the Secretary of State’s proposalsbefore we can comment in detail, but our main focus will be lookingat the impact this will potentially have on the patient and whetherthis change will enhance compliance.”

Community pharmacy body Pharmacy Voice said although Hunt’splan “may seem superficially attractive, there is little evidence that itwill have the desired effect”. “We strongly hope that any systemwill not rely on, or require, community pharmacy teams to have toexplain medicines pricing to patients and the public,” it added. G

PRICING & REIMBURSEMENT

UK proposes prices on packs


Departing from the international non-proprietary name (INN) systemfor biosimilars in the US would create an “unnecessary barrier”

to biologic interchangeability and would risk confusion amongpharmacists, payers and patients, the US Generic PharmaceuticalAssociation (GPhA) has warned in a letter to acting US Food and DrugAdministration (FDA) commissioner Steven Ostroff.

“Organisations representing the nation’s pharmacies, pharmacists,insurers, state employee retirement systems, taxpayers and others agreethat biologics and biosimilars should share the same name in order toensure patient safety and avoid confusion,” said GPhA presidentand chief executive officer Ralph Neas.

When the FDA approved the first US biosimilar earlier this year –Sandoz’ Zarxio version of filgrastim – it used the “placeholder” name‘filgrastim-sndz’ (Generics bulletin, 13 March 2015, page 1). Whilethe letter to Ostroff said it commended the FDA for “making it clearthat the provision of a placeholder INN for Zarxio does not representthe agency’s decision on a comprehensive naming policy for thesemedicines”, it warned that “any departure from the currently acceptedINN system could disrupt the ability to smoothly dispense and trackthese medicines, risking provider confusion and patient safety”, whilealso serving to “effectively separate the biosimilar from existing safetyinformation about the underlying molecule”.

Addressing concerns over tracking and the possibility of the FDAassigning “distinguishable names to reference biologics, biosimilars,and interchangeable biologics”, the letter states that current trackingmechanisms – such as through a product’s National Drug Code (NDC),lot number, brand name and manufacturer – are sufficient to gatherdata on biologics and biosimilars.

“We are concerned that any unnecessary changes may interfere withcurrent pharmacy safety alert systems,” the letter says, adding that“because adverse events and product recalls for small-molecule andbiologic drugs already are successfully identified using the NDC andlot number, there is no compelling evidence that biosimilars should behandled differently”. Shared INNs are “safely and effectively utilised inthe European Union, Canada, Australia and Japan”, the letter points out.

Dispensing complications would also be likely to arise withseparate INNs, the letter states. For example, “existing software wouldneed to be updated in order to group Neupogen (filgrastim) and Zarxiotogether”. Noting that certain biologic prefixes – such as was usedwith Teva’s Granix (tbo-filgrastim) – had been dropped in somedispensing systems, the letter suggests that similar problems withsuffixes could cause “massive confusion among pharmacists, payersand pharmacy benefit managers and may inhibit patient access”.

Moreover, the letter points out, an Express Scripts study hadcalcluated that “the availability of just two biosimilars – Sandoz’ Zarxioand Celltrion’s Remsima (infliximab) – would save US patients andpayers nearly US$22.7 billion between now and 2024”, with thesesavings put at risk by employing distinguishable names for biologics.

Acting through the Biosimilars Council division that it launchedearlier this year (Generics bulletin, 24 April 2015, page 13), the GPhAwas accompanied by several other healthcare organisations as signatoriesto the letter, including US pharmacy associations, retail groups andcompanies such as CVS Health, Express Scripts and Walgreens.

“The Biosimilars Council welcomes the opportunity to work withthe FDA and others to ensure that the biosimilar market in the USoptimises patient access to safe, effective and more affordablealternatives to brand-name biologics,” Neas concluded. G

MARKET NEWS


REGULATORY AFFAIRS

GPhA renews call forshared biologic name

EUROPEAN UNION (EU) member states have reached an agreementon renewal fees for the unitary patent being based on renewalfees currently paid in the four most frequently validated countriesby holders of European patents – Germany, France, the UK and theNetherlands. A select committee of the European Patent Office(EPO) administrative council plans to decide later this year how thefee income should be shared between participating member states.“A company protecting its innovation with the unitary patent willpay less than C5,000 (US$5,535) in renewal fees over 10 yearscovering a territory of 25 member states, instead of the current levelof around C30,000,” commented European Commissioner for InternalMarket and Industry, Elzbieta Bienkowska. “We need to keep themomentum and speed up the ratification process so that the unitarypatent becomes effective as soon as possible,” she said. At present,seven countries have ratified the unitary patent treaty.

GLOBAL BIOSIMILARS SALES could hit US$55 billion by 2020,according to GBI Research. The business-intelligence providerbelieves the value of the biosimilars market will reach US$20billion by the end of this year. “There are currently 642 biosimilartrials being conducted, with 146 unique molecules,” analyst SumithLadda commented, adding that oncology drugs accounted for36% of that pipeline.

PDA – the US Parenteral Drug Association – is on 28-30 Septemberholding a joint regulatory conference with the US Food and DrugAdministration (FDA). The event in Washington DC, US, will forthe first time simultaneously translate to and from Japanese.

BARMER-GEK has struck supply deals for 12 molecules andcombinations with 11 different generics companies. Two-yearcontracts to supply the drugs – which include cardiovascular, oncologyand Parkinson’s disease treatments – will begin on 1 September thisyear. For each ingredient, the German health insurance fund hasappointed up to three suppliers. The 12 drugs have combined annualsales through the fund of C84 million (US$93 million).

EMA – the European Medicines Agency – now requires that allapplications for centralised marketing authorisations be submittedelectronically. From January 2016, electronic application forms willalso be mandatory in the European Union (EU) for all marketing-authorisation procedures, including for decentralised and mutual-recognition applications.

CDER – the Center for Drug Evaluation and Research within theUS Food and Drug Administration (FDA) – said it had 52 biosimilardevelopment programmes notified, but not yet accepted for review,as of 31 March 2015. Between October 2014 and March 2015, theagency held 29 biosimilar development meetings and received 26requests for such meetings. The CDER granted 27 first-time genericapprovals in the six-month period.

ONLINE PHARMACIES in the European Union (EU) must from1 July display a dedicated logo required under the Falsified MedicinesDirective. Upon clicking on the logo, online shoppers should betaken to a national regulatory authority website that lists all retailerslicensed to sell medicines legally in that member state.

PRO GENERIKA – Germany’s generics and biosimilars industryassociation – has criticised the country’s health insurance funds forseeking further savings through rebate contracts for doxycycline100mg tablets. A pack of 10 tablets of the antibiotic has an ex-factorylist price of just C0.38 (US$0.42), the association pointed out. G

IN BRIEF


The latest draft of proposals from the World Health Organization(WHO) over a ‘biologic qualifier’ code to be added to the

international non-proprietary name (INN) for biologics fails toaddress questions that remain over the system, according to theEuropean Generic and Biosimilar medicines Association (EGA).

The WHO’s INN committee last year published a draft policydocument outlining plans to introduce a voluntary biological qualifiermade up of a four-letter code assigned at random to a biological activesubstance manufactured at a specific site (Generics bulletin, 8 August2014, page 25). This would be separate to the INN but applied to allbiologics to which INNs are assigned, including retrospectively.

The EGA has previously lobbied against linking the qualifierand the biologic drug’s manufacturing site (Generics bulletin, 19September 2014, page 11).

While Derek Calam, chair of the WHO’s INN committee, recentlypledged to modify the proposals to link the qualifier to the marketing-authorisation holder rather than the individual site of manufacture(Generics bulletin, 8 May 2015, page 13), the latest proposals stillrequire applicants to register the manufacturer of the active substanceas well as the manufacturing site or sites.

“EGA appreciates the efforts of the WHO INN office to maintaina globally unified naming system,” said Suzette Kox, the EGA’ssenior director of scientific affairs and coordinator of the EuropeanBiosimilars Group (EBG). “However, the July WHO biologic qualifierproposal does not address the many questions we raised previously.”

“No user testing is foreseen,” Kox pointed out, insisting that“any new identifier system must be tested systematically with allstakeholders to ensure it does not do more harm than good”. The EGA“remains supportive of the use of trade names, or the INN plus thecompany name”, she emphasised.

The WHO INN committee’s latest proposals suggest that thequalifier should be used “as a tool in pharmacovigilance systems inaddition to INN, tradename and, for many biologicals, batch number”.While the biological qualifier “may seem redundant”, the committeeacknowledges, it insists that “its use will provide a valuable cross-check of the veracity of the other information provided”. G

MARKET NEWS


Companies and individuals involved in the generics and biosimilarsindustries have until 24 July to submit their entries to the Global

Generics & Biosimilars Awards 2015. Entrants for the 13 awards –which will be judged by expert panels – can e-mail their entries [email protected] along with evidence of up to 500words to support their proposals.

Now in their second year, the Awards – which are free to enterand attend – will be presented on Tuesday 13 October 2015 at thePalacio Municipal de Congresos, Feria de Madrid, Spain.

Awards have so far been sponsored by firms including co-hostsArk Patent Intelligence, along with Honeywell, Panacea, Pharmacloud,Pharmawise and Thomson Reuters. Still available for sponsorshipare awards for Company of the Year for the Americas, Asia-Pacificand EMEA regions; Biosimilar Initiative of the Year; RegulatoryAchievement of the Year; and Supply Chain Initiative of the Year.G

INDUSTRY AWARDS

Awards entries close in July

EGA – the European Generic and Biosimilar medicines Association –has called for “more predictable planning by the European Union(EU) to stimulate competition in pharmaceutical markets withgeneric, biosimilar and value-added medicines” at a universalhealth conference held in Riga, Latvia at the end of June. “Withoutgeneric medicines,” the EGA said, “Europe’s health systems would befacing an additional bill of C40 billion (US$44.4 billion) each year.”

BIO – the US Biotechnology Industry Organization brandassociation – has commended Texas governor Greg Abbott forsigning into law state legislation to “create a pathway for thesubstitution of interchangeable biologic medicines”. The billincludes post-dispensing communication requirements for which theUS Generic Pharmaceutical Association (GPhA) recently voiced itssupport (Generics bulletin, 22 May 2015, page 23).

AUSTRALIAN brand industry association Medicines Australia saysthat local health minister Sussan Ley has fallen short of addressingsafety concerns on biosimilars by failing to agree on a strategicagreement with the group. The country’s Generic Medicines industryAssociation (GMiA) recently reached its own five-year deal withthe country’s government (Generics bulletin, 5 June 2015, page 14).“Medicines Australia had offered to work with the government onserious patient safety concerns which will allow the substitution ofbiosimilar medications by pharmacists”, the brand industry bodystated (Generics bulletin, 26 June 2015, page 21).

FRENCH anti-counterfeiting body IRACM has launched aninformation campaign to help the public better understand issuessurrounding counterfeit medicines. Running from 1 July to 31December 2015, the campaign – which will appear in print andonline – uses the slogan “counterfeit medicine, what is it?”.

EMA – the European Medicines Agency – has opened for consultationa draft question-and-answer document on “sodium in the contextof the revision of the guideline on excipients in the label and packageleaflet of medicinal products for human use”. The document is openfor comment until 30 September.

EMERGING MARKETS will account for a third of globalpharmaceutical spending by the end of 2015, according to a reportby Cambridge Consultants. However, such markets “cannot begrouped into a single cluster to chalk out common strategies”, theresearcher said, suggesting clustering markets around parameterssuch as regulatory pathways or therapeutic applications.

FDA – the US Food and Drug Administration – has submitted apackage of information including details of the Generic Drug UserFee Amendments, such as guidance on controlled correspondence, tothe US Office of Management and Budget (OMB) for review.Comments on the collection of this information may be submittedto the agency until 3 August.

CANADA’s Federal Court has issued a notice setting out initialrecommendations by a working group that are “designed to moderniseand improve practice and procedure, with the overarching goal ofachieving increased proportionality in proceedings before the court”.The recommendations include earlier involvement of the trial judgein case-management to enable “more effective scheduling of trials”,as well as a short-notice wait list for earlier trial dates. Furthermore,the group recommends that there should be “no new demonstrativeevidence” introduced at trial, with any demonstrative evidenceexchanged by parties at least 60 days before trial. G

IN BRIEFREGULATORY AFFAIRS

Questions remain onbiologic INN qualifier


Canada will require drug manufacturers to provide “six-monthsadvance notice of anticipated drug shortages or discontinuations

on a public website” and will have to publicly declare unanticipatedshortages within two days of knowing about the shortage, under newregulations proposed by the country’s Department of Health.

“Earlier, more comprehensive and reliable information on drug-supply disruptions will give healthcare providers more time andconfidence to make alternate treatment plans,” local agency HealthCanada said. The proposals have been published in the Canada Gazettefor a 75-day comment period. “Health Canada will also soon issuea request for proposals for a third party to create and administer thenew independent reporting website,” the agency said.

Meanwhile, Canada’s health minister, Rona Ambrose, hasannounced that plain-language labelling regulations are coming intoforce, starting with requirements for manufacturers of prescriptiondrugs to “provide mock-ups of labels and packages for Health Canadareview, and to provide evidence that proposed brand names will notbe confused with previously-approved brand names”. Similarrequirements for non-prescription drugs will come into effect in 2017.

Ambrose has also just launched the next phase of Health Canada’s‘regulatory transparency and openness framework’, a three-year planthat “charts the path forward for making more information availableand easier to understand in 2015-2018”. G

MARKET NEWS


59

60

59

60

euroPLX59

Athens (Greece)

Novem

ber 23+24, 2015

euroPLX60

Barcelona(Spain)

March

7+8, 2016

The Original since 1995.Often copied. Never equaled.

Seeking and offering business opportunities in patented and generic (incl.biosimilars), prescription and OTC drugs, medical devices, and nutraceuticals -development, licensing, marketing, promotion, and distribution…

Each euroPLX Conference’s actual collaboration interests are summarised anddisplayed onwww.europlx.com as an hourly updated Dynamic PartneringFocus, as soon as sufficient data are submitted by registrants.

[email protected]. ++49 (6221) 426296-0

Year-RoundBusiness D

evelopment

Since 20YearseuroPLX is the world’s most often held partneringconference for the pharma and biotech industries.

Because of results delivered.Second to none. Don’t miss the next two.

euroPLX 59 Athens (Greece)November 23 + 24, 2015Hotel Grande Bretagne, Athens

euroPLX 60 Barcelona (Spain)March 7 + 8, 2016Hotel Fairmont Rey Juan Carlos I, Barcelona

Register online:www.europlx.com

REGULATORY AFFAIRS

Canada takes actionto combat shortages

Reverse payments from originators to generics firms in patent-litigation settlements do not have to be in cash form to contravene

competition laws, the US Court of Appeals for the Third Circuit hasdecided in a case brought against GlaxoSmithKline and Teva bydrugstores and other direct drug purchasers.

“We are asked to decide,” the court summarised, “whether [theUS Supreme Court decision] FTC vs Actavis covers, in addition toreverse cash payments, a settlement in which the patentee drugmanufacturer agrees to relinquish its rights to produce an authorisedgeneric of the drug to compete with the first-filing generic’s drugduring the generic’s statutorily granted 180 days of market exclusivityunder the Hatch-Waxman Act as against the rest of the world.”

Unusual and unexplained transferGlaxoSmithKline’s commitment not to market an authorised

generic of Lamictal (lamotrigine) as part of a settlement with Teva fellunder the Supreme Court’s holding of reverse payments potentiallybeing anti-competitive “because it may represent an unusual,unexplained reverse transfer of considerable value from the patenteeto the alleged infringer, and may therefore give rise to the inferencethat it is a payment to eliminate the risk of competition,” the Courtof Appeals said in vacating a New Jersey district court’s ruling fromJanuary 2014 and remanding the case for further proceedings. G

SETTLEMENTS

US reverse paymentsmay go beyond cash


AstraZeneca’s formulation patent for its Seroquel RP (quetiapine)extended-release antipsychotic agent is invalid due to lack of

inventive step, a panel of three judges in Turin, Italy, has ruled.Adopting a “problem-solution approach”, the three Ordinary

Court of Turin judges identified the nearest prior art to the Italian partof European patent EP0,907,364 – which covers extended-releaseformulations of quetiapine using a gelling agent – to be the immediate-release quetiapine patent EP0,240,228, for which a supplementaryprotection certificate (SPC) expired in 2012.

A skilled person would have wanted to solve the technical problemof achieving stable levels of quetiapine in blood plasma withoutfrequent dosing, the judges decided.

“At the priority date of the [‘364] patent,” the judges said, “bothextended-release formulations of medicines and the use of gelling agentssuch as hydroxypropylmethylcellulose (HPMC) were already known.”

Prior-art Tench and Gendron documents encouraged administeringextended-release antipsychotics, the Turin court noted, while a Gefvertdocument stressed the importance of a once-daily dosage of quetiapinein improving patient compliance.

The Gefvert document has also been instrumental in invalidatingthe ‘364 patent – which expires in 2017 – in several other Europeancountries. It has been cited in cases in Belgium, Germany, theNetherlands, and the UK (Generics bulletin, 10 April 2015, page 15).G

PRODUCT NEWS


SPECIAL LICENSINGSPECIAL LICENSINGOPPORTUNITIESOPPORTUNITIES

DOSSIERS AVAILABLEASAfilm-coated tablets – 75, 100, 150 and 160mg

Betahistinetablets – 8, 16 and 24mg

Hydroxyzinefilm-coated tablets – 10 and 25mg

Paracetamol/Codeinetablets, several combination strengths – from 400/30mgup to 1,000/60mg

DOSSIERS AVAILABLE SOONLoperamide ODT2mg

Paracetamol SR665mg (available only outside Nordics)

Tranexamic acidfilm-coated tablets – 250, 500, 750 and 1,000mg

Other opportunities available at www.neogen.beFor more information please contact

[email protected]

SCHIZOPHRENIA DRUGS

Italian court voidsSeroquel RP patent

Companies offering controlled-release solid oral-dose forms ofoxycodone in Canada will have three years in which to incorporate

tamper-resistant properties into their formulations, under plans unveiledby the country’s Department of Health. A pre-consultation noticepublished in the Canada Gazette is open for comment until 4 August.

Draft regulations for solid-dose drugs with oxycodone as the onlyactive ingredient foresee the country’s regulatory agency, HealthCanada, implementing “one process for assessing a product’stamper-resistant properties”. Authorisations of such properties will“link to the existing drug submission” and a drug will be consideredtamper-resistant “if its product monograph includes a statement thatthe product has a tamper-resistant property”.

Scientific evidence required to support statements of tamper-resistance in opioid product monographs are outlined in a separatedraft Health Canada guidance published at the end of last year. Thisdetails the agency’s expectations for in vitro manipulation and extractionstudies, pharmacokinetic studies and clinical-trial data demonstratinga reduction in ‘drug liking’. For abbreviated new drug submissions(ANDS), “comparative studies provided in support of tamper-resistantfeatures should provide sufficient evidence to support equivalenttamper-resistant properties as the Canadian reference product (CRP)”.

The Department of Health is proposing “a three-year coming-into-force period to provide sufficient time for product reformulationand the necessary supply-chain adjustments”.

Outlining responses to a consultation exercise started last year,the Department acknowledges that the pharmaceutical industry hadhighlighted the complexity of supply chains. “Some manufacturersestimated that it would take several years to transition to newformulations and receive marketing approvals,” it notes.

“Some patients, healthcare professionals and organisationsexpressed concern that this proposal could affect the availability andaffordability of existing medications,” the Department recognises.Nevertheless, it says, “the majority of comments received agreed thatif new technologies were available to help mitigate the harms ofprescription drug abuse, products at high risk for abuse should berequired to incorporate the technology into their formulation”.

Once they achieve approval for tamper-resistance statements,companies will have to gather data on abuse and abuse potential.

Earlier this year, Health Canada denied as “inaccurate” mediareports that it planned to withdraw existing approvals for generic rivalsto Purdue Pharma’s OxyContin (oxycodone) controlled-release tabletsdue to concerns over prescription-drug abuse (Generics bulletin,22 May 2015, page 21). Generic rivals to OxyContin were authorisedin Canada at the end of 2012 (Generics bulletin, 14 December 2012,page 17), when Health Canada also introduced conditions governingcontrolled-release formulations of oxycodone, including requirementsfor manufacturers to submit monthly sales reports, report losses orthefts immediately, and notify the authorities of “unusual orders”.

The planned tamper-resistant properties for controlled-releaseoxycodone form part of a wider strategy in Canada to combatprescription drug abuse. The government is investing around C$130million (US$102 million) per year in a series of measures to combataddictions and abuse, including a commitment of CS$44 million overfive years to expand the focus on a national strategy beyond illicit drugsto prescription medicines. Measures include a national educationcampaign, more frequent pharmacy inspections and extra fundingfor prevention and treatment services. G

OPIOID ANALGESICS

Canada will demandoxycodone protection


UK Patent Court Judge Richard Arnold was wrong last year to rulethat Actavis’ proposed rival to Eli Lilly’s Alimta (pemetrexed

disodium) would not indirectly infringe the originator’s vitamin-dosageregimen patent that expires in June 2021, the UK Court of Appealshas decided. And as “there was no detectable difference in the laws ofFrance, Italy and Spain on the approach to contributory infringement”,Actavis should also be denied declarations of non-infringement in thosecountries, the UK court said, even though a German court of appealearlier this year dismissed Lilly’s indirect infringement argument.

Arnold’s ruling last year had paved the way for Actavis to launchits dipotassium salt version when a supplementary protection certificate(SPC) linked to the pemetrexed compound patent expires in Decemberthis year (Generics bulletin, 6 June 2014, page 17).

But a panel of three UK Court of Appeal judges found thatActavis’ proposed pemetrexed diacid, ditromethamine or dipotassiumformulations amounted to indirect, or contributory, infringement ofEuropean patent 1,313,508, which covers pemetrexed disodium usedin combination with vitamin B derivatives. This was because insupplying its pemetrexed salts, the generics firm was providing ameans for a doctor or pharmacist who used saline to make up thesolution for administration to infringe the ‘508 patent.

Dissolving in saline supplies sodiumA skilled team, the Court of Appeal said, would understand from

the ‘508 patent that pemetrexed disodium was used to refer to solutionswhich contained both pemetrexed and sodium ions in solution. Bydissolving or diluting Actavis’ pemetrexed salts in saline, a doctoror pharmacists would provide “a source of abundant sodium ions”, andthereby infringe Lilly’s patent.

On the issue of whether the UK court had jurisdiction in otherEuropean countries, the panel recognised that patent validity was asolely national issue. However, they said, the similarity to UK law of“approaches to the contributory infringement” justified refusingActavis non-infringement declarations in France, Italy and Spain.

Addressing a decision earlier this year by a German court ofappeal to overturn a Düsseldorf regional court finding that Actavis’proposed generic would infringe the vitamin-regimen patent (Genericsbulletin, 13 March 2015, page 17), the UK panel was “not persuaded”by the court of appeal’s finding that neither Actavis nor its customersused pemetrexed disodium at any time to prepare a medicine. G

PRODUCT NEWS


ONCOLOGY DRUGS

UK court reversesActavis’ Alimta win

Sandoz has extended its portfolio of generic medicines in Japanby introducing alternatives to Sanofi’s Plavix (clopidogrel)

anticoagulant and to Astellas’ Prograf (tacrolimus) immunosuppressant.The company has also extended its line of rivals to Kowa’s Livalo(pitavastatin) cholesterol-lowering agent.

Meanwhile, Daiichi Sankyo and Maruishi Pharmaceutical willcollaborate on marketing the injectable analgesic remifentanil in Japan.“Maruishi is currently applying for a manufacturing and marketinglicence,” Daiichi pointed out, adding that once this was obtained, “theplan is for Maruishi to handle its manufacture and Daiichi to handle itsmarketing, while both companies will conduct promotion activities”.G

CARDIOVASCULAR DRUGS/IMMUNOSUPPRESSANTS

Sandoz adds to Japan range

French public hospital organisation Assistance Publique – Hôpitauxde Paris (AP-HP) has awarded its first tender for infliximab to

Hospira. AP-HP – which covers 39 hospitals in Paris, treating aroundseven million patients annually – anticipates a discount to the brandof 45%, saving it around C6 million (US$6.6 million) annually throughthe tender that it launched in February.

“Access to therapeutic innovation while at the same timecontrolling drug spending represents a major challenge, to which thearrival of biosimilars can respond,” AP-HP stated.

While patients would benefit from savings, AP-HP emphasisedthat “quality, effectiveness and safety were constant priorities” inassessing the bids. Moreover, the body cited a “large consensus ontherapeutic equivalence between products” for biosimilar infliximab.Using the biosimilar would help both to lower costs and widen accessto the drug while respecting a legal prohibition in France on switchingpatients already established on a biological therapy, it predicted.

In Germany, Hospira says more than 1,000 patients have beentreated with its Inflectra (infliximab) brand since the biosimilar rival toMerck, Sharp & Dohme’s Remicade was launched in February this year.

From 1 July, Inflectra – which Hospira says offers a 25% discountto the reference brand – has been included in open-house rebatecontracts with funds such as Techniker Krankenkasse and DAK thattogether cover more than half of Germans with statutory insurance.

“We have started successfully in the German market and the initialfeedback from doctors is positive,” stated Hospira’s managing directorfor Germany, Petra Sturm. She highlighted a recent position paper fromthe country’s Paul Ehrlich institute that said the regulatory agency hadreceived no reports or signs that switching patients to biosimilar infliximabhad caused any problems (Generics bulletin, 26 June 2015, page 17).

In the UK, the availability of biosimilar infliximab is “not currentlya key driver of cost effectiveness”, even though using biosimilar rivalsto Remicade can save hundreds of pounds per patient each year,according to a draft guidance on biological treatments for rheumatoidarthritis that has been published for comment by the UK’s NationalInstitute for health and Care Excellence (NICE).

While the net price of Remicade is £419.62 (US$659.21) per 100mgvial, the guidance states, biosimilar Inflectra from Hospira and Remsimafrom Napp offered a 10% list-price discount, based on informationprovided by the companies. This results in a saving of £704.93 perpatient in the first year of treatment, although “costs may vary indifferent settings because of negotiated procurement discounts”.

“The incremental cost-effectiveness ratio (ICER) for infliximabbiosimilars plus methotrexate was £37,200 per quality-adjusted life year(QALY) gained, compared with an ICER of £39,000 per QALY gainedwhen using the price of the originator,” NICE notes. Generally, thebody does not consider drugs with costs above £20,000 to £30,000per QALY to be cost-effective.

Preliminary recommendations in the guidance propose thatclinicians “start treatment with the least expensive drug, taking intoaccount administration costs, dose needed and product price per dose”.Few people, it notes, start treatments with infliximab “because it isgiven by infusion rather than subcutaneous injection and is associatedwith greater administration costs than other TNF-inhibitors”.

While some National Health Service (NHS) trusts are startingpatients on biosimilar infliximab, the guidance observes, “if a person isalready on a treatment and their disease is responding, they would notbe switched to a biosimilar”. G

BIOLOGICAL DRUGS

Hospira’s infliximabwins French tender


Awards Sponsored by

Cocktail Reception &Awards Presentation

Tuesday 13 October

Palacio Municipal de CongresosFeria de Madrid, Spain

DPS Col Pg.1 Adv.2_Layout 1 03/07/2015 16:02 Page 1

The Awards

Company of the Year

Company of the Year, Americas

Company of the Year, Asia-Pacific

Company of the Year, EMEA

Acquisition of the Year

Leader of the Year

Innovation of the Year

Business Development of the Year

API Supplier of the Year

Biosimilar Initiative of the Year

Patent Litigation of the year

Regulatory Achievement of the Year

Supply Chain Initiative of the Year

EEnntteerr,, SSppoonnssoorr,, AAtttteennddFor more information:

VViissiitt www.generics-bulletin.com EEmmaaiill [email protected] CCaallll +44 1564 777550

The tremendous work done by executives in theglobal generics and biosimilars industries duringthe past year will be recognised by the GlobalGenerics & BiosimilarsAwards 2015,presented by Generics bulletin in associationwith Ark Patent Intelligence.

Now in their second year, these Awards willreward 'best practice' in the generics andbiosimilars space,while encouraging and supportingall that's good in the sector.

Business development initiatives – such asthrough innovative product development, cleverlicensing deals or smart legal manoeuvres – are atthe heart of theGlobal Generics & BiosimilarsAwards 2015.

Awards will also go to the best executives andleading companies that have recorded outstandingachievements during the past 12 months.

TheAwards will be presented on 13 October atthe Palacio Municipal de Congresos which iswithin walking distance of the IFEMA Conventionand Congress centre, Feria de Madrid, Spain.

Presenting...The secondAnnualGlobal Generics & BiosimilarsAwards

Make sure your outstanding businessachievements are celebrated by the globalgenerics and biosimilars industries.

DPS Col Pg.2 Adv.2_Layout 1 26/05/2015 15:50 Page 1

Two US patents protecting The Medicine Company’s (MDCO’s)Angiomax (bivalirudin) injectable until January 2029 are invalid,

the US Court of Appeals has ruled in a decision favouring Hospira.The ruling – which leaves no remaining valid or unexpired

Angiomax patents listed in the US Food and Drug Administration’s(FDA’s) Orange Book – overturns a Delaware district court’s rulinglast year that US patents 7,582,727 and 7,598,343 were valid, butnot infringed by Hospira’s abbreviated new drug application (ANDA).

“We are evaluating the court’s ruling and considering our nextsteps,” MDCO commented.

The Delaware court, a panel of three appeals court judges stated,had “clearly erred” in deciding that three bivalirudin batches preparedfor MDCO by Ben Venue over a year before the ‘727 and ‘343 patentswere filed in July 2008 “were not sold…and were prepared primarilyfor experimental purposes”.

“While the district court is correct that Ben Venue invoiced thesales as manufacturing services, and title to the pharmaceutical batchesdid not change hands, that does not end the inquiry,” the appeals courtstated. “MCDO paid Ben Venue for performing services that resulted inthe patented product-by-process, and thus a ‘sale’ of services occurred.”

“Ben Venue marked the batches with commercial productcodes and customer lot numbers and sent them to MDCO forcommercial and clinical packaging, consistent with the commercialsale of pharmaceutical drugs,” the court stated. This amounted to“significant” commercial activity, as the originator had admittedeach batch had a commercial value of “over US$10 million”.

Earlier this year, India’s Sun reached a settlement with MDCOentitling it to launch a US generic version of Angiomax on 30 June2019, or “earlier under certain circumstances”, in return for concedingthat the ‘727 and ‘343 patents were valid (Generics bulletin, 10 April2015, page 18). Teva may also launch on that date following a settlementreached in 2011, while Fresenius Kabi’s APP Pharmaceuticals affiliatehas a slightly earlier settlement launch-date of 1 May 2019.

Having last year fought off an invalidity challenge against the‘727 patent from Mylan in an Illinois district court (Generics bulletin,3 November 2014, page 19), MDCO noted, at the time of the Sunsettlement, that it remained in litigation with the US firm, along withgenerics players Apotex, Accord, Aurobindo, Dr Reddy’s and ExelaPharma Sciences. US sales of Angiomax reached US$600 million in2014, representing the bulk of global sales of the anticoagulant thattotalled US$636 million. As Generics bulletin went to press, the FDAhad not approved any ANDAs for US alternatives to Angiomax. G

PRODUCT NEWS


ANTICOAGULANTS

Angiomax patentsare invalidated in US

French doctors should favour prescribing generic buprenorphinetablets over their branded equivalent Subutex, according to the

country’s Académie Nationale de Médicine. The advisory body statedthat generic versions of RB’s opioid-dependence drug were “lesssoluble and cannot be used for injection”, so were harder to abuse.

Actavis, Arrow, Biogaran and EG Labo have versions ofbuprenorphine listed against Subutex on France’s répertoire ofsubstitutable generic equivalents, along with Ethypharm, Mylan,Sandoz, Sun and Teva. G

OPIOID-DEPENDENCE TREATMENTS

France backs buprenorphine

EMA – the European Medicines Agency – has adopted bioequivalenceguidances for several drugs. Having reviewed received comments,the agency has adopted guidelines for capecitabine, sorafenib,tadalafil and telithromycin presented as film-coated tablets, as wellas for sunitinib hard capsules and for voriconazole in the form of50mg and 200mg tablets plus 40mg/ml powder for oral suspension.The agency’s pharmacokinetics working party has just adopted forsix-month public consultation bioequivalence guidances for prasugreland sitagliptin film-coated tablets, asenapine sublingual tabletsand zonisamide hard capsules.

FOUR COMPANIES – Alembic, Lupin, Mylan and Sandoz – havesimultaneously become the first firms to secure US approval forgeneric alternatives to Pfizer’s Pristiq (desvenlafaxine succinate)50mg and 100mg extended-release capsules. The US Food and DrugAdministration (FDA) lists three patents against the antidepressantbrand, two of which expire in 2022, and one in 2027. BreckenridgePharmaceutical – which has an alliance with Alembic – said it hadreached a settlement of paragraph IV litigation with Pfizer thatallowed for generic entry on an undisclosed date before patent expiry.

TEVA has begun shipping a generic version of Boehringer Ingelheim’sAggrenox (aspirin/dipyridamole) 25mg/200mg extended-releasecapsules in the US. The 1 July launch-date matches a date agreedupon in a patent-litigation settlement its Barr affiliate reached withthe German originator seven years ago, although that settlemententitled Barr to launch an authorised generic of the cardiovascularbrand (Generics bulletin, 1 September 2008, page 18). The Israelifirm’s launch comes around a year-and-a-half ahead of sole USAggrenox patent 6,015,577 expiring on 18 January 2017, and isthe first rival on the market according to the US Food and DrugAdministration (FDA’s) Orange Book. Teva said the brand hadUS sales of US$457 million in the 12 months ended April 2015.

SANDOZ has secured US approval for its Tri-Lo-Estarylla(ethinylestradiol/norgestimate) equivalent to Janssen’s OrthoTri-Cyclen Lo. Lupin gained the first approval for a rival to theoriginal in 2012, but later that year lost a challenge to a patentprotecting Janssen’s brand until December 2019 (Generics bulletin,1 October 2012, page 18).

ACTAVIS UK has reduced the National Health Service (NHS) listprices for its oxycodone-based Lynlor immediate-release capsulesand Reltebon prolonged-release tablets. The firm said its price forthe opioid analgesics was now 40% below that of both the brandedoriginals and the Drug Tariff pharmacy reimbursement price. Actavis –which makes the analgesics at its UK facility in Barnstaple, Devon –noted that UK doctors had prescribed 42% of oxycodone tabletsgenerically in January 2015.

AUROBINDO has received final US approval for a rival to Pfizer’sDilantin (phenytoin sodium) 100mg extended-release capsules.The Indian firm has also gained approval for a rival to the originator’sZithromax (azithromycin) 500mg vials, and it plans soon to launchentacapone 200mg tablets following US clearance for the rival toOrion’s Comtan Parkinson’s disease brand.

LEE PHARMA has applied to India’s Controller of Patents for acompulsory licence to Indian patent IN206,543 that protectsAstraZeneca’s saxagliptin-based diabetes brands Onglyza andKombiglyze. The Hyderabad-based firm claims that “the patentedinvention is not available to the public at a reasonably affordableprice”, nor is the invention “worked in the territory of India”. G

IN BRIEF


Eli Lilly has been fined BRL36.6 million (US$11.8 million) byBrazil’s Administrative Council for Economic Defense (CADE)

for filing “sham litigation” in Brazil to maintain its monopoly for thecancer treatment Gemzar (gemcitabine).

“By means of contradictory and misleading lawsuits filed in thefederal courts of Rio de Janeiro, the federal district and Sao Paulo,the company gained the exclusive rights to trade Gemzar,” CADEdeclared. An analysis by CADE of documents filed in those courtsrevealed that Lilly had “omitted relevant information” about changingthe scope of its gemcitabine patent, which initially related exclusivelyto a process for making the active pharmaceutical ingredient (API).

This had allowed Lilly in July 2007 to obtain an injunction againstBrazil’s Anvisa regulatory agency authorising generic versions of thecancer drug. The injunction was not lifted until March 2008, whenBrazil’s Superior Court of Justice ruled that Lilly’s monopoly wascausing “serious harm to public health and the economy”.

CADE’s Ana Frazão said Lilly had engaged in “sham litigation”during which it did not disclose that its request to amend its processpatent had been denied. Furthermore, the originator had exploited itsmonopoly on gemcitabine for treating breast cancer to prevent Sandozfrom marketing its Gemcit alternative for other cancers.

During its extended monopoly, Lilly had “abused its dominantposition” by charging BRL540 for Gemzar, before dropping the priceto BRL189 once the injunction was lifted. G

PRODUCT NEWS


Existing MAs OpportunityMedochemie Ltd, a generic manufacturer with headquartersin Cyprus and 39 years history in the pharma industry, islooking for partners interested in acquiring existing MarketingAuthorisations in Belarus, Bulgaria, Czech Republic,Kazakhstan, Latvia, Lithuania, Moldova, Romania, Russia,Slovakia and Uzbekistan.

Medochemie Ltd ● 1-10 Constantinoupoleos Street ● 3011 Limassol ● CyprusTel: 0035725867600 Fax: 0035725560863 www.medochemie.com

For more information, please contactMr Andreas Loizou (Licensing Manager) at

[email protected].

LITIGATION/ONCOLOGY DRUGS

Brazil levies fine forLilly’s sham lawsuits

Lupin’s Australian affiliate, Generic Health, has secured an advantageover Otsuka in a Sydney federal court after Judge David Yates

ruled that key claims of Australian patent 2005,201,772 protectingthe originator’s Abilify (aripiprazole) schizophrenia brand until 2022were invalid and should be revoked.

The ruling comes three years after Yates issued an injunctionagainst Generic Health after finding that the company’s generic tabletsinfringed Claim 7 of the ‘772 patent, which covers a method of treatingcognitive impairment (Generics bulletin, 6 April 2012, page 19).

In Yates’ latest ruling, he found both Claim 1 – covering theproduction of an aripiprazole medicine as a method of treating cognitiveimpairment – and Claim 7 lacked novelty in light of prior-artdocuments. In particular, two patents listed in the ‘772 patent’sspecification – US patent 5,006,528 and European patent EP0,367,141– disclosed that aripiprazole and other carbostyril derivatives wereuseful for improving the symptoms of schizophrenia.

“I am satisfied that, at the priority date, the person skilled in theart would have understood that when EP’141/US’528 refer toaripiprazole’s utility in treating negative symptoms, those symptomsincluded at least some of the symptoms which Claims 1 and 7 ofthe ‘772 patent categorise as cognitive impairment,” Yates stated.

Claim 7, he pointed out, “is directed to the use of aripiprazoleto treat a subset of the symptoms of schizophrenia in certain patientson certain occasions, when it is already known that aripiprazole canbe used to treat schizophrenia generally”. Similarly, Claim 1 coveredproduction of a medicine “for treating patients in respect of the samesymptoms in the same circumstances”. Elucidating information ofthe action of known carbostyril compounds, such as aripiprazole, oncertain receptors did not amount to novelty, Yates ruled.

For the sake of “completeness”, Yates also considered prior-artSerper and Saha documents and found that these also rendered the‘772 patent not novel. However, he rejected several other invalidityarguments, and found that Generic Health’s product would haveinfringed Claim 7 of the ‘772 patent, had it been valid.

Earlier this year, Apotex failed to overturn an Australian rulingthat upheld as valid Abilify’s Australian patent 2002,334,413 (Genericsbulletin, 6 February 2015, page 18). The Canadian firm had previouslybeen subject to an aripiprazole injunction that had been granted onthe basis of the ‘413 patent. G

SCHIZOPHRENIA DRUGS

Australia court rulesAbilify patent invalid

Actavis must disclose the identity of two UK pharmacy chains,totalling around 80 stores, that indicated they would not buy generic

versions of Pfizer’s Lyrica (pregabalin) amid doubts over whether theoriginator’s pain patent would be infringed.

In a ruling delivered shortly before a full invalidity trial gotunderway, Patents Court Judge Richard Arnold ordered the chains beidentified on terms that Pfizer did not approach them without Actavis’or the court’s consent. He urged the litigants to consider “anappropriately phrased joint approach” to the chains. G

EPILEPSY DRUGS/ANALGESICS

Actavis must disclose chains

Key claims of Pfizer’s reissued US celecoxib patent RE44,048 areinvalid due to obviousness-type double patenting, the US Court of

Appeals has confirmed. The decision upholds a Virginia district court’sverdict last year in favour of generics defendants Actavis, Apotex,Lupin, Mylan and Teva (Generics bulletin, 21 March 2014, page 1).

A panel of three appeals judges found that the reissued ‘048patent – which expires in December 2015 – was not protected by a‘safe-harbour’ provision that stops original applications being usedas grounds to invalidate divisional applications.

Generic versions of Pfizer’s Celebrex (celecoxib) analgesic andanti-inflammatory agent entered the US market at the end of last yearunder the terms of settlement deals that several generics firm struckwith Pfizer (Generics bulletin, 16 January 2015, page 20). G

ANALGESICS

US celecoxib patent is invalid


Teva has failed to prevent Novartis from obtaining an order blockingCanada’s Minister of Health from issuing a notice of compliance

(NoC) – effectively a marketing authorisation – for the Israeli firm’sgeneric version of Novartis’ Exjade (deferasirox) to treat iron excess.Describing as unjustified Teva’s allegations that Canadian patent2,255,951 was invalid due to obviousness, insufficiency and lack ofutility, the ruling handed down by Federal Judge James O’Reillyprevents a generic rival to Exjade from entering the market untilpatent expiry on 24 June 2017.

O’Reilly considered Teva’s allegations of obviousness andinsufficiency as well as lack of utility. On the former, O’Reilly stated:“There is no evidence that compounds with these properties wouldhave come within the common general knowledge of the skilledperson, or that they were disclosed in the prior art.” “I note that theinventors spent many years testing hundreds of compounds beforethey arrived at the compounds of the ‘951 patent,” he added.

“Even assuming that Teva identified the relevant prior art, thereis a significant gap between those sources and the inventive conceptof the ‘951 patent,” O’Reilly said. “The evidence demonstrates theinventors had to apply inventive ingenuity to bridge that gap.”

Turning to insufficiency, O’Reilly said that Novartis had“sufficiently disclosed its invention by identifying 30 compounds thatdisplayed the useful properties described in the patent”, rejecting Teva’sassertion that the originator “hid the real invention by failing to identifydeferasirox as the compound that would ultimately make it to market”.

On lack of utility, O’Reilly said “Teva’s allegation of inutility inrespect of the use claims of the patent is justified, but not its parallelallegation in respect of the novel compounds of the ‘951 patent”.

Animal testing to demonstrate iron binding and excretion wassufficient to show the utility of the patent’s compound claims, O’Reillyruled. But animal tests were not a sufficient basis from which tosoundly predict the promise of the patent’s use claims to be usefulin treating iron overload disorders in humans. G

PRODUCT NEWS


HAEMATOLOGY DRUGS

Teva falls to Novartison Exjade in Canada

MPP – the Medicines Patent Pool – has struck agreements withIndia’s Lupin and Strides Arcolab allowing them to produce versionsof Viiv’s Tivicay (dolutegravir) antiretroviral. Another deal withcurrent partner Hetero entitles the Indian company to manufacturepaediatric formulations of AbbVie’s Kaletra (lopinavir/ritonavir)HIV treatment. Separately Viiv has struck a manufacturing agreementwith Desano Pharmaceuticals allowing the Chinese firm to producedolutegravir “for onward sale in China” and certain developingcountries, subject to national approvals. “Viiv and Desano are alsoexploring further options for future manufacture of finished drugproduct and fixed-dose combinations of dolutegravir with activepharmaceutical ingredients (APIs),” the originator commented.

TGA – Australia’s Therapeutic Goods Administration – plans to adoptfrom 1 September European Medicines Agency (EMA) product-specific guidelines on biosimilar human insulin and insulinanalogues, interferon beta and recombinant human folliclestimulating hormone (r-hFSH). A consultation closes on 14 August.

TARO has become the first company to secure final US Food and DrugAdministration (FDA) approval for generic Clarinex (desloratadine)0.5mg/ml oral solution. The approval came as six-month paediatricextensions to three patents listed in the FDA’s Orange Book expiredon 30 June. A similar extension to US patent 6,514,520 protectsMerck & Co’s allergy remedy until 1 December 2018.

WOCKHARDT UK has introduced gentamicin solution forinjection or infusion in packs of five 2ml ampoules. The systemicantibiotic has a trade list price of £11.25 (US$17.36) for the 10mg/mlstrength, and £6.88 for the 40mg/ml version.

ACCORD HEALTHCARE has obtained tentative US approval forits hybrid 505(b)(2) new drug application (NDA) for its cabazitaxel60mg/3ml injectable formulation. Final approval is being held upby paragraph IV patent-infringements suits that Sanofi has filed overUS patents 5,847,170 and 8,927,592 in a New Jersey district court,as well as by a similar suit over the ‘170 patent in North Carolina.Both patents are listed against Sanofi’s Jevtana Kit (cabazitaxel)60mg/1.5ml prostate-cancer treatment.

ZENTIVA has secured a listing in France’s répertoire list of genericequivalents for a version of parent group Sanofi’s Sectral (acebutolol)500mg extended-release tablets. Guerbert has gained a listing foran unbranded version of its own Dotarem (gadoteric acid) 0.5mmol/ml injectable solution, including in a pre-filled syringe.

TEVA has realised its plans to introduce its Seasonique(levonorgestrel/ethinylestradiol) oral contraceptive brand in “select”European countries after launching the extended-regimen tablets inAustria, Italy, Poland and Slovakia. The Israeli firm had last yearreceived a positive opinion from the European Medicines Agency’s(EMA’s) committee for human medicinal products (CHMP),recommending granting a marketing approval for Seasonique, but hadat the time said it expected to begin shipping by the end of 2014(Generics bulletin, 11 July 2014, page 23). Moreover, Teva hadnoted, more European launches would follow. Having first launchedSeasonique, in the US, nine years ago, Teva recently introducedthe contraceptive brand in Brazil, Chile and Israel.

ZYDUS CADILA says it has received its 100th abbreviated newdrug application (ANDA) approval with US clearance forpyridostigmine bromide 60mg tablets. The Indian firm has to datefiled more than 260 ANDAs. G

IN BRIEF

The active ingredients in AstraZeneca’s Symbicort (budesonide/formoterol) and Gilead’s Sovaldi (sofosbuvir) blockbusters are

among 44 drugs for which the US Food and Drug Administration hasunveiled (FDA) draft product-specific bioequivalence guidelines. Theagency has also updated existing guidances for cholestyramine,doxycycline, prasugrel and tiagabine.

In its budesonide/formoterol guideline, the FDA recommendsin vitro single actuation content (SAC) and aerodynamic particle-sizedistribution (APSD) studies using at least three batches of the test andreference products, “with no fewer than 10 units from each batch”.Spray pattern, plume geometry and priming and repriming studies arealso proposed, as is a fasting pharmacokinetic study.

For a clinical endpoint study, the agency says the lowest strengthshould be used with a two-week run-in period followed by six weeksof treatment. The generic device should be “similar in shape and size”to the reference drug and should also incorporate a dose counter.

Among the 44 new draft guidelines are metered aerosols containinglevalbuterol tartrate and azelastine/fluticasone nasal sprays. G

RESPIRATORY DRUGS/HEPATITIS C DRUGS

FDA guides over Symbicort


Hospira has convinced UK Patents Court judge Justice RichardArnold that a patent protecting the use of trastuzumab with taxanes

such as paclitaxel to treat breast cancer is invalid due to obviousness.Arnold ruled that the UK part of European patent EP1,037,926,

which protects Genentech’s Herceptin (trastuzumab) monoclonalantibody, was obvious in light of a prior-art Baselga 97 review articlethat described a Phase III clinical trial of trastuzumab in combinationwith paclitaxel, but did not disclose results of that trial. The Baselgaarticle was published in March 1997, nine months before the ‘926patent’s priority date of 12 December 1997.

“It would not be obvious to the skilled person from readingBaselga 97 that the combination would result in increased efficacy asmeasured by time to disease progression (TTP) compared to taxanealone,” Arnold noted. “The issue is whether the skilled person wouldhave a fair expectation of success, meaning a fair expectation ofincreased efficacy as measured by TTP of the combination comparedto taxane alone, if he were to undertake such a trial.”

Baselga 97, Arnold observed, described the results of Phase IIand xenograft studies as “positive” and “encouraging”. “Moreover,it says that these results have ‘led to’ the design of the Phase III trial.”

“The skilled person would agree with the assessment of the authorsof Baselga 97, namely that the results of the previous studies were‘positive’ and ‘encouraging’ and justified the decision to move forwardto a Phase III trial, even though there had been no Phase II trial ofthe combination of trastuzumab and a taxane,” Arnold concluded infinding the patent obvious.

However, Arnold rejected Hospira’s argument that the ‘926 patentlacked novelty. “It is now well established in the case law of the Boardsof Appeal of the European Patent Office (EPO) that a prior disclosureof the existence of a clinical trial does not anticipate a claim whichincludes a specified therapeutic effect revealed by the (undisclosed)results of that clinical trial, unless the therapeutic effect can be deriveddirectly and unambiguously from the prior disclosure,” he pointed out.

“As counsel for Genentech submitted, one cannot intend toadminister the combination of trastuzumab and a taxane to achieveincreased efficacy in the treatment of breast cancer compared to thetaxane alone unless one knows that that clinical benefit will obtained.”

Noting that a UK supplementary protection certificate (SPC)linked to Herceptin’s basic European patent 0,590,058 had expired on29 July 2014, Arnold recognised that Hospira had “brought a series ofactions to clear the way by revoking a number of other patents ownedby Genentech relating to trastuzumab” as it looked to bring a biosimilarversion of the blockbuster to market.

Last year’s invalidity ruling on two UK patents – one coveringa dosing regimen and the other protecting certain impurity profiles(Generics bulletin, 18 April 2014, page 15) – had been upheld on appealin January this year, Arnold noted, while Genentech had appealedagainst an invalidity ruling on two lyophilised formulation patents.

“The [‘926] patent has been opposed at the EPO, but the oppositionproceedings are at an early stage,” Arnold noted. G

PRODUCT NEWS


Veterinary Generic Formulationsfor US Market

Licensing/Development/Acquisition/Distribution

Email: [email protected] Box Number 208

Established USA based Generic Veterinary companywith broad experience in marketing and regulatory isseeking products to expand existing product line.

Our company currently markets several Rx products inthe US veterinary market.

We are actively seeking licensing, co-development oracquisition of existing NADA/ ANADA and distributionarrangements.

Products of interest include oral, injectable and OTCpreparations for small and large animals; both companionand food producing.

Interested companies, please send a detailedemail with company information and

products to offer for a confidential discussion.

BIOLOGICAL DRUGS

Hospira defeats UKpatent on Herceptin

Glenmark can begin preparations to introduce the first US rivalto Merck & Co’s Zetia (ezetimibe) 10mg tablets with 180-day

market exclusivity after receiving US Food and Drug Administration(FDA) approval for its abbreviated new drug application (ANDA). Thecholesterol-lowering brand had global sales of US$2.65 billion last year.

More than five years ago, the Indian firm struck a patent-litigationsettlement with the US originator that allowed it to launch genericZetia on 12 December next year, or “earlier under circumstances”,ahead of paediatric exclusivity attached to Merck’s reissued USpatent RE37,721 expiring on 25 April 2017 (Generics bulletin, 28May 2010, page 14). Following the settlement, Glenmark licensedexclusive US rights to its ezetimibe tablets to Par.

Three other patents – US patents 7,030,106 and 7,612,058reissued US patent RE42,461 – are also listed against Zetia in theFDA’s Orange Book. However, the agency explained, the ‘058 and ‘461had not been listed when Glenmark had submitted its ANDA, while noaction had been brought against the Indian firm for its paragraph IVpatent challenge to the ‘106 patent, for which a six-month paediatricextension expires on 25 July 2022.

Mylan currently holds tentative US approval for generic ezetimibetablets, having two years ago had a failed invalidity challenge againstthe ‘721 patent upheld by the US Court of Appeals (Generics bulletin,15 February 2013, page 20). G

CHOLESTEROL-LOWERING DRUGS

Glenmark gains USezetimibe clearance

ALVOGEN has obtained the first US approval for a generic alternativeto Valeant’s Mestinon (pyridostigmine bromide) 180mg extended-release tablets. G

IN BRIEF


PIPELINE WATCH


Following the May expiry of supplementary protection certificates(SPCs) for Sanofi’s blockbuster insulin analogue Lantus (insulin

glargine), June and July bring SPC expiries for Novo Nordisk’sNovoMix (insulin aspart/insulin aspart protamine), a rapid-actinghuman insulin analogue (see Figure 1). These SPCs are based onEuropean patent EP0,705,275, which protects crystalline insulin aspartand protamine, with SPCs on the NovoRapid (insulin aspart) moleculepatent EP0,214,826 having already expired in August 2011.

“Currently there is no biosimilar insulin aspart approved in Europe.Novo Nordisk still holds patents protecting the authorised dosage formof NovoRapid and NovoMix, which may pose a challenge for a firmwishing to develop a biosimilar,” notes Ark Patent Intelligence.

June also brought the expiry of several SPCs linked to Europeanpatent EP0,401,747, which protects the indicated use for Pfizer’s

Rapamune (sirolimus) in preventing organ transplant rejection.Six-month paediatric SPC extensions protecting Amgen’s and

Pfizer’s Enbrel (etanercept) biologic blockbuster end during July inAustria, Finland, Ireland, the Netherlands, Sweden and the UK, withsimilar expiries in other countries in early August. An extension toAustralian patent AU630,497 is also set to expire in July.

Eight years of data exclusivity in the European Union expiredin June for Janssen’s antipsychotic drug Invega (paliperidone), to befollowed by two years of market exclusivity. Furthermore, a one-yearextension for a new indication could bar generics until June 2018.

July brings the expiry of six years of Canadian data exclusivityfor Bristol-Myers Squibb’s antipsychotic agent Abilify (aripipirazole).This will be followed by two-and-a-half years of market exclusivity,while formulation patents could also inhibit generic competition. G

This monthly update of key patent, SPC and data exclusivity data is extracted from Ark Patent Intelligence Expiry Database. Covering 50countries and over 1,600 INNs, Ark Expiry Database contains watertight data teamed with the ultimate in generic launch analysis.

For further information, visit www.arkpatentintelligence.com, or contact:Europe: +44 870 879 0081. North America: +1 704 665 1986.Or e-mail: [email protected].

INN Country

June

Dexketoprofen Switzerland

Gadoxetic acid Austria, Belgium, Czech Republic, Finland,Germany, Greece, Hungary, Ireland, Italy,Netherlands, Norway, Slovakia, Spain, Sweden,Switzerland, UK

Hydroxyethylstarch Switzerland

Insulin aspart Austria, Belgium, Denmark, Greece, Ireland,Netherlands, Sweden, Switzerland, UK

Rizatriptan Switzerland

Sirolimus Austria, Belgium, Denmark, France, Germany,Greece, Hungary, Italy, Luxembourg,Netherlands, Romania, Spain, Sweden,Switzerland, UK

Tenecteplase Austria, Belgium, Denmark, France, Germany,Ireland, Italy, Luxembourg, Netherlands, Portugal,Sweden, Switzerland, UK

July

Dorzolamide/Timolol Slovakia

Etanercept Austria, Finland, Ireland, Netherlands, Sweden, UK

Insulin aspart Italy

Loflupane Austria, Denmark, Finland, France, Germany,Greece, Italy, Netherlands, Portugal, Spain, Sweden

Rasburicase Austria, Belgium, Denmark, Finland, France,Germany, Greece, Hungary, Ireland, Italy,Luxembourg, Netherlands, Norway, Spain, Sweden,Switzerland, UK

Rosiglitazone Belgium, Finland, Italy, Netherlands, Spain

Tenecteplase Greece

Tocilizumab Austria, Belgium, France, Germany, Italy, Romania,Sweden, Sitzerland, UK

Figure 1: Molecules for which supplementary protection certificates (SPCs) expirein certain markets in June and July 2015 (Source – Ark Patent Intelligence)

SPC expiries in June/JulyINN Country/Region

June

Cabazitaxel US

Denosumab Australia

Emamectin Canada*

Follitropin alfa/Lutropin alfa European Union**

Hydromorphone Switzerland

Liraglutide Turkey

Naloxone/Oxycodone South Korea

Paliperidone European Union**

Pazopanib Australia

Tafluprost South Korea

Vorinostat Canada*

July

Alcaftadine US

Amlodipine/Atorvastatin Belgium, France, Germany, Italy,Luxembourg, Netherlands, Sweden, UK

Aripiprazole Canada*

Clofarabine Canada*

Corifollitropin alfa Australia

Dapoxetine South Korea

Eltrombopag Australia

Gadoversetamide European Union**

Ivabradine South Korea

Methoxy polyethylene European Union**glycol-epoetin beta

Retapamulin South Korea

* This will be followed by a no-marketing period of two years during which a notice of compliance willnot be granted to a generic manufacturer. In addition, a further six months data protection will be added tothe 8-year term for studies of aripiprazole and clofarabine in paediatric populations

** This will be followed by two years of market exclusivity, where a generic will not be placed on themarket. In addition, a further one year of market exclusivity for a market authorisation for a newindication deemed to have significant clinical benefit has been awarded for paliperidone.

Data exclusivity expiries in June/July

Figure 2: Molecules for which data exclusivity expires in certain markets duringJune and July 2015 (Source – Ark Patent Intelligence)

NovoMix insulin loses European protection


Accord Healthcare and Sanofi’s Zentiva have received positiveopinions from the committee for human medicinal products

(CHMP) within the European Medicines Agency (EMA) for theirgeneric versions of Lyrica (pregabalin) and Cymbalta (duloxetine)respectively. Hospira got the CHMP’s backing for a generic rival toTaxotere (docetaxel), while Sandoz obtained a positive response toits hybrid filing for aripiprazole tablets.

The European Commission typically issues a pan-Europeancentralised marketing authorisation within 67 days of the CHMPhaving adopted its opinions.

Pregabalin Accord 25mg, 50mg, 75mg, 100mg, 150mg, 200mg,225mg and 300mg hard capsules are to be indicated for epilepsy andgeneralised anxiety disorder, but not for Pfizer’s patented painindication. Generalised anxiety disorder is also among the proposed usesfor Duloxetine Zentiva 30mg and 60mg gastro-resistant capsules, as aremajor depressive disorder and diabetic peripheral neuropathic pain.

Zentiva recently obtained a positive CHMP opinion for pregabalincapsules in eight strengths, while Accord gained the committee’s supportfor its bortezomib 3.5mg powder for injectable solution (Genericsbulletin, 5 June 2015, page 25).

Docetaxel Hospira UK Limited will be available as a 20mg/mlconcentrate for solution for infusion to treat several types of cancer.The CHMP noted that while “studies have demonstrated the satisfactoryquality” of the oncology drug, no bioequivalence study versus Taxoterehad been required.

“Studies have demonstrated the satisfactory quality of AripiprazoleSandoz and its bioequivalence to the reference product, Abilify,” theCHMP stated. Having submitted a hybrid application, Sandoz intends tosupply the antipsychotic as 5mg, 10mg, 15mg, 20mg and 30mg tablets.

The committee recently backed applications for aripiprazoletablets submitted by Pharmathen and Zentiva (Generics bulletin, 8May 2015, page 25). But Mylan’s Generics UK subsidiary withdrewa similar dossier after an inspection of its contract research organisation(CRO) identified “major good clinical practice (GCP) issues”.

Through a hybrid procedure, the CHMP has recommendedgranting a marketing authorisation “under exceptional circumstances”for Santhera’s Raxone (idebenone) as an orphan drug to treat visualimpairment in patients with Leber’s hereditary optic neuropathy. Notingthat such exceptional circumstances included when providingcomprehensive safety and efficacy data was not possible due to therarity of the condition to be treated, the committee said Raxone150mg film-coated tablets were a hybrid of Mnesis (idebenone) 45mgtablets that were indicated for cognitive and behavioural defects.

There was a need, the CHMP concluded following a review, toharmonise prescribing information for GlaxoSmithKline’s Amoxil(amoxicillin) in the European Union (EU). Noting that the antibiotic –which was also available under the Amoxicilline Biogaran andClamoxyl trade names in some countries – has been authorised vianational procedures, the committee said differences had emerged in thesummaries of product characteristics (SmPCs), labelling and packageleaflets in different countries.

Meanwhile, the CHMP has recommended several measures,including the introduction of educational material, to ensure thatpatients and carers use adrenaline, or epinephrine, auto-injectorssuccessfully to treat serious allergic reactions. The EMA committeeconducted a review “following concerns that currently available devicesmay deliver adrenaline under the skin, instead of into a muscle”. G

PRODUCT NEWS


EPILEPSY DRUGS/ANXIETY TREATMENTS

Accord and Zentivagain EMA opinions

AUS patent-litigation settlement struck between Novartis and Sunlast year concerning the originator’s Gleevec (imatinib mesylate)

tablets – which entitles the Indian firm to introduce its version on 1February 2016 – was a deliberate delay tactic by the originator tounlawfully halt generic competition to the oncology drug for anadditional seven months, according to a lawsuit filed against Novartisby two healthcare funds in a Massachusetts district court.

The lawsuit, according to US law firm Hagens Berman, “marksthe first time purchasers of a prescription drug have sought injunctiverelief to try to prevent antitrust overcharges or damages stemmingfrom delayed launch of generic drugs”.

Gleevec’s basic US compound patent – US patent 5,521,184 –expired on 4 July this year, but the leukaemia treatment is protected bythree polymorph and salt patents that all expire in 2019: reissuedUS patent RE43,932 and US patent 7,544,799 that expire on 16 Julythat year, and US patent 6,894,051 that expires on 23 November 2019.The ‘051 patent had been at issue in Sun’s settlement with Novartis(Generics bulletin, 6 June 2014, page 21).

But according to the class-action lawsuit, “Novartis knew thatthose patents would be an impediment to the launch of generic imatinibmesylate, even though the patents had no realistic likelihood of everbeing able to stand up in court as valid patents that could lawfullyexclude competing generic products from the US market”.

Sun has held tentative US approval for a US rival to Gleevec fornearly six years (Generics bulletin, 27 November 2009, page 20),while Apotex received a tentative nod last year. The suit notes that30-month stays on approval for abbreviated new drug applications(ANDAs) filed by Dr Reddy’s, Ranbaxy and Breckenridge end inFebruary, May and December 2017 respectively.

The plaintiffs argue that Novartis’ “patent gamesmanship andfrivolous litigation – undertaken solely for the purpose of extractingsettlements that delay generic entry – violate basic principles ofantitrust law, and should be enjoined”.

Responding to the allegations, a Novartis spokesperson toldGenerics bulletin the claims were “unsubstantiated”. “The patentscovering Gleevec remain legally in force and are covered by a statutorypresumption of validity,” she said, insisting that, “the settlement withSun is a lawful settlement agreement resolving the declaratory judgmentaction filed by Sun challenging the validity of one of the Gleevecpatents”. “We will vigorously defend our patent rights and litigatethese improper allegations,” the spokesperson added. G

ONCOLOGY DRUGS

Novartis sued on USGleevec settlement

Brussels commercial court judge Natalie Swalens will continueto preside over Novartis’ patent-litigation case with Apotex

concerning the originator’s Exelon (rivastigmine) patches after aBrussels Court of Appeal denied Novartis’ request to recuse her overallegations of impartiality due to a prior Exelon judgment she hadhanded out against Novartis in favour of Mylan.

At the end of last year, Swalens had denied Novartis’ request toissue a preliminary injunction against the US firm after reaching aprima facie decision that Mylan’s proposed rivastigmine patches wouldnot infringe the Belgian part of European Patent EP2,292,219. G

LITIGATION/ALZHEIMER’S DISEASE DRUGS

Belgian bar denied on Exelon


EVENTS


24-25 September

■ GMP MeetsRegulatory AffairsPrague, Czech RepublicHighlights of this two-day event willinclude marketing authorisationapplications, regulatory compliance andauthority inspections, drug approvalprocedures and handling variations in theglobal environment.

Contact: Concept Heidelberg.Tel: +49 6221 84 44 0.E-mail: [email protected]: gmp-compliance.org.

30 September-1 October

■ Biosimilars and BiobettersLondon, UKIssues looked at during this two-dayconference are to include biosimilar entry inthe US, IP litigation, and safety of biosimilars.There will be speakers from UK regulatorMHRA, Merck Serono and Teva.

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

12-14 October

■ 12th TOPRA AnnualSymposiumBerlin, GermanyFocusing on regulatory affairs, topicscovered at this three-day event willinclude biosimilars, access to medicines,new clinical trials regulations,pharmacovigilance, patient informationand veterinary legislation.

Contact: TOPRA.Tel: +44 207 510 2560.E-mail: [email protected]: topra.org.

12 & 13-15 October

■ CPhI Pre-Connect Conference& CPhI WorldwideMadrid, SpainCPhI Worldwide is an exhibition andnetworking opportunity which will also

include the co-located events iCSE, P-MECand Innopack. The event will be precededby the Pre-Connect Conference taking placein the same location.

Contact: UBM Information.Tel: +44 207 921 8039.E-mail: [email protected]: cphi.com.

27 & 28-30 October

■ Biosimilars APAC SummitSingaporePreceded by a one-day workshop, thisevent will look at the global and Asia-Pacific regulatory landscape, marketaccess, clinical development and legaland IP issues.

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

2-4 November

■ GPhA Fall TechnicalConferenceMaryland, USAThis three-day event organised by the USGeneric Pharmaceutical Association(GPhA) will look at regulatory andtechnical issues affecting the genericsindustry. There will be speakers from theindustry, and presentations byrepresentatives from the US Food andDrug Administration (FDA).

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

4-6 November

■ 18th APIC/CEFICConference on APIsAmsterdam, The NetherlandsThis bulk-drugs conference will look atregulatory developments and updates aswell as emerging markets and life-cyclemanagement. There will be speakers fromMerck and Pfizer, as well as the FDA andthe European Medicines Agency (EMA).

Contact: Concept Heidelberg.Tel: +49 6221 8444-0.E-mail: [email protected]: api-conference.org.

9-10 November

■ World Biosimilar CongressEurope 2015Basel, SwitzerlandThere will be updates from the EMA onbiosimilar regulatory approval, case studies,roundtable discussions and networkingopportunities at this two-day event. Topicscovered will include clinical development,strategic development, interchangeabilityand legal considerations.

Contact: Terrapinn.Tel: +44 207 092 1257.E-mail: [email protected]: terrapinn.com.

23-24 November

■ EuroPLX 59Athens, GreeceThis meeting provides a forum for business-development decision-makers to discuss andnegotiate agreements, in-licensing, marketingand distribution of patented medicines,generics, biosimilars, OTC products,medical devices and food supplements.

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

16-19 September

■ 18th IGPA Annual ConferenceToronto, CanadaThis four-day event is being organised by the Canadian Generic PharmaceuticalAssociation. It is the annual joint meeting of the Canadian, European, Japanese,Jordanian, South African, Taiwanese and US generics industry associations, the CGPA,EGA, JAPM, JGA, NAPM, TGPA and GPhA. Pharmaceutical executives have theopportunity to take part in conference workshops, and listen to industry experts discusscurrent issues regarding the international pharmaceutical sector during a full schedule ofplenary sessions.

Contact: Julie Tam, CGPA. Tel: +1 416 223 2333.E-mail: [email protected]. Website: igpa2015toronto.com.

SEPTEMBER

13 October 2015, Madrid, Spain.Contact: [email protected].

Now in their second year, these Awards will reward ‘bestpractice’ in the generics and biosimilars space, whileencouraging and supporting all that’s good in the sector.The Awards are open to any company or individualdirectly involved in developing, authorising, marketingand distributing bioequivalent generics or biosimilars.

OCTOBER

NOVEMBER

The second Annual GlobalGenerics and Biosimilars Awards

We also publish OTC bulletin.Visit otc-bulletin.comfor more information.

Gen 10-7-15 Pg. 24_Layout 1 08/07/2015 18:00 Page 2

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


Figure 1 (above): Comparison between the periods 1-31 May and 1-29 June 2015of UK trade prices of the most recently-launched generics listed in category M of theDrug Tariff of pharmacy-reimbursement prices. Averages calculated from at least 30data points. Figure 2 (top right) and Figure 3 (centre right): Biggest averagetrade-price changes between 1-31 May and 1-29 June 2015. Averages calculatedfrom at least 12 data points. Figure 4 (bottom right): Ranking of fastest-movingproducts subject to the most price offers made to independent UK pharmacists (onestrength per ingredient; offers recorded by 29 June). Data for Figures 2, 3 and 4from a basket of about 750 commonly-dispensed generics. Recently-launchedproducts in Figure 1 excluded from Figures 2 and 3 (Source – WaveData).

Detailed product price comparisons and other price analyses are available at www.wavedata.net.

To find out more about subscribing, please email your contact details to [email protected] and quote ‘GB online enquiry’ in the title line.

■ For further information see www.wavedata.co.uk. Alternatively, contact Charles Joynson at WaveData Limited, UK.Tel: +44 (0)1702 425125. E-mail [email protected].

WANT MORE LIKE THIS?

RECENT LAUNCHES

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

Amorolfine lacquer 5% 5ml £3.64 +1 £5.26 +3Atorvastatin tabs 20mg 28 £0.49 -2 £0.80 -4Candesartan tabs 8mg 28 £0.39 +3 £0.66 -1Celecoxib caps 200mg 30 £1.00 -20 £2.21 ±0Cilostazol tabs 100mg 56 £3.67 -33 £9.95 -15Cyclizine tabs 50mg 100 £7.25 ±0 £9.46 +1Desloratadine tabs 5mg 30 £0.42 ±0 £0.81 +3Desogestrel tabs 75µg 84 £1.53 -5 £2.42 -1Donepezil tabs 10mg 28 £0.56 -2 £1.10 -3Entacapone tabs 200mg 30 £4.25 +3 £5.02 ±0Escitalopram tabs 10mg 28 £0.33 -33 £0.90 -4Hydroxychloroquine tabs 200mg 60£3.07 -2 £3.98 ±0Irbesartan tabs 75mg 28 £0.42 ±0 £0.78 ±0Memantine tabs 10mg 28 £0.49 -11 £1.34 -4Montelukast tabs 10mg 28 £0.86 -3 £1.44 -1Naratriptan tabs 2.5mg 6 £0.99 -19 £1.46 ±0Quetiapine tabs 25mg 60 £0.60 -6 £1.11 -1Rabeprazole tabs 10mg 28 £1.10 -4 £1.67 +1Raloxifene tabs 60mg 28 £3.44 +4 £4.91 -1Riluzole tabs 50mg 56 £13.75 ±0 £21.15 -10Rizatriptan tabs 10mg 3 £0.72 -16 £2.31 +7Sildenafil tabs 100mg 4 £0.34 ±0 £0.67 +4Telmisartan tabs 80mg 28 £0.79 -1 £1.62 +2Tolterodine tabs 2mg 56 £1.45 -12 £2.24 -1Zolmitriptan tabs 2.5mg 6 £0.39 ±0 £0.90 ±0

FAST MOVERS

Price offers as at 29 JuneProduct/Strength/Pack size April May June

Omeprazole caps 20mg 28 119 98 102

Lansoprazole caps 30mg 28 95 93 99

Simvastatin tabs 40mg 28 100 92 92

Clopidogrel tabs 75mg 28 93 85 91

Lisinopril tabs 10mg 28 78 81 88

Sertraline tabs 50mg 28 87 74 87

Ramipril caps 2.5mg 28 92 87 86

Warfarin tabs 1mg 28 85 82 86

Mirtazapine tabs 30mg 28 72 68 83

Amitriptyline tabs 25mg 28 88 79 81

BIGGEST FALLERSProduct/Strength/Pack size Lowest Change Average Change

price (%) price (%)

Cimetidine tabs 400mg 60 £0.53 ±0 £0.99 -23

Aripiprazole tabs 10mg 28 £22.95 -30 £46.12 -19




Exemestane tabs 25mg 30 £9.75 -40 £26.77 -15

BIGGEST RISERSProduct/Strength/Pack size Lowest Change Average Change

price (%) price (%)

Alimemazine tabs 10mg 28 £5.40 +2 £9.53 +43

Enalapril tabs 10mg 28 £0.25 +25 £0.52 +41

Enalapril tabs 20mg 28 £0.32 +10 £0.72 +39

Alendronate tabs 70mg 4 £0.21 +11 £0.45 +37Ferrous sulphate tabs 200mg 100 £0.58 +2 £1.88 +36Enalapril tabs 5mg 28 £0.19 -5 £0.48 +33

Half a dozen of our basket of recently-launched products wereavailable at bargain prices last month, after double-digit price falls

in their lowest prices. Each bargain, however, was mainly only availablefrom a single source. Just for 56-tablet packs of cilostazol 100mg wasthe 33% price drop for the lowest price reflected in an average pricefall of 15%, suggesting that other suppliers were also cutting theirprices (see Figure 1).

The lowest price for escitalopram 10mg in 28-tablet packs alsofell by 33%, but this only reduced the average price by 4%. Similarly,one supplier was prepared to discount 30-capsule packs of celecoxib200mg by 20% to just £1.00 (US$1.57), but the product’s averageprice remained unchanged. Riluzole 50mg in 56-tablet packs stoodout with a double-digit average price fall, but a static lowest price.

Another newcomer experiencing double-digit average price fallslast month was aripiprazole in all four of its strengths (see Figure 3).

Launched in January, the ingredient was selling to independentpharmacists and dispensing doctors in May at about a 40% discountto the brand and with a comparable dispensing margin (Genericsbulletin 26 June 2015, page 25). A month later, the discount had grownto over 50% and the margin to a similar proportion, despite anotherlowering of the Drug Tariff reimbursement price.

Elsewhere, trade prices were rising steeply for enalapril (see Figure2), while the two proton-pump inhibitors, omeprazole and lansoprazole,were generating the most price offers in the trade (see Figure 4).

Monthly concessions in pharmacy reimbursement prices –granted by the Department of Health to compensate pharmacists forunexpectedly high trade prices – numbered 19 in June for 13 differentproducts. The list included fosinopril 10mg and 20mg and lisinopril20mg with hydrochlorothiazide 12.5mg, which look likely to bejoined in future by enalapril. G

Bargains offered among recent launches


European generics face a future that will bedramatically different from what has come before.In the wake of dwindling patent-expiry

opportunities, the savings generated by generics willbe squeezed, at the same time as a range of economicand social factors put increasing pressure on nationalhealthcare systems.

These are the findings of a report that has just beenpublished by the IMS Institute for HealthcareInformatics. However, according to that report – titled‘The role of generic medicines in sustaining healthcaresystems: a European perspective’ – generics will be ableto play a continuing key role in sustaining Europeanhealthcare systems, provided that policymakers “activelyrecognise” their full essential contribution, and adapttheir approach to generics accordingly.

“Flat economic growth is forcing continuedausterity measures,” the IMS report points out in itsinitial analysis of the European pharmaceutical market.Meanwhile, an ageing population and a new wave ofinnovation to meet unmet clinical needs are “drawingheavily on healthcare budgets”.

Against this backdrop, “the availability of genericmedicines has contributed to cost containment in overallspending growth”, the report observes. “Within theEuropean Union (EU), the availability of genericmedicines and effect of patent expiries has helped tooffset the increase from branded medicines growth”.

However, “the savings potential from patentexpirations will decline over the next few years”, theIMS report warns. “Following several years ofopportunity for savings in medicine spending fuelledby the expiration of numerous blockbuster medications– with a peak in 2012 – there will be fewer suchopportunities through 2018.”

Alan Sheppard, principal for global generics atIMS Health, acknowledged that “healthcare systemswill continue to be strained, and further action to control

costs will be required”. “A surge in innovation is drawingheavily on healthcare budgets,” Sheppard pointed out,while “lower off-patent opportunities in major markets”for small-molecule medicines would reduce futuresavings from generic medicines (see Figure 1).

Patent expirations, Sheppard stated, saved Europeanpayers an estimated C100 billion (US$110 billion) in2014, and “have contributed to significantly higheraccess for patients in many countries, across manytherapeutic areas”. But in the next five years, savingsfrom patent expirations would be “markedly less”, withan opportunity that would be 20%-50% smaller.

Nevertheless, Sheppard said that generic medicinescould boast “a story of success”, especially in Europe,where off-patent medicines now accounted for morethan nine-tenths of treatment by volume. Andcompetition from generic medicines was driving thecost of off-patent products down by 61% comparedto their cost during market exclusivity, he noted.

“The prescriber’s decision to use an off-patentmolecule may be impacted by many factors,” the IMSreport surmises. “Cost containment is just one aspectand may be problematic, particularly if prescribers donot have visibility to cost or they do not view it asan important consideration.”

When cost was not the determining factor, IMS

MARKET RESEARCH


As patent-expiry

opportunities shrink

for small-molecule

generics in Europe, a

study by the IMS

Institute for

Healthcare Informatics

suggests ways in

which the generics

industry can remain a

key player in sustaining

healthcare systems.

David Wallace reports.

Europe must respond tonarrowing opportunities

Country 2009-2014 2015-2020 Change (%)

US 79.2 74.3 -6.1Germany 6.8 5.0 -27.1France 7.3 3.8 -47.7Italy 4.9 3.2 -35.5UK 4.5 2.1 -52.3Spain 4.2 3.3 -22.2

Figure 1: Value in US$ billions of losses of exclusivity in selectedcountries between 2009 and 2014, and expected between 2015and 2020 (Source – IMS)

Protected brandsOff-patent original brandsNever protected brandsand branded generics

INN or company-branded generics

100

90

80

70

60

50

40

30

20

10

0

Vol

ume

mar

ket

shar

e(%

)

Poland

Hungary

Romania

Czech

Repubilc UK

Slovak

ia

Sweden

Austria

Finland

German

y

Irelan

d

Netherl

ands

Portugal

Belgium

SpainFran

ceIta

ly

Norway

Switzerl

and

Greece

Figure 2: Market share by volume of brands and generics in selected European countries (Source – IMS)


found, prescribing decisions were limited by “a lackof knowledge and understanding of off-patent products”and a lack of experience with newer products, as well asbeing influenced by factors such as formulary guidelinesand a desire to continue a patient’s existing medication.

Sheppard observed that the share of Europe’s ‘neverprotected’ off-patent market – which includes neverprotected brands, branded generics and generics –“accounts for 27% of the total pharmaceutical market invalue and 68% in volume, although the share variesby country” (see Figure 2).

And overall, the IMS report notes, off-patentmedicines – including both off-patent brands andgenerics, as well as the ‘never protected’ products –currently accounts for 92% of all prescription volumein standard units, and just 47% of the value. This wasa “major shift” since 2005, when the same marketrepresented 83% of volume and 42% of value. However,“the change in off-patent volume market share over thelast five years varies greatly across countries”, the reportpoints out (see Figure 3).

“Savings from the off-patent sector also vary bycountry,” IMS observes. Figure 4 shows the extent towhich markets reduce spending following genericmedicines entry compared to pre-entry pricing level, with‘additional savings’ representing the costs that couldbe eliminated with 100% generic medicine penetration.

“For example, in the UK total pharmaceuticalspending was reduced by 70% after the entrance ofgeneric medicines,” IMS notes. “An additional 9.8%savings could be achieved” with full penetration.

“By contrast, in Spain only 52% of savings wereachieved; however, no new savings can be generateddue to the fact that prices of off-patent originals nowmatch the price of generic medicines.”

Despite the typically lower cost of genericmedicines, IMS says, “price savings are achieved mainlywhere competition is encouraged, meaning that pricingstructures are not regulated”.

While it was clear that patent expiries and genericcompetition produced overall savings in Europe (seeFigure 5), IMS observed that “inherent politicaldifferences” across EU member states produced “highlyvariable pricing systems for off-patent medicines”, suchas France and Norway setting reimbursement pricesbased on the price of the original brand prior to patent

expiry; tendering-like systems such as those used inDenmark, Germany, Hungary, the Netherlands andSweden; or market-driven prices such as those of the UK.

“When pricing in the off-patent sector is notregulated, it is influenced by several other factors suchas molecule sales, form, age since patent expiration,and, ultimately, the level of competition,” IMS observes.Notably, the report points out, “the free-market pricingsystem in the US appears to yield the highest off-patentefficiency of any market”.

Competition does not exclusively revolve aroundprice, however, according to IMS’ findings. In the caseof statins in the UK and Ireland, the researcher foundthat choices of molecules played differently whensome products were still patent-protected.

In Ireland, patent-protected products that werestill promoted increased their share compared to theoff-patent molecules, with doctors proving “receptive tothe innovator’s promotional messaging”. Meanwhile, inthe UK, “physicians appear less receptive”, with the useof prescribing guidelines and formularies driving theuse of lower-cost alternatives.

“The implication in markets such as Ireland is thatgeneric medicines, too, need to be promoted if they are tomaintain or gain share, which would increase the cost ofgeneric medicines significantly,” IMS concludes.Whereas in the UK, it says, “new innovative productshave greater difficulty in garnering a premium price

MARKET RESEARCH


Off-patent efficiency Generic medicine rebatein Germany

Additional savings

UK Sweden

Norway

Hungary

Belgium

German

y

Poland

Irelan

d

Switzerl

and

Austria

Italy

France

SpainGree

ce

0

-10

-20

-30

-40

-50

-60

-70

-80

-90

-100

2014

Off

-pat

ent

effi

cien

cy(%

)

Figure 4: Savings from generic medicine competition in selected European countries in 2014 (Source – IMS)

14

12

10

8

6

4

2

0

-2

Cha

nge

inm

arke

tsh

are

(%)

Pola

nd

Cze

ch

Slov

akia

Hun

gary

Rom

ania

Port

ugal

Finl

and

Aus

tria

Ger

man

y

Spai

n

Nor

way

Gre

ece

Irel

and

UK

Swed

en

Bel

gium

Fran

ce

Ital

y

Net

herl

ands

Switz

erla

nd

Figure 3: Change in market share enjoyed by off-patent medicines in selected European countriesbetween 2009 and 2014 (Source – IMS)


over the off-patent molecule”.Another difference between EU

member states is the way in which thebenefits of using generics accrue, thereport observes, with “specific trends notuniform across all European countries”.Figure 6 compares price, volume andtotal treatment cost development inselected therapy areas – includingangiotensin II antagonists, anti-epileptics,anti-psychotics, anti-ulcerants, cholesterolregulators and oral anti-diabetics –across the retail prescription market.

“The benefits vary across markets,”Sheppard commented, noting that “intraditional areas, price reductions arebeing off-set by volume increases”.

Where the impact of price decline was greaterthan that of the volume increase – such as in Germany,the UK, France, Italy, Ireland and Sweden – marketssaw a decline in overall treatment cost. Where theimpact of these two factors was equivalent – as seenin Spain and the Czech Republic – markets saw astabilisation of overall treatment cost. And in“under-served markets” such as Slovenia, Poland andSlovakia, higher volumes brought increased access.

“While considerable price reductions are seen inmany countries, the treatment cost – as measured bydefined daily dose – still varies greatly betweencountries,” IMS states. Nevertheless, “cost per defineddaily dose continues to improve across Europe”.

However, the report emphasises that cost savingsshould not be the only criterion in evaluating genericsmedicines. “It is not price reductions or price controls,but competition that drives savings from genericmedicines,” Sheppard insisted.

To ensure the continued role of generics insustaining European healthcare systems, the IMS reportconcludes, the environment as a whole must beconducive to generic medicine utilisation.

Industrial policy is a key area, the report points out.While 75% of generics consumed in Europe werecurrently produced in Europe, “within tender markets,there is a higher share of generic medicines producedoutside of Europe, which pushes away companies thatare not able to compete on price”.

Risk of shortages should also be taken into account,IMS advocates, while countries should also considerthe indirect impact of off-patent pricing policies onthe supply chain. This could include the difficultiesof forecasting product mix when multiple productswere stocked by wholesalers and pharmacies, or theadverse financial effect on wholesalers and pharmaciesof remuneration based on pack value, compared to the“better remuneration model” of Germany that is basedon the number of packs provided.

“Generic medicines eventually capture the market,”Sheppard observed, “but it is payer and manufactureractions that determine the size of the market.” He urgedthe widespread adoption of ‘generic first’ policies toencourage the use of generics as first-line treatments,as well as improvements in education for doctors andpharmacists on the subject of generics.

Effective use of generic medicines depends onmultiple stakeholders, the IMS study insists. From thepoint of view of manufacturers, Sheppard said, a “levelplaying field” was needed, with a “predictable approachto pricing, transparent procurement policies, and anefficient regulatory approval system”.

Originators needed investment in new treatments,while pharmacies needed pricing and reimbursementpolicies that could accommodate “large volumes ofvery low-cost products”.

For patients, information, access and an option topay for brands was key, Sheppard suggested, whilepayers “required dialogue and cost considerations”.

Fair pricing mechanisms needed to rewardcompetitive entrants while also providing a benefit topayers, and other stakeholders “need to be aware ofthe benefits of generic medicines and be incentivisedto use them”, Sheppard maintained.

Substitution should take place through internationalnon-proprietary name (INN) prescribing or pharmacistsubstitution, he recommended, while measures alsoneeded to be put in place to ensure supply stability.

To maintain the contribution of generic medicines,Sheppard concluded, it was essential that a consensuson the role of generics was reached among healthcareindustry stakeholders, with policymakers activelyrecognising the full role that generic medicines hadto play in healthcare systems.

“The European industrial agenda should includea focus on generic manufacturing,” Sheppard urged,while trust needed to be built across patients, prescribers,pharmacists and payers. “We have to have a fundamentalchange in the way we approach generic medicines.” G

MARKET RESEARCH


Country C Price Volume Treatment costchange (%) change (%) change (%)

Germany -62 +153 -7UK -64 +143 -13France -51 +40 -31Italy -53 +121 -9Ireland -59 +148 -9Sweden -69 +108 -40Spain -50 +109 ±0Czech Republic -53 +132 +2Austria -49 +133 +14Slovenia -69 +152 -30Poland -51 +192 +33Slovakia -63 +207 +9

Figure 6: Comparison of changes in price, volume and treatmentcost across seven therapy areas in selected European countriesbetween 2005 and 2014 (Source – IMS)

180

160

140

1202009 Brands Loss of exclusivity Generics 2014

148

29 27

9 160

Figure 5: Components of change in total medicines spending in Europe between2009 and 2014 (Source – IMS)

Con

stan

tC

billi

ons

“It is not price

reductions or price

controls, but

competition that drives

savings from

generic medicines”


All that’s happening inconsumer healthcareWritten by OTC specialists from an OTC industry perspectiveThe best decision-makers in the OTC industry don’t have the time to go looking forgood information. They let it come to them. They subscribe to OTC bulletin.

Join thousands of subscribers from competitor companies in over 35 countries who arealready benefitting from commercial intelligence about business opportunities in theglobal non-prescription medicines and dietary supplements markets.

GOOD VALUEIndividual

subscription ratesstart from just

£975

INDIVIDUAL SUBSCRIPTIONSAn annual subscription comprises:

n 20 OTC bulletin newsletters;

n AND at least 45 weekly news@OTCbulletinelectronic newsflashes containing the week’s topnews stories (currently delivered by email).

CHOICE OF FORMATSThe 20 OTC bulletin newsletters are available:

n EITHER as the digital OTC bulletin-i for online accessby desktop AND tablet and smartphone. These mobiledevices can have Apple or Android operating systems.

n OR in traditional hard-copy print format, delivered by airmail;

CORPORATE SUBSCRIPTIONSA corporate subscription provides location-, country- orcompany-wide access to OTC bulletin-i.

Contact [email protected].

AVAILABLE INSTANTLY WORLDWIDEOTC bulletin-i is the digital i-edition of OTC bulletin. Now available online fordesktop access, it delivers the latest OTC bulletin on the day of publication withno postal delay. It also comes – at NO EXTRA CHARGE – as an app for mobileaccess by tablet and smartphone.

OTC bulletin-i subscribers also get access to a fully-searchable archive. Thiscontains over five years of OTC news and analysis in more than 100 back issues.These offer an invaluable resource for researching marketing opportunities,benchmarking competitive strengths, evaluating regulatory changes and assessingproduct developments.

Existing subscribers can get 20% OFF when they upgrade their subscriptions toinclude OTC bulletin-i. Contact [email protected].

Take out a subscription TODAY atwww.OTC-bulletin.com

or contact: [email protected]

Bulletin Publishing Group, OTC Publications Ltd, 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. (Tel: +44 (0)1564 777550; Fax: +44 (0)1564 777524).Registered in England No: 2765878. VAT No: GB 608 0432 69

OTC Sister Ad BLUE 04-2015_Generics Sister Advert 23/04/2015 11:03 Page 1

Any multinational pharmaceutical company thathas not yet devised a comprehensive strategyfor addressing the opportunities available in Africa

needs to do so urgently, according to a report releasedby McKinsey & Company.

“In a world of slowing and stagnating markets,Africa represents perhaps the last geographic frontierwhere genuinely high growth is still achievable. Earlymovers with the right approach should be able to capturecompetitive advantage,” the management consultancymaintains in its report entitled ‘Africa: A continent ofopportunity for pharma and patients’.

A sharp increase in the value of Africa’s pharmamarket – patented and generic prescription drugs, aswell as OTC medicines – from US$4.7 billion in 2003to US$20.8 billion a decade later in 2013 benefittednot only pharma players looking to expand beyondstagnated developed markets, but also African patientswho gained greater access to medicines, the report notes.

Demographic and macroeconomic trends suggestsustained growth in healthcare expenditure during thecurrent decade, McKinsey outlines. For example, thecontinent’s gross domestic product (GDP) of US$2.4trillion – rising to US$3.9 trillion in 2020 – is “alreadyon a par with Russia’s”. “We predict Africa’s pharmamarket will be worth between US$40 billion andUS$65 billion by 2020,” the report states.

McKinsey says Africa’s pharmaceutical market wasvalued at US$17.5 billion in 2010, of which US$14.5billion was generated in the top-15 countries – Algeria,Angola, Cameroon, Egypt, Ethiopia, Ghana, Kenya andLibya, as well as Morocco, Nigeria, South Africa,Sudan, Tanzania, Tunisia and Uganda.

The report depicts three possible scenarios formarket growth in the decade running up to 2020. A mostpessimistic ‘base’ outcome foresees sales per capitadoubling to US$35.40 as a 9.8% compound annualgrowth rate (CAGR) lifts the total market value toUS$44.1 billion, including US$37.6 billion from thecontinent’s top-15 countries. At the other end of the scale,an ‘optimistic’ forecast of a 14.4% CAGR gives a totalmarket value in 2020 of US$66.5 billion (see Figure 1).

A “realistic” scenario, according to McKinsey, isan 11.7% CAGR to US$52.2 billion in 2020.

“Over the next five years,” the report predicts,“strong growth can be expected in every segment ofAfrica’s pharmaceuticals market.”

A total pharma market value of around US$20billion in 2013 was divided into US$13 billion forprescription-only brands, US$5 billion for prescriptiongenerics and US$2 billion for non-prescription OTCdrugs, McKinsey observes.

But by 2020, the market consultancy believes,Africa’s generics market could more than treble invalue to US$18 billion. Prescription brands will see asimilar rate of growth to US$42 billion, while OTCsales of US$5 billion could produce a total pharmamarket worth about US$65 billion.

“In South Africa, Egypt, Algeria, Morocco, Nigeriaand Kenya, generics grew at an average CAGR of22.3% between 2004 and 2011, considerably faster thanthe 13.4% for pharmaceuticals as a whole. This trendlooks set to continue,” McKinsey states, noting thatgovernment support for generics is increasing as nationalhealth insurance schemes expand. “For instance,” it says,“South Africa requires pharmacists to inform privatepatients about generic alternatives when they purchaseprescription drugs, and Nigeria has a similar law.”

The report identifies three key factors propellingpharma market growth in Africa: the rise of major cities,expansion in healthcare capacity and an increasinglymature business environment.

“Half the population of Africa will be living incities by 2030,” McKinsey forecasts, adding that by2025, “two-fifths of Africa’s economic growth will comefrom 30 cities with populations of two million or more”.

Citing World Bank data, the report notes that“between 2005 and 2012, Africa acquired 70,000 newhospital beds, 16,000 doctors and 60,000 nurses”.

Evidence of a more mature business environmentincludes a “wave of consolidation” in the pharmaindustry. Jordan’s Hikma has made a string ofacquisitions in the region, the report notes, whileIndia’s Cipla has formed joint ventures in Algeriaand Morocco to complement its takeover of SouthAfrica’s Cipla Medpro.

For pharma companies to win in Africa, McKinseyasserts, they must follow four key principles.

Firstly, companies should “focus on pockets ofgrowth”. “More than two-thirds of the continent’sGDP and cumulative growth of the past decade camefrom just 10 of its 54 countries,” it notes.

Secondly, pharma players need to invest in buildingstrong local sales and marketing teams that are flexibleenough to respond to local requirements. As “talentis still scarce in Africa”, training leaders and buildingcapacities in-house can be crucial.

McKinsey’s third recommendation is that globalplayers “forge local partnerships in the private andpublic sector”. Partners for manufacturing, packagingand distribution can help firms understand local marketdynamics and regulatory requirements, it says.

Fourthly, the consultancy urges firms to “addresssupply and distribution challenges” in Africa. G

MARKETS


Africa offers pharma

companies “genuinely

high growth”, says a

recent report released

by management

consultants McKinsey

& Company.

Aidan Fry reports.

Africa may be last frontier

$17.5bn

$44.1bn

$52.2bn

$66.5bn

3.0

6.5

7.1

7.8

14.5

37.6

45.1

58.7

2010 2020 2020 2020base realistic optimistic

17.4

Sale

spe

rca

pita

(US$

)

35.4 41.8 53.3

CAGR 14.4%

11.7%

9.8%

Figure 1: Forecasted values for Africa’s pharmaceuticals market in 2020 under three scenarios,with compound annual growth rates (CAGRs) compared to 2010 (Source - McKinsey & Co)

Top 15 countries


Teva’s head in France, Erick Roche, has been elected as presidentof the country’s generics industry association, Gemme. He replaces

Biogaran head Pascal Brière, who has become Gemme’s vice-president of economic and hospital affairs under a revised structurefor the association’s board of directors that now includes five, ratherthan three, vice-presidents. This, Gemme said, would allow theassociation to better represent its members.

Paying tribute to Brière’s presidency, Roche – who has “26 yearsof experience at the heart of the French and international genericsindustry” – said that Gemme’s new organisational structure would helpthe association to “position the generics and biosimilars industry in itsrightful place as an essential contributor to our healthcare system”.

Alongside Brière, Gemme’s vice-presidents will include Sandoz’Frédéric Girard, who will be responsible exclusively for biosimilars,having previously been vice-president of biosimilars and hospitalaffairs. A dedicated representative for biosimilars would help Gemme’sbiosimilars division (Generics bulletin, 3 May 2013, page 14) to buildtrust in biosimilar medicines with healthcare professionals and patients,the association said.

Stéphane Joly of Cristers will replace Roche as Gemme’s vice-president for general affairs and communication, while Mylan’sArtur Cwiok will step into Joly’s previous position of vice-presidentfor public and legal affairs. François Douère of Sun’s Ranbaxy willtake on the new role of vice-president of scientific affairs.

EG Labo’s Pascal Faye will remain secretary-general andtreasurer, while Léopold Berthier of Substipharm will continue toact as representative for associate members.

Welcomes Mylan and ZentivaMeanwhile, Gemme has welcomed new members Mylan and

Sanofi’s Zentiva to the association, taking its membership to 16companies. Gemme said the additions confirmed the association’s“central role” and would “increase the scope” of its actions in future.“Gemme is more determined than ever to pursue and reinforce itsactivities to recognise the quality and safety of generics and biosimilarsdispensed in France,” the association stated.

Gemme’s membership comprises Arrow, Biogaran, Cristers,Delpharm, EG Labo and Hospira, as well as H2 Pharma, Médis, Mylan,Ranbaxy, Sandoz, Substipharm, Teva, Venipharm, Zentiva and Zydus. G

PEOPLE


INDUSTRY ASSOCIATIONS

France’s Gemme hasTeva’s Roche as lead

Albert Paonessa, former president of Actavis’ US Anda genericsdistribution operation, has joined Lannett’s board of directors from

1 July. Paonessa served in his role with Anda “for almost 10 years”,having previously worked as the company’s senior vice-presidentof sales, and vice-president of information technology before that.

“Albert is a well-represented generic pharmaceutical industryexpert,” commented Lannett’s chief executive officer, Arthur Bedrosian.“Adding his expertise will be a key strategic advantage for Lannett.”The US-based player – which recently closed its US$42.0 millionacquisition of US liquid generics specialist Silarx (Generics bulletin,26 June 2015, page 5) – noted that Paonessa’s appointment wouldincrease to six the size of the company’s board. G

APPOINTMENTS

Paonessa joins Lannett board

Hikma has appointed Kofi Amegashie, managing director of AdcockIngram’s Africa business outside of South Africa, to head up the

Jordanian firm’s newly-created sub-Saharan Africa business.“Kofi will lead Hikma’s expansion into this region with the aim

of replicating Hikma’s brand success in the Middle East and NorthAfrica (MENA), and establishing a strong foothold in East, West andFrancophone Africa,” the company commented.

“[Amegashie’s] appointment comes at an opportune time forHikma,” explained chief executive of Hikma’s MENA region andemerging markets, Mazen Darwazah, “as we are looking toestablish a strong presence in a number of sub-Saharan markets.”

Amegashie said the region offered “attractive growth opportunitiesacross the varied markets, which we can capture by building profitablehub country businesses and replicating them across sub-regions”.G

APPOINTMENTS

Hikma gets head insub-Saharan Africa

Vectura has announced that AstraZeneca executive James Ward-Lilley will join the company on 1 October this year to take up the

position of chief executive officer and executive director, followingthe departure of incumbent Chris Blackwell “at the end of June”. Thefirm is Sandoz’ development partner for its AirFluSal Forspiro(salmeterol/fluticasone) rival to GlaxoSmithKline’s Seretide,

Ward-Lilley – whose career with AstraZeneca has spanned 28years – currently serves as the UK-based originator’s vice-presidentfor its Respiratory, Inflammation & Autoimmunity global product andportfolio strategy (GPPS). In the interim, chief operations officerand president of US operations Trevor Phillips would serve as thecompany’s chief executive officer, Vectura noted. G

APPOINTMENTS

Vectura changes leadership

VANC has appointed Bob Rai to its board of directors. Citing Rai’s15 years of experience as a pharmacist, the Canadian firm said itwould “eagerly await his input on our strategic direction”.

MOMENTA – the US-based developer that recently partnered withSandoz for its Glatopa rival to Teva’s Copaxone (glatiramer acetate)– has begun searching for a new chief financial officer (CFO) afterincumbent Rick Shea announced plans to retire. G

IN BRIEF

Impax’ former president and chief executive officer, Larry Hsu, hasrelinquished all responsibilities with the US firm after retiring from

its board of directors “to pursue other business activities”.Hsu – who co-founded Impax in 1995 – headed the company

from October 2006 until April last year, when he stepped down tobe replaced by former Actavis executive Fred Wilkinson (Genericsbulletin, 2 May 2014, page 27). G

RESIGNATIONS

Hsu steps down from Impax


The best decision-makers in the generics industry don’t have thetime to go looking for good information. They let it come to them.They subscribe to Generics bulletin.

Join thousands of subscribers from competitor companies innearly 60 countries who are already benefitting from commercialintelligence about business opportunities in the global genericmedicines and biosimilars markets.

GOOD VALUE - Individual subscription rates start from just £895

AVAILABLE INSTANTLY WORLDWIDEGenerics bulletin-i is the digital i-edition of Generics bulletin.Now available online for desktop access, it delivers the

latest Generics bulletin on the day of publication with no postal delay. It also comes – at NO EXTRACHARGE – as an app for mobile access by tablet and smartphone.

Generics bulletin-i subscribers also get access to a fully-searchable archive. This contains overfive years of generics news and analysis in more than 100 back issues. These offer an invaluableresource for researching marketing opportunities, benchmarking competitive strengths, evaluatingregulatory changes and assessing product developments.

Existing subscribers can get 20% OFF when they upgrade their subscriptionsto include Generics bulletin-i. Contact [email protected].

GGeenneerriiccss bbuulllleettiinn print

Generics bulletin-i digital

News@Genericsbulletinelectronic newsflash

INDIVIDUAL SUBSCRIPTIONSAn annual subscription comprises:

n 20 Generics bulletin newsletters;

n AND at least 46 weeklyNews@Genericsbulletin electronicnewsflashes containing the week’s topnews stories (currently delivered by email).

CHOICE OF FORMATSThe 20 Generics bulletin newslettersare available:

n EITHER as the digital Generics bulletin-ifor online access by desktop AND tabletand smartphone. These mobile devices canhave Apple or Android operating systems;

n OR in traditional hard-copy print format,delivered by airmail;

CORPORATE SUBSCRIPTIONSA corporate subscription provides location-,country- or company-wide access toGenerics bulletin-i.

Contact [email protected].

Take out a subscription TODAY at www.Generics-bulletin.com or contact: [email protected]

Bulletin Publishing Group, OTC Publications Ltd, 4 Poplar Road, Dorridge, Solihull B93 8DB, UK. (Tel: +44 (0)1564 777550; Fax: +44 (0)1564 777524).Registered in England No: 2765878. VAT No: GB 608 0432 69

Generics BC House Ad 04-2015_Layout 1 23/04/2015 10:53 Page 1

Lupin makesm ove into Russiat hrough Biocom · agents and central nervous system treatments, as...

Documents

Transcript of Lupin makesm ove into Russiat hrough Biocom · agents and central nervous system treatments, as...