Aurobindo is set to become the largest player in the Portuguese generics market afteragreeing a deal worth C135 million (US$142 million) to acquire local manufacturer

Generis Farmacêutica from Iberia-focused private-equity firm Magnum Capital Partners.Subject to obtaining the requisite approvals from local authorities, the transaction is

scheduled to close by the end of next month.Founded in 1982, Generis targets the Portuguese retail and hospital segments, and boasts a

“wide portfolio of products with major share in the therapeutic areas of cardiovascular andcentral nervous system drugs, anti-infectives, and genito-urinary medicines”. Through the deal,the Indian firm will also obtain Generis’ manufacturing facility in Amadora, Lisbon, whichhas the capacity to produce 1.2 billion tablets, capsules and sachets annually.

The Portuguese firm’s net sales are estimated to reach approximately C72 million this year,up from C64.8 million last year, while earnings before interest, tax, depreciation and amortisation(EBITDA) are expected to climb from C12.7 million to C15.8 million. Synergies from the deal arescheduled to be C2 million in 2018, C5 million in 2019 and “expected to improve further thereon”.

Pointing out that the deal consolidated Aurobindo’s current footprint in Portugal –comprising its Aurovitas and Aurobindo Pharma businesses – Aurobindo reiterated that itslocal operation would “rank number one in the Portuguese generic pharma market, and willhave the largest generic product portfolio consisting of 271 products”.

“The combined entity will benefit from a robust pipeline covering all major moleculescoming off-patent in the next five years,” added Aurobindo’s European operations head,V Muralidharan, who also highlighted Generis’ “unrivalled brand recognition” in Portugal.

Aside from establishing Aurobindo as the leading generics player in Portugal, the dealalso “builds upon an already successful growth strategy” in Europe, according to the Indianfirm, following a steady stream of acquisitions in the region since 2006.

Notably, Aurobindo three years ago bought for around C30 million Actavis’ genericsoperations in seven western European countries, including in Belgium, France, Germany,Italy, the Netherlands, Portugal and Spain (Generics bulletin, 3 February 2014, page 1). G

13 January 2017

Aurobindo signs a dealfor Generis in Portugal

Potential US generic competition to Teva’s 40mg/ml thrice-weekly formulation of Copaxone(glatiramer acetate) could cost the Israeli company as much as US$1.2 billion in turnover

this year, the firm has stated as part of a revised financial forecast presented to analysts in earlyJanuary. While Teva’s 2017 forecast included total Copaxone sales of US$3.8-3.9 billion –including US$3.1-3.2 billion from the US, taking into account existing competition on the daily20mg/ml strength from Sandoz’ Glatopa – this was based on the assumption that there wouldbe “no launch of an AB-rated generic competitor to Copaxone 40mg in the US during 2017”.

In 2016, three US patents protecting the 40mg/ml formulation were invalidated by the USPatent and Trademark Office following inter partes review proceedings (Generics bulletin,9 September 2016, page 16), while further patent litigation is ongoing. “The potential impactof two generic competitors to Copaxone 40mg launching in February 2017 in the US is expectedto reduce revenues by US$1.0-1.2 billion,” Teva acknowledged.

Erez Vigodman, Teva’s president and chief executive officer, said the firm was “movingincreasingly away from our reliance on Copaxone”. G

For further details of Teva’s financial forecast, turn to page 3.

Teva sees US$1bn Copaxone risk

COMPANY NEWS 3

Teva cuts its forecast but 3banks on pipelineWockhardt facility is hit by FDA warning 3Aceto clarifies details of its 4deal with CitronCardinal signs civil settlement with DoJ 4Accord completes on 5deal for Actavis UKAspen and GSK end African collaboration5

MARKET NEWS 6

Review is granted for English pharmacists 6Italian bill provisions will boost biosimilars 6

Medicines for Europe 7has a supply allianceFDA offers update to guidance 7on refusals

PRODUCT NEWS 8

UK upholds ruling on 8rivastigmine patchesPfizer reports results of 9adalimumab studyPar seeks ruling on US patents for Latuda 9

Perrigo divests two to 10US firm CustopharmZydus strikes deal to buy 11six Merck brandsSole status unsure on 11Lannett Kaletra rivalUK Humira patents case moves to trial12Granules deficiencies 12lead to suspensions

PEOPLE 13

Concordia’s Duncan named 13overseas head

FEATURES 14

Russia’s Biocad is prepared to 14become a global player

REGULARS

Events – Our regular listing 8Price Watch UK – UK pricing trends 12

Issue No.291

Gen 13-1-17 Pg.1.indd 1 11/01/2017 17:17

What do you need from your API partner?Custom development and manufacturing orgeneric expertise? Safety, quality and reliability?

Excellent. You’ll enjoy working with Cambrex.

www.cambrex.com

| Active ingredientsDynamic people

Erena Sawyer-WagnerAnalytical ChemistAnalytical Development

3GENERICS bulletin13 January 2017

company news

Concerns over sterility, test data and contamination are amongthe issues highlighted in a warning letter sent by the US Food and

Drug Administration (FDA) to Wockhardt in relation to its Indianmanufacturing facility in Ankleshwar, Gujarat. An inspection conductedby the agency in December 2015 identified current good manufacturingpractice (cGMP) deficiencies linked to both finished-dosage formsand active pharmaceutical ingredients (APIs).

Airflow disturbances were discovered by the FDA during ananalysis of aseptic connections, with the agency identifying “multipleaseptic technique breaches”. “Under dynamic conditions, air did notsufficiently sweep across and away from sterile connections,” theFDA stated, “so the sterility of any product processed under theseconditions could be compromised.”

While reviewing gas chromatography data, the FDA foundunreported results, including an out-of-specification test result for rawmaterials. During in-process sample testing for residual solvent, theagency discovered “only two of three” chromatographic injections of asterile batch had been reported. Furthermore, 12 computerised systemsin Wockhardt’s quality control laboratory had not been validated.

Several “unofficial” notebooks recording sample preparation forout-of-specification investigations, route-of-synthesis experiments andscale-up data contained “discrepancies”, the FDA reported, compared tothe official data retained by the quality unit. The agency observed that“cGMP documentation was discarded without being assessed”.

“Our investigator found torn and shredded equipment maintenancedocuments, raw material labels, and change control work orders inyour scrap yard awaiting incineration,” the FDA stated.

Wockhardt also failed to ensure manufacturing personnel woreappropriate clothing, the FDA reported, with employees “working ingowns that had unravelled stitching extending from hoods, zippers, andpants”. “Five of 10 garments released for use in aseptic productionareas had loose fibres or other damage,” the agency noted. Wockhardtdetermined that “inadequate lighting and ineffective operator trainingwere root causes”, but the FDA deemed this response “inadequate”,claiming “excessive sterilisations” had lead to breakdown of gown fibres.

In August 2016, Wockhardt’s Ankleshwar facility became theIndian firm’s third production plant to be subjected to an importalert by the FDA (Generics bulletin, 26 August 2016, page 3). “Thecompany has already initiated required steps to address the concernsraised by the FDA and is putting all efforts to resolve the matter,”Wockhardt responded.

The FDA had in 2013 placed similar bans on imports into the USfrom Wockhardt’s Indian facilities in Chikalthana and Waluj thatproduce solid-dose formulations and cephalosporin antibioticsrespectively (Generics bulletin, 6 December 2013, page 3).

In December last year, the Indian firm also received a warningletter from the FDA for its CP Pharmaceuticals sterile manufacturingand testing facility in Wrexham, UK (Generics bulletin, 2 December2016, page 2). Issues identified by the agency concerned aseptic andsterilisation procedures and contamination control systems. G

MANUFACTURING

Wockhardt facility ishit by FDA warning

Fewer launches than expected and a protracted acquisition of Actavislast year have led Teva to cut its financial forecasts. This year, the

Israeli firm expects to report sales of US$23.8-24.5 billion andearnings before interest, tax, depreciation and amortisation (EBITDA)of US$8.0-8.4 billion. Teva’s Generics segment – which will nowinclude OTC sales for reporting purposes – is expected to contributesales of US$13.9-14.3 billion in 2017.

Acknowledging that the overall forecast was “significantly below”the US$25.2-26.2 billion sales estimate and US$9.5-10.3 billionEBITDA forecast for 2017 provided by Teva in July last year (Genericsbulletin, 22 July 2016, page 2), president and chief executive officerErez Vigodman recognised that the gap was “disappointing”, but saidTeva was “not immune” to the “significant headwinds” being facedby the healthcare sector. A foreign exchange impact of US$0.8 billionon sales was also a factor “in light of the strengthening US dollar”.

For 2016, Teva expects imminently to report sales of US$21.6-21.9 billion – including Generics turnover of around US$12.0 billion –and EBITDA of US$7.3-7.5 billion, compared to the respectiveforecasts of US$22.0-22.5 billion and US$7.5-7.9 billion offered sixmonths ago. “We continue to make excellent progress on the integrationof Actavis Generics, and our promise of US$1.4 billion in net deal-related synergies and tax savings by 2019,” Teva added.

However, the company insists that it will benefit greatly from itsexpanded pipeline and global footprint this year, with more than 1,000launches planned worldwide. US launches alone are expected to addsales of more than US$750 million at a “fairly conservative” estimate.

While 2016 had been “a transition year for Teva”, Vigodman stated,“2017 will be a year of execution”. Emphasising the “increasingsignificance of the Global Generics business” – leadership of whichwas recently assumed by Dipankar Bhattacharjee, after former GlobalGenerics president and chief executive officer Siggi Olafsson steppeddown (Generics bulletin, 9 December 2016, page 1) – Vigodmansaid Teva was “moving increasingly away from our reliance onCopaxone (glatiramer acetate)”.

Teva’s guidance assumes no generic competition to Copaxone40mg/ml in 2017, but says generic entrants this year could cost theIsraeli firm as much as US$1.2 billion in sales (see front page).

Explaining that the combined Teva and Actavis pipeline meantthat the company was not reliant on any one product, Vigodman saidthe “evolving” business model in the US had seen dependency on“big launches” begin to be replaced by “40-50 products that are inmany ways more durable”. Moreover, he added, Teva had “greaterthan 90% coverage of all potential launches up to 2020” in the US.

By region, Teva said 43-45% of Generics sales would come fromthe US in 2017, where its “robust pipeline and new launches” were“critical to growth beyond price erosion”. Bhattacharjee recognised“mid-single-digit price erosion in the base business in the US”.

Europe – where Teva was seeing “stable, profitable growth” –would provide 26-28% of the US$13.9-14.3 billion figure, with theremaining 28-30% coming from growth markets. “Europe and growthmarkets are expected to generate 45% of the Generics segment profitin 2017,” the firm added.

Bhattacharjee said Teva’s fundamental approach to launches in2017 was that “we have many more shots at the goal”. “The nature ofour pipeline doesn’t mean we will not continue to have largeopportunities,” he acknowledged. “But a larger number of productswill give us a profit that is more durable.” G

ResUlTs FoReCAsT

Teva cuts its forecastbut banks on pipeline

MCKESSON has completed its C$2.9 billion (US$2.2 billion)acquisition of Canada’s Rexall Health (Generics bulletin, 11 March2016, page 3). Around 470 retail pharmacies are included. G

In BRIeF

4 GENERICS bulletin 13 January 2017

company news

13 January 2017 Issue 291

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

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: info@Generics-bulletin.comAdvertising enquiries:As above, or ads@Generics-bulletin.com

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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 by Warwick Printing Company Limited,Leamington Spa CV31 1QD, UK.

US health services provider Cardinal Health has agreed to pay theUS Department of Justice (DoJ) US$44 million to resolve the

outstanding civil penalty portion of a near five-year old settlementwith the US Drug Enforcement Agency (DEA) relating to CardinalHealth’s distribution practices for controlled substances.

In May 2012, Cardinal Health reached a settlement with the DEAafter admitting that the firm’s due diligence efforts for certain pharmacycustomers – and its compliance with an earlier memorandum ofagreement signed in 2008 for similar violations related to distributionpractices at Cardinal Health’s Lakeland, Florida facility – “were, incertain respects, inadequate”.

“The 2012 settlement resulted in a two-year suspension of CardinalHealth’s registration to distribute controlled substances from itsLakeland distribution centre, but did not at the time resolve thegovernment’s civil penalty claims,” Cardinal Health explained.

No further action“The DoJ, including the DEA and the US Attorneys’ offices for

the Middle District of Florida, the Southern District of New York, theDistrict of Maryland and Western District of Washington, have agreedto take no further administrative or civil action on these and relatedmatters,” the US firm added.

Craig Morford, Cardinal Health’s chief legal and complianceofficer, said the agreements allowed the firm to “move forward andcontinue to focus on working with all participants in addressing theepidemic of prescription drug abuse”.

Since signing the initial agreement in 2012, Cardinal Health hasbeefed up its generics scale and reach by acquiring privately-heldgenerics distributor The Harvard Drug Group from Court SquareCapital Partners in a deal worth US$1.12 billion (Genericsbulletin, 26 June 2015, page 2). Two distribution facilities and 450employees were covered by the transaction. G

ReGUlAToRy AFFAIRs

Cardinal signs civilsettlement with DoJ

Aceto “has no reason to believe that it is involved” in recent actiontaken by US states over pricing for generic doxycycline and

glyburide, despite having recently completed a deal for more than100 generic products and “related assets” from US-based CitronPharma – one of the six companies named in the action (Genericsbulletin, 6 January 2017, page 1) – and its Lucid Pharma affiliate.

“Prior to execution of the definitive agreement, Citron advisedAceto that Citron and certain of its employees received grand jurysubpoenas from the Department of Justice relating to the marketing,pricing and sale of four products,” Aceto noted. One of these Citronnever sold, Aceto said, while the remaining three – including glyburide –“accounted in the aggregate for less than 1% of Citron’s net sales forthe six months ended 30 June 2016”.

“Citron discontinued marketing glyburide in early 2015 due to lackof sales,” Aceto observed. “Citron has advised Aceto that it nevermarketed the Doxy DR (doxycycline) generic of Doryx that wasmentioned in the civil complaint filed by the State of Connecticut, anddoxycycline hyclate and Doxy DR were not referenced in the subpoenasreceived by Citron or its employees.”

Moreover, Aceto pointed out, its agreement with Citron “wasstructured as a purchase of assets, with Aceto buying certain agreed-upon products and not the entire Citron business, and with Acetoassuming only specified liabilities”. All other liabilities – includingany associated with the US proceedings – have been retained by Citron,which has indemnified Aceto for the liabilities that it has retained.

Acknowledging that “conduct around pricing” was “underscrutiny”, Aceto said Citron had advised the company that it “actedin full compliance with all applicable laws and regulations”.

The US$429 million Citron deal included US$270 million in cash,along with a US$50 million deferred payment, 5.12 million Acetoshares and performance-related payments of up to US$50 million onfour pipeline products over the next five years. G

MeRGeRs & ACqUIsITIoNs

Aceto clarifies detailsof its deal with Citron

5GENERICS bulletin13 January 2017

company news

Afire that broke out during excavation work at Sun Pharma’sactive pharmaceutical ingredient (API) production facility in

Ahmednagar in Maharashtra, India, claimed the lives of two workersand injured two more, the Indian firm has announced.

Clarifying information to the Bombay Stock Exchange (BSE) inthe wake of a news item that appeared in India’s The Business Linenewspaper, the Indian firm said it was providing support to the familiesof the workers following the incident.

“We are currently investigating the matter with the help of locallaw enforcement,” Sun commented. “There is no loss of productionat the Ahmednagar factory on account of this incident.” G

MANUFACTURING

Sun API fire claims two lives

Aspen and GlaxoSmithKline (GSK) have completed the cancellationof their sales and marketing collaboration in sub-Saharan Africa,

with the South African firm exercising its option to acquire GSK’sremaining thrombosis business in “certain retained markets”.

In 2013, GSK divested its thrombosis portfolio to Aspen, butretained rights to the franchise in certain territories, such as China –including Hong Kong and Macau – India, and Pakistan. Aspen willnow acquire for £45 million (US$55 million) GSK’s rights to theArixtra (fondaparinux) and Fraxiparine (nadroparin) anticoagulantsin these markets. GSK has also agreed to divest its portfolio of fiveintravenous anaesthetics to Aspen for an upfront payment of £180million plus milestone payments of up to £100 million, subject toanti-trust and regulatory clearances.

In September last year, GSK agreed to pay Aspen £45 million tocancel the sub-Saharan partnership (Generics bulletin, 16 September2016, page 3), which was formed as part of a series of transactionsover seven years ago (Generics bulletin, 11 December 2009, page 7).However, a collaboration in South Africa “remains in place”.

Last October, GSK sold its 6.2% shareholding in Aspen,representing 28.2 million shares (Generics bulletin, 7 October 2016,page 3), after GSK had previously halved its investment in the companyby selling an equivalent stake in early 2015 (Generics bulletin, 27March 2015, page 2). G

sTRATeGIC AllIANCes

Aspen and GSK endAfrican collaboration

Lonza and the PolyPeptide group have completed their deal throughwhich Lonza will divest its peptides business in Braine-l’Alleud,

Belgium, to the privately-held firm. Financial terms of the deal – whichwas struck last month (Generics bulletin, 16 December 2016, page 4) –were not disclosed.

With around 280 employees, the facility was “the centre forpeptide chemical development and manufacturing within Lonza”. “Theacquisition will enhance PolyPeptide’s manufacturing capacity andcapabilities and will enable seamless support for its broad portfolio,”commented the PolyPeptide group. Harmonising procedures at theBelgian facility, it added, “will be implemented in the coming months”.G

MeRGeRs & ACqUIsITIoNs

Lonza completes peptides deal

Accord’s £603 million (US$733 million) acquisition of ActavisGenerics in the UK and Ireland has been completed following

approval from the European Commission.The deal – struck by Accord parent company Intas last year

(Generics bulletin, 14 October 2016, page 1) – includes a portfolioof generics plus Actavis’ manufacturing plant in Barnstaple, England,which produces “over 10% of total UK generic medicines”.

Teva’s US$38.8 billion acquisition of Allergan’s Actavis – whichwas completed in August (Generics bulletin, 5 August 2016, page 1) –was conditional on the firm divesting the “great majority of AllerganGenerics” in the UK and Ireland. “Within the UK and Ireland, Tevaretains a number of Actavis’ non-overlapping generic products, pluscertain specialty medicines and OTC products,” the Israeli firm noted.

According to Intas, the acquired Actavis business had sales ofover £250 million in 2015. Noting that the deal would more thandouble Intas’ European operations, Intas said the transaction wouldalso make it a “top 20 generics player globally”. G

MeRGeRs & ACqUIsITIoNs

Accord completes ondeal for Actavis UK

RECIPHARM is set to acquire the pharma division of Kemwell’sIndian operation after obtaining regulatory approval from the IndianForeign Investment Promotion Board (FIPB) for the transaction. InApril last year, Recipharm announced it would pick up the Indianfirm’s domestic contract-manufacturing business for US$120 million(Generics bulletin, 22 April 2016, page 2).

DIVI’S LABORATORIES has filed a “detailed response” to five‘Form 483’ observations received following a US Food and DrugAdministration (FDA) inspection of the firm’s ‘Unit-II’ facility inVisakhapatnam, India (Generics bulletin, 16 December 2016, page 4).

SC PHARMACEUTICALS – the privately-held biopharmaceuticalfirm – has secured an investment of US$45.6 million from a groupof investors “co-led by OrbiMed and a wholly-owned subsidiary ofSun Pharmaceutical Industries”, as well as existing investors 5AMVentures and Lundbeckfond Ventures. The investment will be usedto support the development of “operational and commercialinfrastructure”.

PL DEVELOPMENTS has commissioned a new Greenville Countyfacility in a bid to expand its presence in South Carolina, US. Themanufacturer, packager and distributor said the development wasexpected to generate US$45 million in capital investment and create450 jobs. Logistics operations for the new facility – which will“include enhanced logistics capabilities along with new pharmaceuticalmanufacturing and packaging capabilities” – are set to commencein “early 2017”, with manufacturing to begin in “early 2018”.

PFIZER has acquired development and sales rights to AstraZeneca’slate-stage small molecule anti-infectives business, “primarilyoutside the US”. Included within the agreement are the “newly-approved” European Union (EU) drug Zavicefta (ceftazidime/avibactam); marketed agents Merrem/Meronem (meropenem) andZinforo (ceftaroline fosamil); and the clinical development assetsATM-AVI (aztreonam/avibactam) and CXL (cephalosporin). G

In BRIeF

6 GENERICS bulletin 13 January 2017

maRket news

Afinance bill for 2017 recently approved by Italy’s Senate has beenwelcomed as “an important landmark that encourages a more

dynamic market for biotech medicines and makes more room forbiosimilar drugs” by Marco Filippini, vice-coordinator of the ItalianBiosimilars Group (IBG) within local generics body Assogenerici.

According to the legislation, regional buying centres in Italy will berequired to group together medicines with the same active ingredient,dosage-form and route of administration. When more than threemedicines with the same ingredient are available, purchasing schemeswill need to be conducted using “framework agreements”.

As part of efforts to improve cost rationalisation and improveaccess, the bill states that patients will need to be treated with one ofthe top three medicines listed in the framework agreement, “on thebasis of the cheapest or best value for money”. However, doctors willstill be free to prescribe other medicines to ensure continuity of care.

Tenders must re-open after expiriesMeanwhile, if a brand patent or supplementary protection

certificate (SPC) expires during the period of a supply contract, “thecontracting entity is required to re-open the competitive tender processno later than 60 days after one or more biosimilars with the sameactive ingredient enter the market”.

Filippini – who also serves as Mundipharma Italy’s generalmanager – said the legislation was aimed at “guaranteeing a truerationalisation of the Italian national health service’s resources”.

To this end, Filippini insisted, “it is essential that the savingsobtained this way are not ‘frozen’ by regional governments and areinstead made available to patients who need access to treatment, orare used to purchase innovative medicines that allow an increasinglytargeted approach to treatment”. In this way, he said savings couldbe re-invested to improve access.

Mundipharma – which positions itself as a European “leader inbiosimilars” – markets Celltrion’s Remsima (infliximab) in certainterritories in the region.

The firm also has rights in Belgium, Germany, Ireland, Italy,Luxembourg, the Netherlands and the UK to market Celltrion’s Truxima(rituximab) biosimilar that recently received a positive opinion from thecommittee for human medicinal products (CHMP) within the EuropeanMedicines Agency (Generics bulletin, 6 January 2016, page 1). G

ReGUlAToRy AFFAIRs

Italian bill provisionswill boost biosimilars

Approving 59 final abbreviated new drug applications (ANDAs) inNovember 2016 gave the Office of Generic Drugs (OGD) within

the US Food and Drug Administration (FDA) a total of 113 ANDAapprovals in the first two months of its 2017 fiscal year.

In October and November combined, 28 tentative approvals weregranted while 15 ANDAs were withdrawn, and the agency refused toreceive 17 ANDA applications.

Within these first two months, the OGD received a total of 189ANDAs and 70 prior-approval supplements (PASs), with 923 changesbeing effected (CBE) supplements. Issuing 301 complete responses,the FDA also made 102 drug master file (DMF) completenessassessments over October and November. G

ReGUlAToRy AFFAIRs

FDA exceeds 100 ANDA nods

Ajudicial review of UK government plans to cut funding forcommunity pharmacists in England has been granted to the

Pharmaceutical Services Negotiating Committee (PSNC) by thecountry’s High Court.

The PSNC contends that the UK’s Secretary of State for Health,Jeremy Hunt, “failed to carry out a lawful consultation” on moves toreduce annual funding for community pharmacies in England by 4%to £2.687 billion (US$3.31 billion) from 1 December (Genericsbulletin, 9 December 2016, page 6), after initial plans to reduce fundingfrom October were postponed (Generics bulletin, 16 September 2016,page 7). Plans to cut a further 3.4% funding in 2017/18 to £2.592billion were also set out by the UK government.

An expedited hearing will take place in the week commencing6 February. According to the PSNC, the judge indicated that if theSecretary of State seeks a later hearing date – which would give himmore time to prepare his case – the question will arise of whetherthere should be a delay in the implementation of the legislation whilethe case is ongoing.

“The PSNC still very much regrets that the process the NationalHealth Service (NHS) has followed in the past year has made itimpossible to avoid taking legal action,” commented PSNC chiefexecutive Sue Sharpe, who described the proposed funding cuts as“unprecedented” and insisted that the decision on legal action “was notmade lightly”. However, she said, “we are pleased that our applicationfor leave has been granted and will be heard early in 2017”.

Accusing the UK Department of Health (DoH) of having “usedpoor data” as the basis for its funding decision, the PSNC alsoquestioned the validity of the DoH’s analysis, including its sample sizeand use of accounting returns, as the basis for assessing pharmacies’economic viability and potential closures.

Last year, Sharpe said the funding cut, combined with previouslyannounced reductions to Category M prices “following a significantover-delivery of margin” would have “a significant and negativeimpact” (Generics bulletin, 3 June 2016, page 8).

The DoH – which said it had been working with the PSNC onamending reimbursement through the Drug Tariff, including “changesto Category M for certain generic medicines to better reflect theirmarket price” – noted that Category M alterations affecting genericswere among the first moves that were likely to be implemented. G

ReTAIlING

Review is granted forEnglish pharmacists

Global health initiative Unitaid has recognised the need for it topromote “best practices regarding the adoption, protection and

use of trade-related aspects of intellectual property rights (TRIPS)flexibilities with a view to increasing equitable access to affordableand appropriately-formulated medicines”.

Following a meeting of Unitaid’s executive board in December,the organisation has asked its secretariat to “launch targeted calls forproposals within this area for intervention”.

Pointing to Unitaid’s constitution, the board emphasised that “whereintellectual property barriers hamper competition and price reductions,[Unitaid] will support the use by countries of compulsory licensingor other flexibilities” under the TRIPS framework. G

INTelleCTUAl PRoPeRTy

Unitaid promotes TRIPS use

7GENERICS bulletin13 January 2017

maRket news

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Revised guidance for abbreviated new drug application (ANDA)and prior approval supplement (PAS) filers highlighting

“deficiencies that may cause the US Food and Drug Administration(FDA) to refuse to receive an ANDA” has been released by the agency.

Reasons for an ANDA to be refused by the agency coveredin the guidance – which updates advice published by the agencyaround 18 months ago (Generics bulletin, 5 June 2015, page 16) –include outstanding Generic Drug User Fee Amendments (GDUFA)obligations and lack of a designated US agent for a foreign applicant.

Meanwhile, quality deficiencies, including for inadequatestability, as well as bioequivalence and clinical deficiencies, such asfailed in vivo bioequivalence studies, are also covered in the guidance.The FDA also offers advice on disputing a refuse-to-receive decision.

“This guidance is not meant to be a comprehensive list of thedeficiencies that may or will lead to a refuse-to-receive decision,” theFDA pointed out. “Instead, the guidance features certain recurrentdeficiencies that in the FDA’s experience have led to a refuse-to-receive decision.”

Within the guidance, the FDA observed that between its fiscalyears ended September 2013 and September 2015, the agency refusedto receive 379 ANDAs for reasons other than a failure to pay a GDUFAfee. Of all original ANDA submissions, the FDA refused to receive14% of ANDAs in 2013, 10% in 2014 and 14% in 2015. G

ReGUlAToRy AFFAIRs

FDA offers update toguidance on refusals

European off-patent industry association Medicines for Europe hasstruck a partnership with Supply Chain Wizard, a US-based

consultant “specialising in serialisation and traceability, supply-chainstrategy and operational transformation programmes” worldwide.

“As a leading partner for better healthcare, the organisation aimsto increase the health and well-being of all Europeans, while alsoaddressing the business needs of European pharmaceuticalmanufacturers,” explained Medicines for Europe director generalAdrian van den Hoven. “Partnering with a serialisation and supply-chain expert as well-regarded as Supply Chain Wizard, helps us betterserve both of these audiences.”

The alliance follows a ‘summit’ in Berlin in December “formedto serve as a resource for European pharmaceutical manufacturersmoving to incorporate serialisation processes to meet approachingregulatory deadlines”. Companies and European member states arecurrently preparing to implement the requirements of Europe’s FalsifiedMedicines Directive, the Delegated Regulation for which will applyfrom 9 February 2019 (Generics bulletin, 12 February 2016, page 16).

US-based Supply Chain Wizard – which also has offices inGermany, India, the Netherlands and Turkey – said the alliance would“help European manufacturers of generic, biosimilar and value-addedmedicines connect the dots between learning about pending regulationsand actually meeting their requirements”. G

ReGUlAToRy AFFAIRs

Medicines for Europehas a supply alliance

Gen 13-1-17 Pgs. 2-16.indd 7 11/01/2017 17:25

8 GENERICS bulletin 13 January 2017

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25 Januaryn 10th Pharmacovigilance Conference

London, UKThis conference is organised by Medicines for Europe and willlook at topics including legislation and biologics.

Contact: lucia Romagnoli. Tel: +44 7562 876 873.e-mail: events@medicinesforeurope.com. Register online at www.medicinesforeurope.com/events/phv-2017.

26-27 Januaryn 16th Regulatory & Scientific Affairs Conference

London, UKThis event will follow the Pharmacovigilance Conference at the samevenue in London. Updates on regulatory developments will be covered.

Contact: lucia Romagnoli. Tel: +44 7562 876 873.e-mail: events@medicinesforeurope.com. Register online at www.medicinesforeurope.com/events.

7-8 Februaryn World Affordable Medicines Congress

Barcelona, SpainThis event brings together two conferences – World Generic MedicinesCongress and Biosimilar Drug Development World. There will beinsights into commercial strategies, pricing, and development challenges.

Contact: Health Network Communications. Tel: +44 (0) 207 092 1000.e-mail: customerservices@healthnetworkcommunications.com.Website: healthnetworkcommunications.com.

13-15 Februaryn GPhA 2017 Annual Meeting

Orlando, USAThis conference, organised by the Generic Pharmaceutical Association(GPhA), will look at regulatory issues for the US generics industry.

Contact: GPhA. Tel: +1 202 249 7100.e-mail: jsoup@gphaonline.org. Website: gphaonline.org.

2-3 Marchn 2nd Business Development & Innovation

Opportunities in Consumer Healthcare/OTCLondon, UKOrganised jointly by the Pharmaceutical Licensing Group andOTCToolbox, this event will focus exclusively on business developmentand innovation in the consumer healthcare/OTC market.Contact: oTCToolbox. Tel: +44 121 314 8757.e-mail: deborah.wilkes@otctoolbox.com.Website: plg-group.com/events/2nd-otctoolbox-plg-otc-conference-and-networking-event/.

22-23 Marchn 13th Legal Affairs Conference

London, UKThis Medicines for Europe conference will cover legal andintellectual-property developments regarding generics and biosimilars.

Contact: lucia Romagnoli. Tel: +44 7562 876 873.e-mail: events@medicinesforeurope.com. Register online at www.medicinesforeurope.com/events/13th-legal-affairs-conference/.

Save the date ...n Joint 23rd Medicines for Europe & 20th IGBA Annual Conference

14-16 June 2017, Lisbon, Portugaln Global Generics & Biosimilars Awards 2017

24 October 2017, Frankfurt, Germany

events – January, February & March

The UK part of European patent EP2,292,219 protecting Novartis’Exelon (rivastigmine) patches is invalid due to obviousness and

added matter, the Court of Appeal has confirmed. In April 2015, PatentsCourt Judge Richard Arnold had found that the ‘219 patent lacked anyinventive step over the prior-art US patent 6,335,031, and was alsoinvalid for added matter (Generics bulletin, 22 May 2015, page 17).

Writing the lead opinion for the three-judge appeal panel, JusticeDavid Kitchin noted that Novartis had reached settlements withdefendants Teva, Actavis and Focus over infringement. However, theoriginator was contesting Arnold’s finding of invalidity.

Addressing obviousness, Kitchin described the attack on the ‘219patent – based on the US ‘031 patent published in January 2002 – as“entirely coherent”. “I am satisfied that there was a sufficient basisin the expert evidence to support the judge’s finding that it was routineat the priority date when developing a new formulation to performdose-titration studies to determine the appropriate dose for initiatingtherapy, and that the claimed invention was obvious,” he stated.

On added matter, Kitchin said that Arnold had been “right to findthat the patent does disclose matter extending beyond that disclosed inthe [patent] application in that it discloses the use of a particular startingdose for rivastigmine delivered by a transdermal therapeutic system(TTS) and that this starting dose should be the dose delivered by the5 sq cm TTS#2 loaded with 9mg of the drug”.

Kitchin noted that the European Patent Office’s revocation of the‘219 patent for added matter had been suspended pending appeal.G

AlzHeIMeR’s DIseAse DRUGs

UK upholds ruling onrivastigmine patches

Mylan has bolstered its US$1 billion global over-the-counter (OTC)business in the US by agreeing to acquire global rights to the

Cold-eeze brand from ProPhase Labs. Included within the Cold-eezebrand are zinc-based lozenges, gummies, oral sprays, capsules andoral liquid-dose forms.

Under the terms of the deal, Mylan will purchase “substantiallyall of the assets and other rights relating to the Cold-eeze brand”,including all US businesses and US and international trademarks.

Subject to approval of ProPhase Labs’ shareholders and othercustomary closing conditions, Mylan said, the agreement was set toclose in the first quarter of 2017. “With strong brand recognition inthe pharmacy and a growing and loyal customer base,” the US firmstated, “Cold-eeze will become Mylan’s largest US OTC brandfranchise and further augment its growing US OTC business.” G

oTC DRUGs

Mylan buys Cold-eeze brand

Results from a Phase III study for Biocon and Mylan’s proposedbiosimilar trastuzumab have been published in the Journal of the

American Medical Association (JAMA). Mylan president Rajiv Maliksaid the firm was “proud that JAMA has recognised the results of theHeritage study”, the efficacy and safety data from which was firstrevealed in June last year (Generics bulletin, 10 June 2016, page 13). G

BIoloGICAl DRUGs

Trastuzumab study published

Gen 13-1-17 Pgs. 2-16.indd 8 11/01/2017 17:25

9GENERICS bulletin13 January 2017

pRoduct news

A Study Of Mail OrderAnd Internet PharmacyIn 17 European CountriesPlus Key LearningsFrom The US And China

Available to download atwww.james-dudley.co.uk

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REAPING THE BENEFITS OFAN OMNICHANNEL PRESENCE

MAIL ORDER AND INTERNET PHARMACY IN EUROPE 2017

This expanded fourth edition of MailOrder and Internet Pharmacy inEurope shows how e-commerce isreshaping the pharmacy landscapeand playing a key role inthe omnichannel strategiesof leading healthcare retailers.

Mail Order and Internet Pharmacy in Europecovers: Austria, Belgium, China, CzechRepublic, Denmark, Finland, France,Germanyyy,,, Hungggaryyyry,,, Italyyy,,, Netherlands,,,Norwwrway, Poland, Slovak Republic, Spain,Sweden, Switzerland, the UK and the US.

NEWFOR

2017

Pfizer has announced that its ‘Reflections B538-02’ study comparingthe efficacy, safety, and immunogenicity of the firm’s PF-06410293

biosimilar adalimumab candidate to AbbVie’s Humira referencebrand has met its primary endpoint, as measured by the AmericanCollege of Rheumatology 20 (ACR20) response at week 12.

The randomised, double-blind, two-arm, parallel group equivalencestudy compared Pfizer’s candidate to Humira, each taken withmethotrexate, in patients with moderate-to-severe rheumatoid arthritiswho have had an inadequate response to methotrexate therapy.

“The announcement builds on Pfizer’s robust biosimilar pipelinewhich has now delivered positive top-line data results for three ofour proposed biosimilars,” commented Sumant Ramachandra, headof research and development at Pfizer Essential Health.

In September, Pfizer announced that its ‘Reflections B537-02’confirmatory study for its PF-06438179 infliximab candidate had metits primary endpoint (Generics bulletin, 23 September 2016, page9). Shortly after, the firm’s PF-05280014 proposed trastuzumabcandidate also met its primary endpoint in a trial evaluating thebiosimilar against Genentech’s Herceptin brand (Generics bulletin,9 December 2016, page 11).

Pfizer said its biosimilars pipeline currently consisted of “eightdistinct biosimilar molecules in mid-to-late stage development, andseveral others in early stage development”. G

BIoloGICAl DRUGs

Pfizer reports resultsof adalimumab study

Endo’s Par Pharmaceutical is seeking a declaratory judgement froma Massachusetts district court that the company’s proposed generic

rival to Sunovion’s Latuda (lurasidone) does not infringe three USpatents protecting the antidepressant brand.

Par filed an abbreviated new drug application (ANDA) for 20mg,40mg, 60mg, 80mg and 120mg lurasidone tablets containing paragraph IVcertifications of non-infringement or invalidity against three US patents.These were US patents 8,729,085 and 8,883,794 – both of whichexpire on 26 November 2026 including six months of paediatricexclusivity – as well as reissued patent RE45,573, which runs until23 December 2025, including a similar exclusivity period.

No litigation initiatedHowever, neither Sunovion nor parent company Sumitomo

Dainippon Pharma initiated patent infringement litigation against Parover the patents within the statutory 45-day periods. This, Par noted,was despite Sunovion having in 2015 initiated patent-infringementlawsuits with lurasidone ANDA filers including Emcure and Invagen.

“Par requested, but [Sunovion and Sumitomo Dainippon] did notprovide, a covenant not to sue Par on the ‘085, ‘794 and RE’573patents,” Par states in its filing.

Their actions “have resulted in a substantial controversy” overthe three patents, the generics firm insists, “of sufficient immediacyand reality to warrant the issuance of a declaratory judgement thatthe ‘085, ‘794 and RE’573 patents are not infringed”.

Three other patents listed against Latuda in the Orange Bookmaintained by the US Food and Drug Administration (FDA)have expiry dates of 2 January 2019, 26 December 2026 and 23November 2031. All three patents benefit from six-month periodsof paediatric exclusivity. G

ANTIDePRessANTs

Par seeks ruling onUS patents for Latuda

Transdermal specialist Futura Medical has struck a licensingagreement with Stada’s UK subsidiary through which Stada will

sell the firm’s ‘TPR100’ novel diclofenac pain-relief gel in the UK.Under the terms of the deal – which Futura struck with

Thornton & Ross, the local consumer health specialist that Stadaacquired in a £221 million (US$269 million) transaction in 2013(Generics bulletin, 6 September 2013, page 5) – Thornton & Rosswill “conduct the manufacturing scale-up of TPR100 and hold rightsto manufacture, market and distribute the product in the UK for thelifetime of the product’s patents, which run to at least 2028 in the UK”.

Futura will receive an upfront payment and milestone payments“up to a certain limit”, along with royalties on sales. Other terms ofthe deal were not disclosed.

Insisting that TPR100 benefits from “rapid skin permeation rates”thanks to Futura’s proprietary DermaSys delivery system, the firmsaid the drug had “demonstrated statistically significant results in a2015 clinical study comparing the product against both placebo andcurrently marketed products”. Futura said it expected that “no furtherclinical work will be required ahead of a regulatory submission byThornton & Ross for a UK marketing authorisation expected to bemade in the second half of 2017”. G

ANAlGesICs

Stada sells Futura diclofenac

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10 GENERICS bulletin 13 January 2017

pRoduct news

Perrigo has divested to US injectables specialist Custopharm twoinjectable abbreviated new drug applications (ANDAs), both of

which contain paragraph IV patent challenges.Revealing that it had “attained full-ownership rights to

acetaminophen injection and testosterone undecanoate injection”,California-based Custopharm said it planned to market the productsunder its new Leucadia Pharmaceuticals commercial business arm.

“Both of these products are a tremendous fit with Custopharm’salready diverse offering of specialised and high barrier generics,”commented Bill Larkins, the firm’s chief executive officer, and aformer general manager with Bedford Laboratories.

Having in 2015 partnered with US investor Water StreetHealthcare Partners (Generics bulletin, 27 February 2015, page 34),Custopharm said it was “pursuing new opportunities to collaboratewith pharmaceutical and biotechnology companies and expand itsproduct portfolio”.

At the same time, Perrigo’s wholly-owned UK generic oralliquids business Rosemont Pharmaceuticals has signed a “multi-productlicensing and manufacturing agreement” with US-based TLCTherapeutics. The privately-owned firm’s chief executive officer,Vikram Seoni, said the collaboration created an “immediate late-stagepipeline and strong development platform for our company”.

“This partnership gives TLC the unique opportunity tocommercialise a portfolio of novel oral liquid products, which arelicensed and commercially available in multiple European markets buthave not yet been submitted to the US Food and Drug Administration(FDA),” Seoni commented.

And Perrigo has also recently obtained final FDA approvals forgeneric versions of GlaxoSmithKline’s Nicorette (nicotine) WhiteIce Mint 2mg and 4mg gum. The originator’s reference brand hadsales of US$79 million for the 12 months ended November last year.

“These products will be packaged and marketed as store brandsor retailer ‘own label’ brands and provide consumers with high-quality,value alternatives to Nicorette White Ice Mint gum,” the US storebrands specialist commented. G

ANAesTHeTIC/HoRMoNe DRUGs

Perrigo divests two toUS firm Custopharm

Coherus has confirmed that it is expecting to file a US applicationfor a biosimilar rival to AbbVie’s Humira (adalimumab) in the

first half of 2017 after reporting positive results from the second partof an ongoing, three-part Phase III study comparing its CHS-1420adalimumab candidate to the biologic reference brand.

Having last year reported that the study met its primary endpointof similarity between CHS-1420 and Humira with respect to thepercentage of subjects achieving 75% improvement in the psoriasisarea and severity index (PASI-75) at week 12, Coherus noted thatresults from the second part of the study focused on maintenance ofresponse through week 24.

“In part two, maintenance of PASI-75 was similar across thethree subsequent treatment groups,” Coherus explained, referring topatients treated only by CHS-1420, only by Humira, and thoseswitched from Humira to CHS-1420 from weeks 16-24, “modellinga chronic patient’s transition to a biosimilar”. G

BIoloGICAl DRUGs

Coherus reports Humira trial

ANI PHARMACEUTICALS has launched vancomycin 125mgand 250mg capsules in the US, available in a 50-count bottle,an authorised generic of Vancocin. The market for vancomycincapsules in these presentations was worth around US$21 million,ANI said, citing QuintilesIMS data. The firm has also launchedan authorised generic of Lithobid (lithium) 300mg extended-release tablets, which are used to treat manic episodes of bipolardisorder. The annual US market is approximately US$19 million,according to QuintilesIMS.

SUN PHARMA has announced plans to acquire Novartis’ brandedoncology product, Odomzo (sonidegib). The Indian firm’sagreement – which Sun said would close following anti-trust clearanceand other customary closing conditions – includes an upfrontpayment of US$175 million and additional milestone payments.

CEPHALON, TEVA AND BARR violated antitrust laws relating tothe sale of prescription modafinil, according to a proposed settlementwith purchasers reached in a lawsuit regarding the price thatindividuals in 48 US states and the District of Columbia paid forProvigil (modafinil) and generic versions between 24 June 2006and 31 March 2012. The three companies deny any wrongdoing.

IMPAX has launched a US generic version of Kadian (morphinesulfate) extended-release capsules, available in 20mg, 30mg, 50mg,60mg, 80mg and 100mg doses. According to QuintilesIMS data,the capsules had total sales of approximately US$98.4 million inthe US in the 12 months ended October 2016.

LANNETT has obtained approval from the US Food and DrugAdministration (FDA) for its supplementary new drug application(sNDA) for morphine sulfate 20mg/ml oral solution. The opioidagonist will be available in calibrated bottles and include a calibratedoral dispensing device. The morphine oral solution – which isindicated for the management of acute and chronic pain in opioid-tolerant patients – had US sales of around US$22 million in the yearended October 2016. Lannett said it anticipates launching “shortly”.

CONCORDIA INTERNATIONAL expects to expand sales ofDonnatal (belladonna/phenobarbital) after entering into a three-year co-promotion agreement with RedHill Biopharma. The dealcomes shortly after Concordia eliminated a contract sales forcepromoting Donnatal (Generics bulletin, 6 January 2017, page 5).Over the three-year period, RedHill plans to “promote the product inup to 30 sales territories”. Concordia also plans to continue to sellDonnatal in US territories outside the scope of the RedHill agreement.

FDA – the US Food and Drug Administration – has postponed aclozapine Risk Evaluation and Mitigation Strategy (REMS) launchdue to “recent technical and logistical challenges”. Originally, theprogramme was due to launch in December 2016. The FDA said itwould continue to work with the clozapine product manufacturers’group as it plans “a phased approach” to implementing the programme.

TARO has divested its US rights to Keveyis (dichlorphenamide)to Strongbridge Biopharma, a company focused on developing andselling therapies for “rare diseases with significant unmet need”.Under the terms of the deal, Strongbridge will provide Taro with“upfront and deferred payments of US$8.5 million in twoinstallments”, with Taro also eligible to receive additional futurepayments “upon the achievement of certain sales unit milestones”.Taro said it has agreed to continue to manufacture Keveyis forStrongbridge under an exclusive supply agreement. G

In BRIeF

11GeneRIcs bulletin13 January 2017

pRoduct news

BRAND NEWPORTFOLIO EXTENSION

Neogen will have several new dossiersready for licensing out and submission

by clients in 2017.

The following new dossiers are already available:● Cyanocobalamine 1 mg film coated tablets● Methadon 2.5, 5, 10, 20 & 40 mg tablets● Sodium valproate solution for injection100 mg/ml (3, 4 & 10 ml)

● Xylometazoline menthol 1 mg/ml nasal spray

Coming soon:● Paracetamol 665 mg slow release tablets● ASA 75, 100 & 160 mg enteric coated tablets

For more details, please contact us at licensing@neogen.be

Happy New Yearto all our (potential) clients!

India’s Zydus Cadila has bolstered its domestic portfolio by acquiringa diverse lot of six branded products from Merck, Sharp & Dohme

(MSD), and certain of the US firm’s subsidiaries, for an undisclosed fee.Zydus said the brands included osteoporosis treatments, hormone

replacement therapies, women’s contraceptives, antihypertensivesand a wound management therapy.

The acquired portfolio – Deca-Durabolin (nandrolone decanoate),Durabolin (nandrolone phenylpropionate), Sustanon (testosterone), theMultiload contraceptive device, Sicastat (feracrylum) and Axeten(telmisartan) – had sales of Rs840 million (US$12.4 million) in 2015.

“The deal includes transfer of distribution and commercialisationrights and assignment of trademarks of all the six brands to ZydusHealthcare in India,” Zydus explained.

Meanwhile, the firm added, MSD’s Organon India business in thecountry had also transferred similar rights for the Deca-Durabolinand Durabolin brands to Zydus for Nepal.

Zydus said that with the firm’s own “large field force and widerreach, Zydus expects to make available and grow these brandssignificantly over the next few years”.

“We have a long-standing association with MSD in India andvalue them as a partner,” noted Zydus Healthcare chairman, SharvilPatel. “The brands, with their strong equity are a perfect addition andcomplement our core business and brands.” G

HoRMoNe RePlACeMeNT THeRAPIes

Zydus strikes deal tobuy six Merck brands

Lannett is set to expand its offering after receiving final US Foodand Drug Administration (FDA) approval for its abbreviated new

drug application (ANDA) for a generic version of AbbVie’s Kaletra(lopinavir/ritonavir) oral solution, although questions remain over apossible 180-day exclusivity period for the antiretroviral.

In a letter addressed to Katy Rudnick, manager of regulatoryaffairs with Lannett’s Silarx Pharmaceuticals liquid generics business –which Lannett acquired for US$42.0 million in June 2015 (Genericsbulletin, 26 June 2015, page 5) – the FDA pointed out that Silarx had“failed to obtain tentative approval of this ANDA within 30 monthsafter the date on which the ANDA was filed”, a prerequisite toguaranteeing exclusivity.

“The agency is not, however, making a formal determination atthis time of Silarx’ eligibility for 180-day generic drug exclusivity,”the FDA noted. “It will do so only if a subsequent paragraph IVapplicant becomes eligible for full approval [either] within 180 daysafter Silarx begins commercial marketing of lopinavir/ritonavir oralsolution [or] at any time prior to the expiration of US patents 6,911,214and 8,501,219 if Silarx has not begun commercial marketing.”

According to the FDA’s Orange Book, the former patent expireswith six months of paediatric exclusivity on 28 May 2022, while thelatter covers Kaletra until 28 November 2021. These are the onlyunexpired patents listed against the brand in the Orange Book.

Lannett’s chief executive officer, Arthur Bedrosian, observedthat launch was anticipated “shortly”.

India’s Cipla is currently the only player to hold a tentatively-approved ANDA for lopinavir/ritonavir oral solution, according tothe FDA’s Approved Drug Products database. G

ANTIReTRoVIRAls

Sole status unsure onLannett Kaletra rival

Sandoz has failed in an attempt to lift a UK injunction barring itfrom marketing a generic rival to Pfizer’s Lyrica (pregabalin)

with a full label, including pain indications protected by Pfizer’sEuropean patent EP0,934,061 until 16 July this year.

Noting that Sandoz was subject to an interim injunction that hehad granted in November 2015, Justice Richard Arnold consideredwhether subsequent developments represented a “material change incircumstances” that justified lifting the injunction.

Arnold decided that a UK Court of Appeal decision handed downin October 2016 was not a material change as it had confirmed thevalidity of claims 10, 11 and 12 of the ‘061 patent while the UKSupreme Court was still considering whether to grant Pfizer permissionto appeal against findings that other claims were invalid (Genericsbulletin, 21 October 2016, page 11). However, he said, Pfizer’s pledgenot to seek to use claim 3 of the ‘061 patent – which covers neuropathicpain and was found invalid – to seek injunctions against genericsmarketing pregabalin with “intermediate labels” covering some, butnot all, pain indications was a “material change of circumstances”.

However, Arnold stated, Pfizer had “not merely an arguable, but astrong case that, if claims 10, 11 and 12 are valid, dealings by Sandozin the full-label product will infringe those claims”. Were Sandoz tolaunch a full-label generic, others would soon follow, causing“irremediable harm” to Pfizer that would be difficult to quantify. G

ANAlGesICs

Pregabalin ban persists in UK

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12 GeneRIcs bulletin 13 January 2017

pRoduct news

Up to the minute live retail market pricing is available for theUK and Eire on Wavedata Live at wavedata.net.Alternatively, contact Charles Joynson at WaveData Limited, UK.Tel: +44 (0)1702 425125. E-mail: cjoynson@wavedata.co.uk.

Basket Price Reimbursement Price Pharmacy Profit£1,923.02 £3,315.79 £1,392.77

Price WatchIndex

PharmacyProfit Index90.3 82.7

Monthly change +2.7 Monthly change -3.4

December 2016 December 2016

The Price Watch Index is based on the actual average trade price according to WaveData of arepresentative basket of 20 popular generic products in March 2016, when the Index was 100. Thebasket reflects recent official prescribing data for England and Wales and represents what an averagepharmacy would pay for the products, which were selected as being the top cash generators withinpharmacy. The Pharmacy Profit Index is calculated on the same basis by applying Drug Tariffreimbursement prices to the basket.

Total pharmacy reimbursement in December for our typicalbasket of UK generics remained steady for the third month

running at £3,316 (US$4,106), but with prices rising, pharmacyprofit fell below £1,400 for the month. As a result, the averagedispensing profit margin on the basket fell to almost exactly 42%.

As the year closed, the Price Watch Index of generics pricesshowed a nearly 10 percentage-point decline since March 2016, whenthe Index was first calculated. Pharmacy profit in the same periodfell at almost double the rate to just 82.7% of its March level. Thiswas the result of reimbursement prices for the typical basket fallingby 13% in the period from £3,812.38. G

December 2016

pRIce watcH ....... uk

Portuguese medicines agency Infarmed has issued marketingsuspensions for four pharmaceutical products in the country after

finding more than 10 good manufacturing practice deficiencies at theproduction facility operated by the drugs’ licence holder, Granules India.

Batches of paracetamol 500mg and 1,000mg, marketed by Sandozand Bluepharma respectively, metformin sold by Mylan, and supofencommercialised by Laboratórios Basi that were named by the agencymust also be recalled immediately, Infarmed ordered. The agency said ithad been informed of “therapeutic alternatives for the drugs identified”.

“Patients using batches of the medicinal products…should notdiscontinue treatment, and consult their physician as soon as possibleto have an alternative medicine prescribed,” Infarmed recommended.

Infarmed’s action follows an inspection conducted by the agencyat Granules’ Gagillapur facility in Telangana, India, after whichInfarmed issued an inspection report with 11 observations, relatedto granulation activity and primary tablet packaging.

Commenting on the development, Granules said it had initiated the“necessary steps to address the observations of the inspection agency”.The Indian firm will request a re-inspection of the Gagillapur facility –which manufactures both intermediates and finished dosages – at theearliest possible opportunity. In October last year, Granules announcedthat the facility had passed a US Food and Drug Administration (FDA)inspection with no observations of current good manufacturingdeficiencies (Generics bulletin, 21 October 2016, page 5). G

ANAlGesICs/DIABeTes DRUGs

Granules deficiencieslead to suspensions

Commercial realities have led the UK’s Patents Court to allow adispute over patents protecting AbbVie’s Humira (adalimumab)

blockbuster to proceed to trial this month. Rejecting AbbVie’sapplication for a summary judgement or an order dismissing proceedingsas an abuse of process, Justice Henry Carr said Fujifilm KyowaBiologics (FKB) and Samsung Bioepis should be permitted to clearthe path by challenging several dosage-regimen patents.

Carr noted that both FKB and Samsung Bioepis intended tolaunch a biosimilar rival to Humira in the UK once a supplementaryprotection certificate (SPC) linked to the basic adalimumab patentEP0,929,578 expired on 15 October 2018. To this end, they wereseeking declarations that their products were obvious and/or anticipatedat the priority date of several secondary patents, but AbbVie wasseeking either a summary judgement or an order striking out theproceedings as an abuse of process.

With both FKB and Samsung Bioepis having challenged the UKparts of secondary European patents EP2,940,044 and 1,944,322, FKBalso brought a case against the UK part of EP1,737,491 (Genericsbulletin, 16 September 2016, page 12). A trial on the ‘044 and ‘322patents is set to begin imminently on 16 January, with a trial on the‘491 patent to follow in June this year.

However, Carr observed, AbbVie had on 15 November 2016“without any explanation” informed the biosimilar developers that ithad de-designated the UK from the ‘044 divisional patent and hadinformed the European Patent Office (EPO) that it no longer approvedof the text of the ‘322 patent. Furthermore, the originator said it wasprepared to submit to revocation in the UK of the ‘491 patent, therebyeffectively disclaiming the firm’s dosage-regimen patents in the UKand rendering any further proceedings without “a useful purpose” and“an abuse of process”.

FKB and Samsung Bioepis insisted that a trial in January wouldserve to clear the way in the UK and influence courts “throughoutEurope” as AbbVie sought to create market uncertainty by abandoningpatents at the last minute while filing divisionals with similar claims.The biosimilar developers pointed out that AbbVie had, on the last daypossible before the ‘044 patent was granted, applied for a divisionalpatent, the details of which had not yet been published.

Recognising that AbbVie had publicly pledged to seek injunctionsagainst any adalimumab biosimilars launched ‘at risk’, Carr decidedthat “the judge at trial may well conclude that AbbVie has consistentlyadopted a policy of publicly expressing its confidence in its Humirapatent portfolio, and its intention to enforce it against competitionfrom biosimilars, whilst at the same time shielding patents withinthe portfolio from scrutiny by the court”.

Given that UK sales of Humira exceeded £400 million (US$485million) per year (Generics bulletin, 2 December 2016, page 13), thebiosimilar developers were “entitled to be sceptical” about AbbVie’schoice to abandon patents, Carr commented, especially due to theexistence of “submarine divisionals”.

Carr cited factors supporting the grant of declarations sought byFKB and Samsung Bioepis that included: “AbbVie’s conduct ofthreatening infringement whilst abandoning proceedings at the lastmoment, in order to shield its patent portfolio from scrutiny; the amountof money at stake for the claimants in terms of investment in clinicaltrials and potential damages if they launch at risk; and the need forcommercial certainty, having regard to AbbVie’s threats to sue forinfringement throughout the world”. G

BIoloGICAl DRUGs

UK Humira patentscase moves to trial

Gen 13-1-17 Pgs. 2-16.indd 12 11/01/2017 17:25

13GeneRIcs bulletin13 January 2017

peopLe

Neogen is looking for a LicensingManager

The ideal candidate will have several years experience inout-licensing in Europe and preferably other territories.Neogen’s headquarters are located in Belgium,but some flexibility is possible for the right candidate.We ask candidates to send their interest to ourHR Manager, Marieke Houthuys via hr@alterpharma.beor +32 (0)2 526 64 10.

Please visit our website for more informationwww.neogen.be

Concordia is continuing to reshape its top team after promotingmanaging director of the company’s International business

segment, Graeme Duncan, to the role of International president.Duncan takes the place of John Beighton, who has retired from

the role having served as president of Concordia’s Internationalsegment since July last year.

Former Teva UK managing director Beighton joined the Concordiagroup in October 2015 when Concordia acquired AmdipharmMercury – at which Beighton was chief executive officer.

Having previously held roles with GlaxoSmithKline and Ivax inthe UK, Duncan has taken on his new role less than a year after beingnamed managing director of the International business. He had joinedthe legacy Amdipharm Mercury business – which Concordia acquiredfor US$3.5 billion in October 2015 (Generics bulletin, 6 November2015, page 2) – as global marketing director and vice-president ofcommercial operations in the UK and Ireland in 2015.

According to Ontario-based Concordia, the firm’s Internationalbusiness supplies a “broad portfolio of branded and generic medicinesto wholesalers, hospitals and pharmacies in more than 100 countries”.

Follows Oberman appointmentDuncan’s appointment comes less than two months after Concordia

named former Sagent and Teva executive Allan Oberman as its newchief executive officer, following the departure of company founderMark Thompson in October last year. Oberman had taken a seaton Concordia’s board shortly before Thompson’s resignation wasannounced by the firm (Generics bulletin, 28 October 2016, page 1).

“We are grateful to John for his contribution towards building aglobal business with significant product and geographic diversity,”commented Oberman. Concordia said Beighton would continue toserve as an International board member, “where he will continue to beavailable to provide strategic advice to the International business”.

“As we look ahead, we are confident that Graeme’s deepknowledge of the industry and his broad strategic experience will helphim thrive in his new leadership role,” Oberman added.

Within the last 12 months Concordia has also brought in formerMylan executive Edward Borkowski as its chief financial officer(Generics bulletin, 26 February 2016, page 16). G

APPoINTMeNTs

Concordia’s Duncannamed overseas head

Global head of clinical development of Sandoz’ biopharmaceuticalsbusiness, Malte Peters, is to step down from the position and

depart the company to become chief development officer of Germantherapeutic antibodies specialist MorphoSys from 1 March.

Prior to taking up his current position with Sandoz in June 2015,Peters spent more than 11 years with the generics firm’s parentcompany Novartis “focusing on management of clinical developmentprojects in oncology”. A doctor of medicine, Peters has also previouslyheld teaching appointments in internal medicine and biochemistryat the University of Mainz in Germany.

Chairman of MorphoSys’ supervisory board, Gerald Möller,described Peters as an “ideal addition to the management board ofMorphoSys at this stage of the company’s growth”. “Drawing on hisdeep operational and medical experience in oncology and immunology,”Möller added, “he will focus his efforts on the development of ourclinical and pre-clinical programmes.” G

ResIGNATIoNs

Sandoz’ Peters set toleave for MorphoSys

Mallinckrodt has appointed former Sanofi executive Karen Sheehyas the company’s new chief compliance officer.

Bringing more than 25 years of legal experience to Mallinckrodt,Sheehy previously held positions of increasing responsibility with theDaiichi Pharmaceutical Corporation, Sanofi’s erstwhile US Aventisbusiness and, most recently, Sanofi itself, where she was head ofcompliance for the French firm’s North American business.

“As part of a long-planned transition, current chief complianceofficer Raymond Furey has recruited an expanded compliance teamand this new leader to be co-located with Mallinckrodt’s growingNew Jersey-based Specialty Brands business,” the US firm commented.Furey would now “pursue new opportunities in California, where hisfamily resides”, Mallinckrodt said. G

APPoINTMeNTs

Mallinckrodt appoints Sheehy

PHRMA – the Pharmaceutical Research and Manufacturers ofAmerica – has appointed Johnson & Johnson’s worldwide chairmanof pharmaceuticals, Joaquin Duato, as the brand industryassociation’s new chairman of its board of directors. Duato hastaken on his new role after former chairman George Scangos’recently left his post as Biogen’s chief executive officer (Genericsbulletin, 6 January 2017, page 20).

CAMBREX has announced plans to reshuffle its senior team,moving chief financial officer Greg Sargen to the newly-createdrole of executive vice-president of corporate development andstrategy and bringing in Tom Vadaketh to replace Sargen as chieffinancial officer. Vadaketh will join Cambrex on 20 January.

CIPLA has appointed former Endo president and chief executiveofficer Peter Lankau as an independent director. Y K Hamied, theIndian firm’s non-executive chairman, praised Lankau’s “deepunderstanding of the US pharmaceutical market”. G

In BRIeF

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On the surface, Biocad’s stated ambition to becomean international, research-led biotechnologycompany that “combines a world-class research

centre with modern pharmaceutical production, as wellas pre-clinical and clinical studies compliant withinternational standards” places the Russian companyin a broad peer group.

But by capitalising on its position as “one of theworld’s few full-cycle drug development and manufacturingcompanies” with in-house biotechnology capabilitiesstretching from cell-line development through fill-and-finish to commercialisation, Biocad is confident that ithas several commercial advantages that will enable itto expand its leading position for oncology andautoimmune therapies in Russia to international markets.

Founded around 15 years ago by entrepreneurDmitry Morozov, who now serves as chief executiveofficer of the group, privately-owned Biocad started outby constructing a finished-dosage form facility inPetrovo-Dalnee, just to the west of Moscow. To populatethat plant with products, the company a year later set upa research and development centre based on Moscow’sSoviet Institute of Immunological Engineering. Theintroduction of the Genferon (interferon-alfa 2b) treatmentfor urogenital infections in 2005 was followed a yearlater by the launch of Leucostim (filgrastim), Russia’sfirst granulocyte-colony stimulating factor (G-CSF).

Having since added a centre in Strelna, nearSt Petersburg, for both the development and productionof monoclonal antibodies (mAbs), Biocad now marketsmore than 30 products, 10 of which are biotech drugs. In2014, the firm launched Russia’s first mAb biosimilar,Acellbia (rituximab), and then in 2015 completed thelocal registration process for both the Avegra(bevacizumab) and Herticad (trastuzumab) biosimilars.

As one of the leading pharmaceutical companiesin Russia, Biocad also offers novel biologics such asAlgeron (cepeginterferon alfa-2b) and Extimia(empegfilgrastim), as well as a broad portfolio of small-molecule oncology therapies, anti-infectives andantiretrovirals. This portfolio generated 2015 sales ofwell over RUB10 billion, or around US$200 million,and the Russian company – which employs more than1,000 people, including over 350 in research anddevelopment roles – has ambitious goals to push toUS$500 million and beyond.

By the end of this decade, Biocad expects to beachieving a turnover of at least half a billion dollars bycombining its rapid growth in Russia with significantinternational expansion, the company’s vice-presidentof research and development and international businessdevelopment, Roman Ivanov, told Generics bulletin.“We are very keen on pursuing this goal, and it may bethat we will reach it much faster than 2020,” he statedduring an exclusive interview.

Ivanov insisted that Biocad enjoyed severalcompetitive advantages in the biosimilars arena, not leastby controlling the entire development and production

process. “We are the only player in the region – not onlyin Russia, but also in Eastern Europe and Central Asia –that has commercial-scale facilities for developing andmanufacturing drugs based on monoclonal antibodies,”he pointed out. Having all these skills and abilities in-house ensured that Biocad could control costs byavoiding outlay on outsourcing, he added.

“We have a very talented and capable workforce,with costs comparable to those in India,” Ivanov continued,noting that this provided an advantage over firms operatingnot only in the US and Europe, but also in South-East Asia.

“Even for our first monoclonal antibody, thebiosimilar process development was done almostcompletely in-house,” Ivanov explained. “For ourtrastuzumab biosimilar,” he noted, “we are achievingyields of better than 4.5 grams per litre with an excellentdegree of biosimilarity.”

Single-use reactors give flexibilityBy focusing on single-use reactors at its 2,000 sq m

mammalian-cell expression centre in Strelna nearSt Petersburg, Biocad was able to be flexible inproducing relatively limited batches for specific marketsat defined times, Ivanov stated.

“For us, it is very important to be able to manufacturesmall batches of different mAb products,” he said, addingthat scale-up was performed at a 600 sq m pilot plant inLyubuchany near Moscow, while a 2,900 sq m facilityin nearby Petrovo-Dalnee conducted fill-and-finishactivities with an annual capacity of 3 million vials and4 million pre-filled syringes.

A separate 2,400 sq m building in Petrovo-Dalneecan produce 3 million vials of injectable small-moleculegenerics as well as 9 million suppository cartons per year.The facility is also used by foreign firms to localise theirproduction in Russia.

The Strelna active pharmaceutical ingredient (API)site’s current 6,000-litre capacity was fully employed,so Biocad had accelerated its plans to treble its single-use bioreactor capacity to 18,000 litres over the nexttwo years, Ivanov commented, and raise finished dosage-form production to 8 million units. This urgent need toexpand, he explained, reflected demand for the company’sbiosimilar mAb portfolio that had exceeded Biocad’scommercial expectations.

Having in 2014 led the way with Russia’s first mAbbiosimilar – Acellbia (rituximab) for patients withnon-Hodgkin’s lymphoma and chronic lymphocyticleukaemia – Biocad has since claimed two other firstsin the oncology sector with Russian authorisations forbiosimilar bevacizumab and trastuzumab.

Ivanov said pioneering Acellbia as Russia’s firstbiosimilar had required extensive communication andcollaboration with the country’s regulatory authoritiesto establish a pathway. “The approach towards biosimilarapprovals in Russia has now been almost fully harmonisedwith European Medicines Agency (EMA) and WorldHealth Organization (WHO) guidelines,” he stated. “We

Russia’s Biocad is preparedto become a global playerWith dossiers filed for

its biosimilar monoclonal

antibodies in markets

around the world,

Russia’s Biocad is on its

way to becoming a

global player. Vice-

president of research

and development and

international business

development, Roman

Ivanov, talked to

Aidan Fry about the

company’s plans.

Roman Ivanov

15GeneRIcs bulletin13 January 2017

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have a biosimilarity concept that requires acomprehensive analytical comparability exercise,followed by pharmacokinetic comparability and clinicalconfirmation of safety and efficacy.”

“For the past year,” he continued, “we were the onlysupplier of rituximab to the Russian government.”Noting that rituximab was a special case in being fullyreimbursed through the federal government’s seven-drughigh-cost nosology programme, Ivanov said the arrivalof Biocad’s biosimilar had saved the government “asignificant amount of money” as Roche’s Rituxan/MabThera reference brand had been the highest costdrug supplied through the federal scheme.

Russian regulatory approval for biosimilarbevacizumab at the end of 2015 was followed by Biocadin June this year suing the originator in a New Yorkdistrict court over alleged “predatory pricing in Russia”for bevacizumab, trastuzumab and rituximab (Genericsbulletin, 24 June 2016, page 11). In particular, theRussian firm accused Roche and its affiliates anddistributors of abusing their dominant position, thusartificially creating a situation whereby Avastin(bevacizumab) was more than four-times cheaper inRussia than the US. This, Biocad claimed, formed partof Roche’s strategy to “destroy” the Russian firmand to “prevent it from entering the US market withcheaper biosimilars”.

Ivanov told Generics bulletin the bevacizumabprice erosion of almost 70% since biosimilar entry hadenabled the Russian authorities to treat more than four-times as many patients within the allocated budget.

Having launched its Herticad (trastuzumab)biosimilar shortly after its Russian approval early in2016 (Generics bulletin, 29 January 2016, page 13),Biocad had rapidly overtaken Roche’s Herceptinreference brand to capture a 54% market share in thefirst nine months of 2016 as price erosion for themolecule had settled at around 30%, he observed.

Acknowledging the potential for competition fromIndian biosimilar developers, Ivanov said Biocad hadnot yet seen any impact – or participation in governmenttenders organised by international non-proprietary name(INN) – from Dr Reddy’s Russian approval for itsReditux (rituximab) brand.

Reduced Russian oncology pricesCommenting on Biocad’s recent decision to cut

by up to 41% the firm’s maximum registered prices forseveral oncology drugs included on the official essentialdrugs list, Ivanov said the company had wanted to showwillingness to “supply products at prices much lowerthan those of the reference products”. The voluntary pricereductions – which drew praise from Russia’s FederalAntimonopoly Service (FAS) – did not necessarilytranslate directly to cuts in products’ net prices, he noted.

To support its oncology biosimilars portfolio andpipeline, Biocad has also built up an extensive arrayof small-molecule cancer treatments, as well as ofadjunctive therapies such as the antiemetic agent Avomit(granisetron). Among the company’s branded genericsare Cituvin (vinorelbine), Flugarda (fludarabine),Gemcitar (gemcitabine), Novotax (docetaxel) and Taxacad(paclitaxel), while Biocad also markets drugs such aszoledronic acid, bortezomib, carboplatin and oxaliplatin.

Noting that around 80% of Biocad’s sales camefrom biological drugs, Ivanov said the company derived

significant synergies from offering a small-moleculeoncology portfolio. “During the course of 2016, Biocadbecame the number one company in Russia in termsof sales of oncology products, surpassing Sanofi, Novartisand Roche,” he commented. Ever since launchingLeucostim (filgrastim) as its first oncology drug in 2006,the company had recognised the importance ofcomplementing its biological drugs with attractivesmall-molecule generics, he added.

Beyond cancer drugs, Biocad markets several anti-infective drugs including the Genferon range based oninterferon alfa-2b and the Algeron pegylated interferon-alfa that it launched in Russia for treating hepatitis Cin 2013. Among the firm’s antiretrovirals are emtricitabine,tenofovir and Zilacomb (lamivudine/zidovudine).

Biocad’s interferon beta-1a treatment for multiplesclerosis – which the company expects to launch in2017 – would “probably be the first and only biosimilarinterferon-beta to be developed in line with EMAguidelines”, Ivanov believed. While the market wasgradually shifting towards next-generation treatments,including oral therapies, demand for interferons inRussia remained strong, he observed.

The Russian company’s pipeline has also justdelivered approval for another injectable multiplesclerosis treatment, glatiramer acetate, as an alternativeto Teva’s Copaxone blockbuster (Generics bulletin,18 November 2016, page 19). Ivanov pointed out thatBiocad was vertically integrated from synthesisingthe active ingredient through to marketing.

Biocad is currently completing Phase III clinicaltrials for both darbepoetin and infliximab biosimilarsahead of planned regulatory filings in Russia duringthe first half of 2017, with the clinical data also slatedto support further submissions in other countries. “Inthe case of adalimumab, we have already selected thedelivery device to be supplied by a leading company,”Ivanov revealed. Through its ‘MabNext’ initiative,Biocad also has eight original mAbs currently in thelate stages of development.

Multi-centre clinical trials for the Acellbia rituximabbiosimilar are currently underway in Belarus, Colombia,

Figure 1: The location of clinical trials for several of Biocad’s biological and small-molecule pipelineproducts (Source – Biocad)

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GENERICS bulletin 13 January 2017

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India, Russia, South Africa and Ukraine, covering bothrheumatoid arthritis and non-Hodgkin’s lymphomaindications. Russia and Ukraine are hosting studies forenoxaparin, Extimia, infliximab and interferon beta-1a,while trials for capecitabine, fludarabine and temozolomidewere completed in India and Russia (see Figure 1).

Biocad is in the process of obtaining marketingauthorisations for Acellbia in Egypt, India, Uruguayand Vietnam, while it also expects authorisations for therituximab biosimilar in several other countries such asAlgeria, Pakistan, Sri Lanka, Syria and a dozen countriesthroughout Latin America.

The Russian company recently secured clearanceto participate in a Syrian public tender for rituximab,and has also just received good manufacturingpractice (GMP) certification from the Food and DrugAdministration in the Philippines.

Biocad described the Philippines, where it has alocal distribution agreement in place, as a “strategicallyimportant” market of around 100 million people thatoffered relatively high drug prices.

In the summer of 2016, an expert committee ofMorocco’s ministry of health approved two BiocadAPIs to be filled and finished at a local facility inCasablanca. In Sri Lanka, the Russian company hasachieved several court victories against Roche overbevacizumab and trastuzumab (Generics bulletin, 11November 2016, page 15).

Ivanov noted that while Biocad had expanded beyondRussia into other Commonwealth of Independent States(CIS) members, especially Belarus, the company wasworking actively on expanding globally in regions

including South-East Asia, China, the Middle East andNorth Africa, Latin America, North America andWestern Europe. This, he said, would enable Biocad tothus leverage purchasing, research and sales synergiesacross several continents.

“At the moment, we have our monoclonal antibodiesin the process of registration in more than 50 countriesacross the world,” Ivanov revealed. “The first sales havealready taken place in countries including Sri Lanka,Bangladesh and Vietnam. These are relatively smallmarkets, but taken together, emerging markets willcertainly contribute a lot to our revenues.”

Latin America, Argentina and Mexico are amongthe countries that Biocad is targeting for expansion.And in Brazil – where the Russian company alreadyhas a subsidiary office – the local regulatory agency,Anvisa, in 2015 issued a GMP certificate for producingthe bevacizumab, rituximab and trastuzumab monoclonalantibodies in Russia.

Ivanov said Biocad had already selected local andregional marketing partners in many of its target markets,based on their experience in both tender-driven sales andlocal regulatory processes. “There are a few regions inwhich we do not have deals agreed, such as in centralAfrica, and we do not have any binding agreements inplace in China,” he noted.

“Our goal is to generate at least 30% of our turnoverby 2020 from sales outside of Russia and the CIScountries,” he stated. “Depending on how successfulwe are with approvals in the larger markets of LatinAmerica and South-East Asia, we believe we couldhit that target sooner.” G

“At the moment, we

have our monoclonal

antibodies in the process

of registration in more

than 50 countries

across the world”

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