sandozand biocon strike global biosimilars alliance · 26january2018 sandozand biocon strike global...

26 January 2018

Sandoz and Biocon strikeglobal biosimilars alliance

COMPANY NEWS 2Alkaloid to invest in two production sites 2Celltrion profits from launch of rituximab 2Hospital groups plan to 3create a new firmTorrent buys way into 3controlled substancesDelta and Yicheng hit with warnings by FDA 4Farmak passes audit by Croatian agency 4Ipca acquires Pisgah in 5a US$9.65mn dealHermes to produce for Russia 5Jubilant builds space for tablets and APIs 6

MARKET NEWS 7US gives guidance on recalls and warnings 7Canada offers a trio of bio naming options 7Gottlieb assures GAO on 8complex guidanceUK has contingency for total split with EU 8AMR report depicts industry commitment10US federal shutdown 10limits FDA functions

PRODUCT NEWS 11Spain's Insud lifts bar 11to its NuvaRing rivalPTAB invalidates the last US Zytiga patent 11Mochida aims at first etanercept in Japan 13UK daptomycin order is 13affirmed on appealKorea's Alteogen to do 15aflibercept studiesAmgen and Allergan first with EU Avastin 15

REGULARSEvents – Our regular listing 6Pipeline Watch – Tigecycline 12Price Watch UK – Our regular listing 14People – Jubilant's Yadav is 16named Pharma chief

Issue No.338

Sandoz has formed an exclusive global alliance with Biocon to co-develop and market“next-generation biosimilars” in the immunology and oncology arenas. Neither the

number nor the identity of the targeted molecules have been disclosed, but Biocon said thepartnership covered “multi-billion dollar opportunities” through molecules in “early stagesof development”. The partners will “share responsibility for end-to-end development,manufacturing, and global regulatory approvals”, and will split costs and profits frommarketing the biosimilars equally.

“Worldwide commercialisation rights will be divided and each company’s strengths willbe leveraged within specific geographies,” the two firms stated. Sandoz will lead marketing inthe US, Canada and the European Union (EU), as well as in European Free Trade Association(EFTA) countries and Balkan states. Biocon will lead commercialisation in the rest of the world,including the “developed markets” of Australia and Japan, as well as Russia and the Commonwealthof Independent States (CIS). Intellectual-property and patent-litigation strategies would be “jointlydiscussed and driven”, Biocon told Generics bulletin.

“Together, we will be able to realise benefits at every stage of the value chain, fromdevelopment through manufacturing to commercialisation,” commented Carol Lynch, global headof Biopharmaceuticals for Sandoz. Biocon’s chairperson and managing director, KiranMazumdar-Shaw, insisted the “synergistic partnership will enable us to scale up our capabilitiesfor an ‘end to end’ play in the global biosimilars space”. The deal would, she said, allow thefirm to “move up the value curve” by holding both marketing authorisations and marketingrights under the partnership, including in highly regulated markets.

Furthermore, the alliance with Sandoz would take Biocon’s biosimilars pipeline and portfoliobeyond the near-term opportunities in monoclonal antibodies and insulin analogs covered by thefirm’s partnership with Mylan that was first formed in 2009 and expanded in 2013 (Genericsbulletin, 8 March 2013, page 19). The latest fruits of that collaboration are approvals oftrastuzumab in the US and Brazil (Generics bulletin, 12 January 2018, page 14). G

CPTPP deal drops IP increasesSeveral provisions that would have increased protection for intellectual property (IP) on

pharmaceuticals have been omitted from a Comprehensive and Progressive Agreementfor a Trans-Pacific Partnership (CPTPP) trade deal agreed by 11 countries on 23 January, andset to be signed on 8 March in Chile. The agreement struck in Tokyo, Japan, between ministersfrom Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singaporeand Vietnam includes an annex of suspended provisions – several of which cover IP rights forpharmaceuticals – that were included in the draft Trans-Pacific Partnership (TPP) text beforethe US pulled out of the trade deal last year. These include requirements for data exclusivityof “at least five years” for small molecules and “at least eight years” for biological drugs, aswell as patent-term extensions (Generics bulletin, 24 November 2017, page 1). All CPTPPmembers would have to agree to reinstate such measures for them to apply in future.

“Under CPTPP, there is no requirement for any party to change its data or market protectionsettings for new medicines, including small-molecule medicines, biological medicines andmedicines that contain a previously approved active ingredient,” explained New Zealand’sDepartment of Foreign Affairs and Trade. “There are no patent-term extension obligations,” itstated, adding that the country’s Pharmac drug procurement system was “fully protected”. G

STOP PRESSSeven key claims in US antibodies patent6,284,471 protecting Janssen’s Remicade(infliximab) are invalid due to obviousness-type double patenting, the US Court of Appealshas confirmed in upholding a decision madeby the US Patent and Trademark Office(USPTO) in re-examination proceedings.G

2 GENERICS bulletin 26 January 2018

COMPANY NEWS

South Korean biosimilars developer Celltrion more than doubledits operating profit to KRW517 billion (US$484 million) last year

as the company’s turnover rose by 43.5% to KRW829 billion, accordingto preliminary, unaudited annual results. The firm improved its operatingmargin by 18.6 percentage points to 62.4%.

Citing reasons for its higher sales, Celltrion said its Remsima(infliximab), or CT-P13, biosimilar had expanded its market sharein Europe. The company also benefitted from increased commercialsales of the rival to Janssen’s Remicade in the US, where Pfizer marketsthe biosimilar under the Inflectra brand name.

Furthermore, the Korean company noted, its marketing partnersin Europe had begun to roll out its CT-P10 rituximab biosimilar underbrand names including Truxima. This followed pan-European approvalfor the oncology and rheumatoid arthritis drug from the EuropeanCommission early last year (Generics bulletin, 3 March 2017, page 1).

Changes in product mix following the launch of Truxima, as wellas economies of scale due to the turnover growth, had improved thegroup’s profitability, Celltrion commented.

Celltrion’s performance in the fourth quarter of last year wasslightly behind its average over the full year. While its operating profitalmost doubled to KRW159 billion in the October-December period,sales advanced by a relatively muted 31.0% to KRW236 million.However, the firm’s operating margin rose by 23 points to 67.3%. G

ANNUAL RESULTS

Celltrion profits fromlaunch of rituximab

Alkaloid has commissioned two new production facilities in aninvestment worth over C2.5 million (US$3.1 million). The

Macedonian firm has completed construction of a production plant for semi-solid pharmaceutical forms – including ointments, creams, gels andvagitories – and a second “weighing” plant for monitoring and measuringactive substances and excipients, as well as packaging solid pharmaceuticals.

Together, the facilities cover a total area of 1,000 sq m. Theproduction plant – which covers 460 sq m and required spending ofC1.4 million – will enable “the complete process of scaling raw materials,preparing semi-products, and dosing and packaging of finished productsto take place”. Meanwhile, with a footprint of 240 sq m and an allocatedinvestment of C0.6 million, the weighing plant has a system that “servesto control, monitor and manage the process of measuring activesubstances” and solid forms. The C0.5 million packaging departmentcovers the remaining 300 sq m, and has two production lines – one forblister packaging and another for strip-packaging of solid-dosage forms.

Alkaloid said in 2018 it would “continue investing in productionfacilities and modern technologies”. Estimating full year 2017 sales ofC144 million, the firm anticipates 2018 sales reaching around C154

million. Alkaloid’s Pharmaceuticals division is expected to account for84% of sales, with the remaining 16% coming from the Chemistry,Cosmetics and Botanicals business. The Macedonian firm’s domesticmarket will account for 37% of sales, with exports making up 63%. G

MANUFACTURING/RESULTS FORECAST

Alkaloid to invest intwo production sites

3GENERICS bulletin26 January 2018

COMPANY NEWS

Five US healthcare organisations representing more than 450 hospitalshave announced plans to form a non-profit generics company, to

help address “generic drug market failures” and “stabilise the supplyof essential generic medications administered in hospitals, many ofwhich have fallen into chronic shortage”.

Among the collaboration of hospital groups is IntermountainHealthcare, a system of 22 hospitals and 180 clinics based in Salt LakeCity, Utah. It joins Ascension, SSM Health and Trinity Health, inconsultation with the US Department of Veterans Affairs, “the largestintegrated healthcare system in the country”. “Other health systems willsoon be joining this not-for-profit initiative,” Intermountain promised.

“The new company intends to be a US Food and DrugAdministration- (FDA-) approved manufacturer and will either directlymanufacture generic drugs or sub-contract manufacturing to reputablecontract manufacturing organisations,” noted Intermountain, “providingpatients an affordable alternative to products from generic drugcompanies, whose capricious and unfair pricing practices are damagingthe generic drug market and hurting consumers.”

In an interview with US news channel CNBC, Marc Harrison,president and chief executive officer of Intermountain, revealed thenew company had a list of around 20 existing drugs, in short supplyor too expensive, that it had identified as targets for generics. “Wethink it will be early 2019 before our first drugs come to market,”Harrison predicted. Intermountain forecasted the business would have“plenty of customers ready and eager for its products”.

Discussing financing of the project, Harrison said the organisationsinvolved – the US Department of Veterans Affairs aside – would make“a ‘donation’, although it really is not a donation, as over time thebusiness plan says we’ll get our money back and we’ll capitalise theorganisation that way”. The new company also hoped “to get theattention of philanthropists, who are sick of this activity as well, andwill help support us as we get started”, Harrison added.

“Many of the well-publicised problems in the US generic drugmarket can be attributed to a reduction in the number of suppliers,consolidation of production volumes, and a concentration of marketpricing power,” Intermountain summarised. “As has been widely reported,certain generic drug manufacturers have been widely criticised forunwarranted and arbitrary price increases, and for creating artificialshortages of vital medications.” Harrison acknowledged the newcompany was an “ambitious plan”, but opined the collaboration wouldbe “game-changing for the generic drug market”.

“We expect that the vast majority of drugs we buy will still comein the same channels we have always gotten. The majority of ourbusiness will stay exactly the same,” Harrison noted. “And we thinkmost generic drug manufacturers are doing a great job. We are onlyinterested in those organisations creating shortages and driving prices up.”

Guiding the new company will be an advisory committee comprisinga roster of “well-known experts from the pharmaceutical industry,business, and government”. This includes two retired former Amgenexecutives, Madhu Balachandran and Martin VanTrieste, former Centersfor Medicare & Medicaid Services (CMS) administrator Don Berwick,and ex-US senator Bob Kerrey. They will join Clayton Christensen,a professor at the Harvard Business School, in addition to “senior-level leaders” from the organisations founding the company.

“If the only way to provide our communities with affordable drugsis to produce them ourselves, that is what we will do,” they said. Gn [email protected]

BUSINESS STRATEGY

Hospital groups planto create a new firm

Torrent Pharmaceuticals has ventured into the US controlledsubstances sector by paying an undisclosed fee for local generics

and OTC player Bio-Pharm Inc (BPI). “This acquisition is an importantstep for increasing Torrent’s presence in the US, is consistent withour strategy of dosage-form diversification, and provides us with newcapabilities, including manufacturing and research and developmentpresence in the US,” the Indian company commented.

“Established in 1992,” Torrent explained, “BPI has a proven trackrecord in the research, development and manufacturing of oralsolutions, suspensions and suppositories.” In particular, the Indian firmpointed out that BPI’s 7,000 sq m facility at its headquarters in Levittown,Pennsylvania, had not only been approved by the US Food and DrugAdministration (FDA), it was also authorised to produce controlledsubstances within US Drug Enforcement Administration (DEA)schedules II to IV. Such products, Torrent observed, could only bemade in the US under government regulations.

To date, Torrent revealed, BPI had 10 abbreviated new drugapplications (ANDAs) approved by the FDA, and another 10 ANDAsunder review by the agency for the US firm and its partners. A further17 products are in development.

BPI – which is headed by its president, Umakant Shah – currentlymarkets a portfolio of prescription and OTC liquid products includingacetaminophen, cetirizine, diphenhydramine, guaifenesin, ranitidineand risperidone oral solutions, along with carbamide peroxide eardrops and oxymetazoline nasal spray. Furthermore, the US-based firmoffers alternatives to Anusol (hydrocortisone), Dulcolax (bisacodyl)and Preparation H (cocoa butter/phenylephrine) suppositories.

“Torrent plans further investments to expand the BPI facilities,including research and development capabilities, and will increase thenumber of product filings from BPI,” the Indian firm stated.

As of 30 September 2017, Torrent had 29 ANDAs pending FDAapproval. The company’s US turnover during the three months endedSeptember 2017 fell by a fifth to Rs2.55 billion (US$39.9 million), withthe firm acknowledging that sales had been impacted by “continuedprice erosion and customer consolidation”. G

MERGERS & ACQUISITIONS

Torrent buys way intocontrolled substances

Beximco Pharmaceuticals has acquired a majority 85.2% stake infellow Bangladeshi firm Nuvista Pharma for £18.2 million

(US$25.2 million). In early October last year, Beximco entered intoa non-binding memorandum of understanding with the hormone andsteroid drug specialist (Generics bulletin, 13 October 2017, page 3).

Nuvista – formerly part of Organon – has a local brandedpharmaceuticals manufacturing facility in Tongi, Dhaka, and also hasa “long-term manufacturing and marketing collaboration with MerckSharp and Dohme (MSD)”. According to Beximco, Nuvista had totalsales of BDT1.71 billion (US$20.6 million) in the year ended 30 June2017. Noting that the Nuvista deal “marked the first acquisition in thecompany’s history”, Beximco said Nuvista’s “unique portfolio of 50generic products complements Beximco’s existing product range”.

Having entered into share purchase agreements with six shareholders,Beximco said “the final consideration will be paid in cash on completionof the acquisition”, expected on or before 28 February. G


Beximco acquires Nuvista stake


COMPANY NEWS

[email protected]

Issue 338 l 26 January 2018

Director of Subscriptions: Val Davis Group Sales Manager: Rob Coulson

Awards Manager: Natalie Cornwell Production Controller:Debi Robinson

Production Editor: Jenna Meredith Managing Director: Philip Jarvis

l General enquiries: [email protected] l Subscription enquiries: [email protected]

l Editorial enquiries: [email protected] l Advertising enquiries: [email protected]

Editor: Aidan Fry

[email protected]

Deputy Editor: David Wallace

[email protected]

Assistant Editor: Dean Rudge

[email protected]

Business Reporter: Grace Montgomery

Terms & Conditions: See www.generics-bulletin.com/subscribe.While due care has been taken to ensure the accuracy of information contained in this publication,the publisher makes no claim that it is free of error and disclaims any liability whatsoever for anydecisions or actions taken as a result of its contents.

Published by OTC Publications Ltd, 4 Poplar Road, Dorridge, Solihull B93 8DB, UK.Tel: +44 (0) 1564 777550 Fax: +44 (0) 1564 777524Company registered in England No 02765878.© OTC Publications Ltd. All rights reserved.Generics bulletin® is registered as a trademark in the European Community.Printed by Warwick Printing Company Ltd. ISSN 1742-0784

Farmak has passed an inspection carried out by Croatia’s medicinesand medical devices agency, Halmed. In December last year, the

agency inspected Farmak’s conditions for the production of sterileand non-sterile medicinal products.

In 2015, Halmed conducted two inspections of the firm, whichresulted in “the issuance of appropriate certificates”. “The continuationof the good manufacturing practice (GMP) certificate…is a confirmationof the quality of the medicinal products manufactured by [Farmak], anda permit for their commercialisation on the market,” the agency stated.

Meanwhile, Farmak said that last year the company launched 21medicinal products, including its biosimilar Ilar (insulin glargine),Zipelor (benzydamine) and Diprofol (propofol). In addition, the firmsaid it had “about 125 projects in the pipeline”.

Furthermore, Farmak said it had, in total, invested over US$500million in its production facilities, including on equipment andmodernising the sites. “Currently,” the company noted, “there are 10large-scale capital investment projects at different stages of implementation.”

Stressing that the firm’s priority was to “increase our presence inother countries”, Farmak said this included “the development of exportpotential and expansion in Europe and other countries”. The companyalso plans to “pursue its active development and implementation ofinnovative approaches to production and management”. G

MANUFACTURING/BUSINESS STRATEGY

Farmak passes auditby Croatian agency

Grindeks says its key “strategic markets for business development”this year will be the European Union (EU) and South-East Asia.

The Latvian pharma producer is forecasting turnover growth of “atleast 10%” in 2018 as it looks to enter new markets and raise its exportvolumes to EU member states, the US, Canada, Japan and Vietnam.

The company – which will release its 2017 financial results on 28February – also intends to make “significant investments in development”and to respond to rising demand by boosting its production capacity.“This year, we will invest at least C7 million (US$9 million) in ourmanufacturing facilities in Latvia, Estonia and Slovakia,” revealedthe group’s chairman, Kirovs Lipmans. G

BUSINESS STRATEGY/RESULTS FORECAST

EU and Asia key for Grindeks

Australia’s Delta Laboratories and China’s Yicheng Chemical havereceived warning letters from the US Food and Drug Administration

(FDA) concerning their manufacturing facilities. Inspections at thesites found “significant deviations” from current good manufacturingpractice (cGMP), relating to finished-dosage forms and activepharmaceutical ingredients (APIs) respectively.

In March 2017, the FDA inspected Delta’s Australian plant inSomersby, New South Wales, and discovered that the firm had failedto investigate release and stability testing failures concerning twobatches of an undisclosed drug. “These product failures includedviscosity and appearance,” the FDA noted, including tubes swellingat the three-month stability time point – which could be indicative ofmicrobial growth and spoilage – as well as packaging defects. Theagency had already placed Delta on import alert in September last year.

Maintaining that Delta’s manufacturing processes “have not beenshown to be consistent and reliable”, the FDA said that “consequently,batches of your drug products are likely to significantly vary instrength, quality and purity”. “You did not have adequate stabilitydata to demonstrate that the chemical and physical properties of yourdrug products remain acceptable throughout the labelled expiry period,”the FDA told the firm. “Two lots reviewed during our inspection failedon stability at various tests and time points.” However, these lots weredistributed to the US, the agency pointed out.

Meanwhile, an inspection at Yicheng’s site in Changzhou, Jiangsu –which took place in July last year – found that the company failed topackage drugs under appropriate conditions to avoid potential cross-contamination. According to the agency, Yicheng weighed and repackagedtwo different API products “in the same room, using non-dedicatedequipment”. The firm said it would “designate a time to handle, re-packand re-label [the undisclosed API] in an area which would be cleanedbefore and after such operations”, but the FDA said “cleaning cannotsubstitute for proper segregation”. “Your current practices demonstratean unacceptably high risk of API cross-contamination,” it concluded.

Furthermore, Yicheng failed to keep repackaging batch records,and “lacked documentation or procedures to ensure that each batch canbe traced from your API suppliers, through your repackaging operations,and into commercial distribution”.

The FDA “strongly recommends” that both Yicheng and Delta engagea qualified consultant to assist them in meeting cGMP requirements. G

MANUFACTURING

Delta and Yicheng hitwith warnings by FDA


COMPANY NEWS

Teva plans to lay off more than 200 US workers at multiple locationsin the state of Pennsylvania by the end of this year.According to a notice filed with the Pennsylvania Department

of Labor and Industry, the Israeli firm – which has North Americanheadquarters in the North Wales borough of Pennsylvania’s MontgomeryCounty – will let go of 65 staff at locations in Horsham and NorthWales, 47 in West Chester and 96 at sites in Frazer and Great Valley,for a total of 208 workers.

The announcement comes weeks after Teva announced plans toreduce its global workforce by at least 14,000, or more than a quarterof its total staff, as part of a broader cost-cutting initiative (Genericsbulletin, 22 December 2017, page 1).

The leading generics company in North America, Teva employsmore than 6,500 people at more than 30 locations across the US andits territories. G

MANUFACTURING

Teva to lay off 200 in the US

JB CHEMICALS & PHARMACEUTICALS has received EuropeanUnion (EU) good manufacturing practice (GMP) clearance forits formulations facility in Panoli, India, from Malta’s medicinesauthority. This followed an inspection in September and Octoberlast year of the plant that makes tablets, capsules and oral liquids,as well as semi-solid products such as creams, gels and ointments.The site had already been approved by both EU and US authoritiesto make tablets.

STADA has struck a deal for early termination of a licenceagreement with Sanofi covering the German group’s Hedrin OTChead-lice treatment in Belgium, Portugal and Spain. Stada’s localaffiliates – Eurogenerics in Belgium, Ciclum Farma in Portugal andLaboratorio Stada in Spain – will market the OTC product under thenationally established Silikom, Piky and Neositrin brands names.“Hedrin is the group’s first truly pan-European product anddemonstrates the path we would like to take with other strongproducts such as Fultium, ViruProtect or Ladival,” explained Stada’schief executive officer, Claudio Albrecht, highlighting potential toexpand reach to the vitamin D, cold prophylaxis and suncare ranges.

STRIDES SHASUN has completed its acquisition of a controllingstake in South Africa’s Trinity Pharma. The ZAR55 million(US$4.33 million) deal for a 55% holding in the generics specialistwas announced at the end of last year (Generics bulletin, 12 January2018, page 3). The current management will continue to run thefirm under the supervision of Strides.

INFORMA – the parent group of Generics bulletin, Scrip andPink Sheet – has made an offer to acquire UBM, “the largestpure-play business-to-business events organiser in the world” andthe owner of the CPhI series of pharmaceutical industry trade fairs.If the cash-and-shares deal – valued at around £3.6 billion (US$5.0billion), and representing about a 30% premium to UBM’s closingshare price on 15 January – is completed according to the offer,Informa’s chief executive officer, Stephen Carter, will retain thesame role in the combined group.

ZYDUS CADILA says its active pharmaceutical ingredient (API)facility in Dabhasa, India, passed an inspection conducted by theUS Food and Drug Administration (FDA) this month withoutresulting in any ‘Form 483’ observations. The company also hasAPI plants in Ankleshwar and Navi Mumbai, India, as well as asite dedicated to bulk oncology agents in Ahmedabad, India.

INTREXON – the US-based biotech group – has raised gross proceedsof around US$86 million from a public offering of 6.90 millionshares at US$12.50 each. In the third quarter of last year, thecompany – which recently struck a deal with Arch Pharmalabs todevelop a fermentation-based active pharmaceutical ingredient (API) –posted a net loss of US$39.7 million on a turnover of US$46.0 million.

MOREPEN credited, in part, growth of around a quarter in its salesof bulk atorvastatin and montelukast for the Indian company’s totalnet sales rising by 1.9% to Rs1.40 billion (US$21.9 million) in itsfinancial third quarter ended 31 December 2017. Morepen – whichrecently received US Food and Drug Administration (FDA) approvalto supply bulk montelukast sodium to customers in the US – saidits total active pharmaceutical ingredient (API) turnover was stableat around Rs800 million, but sales by its finished-dose Formulationsunit fell by 5%. Among the drugs currently in the firm’s APIs pipelineare the diabetes drugs alogliptin and canagliflozin, as well asempagliflozin and vildagliptin. G

IN BRIEF

Ipca Laboratories has through its subsidiary Onyx Scientific acquiredchemistry solutions provider Pisgah Labs for US$9.65 million. Ipca

said the share-purchase agreement for a 100% holding in Pisgah wouldenable the Indian firm to “establish a foothold in the US market in thefield of contract research”.

Originally founded in 1981 as a contract manufacturer anddeveloper of active pharmaceutical ingredients (APIs) and intermediates,Pisgah has been a chemistry solutions provider for over three decades.Ipca observed that Pisgah had total sales of US$2.89 million in theyear ended 30 April 2017, and earnings before interest, tax, depreciationand amortisation (EBITDA) of US$1.14 million.

Stating that Ipca had a “strong thrust on exports, which nowaccount for nearly 47% of the company’s outcome”, the Indian firm –which has struggled to comply with US manufacturing standards – saidPisgah would continue to operate out of its facility in North Carolina.

“Onyx and Pisgah’s capabilities in chemistry services will dovetaileffectively with the company’s capabilities in supporting Phase II tocommercial-scale programmes,” Ipca stated, “and also enable thecompany to manufacture small-volume APIs for the US market.” G


Ipca acquires Pisgahin a US$9.65mn deal

Hermes Pharma’s two production plants in Wolfratshausen, Germany,and Wolfsberg, Austria, have been deemed compliant with good

manufacturing practice (GMP) following inspections by Russianauthorities. As a result, both facilities are now authorised to manufacturegranules and lozenges, as well as effervescent and chewable tablets.

The Wolfratshausen plant – which has a footprint of 12,400 sq m –is optimised for producing moisture-sensitive effervescent tablets, andmanufactures 800 million effervescent and chewable tablets annually.Meanwhile, the Wolfsberg facility covers an area of 12,500 sq m,encompassing an 8,000 sq m clean room and a fully automatedhigh-rack warehouse. G

MANUFACTURING

Hermes to produce for Russia


COMPANY NEWS

12-14 Februaryn Access! 2018 – AAM Annual Meeting

Orlando, USAThis event, organised by the Association for AccessibleMedicines, will look at regulatory topics and the challengesfacing the US generics industry.

Contact: Association for Accessible Medicines. Tel: +1 202 249 7100.E-mail: [email protected]. Register online atwww.accessiblemeds.org/events.

27-28 Februaryn 12th Biosimilars Congregation 2018

London, UKTopics covered at this event include strategies for market access,interchangeability, and regulatory issues. Speakers during this two-day conference will include representatives from Fresenius Kabi,Glenmark, Lupin, Teva and Wockhardt, as well as Generics bulletineditor Aidan Fry.

Contact: Virtue Insight. Tel: +44 203 6120 886.E-mail: [email protected]: www.virtueinsight.com/pharma.

5-6 Marchn EuroPLX 66

Lisbon, PortugalThis two-day meeting provides an opportunity to discuss andnegotiate agreements, development, in-licensing and marketing,promotion and distribution.

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

25 Apriln 14th Legal Affairs Conference

London, UKThis one-day conference organised by Medicines for Europe willcover legal and intellectual-property developments regardinggenerics and biosimilars. This event will be followed by the 16thBiosimilar Medicines Conference, at the same venue.

Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.medicinesforeurope.com/events.

26-27 Apriln 16th Biosimilar Medicines Conference

London, UKThis Medicines for Europe conference will look at the latestregulatory topics, market access and procurement and internationaldevelopments within the biosimilars industry. There will also benetworking opportunities at this event.

Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.medicinesforeurope.com/events.

EVENTS – February, March, April

SAVE THE DATE...Tuesday 9 October 2018, Madrid, Spain

Jubilant Life Sciences’ Jubilant Pharma business is increasingmanufacturing capacity for solid-dosage formulations “to meet

increasing requirements” in the US, European Union (EU) andadditional global markets, one of several strategic moves announcedby the Indian player as it reported “record” financial results for itsfinancial third quarter ended 31 December.

The expansion work is to be completed in the firm’s next financialyear ending 31 March 2019, according to Jubilant. Two of JubilantPharma’s six manufacturing facilities cater to finished-dose formulations –in Roorkee, Uttarakhand, India and Salisbury, Maryland, US – bothof which are approved by the US Food and Drug Administration (FDA).

Meanwhile, Jubilant noted that it had during its third quartercompleted adding capacity in its active pharmaceutical ingredient (API)manufacturing facility in Nanjangud, Karnataka, India, “to meet higherdemand going forward”, while the Nanjangud site had during the quarterbeen jointly inspected by the FDA and Health Canada. “[Jubilant]received a compliant rating from Health Canada,” noted the firm.

Further strategies include increasing lyophilisation capacities inthe firm’s allergy-therapy and contract manufacturing organisation(CMO) businesses, as well as a “ramp up” in orders for the latterorganisation, totalling US$693 million and the addition of “three newclients during the year”.

Jubilant’s plans came as the firm reported Pharmaceuticals sales thatleapt by more than two-fifths to Rs11.0 billion (US$172 million). Thiswas due entirely to North American turnover surging by 73% to Rs9.15billion (see Figure 1), after Jubilant acquired the US radiopharmacybusiness of Triad Isotopes, a US$225 million operation, from 1 September.

Broken down by product category, Jubilant’s non-injectableGenerics sales fell by a tenth to Rs3.12 billion, “mainly due to continuedpricing pressure in the US market”, the firm noted. However, this wasmore than rescued by Specialty Pharma Injectables sales rising by 81%to Rs7.89 billion – the “highest ever”, Jubilant noted – followingthe Triad purchase.

In total, Jubilant’s sales rose by 42% to Rs20.7 billion, including asurge in the Life Science Ingredients business. The firm’s grouppre-tax profit leapt by 57% to Rs2.61 billion, bolstered by lower financecosts year-on year, giving a pre-tax margin of 12.6%.

“We continue to reduce debt levels through internal cash generationfor a strong balance sheet,” commented Jubilant. Gn [email protected]

BUSINESS STRATEGY/THIRD-QUARTER RESULTS

Jubilant builds spacefor tablets and APIs

North America 9,150 +73 –Europe/Japan 850 -38 –India 340 -8 –Rest of World 660 -16 –Pharmaceuticals 11,010 +41 22.2

Life Science Ingredients 9,220 +46 22.3

Drug Discovery Solutions 450 +2 7.0

Jubilant Life Sciences 20,680 +42 20.8**

* rounded to the nearest Rs10 million ** includes acquisition-related costs of Rs110 million

Figure 1: Breakdown by region and business segment of Jubilant Life Sciences’sales and earnings before interest, tax, depreciation and amortisation (EBITDA)margin in its financial third quarter ended 31 December 2017 (Source – Jubilant)

Third-quarter sales Change EBITDA(Rs millions*) (%) margin (%)


MARKET NEWS

Three proposed options for naming biological drugs, includingbiosimilars, have been outlined by Health Canada and the Institute

for Safe Medication Practices Canada (ISMP Canada), as part of astakeholder consultation that is running until 9 February 2018. Theobjective of the consultation – which takes the form of a questionnaire –will be to “gain insight into stakeholder views on the practical impactsof different approaches to the naming of biologic drugs and biosimilarsthroughout the medication-use process, including prescribing, dispensing,and adverse drug reaction reporting”.

The first option offered by the questionnaire – the ‘status quo’option – is to continue the current Canadian drug identification andnaming approach, under which biosimilars, reference biologics andinnovator biologics that share the same non-proprietary name can bedistinguished by their unique brand names or drug identification numbers(DINs), with only the non-proprietary name used in some settings.

Option two set out by the consultation is to use the brand namewith the non-proprietary name to distinguish among biologics. “Bothbrand and non-proprietary names would be used,” ISMP Canadaexplains, “so biosimilars, reference biologics and innovator biologicsthat share the same non-proprietary name would be distinguished bytheir unique brand names”. Under this scenario, new guidelines wouldbe provided on “the importance of using both the brand name andnon-proprietary name in prescribing, dispensing, administration anddocumentation, including adverse reaction reporting”.

Finally, the third option is to implement a four-letter suffix to thenon-proprietary name, similar to the system introduced in the US.“All biologic drugs – including biosimilars, reference biologics andinnovator biologics – would receive a unique, meaningless four-lettersuffix appended to the non-proprietary name.”

Guidelines would be provided to support this third option, whichISMP Canada said would be “developed to align with the US Food andDrug Administration’s (FDA’s) suffix-based naming convention asmuch as possible”. Moreover, “a resolution would be found to matchsuffixes where biologics or biosimilars are submitted for authorisationto Health Canada before the FDA”. A question within the consultationasks whether such a system should also be applied retrospectively.

Several factors should be considered by respondents to thequestionnaire, ISMP Canada urges. These include “how you currentlyidentify biologics in your practice or environment”, as well as the needfor a naming approach that accurately identifies biologics throughoutthe process of using a medication – including prescribing, dispensing,and administration and documentation issues.

Respondents should also consider how to ensure patients receivethe drug intended by the prescriber and the prevention of medicationerrors, ISMP Canada suggests, as well as the need for accurate attributionand reporting of adverse events for safety-monitoring purposes.

Barriers to compatibility with drug information systems anddatabases – such as character limits for name length, or the ability toenter names in multiple fields – should also be considered, along with“the impact of implementing each naming approach, including changesthat would be needed by various stakeholders, along with associatedresource and time requirements”.

Results of the consultation would be used to understand the impactof the three approaches and gain insight into stakeholder perspectives,ISMP Canada explained. The consultation will “inform Health Canada’spolicy decision on a naming convention for biologic drugs”. Gn [email protected]

REGULATORY AFFAIRS

Canada offers a trioof bio naming options

Draft guidance on public warnings and notifications of recalls hasbeen published for comment by the US Food and Drug

Administration (FDA). “Specifically,” explained FDA CommissionerScott Gottlieb, “the draft guidance outlines circumstances when acompany should issue a public warning about a recall, describes thegeneral timeline for companies to issue such a warning, discusses whatinformation should be included in a public warning, and describessituations where the FDA may take action to issue its own publicwarning should a company’s warning be deemed insufficient.”

Calling the draft guidance “a key step to enhance the recall process”,Gottlieb said it was intended to “give industry clear direction on howto navigate and work with the FDA to make sure that recalls arecommunicated promptly”.

“FDA’s policy is to evaluate the particular circumstances of eachindividual recall in determining whether a public warning is needed,”the draft guidance notes, “as part of the recall strategy”. The agencymay issue a public warning or notification before formally classifyinga recall, it observes.

‘Urgent situations’ require warningsPublic warnings are “for urgent situations”, the guidance states,

such as “for urgent recalls of prescription drugs or medical deviceswhen retail-level consignees cannot identify persons to whom the drugor device was dispensed”. However, when recalled products have onlybeen distributed to direct accounts, “a prompt and initial oralcommunication to such accounts informing them of the recall maybe adequate”. The FDA assesses the need for public warnings basedon the particular circumstances of the recall.

While the FDA “generally gives firms the first opportunity toprepare and issue public warnings during recalls” – and expects firmsto develop their own recall strategy – the agency reviews and commentson such strategies, and may supplement company warnings with theagency’s own public statement “if necessary”. If a company does notinclude a public warning that the FDA believes is appropriate, theagency “will generally request one from the recalling firm”.

“Public warnings should not contain content that detracts fromor defeats the purpose of the warning,” the guidance instructs. “Briefand succinct warnings are generally better at informing consumers of aproduct hazard.” Messages that “cloud or lengthen” a warning maydistract a consumer “and should be avoided”, as should any promotionof the qualities of the product being recalled. Also, phrases that can beseen as trying to minimise a hazard – such as “an abundance of caution” –should not be used in cases such as a drug resulting in illness or injury.

“A public warning may be considered deficient if, among otherthings, it does not adequately describe the recalled product, describethe health hazard involved, or identify relevant information aboutthe product’s distribution,” the guidance states. Factual statementsthat are unable to be verified by the FDA may also lead the agencyto issue a separate public warning.

On methods of distributing warnings, the FDA says it is “open todifferent vehicles of dissemination that best convey the informationof the particular recall”, noting that the agency and industry havehistorically used general, as well as specialised, news media, “forexample professional or trade press, among other means”. The FDAprovides public access to information on recalls by posting a listing ofrecalls according to their classification in the FDA enforcement report.Gn [email protected]

REGULATORY AFFAIRS

US gives guidance onrecalls and warnings


MARKET NEWS

The US Food and Drug Administration (FDA) is “actively working”towards announcing plans to issue or revise guidance for complex

generics, FDA Commissioner Scott Gottlieb has reassured the USGovernment Accountability Office (GAO). A GAO report had urgedthe agency to “increase transparency” by revealing details of any plansthat will affect such guidance within the next year.

In its report – titled ‘FDA should make public its plans to issueand revise guidance on non-biological complex drugs’ – the GAOobserves that, while the FDA publishes a list of possible topics forguidance development or revision for the next year, this list of forthcomingguides does not include product-specific guidance documents.

“The lack of advance communication on guidance issuance andsubsequent revisions can create setbacks for generic drug sponsors,”the GAO insisted. “It may take considerable time, effort and otherresources for them to update their applications to market a generic drugin response to unexpected changes in guidance.” This, the GAO warns,“could delay or prevent the entry of some generics to the market”.

Based on interviews with 19 industry stakeholders – comprising10 ‘generic sponsor representatives’ and four ‘external expert groups’,as well as five ‘brand sponsor representatives’ including Teva – theGAO concludes that the FDA Commissioner “should, in order toincrease transparency, publicly announce the agency’s plans for issuingnew product-specific guidance for a drug that is non-biological andcomplex within the next year”, along with any planned “significantrevisions” to existing guidance.

In a response contained within the GAO report, the US Departmentof Health and Human Services (HHS) comments that “the HHS concurswith the GAO’s recommendation and will identify the most appropriatemechanism to notify the public” of new product-specific guidanceand planned revisions “that may be issued in the next year”. And afterthe publication of the report, Gottlieb released a further statementindicating that “we agree with the GAO’s recommendation and theFDA is actively working to accomplish this goal through new policiesthat are already underway”.

Following the announcement of its drug competition action planlast year (Generics bulletin, 2 June 2017, page 1), the FDA had“advanced many policies aimed at making it easier to bring genericcompetition to complex drugs”, Gottlieb pointed out, adding that theagency was “currently undertaking an economic analysis to evaluatethe impacts of our policies and to guide further policymaking”. “We willrelease the results of this analysis as soon as they are available,” he said.

Moreover, under the second generic drug user fee amendments(GDUFA II) the FDA would “focus resources specifically intended toaid generic drug developers of complex products”. “We are working todevelop additional guidance for industry with the aim of clarifying‘sameness’ requirements for ANDAs,” Gottlieb explained, suggestingthat “this guidance may be particularly helpful for complex generics,including specific guidance on drug-device combination products”.

“We are looking for ways to maximize scientific and regulatoryaccuracy with respect to complex generics,” he insisted, pointing outthat “to date, we have published 1,541 product-specific guidances with130 in 2017 alone”, 47 of which were specific to the development ofcomplex generics. “We believe that the publication of 1,541 product-specific guidances since 2007 has been a valuable resource welcomedby the generic industry,” Gottlieb concluded. “We believe the incrementalsteps outlined by the GAO will also be beneficial.” Gn [email protected]

REGULATORY AFFAIRS

Gottlieb assures GAOon complex guidance

Principles that will govern the UK medicines framework after thecountry’s ‘Brexit’ departure from the European Union (EU) in the

event of no ongoing relationship with the European Medicines Agency(EMA) network have been outlined by the UK Medicines and Healthcareproducts Regulatory Agency (MHRA).

“Companies have been asking for detail about UK legislativerequirements in different scenarios,” the regulator acknowledged. “TheMHRA is aware that companies who market pharmaceuticals in theEU and UK will need to plan and make decisions in advance of theUK’s departure from the EU in March 2019.”

Guidelines adopted by the European Council – after it agreed latelast year to move on to the second phase of UK-EU negotiations overBrexit – “acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EUrules and regulations,” the MHRA noted. “The aim is for access to oneanother’s markets to continue on current terms throughout this period.”

Both the UK and EU “recognised the importance of such a periodin the interests of providing certainty and continuity to businesses andindividuals”, the MHRA emphasised. “The UK expects to be able torapidly agree the detail with the EU in 2018.”

Insisting that the guidelines “reconfirm the EU’s desire to establisha close future partnership with the UK”, the MHRA said the UKremained “fully committed to continuing the close working relationshipwith its European partners, in the interest of public health and safety”.

Four principles guide MHRAHowever, in the event that no implementation period is agreed and

there is “no ongoing relationship with EMA networks”, the MHRAsaid its approach would be guided by four principles: that there wouldbe “no sudden changes to the UK regulatory framework” as EUlegislation was converted into UK law at the moment of exit; that theMHRA would be “pragmatic” in establishing UK regulatory requirementsand would give “adequate notice” to firms to allow sufficient time toimplement any changes; that the agency would make use of existinginformation to complete administrative tasks for continuity of workand licences; and that “we would ensure the minimum disruption andburden on companies as the UK exits the EU, while building on theexisting relationship between MHRA and firms”.

In the case of products already in circulation before the official UKwithdrawal date, the MHRA noted, a joint report on progress madein the Brexit negotiations “makes clear that goods placed on the marketunder Union law before the withdrawal date may freely circulate onthe markets of the UK and the Union, with no need for productmodifications or re-labelling”.

“We will continue to engage with business, patient groups andother stakeholders to help plan ahead with certainty,” the MHRAconcluded, “and will look to publish more technical detail if appropriate.”

Calling the MHRA’s statement a “welcome update”, local brandindustry body ABPI nevertheless said that plans for the possibility ofno ongoing relationship “require further detail, and further highlightwhy a realistic implementation period needs to be urgently agreed”.The British Generic Manufacturers Association (BGMA) has alsourged the agreement of transitional arrangements, and has consistentlycalled for the UK and EU to find a way of maintaining the benefits ofa single European regulatory system for medicines (Generics bulletin,22 December 2017, page 4). Gn [email protected]

REGULATORY AFFAIRS

UK has contingencyfor total split with EU

In the market for a CMO partner?

Well if your molecule is sellingfor peanuts, we may not bethe right shop for you ...

But if you are looking for a stronger partner worth theirweight in value, contact your new partner,Chartwell:

■ Flexibility and speed in turnaroundand cycle time

■ Long history of quality and complianceexcellence

■ Creative business approaches ensurereal value for all

■ Import alerts a concern?We areproudly based in the USA

■ Manufacturing capability for complexand creative products

■ Relentless attention to customers’ andpartners’ detailed needs

■ Partner with us and consider our plantand professionals like your own

Contact:Lance Kann,

Senior EVP, Corporate DevelopmentChartwell Pharmaceuticals LLCTel: +1 845 268 5000 x506

[email protected]

Chartwell F.Pg 15-1-18.indd 1 15/01/2018 09:26


MARKET NEWS

Medicines for Europe is among the healthcare industry stakeholderswho have welcomed the first report on antimicrobial resistance

(AMR) by the AMR Industry Alliance, which “brings together over100 biotech, diagnostics, generics and research-based biopharmaceuticalcompanies and trade associations from 20 countries” and shows that“broadly the Alliance membership is already active and making positivecontributions to the challenge of AMR”.

Adrian van den Hoven, director general of Medicines for Europe,said the report was a “key milestone in cementing industry commitmentto tackling this global challenge in a collaborative manner”. Insistingthat “the right balance should be found between facilitating accesswhile ensuring appropriate use”, van den Hoven said “this can onlybe achieved by multiple stakeholders working together to define theprinciples of appropriate use”.

“Patients who need antibiotic medicine should be able to haveaccess to the appropriate treatment they need to get better,” van denHoven insisted, while “equally, medical professionals need to be ableto choose from a wide range of antibiotics to provide optimal treatmentfor their patients”. “The AMR Industry Alliance – and Medicines forEurope as a member – is committed to being part of this dialogue, andtaking action which we hope will change the tide on AMR.”

Data and case studies in the report highlight the “practical steps”that members are taking to respond to AMR in the areas of research,science, access, appropriate use and the environment. On access, theAMR Industry Alliance said, many generics firms – as well asoriginators – with AMR-relevant products “believe more work is neededto determine how to balance expanding access with appropriate use,reduce falsified products, and work with other stakeholders to addressaccess issues in low- and middle-income countries”.

Noting that the report had aggregated data from 36 companies“from all four categories represented in the alliance” – research-based,generics, diagnostics and small-to-medium-sized enterprises (SMEs) –the Alliance said that half of the generics firms concerned, or three outof six generics companies, had provided input for the report. All 11research-based firms contributed, along with five of 15 diagnosticsmembers and 17 out of 68 SMEs.

“The Alliance is committed to reporting progress every two years,”it stated. “It is also dedicated to refining its approach to better addressthe challenges for its members in responding, so that it can achievegreater participation than seen in this first report.” G

INDUSTRY ASSOCIATIONS

AMR report depictsindustry commitment

Regulatory submissions to the US Food and Drug Administration(FDA) requiring a fee payment were not able to be accepted during

the “lapse period” resulting from the recent US federal ‘shutdown’,the agency has confirmed.

“During the lapse period, the FDA [did] not have legal authorityto accept user fees assessed for FY2018”, the agency said, referringto the US financial year ending 30 September 2018. The FDA was notable to resume accepting such fees “until an FY2018 appropriationfor the FDA [was] enacted”.

A continuing resolution was agreed by the US Senate on 22January that extends federal funding until mid-February.

Acknowledging that “only some of our work is permitted tocontinue during a lapse in funding” the FDA noted that during such aperiod “agency operations continue to the extent permitted by law,such as activities necessary to address imminent threats to the safety ofhuman life and activities funded by carryover user-fee funds”.

“Vital activities” that were able to be maintained by the agencyduring the shutdown include: maintaining core functions to handleand respond to emergencies, such as outbreaks of foodborne illnessor ‘flu; supporting high-risk product recalls when consumers wereendangered; pursuing criminal and certain civil investigations whenpublic health is at risk; screening products imported to the US; andaddressing other “critical public-health issues”. G

REGULATORY AFFAIRS

US federal shutdownlimits FDA functions

Approvals for hybrid 505(b)(2) applications in the US “rosedramatically” in 2017, “from 45 approvals in each of the last two

years to an all-time high of 63” in 2017, according to data from hybrid505(b)(2) consultancy Camargo.

Noting that the median review time for the 63 approvals was 10.0months, Camargo pointed out that this was shorter than the 12.5 medianreview time for approvals from 2012 to 2016.

Four 505(b)(2) applications designated for priority review hadreview times of six months or less, while 14 had review times greaterthan 13 months. “In all, there were 13 priority review products and16 orphan designated products,” Camargo noted. G

MARKET RESEARCH

Hybrid approvals more rapid

Parties renegotiating the North American Free Trade Agreement(NAFTA) between Canada, Mexico and the US, must “reject any

provisions that would expand or strengthen pharmaceutical monopoliesand enforcement at the expense of access to affordable medicines”,according to an open letter published by interest groups including Oxfam,Public Citizen, HealthGap, and the Canadian HIV/AIDS Legal Network.

“We have heard troubling reports that the negotiating parties areconsidering changes to NAFTA’s intellectual-property (IP) chapterthat would further expand the monopoly protections of prescriptiondrug corporations,” the letter states, while lobbyists were also urgingrestrictions on governments’ rights to control pricing and reimbursement.And there were “pressures from business lobbies to maintain investor-state dispute settlement, including with respect to IP-related investments”.

“All of these measures would contribute directly to escalatingconsumer prices and worse access to treatment in Canada, Mexicoand the US,” the letter insists. Enhanced protections for pharmaceuticalsurged by the US during Trans-Pacific Partnership (TPP) negotiationshad been “universally unpopular” and were “fiercely resisted bynegotiators from other TPP countries, ultimately dragging out the TPPnegotiation for years and contributing directly to its failure”.

“Whatever other goals the Canadian, Mexican and US governmentshave for NAFTA’s renegotiations, it is critical to do no further harmwith respect to health and access to affordable medicines,” the letterconcludes. Thus, any IP chapter should avoid “greater monopolies” onpatentability standards and patent disclosure; data and market exclusivity,for both small molecules and biologics; patent registration and linkage;mandatory patent-term extensions; and enforcement, including ruleson damages, injunctions and border controls. G

INTELLECTUAL PROPERTY

NAFTA must not harm access


PRODUCT NEWS

The US Patent and Trademark Office’s (USPTO’s) Patent Trial andAppeal Board (PTAB) has cleared the path for generics of Janssen’s

Zytiga (abiraterone acetate) blockbuster to reach the market as earlyas September this year, after invalidating a key patent shielding theprostate-cancer treatment.

After instituting inter partes reviews of claims 1-20 in UScomposition and method-of-use patent 8,822,438, the PTAB issuedthree final written decisions – two consolidated and one standalone –determining the petitioners had shown by a “preponderance of evidence”that all 20 claims were unpatentable over certain prior-art documents.

Petitioners in the case included Amerigen, Argentum, Mylan,Wockhardt, and Teva and its Actavis business, as well as Amneal,Dr Reddy’s, Sun, and Hikma and its West-Ward subsidiary. As Genericsbulletin went to press, the US Food and Drug Administration (FDA)had issued no tentative or final approvals for Zytiga abbreviated newdrug application (ANDA) products.

The ‘438 patent is the sole unexpired Zytiga patent listed in theFDA’s Orange Book, set to expire on 24 August 2027. Zytiga’s US saleswere US$826 million in the first nine months of last year, and US$1.75billion globally, according to Janssen parent Johnson & Johnson (J&J).

Responding to the PTAB’s decision, J&J said it “stronglydisagreed” and was “evaluating our options with respect to a requestfor rehearing and/or appeal to the Court of Appeals for the FederalCircuit”. “We believe the ‘438 patent is valid and will continue tovigorously defend it,” the originator insisted.

In reaching its final written decisions, the PTAB favoured evidenceprovided by the generics firms showing that it would have been “obviousto the ordinary artisan at the time of invention” to combine prior-artdocuments – including articles from The Journal of Urology from1990 and the British Journal of Cancer from 2004 – with a “reasonableexpectation of success of achieving the method of challenged claim 1”.

Claim 1 is the only independent claim of the ‘438 patent, whichdescribes the administration of a CYP17-inhibitor, such as abirateroneacetate – “useful in the treatment of cancer, specifically, androgen-dependent disorders like prostate cancer” – with “at least one additionaltherapeutic agent”, including certain anti-cancer agents and steroids.Claim 1 specifically names prednisone as the additional therapeutic agent.

According to a J&J filing from late last year, the originator hasongoing patent-infringement proceedings involving the ‘438 patentagainst more than a dozen ANDA filers.

A case involving the majority of filers in a New Jersey districtcourt – including Actavis, Amneal, Apotex, Citron, Dr Reddy’s andMylan, as well as Par, Sun, Teva, Wockhardt, Hikma and West-Ward –previously scheduled for October last year has been postponed pendingcontinued pre-trial activities through the first quarter of 2018.

Meanwhile, J&J has also filed suit against Amerigen andGlenmark in a New Jersey district court, and has an additional suitagainst Teva in the same court.

The 30-month stay on ANDA approvals for Zytiga generics expireslater this year, on 24 September for Argentum and on 28 Octoberfor certain other ANDA filers, according to a letter filed by lawyersrepresenting Mylan to New Jersey District Judge Kevin McNulty onthe day the PTAB decisions were announced. “Defendants in this casehave raised, among others, the same three invalidity grounds thePTAB found sufficient to invalidate the claims of the ’438 patent,”the lawyers pointed out.n [email protected]

ONCOLOGY DRUGS

PTAB invalidates thelast US Zytiga patent

Insud Pharma and its Exeltis subsidiary have succeeded in removinga injunction preventing the Spanish firm from marketing locally its

Ornibel (ethinylestradiol/etonogestrel) alternative to Merck, Sharp &Dohme’s (MSD’s) NuvaRing.

In September last year, MSD obtained an ex parte preliminaryinjunction in Spain, which temporarily blocked Insud from marketingthe contraceptive vaginal ring in the country. However, that preliminaryinjunction has now been overturned by a commercial court in Barcelona.Arguing that the injunction imposed on Ornibel in Spain was“unwarranted”, Insud insisted that it would “continue to vigorously contestfurther attempts to inhibit the marketing of its product across Europe”.

Ornibel – which has an “innovative design” in the form of a “newpolymer composition” – is manufactured by Insud’s Spanish subsidiaryLeon Farma, and has been marketed “in Spain and across multiplecountries in Europe”, where it had been “well accepted by gynaecologists,pharmacies and users”, Insud said.

Insud – until late last year known as Chemo Group – recentlyintegrated its three areas of business under a single umbrella (Genericsbulletin, 1 December 2017, page 3). Exeltis is the branded sales andmarketing arm, while Chemo, the group’s industrial division, developsand manufactures finished dosage-forms and active pharmaceuticalingredients (APIs). The third division, mAbxience, specialises inbiosimilar monoclonal antibodies. G

CONTRACEPTIVES

Spain’s Insud lifts barto its NuvaRing rival


PIPELINE WATCH

Figure 1: Molecules for which supplementary protection certificates (SPCs) expirein certain markets in January and February 2018 (Source – Ark Patent Intelligence)

Figure 2: Molecules for which data exclusivity expires in certain markets duringJanuary and February 2018 (Source – Ark Patent Intelligence)

This monthly update of key patent, SPC and data exclusivity data is extracted from IQVIA’s Ark Patent Intelligence Expiry Database.Covering 130 countries and over 3,000 INNs, Ark Expiry Database contains watertight data teamedwith the ultimate in generic launch analysis.For further information, visit www.arkpatentintelligence.comor e-mail: [email protected].

February 2018 will bring the expiry of six-month paediatric extensionsto supplementary protection certificates (SPCs) granted in several

European Union (EU) member states for Pfizer’s Tygacil (tigecycline)antibiotic. For example, in the UK, the extension to an SPC filed byPfizer’s Wyeth affiliate that references European patent EP0,536,515ends on 20 February this year, and Tygacil faces similar ends to SPCsin Austria, Belgium, Denmark, France, Germany, Greece, Ireland andItaly, as well as in Luxembourg, the Netherlands, Portugal, Spain andSweden. European data exclusivity for Tygacil powder for infusionexpired in April 2016 (Generics bulletin, 22 April 2016, page 12).

Pfizer reported third-quarter Tygacil sales in its Developed Europeregion – Western Europe, Scandinavian countries and Finland – aheadby 8% to US$20 million, making the treatment for complicated intra-abdominal, skin and soft-tissue infections the only major brandwithin Pfizer’s Sterile Injectable Pharmaceuticals (SIP) business unitto grow in the region. In September last year, Accord Healthcarewithdrew its application to the European Medicines Agency (EMA)for a pan-European centralised approval for tigecycline 50mg vials,citing not only a lack of good manufacturing practice (GMP) complianceat a site producing the active substance, but also the “company’smarketing strategy” (Generics bulletin, 22 September 2017, page 13).

Global third-quarter sales of the injectable antibiotic for Pfizerdipped by 12% to US$60 million, largely by virtue of turnover in theUS sliding by nearly two-thirds to US$9 million. Fresenius Kabiclaimed towards the end of 2016 to have become the first company tooffer an alternative to Tygacil in the US by introducing 50mg/10mlsingle-use vials authorised through the hybrid 505(b)(2) regulatorypathway (Generics bulletin, 8 December 2016, page 13). In grantingapproval for Kabi’s version, the US Food and Drug Administration(FDA) noted that the injectables specialist had reached a patent-litigation settlement with Pfizer over US formulation patent 7,879,828and polymorph patent 8,372,995 that expire in February 2029 andOctober 2030 respectively.

Sandoz holds abbreviated new drug application (ANDA) approvalfor tigecycline 50mg vials, while Pfizer has reached settlements overthe formulation and polymorph patents with Accord and Mylan. Intas’Accord has just secured FDA approval for its 50mg/10ml vials oflyphilised powder as a new drug application (NDA).

Looking at data exclusivity details in its Ark Patent Intelligence

Expiry Database, IQVIA notes that Kastle’s Kynamro (mipomersensodium) loses its new chemical entity (NCE) exclusivity in the US on29 January this year. The subcutaneous treatment for homozygousfamilial hypercholesterolemia benefits from orphan drug exclusivityin the US running through to January 2020, while unexpired patentslisted against the cardiovascular brand in the FDA’s Orange Bookexpire in 2021, 2023 and 2027.

IQVIA observes that the commercial scope of Kynamro – andthus its attractiveness to generics firms looking for global developmentprojects – is limited by the lack of a marketing authorisation formipomersen in the EU. In March 2013, the committee for humanmedicinal products (CHMP) within the EMA confirmed an earliernegative opinion advising against approval of Kynamro because ofliver toxicity and cardiovascular risk. G

JanuaryDutasteride SwitzerlandRosuvastatin* GreeceFebruaryErtapenem SwitzerlandTigecycline* Austria, Belgium, Denmark, France, Germany, Greece,

Ireland, Italy, Luxembourg, Netherlands, Portugal,Spain, Sweden, UK

* expiry of paediatric extension

JanuaryAlogliptin USBesilesomab European Union**Corifollitropin alfa (Elonva) European Union**Empagliflozin/linagliptin USGaxilose TurkeyMaraviroc SwitzerlandMipomersen USRadotinib South KoreaRilpivirine South KoreaSomatropin South KoreaTrastuzumab South KoreaVandetanib Australia, Canada*FebruaryCeftaroline fosamil AustraliaClenbuterol Canada*Cobicistat AustraliaColistin TurkeyFampridine Canada*Fesoterodine Canada*Ipilimumab Canada*Lanthanum ChinaMetreleptin US***Ospemifene USPomalidomide USRaltegravir SwitzerlandSilodosin European Union**Vandetanib TurkeyVemurafenib Canada*, Turkey* This will be followed by a no-marketing period of two years during

which a notice of compliance will not be granted to a generic manufacturer.** This will be followed by two years of market exclusivity, where a

generic will not be placed on the market*** This will be followed by a no-marketing period of eight years during which

approval will not be granted to a biosimilar manufacturer.

SPC expiries in January and February

INN Country

Data exclusivity expiries in January and February

INN Country

Tigecycline tracks towards end of SPCs


PRODUCT NEWS

AUK patents court judge did not err in finding that the UK part ofa European patent describing a “new way” to purify daptomycin –

the active ingredient in Cubist Pharmaceuticals’ Cubicin (daptomycin)antibiotic – was invalid, and therefore should be revoked, the Courtof Appeal of England and Wales has affirmed.

In a lower court ruling from June 2016, Justice Henry Carr waspersuaded by Hospira’s argument that the UK part of Cubicin’sEuropean patent EP2,264,047 lacked an inventive step (Genericsbulletin, 17 June 2016, page 9). Following the decision, Carr madean order for the ‘047 patent’s revocation, in October 2016.

Carr found that even though prior-art document Lin & Jiang – anarticle on recovering and purifying lipopeptide biosurfactants publishedin the Biotechnology Techniques journal in 1997 – described a methodfor purifying surfactin, and not daptomycin, “the skilled team wouldhave appreciated that this method could be used more generally”.

Prior-art method relevant to purification“The skilled team would have appreciated that the method of

Lin & Jiang was of potential relevance to the purification ofdaptomycin,” Carr also ruled.

And on appeal, Justices David Kitchin and Kim Lewison weresatisfied that Carr “had an ample evidential basis to find that the claimedinvention was obvious in light of Lin & Jiang”. “His finding was properlyreasoned,” the appeals judges decided. “He made no error of principle.”

As part of his June 2016 order, Carr also found invalid and revokeda further two UK parts of Cubicin patents. These included a furtherpurification method patent, EP1,252,179, as well as dosing regimenpatent EP1,115,417. However, Cubist, which is now a part of Merck& Co, did not appeal these decisions.

The European Commission granted a pan-European marketingauthorisation for Hospira’s daptomycin on 22 March last year. G

ANTIBIOTICS

UK daptomycin orderis affirmed on appeal

Mochida Pharmaceutical says it has received the first marketingauthorisation for a biosimilar rival to Enbrel (etanercept) from

Japan’s ministry of health, labour and welfare (MHLW). The Japanesefirm intends to announce its plans to launch its Etanercept BS vials,syringes and pens through a distribution agreement with Ayumi onceit has obtained a national health insurance (NHI) price listing.

The MHLW approval covers etanercept 10mg and 25mg vials forsubcutaneous injection that are indicated for treating rheumatoid arthritisin adults as well as juvenile idiopathic arthritis in children. Mochida’s25mg and 50mg syringes, as well as its 50mg pen, are authorised onlyfor rheumatoid arthritis in adults.

Having collaborated with South Korea’s LG Chem to develop thebiosimilar that was previously known as LBEC0101 – and submittedits dossier to the MHLW almost a year ago (Generics bulletin, 24February 2017, page 14) – Mochida will manufacture the subcutaneousdelivery forms of etanercept products and co-distribute them with Ayumi.

LG Chem recently had published in the British Medical Journal(BMJ) results from a Phase III 54-week study on LBEC0101 that it

conducted in Japan and Korea. The data from the trial in 374 patientssuggested that the biosimilar had equal efficacy and a “comparablesafety profile” to Enbrel (Generics bulletin, 12 January 2018, page 15). G

ARTHRITIS DRUGS

Mochida aims at firstetanercept in Japan

Teva has edged closer to launching imminently the first generic ofHelsinn Healthcare’s Aloxi (palonosetron) intravenous injectable,

following two favourable decisions by a US Court of Appeals.After first rejecting the originator’s request for rehearing en banc

to an earlier appeals court decision from May last year that invalidatedfour patents shielding the antiemetic brand – a landmark interpretationof the America Invents Act’s (AIA’s) on-sale bar provision (Genericsbulletin, 5 May 2017, page 11) – the appeals court on 22 Januaryrejected Helsinn’s follow-up bid to stay the ruling while the originatorpetitions the US Supreme Court to review the decision.

Thus, the appeals court ordered, the mandate invalidating the fourpatents will issue on 29 January. In rejecting Helsinn’s motion, theappeals court insisted its May 2017 decision had been “a narrow one”,and Helsinn had not demonstrated it would suffer “irreparable injury”.

Teva, as well as Sagent, currently hold tentative approvals forAloxi intravenous injectable abbreviated new drug application (ANDA)products. Dr Reddy’s, Exela Pharma, Fresenius Kabi and Sandoz holdfinal approvals. Reddy’s and Sandoz are able to launch their genericsfrom 30 September this year, under the terms of patent-litigationsettlements reached with Helsinn. G

ANTIEMETICS

Teva edges closer with Aloxi

LUPIN has launched a generic version of Pfizer’s Vibra-Tabs(doxycycline) 100mg tablets following approval from the US Foodand Drug Administration (FDA). Citing Iqvia data, the firm notedthat 100mg doxycycline had annual US sales of US$144 million.

KISSEI PHARMACEUTICAL and JCR Pharmaceuticals have jointlyannounced positive results of their Phase III study for JR-131, aproposed biosimilar to darbepoetin alfa. The study demonstratedequivalence in efficacy and safety compared with darbepoetin, thefirms noted. Since reaching a collaborative research and developmentagreement for the renal anaemia treatment in September 2013, Kisseiand JCR have “been advancing the development with the aim toapply for marketing approval in 2018”.

AMNEAL has launched a generic alternative to Perrigo’s Entocort(budesonide) 3mg capsules. The US firm said that the capsules “arenow shipping to wholesalers, distributors and direct to the trade”.

APOTEX has been awarded US$11 million by Canada’s Ontariosuperior court of justice for costs and lost profits it says it incurredafter the US Food and Drug Administration (FDA) rejected clinicalstudies conducted for the firm by Nordion’s MDS. Issues flagged upduring MDS’ bioequivalence studies of both generic amoxicillin/clavulanic acid and levodopa/carbidopa led Apotex to repeat thestudies, delaying US market entry. The court agreed with Apotexthat MDS had breached the agreements held between the firms.

HIKMA’S West-Ward Pharmaceuticals has launched a US generic ofBaxter’s Ifex (ifosfamide) injectable in 1g/20ml vials. The productis indicated for use in combination with certain other approvedantineoplastic agents for third-line chemotherapy of germ cell testicularcancer, and in combination with mesna for cystisis prophylaxis. G

IN BRIEF


PRICE WATCH.....UK

Figure 1 (above): Comparison between the periods 1-30 November 2017 and 1-31December 2017 of UK trade prices of the most recently-launched generics listed incategory M of the Drug Tariff of pharmacy-reimbursement prices. Averages calculatedfrom at least 17 data points. Figure 2 (top right) and Figure 3 (centre right): Biggestaverage trade-price changes between 1-30 November 2017 and 1-31 December 2017.Averages calculated from at least 13 data points. Figure 4 (bottom right): Rankingof fastest-moving products subject to the most price offers made to independent UKpharmacists (one strength per ingredient; offers recorded by 31 December). Data forFigures 2, 3 and 4 from a basket of about 750 commonly-dispensed generics. Recently-launched products in Figure 1 excluded from Figures 2 and 3 (Source – WaveData).

Aripiprazole tabs 10mg 28 £1.00 -11 £5.29 +19Benzydamine 0.15% 300ml £4.69 ±0 £5.40 +1Carbimazole tabs 5mg 100 £34.20 -5 £38.66 -3Celecoxib caps 200mg 30 £0.82 +1 £1.22 -8Cilostazol tabs 100mg 56 £3.33 +6 £4.14 +1Cyclizine tabs 50mg 100 £5.20 -4 £6.48 -5Desogestrel tabs 75µg 84 £1.99 +2 £2.48 -7Duloxetine caps 30mg 28 £4.12 +40 £6.40 -4Entacapone tabs 200mg 30 £2.64 +15 £3.46 +2Eplerenone tabs 25mg 28 £4.10 ±0 £30.39 -8Escitalopram tabs 10mg 28 £0.57 +54 £0.81 ±0Frovatriptan tabs 2.5mg 6 £5.95 -10 £7.68 -4Memantine tabs 10mg 28 £0.55 -7 £0.90 -5Montelukast tabs 10mg 28 £0.75 +3 £0.95 -15Nefopam tabs 30mg 90 £12.49 -7 £19.03 ±0Nortriptyline tabs 10mg 100 £3.95 -12 £10.86 +9Olmesartan tabs 10mg 28 £0.90 +1 £1.40 +3Pregabalin caps 150mg 56 £3.25 ±0 £7.76 +2Raloxifene tabs 60mg 28 £2.26 +46 £2.92 +4Rasagiline tabs 1mg 28 £1.58 +13 £5.79 -11Rizatriptan tabs 10mg 3 £6.77 -10 £10.75 -8Sevelamer tabs 800mg 180 £23.99 +12 £26.81 -12Sildenafil tabs 100mg 4 £0.24 ±0 £0.41 -5Telmisartan tabs 80mg 28 £0.88 ±0 £1.46 -6Zonisamide caps 100mg 56 £5.24 -5 £15.82 -4

Simvastatin tabs 20mg 28 98 84 73Ramipril caps 10mg 28 91 95 71Lansoprazole caps 15mg 28 102 97 71Atorvastatin tabs 20mg 28 100 118 70Lansoprazole caps 30mg 28 111 118 69Sertraline tabs 50mg 28 97 112 68Fluoxetine caps 20mg 30 98 110 67Omeprazole caps 20mg 28 103 106 64Bisoprolol fumarate tabs 2.5mg 28 93 93 64Tamsulosin MR caps 400µg 30 86 83 63

Topiramate tabs 100mg 60 £2.17 +40 £18.52 +419Topiramate tabs 50mg 60 £1.27 +35 £9.69 +314Topiramate tabs 25mg 60 £1.17 +18 £5.34 +197Topiramate tabs 200mg 60 £4.60 +62 £19.60 +148Felodipine MR tabs 10mg 28 £4.79 +384 £6.52 +82Felodipine MR tabs 5mg 28 £3.99 +387 £4.98 +79

Sertraline tabs 50mg 28 £0.40 -5 £0.65 -60Mycophenolate caps 250mg 100 £4.65 -1 £10.99 -47Gamolenic acid caps 80mg 120 £3.49 ±0 £8.01 -41Gamolenic acid caps 40mg 240 £3.49 ±0 £8.28 -39Ampicillin caps 250mg 28 £4.28 -5 £5.97 -35Ciprofibrate tabs 100mg 28 £8.50 ±0 £21.09 -33

Up to the minute live retail market pricing is available for the UK and Eire on Wavedata Live at wavedata.net.

Alternatively, contact Charles Joynson at WaveData Limited, UK.Tel: +44 (0)1702 425125. E-mail: [email protected].

RECENT LAUNCHESProduct/Strength/Pack size Lowest Change AverageChange

price (%) price (%)

BIGGEST RISERSProduct/Strength/Pack size Lowest Change AverageChange

price (%) price (%)

BIGGEST FALLERSProduct/Strength/Pack size Lowest Change AverageChange

price (%) price (%)

FAST MOVERSPrice offers as at 31 December 2017

Product/Strength/Pack size October November December

WANT MORE LIKE THIS?

Topiramate tablets in four strengths topped the December 2017 listfor the fastest-rising UK trade prices, according to the latest figures

provided by WaveData. The 60-tablet packs of 25mg, 50mg, 100mgand 200mg tablets experienced average price leaps of between 148%and 419%, despite the cheapest available prices seeing only double-digit increases (see Figure 2).

The anticonvulsant featured on the list of price concessions forDecember authorised by the UK’s Department of Health (DoH). The25mg strength’s concession price of £4.90 (US$6.79) was not quiteenough to match the average of £5.34, while the £14.00 concessionfor the 100mg presentation also fell short of the £18.52 average.

However, the concession price of £18.11 for the 50mg tabletscomfortably exceeded the £9.69 average recorded by WaveData, whilethe 200mg strength was not granted a concession in December.

Felodipine modified-release tablets in 5mg and 10mg strengths –which saw average increases of 79% to £4.98 and of 82% to £6.52respectively – were also not featured on the list of concessions. The UK’sPharmaceutical Services Negotiating Committee (PSNC) noted that theDoH’s list was still not fully adequate to compensate independentpharmacists, with many concessions “lower than we had sought”(Generics bulletin, 19 January 2018, page 9).

Elsewhere, aripiprazole 10mg tablets saw the largest average shiftamong our recent launches, as the average price for a 28-count packrose by 19% to £5.29 (see Figure 1).

Meanwhile, sertraline 50mg tablets in 28-tablet packs saw theiraverage price drop by three-fifths (see Figure 3). Also featured weremycophenolate 250mg capsules that almost halved in price, whilegamolenic acid capsules in two strengths dropped by around two-fifths.G

Topiramate tops December UK price rises


PRODUCT NEWS

South Korean biosimilar developer Alteogen says it will this yearfile an investigational new drug (IND) application with the US

Food and Drug Administration (FDA) for its biosimilar candidatereferencing Regeneron’s Eylea (aflibercept).

The Korean firm believes its proprietary technology will resultin a finished product that is more resilient to high temperatures andwill be rewarded with a longer shelf-life than the reference brand, whichgenerated US sales up by 12% to US$953 million for Regeneron in thethird quarter of 2017. Net sales of the blockbuster brand outside ofthe US, where Bayer holds marketing rights, were US$564 million.

Alteogen recently completed pre-clinical studies for its ALT-L9ophthalmic candidate – including a 13-week toxicity trial – and intendsto present in the near future data showing equivalence to the Eyleaintravitreal injectable treatment for wet age-related macular degeneration(AMD). “We plan to present the official analysis report of the pre-clinical results at an academic conference, and expect out-licensingnegotiations to be accelerated,” stated the Korean firm’s chiefexecutive officer, Park Soon-Jae.

As part of a collaboration with Japan’s Kissei formed in February2014, Alteogen is receiving development milestone payments. TheKorean firm plans to launch aflibercept in Japan and China uponpatent expiry in 2022. The company’s other leading biosimilar projectis its ALT-L2 alternative to Roche’s Herceptin (trastuzumab). G

OPHTHALMIC DRUGS

Korea’s Alteogen todo aflibercept studies

Amgen’s Mvasi (bevacizumab) biosimilar has been granted a pan-European marketing authorisation by the European Commission,

representing the first biosimilar of Genentech’s Avastin (bevacizumab)treatment for multiple forms of cancer approved in the EuropeanUnion (EU), as well as the first European approval stemming fromAmgen’s biosimilars development partnership with Allergan.

No launch date has been forecast by the development partners,although Genentech parent Roche noted last year that “basic, primarypatents” currently shielded Avastin in Europe until “around 2020”.

“Approval from the European Commission grants a centralisedmarketing authorisation with unified labelling in the 28 countries thatare members of the European Union (EU),” Amgen summarised.Meanwhile, Norway, Iceland and Liechtenstein, members of theEuropean Economic Area (EEA), will take “corresponding decisionson the basis of the decision of the European Commission”.

The approval – covering treatment of six types of cancer – wasbased on a “comprehensive data package that demonstrated Mvasi andbevacizumab are highly similar, with no clinically meaningful differencesin terms of the efficacy, safety and immunogenicity between the products”,Amgen noted. The European Medicines Agency’s (EMA’s) committeefor medicinal products for human use (CHMP) had recommended thegranting of a marketing authorisation in November last year (Genericsbulletin, 17 November 2017, page 1). G

ONCOLOGY DRUGS

Amgen and Allerganfirst with EU Avastin


PEOPLE

Pramod Yadav has been appointed chief executive officer of JubilantLife Sciences’ Jubilant Pharma business, with effect from 1 April

this year, as part of a reshuffle.Currently, Yadav is co-chief executive officer of Jubilant’s Life

Science Ingredients operation, sharing responsibilities with RajeshSrivastava. He will replace as chief executive officer of Jubilant PharmaGurpartap Singh Sachdeva, who – having held his current role sinceJanuary 2015 (Generics bulletin, 16 January 2015, page 30) – willstep down from 31 March due to undisclosed personal reasons.

As part of the pending move, Yadav – who has been with the Jubilantgroup for more than two decades – has resigned as director and whole-time director of the Jubilant Life Sciences group with immediate effect.

From his base at Jubilant Pharma’s US headquarters in Yardley,Pennsylvania, Yadav in his new role will have “overall responsibility”for Jubilant’s pharmaceuticals business, and will report to the JubilantPharma board of directors. He will oversee a business that has justreported sales that rose by 41% to Rs11.0 billion (US$172 million)in the firm’s third quarter ended 31 December 2017, amounting tomore than half of Jubilant Life Sciences group turnover (see page 6).

Meanwhile, as part of the reshuffle, Srivastava is set to become thesole chief executive officer of the Life Science Ingredients operation,and with immediate effect has been appointed as an additional directorand whole-time director of the Jubilant Life Sciences group. G

APPOINTMENTS

Jubilant’s Yadav isnamed Pharma chief

GRINDEKS’ supervisory council has re-relected Juris Bundulisas chairman of the Latvian company’s board. At the same time, thefirm has announced that Juris Hmelnickis has been elected to theboard. Hmelnickis – who has worked at Grindeks since 2000 – hasbeen quality director and qualified person for Grindeks since 2010,and has served as chairman of Grindeks subsidiary Kalceks since2014. Meanwhile, fellow board member Janis Romanovskis willcontinue to serve as the firm’s chief finance and administrative officer.

BIOSIM – the Spanish biosimilars association – has re-electedSandoz’ Joaquín Rodrigo as president of the association, a positionhe has held since the group was inaugurated in 2015. Rovi’s JoséEduardo González will serve as vice-president, with Mylan’s JavierAnitua as secretary and Pfizer’s Concha Serrano as treasurer. Othermembers of the Biosim board include Amgen’s Ana Vieta, Biogen’sSérgio Teixeira, and Kern’s Pepa Martinez, along with Eli Lilly’sTeresa Millán and Naouel Zouaghi of Insud Pharma’s mAbxience.

GERRESHEIMER has named Lukas Burkhardt as a member ofits board with responsibility for the German firm’s primary packagingglass division from 1 January 2018.

SANOFI has appointed Dominique Carouge as executive vice-president head of business transformation from 15 February. Inthe role, he will be “in charge of accelerating the transformationof the company and will be a member of the executive committee”.Carouge was previously Sanofi’s deputy chief financial officer andhead of finance operations and group controlling.

WALGREENS BOOTS ALLIANCE has named former DixonsCarphone group chief executive Sebastian James as senior vice-president and managing director. Joining the company in “the summerof 2018” by contributing “in a number of key areas”, James willofficially take up the position on 1 September, reporting to co-chiefoperating officer Alex Gourlay. James replaces Elizabeth Fagan,who will become non-executive chairman after that date.

LANNETT has added recently appointed chief executive officerTimothy Crew to the company’s board of directors, taking thenumber of directors to seven. The former Teva and Cipla executivewas appointed as the new Lannett head late last year, replacingArthur Bedrosian (Generics bulletin, 12 January 2018, page 20).

PFENEX has named Neothetics’ Susan Knudson as chief financialofficer from 1 February. After a “thorough search”, Pfenex welcomedKnudson, citing her “breadth of financial and operational expertise,accomplishments and track record as a strong business leader withmore than 20 years of experience in the biopharmaceutical industry”.

MAPS – the Medical Affairs Professional Society – has appointedOrnah Levine-Dolberg as its inaugural president of the Europe,Middle East and Africa (EMEA) region, effective immediately.She is currently Glenmark’s vice-president and global head ofmedical affairs and research and development.

GEDEON RICHTER has announced that Christopher Long hasresigned from the Hungarian company’s board of directors.

TFS INTERNATIONAL has appointed János Filakovský as chiefexecutive officer, taking over from interim head Jim Utterback.The contract research organisation said Filakovský “brings a wealthof experience to TFS from the life science industry, including over20 years serving in different leadership roles at Quintiles”. G

IN BRIEF

DEVELOP WINNINGDISTRIBUTION STRATEGIES

OTC DISTRIBUTION IN EUROPE2018 EDITIONDISRUPTIONCHANGESTHE PLAYING FIELD

Available soon to download or orderonline at www.james-dudley.co.uk

®

JAMES DUDLEYMANAGEMENT ®

Now in its 11th edition, thisin-depth study identifies thefactors driving change in thesupply network serving Europe’snon-prescription and OTCself-medication sectors.

It provides a commmppprrreeehhheeennnsssiiivvveee,data-driven analysis of theunfolding strategies required toachieve competitive success.

OVER 20 COUNTRIES AND 300GRAPHS, TABLES & FIGURES

sandozand biocon strike global biosimilars alliance · 26january2018 sandozand biocon strike global...

Documents