company news fda nod must precede 180-day …...pharma city (jnpc) parawada district,thevizag...

Biosimilar applicants in the US must wait until they hold US Food and DrugAdministration (FDA) approval before providing to the reference-brand owner the

mandatory 180-notice of commercial marketing, the US Court of Appeals has confirmed.This requirement applies regardless of whether or not the biosimilar applicant provideddetails of its dossier and manufacturing process to the originator.

Last year, the Court of Appeals found in a dispute between Amgen and Sandoz overfilgrastim that the 180-day notice could only be given after biosimilar approval (Genericsbulletin, 7 August 2015, page 1). On that basis, a Florida district court granted Amgen apreliminary injunction against Apotex giving effective notice of launching its biosimilarNeulasta (pegfilgrastim) until after approval (Generics bulletin, 8 January 2016, page 11).

On appeal, Apotex argued that its position differed to that of Sandoz in that Apotex hadentered into a dossier, manufacturing information and patent exchange with Amgen. But thecourt disagreed, stating that “the commercial-marketing provision is mandatory and enforceableby injunction, even for an applicant in Apotex’ position”.

“The final biosimilar product cannot be known with certainty until the FDA licenceissues,” it added. “The 180-day period gives the reference-product sponsor time to assess itsinfringement position for the final FDA-approved product as to yet-to-be-litigated patents.”

The appeals panel ruled unanimously that the 180-day notice requirement was “a standalonenotice provision not dependent on the information-exchange processes”. The judges dismissedApotex’ argument that the notice period effectively extended the brand owner’s exclusivity bysix months to 12.5 years, asserting that “any such delay beyond 12 years should occur lessand less as time goes by”. This was because, for newer biologics, biosimilar applicants couldfile for approval four years into the 12-year brand exclusivity, allowing the FDA to tentativelyapprove the biosimilar at least 180 days before the 12-year exclusivity expired. G

8 July 2016

Torrent expands via Glochem plant deal 2Siegfried receives approval from China 2Shanghai Desano hit by 3FDA site warningRichter buys Finox to boost biosimilars 3McKesson prepares a 4European private label

MARKET NEWS 5

Canada unveils rules to monitor shortages 5API imports allowed 5after certificate endsBiosimilars facing a key year in Belgium 6South Africa plans 5.7% price increase 6Epoetins gain half of the European market 7

PRODUCT NEWS 8

AstraZeneca furthers rosuvastatin efforts 8Sandoz’ etanercept is reviewed in Canada 8Lannett says ANDA revocation 9is unlawfulIndia issues revised biosimilar guidance 10Atazanavir case will be 10heard again in USCinfa seeks partners for rival to Neulasta 11Reddy’s and Sandoz 11work around BuTrans

FEATURES 14

India’s Natco is aiming to 14expand through alliancesWorking with global marketing partnersfor its vertically-integrated pipeline iscrucial to Natco Pharma’s plans toexpand beyond its Indian base. AidanFry examines the company’s strategy.

REGULARS

Events – Our regular listing 9

Price Watch UK – UK pricing trends 10

Paragraph IV Watch – Ferriprox 12

People – Steffen Retzlaff is 16restricted at Stada

COMPANY NEWS 2 FDA nod must precede180-day launch notice

French pharmacists have been set a target of 86% penetration by generics of the availablemarket by the end of 2016, as part of efforts to increase generic substitution at the pharmacy

level. The objective – which will be calculated on the basis of France’s répertoire list ofsubstitutable generics as of 30 June 2015 – marks an increase of one percentage point over2015’s target of 85%, which was achieved or surpassed by 15 of the country’s regionaldépartements by the end of last year.

Published in France’s Journal Officiel, the 2016 target – which should be reached by31 December – is based on an agreement negotiated between French health insurance unionUNCAM and local pharmacy associations FSPF and USPO at the end of 2015. Local healthinsurers had initially proposed an 87% objective in negotiations (Generics bulletin, 8 January2016, page 8). Sanctions are foreseen against pharmacists that fail to achieve a substitutionrate of 70% of eligible prescriptions or higher.

The national objective comes against the backdrop of a French “national plan of actionto promote generic medicines” that was announced last year (Generics bulletin, 10 April2015, page 1). An information campaign to promote generics to doctors and patients wasrecently launched with the support of the country’s health ministry, local health insurerCNAMTS, and medicines agency ANSM (Generics bulletin, 1 July 2016, page 7), while abroader public campaign is expected later this year. G

France sets substitution target

Next issue – 22 July 2016

Gen 8-7-16 Pg. 1_Gen 18/11/05 Pg. 1 06/07/2016 14:48

Torrent Pharma has agreed to acquire an active pharmaceuticalingredient (API) manufacturing unit located in Vizag, India, from

Hyderabad-based Glochem Industries. Situated in the Jawaharlal NehruPharma City (JNPC) Parawada District, the Vizag facility currentlyhas three blocks for advanced intermediates manufacturing, and fourblocks for API production.

The plant – which is approved by the US Food and DrugAdministration (FDA) and European regulatory authorities – is a“multi-product facility” that has “capabilities for onsite development,analytical method development, a quality control laboratory and apilot plant”, Torrent said.

Acquiring the approved unit, Torrent insisted, would be “beneficialin the company’s growth trajectory”, as it would help the firm“vertically integrate its abbreviated new drug application (ANDA)filings in the future”. Presently, Torrent has five formulationmanufacturing units and with this acquisition, the firm noted, it would“have three API facilities for the regulated markets in the near future”.

Torrent’s executive director of operations, Jinesh Shah, said theacquisition of the unit would “further help in backward integration”.“It will scale up Torrent’s manufacturing capacity to meet thegrowing demand from the international markets,” he remarked.

The agreement also includes “a few” drug master files (DMF),as a “going concern on a slump sale basis”. Financial terms of thedeal were not disclosed. G

COMPANY NEWS

2 GENERICS bulletin 8 July 2016

8 July 2016 Issue 270

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

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Company registered in England No 2765878.Printed byWarwick Printing Company Limited,Leamington Spa CV31 1QD, UK.

MANUFACTURING

Torrent expands viaGlochem plant deal

Final operating approval has been issued for Siegfried Group’sChinese Nantong bulk-drugs site by the country’s Environmental

Protection Bureau (EPB). “All approvals and certificates required bythe authorities for large-scale production have now been obtained,”the Swiss firm confirmed. According to Siegfried, its Nantongproduction site is “located in one of China’s most up-to-dateindustrial parks, northwest of Shanghai”. Employing about 200staff, the site’s production capacity amounts to 350 cubic meters.

Trial operation for the commercial facilities started a year ago,and the facility was inaugurated in August 2015. “The pilot plantshave been producing for 18 months and initial orders for large-scaleproduction have been received,” the firm stated, adding that productswould be transferred from other locations to Nantong.

According to the firm, the Nantong facility is a “significant siteaddition” to Siegfried’s production network in a “cost-effectiveproduction environment”, and it will “strengthen the company’slong-term competitiveness”. “Our production network and thus ourcustomers can now profit from a modern multi-purpose plant, complyingwith the highest safety, environmental and quality standards,” saidWalter Kittl, Siegfried’s head of global operations.

In October last year, the company completed a C270 million(US$304 million) acquisition of three former BASF bulk-drugmanufacturing facilities in France, Germany and Switzerland (Genericsbulletin, 23 October 2015, page 9). G

MANUFACTURING

Siegfried receivesapproval from China

CELESIO said volume growth across its British pharmaciescontributed to group sales rising by 3.7% as reported to CC21.4 billion(US$23.8 billion) in the German firm’s financial year ended 31 March2016. This translated to a 1.2% increase at constant currencies. G

IN BRIEF

DR REDDY’S LABORATORIES has completed a previously-announced deal to buy back approximately 5.08 million of its ownequity shares for around Rs15.7 billion (US$232 million). Thescheme was first approved by the Indian firm’s board in February. G

IN BRIEF

Gen 8-7-16 Pgs. 2-16_Layout 1 06/07/2016 14:49

Gedeon Richter has bolstered its women’s healthcare portfolio andstrengthened its presence in “main European markets” by acquiring

Swiss-based biotechnology firm Finox Biotech in a deal worthSFr190 million (US$195 million).

The Hungarian firm has also furthered its biosimilars interests, byobtaining through the transaction global rights outside of the US toFinox’ Bemfola (follitropin alfa) biosimilar alternative to Merck-Serono’sGonal-F original. Willy Michel, Finox’ founder, chairman, andlargest shareholder will retain US rights.

Bemfola, a recombinant human follicle stimulating hormone, wasfirst granted European Union (EU) marketing authorisation approvalin May 2014, and has since been made available “in Israel, in the MiddleEast and in Australia”, being sold “in more than 20 countries”.

“Finox is in a commercial expansion phase in Europe and isgrowing rapidly,” Michel commented. “The achievement of the companyin launching Bemfola in more than 20 countries within 12 months, andreaching double-digit market share in many of them is unprecedented,and I am aware of the investment that this requires.”

Commenting on the acquisition, Richter said privately-ownedFinox represented “a unique opportunity for Richter to widen its corewomen’s healthcare franchise”, adding that the transaction “furtheremphasises [Richter’s] commitment to biosimilars”. The Hungarian firmadded that it would integrate the Swiss firm’s team “focusing on femalefertility as part of its growing specialised women’s healthcare business”.

Last year, Richter’s women’s healthcare sales in its EU region,excluding Hungary, increased by 16.0% to C183 million (US$204million), comprising just under half of total women’s healthcareturnover that rose by 7.9% to C382 million. Richter earlier this yearexpanded its presence by taking full control of its women’s healthcareand OTC joint venture with long-term Chinese marketing partnerRxmidas Pharmaceuticals (Generics bulletin, 29 January 2016, page 2).

Richter’s biosimilars interests, meanwhile, currently include apending European marketing authorisation application for a biosimilarversion of Amgen’s Neulasta (pegfilgrastim) that was accepted forfiling by the European Medicines Agency (EMA) at the end of lastyear (Generics bulletin, 8 January 2016, page 12). Under a licensingand distribution agreement reached earlier in 2015, the Hungarianfirm will co-market the biosimilar in Europe outside of Russia withStada (Generics bulletin, 1 September 2015, page 23). G

COMPANY NEWS

3GENERICS bulletin8 July 2016

MERGERS & ACQUISITIONS

Richter buys Finoxto boost biosimilars

China’s Shanghai Desano Chemical Pharmaceutical has receiveda warning letter from the US Food and Drug Administration

(FDA) against its active pharmaceutical ingredient (API) manufacturingfacility in the Pudong district of Shanghai. An inspection conductedby the agency in May last year identified current good manufacturingpractice (cGMP) deficiencies related to laboratory control recordsand production deviations.

The FDA discovered laboratory personnel had carried out“unofficial testing without appropriate documentation, justificationand investigation”. A ‘test’ folder of unofficial analyses was found,revealing that the firm performed around “8,400 unofficialchromatographic analyses between 2012 and 2014”. The FDA saidthat the “volume of data” within these ‘test’ folders suggested thatperforming unofficial analyses was a “common practice” at the facility.

Shanghai Desano claimed that some of the analyses were “relatedto out-of-specification investigations”, but the FDA found this responseto be lacking a “comprehensive assessment” of oversight.

Deviations not investigatedDuring the inspection, it was found that electronic logs of

production deviations in a folder entitled ‘GMP Anomalies’ were notinvestigated or reported in the official deviation logbook. This includedincomplete batch records, batch records pre-filled before manufacturingand failure to record temperature, humidity and pressure. The FDAwas told by Shanghai Desano that these failures were due to “deficientprocedures and operators’ errors”, yet the agency deemed this responseinadequate on the basis that the “protocol did not include a thoroughreview of complaints to determine if undocumented deviations couldbe linked to product quality defects”.

The FDA has demanded that Shanghai Desano conduct acomprehensive investigation into the extent of the inaccuracies andproduce a risk assessment of the “potential effects of the observedfailures on the quality of its drugs”. The Chinese company must alsoprovide a management strategy that “includes details of its globalcorrective action and preventive action plan”.

Until all deviations have been corrected and cGMP complianceis confirmed by the Chinese company, the FDA reiterated, the agencymay “withhold approval of any new applications or supplementslisting your firm as an API manufacturer”. G

MANUFACTURING

Shanghai Desano hitby FDA site warning

Strides Shasun says its ‘flagship’ KRS Gardens oral-dosage facilityin Bangalore, India, is “now US Food and Drug Administration

(FDA) compliant” after announcing the “successful completion” ofan inspection by the agency.

The development comes after the Indian firm last month obtainedan establishment inspection report (EIR) from the FDA for site(Generics bulletin, 17 June 2016, page 4). “The audit was carried out[in relation] to a product filed from the new semi-solids block, fromwhere the company has made a series of filings,” Strides noted.

Separately, an FDA inspection at fellow Indian firm Alembic’s twoactive pharmaceutical ingredient (API) facilities that are both located atits site in Panelav, India, resulted in no Form 483 observations. G

MANUFACTURING

FDA approves Strides facilityAcino has picked up the Middle East and North Africa (MENA)

operation from Netherlands-based Norgine, along with the rightsto four laxative products in the region for an undisclosed sum.

The basket of products includes Norgine’s Movicol (macrogol),Moviprep (polyethylene glycol electrolyte), Klean-Prep (macrogol) andNormacol (sterculia) constipation and pre-surgery brands.

“The acquisition of Norgine’s MENA operation is perfectly in linewith our dynamic growth strategy in our key markets in the Middle Eastand Africa,” commented Kalle Känd, Acino’s chief executive officer.

Noting that the transaction included the transfer of Norgine’semployees and entities in Egypt and employees in Tunisia, Norginesaid it would “continue to manufacture its own products for Acino”. G

MERGERS & ACQUISITIONS

Acino acquires Norgine assets

Gen 8-7-16 Pgs. 2-16_Layout 1 06/07/2016 15:02

McKesson intends by the end of its current financial year in March2017 to follow the example of its NorthStar range in the US and

its Sivem portfolio in Canada by introducing a private-label genericsoffering to retail pharmacies in Europe through its Celesio business.

“By the end of this fiscal year, we will have introduced a private-label line of products in the European market, beginning with the UK,”revealed the US-based group’s president of Distribution Services,Paul Julian, at a recent investors’ day.

Marc Owen, chairman of Celesio’s management board, said theEuropean operation was bringing private-label products into the coretherapeutic categories, such as skincare and pain relief, in its networkof around 2,200 owned retail pharmacies. Such initiatives, he added,were being made available to more than 4,300 independent pharmaciesthat had signed up to Celesio’s banners or franchises, such asGesundLeben in Germany and Pharmactiv in France.

“When we can go to an independent pharmacy in Germany andsay that it can take advantage of McKesson’s global procurementscale to provide private-label GesundLeben ibuprofen, it helps boththem and us,” he explained.

Owen expressed confidence that McKesson’s global sourcing andprocurement office in London, UK, would at least deliver its targetof US$275-US$325 million of synergies by the end of the group’s2017 fiscal year in March 2017.

Julian said a generics sourcing deal recently struck in the US withWalmart would be “standing on its own two feet” by March next year(Generics bulletin, 20 May 2016, page 3).

In the US, Julian said working with Sandoz on launching thecountry’s first biosimilar, Zarxio (filgrastim-sndz), had been “verysuccessful for McKesson”. Nick Loporcaro, president of McKessonSpecialty Health, said the group’s access to around 8,500 US specialists– including 3,400 oncologists – had helped to achieve Zarxiopenetration that was “six-fold that of the industry average”. G

COMPANY NEWS


BUSINESS STRATEGY

McKesson prepares aEuropean private label

Companies and individuals involved in the generics and biosimilarsindustries have just one week left to submit their entries to the

Global Generics & Biosimilars Awards 2016. Entrants for the 14awards – which will be judged by expert panels – can e-mail theirentries to [email protected] until Friday 15 July, alongwith evidence of up to 500 words to support their proposals.

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

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

INDUSTRY AWARDS

Awards entries close in July

MYLAN’S provisional date for European approval of its proposedmerger with Meda has been pushed back by two weeks until 20July by the European Commission’s competition authority. Thecompany was previously given a provisional deadline of 6 July bythe authority (Generics bulletin, 10 June 2016, page 3), but thedeadline has been extended after certain undisclosed commitmentswere submitted by Mylan to the authority at the end of June. Mylanrecently announced that its offer to acquire Sweden’s Meda forSEK83.6 billion (US$9.9 billion) would run from 17 June to 29 July.

RECIPHARM has formed a global alliance to “introduce newserialisation capabilities” with Italian firms Marchesini and SEAVision, and US-based TraceLink, “the world’s largest pharmaceuticaltrack and trace network”. Swedish contract development and researchorganisation (CDMO) Recipharm said it had selected Marchesiniand SEA Vision “after assessing various vendors” to meet Recipharm’shardware and software requirements for serialisation at device, lineand site level, while TraceLink would “meet the CDMO’s enterpriseserialisation management and global tracking needs”.

SAFIC-ALCAN has taken full ownership of China’s SichuanHuaFaMei Enterprise, following the French distributor’s acquisitionof a 50% share in the Chinese raw materials supplier in 2006. “Actingpresident Charles Hu will remain in place and will continue toactively manage the business,” Safic-Alcan confirmed. “Acquiringfull ownership of Sichuan HuaFaMei Enterprise is part of ourstrategy to expand in Asia,” the company said, noting that the dealwould give it “direct access to the multinational pharmaceuticalcompanies located in China, and the opportunity to build uponthe existing infrastructure to have a foothold in Asia from whichSafic-Alcan can expand throughout the region”.

CONCORDIA HEALTHCARE has changed its name to ConcordiaInternational. Mark Thompson, the company’s chairman and chiefexecutive, said the new name “better reflects the global nature ofour business”, adding that “with sales channels in more than 100countries and a diverse therapeutic mix of products, we are excitedabout the opportunity ahead of us”. Meanwhile, commenting onthe depreciation of the UK pound in the wake of the country’sdecision to exit the European Union (Generics bulletin, 1 July2016, page 1), the Canada-based group said the “pound sterling-denominated free cash flow from Concordia International’s 2016operations is naturally hedged in 2016 by its pound-sterling-denominated liabilities”. Sterling depreciation therefore “does notimpact the company’s ability to service its debt”, although“beyond 2016 the company will monitor its hedging needs”.

JB CHEMICALS has received good manufacturing practice (GMP)approval for its tablet manufacturing facility in Panoli, India,following an inspection by the US Food and Drug Administration(FDA). The four-day routine investigation – which took place lastmonth – resulted in no ‘Form 483’ observations of deficiencies forthe Indian company.

ELITE PHARMACEUTICALS said its sales rose by about 150%to US$12.5 million in the financial year ended 31 March 2016 asa result of “across the board increases in both manufacturingrevenues and licence fees”. Growth from a “strong, sustained andbroad expansion” in the sales of Elite’s product revenues meantmanufacturing sales more than doubled from US$3.8 million lastyear to US$8.0 million in the financial year. Licensing fees more thantrebled from US$1.1 million last year to US$4.5 million in 2016,partly due to “growth in generic product fees”. G

IN BRIEF

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Extending Germany’s ‘aut idem’ automatic substitution frameworkto biological drugs would be “possible in principle”, Antje Haas

from the umbrella body of German statutory health insurance funds,the GKV-Spitzenverband, told a biosimilars workshop held by thecountry’s regulatory agency, BfArM, on 27 June.

Haas said substitution, based on equivalent safety and efficacy,could be implemented through prescribing guidelines laid down byGermany’s health technology assessment body, the G-BA. Shestressed the importance of real-world evidence to support switching.

The G-BA’s Antje Behring agreed that studies into switchingto biosimilars should be evaluated and stressed the importance of“financial incentives for doctors and patients”, such as exemptionsfrom patient co-payments. Representing the industry’s Pro Biosimilarsworking group, Andreas Eberhorn appealed for all parties to “abandonentrenched positions” and follow best practices at a regional level. G

Manufacturers in Canada must “report anticipated drug shortagesand discontinuances of sales no less than six months in advance”

and publicly declare any shortages not previously reported withinfive days of learning about them, according to final regulationsreleased by Health Canada.

The regulations, published in the Canada Gazette, state thatmanufacturers will be required to provide additional information oncea drug is discontinued, including the drug identification number andthe latest expiry date. Health Canada has also advised that it mustbe notified when sales of certain drugs have been disrupted and theyhave not been sold in Canada for 12 consecutive months.

A third-party website to log shortages is being developed withenhancements such as drug-specific email alerts, improvedsearchability and a mobile application. This will replace the industry’swebsite www.drugshortages.ca “by spring 2017”, but until then, HealthCanada advises manufacturers to continue posting shortages anddiscontinuances to the existing site. A draft guidance document tohelp drug manufacturers comply with the new requirements will beavailable shortly for consultation, Health Canada adds.

Stating last year that “earlier, more comprehensive and reliableinformation on drug supply disruptions will give healthcare providersmore time and confidence to make alternate treatment plans”, HealthCanada previously published proposals for comment in the CanadaGazette (Generics bulletin, 10 July 2015, page 13).

“We are committed to increasing our efforts to improve reportingof shortages,” stated minister of health, Jane Philpott.

Separately, Health Canada has released industry guidance forhealth product labels in the form of two ‘good label and packagepractices’ guides – one for over-the-counter drugs and natural healthproducts and the other for prescription drugs – as part of HealthCanada’s ‘plain language labelling initiative’.

The guidance will “provide industry with direction for designingclear and effective health product labels and packages”, and includesa new standardised facts table on outer labels of non-prescription drugs,a requirement which will be phased into the Canadian marketplacestarting June 2017, according to the agency. G

MARKET NEWS


REGULATORY AFFAIRS

Canada unveils rulesto monitor shortages

Active pharmaceutical ingredients (APIs) can be imported into theEuropean Union (EU) even after their accompanying written

confirmation of compliance with good manufacturing practice (GMP)has expired, the latest European Commission question-and-answerdocument on importing active substances has clarified.

The document states that APIs accompanied by expiredwritten confirmations are acceptable “provided that the paperworkaccompanying the consignment unequivocally proves that the wholeconsignment has been manufactured and released for sale by the qualityunit before the expiry date of the written confirmation, and providesa solid justification of why a valid confirmation is not available”.

Guarantees provided by written confirmations apply to any APIbatch “which was released for sale within the period of validity ofthe written confirmation, even if not exported in that time period”,the document explains.

While active substances imported into the EU after 2 July 2013have been required to be accompanied by a confirmation that theywere made under GMP conditions – unless imported from a countryexempt from certification – the document clarifies that this requirementdoes not apply to starting materials and intermediates.

Authorities in India – which is not listed as exempt by theEuropean Commission – had, as of 1 July, issued renewals of three-year confirmations to 88 API suppliers, including to many of theIndian industry’s leading players. These confirmations, granted justahead of the EU regulations coming into effect in July 2013, hadbeen due to expire imminently.

Separately, the European Commission has revised a question-and-answer document on anti-counterfeiting safety features comprisingunique two-dimensional barcodes and anti-tampering devices. Thesewill be mandatory on prescription medicines packs in the EU from9 February 2019, although Belgium, Greece and Italy have the optionof deferring such requirements for up to an additional six years.

Issues covered by the document include applying features aheadof the February 2019 deadline, variations to marketing authorisationsand technical specifications for both the unique identifier barcodesand the anti-tampering devices. G

REGULATORY AFFAIRS

API imports allowedafter certificate ends

Aconvention of governments, patient groups and industrystakeholders brought together by the World Health Organization

(WHO) will seek to “develop a fair pricing model” for medicines.In an opinion piece published on the Huffington Post website,

WHO assistant director-general for health systems and innovation,Marie-Paule Kieny, argues that such a model will “hinge on greatertransparency in industry’s research and development and marketingapproaches” and will also need to understand factors affecting pricingand barriers to market entry.

“The generic pharmaceutical industry is losing interest inmanufacturing older, off-patent medicines because the market pricehas been slashed to a level that it no longer provides an incentive toproduce them,” Kieny contends. “The result is either low-qualitymedicines, or no medicines at all,” she says, citing recent shortagesof the antibiotic benzathine and the arthritis drug methotrexate. G

PRICING & REIMBURSEMENT

WHO seeks pricing consensusREGULATORY AFFAIRS/BIOLOGICAL DRUGS

Funds float substitution idea

Gen 8-7-16 Pgs. 2-16_Layout 1 06/07/2016 15:02

MARKET NEWS


An event held in Belgium uniting healthcare professionals, expertson biosimilars and the country’s health minster has emphasised the

safety and efficacy of biosimilars, as well as their economic benefits.The Belgian Biosimilars Conference comes as biosimilars face a“crucial year” in 2016, according to local generics and biosimilarsindustry association FeBelGen, in the wake of an industry agreementaimed at boosting uptake by the end of the year.

Agreed at the start of this year, the deal between FeBelGen, brandassociation Pharma.be and several Belgian doctors’ and hospitalassociations aims to “provide the necessary momentum” for theuse of biosimilars, including by setting initial goals for the uptakeof biosimilar epoetin, filgrastim and infliximab (Generics bulletin,15 January 2016, page 5). An initial evaluation of progress is due thismonth, with the ministry having suggested that legislative measureswould follow if the consumption of biosimilars did not increase.

At the Belgian Biosimilars Conference, health minister Maggie deBlock confirmed that “more coercive measures” would be applied from1 January 2017 to encourage uptake if the outlook did not improve.Meanwhile, a host of doctors and academics testified as to the safetyand reliability of biosimilars, as well as pointing to the “tens of millionsof treatment days” already registered with biosimilars in Europe.

Meanwhile, FeBelGen’s latest Biosimilars Newsletter has alsocollated recent opinions and publications of healthcare bodiesacross Europe – including from Denmark, Finland, France and theNetherlands – to add weight to the argument for switching betweenbiologic brands and their biosimilar counterparts. G

REGULATORY AFFAIRS

Biosimilars facing akey year in Belgium

South Africa’s minister of health, Aaron Motsoaledi, intends nextyear to increase by up to 5.70% single exit prices (SEPs), the

uniform maximum prices chargeable to private-sector patients formedicines, excluding dispensing fees. Interested parties have until24 September to submit comments.

Acting upon the advice of an expert pricing committee, Motsoaledisaid the planned 5.70% price rise was “based on the inflation datafrom the point of the previous review up to the latest available data”.The 2017 SEP review would, he added, take into considerationprevious price adjustments that were necessary “to maintain securityof supply due to the prevailing economic climate”.

While Motsoaledi granted a 4.80% SEP rise at the start of thisyear (Generics bulletin, 29 January 2016, page 8), industry haspushed for further increases to compensate for the effects of the steepdevaluation of the rand on the cost of imports such as raw materials.

Reporting its half-year results in March this year, Aspen said theweaker rand was presenting a “commercial challenge”, particularlyfor imports. With the SEP fixed on a rand basis, the South Africancompany was having to “relook at strategies to retain profitability” asthe commercial viability of several products was called into question.

At the same time as he proposed the 5.70% SEP increase,Motsoaledi invited comments on amended dispensing fees,exclusive of value-added tax (VAT). For drugs with an SEP of lessthan ZAR115.00 (US$7.91), the maximum dispensing fee is to beno more than 30% of the product’s SEP. For more expensivemedicines, the dispensing fee must not exceed ZAR34.50. G

PRICING & REIMBURSEMENT

South Africa plans5.7% price increase

Switzerland’s regulatory agency, Swissmedic, had receivedEuropean Union (EU) reports on five applications made under the

centralised and decentralised marketing-authorisation procedures asof the end of last year, according to the agency’s 2015 annual report.

The Swiss agency is discussing its experiences of the information-sharing pilot with the European Medicines Agency (EMA) and nationalEU authorities through the International Generic Drug RegulatorsProgramme (IGDRP).

During 2015, Swissmedic discussed the “authorisation processfor biosimilars” through a patient and consumer organisations workinggroup that it established two years ago. Meanwhile, the agency continuedto participate in two EU-Pharmaceutical Inspection Co-operationScheme (PIC/S) working groups on good manufacturing practice(GMP) – one that is revising sterile products guidelines, and the otherthat is drafting various data-integrity guides for industry and inspectors.

“Two Swissmedic inspectors were enrolled on the EuropeanDirectorate for the Quality of Medicines (EDQM) internationalinspection programme for manufacturers of active pharmaceuticalingredients (APIs),” the agency revealed, adding that they had takenpart in audits in China and Japan.

Last year, Swissmedic doubled the number of ad hoc GMP orgood distribution practice (GDP) inspections it conducted “due tocomplaints or suspected infringements of the law”. However, theagency’s total number of GMP/GDP inspections fell by 8% to 565. Thiswas due to an 18% drop to 235 in the number of manufacturer audits. G

REGULATORY AFFAIRS

Swissmedic shares EU reportsAn online ‘biosimilars resource center’ (BRC) that is claimed to be

“an unbiased, policy-neutral repository of educational resourcesand information on biosimilars for pharmacists, physicians, nurses andother healthcare providers” has been launched by the US Academyof Managed Care Pharmacy (AMCP).

“The BRC does not accept advertising or corporate sponsorship,and will maintain complete neutrality in the information it presents,”the association of around 8,000 members insisted.

Through the BRC website at www.biosimilarsresourcecenter.org,the AMCP is looking to provide “a comprehensive range of educationaland resource materials aimed at pharmacists, physicians and otherproviders, including frequently asked questions, whitepapers, web-based seminars, continuing education programmes and journal articles”.

“Biosimilars are new to the US market, and many healthcareprofessionals are still unfamiliar with their potential to improve patientcare and lower costs,” commented the AMCP’s chief executive officer,Susan Cantrell. “Providers will have many questions about biosimilars,so we are committed to making the BRC a comprehensive, one-stopresource for unbiased, up-to-date information.”

In creating the online resource, the AMCP worked in partnershipwith the American Association of Colleges of Pharmacy, the AmericanPharmacists Association, the American Society of ConsultantPharmacists, the Hematology/Oncology Pharmacists Association,the National Alliance of State Pharmacy Associations and the NationalCommunity Pharmacists Association. G

COMMUNICATION CAMPAIGNS/BIOLOGICAL DRUGS

US website offers resources

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MARKET NEWS


Biosimilar epoetins captured just over half of the European Union(EU) market by volume from their reference products last year,

according to an updated version of a report prepared by IMS Healthfor the European Commission. A previous version of the report,based on 2014 data, put the biosimilar epoetin share, measured bytreatment days, at 43% (Generics bulletin, 8 January 2016, page 1).

According to the June 2016 update that was presented at astakeholder conference on biosimilars hosted by the Commissiontowards the end of last month (Generics bulletin, 24 June 2016,page 7), biosimilar epoetin alfas and epoetin zetas – marketed underthe brand names Abseamed, Binocrit, Epoetin Alfa Hexal, Retacritand Silapo – accounted for just over a third of the accessible marketcomprising the reference product, non-reference off-patent originalsand the biosimilars. This represented an increase of five percentagepoints from the 29% recorded in 2014.

In the total volume market, including patent-protected non-reference brands, biosimilars’ share improved by four points to 19%.IMS Health noted that reference products such as Eprex/Erypo hadclung onto 18% of the total market, while non-accessible epoetins– long-acting pegylated versions such as Aranesp, Mircera and Nespo –captured 45% of the market by volume. The other 18% was held bynon-referenced, off-patent brands such as Teva’s Eporatio (epoetin theta).

Comparing 2015 against the year before biosimilar entry, IMSHealth said the list price per treatment day had fallen by a third versusthe reference drug, although this drop covered a range from over 70% inBulgaria and Portugal to just 1% in Belgium. Volumes for biosimilarsand their reference drugs rose by 71% over the same period.

For granulocyte-colony stimulating factors (G-CSFs), biosimilarfilgrastims – Grasalva, Grastofil, Nivestim, Ratiograstim and Zarzio –captured 85% of the reference-product market last year, 72% of theaccessible market and 23% of the total market. The correspondingfigures in 2014 were 81%, 67% and 21%. The biosimilars offered a32% price discount last year to both their reference products and theaccessible market prior to biosimilar entry.

Biosimilar infliximab under the Inflectra and Remsima brandnames took 13% of the reference-product and accessible markets atan average 8% price discount to the original, Janssen’s Remicade.

Sandoz’ Omnitrope (somatropin) took 35% of the accessiblemarket at a 19% price discount last year, while Finox’ Bemfola(follitropin alfa) took a 4% share despite a negligible price differenceto its reference brand, Merck-Serono’s Gonal-F. The report wascompiled too early to assess data from the launch of Samsung Bioepis’Benepali (etanercept) biosimilar in countries including Germany,Norway, Sweden and the UK, while no market share was recordedfor Eli Lilly’s Abasaglar (insulin glargine) biosimilar of Lantus.

Looking at the overall biosimilars market, IMS Health observedthat competition had reduced average prices by up to a third versusreference products, with some countries showing price cuts of around60% for epoetin and G-CSF. Lower prices had increased patientaccess in countries with low initial usage, but in general, “thecorrelation between biosimilars’ market share and price is weak”.

However, the market researcher noted, originators had achievedsuccesses in defending market share, whether by cutting the referencebrand’s price to close to that of the biosimilars – such as had beenseen with somatropin in Sweden – or by originators introducing long-acting and pegylated versions without a price premium, as had occurredwith G-CSF in Denmark. G

MARKET RESEARCH

Epoetins gain half ofthe European market

MEDIA COVERAGE in the UK of the controversy over the risksand benefits of statins will lead to “at least 2,173 excesscardiovascular events” in the 10 years after two articles publishedin the British Medical Journal (BMJ) were “perceived as criticalof statins”. A study just published in the same journal found thatpatients already taking statins were “more likely to stop taking themfor both primary and secondary prevention after the high mediacoverage period” in late 2013 and early 2014. Further, stratifiedanalyses showed that older patients and those with a longer continuousprescription were “more likely to stop taking statins after the mediacoverage”. However, “this increase seemed to be temporary, andcessation had returned to expected levels after six months”.

A PARTNERSHIP between 15 Sub-Saharan African countries, theWorld Health Organization (WHO) and the European Union (EU)has started discussing future steps and priorities, “such as plansto move towards universal health coverage”. Noting that several Sub-Saharan countries were “seeking partners to improve their ownpharmaceutical systems”, the WHO highlighted pricing as a majorbarrier to access. “Generic medicines in low-income countries are onlyavailable in about 58% of facilities and on average cost 2.5-timesmore than the international reference price,” the WHO noted.

PCMA – the Pharmaceutical Care Management Associationrepresenting US pharmacy benefit managers – has described a recentSenate judiciary sub-committee hearing on the Creating andRestoring Access to Equivalent Samples (CREATES) Act as “animportant step toward ensuring competition and affordability in theprescription drug marketplace”. The draft legislation aims to tackleabuse of risk evaluation and mitigation strategies (REMS), suchas by denying generics firms the samples they need to conductbioequivalence studies (Generics bulletin, 1 July 2016, page 6).

THE US COURT OF APPEALS for the Federal Circuit has deniedMylan’s petition for a panel rehearing or rehearing en banc of adecision earlier this year on the jurisdiction of local district courtsin patent litigation. The court ruled in March this year that Mylancould be sued for patent infringement in a Delaware court becausethe generics firm regularly conducted business and sold productsin the state (Generics bulletin, 25 March 2016, page 1).

EMA – the European Medicines Agency – says its committee forhuman medicinal products (CHMP) will on 15 September deliverits opinion on medicines containing metformin. This follows an‘Article 31’ pharmacovigilance referral for the diabetes drug.

SIX US BIOLOGICS PRESCRIBERS’ GROUPS, representingendocrinologists and rheumatologists, have commended Section11 of S.2700, a provision of the proposed 21st Century Cures Act.The draft legislation states that sections of the US Federal Food, Drug,and Cosmetic (FD&C) Act that refer to “an official compendium”do not apply to biologic drugs. “Section 11 will ensure that theFood and Drug Administration (FDA) sets biosimilars policy, notthe US Pharmacopeia,” the prescribers groups stated in a letter tothe bill’s bipartisan sponsors.

REPURPOSING OF ESTABLISHED MEDICINES and activesubstances was among the topics discussed during the latest meetingof the European Commission’s expert group on safe and timelyaccess to medicines for patients (STAMP). The Commission’sSANTE health directorate made a presentation on the basis ofprevious discussions, while UK representatives gave an overviewof replies to a questionnaire. G

IN BRIEF

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Sandoz Canada’s filing for biosimilar etanercept has beenaccepted for review by Health Canada. The US Food and Drug

Administration (FDA) accepted Sandoz’ etanercept filing in Octoberlast year (Generics bulletin, 23 October 2015, page 21), and it is dueto be discussed by the FDA’s Arthritis Advisory Committee on 13July (Generics bulletin, 17 June 2016, page 11). The rival to Amgen’sEnbrel was also accepted by the European Medicines Agency (EMA)for regulatory review in the fourth quarter of 2015.

Last year, Sandoz also received approval from Health Canadafor a number of additional indications for Omnitrope (somatropin),the firm’s first biosimilar.

The company outlined plans last month to make “five majorglobal biosimilar launches by 2020” (Generics bulletin, 24 June 2016,page 11), which Sandoz said would be “enabled by an aggressiveregulatory submissions strategy of 11 filings over a three-year period”.

Furthermore, the firm said plans to invest over US$1 billionbetween 2010 and 2020 in “state-of-the-art biomanufacturing facilities”in Schaftenau and Kundl, Austria, would “ensure that Sandoz’ biosimilarmedicines reach patients and healthcare professionals around the world”.

The surge in biosimilar medicines will “drive significant changein health system costs, patient access and competition by 2020”,according to a recent IMS report cited by Sandoz (Generics bulletin,8 April 2016, page 14). G

PRODUCT NEWS


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BIOLOGICAL DRUGS

Sandoz’ etanercept isreviewed in Canada

AstraZeneca is furthering its efforts to prevent the US Food and DrugAdministration (FDA) from granting final approvals for generic

rivals to the originator’s Crestor (rosuvastatin) with a rare indication‘carved out’ by suing the agency in a Columbia district court.

The UK brand company is seeking an order enjoining the FDAfrom applying what AstraZeneca argues is an “unlawful” interpretationof the agency’s own paediatric-labelling and carve-out regulations,set forth last year when the agency approved generic versions ofOtsuka’s Abilify (aripiprazole) with a protected indication carvedout (Generics bulletin, 5 June 2015, page 22).

Under the FDA’s application of the ‘Abilify’ interpretation ofgeneric labelling, which is an “unexplained departure from pastagency practice”, AstraZeneca claims, generic versions of Crestorcould “flood” the market from as early as 8 July 2016, when thefirm’s reissued compound patent RE37,314 expires.

AstraZeneca said it was currently providing the FDA and USDepartment of Justice with a copy of this lawsuit “and will promptlyconfer to see if defendants will agree to an expedited briefing schedulethat would enable this court to resolve this case before the FDAapproves the generic Crestor abbreviated new drug applications(ANDAs)” when the ‘314 patent expires. If no such agreement waspossible, “then AstraZeneca will have no choice but to file anapplication for a temporary restraining order”, the firm noted.

Last month, the originator submitted a citizen petition to the FDAurging the agency to deny final approval of generic versions of Crestoruntil 27 May 2023 (Generics bulletin, 24 June 2016, page 9), whenrecently-granted orphan drug exclusivity (ODE) expires covering theuse of Crestor to treat homozygous familial hypercholesterolaemia(HoFH) in paediatric patients aged between seven and 17.

Tentative FDA approvals for rosuvastatin tablets are currently heldby Alkem, Apotex, Aurobindo, Glenmark, Mylan and Par, as well asSandoz, Sun, Teva and Torrent. Crestor was, by value, the fourth-largest selling drug in the US for the year ended September 2015,according to IMS Health data. Sales grew by 7.8% to US$6.25 billion.

Actavis launched the first US generic versions of rosuvastatin inMay, under the terms of a settlement agreement reached by its erstwhileWatson business three years ago (Generics bulletin, 6 May 2016,page 11), “The status of Watson’s generic rosuvastatin product is notat issue in this suit,” AstraZeneca made clear. G

CHOLESTEROL-LOWERING DRUGS

AstraZeneca furthersrosuvastatin efforts

Amneal has launched its generic version of Lutera (levonorgestrel/ethinylestradiol) in the US under the name Larissia. The oral

contraceptive – available as 0.1mg/0.02mg tablets – is a furtheraddition to the company’s “growing line of women’s health products”,which also includes hormone replacement therapies.

“Our women’s health product pipeline is rich with complexformulations, new dosage forms and devices dedicated to addressingspecific women’s health concerns,” commented Amneal’s executivevice president of sales and marketing, Jim Luce. “We are committedto expanding this category beyond 2016.” Amneal plans to “furtherstrengthen the company’s growing women’s health line” with severalother products “planned for launch before year-end”. G

ORAL CONTRACEPTIVES

Amneal launches Lutera rival

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The US Food and Drug Administration’s (FDA’s) decision to rescinda generic marketing approval it had given to Lannett based on the

agency’s later conclusion that the approval was “mistakenly granted”was unlawful and should be set aside, the US firm has alleged in legalproceedings against the FDA.

In a five-count complaint, Lannett asserts that an FDA drugapproval is a “constitutionally-protected property right”, and thus theFDA’s governing statute “requires an opportunity for a hearing beforethe agency may rescind a previously-granted approval”, which thefirm says it did not receive.

Lannett’s dispute before a Columbia district court concerns theFDA’s decision to rescind approval of Lannett’s abbreviated new drugapplication (ANDA) covering a generic version of Merck & Co’sTemodar (temozolomide) capsules in six strengths.

In connection with Lannett’s ANDA submission, the FDA inMarch this year inspected a facility belonging to the manufacturerof the temozolomide active pharmaceutical ingredient (API) identifiedin Lannett’s application, China’s Chongqing Lummy.

The inspection revealed current good manufacturing practice(cGMP) deficiencies, including a failure to implement controls toprevent data manipulation and to “document manufacturing operationsat the time they are performed”, and resulted in Lummy being issuedwith a warning letter. Nevertheless, the FDA approved Lannett’sANDA shortly thereafter (Generics bulletin, 8 April 2016, page 11).

The FDA then, however, sent Lannett a ‘General Advice’ letter,“indicating that Lummy would not be releasing any new temozolomideAPI into the US market until the FDA deemed the Lummy facilityacceptable”. A requested conference call with Lannett followed inearly April, during which Lannett confirmed that it had not launchedits generic temozolomide capsules but did not agree to the FDA’srequest to withdraw or rescind the ANDA. Instead, the firm requestedthat the agency “state its position regarding ANDA withdrawal orrescission in writing”.

In accordance, the US firm then received an ‘ANDA GeneralAdvice’ letter from the FDA stating that ‘due to review andendorsement process errors’, in connection with potential cGMPviolations identified at Lummy’s site, the “FDA had preliminarilydetermined that it had made a mistake in approving Lannett’s ANDA”.Lannett’s counsel responded by arguing that if the FDA wished torevoke an ANDA, “the agency must follow hearing procedures of[New Drugs statute] 21 US Code § 355(e)”.

However, the FDA, the following month, sent Lannett a rescissionletter, in which the agency said information about the state of Lummy’scGMP “was not adequately conveyed to FDA officials making the finaldecision”, and that the approval was thus “a mistake”. “The rescissionorder is final and definitive,” Lannett states, “[and] also determines thatit is unlawful to distribute Lannett’s drug.”

“The FDA did not provide Lannett with the statutorily-requiredopportunity to cure the manufacturing issues of concern to the agencybefore revoking the approval”. Moreover, “the FDA’s statements inthe [rescission] letter establish that rescission of the ANDA wasnot necessary to prevent distribution of temozolomide with APImanufactured by Lummy,” Lannett also asserts.

Calling on the court to set aside the rescission and declare itunlawful, Lannett requested the court enjoin the FDA from revokingits ANDA “in the future without a hearing, and without following theprocedures established by 21 US Code § 355(e)”. G

PRODUCT NEWS


2-5 August■ 3rd PharmaCon,

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

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

7-8 September■ GPhA Biosimilars Council Conference

Maryland, USAThis is a two-day interactive conference looking at topics includingaccess, regulatory issues, reimbursement, interchangeability andthe legal landscape.

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

29-30 September■ Biosimilars Europe

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

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

3 & 4-6 October■ CPhI Worldwide

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

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

24-26 October■ GPhA Fall Technical Conference

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

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

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

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EVENTS – August, September & October

SAVE THEDATE...

ONCOLOGY DRUGS

Lannett says ANDArevocation is unlawful

Gen 8-7-16 Pgs. 2-16_Layout 1 06/07/2016 15:02

Breach-of-contract claims levelled by Bristol-Myers Squibb (BMS)against Mylan over the pair’s distribution agreement for the US

originator’s Reyataz (atazanavir) in certain territories will be heardfor a third time, after the US Court of Appeals vacated and remandedfor further proceedings a prior New York district court ruling.

BMS had five years ago entered into the agreement with Mylan’sMatrix, allowing Matrix to sell generic versions of the HIV treatmentin “certain under-developed countries without fear of litigation”,including in “India and 44 countries in Sub-Saharan Africa”.

The originator has insisted that a shipment of atazanavirdistributed by Matrix to Venezuela via the Pan-American HealthOrganization (PAHO) fell outside the scope of the agreement. ANew York district court has, however, dismissed twice BMS’ claims.

“Because we cannot say that BMS has failed to state a claimunder at least one of the allegedly applicable laws,” the appeals courtruled, “nor can we determine at the motion-to-dismiss stage whichlaw indeed governs the Matrix-PAHO transactions to which BMS wasnot a party, we conclude that the district court improperly dismissedthe second amended complaint.” G

ANTIRETROVIRALS

Atazanavir case willbe heard again in US

Martindale Pharma has extended its relationship with strategicpartner Unimedic by striking a licensing agreement for its

‘emergency care’ sterile ampoule products in Sweden, Denmark,Norway and Finland. Three undisclosed products would be launchedunder the deal, Martindale said, and the companies would worktogether on regulatory and supply-chain activities leading up to thelaunch. Financial terms of the agreement were not disclosed.

The Scandinavian deal adds to the established relationship throughwhich Unimedic already markets Martindale’s injectable adrenalinein the region (Generics bulletin, 1 April 2016, page 10).

Michael Harris, Martindale’s chief executive officer, saidextending the partnership with Unimedic would “provide furtheropportunity to launch our products into additional markets”. Martindaleplanned to add additional emergency care products to the deal “inthe next few months”, Harris noted. G

CRITICAL-CARE DRUGS

Martindale and Unimedic ally

PRODUCT NEWS


PRICE WATCH ....... UK

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: [email protected].

Price WatchIndex

PharmacyProfit Index94.2 85.3

Monthly change -2.9 Monthly change -13.8

Basket Price Reimbursement Price Pharmacy Profit£2,005.50 £3,442.27 £1,436.77

June 2016 June 2016

The Price Watch Index is based on the actual average trade price according to WaveDataof a representative basket of 20 popular generic products in March 2016, when the Indexwas 100. The basket reflects recent official prescribing data for England and Wales andrepresents what an average pharmacy would pay for the products, which were selected asbeing the top cash generators within pharmacy. The Pharmacy Profit Index is calculatedon the same basis by applying Drug Tariff reimbursement prices to the basket.

Average monthly trade prices of our representative basket ofUK generics have fallen by 5.8% since March, when the

Price Watch Index was set at 100. An Index of 94.2 in June alsorepresented a 2.9 percentage-point fall from the previous month.

Meanwhile, the Department of Health (DoH) has been clawingback at a faster rate its reimbursement spending on the populargenerics in our basket. Whereas independent pharmacists weremaking £1,683.51 from dispensing the basket in March, they wereonly profiting by £1,436.77 last month, a fall of 14.7% to 85.3%of the March figure.

Not that the squeeze on average pharmacy profits by the DoHhas been consistent over the past few months. Average profit felldramatically by 15.3 percentage-points in April, only to recoverto an Index figure of 99.1 in May. Another 13.8 percentage-pointfall in June, however, has seen the Profit Index drop back to asimilar low point. G

June 2016

Revised guidance for ‘similar biologics’ in India that has just beenpublished by the country’s Central Drugs Standard Control

Organisation (CDSCO) and the Department of Biotechnology(DBT) reiterates that biosimilars can be registered in India usingreference biologics approved in any International Conference onHarmonisation (ICH) country.

This change – which allows biosimilars to be registered in Indiausing reference biologics approved in the European Union (EU), alongwith countries including Japan, the US, Canada and Switzerland –was among a series of amendments made to India’s existing pathwayfor registering biosimilars in guidance published earlier this year(Generics bulletin, 8 April 2016, page 7).

“In case the reference biologic is not marketed in India [it] shouldhave been licensed in an ICH country,” the guidance reaffirms. “Thereference biologic can be imported for developing the similar biologicfor quality, pre-clinical and clinical comparability.”

The revised guidance is largely similar to the updated guidancepublished earlier this year, although it features a new section detailingimmune responses in animals under data requirements for pre-clinicalstudies, as well as an amended set of sections on data requirementsfor clinical trial applications.

Under previous guidance laid out four years ago (Genericsbulletin, 13 July 2012, page 1), biosimilar applications were approvedby the CDSCO and the DBT on a case-by-case basis, through anabbreviated version of the pathway used for new drugs. G

REGULATORY AFFAIRS

India issues revisedbiosimilar guidance

SUNSHINE BIOPHARMA has signed a further ‘cross referencingagreement’ with a “major pharmaceutical company” covering aselection of three generic cancer and benign prostatic hyperplasiatreatments. The Canadian firm’s agreement is for generic versions ofAstraZeneca’s Casodex (bicalutamide), Novartis’ Femara (letrozole),and Merck’s Propecia (finasteride). G

IN BRIEF

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Dr Reddy’s and Sandoz have successfully worked around two UKpatents protecting the BuTrans (buprenorphine) transdermal

patches marketed by Mundipharma affiliate Napp. Patents Court JudgeRichard Arnold found that proposed generics from both firms felloutside of the key claims of the UK parts of European patentsEP2,305,194 and EP1,731,152, both of which expire in February 2018.

Observing that Napp sold around 10 million BuTrans patches peryear in the UK, Arnold noted that the originator’s Qdem affiliatehad been offering an authorised generic under the Butec brand namesince 1 February this year.

At around the same time, Sandoz obtained a UK marketingauthorisation under the Reletrans brand name for seven-daybuprenorphine patches manufactured in Germany by its Hexalsubsidiary. Sandoz, he said, had been “ready to launch the productsince about mid-March 2016”, but had given temporary undertakingsto hold off pending an expedited trial in June this year.

Dr Reddy’s responded to Napp’s application for an injunction bycounterclaiming for a declaration of non-infringement. Arnold notedthat, as of the last day of the trial, the Indian firm had not yet obtaineda UK marketing authorisation for its patches and “had only just gotto the point of starting production”.

Both patents at issue were, Arnold said, divisionals from theparent European patent EP0,964,677, which had been revoked by thetechnical board of appeal at the European Patent Office (EPO), althoughthat decision was under petition for review. Appeals were also pendingagainst the EPO’s decision to reject opposition proceedings against the‘194 patent, on which Arnold chose to focus in his infringementconsiderations as part of the ruling.

It was only necessary to consider Claim 1 of the ‘194 patent,Arnold insisted. This covers buprenorphine transdermal deliverydevices comprising, by weight, 10% buprenorphine base, 10%-15%levulinic acid, about 10% oleyl oleate, 55%-70% polyacrylate and0%-10% polyvinylpyrrolidone. Construing the claim to refer to thefinished product, Arnold said the numerical limits and ranges shouldbe regarded as “expressed to the nearest whole number”.

Sandoz’ patch falls outside claimOn this basis for Sandoz, he continued, “the issues on infringement

are whether the Sandoz product has 10% by weight buprenorphine,10-15% levulinic acid and about 10% oleyl oleate.” Taking the court’sclaim construction, Napp accepted that Sandoz’ patches “will not fallwithin the claim, regardless of statistical considerations”. Furthermore,Arnold added, even under Napp’s favoured construction, the originatorconceded that none of the commercial laminates manufactured bySandoz’ Hexal to date infringed the patent.

Tackling Napp’s argument that the inherent variability of patchproduction meant a small sample of Sandoz’ generics could infringe,Arnold pointed out that the originator had “chosen to accept” Sandoz’analytical data, so had “only itself to blame” for his ruling that aninjunction would be “disproportionate, because the harm to the patenteefrom infringement on such a small scale would be indistinguishablefrom the harm caused by wholly non-infringing acts”.

Similarly, Napp “did not raise any issue as to the precision” ofanalytical methods used by Dr Reddy’s to assess the levulinic acidand oleyl oleate content of its laminate. Arnold found that “the testingregime and statistical protocol proposed by Dr Reddy’s is suitable”to ensure that any infringement would be “to a de minimis extent”. G

PRODUCT NEWS


ANALGESICS

Reddy’s and Sandozwork around BuTrans

BIOLOGICAL DRUGS

Cinfa Biotech is seeking partnerships to market its biosimilarpegfilgrastim in Europe after announcing positive data from a

clinical trial for the biosimilar to treat chemotherapy-inducedneutropenia. The Spanish firm’s B12019 pegfilgrastim candidate metthe primary endpoints of the trial to demonstrate its pharmacokinetic(PK) and pharmacodynamic (PD) equivalence with originatorproduct Neulasta, with secondary endpoints “safety, tolerabilityand immunogenicity” of the products also deemed “comparable”.

The single-dose, randomised, double-blind crossover studyenrolled 172 healthy volunteers in Germany, and was designed basedon scientific advice received from the European Medicines Agency(EMA). A manufacturing process was “implemented at commercialscale” at the end of last year (Generics bulletin, 23 October 2015,page 26). Cinfa stated its biosimilar rival to Neulasta was the “firstproduct within a pipeline of high quality biosimilars for a range ofindications, including cancer and inflammatory diseases”.

Cinfa’s managing director, Ruediger Jankowsky, said the“significant milestone” of the positive results from the clinical trial“confirms our development strategy”, which is based on the “mostup-to-date scientific considerations and includes a second clinicalstudy to investigate the immunogenicity of B12019”. “We will nowaccelerate the establishment of partnerships for commercialisation,”he added, “as we expect a timely submission for approval in Europe.”Further data will be presented at upcoming scientific conferences.G

Cinfa seeks partnersfor rival to Neulasta

Gen 8-7-16 Pgs. 2-16_Layout 1 06/07/2016 15:02

PARAGRAPH IV WATCH


In today’s competitive climate, nearly every original drug in the USis seen as a target for a paragraph IV patent challenge, even those

with extremely modest market potential. In an effort to minimisecompetition, generic drug companies have frequently sought out nicheproducts they think are likely to attract few other challengers, whetherfor reasons of limited market potential, product complexity, or otherfactors that reduce commercial interest. In the case of Taro’s paragraph IVchallenge to ApoPharma’s Ferriprox (deferiprone) tablets, we see anexample where such niche targeting may have succeeded.

Many generic companies seek to maximise profit potential byaggressively pursuing eligibility for the 180-day generic marketexclusivity offered to the first filer of an abbreviated new drugapplication (ANDA) containing a paragraph IV certification that atleast one patent is invalid, unenforceable or not infringed by theANDA. As the first generic entrant, a company can secure marketshare and enjoy six months of sales before the advent of furthercompetition to the brand drives prices down substantially.

Companies race to be the first to file, but in the case of productscovered by a five-year new chemical entity (NCE) exclusivity, thereis a specific date on which the first ANDAs can be submitted, theso-called NCE -1 date that is exactly one year before the expirationof the NCE exclusivity. With that date as a target, competition is oftenheightened by the prospect of certain eligibility for the 180-dayexclusivity, with some products drawing upwards of 10 ANDAs filedon the NCE -1 date.

Ferriprox (deferiprone) tablets, ApoPharma’s treatment for ironoverload in thalassemia patients, were first approved in the EuropeanUnion (EU) in August 1999, but did not receive approval in the USuntil October 2011. At that time, deferiprone was granted an NCEexclusivity expiring on 14 October 2016.

Only listed patent expiries in 2021With a small patient population, relatively low interest from

generics developers might be expected, but the oral solid formulationand relatively long availability in Europe would suggest somecompetition among filers on the NCE -1 date. The only patent listedfor Ferriprox in the Orange Book – US patent 7,049,328 expiring on28 June 2021 (see Figure 1) – is directed to a method of treating iron-induced cardiac disease, meaning that there are no patents coveringthe compound or formulation to overcome.

In addition, deferiprone is under development for other indicationssuch as amyotrophic lateral sclerosis (ALS) and Parkinson’s disease,which could enhance generic market potential in the long term.

The NCE -1 date for Ferriprox was 14 October 2015, yet accordingto the US Food and Drug Administration (FDA), no ANDA containinga paragraph IV certification was filed for deferiprone tablets untilthe end of January 2016. ApoPharma received notice of Taro’s ANDAin April 2016 and duly filed a patent-infringement suit in the EasternDistrict of Texas in May this year.

“With no other companies yet to be sued, one must assume thatTaro was, indeed, the first to file, despite filing its ANDA after theNCE -1 date. For whatever reasons, Taro saw the niche opportunity thatno others have yet pursued,” comments Thomson Reuters, whichcompiles a database of paragraph IV challenges and associated litigation.

Brands facing NCE -1 dates over the coming months includeAstellas’ Xtandi (enzalutamide) prostate-cancer brand, Eisai’s Fycompa(perampanel) epilepsy drug and Pfizer’s Xeljanz (tofacitinib) treatmentfor rheumatoid arthritis. This opens them up to potential paragraphIV patent challenges (see Figure 2). G

Taro is first to target US Ferriprox patentKEY DETAILS: FERRIPROX

Brand: FerriproxActive ingredient: deferiproneDelivery form: 500mg tabletsBrand owner: ApoPharma

First paragraph IV 29 January 2016filing submitted to FDA:

Known paragraph IV filers: Taro

Orange Book patents: 7,049,328 – 28 June 2021

District court locations: Eastern District of Texas

Litigation references: ApoPharma Inc. et al. vsTaro Pharmaceutical Industries et al.2:16-cv-00528

Figure 1: Paragraph IV challenges to ApoPharma’s Ferriprox (deferiprone) tablets inthe US (Source – Thomson Reuters)

Thomson Reuters draws on strategic intelligence and competitive analysis information on the US genericsindustry to create Newport Premium™, the critical product-targeting and global business-development systemfrom the industry authority on the global generics market.

For further details contact Benjamin Burck, Thomson Reuters API Intelligence, 215 Commercial Street, Portland, Maine 04101, USA.Tel: +1 207 808 7977. Fax: +1 207 871 9800. E-mail: [email protected]. Website: scientific.thomsonreuters.com/newport.

Active Brand Earliest ANDAingredient name submission date

Carfilzomib Kyprolis 20 July 2016Aclidinium bromide Tudorza Pressair 23 July 2016Linaclotide Linzess 30 August 2016Enzalutamide Xtandi 31 August 2016Bosutinib monohydrate Bosulif 4 September 2016Teriflunomide Aubagio 12 September 2016Regorafenib Stivarga 27 September 2016Perampanel Fycompa 22 October 2016Omacetaxine mepesuccinate Synribo 26 October 2016Tofacitinib citrate Xeljanz 6 November 2016Tofacitinib citrate Xeljanz XR 6 November 2016Cabozantinib malate Cabometyx 29 November 2016Cabozantinib malate Cometriq 29 November 2016Ponatinib hydrochloride Iclusig 14 December 2016Pasireotide Signifor 14 December 2016Pasireotide pamoate Signifor LAR 14 December 2016Lomitapide mesylate Juxtapid 21 December 2016Teduglutide Gattex Kit 21 December 2016Apixaban Eliquis 28 December 2016Bedaquiline fumarate Sirturo 28 December 2016Crofelemer Fulyzaq 31 December 2016

Figure 2: Active ingredients subject to new chemical entity (NCE) exclusivitiesfor which abbreviated new drug applications (ANDAs) can be submitted betweenJuly 2016 and December 2016 (Source – Thomson Reuters)

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

Over the past five years, Natco Pharma has madesolid progress. The Indian company, in whichits owner-operator ‘promoters’ hold a 51.3%

controlling stake, has grown its turnover on average bya fifth each year, reaching sales of just over Rs11.5billion (US$171 million) in the 12 months ended 31March 2016 (see Figure 1).

Under the leadership of chairman VC Nannapeneniand vice-chairman and chief executive officer RajeevNannapeneni, Natco has also over the same periodimproved its earnings before interest, tax, depreciationand amortisation (EBITDA) at a faster rate than sales,thereby improving its EBITDA margin to 24.3%.

Much of that growth has come in the Indian group’sdomestic market, particularly in the oncology sector,where Natco has built a portfolio of nearly 30 productsto support its flagship Veenat (imatinib mesylate)leukaemia treatment. But having launched its firstabbreviated new drug application (ANDA) in the USalmost a decade ago, the Indian company has also beenexpanding abroad, not only in the US, but also byestablishing subsidiaries in countries including Australia,Brazil and Canada. The firm’s products are nowmarketed in 40 countries worldwide.

Incorporated in 1981 and headquartered inHyderabad, India, Natco has built a vertically-integratedbusiness model that combines both active pharmaceuticalingredient (API) and finished-dosage form developmentand production. The group currently operates two APIand five formulations facilities.

As Figure 2 shows, the Indian group’s domesticformulations business – including gastro-hepatologydrugs such as Hepcinat (sofosbuvir) – accounted forjust over half, or around Rs6.0 billion, of its Rs11.5billion group turnover in its 2016 financial year ended31 March 2016. International formulations reachedabout Rs2.0 billion or 17% of the group total, whileglobal API sales contributed Rs1.6 billion or 14%. Theremaining Rs1.9 billion or 17% came from otheroperations, including contract manufacturing.

Natco maintains that it has established a “strongfoundation” under its experienced management team bycombining its solid research and development andmanufacturing capabilities for both raw materialsand finished forms to ensure it can offer “verticalintegration for most of its formulation products”. Formarketing and distribution, the company pursues a“de-risked business model through partnerships withglobal pharmaceutical players”.

Based on that foundation, the firm has set up three“pillars of growth”: expanding its US footprint througha differentiated pipeline of niche and complex products;building an emerging presence in Europe, Asia and restof world markets, such as by launching Hepcinat inmore countries; and defending a leading position inIndia’s oncology and gastro-hepatology markets.

Partnering with global and regional generics playersincluding Actavis, Alvogen, Breckenridge, Dr Reddy’s,Lupin and Mylan has been central as Natco hasnavigated the regulatory and legal challenges of creatinga US portfolio and pipeline. Typically, the Indian firm’spartner for a specific product undertakes responsibilityfor both patent litigation and ANDA approval.

“Global generic pharmaceutical companies havesignificant insight into global legal procedures andprotocols, enabling us to draw on their experience tosuccessfully obtain the necessary regulatory approvalsand effectively commercialise our products,” the Indiancompany explained.

At present, Natco’s marketed portfolio in the UScomprises immediate-release solid dosage forms ofmolecules including alprazolam, anastrozole,lansoprazole, ondansetron and rizatriptan. As of 31March 2016, the firm held 13 final and three tentativeANDA approvals that target a combined addressablemarket of around US$1 billion.

However, the company is compiling a US pipelineof “niche and complex generics” that take aim at afar larger combined market. Of the 38 ANDA filingsthat Natco had made by March this year, targeting an

BUSINESS STRATEGY


Working with global

marketing partners

for its vertically-

integrated pipeline

is crucial to Natco

Pharma’s plans to

expand beyond its

Indian base. Aidan Fry

examines the

company’s strategy.

India’s Natco is aiming toexpand through alliances

14

12

10

8

6

4

2

0

(Rs

billi

ons)

Sales EBITDA

5.3

1.2

6.7

1.5

7.6

2.0

8.4

2.1

11.5

2.8

2012 2013 2014 2015 2016

Figure 1: Natco Pharma’s sales and earnings before interest, tax, depreciation and amortisation(EBITDA) in its financial years ended March 2012 to March 2016 (Source – Natco)

Sales CAGR 19.9%

Internationalformulations

17%

Domesticformulations

52%

APIs14%

Others17%

Figure 2: Breakdown of Natco Pharma’s sales of Rs11.5 billionin the year ended 31 March 2016 (Source – Natco)

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addressable market of US$16.4 billion, 16 includedparagraph IV challenges – some of which it believeshave first-to-file status – stating that at least one patentprotecting the reference brand is invalid, unenforceableor not infringed by the firm’s submission. “Ourparagraph IV filings target brands with a combinedmarket size of US$14.0 billion,” the firm stated.

Having withdrawn one pending ANDA, Natcocurrently has 21 under review that target brands with acombination annual turnover of about US$15.5 billion.

By far Natco’s biggest paragraph IV opportunitymeasured by brand sales is the generic versions of Teva’sblockbuster Copaxone (glatiramer acetate) 20mg and40mg pre-filled syringes for which the Indian companyhas partnered with Mylan (see Figure 3).

Natco’s pipeline also includes a US generic ofanother multiple sclerosis blockbuster, Novartis’ Gilenya(fingolimod) capsules. Tying in with the Indian firm’sdomestic strength in oncology, many of its USparagraph IV challenges are for cancer treatments suchas Gleevec (imatinib), Jevtana (cabazitaxel), Treanda(bendamustine) and Tykerb (lapatinib ditosylate). Natcohas also just secured tentative approval from the USFood and Drug Administration (FDA) for its sorafenib200mg tablets that are rivals to Bayer’s Nexavar.

Beyond oncology drugs, Natco’s other paragraph IVtargets include Tamiflu (oseltamivir) capsules for whichthe Indian company has formed an alliance with Alvogen.Under the terms of patent-litigation settlement reachedat the end of last year (Generics bulletin, 8 January2016, page 14), Alvogen will be able to launch aheadof Tamiflu’s US patent expiry in February 2017.

This US pipeline is, Natco says, designed to be“predominantly focused on high barrier-to-entry productsthat are difficult to formulate, difficult to manufactureor may face complex legal and regulatory challenges.”

In Canada, Natco currently offers many of thesame molecules as in the US, including anastrozole,granisetron, letrozole, ondansetron and zolmitriptan.Having incorporated a Canadian operation in 2013,the firm obtained a local drug establishment licence in2015. It has received approval for eight of the 11 filingsit has made in Canada.

Setting up a Canadian operation came two years

after Natco had established a business in Brazil, wherethe firm has to date filed for nine products with localregulatory agency Anvisa. With a local subsidiary inAustralia since 2014, the company has made two filings,while two of the nine dossiers it has submitted inSingapore have been approved.

In Europe, Natco relies on distribution partnershipscovering regions including Germany, the UK andEastern Europe to market its four approved drugs – theoncology drugs anastrozole, bendamustine and imatinib,as well as the migraine remedy rizatriptan.

Drawing on its generic version of Gilead’s Sovaldi(sofosbuvir), the Indian group is also looking to bolsterits presence in other regions, such as in the Indian sub-continent and in the Middle East. Introducing theHepcinat and Hepcinat LP (sofosbuvir/ledipasvir)hepatitis C brands in India and Nepal last year througha non-exclusive licensing agreement with Gilead helpedNatco to establish a domestic specialty pharma divisionthat it has also bolstered by rolling out Natdac(daclatasvir) through an agreement with Bristol-MyersSquibb that was brokered by the Medicines Patent Pool(Generics bulletin, 29 January 2016, page 9).

Such specialty drugs add to the leading positionin India’s oncology market that Natco has establishedsince entering the segment in 2003 with its Veenat(imatinib) branded generic. Having also secured acompulsory licence to offer a local version of Bayer’spatented Nexavar oncology drug (Generics bulletin, 23March 2012, page 17), the company broadened its Indianoncology offering to almost 30 products, generatingan annual turnover of just over Rs2.5 billion.

Underpinning Natco’s global operations andambitions is a solid operational base. The companyspends 6% to 7% of its turnover each year on researchand development. Its APIs operation – based at facilitiesin Chennai and Mekaguda, India – has a portfolio of33 US drug master files (DMFs), with at least 16 moreunder development, in therapeutic categories includingasthma, central nervous system, gastrointestinal,migraine, oncology and osteoporosis.

“Around 60% of our ANDA portfolio is verticallyintegrated, targeting a total addressable market ofUS$10.6 billion,” the Indian company pointed out.G

BUSINESS STRATEGY

“Our paragraph IV filings

target brands with a

combined market size

of US$14.0 billion”


Brand Molecule Therapeutic segment/ Dosage Paragraph IV Paragraph III Market sizeindication form (US$ millions)

Copaxone 20mg & 40mg Glatiramer 20mg & 40mg Multiple sclerosis Pre-filled syringe a 4,350

Gleevec Imatinib Cancer, CML Tablets a 2,375

Gilenya Fingolimod Multiple sclerosis Capsules a 1,765

Revlimid Lenalidomide Multiple myeloma Capsules a 997.9

Treanda Bendamustine Leukaemia Injection a 709.7

Entocort Budesonide Crohn’s disease Capsules a 516.2

Nuvigil Armodafinil Sleep disorders Tablets a 482.1

Tamiflu Oseltamivir Influenza infection Capsules a 403.0

Vidaza Azacitidine Myelodysplastic syndrome Injection a 238.6

Doxil Doxorubucin Ovarian cancer Injection (liposomal) a 203.0

Jevtana Cabazitaxel Prostate cancer Injection a 137.3

Fosrenol Lanthanum carbonate End-stage renal disease Tablets a 118.6

Tykerb Lapatinib ditosylate Breast cancer Tablets a 73.9

Nexavar Sorafenib Kidney cancer Tablets a 72.8

Tracleer Bosentan Hypertension Tablets a 40.3

Figure 3: Key filings within Natco Pharma’s disclosed US pipeline (Source – Natco)

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Mundipharma’s Marco Filippini has been named as vice-coordinator of the Italian Biosimilars Group within local

generics industry association Assogenerici, as the group is restructuredto “better respond” to the needs of “this increasingly important sectorof the drugs market”. He will work alongside fellow vice-coordinator,Baxter’s Stefano Collatina.

Assogenerici said the Italian Biosimilars Group had taken on a“new, more functional governance model” in the interests of autonomyand to help it to “take on present and future challenges”. Thesechallenges included meeting the need to “open up to the outside, tonew industrial realities” that differed from those traditionally servedby Assogenerici, for biosimilars manufacturers and stakeholders.

Mundipharma said the appointment of Filippini – who is thefirm’s general manager in Italy and is regional director for Franceand southern Europe – “confirms Mundipharma’s commitment to thebiosimilar sector, following its 2015 launch of Remsima (infliximab)”.

Collatina was appointed as Assogenerici’s vice-president withresponsibility for hospital drugs – as well as coordinator of the ItalianBiosimilars Group – last year, replacing Hospira’s Francis Colantuoniafter Hospira was acquired by Pfizer (Generics bulletin, 23 October2015, page 35). With the reorganisation of the biosimilars group, hehas been replaced in the hospital drugs role at Assogenerici by AccordHealthcare Italy’s Massimiliano Rocchi. G

INDUSTRY ASSOCIATIONS

Biosimilars groupreorganised in Italy

Stada’s Steffen Retzlaff is no longer responsible for the Germanfirm’s local Hemopharm and Stadavita units, the company has

confirmed. However, he will continue to oversee the firm’s businessesin the Asia-Pacific and Middle East and North Africa (MENA) regions.

“Steffen Retzlaff will focus his activities in Stada’s very importantand strong business in the Asia-Pacific and MENA market region,”a spokesperson for the company told Generics bulletin. “Thereforehe will no longer oversee Hemopharm and Stadavita.” However, theGerman firm offered no comment on who would replace him.

The move follows the resignation in June of his father, HartmutRetzlaff, as the company’s chief executive officer “due to a serious,long-term illness” (Generics bulletin, 10 June 2016, page 1). Executiveboard member Matthias Wiedenfels has stepped in as chief executive“until further notice”, also taking responsibility for corporate strategyand production. Meanwhile, finance head Helmut Kraft has takencharge of sales and marketing, research and development, andpurchasing and supply-chain management.

Board shake-up is imminentIn response to media reports that Stada had also dismissed former

advisors to the chief executive officer, the company’s spokespersontold Generics bulletin that the firm “could not comment on contractswith external advisors”.

Stada’s supervisory board is due to see a shake-up at the firm’sannual general meeting on 26 August, after setting up a specialnomination committee to identify “at least three” new candidates(Generics bulletin, 27 May 2016, page 16). This will begin the processof “significantly renewing” the firm’s supervisory committee two yearsearlier than previously scheduled.

The planned shake-up came after minority Stada shareholderActive Ownership Capital in May proposed the firm replace threeof its nine supervisory board members, with mooted replacementsincluding Active founding partner Klaus Röhrig (Generics bulletin,20 May 2016, page 16). Stada asked the Active candidates to take“a reflection period to consider taking part in the selection process”.

According to Stada, the proposed candidates will be selected“on the basis of a clearly defined set of criteria”, with “particularemphasis” placed on “relevant expertise and experience in the fieldsof generic pharmaceuticals and OTC products”. G

PEOPLE


MANAGEMENT RESHUFFLES

Steffen Retzlaff isrestricted at Stada

INTREXON has appointed Fred Hassan to its board of directors.Hassan is currently a partner and managing director at global private-equity firm Warburg Pincus, having previously served as chairmanand chief executive officer of both Schering-Plough and Pharmacia,after earlier spending a “significant tenure” with Sandoz.

ISPE – the International Society for Pharmaceutical Engineering –has hired Mark Hernick as chief financial officer (CFO) and vice-president of administration, citing his “extensive competencies in for-profit and not-for-profit organisations”. Hernick previously held theposition of CFO for the American Geophysical Union (AGU). G

IN BRIEF

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