10 February 2017

Recommendations calling for “greater transparency and availability” of data on medicinesshortages have been outlined in a joint report released by eight European associations –

including European off-patent association Medicines for Europe, as well as brand industrybody EFPIA and OTC association AESGP – as “part of their wider commitment to tackling theissue”. Building on “existing good practices”, the report outlines specific features of “ideal”systems, which the associations hope can “enhance information systems at a national level”.

To mitigate shortages before they arise, the report insists national supply-chain actorsshould have a “tool to communicate openly without barriers”. Reporting suspected shortages isencouraged in “a similar spirit” to reporting suspected adverse drug reactions. According to theassociations, a standardised reporting template would “aid clear and consistent reporting ofsuspected shortages”. Information on verified shortages should be made “generally available to thepublic where appropriate”, with access restricted only on “reasonable and justifiable grounds”.

“Information systems should be as reliable, up-to-date and as comprehensive as possible,”the report urges. “The systems should indicate, where appropriate, whether alternatives areavailable, allowing decisions regarding substitution and therapeutic alternatives to be made atpractice level.” Also covering governance and competition law issues, the document argues that“collaboration between supply-chain actors to provide information systems should beunderpinned by a national code of collaborative action”. G

EU report set to tackle shortages

COMPANY NEWS 2

Sandoz expands site capacity in Slovenia 2Kyowa Hakko aims at biosimilar frontier 2Pfizer claims lead on biosimilars turnover 3Strides renames itself 3and plans a shake-up

US and Europe dent Zydus Cadila’s sales 4Two firms struck by FDA warning letters 4Dr Reddy’s prepares for 5US re-inspectionLannett has approval to expand Cody site 5Aceto eyes launches as sales see a slide 6Abbott hails shape of its Established unit 6

Torrent tumbles over 7aripiprazole in the US

Glenmark’s sales rise as its profit explodes 7

MARKET NEWS 8

GPhA cites support for EU co-operation 8Industry sets goals to 9streamline regulation

Collaboration key to ensure data integrity 9Europe takes a step to CETA enactment10Brexit paper ducks questions over EMA 11Trump pledges to end 11‘global freeloading’

US bill aims at more competition faster 12

PRODUCT NEWS 13

Apotex and Meridian ally 13in docetaxel dealEPO culls patent on dasatinib molecule 13Alimta patent upheld 14by Japan’s high courtNon-infringing option 14relevant, Canada says

Alvogen has Korean deal with Dipharma15

Amneal succeeds on 15Nasonex rival in US

REGULARSEvents – Our regular listing 10Price Watch UK – UK pricing trends 12People – Ex-Stada Schumann 16named Biofidus chair

Issue No.295

Teva has begun searching for a new permanent leader after its president and chiefexecutive officer Erez Vigodman stepped down with immediate effect by “mutual

agreement”, also leaving the Israeli firm’s board of directors. On an interim basis, chairmanYitzhak Peterburg has been named interim president and chief executive officer, steppingdown from his role as chairman in accordance with Israeli companies law. “We intend toconduct a comprehensive search to identify the best person to lead the company for yearsto come,” stated Teva’s new chair Sol Barer, who has served on the board since 2015.

Peterburg insisted the firm was “focusing on executing its strategic priorities to transformTeva, with immediate focus on realising the cost synergies and strategic benefits” of its US$38.8billion Actavis Generics acquisition (Generics bulletin, 5 August 2016, page 1). Pledging towork with “the entire Teva team” to “conduct a thorough review of the business”, Peterburgsaid he intended to “find additional opportunities to enhance value for shareholders”.

Having most recently served on Teva’s board since 2012, Peterburg was previously vice-president in charge of Global Branded Products from 2010 to 2011, before which he was a boardmember from 2009 to 2010. Citing the firm’s “deep bench of talented leaders”, he said themanagement change would have “no impact on our ability to execute going forward”, given the“strength of our generics pipeline, unique research and development capabilities and unparalleledfootprint”. Meanwhile, Barer emphasised that Teva’s board, drawing on its “decades” ofexperience, would “continue to play an active role in driving the company’s strategy”.

Teva’s search for Vigodman’s replacement comes soon after the firm appointed DipankarBhattacharjee as president and chief executive officer of its Global Generic Medicines Group,succeeding Siggi Olafsson (Generics bulletin, 9 December 2016, page 1). At the time, Vigodmaninsisted the firm would “continue to focus on integrating and realising the value of the ActavisGenerics transaction”, and driving “efficiencies across the generics organisation”. G

Teva looks for new chiefas Vigodman steps down

2 GENERICS bulletin 10 February 2017

company news

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Japanese originator Kyowa Hakko Kirin has established a businessunit that will “work toward obtaining approval to manufacture and

market an authorised version” of the company’s key Nesp(erythropoietin) biologic brand in its domestic market.

The Japanese group said the Tokyo-based Kyowa Kirin Frontierunit formed part of its strategy to create a “unique business structure”and to respond to “social demands for medical cost containment”.

Kyowa Hakko reported Nesp sales down by 2% to ¥56.3 billion(US$498 million) last year. The erythropoiesis stimulating agentaccounted for a little over a fifth of the firm’s Pharmaceuticals salestotalling ¥263 billion – and just over 16% of group turnover that slippedby 6% to ¥343 billion – in 2016. While the Japanese firm said it hadexperienced “steady growth of the market” for Nesp, drug-pricerevisions had depleted brand turnover.

“In our biosimilars business, which is a joint venture with Fujifilm,”Kyowa Hakko commented, “we are making steady progress indeveloping top-quality, highly cost-competitive pharmaceutical products,with the aim of introducing them in markets around the world.” TheFujifilm Kyowa Kirin Biologics (FKB) venture’s FKB327 adalimumabcandidate is currently in Phase III clinical development with a viewto filing in the US and Europe. FKB is also conducting a Phase III“international joint clinical trial” for the FKB238 bevacizumab candidatethat it is developing through its Centus alliance with AstraZeneca. G

Business strategy

Kyowa Hakko aimsat biosimilar frontier

Sandoz’ Slovenian subsidiary Lek is set to develop its domesticoperations by expanding broad-spectrum antibiotic production

capacities at its Prevalje penicillin site in Slovenia. The investmentin the facility – which will be used to “significantly increase capacity”and hire more staff for the plant – comes in response to “the continuinggrowth of demand in recent years”.

Lek noted the investment would “facilitate the expansion of thefacility on the land bought in the immediate vicinity last year fromKoratur”. Production lines are due to start in 2019, after which “newlines will be gradually phased in by 2023”.

Over the past 10 years, Sandoz’ parent firm Novartis had invested“more than C30 million (US$32.2 million)” developing and modernisingfacilities in Prevalje, Lek said. “The new investment is based on theexisting high quality process of products as well as the knowledgeand experience that distinguish this Novartis site,” the firm observed.

Zlatko Ajd, head of penicillin products production at the Prevaljesite, noted that the company’s products were used to treat patients in60 markets. “In recent years, the demand has been continuouslygrowing, and in order to meet this demand, we have recently introduceda number of process improvements,” he stated.

“We are pleased that Novartis has decided to invest,”Ajdcommented, “as the expansion of the current capacity will facilitatefurther development of the site and employment.” G

ManuFaCturing

Sandoz expands sitecapacity in Slovenia

3GENERICS bulletin10 February 2017

company news

Pfizer claims it is the world’s leading biosimilars company, measuredby total sales. “Globally, we have three marketed biosimilars and

are the leader in total sales, as well as having a robust pipeline ofbiosimilar assets,” chairman and chief executive officer Ian Read toldinvestors as he announced annual results including a US$319 millioncontribution from the firm’s Inflectra/Remsima (infliximab), Nivestim(filgrastim) and Retacrit (epoetin zeta) biosimilars (see Figure 1).

Inflectra/Remsima – “the first biosimilar monoclonal antibodyavailable in the US” – made up US$192 million of the global US$319million biosimilars turnover.

Starting to ship Inflectra (infliximab-dyyb) in the US at the endof November generated total US biosimilar sales for Pfizer of US$4million by the end of last year, amounting to around one month of sales.“We anticipate that the uptick in the first few months in the US willbe slow,” the group president of Pfizer Essential Health, John Young,told investors. “That represents our progress in Europe, where we haveseen that after the first few months as physicians get comfortable withbiosimilars, the rate of uptick really begins to accelerate.”

The bulk of non-US biosimilar turnover totalling US$315 millioncame in Pfizer’s ‘Developed Europe’ region – Western Europe,Scandinavia and Finland – where sales reached US$277 million in 2016,comprising US$171 million from Inflectra/Remsima and US$106million from the other two marketed biosimilars, Nivestim and Retacrit.

Developed markets in the rest of the world added US$8 million,including US$5 million from Inflectra/Remsima. The infliximabbrand made up US$12 million of total biosimilars sales in EmergingMarkets that reached US$30 million.

“In terms of biosimilar launches, we are very well positioned to bethe leader that we are today in terms of revenues over the next five to10 years,” Young insisted. “We anticipate in the 2018-2019 timeframe,we will be able to file around five biosimilar products.”

At the end of last year, Pfizer re-submitted its US application forepoetin after Hospira received a complete response letter in 2015.Having recently announced positive top-line results from trials forbiosimilar adalimumab, infliximab and trastuzumab, Pfizer expectsread-out from bevacizumab and filgrastim studies this year.

Biosimilars represented a little over 1% of Pfizer Essential Health’sturnover that grew by 7% to US$23.6 billion as a full-year contributionfrom Hospira pushed up sales of sterile injectables by 53% to US$6.02billion. This more than offset sales of peri-loss of exclusivity (peri-LOE) products that have just lost or are expected to lose protectionthat fell by more than a fifth to US$4.22 billion. G

annual results

Pfizer claims lead onbiosimilars turnover

Annual sales Reported Operational(US$ millions) change (%) change (%)

Innovative Health 29,197 +9 +11

Legacy brands 11,194 -5 ±0Sterile injectables 6,018 +53 +56Peri-LOE products 4,220 -21 -18Infusion systems 1,158 – –Pfizer CenterOne 718 +17 +18Biosimilars 319 – –Essential Health 23,627 +7 +11

Pfizer 52,824 +8 +11

Figure 1: Breakdown by division of Pfizer’s sales in 2016 (Source – Pfizer)

Strides Shasun plans to spin-off its commodity active pharmaceuticalingredient (API) business into a standalone entity and divest the

firm’s generic manufacturing operation in Africa as part of a broadrestructuring initiative geared towards sharpening the firm’s focuson operating as a front-end, finished-dose formulations business.

Meanwhile, the Indian firm – which will adopt the name StridesPharma as its corporate identity – also intends to sell its probioticbusiness, picked up through its acquisition of Medispan’s Indianbranded products operation last year (Generics bulletin, 6 November2015, page 6), and “pursue an independent strategy” for the firm’sStelis Biopharma biotech subsidiary.

Since divesting its Agila injectables business to Mylan at the endof 2013, Strides noted, the firm had “completed several strategiccorporate actions with a clear focus to build a vertically integrated,consumer-focused global formulations business”. Since “movingaway” from its prior business-to-business (B2B) focus, Strides’ “core”front-end businesses were now “witnessing a strong growth trajectory”.

Strides said spinning-off its API business “would create one ofthe largest standalone API companies in the country”. “As part ofthe same scheme, the human active ingredient business of [affiliate]SeQuent Scientific is also proposed to be carved-out into this newcompany, thereby providing critical size,” Strides added.

The proposed standalone business would comprise fivemanufacturing sites, including three approved by the US Food andDrug Administration (FDA), Strides said, and a portfolio of drug masterfiles “to start with”. “The ever evolving regulatory landscape highlightsthe need for having a standalone API player adhering to highercompliance levels. Also, being a B2B business, it needs a differentiatedstrategic direction to grow and deliver value,” the Indian player said,adding that the scheme had received approval from both firms’ boards.

Meanwhile, Strides revealed its plot of six generic manufacturingfacilities in Africa would be divested “to the existing managementteam led by Sinhue Noronha”. “Potential future business opportunities[are] to be tapped through a long-term manufacturing agreement withthe divested entities,” Strides commented. The firm anticipatesreceiving around US$16 million in cash for the business that generatedturnover of US$21 million over the past 12 months.

Concerning Stelis, Strides said it had “over the last few months”been evaluating “various options” to spin-off the business, but hadconcluded Stelis was “still not ready for a separate listing” owingto a continued need to invest in the business. “Stelis will continueto pursue a B2B business model. The company will derive incomefrom contract development and manufacturing organisation andlicensing engagements in the regulated markets, and from its front-end presence in the emerging markets.”

Following the completion of Strides’ restructuring, the firm plansto operate through two dedicated business units: Regulated Marketsand Emerging Markets. “The structuring is directed towards havinga sharper focus on compliance, supply chain and front-ends to providethe necessary growth impetus for its consumer-facing formulationsbusiness. This business is expected to have a superior margin profile,better asset turnover and a healthy return on capital,” the firm noted.

Strides’ restructuring announcement came as the firm reportedgroup sales that climbed by 21% to Rs9.27 billion (US$138 million) inits financial third quarter ended 31 December 2016. Growth was drivenby turnover from the firm’s Regulated Markets business, includingthe US and Australia, shooting up by two-fifths to Rs4.48 billion.G

Business strategy/third-Quarter results

Strides renames itselfand plans a shake-up

4 GENERICS bulletin 10 February 2017

company news

10 February 2017 Issue 295

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

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

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

Two firms – India’s CTX Life Sciences and Italy’s Facta Farmaceutici– have received warning letters from the US Food and Drug

Administration (FDA) relating to their manufacturing facilities.Inspections identified “significant” current good manufacturingpractice (cGMP) deficiencies, concerning active pharmaceuticalingredients (APIs) and finished-dosage forms respectively.

In February 2016, the FDA inspected CTX’ Indian site in Surat,Gujarat, discovering deficient cleaning and maintenance practices.“Our investigator observed rust, insects, damaged interiors, and/ordrug residues in pieces of manufacturing equipment,” the agency noted,despite the firm describing the equipment as “clean”.

Batches of API had been released without ultraviolet testing, theFDA found, to which CTX responded that the ultravioletspectrophotometer had “broken down”. Deeming this response to beinadequate, the agency said it was “unacceptable to distribute batcheswithout conducting the required quality-control tests”.

Meanwhile, an inspection by the FDA at Facta’s facility in Teramo,Italy, in January 2016 discovered data discrepancies for “multiplesterile drug product lots”, which were “not adequately explained”.“Your original data showed failing results, but data you reportedshowed passing results,” the agency stated.

Furthermore, original data had been stored in an “‘unofficial’and uncontrolled” electronic spreadsheet, the FDA observed.

According to the FDA, Facta “failed to establish an adequatequality control unit”, with the investigator observing “many copiesof uncontrolled blank and partially-completed cGMP forms”. Andemployees “used paper shredders to destroy critical laboratory andproduction records without the appropriate controls and procedures”.

“Until you correct all violations completely and we confirm yourcompliance with cGMP,” the agency warned both companies, “the FDAmay withhold approval of any new applications or supplements listingyour firm as a drug manufacturer.” G

ManuFaCturing

Two firms struck byFDA warning letters

Double-digit sales declines in its US and European Formulationsbusinesses caused Zydus Cadila to report a 0.7% dip in its gross

sales to Rs23.0 billion (US$341 million) in the Indian firm’s financialthird quarter ended 31 December 2016. Zydus has just moved tostrengthen its US presence by acquiring local pain-managementspecialist Sentynl Therapeutics, marking the Indian firm’s “entry intothe specialty prescription market in the US” (Generics bulletin, 27January 2017, page 4).

Those falls outweighed double-digit gains in Zydus’ Formulationsoperations in India – where the company recently bought six brandsfrom Merck, Sharp & Dohme (Generics bulletin, 13 January 2017,page 11) – Latin America and the firm’s Emerging Markets region,as well as by its active pharmaceutical ingredients unit (see Figure 1).

Zydus’ pre-tax profit fell by two-fifths to Rs3.24 billion despite a6.7% decrease in research and development spending to Rs2.21 billion.G

third-Quarter results

US and Europe dentZydus Cadila’s sales

Third-quarter sales Change Proportion(Rs millions) (%) of total (%)

US 8,869 -17.2 39India 7,968 +10.7 35Emerging Markets 1,139 +20.6 5Latin America 659 +21.1 3Europe 653 -14.1 3Formulations 19,288 -4.3 84

APIs 1,053 +25.7 5

Others 2,682 +23.1 12

Zydus Cadila 23,024 -0.7 100

Figure 1: Breakdown of Zydus Cadila’s gross sales in its financial third quarterended 31 December 2016 (Source – Zydus Cadila)

5GENERICS bulletin10 February 2017

company news

Lannett is set to “significantly increase” production of activepharmaceutical ingredients (APIs) and strengthen its vertical

integration efforts for pain-management products after the US firm’sboard of directors approved plans to expand Lannett’s Cody LaboratoriesAPI manufacturing business.

Addressing investors as Lannett presented financial results for thefirm’s financial second quarter ended 31 December 2016, Lannettchief Arthur Bedrosian said the company’s board had approved aUS$50 million investment to expand Cody’s pain-management facilities,which are located in Park County, Wyoming.

“The board agreed to the project after reviewing the findings of astudy showing the benefits of increased production of APIs at our Codyplant to further strengthen Lannett’s vertical integration,” he said.

Acquired by Lannett in 2007, and approved since 2008 to importraw materials for processing into controlled substances, Cody currentlyoperates from around 7,000 sq m of manufacturing space. Bedrosiantold investors that Lannett would “probably start to see some benefits”from the Cody upgrade between two and three years post-expansion.

“Our goal is to be vertically integrated in pain management, andpain management includes quite a number of products well beyondopioids,” Bedrosian added.

Turning to Lannett’s agreement to co-develop for the US marketan undisclosed generic insulin product with a partner in China, whichwas signed last year, Bedrosian forecasted to investors the product“should be on the market in two years”.

“We have a major partner in [China’s] ATC Group that is takingthis project further to the point where we can now take the reins andassemble the data for a successful filing with the US Food and DrugAdministration (FDA),” Bedrosian commented. “In addition, weexpect to meet soon with ATC to discuss the work required to file inthe European Union as well.”

Lannett’s sales increased by 34.5% to US$171 million during itsfinancial second quarter, as the firm benefitted from “higher salesacross a number of products”, along with the addition of its acquiredKremers Urban operation.

During the quarter, Lannett secured four product approvals,including for memantine tablets, metaxalone tablets, morphine sulfateoral solution, as well for lopinavir/ritonavir oral solution through thefirm’s Silarx generic oral liquids business. However, the FDA has notyet determined whether to grant for the antiretroviral a 180-day marketexclusivity period (Generics bulletin, 13 January 2017, page 11).

Discussing Lannett’s pipeline, Bedrosian revealed the firmcurrently had 29 abbreviated new drug applications (ANDAs) pendingFDA approval, including 11 with a paragraph IV certification, as wellas an additional 11 ANDAs filed through partnerships.

A US$23.0 million impairment charge related to discontinuinga project within the Kremers Urban pipeline hurt Lannett’s bottom line,although the firm’s operating profit rose by 13.1% to US$34.3 million.On the other hand, Lannett’s gross margin slid almost five percentagepoints to 51.5%, which the firm said was mainly due to lower salesof high-margin fluphenazine. This offset higher than anticipated salesof methylphenidate extended-release, for which the firm recentlybagged an extension to submit evidence to the FDA as part of Lannett’sbid to retain its ANDA (Generics bulletin, 9 December 2016, page 11).

Although Bedrosian did not elaborate, he informed investors thatLannett was “aware of negative speculation with regard to our company”.“We are not going to dignify it with a response,” he insisted. G

ManuFaCturing/seCond-Quarter results

Lannett has approvalto expand Cody site

Dr Reddy’s Laboratories anticipates the US Food and DrugAdministration (FDA) re-inspecting during the next two months

several Indian production sites that were covered by warning lettersissued by the US agency in November 2015.

A little over a year ago, Reddy’s responded to the FDA’sobservations of good manufacturing practice (GMP) deviations at itsactive pharmaceutical ingredient (API) plants in Miryalaguda andSrikakulam, as well as at the firm’s oncology finished-dose facility atDuvvada (Generics bulletin, 9 December 2015, page 3). “The companybelieves that it can resolve the issues raised by the FDA satisfactorilyin a timely manner,” Reddy’s stated, adding that the agency had scheduledrepeat audits of the sites during February and March this year.

Successfully concluding audits of plants affected by warning lettersis one of the Indian group’s key priorities, along with meeting product-development timelines and strengthening its pipeline; scaling up newly-entered geographies across Europe and emerging markets; expandingits biosimilars footprint across select emerging market geographies;and ensuring operational excellence to achieve cost leadership.

Lower contributions from North America and Venezuela ledReddy’s to report sales by its Global Generics division down by 9%to Rs30.6 billion (US$451 million) in the group’s financial thirdquarter ended 31 December 2016.

North America Generics turnover tumbled by 15% to Rs16.6 billion,“primarily on account of increased competition in valgancyclovir andour injectables franchise, coupled with continuing pricing pressure”.

As of 31 December, Reddy’s had 90 abbreviated new drugapplications (ANDAs) and two 505(b)(2) hybrid filings pending FDAapproval. The 90 ANDAs include 59 paragraph IV patent challenges,of which 20 are first-to-file opportunities, Reddy’s believes.

Excluding Venezuela, a reported 7% Emerging Markets declineto Rs5.95 billion became 7% growth. This was despite a 2% slip toRs3.09 billion in Russia, as Kazakhstan and Ukraine led a 16% riseto Rs1.01 billion in other Commonwealth of Independent States (CIS)countries and Romania. Reddy’s said it was “gaining traction” followingits entry into Colombia (Generics bulletin, 21 October 2016, page 12).

India also contributed Rs5.95 billion to the Global Generics total(see Figure 1), while European sales rose by 11% to Rs2.15 billion.Group turnover declined by 7% to Rs37.1 billion. With research anddevelopment spending up by 21% to Rs4.96 billion, Reddy’s reporteda 22% drop in pre-tax profit to Rs5.92 billion. G

ManuFaCturing/third-Quarter results

Dr Reddy’s preparesfor US re-inspection

Third-quarter sales Change Proportion(Rs millions) (%) of total (%)

North America 16,595 -15 45Emerging Markets* 5,948 -7 16India 5,947 +2 16Europe** 2,148 +11 6Global Generics 30,638 -9 84

Pharma Services/APIs 5,400 +6 13

Proprietary Products/Other 1,027 -1 3

Dr Reddy’s 37,065 -7 100

* refers to Russia, other CIS countries, Romania and rest of world markets including Venezuela** primarily Germany, the UK and out-licensing sales business

Figure 1: Breakdown by region and business segment of Dr Reddy’s Laboratories’sales in its financial third quarter ended 31 December 2016 (Source – Dr Reddy’s)

6 GeneRIcs bulletin 10 February 2017

company news

Abbott feels its Established Pharmaceuticals Division (EPD) “hasgrown into the business that we envisioned when we created and

further shaped it through a series of strategic actions, including thesale of our developed markets business and the acquisitions of CFRPharmaceuticals in Latin America and Veropharm in Russia”.

Chairman and chief executive officer Miles White told investorsthat “with leading market positions in several geographies, includingIndia, Russia and Latin America, EPD is well positioned for sustainedabove-market growth in some of the largest and fastest-growingpharmaceutical markets in the world”.

Discussing the EPD unit’s prospects, White said “several driversof growth” included an emerging, increasingly wealthy middle classin many emerging markets. While local healthcare systems wereexpanding rapidly, most countries retained a cash-payment rather thanreimbursement model.

Such emerging markets were, White believed, “target-rich forgeographic expansion, and beyond that for portfolio expansion”.Therefore, he explained, Abbott was working organically on expandingin its key therapeutic areas, including through developing added-valueformulations and improving its distribution structures.

“In a lot of these countries, we are a leader with not that big ashare, so you get all the benefits of being the leader with a lot ofpotential expansion and share gain,” he commented.

Last year, Abbott reported EPD sales that increased by 3.7% toUS$3.86 billion, which the US-based group said equated to 10.5%operational growth. That total comprised US$2.91 billion from “keyemerging markets” such as Brazil, Russia, India and China (BRIC)along with US$947 million from other markets (see Figure 1).

A reported 10.6% EPD sales rise to US$979 million in the fourthquarter of last year was matched in Abbott’s key emerging markets,where sales reached US$777 million. The division’s overall 12.6%operational sales rise in the fourth quarter “was led by double-digitgrowth in the BRIC countries”, which comprise around 45% of EPD’sturnover, “as well as strong growth in several countries throughoutLatin America, including Colombia, Mexico, Peru and Argentina”.

“We continuously refresh and enhance our localised productofferings through internal development, cross-registration of brandsacross geographies, as well as local and regional acquisitions and in-licensing,” White remarked. “In 2017, we will further strengthen ourdevelopment capabilities with an expanded EPD innovation centrein India. In addition to developing new drug formulations, dosing andother differentiated offerings, the centre will act as a hub, shippingproducts to over 30 countries.” G

Business strategy/annual results

Abbott hails shape ofits Established unit

Division Annual sales Reported Operational(US$ millions) change (%) change (%)

Nutrition 6,899 -1.1 +1.2

Medical Devices 5,233 +3.8 +4.5

Diagnostics 4,813 +3.6 +5.5Key emerging markets 2,912 +4.7 +13.3Other 947 +0.9 +2.0Established Pharma 3,859 +3.7 +10.5

Other 49 – –

Abbott 20,853 +2.2 +4.8

Figure 1: Breakdown by division of Abbott’s sales in 2016 (Source – Abbott)

Aceto anticipates several product launches in the US by the end ofits financial year in June 2017, after acquiring over 100 generic

products and ‘related assets’ from US-based generics developmentand marketing firm Citron Pharma and its Lucid Pharma affiliate inDecember (Generics bulletin, 11 November 2016, page 3).

Noting that Aceto launched two generics during its financialsecond quarter ended 31 December 2016 – taking the total to five forthe group’s first half – chief executive officer Sal Guccione saidthe company expected to launch up to 10 products from its RisingPharmaceuticals US generics arm during the second half of the financialyear. Within the same period, Aceto plans to launch around 15approved products acquired from Citron, potentially taking thefirm’s total annual number of expected product launches up to 30.

“We are in the early phases of integrating the products into ourRising Pharmaceuticals business, with new leadership,” Guccione

stated, “and look forward to significant contributions in the future.”Guccione added that active pharmaceutical ingredient (API)

supply challenges that had caused back orders on two Rising productshad “now been resolved”. “Although fiscal 2017 is a challengingyear, we expect to see sequential improvements in performanceduring our third and fourth quarters,” he commented, estimatingfull-year sales growth to be in the “mid-to-high teen” range.

In Aceto’s second quarter, the firm reported group sales downby 4.6% to US$126 million, with its Human Health business slippingby 8.6% to US$54.0 million, “primarily due to increased competition”at Rising (see Figure 1). However, this was “partially offset” by Citronand Lucid, which jointly contributed US$5.0 million. G

Business strategy/seCond-Quarter results

Aceto eyes launchesas sales see a slide

Business Second-quarter sales Change Grosssegment (US$ millions) (%) margin (%)

Human Health 54.0 -8.6 31.3Pharma Ingredients 36.8 +7.4 15.4Performance Chemicals 34.8 -9.3 23.7

Aceto 125.6 -4.6 24.5

Figure 1: Breakdown by business segment of Aceto’s sales and gross margin inits financial second quarter ended 31 December 2016 (Source – Aceto)

Canadian generics specialist Vanc Pharmaceuticals says it is“currently taking steps to increase its revenue stream in 2017” by

leveraging its national sales force and distribution network.“The performance of the company’s sales has certainly been erratic

over the last 18 months,” Vanc observed. “However, the companyendured these teething pains while developing a strategic offering thatwe believe will provide a platform for long-term growth.”

Prior to 2016, Vanc noted, considerable resources and time hadbeen spent in sourcing and licensing products, “obtaining Health Canadaapprovals and listing these products in the provincial formulariesacross the country”. Having established a national salesforce in 2016,the company also set up a second warehouse in Ontario, Canada, tosupplement shipments from its Vancouver warehouse. G

Business strategy

Canada’s Vanc plans ahead

7GeneRIcs bulletin10 February 2017

company news

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Launching the first US generic version of Merck & Co’s Zetia(ezetimibe) blockbuster with 180 days of generic market exclusivity

helped Glenmark to double its US sales during its financial thirdquarter ended 31 December 2016.

The Indian firm’s US sales rose by 102% to Rs12.3 billion(US$183 million), amounting to just under half of group sales that roseby more than two-fifths to Rs25.4 billion (see Figure 1). For Glenmark’scorresponding quarter last year, the US contributed only 34% ofgroup sales (Generics bulletin, 5 February 2016, page 7).

Having introduced the cholesterol-lowering agent at the tail endof its financial quarter via a settlement agreement with Merck, Glenmarkrecently said the product was expected to add US$200-US$250 millionto the firm’s sales during the product’s first six months on the market(Generics bulletin, 27 January 2017, page 14).

Glenmark’s further projection that its profit would swell in thewake of introducing generic Zetia was also realised, as the firm’spre-tax profit soared by 139% to Rs6.55 billion. Glenmark is splittingprofits on sales with Par, having previously licensed exclusive rightsto the US firm (Generics bulletin, 16 December 2016, page 13).

Launched three more productsDuring its financial third quarter, Glenmark also launched in the

US triamcinolone and the nystatin/triamcinolone combination creams,as well as potassium chloride extended-release tablets.

Meanwhile, Glenmark revealed it had filed 11 US applicationsduring the first nine months of its financial year, after filing anadditional five during the quarter. The Indian firm plans to file a further10 by the end of its financial year on 31 March.

Away from the US, Glenmark reported mid-single digit growthin its domestic market, following increased market share for severaltherapeutic segments, and returned to growth in its Europe business.Following a sales slip of 16% during the prior-year quarter, Europeansales rose by 11% to Rs1.96 billion, or 15% in constant currencies,“aided by good growth in the Western Europe region”. “The CentralEastern Europe region continued to remain subdued, thus impactingthe overall growth for the region,” the Indian firm noted.

Glenmark’s continued slump in Latin America – where sales slidby just under a quarter to Rs947 million – was more than outweighedby a turnover rise of a third to Rs1.92 billion for Glenmark’s activepharmaceutical ingredients, while the firm’s Rest of the Worldoperation – including markets in Africa, Asia and the Commonwealthof Independent States – also showed mid-single digit sales growth. G

third-Quarter results

Glenmark’s sales riseas its profit explodes

Third-quarter sales Change Proportion(Rs millions) (%) of total (%)

US 12,308 +102.2 49India 5,169 +5.9 20Africa/Asia/CIS 2,511 +6.3 10Europe 1,957 +11.0 8Latin America 947 -23.4 4API 1,921 +32.5 8Licensing/other 537 – 2

Glenmark 25,350 +42.6 100

Figure 1: Breakdown of Glenmark Pharmaceuticals’ sales in its financial thirdquarter ended 31 December 2016 (Source – Glenmark)

Third-quarter sales Change Proportion(Rs millions*) (%) of total (%)

India 5,030 +12 35US 3,100 -44 21Germany 2,040 +24 14Brazil 1,590 +35 11Licensing/other 2,670 +4 19

Torrent Pharma 14,430 -6 100

* rounded to nearest Rs10 million

Figure 1: Breakdown of Torrent Pharmaceuticals’ sales in its financial thirdquarter ended 31 December 2016 (Source – Torrent)

Greater competition on aripiprazole in the US caused TorrentPharmaceuticals to suffer a 6% slide in group turnover to Rs14.4

billion (US$215 million) in the Indian company’s financial thirdquarter ended 31 December 2016.

As Figure 1 shows, a 44% tumble to Rs3.10 billion in the US morethan outweighed a 12% gain to Rs5.03 billion in India, growth of almosta quarter to Rs2.04 billion by Torrent’s Heumann business in Germany,and a rise of more than a third to Rs1.59 billion in Brazil, where thefirm recently launched first-to-market olmesartan and trazadone brandedgenerics. Torrent’s pre-tax profit fell by 35% to Rs2.45 billion. G

third-Quarter results

Torrent tumbles overaripiprazole in the US

8 GENERICS bulletin 10 February 2017

meDIcInes FoR eURope

Regulators in the US and European Union “must co-operate” to“create a more efficient, harmonised regulatory approach”

supporting single development programmes for biosimilars and complexgenerics as well as the mutual recognition of current good manufacturingpractice (cGMP) inspections, according to the US GenericPharmaceutical Association (GPhA).

Addressing Medicines for Europe’s 16th regulatory and scientificaffairs conference held in London, UK, in late January, David Gaugh,the US association’s senior vice-president of sciences, regulatoryand international affairs, said progress was ongoing in both areas.

“We see [a single development pathway of generic medicines] asbeing very key in the US, and we think it is something that will happen.And the fact of the matter is that the biosimilar cluster that came aboutthree-to-four years ago has already begun working,” he said.

Gaugh noted, however, several issues were delaying progress. Hedescribed legal concerns as “the biggest issue”, while the alignmentof regulatory standards and specifications, and convergence on theuse of a ‘foreign’ reference product – a European product in the USor vice versa – were also causing problems.

Single development pathway is possibleNevertheless, Gaugh said single development programmes were

still “a real possibility”, despite talks on a Transatlantic Trade andInvestment Partnership (TTIP) trade deal currently being put on hold.

“The US Food and Drug Administration (FDA) told us when wemet with them in September that absolutely a single developmentpathway will not be part of TTIP,” he said, referring to a joint Medicinesfor Europe and GPhA delegation that had held a round of TTIPmeetings with institutions including the FDA (Generics bulletin,30 September 2016, page 11). “The FDA will not allow tradeagreements to force how a product will be developed,” Gaugh insisted.

Turning to mutual recognition of cGMP inspections, hemaintained that “whether TTIP continues or not, mutual recognitionwill continue”. Pointing to ongoing progress on the matter, includingjoint inspections being conducted and scientific knowledge beingshared, Gaugh noted the “current focus” was on European Union(EU)/US recognition, “and once complete, the FDA intends to expandinto other very highly regulated markets”.

Thus far, Gaugh pointed out, the FDA had observed 14 jointaudits performed by different EU member states, and received sixcompleted audit reports. “Their expectation is that they will have allof the member states done by the end of 2017,” he revealed. “Theywon’t have the letters of agreement in place by then, but at leastthey will have the inspections done and be ready to move forward.”

“There very much appears to be a commitment from [the FDA]to move forward on this,” Gaugh continued. “Hopefully in the nextfew years we’ll see it.”

In October last year, the latest report on the TTIP free-tradeagreement released by the European Commission predicted thatmutual-recognition inspections between the US and the EuropeanUnion could be in place as early as last month (Generics bulletin,4 November 2016, page 1).

Meanwhile, Medicines for Europe’s deputy director-general andhead of regulatory affairs, Beata Stepniewska, suggested that the“first nice surprise could be related to recognition of inspections”. “Ithink that is the first area where we will receive a positive message inthe near future,” she added. G

regulatory aFFairs

GPhA cites supportfor EU co-operation

APPS used in connection with healthcare and medicines could beclassified as medical devices, according to David Lewis, Novartis’global head of pharmacovigilance. Pointing out the potential “pitfalls”of social media and technology supporting patient safety at the 10thMedicines for Europe pharmacovigilance conference in London,UK, in January, Lewis emphasised that this was a “rapidly-evolvingarea requiring the attention of manufacturers and marketing-authorisation holders”.

PhV IWG – the Pharmacovigilance Inspectors Working Groupestablished by the European Medicines Agency (EMA) – shouldseek to simplify and harmonise pharmacovigilance inspectionactivities across countries and regions, according to Wendy Huisman,chair of the Medicines for Europe pharmacovigilance working group.Co-operation was needed between national regulators to minimiseduplication and maximise the use of resources, she urged, whilegreater clarity was needed through more specific guidance on thetype of partners expected to be audited. A ‘listening meeting’ lastSeptember with the PhV IWG “may be the first of several directindustry/inspector interactions moving forwards”, Huisman highlighted.

EMA – the European Medicines Agency – will from the secondquarter of 2017 organise ‘webinar’ training sessions to help addressquestions arising from training pharmacovigilance staff based onthe Eudravigilance training plan, according to Sabine Brosch ofthe agency’s pharmacovigilance and epidemiology department.From the third quarter, face-to-face training courses will be offered.

‘BIG DATA’ – large sets of data that can be analysed to revealbehavioural patterns and trends – offer an opportunity to build real-world evidence of the patient experience with medicines, accordingto Medicines for Europe’s head of regulatory affairs, BeataStepniewska. However, she observed, ‘big data’ needed huge resourcesto process, and analysis was needed to identify the opportunitiesfor both patients and industry. Also, she pointed out, it was still notyet clear how such information could be used by regulators.

FEES paid by marketing authorisation holders to regulators in Europein connection with variations could be made “more pragmatic”by adopting a “flat fee system”, according to Christa Wirthumer-Hoche of the Austrian medicines and medical devices agency BASG.Acknowledging that such a move could be challenging in somecountries due to the restrictions of national legislation, and the factthat older, more stable products could be seen as ‘losers’ under sucha system, Wirthumer-Hoche nevertheless insisted that a flat feesystem had many advantages. It offered simplification of theadministrative procedure, better predictability for both regulatorsand marketing authorisation holders, and greater transparency, shetold the 16th Medicines for Europe regulatory and scientific affairsconference in London, UK, in January.

MHRA – the UK’s Medicines and Healthcare Products RegulatoryAgency – is an important and valued authority within theEuropean framework, Medicines for Europe’s head of regulatoryaffairs, Beata Stepniewska, has affirmed. Acknowledging the UK’s‘Brexit’ decision to leave the European Union (EU), Stepniewskasaid it would be desirable to retain the MHRA within the network,noting that a “huge number of procedures” in Europe were processedby the agency, especially when it came to the decentralisedprocedure. However, she insisted, the ongoing involvement of theMHRA would have to take place within the established legalframework. Nevertheless, she remained hopeful of finding a way ofmaintaining co-operation with the UK regulator. G

In BRIeF

9GENERICS bulletin10 February 2017

meDIcInes FoR eURope

Collaboration between regulators and manufacturers is an essentialaspect of ensuring data integrity, generics industry leaders and

regulatory experts insisted at the 16th regulatory and scientific affairsconference held by European off-patent association Medicines forEurope in London, UK, in late January.

Apotex’ Ignacio Moreno, leader of the firm’s European corporatequality-assurance audit team, told delegates it was imperative forcompanies to build a ‘quality culture’ throughout the organisation.Compared to a ‘quality system’ that ensures a consistent production inline with regulatory requirements – which “enables quality performancebut does not guarantee it” – Moreno said a quality culture was moreconcerned with decision-making and behaviour, at all levels of a firm.

In short, he said, a quality culture translated to “doing the rightthing while no-one is looking”. This should be the “foundation of asustainable quality system”, he insisted.

Meanwhile, Stephen Vinter of the UK’s Medicines and HealthcareProducts Regulatory Agency (MHRA) outlined challenges for regulatorsin ensuring data integrity. These included difficulties in verifying datareported and how it was generated, as well as the timeliness of reviews.“It is usual that when a bioequivalence inspection is conducted, theapplication is already with the regulator,” he observed.

For industry and regulators to collaborate effectively, he said,there needed to be understanding of the challenges facing each party,as well as open communication – including making regulatorsaccessible to industry, and ensuring that there was open reporting of anydata-integrity issues so that regulators could act – and “continuousdevelopment of guidance”.

Common practice standards were required, suggested SusanaAlmeida, senior director of European operations for Inflamax Research.To this end, she noted, Medicines for Europe’s bioequivalence workinggroup had drawn up a ‘white paper’ on the subject that was currentlypending endorsement by the European Medicines Agency (EMA).

Koen Nauwelaerts, quality and regulatory affairs manager atMedicines for Europe, said the white paper set out a three-step processfor manufacturers seeking to ensure data integrity at contract researchorganisations (CROs). The first step was to review the dossier. Then,more information could be requested by the marketing authorisationholder if necessary. Finally, if doubt remained, an audit could takeplace, he recommended.

Co-operation was needed to make the most of the advantagesenjoyed by both regulators and industry, Almeida said. She noted thatagencies had access to data across all marketing authorisation holdersand were able to launch inspections unannounced, unlike audits byfirms of their CROs that needed to be arranged in advance.

“At the end of the day, the marketing authorisation holder isresponsible for the product,” affirmed Medicines for Europe’s head ofregulatory affairs, Beata Stepniewska. But industry and regulators wereboth able to make a contribution to enforcing data integrity, she outlined.

Feedback from regulators was important to manufacturers whenselecting a CRO to work with, Stepniewska said. While marketingauthorisation holders only had access to details of their own products,she observed, regulators were able to take a broader view.

Acknowledging high-profile examples of compromised dataintegrity in the past, Stepniewska said “we would not want this to turninto a trend”. “We should be very vigilant not to reproduce these cases,”she insisted, suggesting that there was a “learning curve” for industryon how best to perform audits. G

regulatory aFFairs

Collaboration key toensure data integrity

Specific short-term and medium-term objectives for improvingEuropean regulation have been outlined by off-patent industry

association Medicines for Europe. The targets build on a detailed reportthat was first issued by the association in late 2015 reviewing theEuropean regulatory environment for generic medicines.

Recommendations from the report had included optimising the useof decentralised and centralised marketing-authorisation procedures,eliminating duplications, reversing the “progressive increase in thenumber and scope of variations” to marketing authorisations, andrevising the fee structure (Generics bulletin, 2 October 2015, page 1).

Addressing delegates to the 16th Medicines for Europe regulatoryand scientific affairs conference in London, UK, in late January, thechair of the association’s regulatory and scientific affairs committee,Caroline Kleinjan, outlined improvements desired by industry. These,she explained, were primarily focused on reducing duplication andsimplifying and reducing variations.

In 2017, Kleinjan said, industry wanted to see the introduction ofbulk variation concepts, as well as the use of exemptions if changeswere not applicable to concerned member states. Between 2017 and2018, a target was to analyse the suitability of types of variations forinclusion in a database, as well as seeking changes to the variationclassification guideline. And by 2019, Kleinjan outlined, “admin-type”variations should be reported via a database, and drug master file(DMF) updates reported through a different system.

On duplication, Kleinjan said that in 2017 industry hoped to seejust one submission and one validation, with “no national requirements”.In 2017-2018, there should be a “once only” assessment of DMFs anddata submission, such as through a single submission portal. Andby 2019, duplication should be reduced to the extent that applicantsneeded only “one dossier, in one place, at one time, via one system”.

Medicines for Europe’s head of regulatory affairs, BeataStepniewska, explained that the association was adopting a “stepwiseapproach to the timeline”, with a short-term focus on optimisation.In the longer term, she outlined, it would be “extremely important tosee evolution in the regulatory framework”. G

regulatory aFFairs

Industry sets goals tostreamline regulation

Patient information leaflets and product information are “outdated”in their current form, according to Peter Bachmann, chair of the

co-ordination group for mutual recognition and decentralised procedurefor human medicines (CMDh). Addressing delegates to the 16thMedicines for Europe regulatory and scientific affairs conferencein London, UK, in late January, Bachmann said current “stone age”thinking was “old-fashioned” and based on ‘paper’ thinking.

Information received by patients “may already not be the newestversion” by the time it is received, he pointed out, and would “neverbe updated” in static paper form. A “dynamic approach with flexibleoutput channels for product information” was needed, he insisted,noting that this would be particularly beneficial for patients in smallmarkets and would offer flexibility in the cases of shortages in a specificmarket. While previous proposals involving a QR code on packagingthat could be scanned to access information might now be a littleoutdated, he admitted, the basic idea was “still valid”. G

regulatory aFFairs

‘Information gap’ must close

10 GeneRIcs bulletin 10 February 2017

maRket news

2-3 Marchn 2nd Business Development & Innovation

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

22-23 Marchn 13th Legal Affairs Conference

London, UKThis Medicines for Europe conference will cover legal andintellectual-property developments and sustainability. The eventwill be followed by the 15th Biosimilar Medicines Conference atthe same venue.

Contact: lucia romagnoli. tel: +44 7562 876 873.e-mail: events@medicinesforeurope.com. register online atwww.medicinesforeurope.com/events/13th-legal-affairs-conference/.

23-24 Marchn 15th Biosimilar Medicines Conference

London, UKThis Medicines for Europe event will look at market access andtrends, regulatory developments and legal and intellectual-propertyaspects concerning biosimilars.

Contact: lucia romagnoli. tel: +44 7562 876 873.e-mail: events@medicinesforeurope.com. register online atwww.medicinesforeurope.com/events/bios-2017/.

23-24 Mayn GPhA CMC Workshop

Maryland, USAThis two-day workshop will provide an understanding of CMCregulatory requirements and the challenges of approval.

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

29-30 Mayn EuroPLX 64

Vienna, AustriaThis meeting provides an opportunity to discuss and negotiateagreements, development, in-licensing and marketing, promotionand distribution.

Contact: rauCon. tel: +49 6221 426296 0.e-mail: meetyou@europlx.com. Website: europlx.com.

EVENTS – March, April & May

Save the date ...n Joint 23rd Medicines for Europe &

20th IGBA Annual Conference14-16 June 2017,Lisbon, Portugal

n Global Generics & BiosimilarsAwards 201724 October 2017,Frankfurt, Germany

The Comprehensive Economic Trade Agreement (CETA) signedby the European Union (EU) and Canada last year could apply

provisionally in the EU from April this year. Following its approvalby a trade committee within the European Parliament, the CETA tradedeal will be put to a ratification vote before the entire Parliament duringa plenary session to be held on 15 February in Strasbourg, France.

“By approving CETA, we have taken a significant step forward,”insisted the parliament’s rapporteur for the trade agreement, ArtisPabriks, following the committee’s vote of 25 for and 15 against, withone abstention registered.

Chapter 20 of the CETA text, which covers intellectual property,contains specific sections on patents and data exclusivity forpharmaceuticals. Article 20.27 provides for patent-term extensions oftwo to five years to compensate for regulatory review periods, whileArticle 20.28 allows for patent-linkage mechanisms that “ensure thatall litigants are afforded equivalent and effective rights of appeal”.

Six-year data exclusivity minimumData exclusivity provisions under Article 20.29 of the CETA

text require at least a six-year period in which generics applicantscannot reference the protected data for filing and at least eight yearsof protection from generic approvals.

A draft bill to implement the CETA deal that is currently at thecommittee stage in Canada’s House of Commons will amend thecountry’s Patents Act to create two-year certificates of supplementaryprotection for pharmaceuticals and also seek to address the possibilityof litigation being conducted twice over the same drug patent underboth patent-linkage and standard mechanisms (Generics bulletin, 11November 2016, page 11).

While the CETA text contains a general chapter on regulatoryco-operation, a separate protocol addresses mutual recognition ofgood manufacturing practice (GMP) inspections and certificates. G

trade agreeMents

Europe takes a stepto CETA enactment

Panacea will sponsor the Award for Company of the Year in theEurope, Middle East and Africa (EMEA) region at the Global

Generics & Biosimilars Awards 2017. Companies and individualsinvolved in the generics and biosimilars industries can submit by 14July their entries for 14 awards, which will be judged by expert panels.

Now in their fourth year, the Awards – which are free to enterand attend – will be presented on Tuesday 24 October 2017 at theFrankfurt Marriot Hotel in Frankfurt, Germany.

Co-hosts QuintilesIMS are among the sponsors of awards thatrecognise the top generics and biosimilars firms in three individualregions and globally; the year’s outstanding acquisitions, businessdevelopments, regulatory achievements and innovations; the highest-achieving industry leaders; successes in the fields of biosimilars andactive pharmaceutical ingredients (APIs); industry partners; patentlitigation; and corporate social responsibility activities.

Details on how to enter, including an information pack and entryform, can be downloaded from the Generics bulletin website. Gn To request tickets to attend the awards, and for any further details, pleasee-mail awards@generics-bulletin.com.

industry aWards

Panacea eyes EMEA success

11GeneRIcs bulletin10 February 2017

maRket news

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Newly inaugurated US President Donald Trump has promised toend “global freeloading” on US pharmaceutical companies by

countries that control drug prices.Meeting with leaders of originator drug companies, Trump argued

that “foreign price controls reduce the resources of American drugcompanies to finance research and development and innovation”. UStrade policy would “prioritise that foreign countries pay their fair sharefor US-manufactured drugs” to ensure that local originators couldaccelerate the development of new therapies, he pledged.

At the same time, Trump insisted that “astronomical” prices fordrugs in the US – including through the Medicare and Medicaid socialwelfare programmes – had to be brought “way down”. “Competition isthe key to lower drug prices,” he proclaimed. “We can increasecompetition and bidding wars big time,” he said, highlighting theopportunity to save “tens of billions of dollars”.

“I will oppose anything that makes it harder for smaller, youngercompanies to take the risk of bringing a product to a vibrantlycompetitive market,” Trump continued. “That includes price-fixingby the biggest dog in the market, Medicare.”

Recognising that many of the drugs used in the US were notmanufactured locally, Trump blamed excessive regulation and hightaxation in the US for forcing companies overseas.

“Other countries have no regulation and you go there for thatreason,” he told the originator bosses. “We have a fantastic person thatI think I will be naming fairly soon who is going to streamline the USFood and Drug Administration (FDA),” he announced, maintainingthat it was unacceptable that it could take 15 years and US$2.5 billionto bring a novel medicine to market.

Unprecedented regulation cuts“We are going to be cutting regulations at a level that nobody has

ever seen before,” Trump claimed. “We are going to be lowering taxesbig league,” he told leaders of companies including Amgen, Eli Lilly,Johnson & Johnson and Novartis.

Hailing the “positive, productive meeting”, Stephen Ubl – chiefexecutive officer of the US originators’ industry body PhRMA – saidTrump and the company heads had “discussed many areas of commonground, including: advancing stronger trade agreements to level theplaying field with countries around the world; reforming our tax codeto spur investment and job creation here in the United States; andremoving outdated regulations that drive up costs and slow innovation.We believe if these policies are enacted, it will translate to up to 350,000new jobs over the next 10 years as a result of growth in thebiopharmaceutical industry”.

“Our industry takes seriously the concerns raised about theaffordability and accessibility of prescription medicines, and we haveexpressed our commitment to working with the administration toadvance market-based reforms,” Ubl commented.

The Biotechnology Innovation Organization (BIO) said Trump’sideas “will go a long way toward ensuring that patients have affordableaccess to today’s innovative medicines and that our companieshave the policy and regulatory environment they need to bring anew generation of breakthrough medicines”.

In particular, the biotech body praised the President’s pledge tomake it easier for smaller companies to bring products to market,claiming that Trump “clearly understands” the dynamic of smallerstart-up companies working on “cutting-edge” research. G

PriCing & reiMBurseMent

Trump pledges to end‘global freeloading’

Questions around the future location of the London-based EuropeanMedicines Agency (EMA) and the UK’s relationship with the agency

are no clearer after the UK government published a white paper onits plans for its ‘Brexit’ withdrawal from the European Union (EU).

In its white paper, the UK government recognises that the EMA isone of several EU agencies established to support member states andcitizens. “These can be responsible for enforcing particular regulatoryregimes, or for pooling knowledge and information-sharing,” it notes.

“As part of exit negotiations, the government will discuss with theEU and member states our future status and arrangements with regardto these agencies,” the paper states without giving further details.

Legislation to formally trigger the UK’s exit from the EU byinvoking Article 50 of the EU treaty is currently passing throughparliament, and the UK government intends to start a negotiationprocess by the end of March this year.

“It is in no one’s interest for there to be a cliff-edge for business ora threat to stability, as we change from our existing relationship to anew partnership with the EU,” the UK government argues in the paper.“Instead, we want to have reached an agreement about our futurepartnership by the time the two-year Article 50 process has concluded.”

“The government will make no attempt to remain in the EU by thebackdoor, nor will we hold a second referendum on membership,”the white paper clarifies. G

regulatory aFFairs

Brexit paper ducksquestions over EMA

12 GeneRIcs bulletin 10 February 2017

maRket news

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

Basket Price Reimbursement Price Pharmacy Profit£2,091.06 £3,197.17 £1,106.11

Price WatchIndex

PharmacyProfit Index98.2 65.7

Monthly change +7.9 Monthly change -17.0

January 2017 January 2017

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

UK pharmacists had a dreadful start to the New Year, watchinghelplessly as their dispensing margins were squeezed between

rising generics prices and falling reimbursement prices.Measured by our representative basket of 20 popular generic

products, our Pharmacy Profit Index dropped dramatically by 17.0percentage points in January, its largest monthly fall by far, to just65.7. Pharmacists were thus earning almost 35% less fromdispensing the basket than they were last March, when the Indexwas first calculated.

In financial terms, pharmacists on average pocketed just£1,106.11 (US$1,379.50) in January from dispensing our typicalbasket. This was a shortfall of more than £575 compared with the£1,683.51 they had made just 10 months earlier.

Rising generics prices gave the basket a value of over £2,000for the first time since last August. At £2,091.06, its value wasalmost back to the £2,128.87 where it started last March, and wasreflected in a Price Watch Index up by 7.9 percentage-points to 98.2.

Having kept reimbursement prices almost level for threemonths at about £3,316, the Department of Health’s new quarterlyDrug Tariff for January 2017 shaved more than £100 from thebasket’s total to just £3,197.17. This was 83.9% of where it hadbeen last March, representing a reimbursement price cut of 16.1%for the generics in our typical basket. G

January 2017

pRIce watcH ....... Uk

price xxxxx

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Price WatchIndex

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Jan 2017

Bleak times borneby UK pharmacists

Affected parties have until 10 March to comment on an initialinventory of approved abbreviated new drug applications (ANDAs)

drawn up by the US Food and Drug Administration (FDA). Commentscan be submitted in written form or electronically via the docketFDA-2016-N-4508 at www.regulations.gov.

Information gathered will be used to set accurate annual programmefees under the second iteration of the Generic Drug User FeeAmendment (GDUFA II) that will come into effect on 1 October thisyear. The FDA intends to group affiliated companies for the purposesof the three-tier fees for companies holding five or fewer ANDAapprovals, between six and 19 approvals, or 20 or more approvedANDAs (Generics bulletin, 4 November 2016, page 9).

A spreadsheet released by the FDA towards the end of last yearcontained details of almost 10,000 approved ANDAs (Generics bulletin,6 January 2017, page 12). G

regulatory aFFairs

FDA seeks ANDA comments

Transferable priority review vouchers that are subject to specificuser fees as well as a study on the impact of risk evaluation and

mitigation strategy (REMS) requirements are among the provisionsincluded in a bipartisan bill introduced in the US House of Representativesby Congressmen Gus Bilirakis and Kurt Schrader.

According to its sponsors, the HR 749 ‘Lower Drug Costs throughCompetition Act’ will “incentivise drug-makers to develop genericdrugs when competition does not exist, or when there is a drug shortage”.

The priority review voucher would, Bilirakis and Schrader believe,encourage generics producers to provide competition to off-patentbrands that have undergone “disproportionate price hikes”. Thevouchers would require the US Food and Drug Administration (FDA)to act on applications “not later than 180 calendar days” after theywere submitted and accepted for review.

Requires action with 180 daysSimilarly, an amendment to section 505(j) of the Federal Food,

Drug and Cosmetic Act would require applications to be prioritisedand acted up with 180 days for drugs on the ‘506E’ shortage list thathave been launched by a maximum of one manufacturer during thepast three months and for which a maximum of two tentative approvalshave been granted. The bill also allows for expedited inspections ofplants making such products.

Under the terms of the bill – which has been referred to the Housecommittee on energy and commerce, and replicates several featuresof last year’s HR 4784 bill – the US Comptroller General would berequired to “conduct a review of the implement and effectiveness” ofthe REMS programme. This would cover abbreviated new drugapplications (ANDAs), new drug applications (NDAs) and biologicapplications. A biannual report on pending generic applications andaverage approval times would also be required, while a separateprovision would cover applications for tropical-disease treatments.

Under the second Generic Drug User Fee Amendments (GDUFA II),the FDA has committed to ANDA review times of 10 months asstandard and eight months for priority applications (Generics bulletin,7 October 2016, page 1). G

regulatory aFFairs/PriCing & reiMBurseMent

US bill aims at morecompetition faster

13GENERICS bulletin10 February 2017

pRoDUct news

Bristol-Myers Squibb’s (BMS’) European composition-of-matterprotecting its Sprycel (dasatinib) oncology blockbuster until April

2020 is invalid, the European Patent Office (EPO) has ruled on appeal.Acting on oppositions to European patent EP1,169,038 that had

been filed by Actavis, Apotex and Mylan – as well as by lawyers foran undisclosed party – in May 2013, the EPO’s opposition divisionhad one year ago revoked the ‘038 patent. However, the patent entitled‘Cyclic protein tyrosine kinase inhibitors’ remained in force whilethe originator took the case to the EPO’s board of appeal.

Following oral proceedings at the start of February, the EPO’sboard of appeal has upheld the earlier revocation. BMS said both dataexclusivity and orphan-drug exclusivity for Sprycel in the EuropeanUnion (EU) expired in November last year. Based on the ‘038 patent,some EU member states granted supplementary protection certificates(SPCs) running until November 2021.

Last year, the originator achieved a 13% increase in worldwideSprycel sales of US$1.82 billion, of which just over half – US$969million – was achieved in the US. Noting that its basic US dasatinibmolecule patent also expired in 2020, BMS said it had in 2013 reacheda settlement with Apotex in litigation over a patent covering a monohydrateform of the treatment for chronic myeloid leukaemia. Under the termsof that deal, Apotex can launch generic dasatinib in the US fromSeptember 2024, or earlier under certain circumstances.

Dasatinib is scheduled in 2020 to lose basic patent protection inChina, according to BMS, while similar protection in Japan willexpire in 2021. G

onCology drugs

EPO culls patent ondasatinib molecule

Apotex’ Apobiologix division has entered into a definitive agreementwith oncology specialist Meridian Laboratories to develop and

market docetaxel for injection in a “one-vial liquid improvedformulation” for the US market.

Under the terms of the deal, Apobiologix – which focuses ononcology and haematology biologic products – will issue a combinationof milestone payments and royalties to Meridian, although specificfinancial details were not disclosed. Through the agreement, Meridiannoted there was a possibility for co-developing and marketing futureproducts with Apobiologix, which has a “strong oncology pipeline”.

Meridian added that the US Food and Drug Administration (FDA)had agreed with its proposal to use the 505(b)(2) regulatory pathwayfor the new drug application (NDA) submission of the injectable. G

onCology drugs

Apotex and Meridianally in docetaxel deal

Egis Pharmaceuticals has strengthened its position in Russia’s OTCand women’s health markets by acquiring for an undisclosed fee

several brands from Croatia’s Jadran-Galenski Laboratorij (JGL). Theacquired products had sales of C12 million (US$13 million) in 2015.

“The acquired skin-repair and wound-healing D-Panthenol is thesecond largest brand in the dexpanthenol market in Russia, and becomesEgis’ fourth-largest product family and the second-largest in its OTCsegment, based on turnover,” Hungary’s Egis commented. “The familyof five presentations of dexpanthenol has a strong fit with Egis’ currentoperational model and existing portfolio in Russia, with high synergypotential,” it added, highlighting plans to broaden availability.

Building on its established presence in the gynecological sector,Egis has also acquired JGL’s Russian gynecology portfolio – theprobiotic Vagilac, Feminal (red clover/isoflavones) and Folacin (folicacid). “The products indicate unexploited distribution potential dueto a growing market and Egis’ experience in this therapeutic area inRussia,” the Hungarian company insisted.

In its 2015/2016 financial year, Egis generated around C100 millionfrom its primary export market, Russia. In total, exports made upfour-fifths of group turnover that reached C536 million.

“The company seeks opportunities to further expand its high-quality portfolio, gain access to new markets and strengthen its positionin major export markets, primarily in the OTC segment,” stated Egis,adding that it had grown the Biovital brand acquired from Bayer in Polandby 150% “due to successful integration and seasonal campaigns”.G

derMatology drugs/WoMen’s health drugs

Egis acquires Russian brands

Gefitinib tablets manufactured by Qilu Pharmaceutical are amonga raft of recent marketing approvals granted to local producers

by China’s State Food and Drug Administration (SFDA).At around the same time, the Chinese regulatory agency granted

authorisations for two antiretroviral agents – efavirenz tablets madeby Shanghai Desano Biopharmaceutical and tenofovir disoproxilfumarate from Chengdu Brilliant Pharmaceutical. G

onCology drugs

China approves gefitinib tabs

Edenbridge Pharmaceuticals is “exploring partnering, licensing anddivestiture opportunities” for its generic version of Actelion’s

Zavesca (miglustat) 100mg capsules that is poised for a centralisedauthorisation. The European Medicines Agency (EMA) recentlyrecommended that the Gaucher disease treatment be granted pan-European approval (Generics bulletin, 3 February 2017, page 9).

Noting that it had filed for approval of its Yargesa branded genericthrough partner JensonR+, based on an in vivo bioequivalence study,US-based Edenbridge said its miglustat capsules would be “the firstgeneric version of Zavesca approved through the centralised procedure”.The total European Union (EU) market for miglustat capsules wasvalued at around C50 million (US$53 million), Edenbridge added.G

gauCher disease drugs

Edenbridge explores miglustat

Mylan has agreed to pay just over US$96.5 million to settle a class-action complaint brought by direct purchasers over a patent-

litigation settlement covering Cephalon’s Provigil (modafinil).In a court filing, the plaintiffs noted that the deal had been struck

“after over a decade of litigation and three rounds of mediation”. Whilethey have already settled with Cephalon and parent company Teva,they continue to pursue claims against Sun Pharma’s Ranbaxy. G

narColePsy drugs

Mylan settles on US modafinil

14 GENERICS bulletin 10 February 2017

pRoDUct news

Avitamin-dosing regimen patent shielding Eli Lilly’s Alimta(pemetrexed disodium) is valid, Japan’s Intellectual Property High

Court has ruled, affirming a decision made by the Japan Patent Officein late 2015 after Sawai initiated invalidation proceedings.

Lilly said the patents “could provide intellectual-property protectionfor Alimta in Japan until June 2021”. The US firm added it would“take necessary actions to defend and enforce the patents”.

“We are pleased with the decision from Japan’s IntellectualProperty High Court confirming the validity of the Alimta vitaminregimen patents,” stated Michael Harrington, Lilly’s senior vice-presidentand general counsel. “Lilly’s significant scientific research in support ofthe Alimta vitamin regimen deserves intellectual-property protection.”

Last month, a US Court of Appeals agreed with a district court’sdecision that US vitamin-dosing regimen patent 7,772,209 – whichprotects Lilly’s Alimta until expiry on 24 May 2022, including a six-month paediatric extension – was valid and infringed by Teva’sproposed generic version (Generics bulletin, 20 January 2017, page 11).

Meanwhile, Sawai has reached a settlement in the US with KowaPharmaceuticals and Nissan Chemical Industries over patent litigationconcerning Kowa’s Livalo (pitavastatin) 1mg, 2mg, and 4mg tablets.The infringement case revolved around US patents including substancepatent 5,856,336, which expires on 25 December 2020, and method-of-use patent 8,557,993 which runs until 2 February 2024.

Under the terms of the agreement, Sawai will be able to marketits generic version of the cholesterol-lowering agent from 2 May 2023,or earlier “under certain circumstances”. Other details of the settlementwere not disclosed.

Litigation between Zydus Cadila and Kowa and Nissan concerningLivalo was settled on similar terms last month (Generics bulletin,20 January 2017, page 15). G

onCology drugs

Alimta patent upheldby Japan’s high court

Teva has filed an abbreviated new drug application (ANDA) withthe US Food and Drug Administration (FDA) containing a

paragraph IV patent challenge for a generic version of Novo Nordisk’sVictoza (liraglutide) for injection. The Israeli firm believes it is a “firstapplicant” to file an ANDA for the generic rival to Victoza, so thereforebelieves it may be entitled to 180 days of generic market exclusivity.

Citing data from QuintilesIMS, Teva noted that annual US salesfor Victoza – which is indicated for adults with type 2 diabetes –reached around US$3.2 billion in 2016.

According to the FDA’s Orange Book, there are nine patentsshielding Novo Nordisk’s Victoza – with the latest expiring on23 September 2032 – including re-issued patents RE43,834 andRE41,956, which run until 28 January 2019 and 21 January 2021.G

diaBetes drugs

Teva first to file Victoza rival

LUPIN has received final US Food and Drug Administration (FDA)approval for its triamcinolone acetonide 0.025%, 0.1% and 0.5%cream, with a launch planned “shortly”. Citing QuintilesIMS data,the Indian firm said the US market was worth US$55.7 million.G

In BRIeF

The availability of non-infringing alternatives should be taken intoaccount when calculating damages for patent infringement, Canada’s

Federal Court of Appeal has stated in partially granting an appealbrought by Apotex over perindopril. The Court of Appeal hasremitted the case to a federal court for reconsideration.

In 2008, a federal court had found that generic perindopril tabletswhich Apotex was manufacturing in Canada, in part for export,infringed Servier’s valid Canadian patent 1,341,196 protecting Servier’sCoversyl (perindopril) antihypertensive. That finding was upheldon appeal in 2009, at which point Servier elected to recover profitsearned through Apotex’ infringing activities.

“At issue in this appeal are Apotex’ profits from the sale ofperindopril tablets abroad, particularly sales made to affiliates of Apotexlocated in Australia and the UK,” the appeals judges summarised. Theyagreed with Apotex that the federal court had erred by rejecting therelevance of “any available non-infringing perindopril” and failing toconsider the evidence provided by three potential product suppliers– Signa, Ipca and Intas.

Pointing out that the evidence suggested “Apotex would and couldhave obtained significant quantities of non-infringing perindopril”,the Court of Appeal told the lower court to consider whether Apotexcould have procured non-infringing products from any of Signa, Ipcaor Intas and then supply them to its affiliates in Australia and the UK.

“Should the federal court answer the issue remitted to it in theaffirmative, it follows that the federal court must quantify the impactof that finding on Apotex’ profit on sales made to Apotex Australiaand Apotex UK,” the appeals judges stated. “The federal court shouldthen consider what, if any, entitlement Apotex has to interest on moniesit paid to Servier which are in excess of its obligation as calculatedtaking a non-infringing alternative into account.” G

CardiovasCular drugs

Non-infringing optionrelevant, Canada says

Apotex, Aspen, Mylan’s Alphapharm and Sandoz have succeededin rebutting a challenge brought by Lundbeck in Australia’s Federal

Court over patent-term extensions to intellectual property protectingits Cipramil (citalopram) and Lexapro (escitalopram) antidepressants.

Lundbeck had challenged a decision by Australia’s deputycommissioner of patents to hear and determine at the same time allissues relating to the dispute, which revolved around Australian patent623,144. But the generics firms insisted that no reviewable error hadbeen made. Accepting the generics firms’ argument, Federal CourtJudge Jonathan Beach found “no reviewable error has been made”.

Acknowledging that two “principal questions of construction havebeen raised” in relation to the statutory framework governing patent-extensions in Australia, Beach said the construction of the genericsfirms should be accepted.

Summarising the “correct construction”, Beach said a genericsfirm may be granted a licence “where at any time before the extensionof time was advertised they exploited – or took definite steps to exploit –the invention concerned”, and those steps had the “relevant nexus” tothe statutory criteria regarding upholding patent protection, “namelythe failure to do the relevant act within the time allowed, or thelapsing of a patent application, or the ceasing of a patent”. G

antidePressants

Lundbeck loses in Australia

15GENERICS bulletin10 February 2017

pRoDUct news

Amneal has received a boost in its plans to launch a US genericversion of Merck & Co’s Nasonex (mometasone furoate) nasal

spray after a US district court ruled that the generics firm’s abbreviatednew drug application (ANDA) product did not infringe the originator’sUS formulation patent.

Merck’s patented invention shielded by US patent 6,127,353 –which is set to expire on 3 April 2018, including six months ofpaediatric exclusivity – is mometasone furoate monohydrate, whichwas developed by the originator as an improvement on predecessorformulation anhydrous mometasone furoate.

At issue in the trial was whether Amneal’s 50µg spray – whichuses anhydrous mometasone furoate as the active pharmaceuticalingredient (API) – contained or would contain mometasone furoatemonohydrate during the product’s two-year shelf life.

“Merck does not allege that the pre-formulation activepharmaceutical ingredient used in Amneal’s ANDA product containsmometasone furoate monohydrate or otherwise infringes the ‘353patent,” explained Delaware District Judge Sue Robinson.

“Weighing the evidence at bar,” Robinson stated, “the courtconcludes that Merck has not carried its burden to prove, by apreponderance of evidence, that mometasone furoate monohydrate ispresent in Amneal’s ANDA product during its two-year shelf life.”

Amneal currently holds tentative US Food and Drug Administration(FDA) approval for its ANDA.

Robinson’s ruling comes just under a year after Apotex introducedthe first US generic version of Nasonex, following an earlier decisionfrom a New Jersey district court that the Canadian firm’s genericproduct did not infringe the ‘353 patent (Generics bulletin, 1 April2016, page 10). An invalidity attack launched by the generics playeragainst the ‘353 patent was, however, rejected by the court.

Merck has also, in 2015, brought a further patent-infringementlawsuit against Apotex concerning a generic alternative to Nasonexthat “allegedly differs from the generic version in the previous lawsuit”.

Teva is also currently entangled in US litigation concerning itsproposed generic version of Nasonex, for which the firm does notcurrently hold any form of FDA approval. In November last year,Robinson ruled also that the Israeli firm’s proposed generic Nasonexproduct did not infringe the ‘353 patent, but furthermore found thatthe patent was valid. Merck has appealed this ruling.

Meanwhile, Amneal has sued the FDA over the agency’s decisionthat the generics firm had forfeited 180-day market exclusivity for itsrival to Allergan’s Namenda XR (memantine) extended-release capsules.Lupin, Mylan and Sun obtained final FDA approval for genericNamenda XR at the end of September 2016, followed two monthslater by Apotex. Amneal’s approval came on 12 October last year.

In a suit filed in the district of Columbia, Amneal seeks to overturnthe FDA’s refusal to grant the firm 180-day exclusivity because thegenerics firm did not obtain tentative approval for its ANDA within 30months of filing. The generics firm argues that the agency took almostfive months to refuse to receive the ANDA due to insufficient acceleratedstability data. After a typographical correction had addressed the stabilitydata issue, the FDA finally accepted Amneal’s filing in February 2014.

Amneal’s suit also claims that the FDA’s unusual demand for datafrom a full-scale commercial batch caused “an additional 14-monthdelay” in tentative approval. “The FDA is using forfeiture to ‘penalise’Amneal for review or changes of approval requirements imposedby the agency,” the company alleges. G

allergy reMedies

Amneal succeeds onNasonex rival in US

Dipharma and Alvogen have launched Diterin (sapropterindihydrochloride) 100mg tablets in South Korea, through an

exclusive collaboration agreement between the two firms. Used to treathyperphenylalaninemia in patients with rare genetic diseasephenylketonuria, Diterin is the only drug approved in South Korea bythe Korean Ministry of Food and Drug Safety (MFDS) for that indication.

Under the terms of the deal, Alvogen owns the exclusive rightsto sell the product in the South Korean market. Swiss firm Dipharma –which specialises in rare diseases – said it was “currently working tomake Diterin available in all countries worldwide”.

“We are happy to provide Diterin to the South Korean market, asthis treatment can make a difference in the management of phenylalaninelevels for many patients suffering from lifelong phenylketonuria,contributing to prevent the appearance of potential transient to non-reversible mental impairment,” stated Peter Vazharov, Alvogen’ssales and marketing vice-president of the Asia-Pacific operation.

Dipharma’s chief executive officer, Marc-Olivier Geinoz, said thefirm would “continue to expand our portfolio of high-quality products –including Diterin – to offer improved solutions to each and every patientsuffering from inborn errors of metabolism all around the world”.G

PhenylKetonuria drugs

Alvogen has Koreandeal with Dipharma

Neogen says it is experiencing “increasing demand” for its paracetamol500mg and 1,000mg film-coated tablets following the withdrawal

of similar products in several European markets. “Recently, Neogenhas had several requests for supply changes, or takeover of some of itsexisting licences, enabling clients to fulfill its supply commitmentsto buyers”, the Belgian firm stated.

Batches of paracetamol 500mg and 1,000mg marketed by Sandozand Bluepharma were recently withdrawn in Portugal after localmedicines agency Infarmed identified good manufacturing practice(GMP) deficiencies at production facilities operated by licence holderGranules India (Generics bulletin, 13 January 2017, page 12). Granuleshas just reported that a re-inspection by Infarmed at the start ofFebruary “was completed successfully”. G

analgesiCs

Neogen notes paracetamol rise

16 GENERICS bulletin 10 February 2017

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Stada’s former chief production and development officer, ChristofSchumann, has been appointed as supervisory board chairman

of German bioanalytical company Biofidus.Specialising in the characterisation of biopharmaceuticals and

biosimilars – including monoclonal antibodies – Biofidus’ servicesinclude “a wide variety of bioanalytical methods such as spectroscopic,chromatographic, and mass spectrometric assays focused on thecharacterisation of proteins as well as small molecules”.

An industry consultant, Schumann – who left Stada in July 2010(Generics bulletin, 6 August 2010, page 22) after the German groupdecided not to renew his contract (Generics bulletin, 28 May 2010,page 31) – brings to Biofidus “more than 25 years of experience inthe pharmaceutical and biopharmaceutical industry”. G

aPPointMents

Ex-Stada Schumannnamed Biofidus chair

GLENMARK’s board of directors has approved the appointmentof Harish Kuber as the Indian firm’s company secretary andcompliance officer, made effective from 2 February.

ARENT FOX – a US-based law firm – has appointed two formerUS Food and Drug Administration (FDA) officials to the firm’sFood, Drug, Medical Device & Agriculture practice. Joining fromMcGuireWoods, Brian Malkin, who has previously served asregulatory counsel at the US agency, has been named counsel, whilePaul Gadiock, who was most recently associate director for policywith the FDA’s Center for Devices and Radiological Health division,has been appointed senior attorney.

STRIDES SHASUN has named Manjula Ramamurthy as itscompany secretary. Ramamurthy, an associate member of theInstitute of Company Secretaries of India, has taken her new rolefrom Strides executive Badree Komandur, who was formerlycompany secretary and group chief financial officer. Komandurwill continue to serve in the latter role.

FTC – the US Federal Trade Commission – commissionerMaureen Ohlhausen has been appointed as acting chairman.Ohlhausen’s term as commissioner expires in September next year.

SANOFI has promoted company executive Hugo Fry to becomegeneral manager of the French firm’s UK business. Meanwhile,Sanofi has appointed TMC Pharma executive Hubert Bland as itsUK medical chair and medical head of diabetes and cardiovascularfor the UK and Ireland. G

In BRIeF

ACETO has confirmed the appointment of former Citron Pharmachief Vimal Kavuru to its board of directors. As part of Aceto’sUS$412 million agreement to acquire assets from Citron Pharma andits Lucid distribution affiliate, Kavuru was promised a seat on Aceto’sboard, and also appointed president of Aceto’s Rising Pharmaceuticalsunit (Generics bulletin, 11 November 2016, page 16). G

In BRIeF