France plans price cuts as Gemme urges action · quality and usability of its information services,...

2 October 20152 October 2015

Sandoz opens plant and supports access 3Aceto aims to launch ten 4products by JuneConcordia will pay US$3.5bn for AMCo 5Aspen believes US is the next frontier 6Mylan and Perrigo take fight to courts 8Strides agrees to buy Sun CNS businesses 9Wholesaler demand 10strengthens Nichi-Iko

MARKET NEWS 11

BGMA lends support for 11biosimilars guideExecutives differ over vertical integration12EMA andWHO will 13expand cooperationGerman SpectrumK seeks tender offers 14GPhA rebuts FDA on size 15and shape guideUS action urged on inter partes review 16EGA report focuses on added efficiency 17

PRODUCT NEWS 20

Abasaglar arrives into German market 20Tadalafil patent ruled 21as obvious in CanadaCanada cuts down moxifloxacin term 22Epirus buys Bioceros to 23bolster its pipelineAllergan and Amgen advance on Avastin 24US hybrids must not 25sidestep ANDA routeLyrica pain patent is invalid, UK declares 27

FEATURES 30

Alvogen sets US$3bn goal 30following fresh investment

Beximco aims for a fifith of 32its business to be overseas

REGULARS

Paragraph IVWatch – Zytiga 26Events – Our regular listing 28PriceWatch UK – UK pricing trends 29People – Chagnaud to head up 35Poland’s Polpharma

COMPANY NEWS 3

Cutting medicines prices, more fully developing the generics market and realisingsavings through the increased uptake of biosimilars are three of the key pillars of

plans unveiled by the French government to restrict growth in healthcare spending tojust 1.75% in 2016 by realising savings of C3.41 billion (US$3.80 billion). However, localgenerics industry association Gemme has cautioned against prioritising potential pricecuts for generics over measures to drive the increased use of generics.

Price cuts for medicines will save C550 million, according to the proposals set out by Frenchfinance minister Michel Sapin and health minister Marisol Touraine, along with budget secretaryChristian Eckert. The “promotion and development of generics” will produce economies ofC395 million, while savings from biosimilars will come to C30 million.

But in response to the proposals, Gemme said it had “serious concerns of significant pricecuts planned for the coming year”. Noting that France’s generics industry had suffered “repeatedprice cuts” worth C232 million in 2014 and C150 million this year, Gemme said these had putat risk the sustainability of the French and wider European generics sector. “If, as in theprevious year, the item dealing with the promotion and development of generics places moreemphasis on price reductions than on developing the use of generic drugs, these proposals areonce again illusory,” suggested Gemme’s president, Erick Roche.

Earlier this year, France’s health ministry announced a “national plan of action to promotegeneric medicines” that included raising levels of generic prescribing within hospitals and inoutpatient care, along with a public communication campaign and saving around C350 millionby 2017 through increasing by five percentage points the rate of prescribing within the country’srépertoire of generic equivalents (Generics bulletin, 10 April 2015, page 1).

Roche – who is also president of Teva’s French operation – said the latest proposals were“inconsistent with the government’s commitment in the context of the action plan for thedevelopment of generic medicines”. Insisting that the generics industry should not be forcedto contribute savings in a manner disproportionate to its share of healthcare spending – and thatconcrete “structural measures” were needed to better develop France’s generics sector – Rocheconcluded that the latest proposals could amount to a “dangerous position that solves nothing”. G

France plans price cutsas Gemme urges action

Optimising the use of Europe’s decentralised and centralised marketing-authorisationprocedures, reversing the “progressive increase in the number and scope of variations”,

better using telematics tools to support regulatory processes and revising the regulatory feestructure are among recommendations proposed by the European Generic and Biosimilarmedicines Association (EGA) in a report that the association is billing as “the most detailedreview of the European regulatory environment for generic medicines since 2010”.

Streamlining marketing-authorisation application procedures by eliminating “unnecessaryduplications” and enabling “rapid addition of new countries and marketing-authorisation holders”would “more closely reflect the operation of the generic medicines industry, and more importantlygive the possibility to respond faster to patient and market needs”, the EGA suggests. Meanwhile,rolling back aspects of good manufacturing practice (GMP) and the supply chain into thedomain of the GMP inspectorate would enable a “more practical oversight” than is offeredby the variations process, the body believes. G

For further details of the report, turn to page 17.

EGA calls for regulatory overhaul

Gen 2-10-15 Pg. 1_Gen 18/11/05 Pg. 1 30/09/2015 17:56

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Jordanian player Hikma is looking to expand its presence in theMiddle East and North Africa (MENA) region by agreeing to

acquire a 98.09% stake in Egyptian oncology specialist EIMC UnitedPharmaceuticals (EUP) for an undisclosed sum. The transaction witha consortium of shareholders is subject to certain antitrust approval.

Established in 2003, EUP specialises in cancer drugs, marketingtreatments including carboplatin, doxorubicin, leucovorin andoxaliplatin, as well as other branded generics and over-the-counterremedies such as malaria drugs and iron-deficiency treatments.

Meanwhile, the Egyptian firm has a broad pipeline of bothoncology and other drugs, with “the potential to [introduce] around50 products by 2020”.

Through the transaction, the Jordanian firm will obtain EUP’smanufacturing site in Badr City, near Cairo, that has been certified bythe European Medicines Agency (EMA) as well as by multiple healthauthorities across the MENA region. The plant – through which theEgyptian firm contract-manufactures for multiple originators, includingAstraZeneca and Roche – is capable of producing oncology and othervials and ampoules, as well as capsules, tablets and liquids.

Oncology and injectables are priorities“Egypt is a very important market for Hikma, and we have been

rapidly growing our business there over the last few years,” commentedthe firm’s vice-chairman and MENA region head, Mazen Darwazah.“Across the group, expansion in the areas of oncology and injectablesare key strategic priorities and I am very pleased to be developingour capabilities in the MENA region.”

Hikma claims to be currently the eleventh largest manufacturerin Egypt, with an estimated 2.0% of the local US$3.8 billion pharmamarket, according to IMS Health data.

At the start of 2013, the Jordanian group agreed to pay aroundUS$22 million for Egyptian player EPCI in a deal that included aformulations facility (Generics bulletin, 1 February 2013, page 3). TheEPCI transaction followed the US$60.5 million acquisition of AlkanPharma in 2007 that gave Hikma a foothold in the Egyptian market. G

COMPANY NEWS

3GENERICS bulletin2 October 2015

MERGERS & ACQUISITIONS

Hikma agrees to buyEgyptian player EUP

Teva has become the first global pharmaceutical company to “tapthe power” of information technology specialist IBM’s Watson

Health Cloud, a cognitive computing platform “delivered through thecloud” for analysing high volumes of data and proposing evidence-based options. According to the two companies, the unit formed by IBMin April this year will “help improve the ability of doctors, researchersand insurers to innovate by surfacing new insights from the massiveamount of personal health data being created daily”.

By working with IBM, Teva believes it will be able to “collectand analyse real-world evidence, draw powerful insights and informa variety of initiatives such as reducing drug misuse or increasingprescribed medication adherence”. Chief information officer Guy Hadarisaid the cloud platform would allow the firm to “put the best informationand insights in the hands of physicians, care teams and patients, [and]to empower treatment optimisation for individuals and populationsacross the spectrum of acute and chronic conditions”. G

BUSINESS STRATEGY

Teva links with IBM for cloudPatent-intelligence provider GenericsWeb has been acquired by

IMS Health. GenericsWeb – which bills its Ark Patent Intelligenceplatform as “the best-in-class online pharmaceutical patent intelligence”– counts among its subscribers “some of the largest pharmaceuticalresearch and development and generics firms, legal firms and serviceproviders” and has users in more than 45 countries.

“With this acquisition, IMS Health continues to enhance thequality and usability of its information services, providing morecomprehensive data, better search functionality and greater patentknowledge,” the company said. GenericsWeb’s founder, LeightonHoward, has taken on the role of IMS Health’s director of offeringmanagement, patent intelligence.

IMS Health said it would not only gain a team of experiencedpatent experts, it would also be able to provide “world-leading patentinformation” through a “state-of-the-art database and delivery platform”that included a portal for collating global litigation activity. G


IMS acquires GenericsWeb

Sandoz has officially opened its BioInject facility for producingpre-filled syringes and devices for biosimilars and novel biologics

drugs in Schaftenau, Austria. A C150 million (US$167 million)investment at the site has created 100 new “highly-qualified” jobs.

With the capacity to fill 18,000 syringes per hour, the facilitywould “play an important role in driving the next wave of biosimilarsgrowth at Sandoz and Novartis”, the firm commented.

Noting that the BioInject site – which can pack 100 syringes perminute – would become a “central part” of parent group Novartis’bio-manufacturing network that includes facilities in Slovenia,Singapore and France, Carol Lynch, global head of Sandoz’Biopharmaceuticals and Oncology business, said the new facility“stands as a testament to both Sandoz’ technological leadership inbiologics as well as the company’s commitment to further strengtheningits global leadership in biosimilars”. More than C2.2 billion had beeninvested in Austria since Novartis was first established 19 years ago,Sandoz pointed out.

Meanwhile, Sandoz is supplying at least two-thirds of an initial15 medicines that Novartis is offering to governments, non-governmental organisations and other public-sector healthcare providersoperating in low- to middle-income countries at a monthly cost ofUS$1.00 per treatment.

According to the Swiss group, the Novartis Access initiative is a“first-of-its-kind portfolio approach” to increasing availability andaffordability of treatments for cardiovascular diseases, diabetes,respiratory illnesses and breast cancer. The portfolio of generic andpatented medicines will be launched initially in Ethiopia, Kenya andVietnam, although Novartis plans to roll out the initiative to 30countries, depending on demand.

“The products included in the Novartis Access product portfoliohave been selected based on the World Health Organization’s (WHO’s)Essential Medicines List and are among the most commonly prescribedmedicines in these countries,” the group explained. “Novartis expectsthis new approach to be commercially sustainable over the long term,enabling continuous support in those regions.” G

MANUFACTURING

Sandoz opens plantand supports access

Gen 2-10-15 Pgs. 2-11_Layout 1 30/09/2015 17:56

Sun Pharmaceuticals is considering selling a manufacturing facilityin Cashel, near County Tipperary, Ireland, that it picked up

through its US$4 billion acquisition of Ranbaxy, in order to better“optimise manufacturing capacity, costs and efficiencies”. “Decisionsare being made to either close or divest some of our manufacturingfacilities,” a Sun spokesperson told Generics bulletin, noting thatthe Irish site was “currently identified for divestment”.

According to Irish industrial development agency IDA Ireland,the Cashel site was opened in 1996, employs “close to 100 people”,and produces “mainly” tablet formulations for the UK market. TheIndian firm – following the completion of its merger with Ranbaxy inMarch – has, combined, 45 finished-dose and active pharmaceuticalingredient (API) manufacturing sites spread across five continents.

US supply disruptions have hindered Sun following US Food andDrug Administration (FDA) scrutiny of its finished-dose formulationsite in Halol, India, while the company is tackling manufacturingdeficiencies at four plants picked up through the Ranbaxy acquisition.

Sun is also looking to expand its nascent US ophthalmologybusiness by agreeing to merge with California-based branded specialistInSite Vision in an all-cash, US$0.35 per share deal valued at aroundUS$48 million. The transaction is slated to close by the end of this year.

Insite will add two ophthalmic brands to the Indian firm’sburgeoning ophthalmics portfolio – AzaSite (azithromycin) 1%solution and Besivance (besifloxacin) 0.6% suspension – as well aseight products currently under development.

The US firm had in the first six months of this year sales ofUS$3.8 million and an earnings before interest, tax, deprecation andamortisation (EBITDA) loss of US$6.4 million.

“This potential acquisition is a part of our overall objective oftransitioning to a specialty company,” commented Sun’s North Americachief executive officer, Kal Sundaram. “Besides dermatology, we haveidentified ophthalmology as one of the key segments for establishingour branded presence in the US.” G

COMPANY NEWS

4 GENERICS bulletin 2 October 2015

2 October 2015 Issue 239

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

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MANUFACTURING

Sun looks to sell offIrish tablets facility

Aceto says it is “well positioned” to launch between six and ten newgenerics during its current financial year ending 30 June 2016,

having amassed a pipeline of 60 generic filings, including three thathave been approved by the US Food and Drug Administration (FDA)and are pending launch.

With a further 47 generic candidates in various stages ofdevelopment, the US firm said it was continuing with its transformationtowards becoming a human-health focused company, adding that it was“strategically positioned for growth through geographic expansion,new product offerings and bolt-on acquisitions”.

Human Health becomes dominant segment“The mix is shifting towards a Human Health oriented business,”

Aceto said, noting that the segment had gone from accounting for14% of net sales in 2010 to 41% in 2015. Over the same period, theHuman Health segment went from contributing 14% of Aceto’sgross profit to accounting for more than half at 56%.

In its financial year ended 30 June 2015, Aceto’s sales rose by7.2% to US$547 million as Human Health turnover jumped by two-fifths to US$225 million on the back of previously announced priceincreases and new launches (see Figure 1). Meanwhile, the US firm’soperating profit leapt by more than a quarter to US$56.3 million. G

BUSINESS STRATEGY/ANNUAL RESULTS

Aceto aims to launchten products by June

Business Annual sales Change Grosssegment (US$ millions) (%) margin (%)

Human Health 225.3 +40.6 33.6Performance Chemicals 172.4 -0.6 19.1Pharma Ingredients 149.3 -15.4 17.9

Aceto 547.0 +7.2 24.8

Figure 1: Breakdown by business segment of Aceto’s sales and gross margin inits financial year ended 30 June 2015 (Source – Aceto)

Gen 2-10-15 Pgs. 2-11_Layout 1 30/09/2015 17:56

COMPANY NEWS


Concordia has signed a definitive agreement with Cinven to acquireits Amdipharm Mercury (AMCo) business in a transaction worth

US$3.5 billion. Formed in 2013, AMCo was the result of a mergerbetween Amdipharm and Mercury Pharma that was put together byCinven (Generics bulletin, 22 March 2013, page 6).

The deal – which will see AMCo acquired for a combination ofaround US$1.2 billion cash, US$0.7 billion in common shares ofConcordia and around US$0.22 billion “performance-based earn-outpayable in cash in the fourth quarter of 2016”, and includes assumingaround US$1.4 billion in AMCo debt – has been approved by the boardsof directors of both Concordia and Cinven, and is “strongly supported”by AMCo’s management team. As a result of the transaction – whichis expected to close in the fourth quarter of 2015 – Cinven will holdan expected 19.9% ownership in Concordia.

Citing AMCo’s “strong international footprint, with sales in morethan 100 countries”, Concordia said the firm also had a “strongcompetitive position on the vast majority of its products, driven bycomplexities in their manufacturing and regulatory processes”. The dealprovides Concordia with a “well-diversified niche portfolio of morethan 190 well-established off-patent molecules”, as well as offeringthe firm “entry into new therapeutic areas such as endocrinology,ophthalmology and urology”.

On a proforma basis, AMCo was expected to record full-year salesof US$530-560 million in 2015, Concordia noted, having experienceda compound annual growth rate (CAGR) of 18% between 2012 and2014. The combined company would have proforma sales ofUS$870-920 million for the full year of 2015, with adjusted earningsbefore interest, tax, depreciation and amortisation (EBITDA) ofUS$510-540 million.

AMCo said the deal would “position the combined businessperfectly for further growth”, resulting in a “highly complementary yetgeographically-diverse business”. Concordia noted that the combinedcompany enjoyed a “strategic fit and shared management philosophyfocusing on niche life-cycle management opportunities for off-patentprescription drugs”, and was “broadly diversified, with no single productaccounting for greater than 10% of sales”.

Describing AMCo’s portfolio as “defensible”, Concordia pointedout that the firm specialised in “difficult to manufacture products withhigh technical barriers and complex regulatory approval”, such aslevothyroxine sodium which accounted for around 8% of AMCo’s sales.

Of AMCo’s top 20 products by value in 2015, Concordia said,88% had two or fewer competitors, with more than two-fifths – 43% –enjoying exclusivity with no competitors (see Figure 1).

Meanwhile, AMCo’s geographical spread offered a “strongfoothold and attractive position in the UK, [one of] Europe’s largestpharmaceutical markets”, Concordia observed (see Figure 2).“Strategic distributor alliances and a local presence in certain Europeanand Middle-Eastern and North African markets are expected to enablegrowth on an international scale,” the firm added, describing AMCoas a “scalable platform across geographies and therapeutic areas”.

Opened ‘hub’ office in DubaiAMCo recently opened an office in Dubai to act as a hub for the

firm’s expansion throughout the Middle East and North Africa,including in Algeria and Saudi Arabia, under the leadership of regionalmanager Werner Rooseboom (Generics bulletin, 22 May 2015, page 27).

Mark Thompson, Concordia’s chairman and chief executiveofficer, said the firm was “not only acquiring products and commercialinfrastructure, but a seasoned management team who has done afantastic job of building a solid and successful international operation”.

Moreover, AMCo offered “operating leverage” through aproprietary ‘centre of excellence’ in India that handled a range offunctions including regulatory, commercial, strategic development,international operations and finance.

Describing the transaction as a “key milestone and pivotal turningpoint in Concordia’s strategy”, Thompson said acquiring AMCo would“uniquely position the combined company as a leading internationalpharmaceutical company with extensive geographical reach, a diversifiedand attractive product portfolio, and an asset-light business model thatwe expect will allow us to focus investments and resources on furthergrowing our business”.

Following its announcement of the deal to acquire AMCo,Concordia has announced a public offering of around eight millioncommon shares, the proceeds of which will be partly used to fundthe transaction and associated expenses.

AMCo chief executive officer John Beighton emphasised that itwould continue to be “business as usual” for the firm’s customers,suppliers and business partners, which he insisted “will be able tointeract with AMCo in the same way as they do today”. G


Concordia will pay US$3.5bn for AMCo

Exclusive –no competitors

43%

One or twocompetitors

45%

More than twocompetitors

12%

Figure 1: Breakdown of competition to AMCo’s top 20 products measured byvalue in 2015 (Source – Concordia)

Europe19%

Rest of World15%

UK66%

Figure 2: Breakdown by region of AMCo’s sales in 2015 (Source – Concordia)

Gen 2-10-15 Pgs. 2-11_Layout 1 30/09/2015 17:56

COMPANY NEWS


Expanding and solidifying its place in the US market is the “nextbig frontier” for Aspen Pharmacare, according to the South African

firm’s chief executive officer, Stephen Saad. Speaking with localbroadcaster Business Day TV, Saad commented that the “globally-strong positions in niche areas” Aspen had gained through recentacquisitions, coupled with the approximate US$800 million it hadobtained through divestments, had created a platform to stake a claimin the world’s largest pharma market.

However, Saad maintained, the firm would only look to marketproducts where there was little competition. “You cannot go and offer[an] Aspen offering in South Africa in the US market. There are alreadya lot of big players who do that there,” he insisted. “So we have to comein with something different and differentiated. We have got a nicherange of products that we believe we will bring into the US market.”

Expansion into the US had begun “some time back”, Saad noted,adding that Aspen was expecting product registrations to startmaterialising by the end of June 2016. Aspen’s US sales fell by 17%to ZAR894 million (US$64 million) in its financial year ended 30June 2015, after the firm a year ago divested the US rights to itsArixtra (fondaparinux sodium) anticoagulant to Mylan for US$300million, citing “a lack of knowledge of the US generics sector”.

Meanwhile, Saad maintained that Aspen would look to “grow offthe strengths we have…in heparin-based products, where we have globalleadership in terms of supply of traceable porcine products, [and in]the women’s health region, where we are very strong”. The SouthAfrican company is moreover anticipating synergies of “at leastZAR2.5 billion over the next three years” stemming from recent deals.

International sales ahead by 46% to ZAR18.2 billion, resultingfrom strong growth in Europe and the Commonwealth of IndependentStates (CIS), as well as in Latin America, helped Aspen to increaseits group sales by more than a fifth to ZAR36.1 billion in its 2015financial year. As a result of the International growth, the segmentaccounted for exactly half of Aspen’s sales (see Figure 1).

In Latin America, sales leapt by more than three quarters toZAR6.13 billion, driven by turnover in Aspen’s Spanish Latin Americabusiness doubling to ZAR5.34 billion. Anticoagulant sales increasedby 70% in Mexico, while Aspen introduced pharma sales teams inChile, Colombia, Ecuador and Peru. But operations in Brazil, wheresales inched ahead by 1% to ZAR798 million, had been “muted”,

Aspen noted, following supply disruptions from partner Merck.Meanwhile, in Europe and the CIS, anticoagulant sales doubling

to ZAR4.45 billion saw turnover in the region ahead by 45% toZAR10.5 billion. Aspen had at the start of the year bolstered itsanticoagulants portfolio by agreeing to acquire the rights to Novartis’Mono-Embolex (certoparin sodium) injectable for US$142 million(Generics bulletin, 27 February 2015, page 27).

In its domestic market, almost two-thirds of the South Africanfirm’s turnover that rose by 16% to ZAR8.61 billion came from privatesector sales ahead by 12% to ZAR4.86 billion, as Aspen offloadeda basket of injectables and established brands to Endo in a dealworth ZAR1.6 billion (Generics bulletin, 22 May 2015 page 4).

The bulk of turnover in Aspen’s Asia-Pacific region that fell by3% to ZAR8.50 billion came in Australia and New Zealand, wheresales dropped by 8% to ZAR7.22 billion following the terminationof licenses in the former country. Moreover, Aspen on 1 Septembercompleted the sale of its Australian generics business to Strides Arcolabfor A$265 million following an agreement reached earlier in the year(Generics bulletin, 5 June 2015, page 3).

In Aspen’s Asian operation, sales rose by just under two-fifthsto ZAR1.29 billion, as the firm began trading in Japan from 1 July(Generics bulletin, 13 March 2015, page 8). “[We] are in the processof finalising a collaboration with GlaxoSmithKline to launch authorisedgenerics,” Aspen commented, noting that Japanese sales had “almostdoubled” to ZAR476 million.

Meanwhile, a combination of “supply challenges for key products”,“significant currency devaluation” and “political unrest in Nigeria”in Aspen’s Sub-Saharan African business caused turnover to increaseby just 1% to ZAR2.78 billion. West African sales down by 2%contributed over half of turnover, and stagnant sales in East Africamore than a third. However, turnover in Southern Africa that contributedthe remaining tenth to group turnover rose by almost a fifth.

Aspen’s operating profit increased by 14% to ZAR8.45 billion butlarger selling and distribution and administrative costs caused the firm’soperating margin to slide by 1.8 percentage points to 23.4%. G

BUSINESS STRATEGY/ANNUAL RESULTS

Aspen believes US is the next frontierAnnual sales Change Proportion of

(ZAR millions) (%) total (%)

Europe/CIS 10,456 +45 29Latin America 6,128 +76 17North America 894 -17 2Middle East, North Africa 679 +2 2International 18,157 +46 50

Private Sector 4,857 +12 13Public Sector 1,573 +14 4Consumer 1,369 +23 4Manufacturing 809 +34 2South Africa 8,608 +16 24

Australia, New Zealand 7,217 -8 20Asia 1,287 +39 4Asia-Pacific 8,504 -3 24

Sub-Saharan Africa 2,777 +1 8

Eliminations -1,919 ±0 -5

Aspen Pharmacare 36,127 +22 100

Figure 1: Breakdown by region of Aspen Pharmacare’s sales in its financial yearended 30 June 2015 (Source – Aspen)

InternationalZAR4.61bn

+27%

South AfricaZAR1.83bn

+11%

Asia-PacificZAR1.71bn

-6%

Sub-Saharan AfricaZAR307mn

-6%

Figure 2: Breakdown by region of Aspen Pharmacare’s operating profit thatincreased by 14% to ZAR8.45 billion in the company’s financial year ended 30June 2015 (Source – Aspen)

Gen 2-10-15 Pgs. 2-11_Layout 1 30/09/2015 17:56

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Mylan and Perrigo have sued each other in a US court after theformer launched a takeover offer made directly to the store-brand

specialist’s shareholders. In its complaint filed in a New York districtcourt, Perrigo alleged that “Mylan disseminated materially false andmisleading offering materials” to its shareholders and sought aninjunction preventing Mylan from closing its tender offer until ithad made “appropriate corrective disclosures”.

Perrigo claims Mylan is employing a ‘carrot-and-stick’ approachto getting Perrigo’s shareholders to tender shares. The carrot is apromise of US$800 million in annual operational synergies, while thestick is a threat, if not enough shareholders tender their holdings, to“delist Perrigo’s shares from all public stock exchanges, a move thatMylan admits will likely destroy value for Perrigo shareholders”.

However, Perrigo asserts, “Mylan’s synergies estimates are nolonger valid” as its ability to realise savings will be limited by operatingPerrigo as a majority-owned subsidiary, rather than a wholly-ownedaffiliate. “Mylan does not have the power to delist Perrigo’s shares,”the firm maintains, adding that to do so would violate securities laws.

In its counterclaims, Mylan says Perrigo’s management – includingpresident, chairman and chief executive officer Joe Papa, who“personally invested more than US$220,000 in Mylan stock” in Marchthis year – is seeking to mislead shareholders into rejecting the takeoveroffer of US$75.00 in cash plus 2.3 Mylan shares for each Perrigo share.

Mylan’s filing goes on to take issue with Perrigo’s description ofthe premium on offer to shareholders, the scale of synergies, howaccretive the proposed deal would be and on the stance of Mylan’slargest shareholder, Abbott. Separately, Mylan described as “futile”and “entirely without merit” a suit Perrigo has filed in Israel.

Perrigo had filed its suit on the same day that Papa wrote toshareholders urging them not to tender their shares in the offer thatexpires on 13 November. Papa argues in the letter that “Mylan’s offersubstantially undervalues the company’s current cash flows, business andfinancial platforms and growth opportunities”. Mylan’s offer “presentsclear risks and would result in value destruction for shareholders,including forcing them into a ‘corporate governance prison’”.

“Mylan’s pursuit of Perrigo ‘at all costs’ highlights a number ofextraordinarily troubling corporate governance values,” Papa asserts,citing Mylan’s plans to delist Perrigo’s shares if it obtains majoritycontrol. Mylan reduced its acceptance threshold for its offer from notless than 80% to greater than 50% of Perrigo’s shareholders beforelaunching its bid (Generics bulletin, 11 September 2015, page 3). G

COMPANY NEWS



Mylan and Perrigotake fight to courts

Endo International has divested glycopyrrolate and methimazoletablets to Aceto’s Rising unit as a condition for securing US

approval for its US$8.05 billion acquisition of Par Pharmaceutical.Endo, which must supply the two drugs to Rising for two years, hasalso agreed to sell rights to its meclizine tablets to the Aceto unit.

Having completed its purchase of Par from private-equity firmTPG on 28 September, Endo said its combined US generics businesswould operate under the Par Pharmaceutical banner, led by Par’schief executive officer Paul Campanelli. Endo now anticipates agroup turnover this year of US$3.22-US$3.27 billion. G


Endo divests three to Aceto

INDIAN MANUFACTURING FACILITIES operated by Akorn,Polydrug Laboratories and Sri Krishna Pharmaceuticals have beensubjected to import alerts by the US Food and Drug Administration(FDA). Akorn’s alert relates to “all drug and drug products” made atits facility in Paonta Sahib that the US-based firm acquired fromKilitch Drugs. Polydrug’s import ban covers its site in Ambernath nearMumbai, while the FDA has restricted imports from Sri Krishna’sNacharam plant, although the firm’s sodium phenylbutyrategranules are exempt from detention without physical examination.

UNILIFE is reducing its workforce by 17%, or around 50 employees,as the injectable drug-delivery specialist continues to review itsstrategic alternatives, including a takeover, following expressionsof interest from third parties. The US-based firm plans to reduceresearch and development spending by at least a quarter, and selling,general and administrative expenses by a fifth in its current financialyear. In the 12 months ended 30 June 2015, Unilife reported anoperating loss of US$80.4 million on a turnover that declined bya tenth to US$13.2 million.

VIVIMED LABS expects to raise Rs3.80 billion (US$57.3 million)from divesting certain assets of its Speciality Chemicals personalcare, homecare and business to Clariant. Speciality Chemicalsaccounted for almost a third of the Indian group’s turnover that rose by2% to Rs13.9 billion in the year ended 31 March 2015, with theremainder coming from its Healthcare finished and bulk drugs segment.

TEVA has been fined HuF792.2 million (US$2.83 million) byHungary’s competition authority, the GVH, for allegedly collaboratingwith competitors to harmonise prices in public-procurement hospitaltenders and then carving up the market between them. Fines of thesame magnitude were imposed on Euromedic-Pharma andHungaropharma, while the authority placed smaller fines on twoconsultancies. According to the authority’s investigations – whichincluded dawn raids conducted in April 2013 – the “cartel members”modified the tender for 12 hospitals in November 2011 so as toexclude potential competitors to supply 919 active ingredients.

SVIZERA LABS has been sent a ‘notice of concern’ by theWorld Health Organization (WHO) following an inspection of theIndian firm’s facility in Turbhe near Mumbai, India, in June this year.The WHO’s pre-qualification said Svizera “may have manipulateddissolution-test results” and had “failed to ensure the integrity of data”.

PAN DRUGS allowed pigeons access to areas near productionequipment by leaving holes in the walls and roof of its activepharmaceutical ingredient (API) facility in Baroda, India, accordingto a warning letter issued by the US Food and Drug Administration(FDA). Other good manufacturing practice (GMP) deficiencies listedin the letter include “rust, dirt, lubrication leaks and exposed insulationmaterial” around open manufacturing equipment.

IGI LABORATORIES has submitted its eighth abbreviated newdrug application (ANDA) to date this year. The US company nowhas 30 ANDAs pending approval.

JHL BIOTECH – the Taiwanese biosimilars developer – has furtheredits strategy of collaborating on biosimilar development in Brazilafter hosting a delegation of “Brazilian government officials andtop-ranking biotech executives” at its headquarters and productionfacility in Hsinchu. As part of the visit, the delegation toured JHL’sfacilities, “which have been expanded in the past year to includeformulation and molecular cell-biology laboratories”. G

IN BRIEF

Gen 2-10-15 Pgs. 2-11_Layout 1 30/09/2015 17:56

India’s Strides Arcolab says it has gained a “strong entry point intothe Indian central nervous system (CNS) market” by agreeing to

buy from Sun Pharma its Ranbaxy affiliate’s Solus and Solus CareCNS marketing divisions for Rs1.65 billion (US$25.1 million). Thetransaction – which includes employees from the two divisions – issubject to Competition Commission of India (CCI) approval, while“other terms and conditions are confidential”.

The sales of the two businesses – which combined had sales ofaround Rs920 million for the 12 months ended July 2015 – is alignedwith Sun’s strategy “to firmly consolidate our CNS business in India”,according to Abhay Gandhi, chief executive officer of Sun’s Indianoperation. “Post successful completion of [the] Ranbaxy merger wehad an opportunity to assess the entire portfolio of our India business.We have evaluated each and every therapy segment that we are presentin and how these businesses can grow going forward,” he added.

Strides, meanwhile, has been actively looking to expand bothits global and domestic operations through transactions this year,with deals for fellow Indian firm Shasun and for Aspen’s Australiangenerics business. “The acquisition of Solus and Solus Care divisionsis of strategic significance to the growth of our branded business inIndia,” declared the firm, which has secured board approval to raise upto Rs15 billion by issuing bonds or other equity-linked instruments.The fundraising is subject to shareholders’ and statutory approvals. G

COMPANY NEWS


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Strides agrees to buySun CNS businesses

Awarning letter issued by the US Food and Drug Administration(FDA) against Impax’ manufacturing facility in Hayward,

California, more than four years ago has been lifted, after the US firmwas informed that it had “successfully addressed all items raised” inthe letter following a recent inspection. “Quality-management andcompliance systems are deemed to be acceptable,” Impax stated.

“With the resolution of the warning letter, we are excited about thepotential for approvals and launches of new products from the facility,”commented Impax’ president and chief executive officer, Fred Wilkinson,who identified bringing the Hayward site back to compliance as oneof four key priorities when he took the helm in April last year.

Soon after the FDA issued the all-clear, the agency approvedImpax’ abbreviated new drug applications (ANDAs) filed from theHayward site for generic versions of Valeant’s Mestinon Timespan(pyridostigmine bromide) 180mg extended-release tablets and Testred(methyltestosterone) 10mg capsules, with the latter being the firstgeneric rival approved.

Having received the warning letter in May 2011 (Generics bulletin,30 June 2011, page 5), Impax had seen over the years numerousremediation activities and responses to FDA observations ofmanufacturing deficiencies fail. Most recently, in June, the US firmresponded to three Form 483 observations that had arisen during athree-week inspection of the plant during April and May. G

MANUFACTURING

Impax’ Hayward siteresolves deficiencies

Gen 2-10-15 Pgs. 2-11_Layout 1 30/09/2015 17:56

McKesson has agreed to pay C408 million (US$455 million) incash for the pharmaceutical distribution division of Ireland’s

UDG Healthcare. The deal includes UDG’s wholesaling operations inNorthern Ireland and the Republic of Ireland; TCP, a leading homehealthcare provider in the Republic of Ireland; and Masta, UDG’s travelhealthcare business based in the UK.

Marc Owen, executive chairman of McKesson’s Celesio businessin Europe, said UDG’s United Drug and Sangers distribution operations,as well as its home and travel healthcare units, would complement thegroup’s existing assets in Ireland and the UK. As part of the deal, morethan 1,000 UDG employees will join McKesson.

The US group expects to complete the transaction during thefirst half of 2016, at around the same time as it closes a deal for 281UK pharmacies operated by the Sainsbury’s supermarket chain.However, the UK’s Competition and Markets Authority is currentlyinvestigating the Sainsbury’s acquisition, and intends to reach adecision on 11 November.

In the US, McKesson has struck a five-year distribution deal,starting on 1 April 2016, that includes sourcing generic and brandedpharmaceuticals for the Albertsons chain of almost 1,700 pharmaciesspread across 33 states. The US distributor said Albertsons would“benefit from the scale and strength of McKesson’s proprietaryOneStop generics programme”. G

COMPANY NEWS



McKesson acquiresUDG distribution unit

Stronger sales through wholesalers enabled Nichi-Iko Pharmaceuticalto report group turnover 15.3% higher at ¥35.0 billion (US$290

million) in its financial first quarter ended 30 June 2015. Genericslisted during the Japanese company’s financial year ended 31 March2015 contributed ¥1.49 billion.

Nichi-Iko’s gross margin improved by just over half a percentagepoint to 37.5%, while a freeze in research and development spendinghelped to lift the firm’s operating margin by half a point to 9.0% ona 22.2% operating profit rise to ¥3.17 billion.

In its current financial year ending 31 March 2016, Nichi-Ikoanticipates achieving an operating margin of 9.1% on a turnover ofjust over ¥137 billion. G

FIRST-QUARTER RESULTS

Wholesaler demandstrengthens Nichi-Iko

BIOCON has opened a 10,000 sq m insulin devices facility inBangalore, India. The first product launched from the plant is BasalogOne, a ready-to-use insulin glargine disposable pen designed incollaboration with Becton Dickinson that the company is marketingin India. Having launched the Basalog brand in 2009, Biocon hasdesigned the once-a-day Basalog One device to use a 3ml cartridgeof 100IU insulin glargine manufactured in India. G

IN BRIEF

Gen 2-10-15 Pgs. 2-11_Layout 1 30/09/2015 17:56

Changes planned to ensure that Swiss pharmacists receive the samefinancial incentives for dispensing a generic as for a brand have

been welcomed by local generics industry association Intergenerika.Noting that Switzerland’s Federal Council had “signalled its intention”to modify the financial incentives linked to distributing and dispensingmedicines, Intergenerika said this “corresponded to a long-heldrequest by our association”.

In response, the association has set out a series of suggestions forhow best to manage a framework that will offer “identical absolutemargins for identical active substances”.

“Commercial profitability will be identical when dispensing acheaper generic or selling a more costly original,” Intergenerikaexplained, noting that this would allow the correction of “a significantnegative incentive” to dispense brands instead of generics. Pharmacistswould no longer be “penalised for dispensing generics”, the associationsaid, “but will be able to benefit from a neutral income situation”.

Moreover, the association suggested, with equal margins fororiginals and generics, there would no longer be any financial interestin over-complicating the process of generic substitution.

“With our model,” Intergenerika insisted, savings would not derivefrom “a reduction in margins”, but through the increased use of genericsthat the association claimed could generate economies of as muchas SFr150 million (US$154 million). G

MARKET NEWS


PRICING & REIMBURSEMENT

Swiss group seekinga level playing field

The British Generic Manufacturers Association (BGMA) has joinedwith the Association of the British Pharmaceutical Industry (ABPI)

and the UK BioIndustry Association (BIA) in supporting a newinformation document on biosimilars published by the National HealthService (NHS) in England.

Entitled ‘What is a biosimilar medicine?’, the document is aimedat “key clinical and non-clinical stakeholders” and represents “the firstcollaborative publication on biosimilar medicines at a country level,following the 2013 launch of the European Commission’s [‘Tajani’]consensus document” (Generics bulletin, 3 May 2013, page 1).

Warwick Smith, director general of the BGMA, said the association“strongly supports NHS England’s efforts to ensure that balancedinformation and guidance is made available across the NHS to supportthe appropriate use of the growing number of biosimilar medicinesin the best interests of patients”. “In our view,” he added, “2015represents a breakthrough year for biosimilars which have the potentialto offer the NHS considerable cost savings.”

A biosimilar is described in the document as “a biological medicinewhich has not been shown to have any clinically meaningful differencesfrom the originator biological medicine in terms of quality, safety andefficacy”, although “not considered generic equivalents”. “NHS Englandsupports the appropriate use of biosimilars”, the document states,“which will drive greater competition to release cost efficiencies”. G

REGULATORY AFFAIRS

BGMA lends supportfor biosimilars guide

Gen 2-10-15 Pgs. 2-11_Layout 1 30/09/2015 17:56

Principles for furthering trade in generic and biosimilar medicineswere presented by the International Generic Pharmaceutical

Alliance (IGPA) to the World Trade Organization (WTO) during ameeting in Geneva, Switzerland, on 30 September.

Having commissioned a report on pro-industry principles that couldbe included in future international trade agreements (Generics bulletin,5 December 2014, page 20), the IGPA’s trade committee wants to take amore strategic and proactive approach to shaping the terms of trade deals.

Outlining the report’s principles during the IGPA’s 18th annualconference held in Toronto, Canada, last month, IGPA trade committeechairman Jim Keon said they would include greater regulatoryconvergence, single development programmes for generics andbiosimilars, penalties for abusing intellectual-property rights andincentives for challenging weak or invalid patents.

Discussing intellectual-property provisions, Keon said Bolar-typeflexibilities allowing exports to countries without protections in placeshould be mandatory in trade deals, while patent linkage was “bestconsidered unnecessary”. Data-exclusivity periods should be no longerfor biologics than for small-molecule drugs, he argued. G

IGPA CONFERENCE


TRADE AGREEMENTS/INDUSTRY ASSOCIATIONS

IGPA details to WTOits trade deal agenda

The threat of tendering in Canada “is starting to rear its head again”as general election debates include the future of drug coverage,

according to Apotex’ Jeff Watson, who serves as chairman of theCanadian Generic Pharmaceutical Association (CGPA).

Noting that savings through tender-type provisions in theNetherlands were often cited in Canadian debates, Watson insisted thatthe country could achieve low-cost access “without a tendering model”.He said negotiations were underway over the follow-up to a three-yearpan-Canadian tiered pricing framework that had recognised thecomplexity of developing non-solid orals and rewarded first-to-marketproducts (Generics bulletin, 11 September 2015, page 24). G


Canadian firms fear tenders

The International Generic Pharmaceutical Alliance (IGPA) will soonchange its name to the International Generic and Biosimilar

medicines Association (IGBA). The body – which embraces localassociations covering Canada, Europe, Japan, Jordan, South Africa,Taiwan and the US, as well as associate members in Australia, Braziland Mexico – will also become a legal corporation later this year.

Speaking at the IGPA’s 18th annual conference in Toronto, Canada,last month, the alliance’s chairman Jim Keon said its managementcommittee was in “advanced talks” with bodies including the MalaysianOrganisation of Pharmaceutical Industries (MOPI) about joining.

Keon, who heads the Canadian Generic Pharmaceutical association(CGPA), on 1 October handed over the chair of the IGPA to VivianFrittelli, chief executive officer of South Africa’s National Associationof Pharmaceutical Manufacturers (NAPM). The 19th IGPA annualconference will take place on 8-10 June in Dubrovnik, Croatia. G

INDUSTRY ASSOCIATIONS

IGPA will adopt IGBA name

DATA INTEGRITY is perhaps “the biggest issue facing the industry”,warned Brendan Cuddy, head of the manufacturing and qualitycompliance service within the European Medicines Agency. Oncethe trust “at the heart” of the regulatory system was lost, it wouldbe very difficult to restore, he said. “To compete, you have to investin quality,” he insisted.

HALAL PHARMACEUTICALS represent a major opportunity forMalaysian and other south-east Asian manufacturers, Kotra Pharma’sCheah Ming Loon outlined. He described Malaysia as “a pioneer”in serving a US$500 billion global market of 1.8 billion Muslimswho would favour medicines that conformed with halal regulations.

EUROPEAN SAVINGS generated through generics should not beused exclusively to fund access to patented novel drugs, FreseniusKabi’s Marc-Alexander Mahl insisted. Representing the EuropeanGeneric and Biosimilar medicines Association (EGA), Mahl arguedthat the financial headroom created by generics should also coveroff-patent value-added products. Mahl appealed to European payersto recognise the value of added-value delivery systems, such as pre-filled syringes compared to standard vials, in their tender processes.

LOWER GLOBAL OIL PRICES could drive up demand for low-cost generics and biosimilars in the Middle East and North Africa(MENA) region, forecasted Maher Kurdi, vice-chairman of theJordanian Association of Pharmaceutical Manufacturers (JAPM).Hayat Pharma’s Kurdi said national governments were looking to cutcosts at a time when they were having to dip into financial reservesto cover budget deficits caused by relatively low oil revenues. G

IN BRIEF

Senior executives participating in a round table during the 18thannual International Generic Pharmaceutical Alliance (IGPA)

conference in Toronto, Canada, last month were divided over whethervertical integration for raw materials was necessary to succeed.

Apotex’ president and chief executive officer Jeremy Desai said hewas “a strong advocate for vertical integration, even more so now”.Whereas it was previously important for speed of development andcircumventing intellectual property, “in the world of higher scrutiny onthe compliance front, having control of active pharmaceutical ingredient(API) sourcing is absolutely critical”, he maintained, highlighting anability to react quickly to regulators’ questions. “It is not really acost-driven decision now, it is about security of supply,” he stated.

But Sagent’s newly-appointed chief executive Allan Oberman saidhe had “never believed that as a core strategy a generic manufacturerneeds to be vertically integrated to succeed”. Having its own API sourcecould make sense for smaller niche players, he conceded. But for broad-portfolio players, investing heavily in vertical integration may not bringan effective return on capital, he argued. Similarly, he added, the lengthycycle times for finished-dose facilities meant trying to make all productsyourself “limits your flexibility” to respond to market dynamics.

Pharmascience’s chief operating officer, Larry MacGirr, suggestedthat companies should explore innovative supply-chain approaches,such as virtual ownership and transparent alliances. G

BUSINESS STRATEGY

Executives differ oververtical integration

Gen 2-10-15 Pgs. 12-16_Layout 1 30/09/2015 17:58 Page 2

Italy has initiated the process to participate in the European Union’s(EU’s) unitary patent scheme and expects to receive formal

acceptance of its request to participate from the European Counciland European Commission “very soon”, according to the EuropeanPatent Office (EPO).

The move came “after clarification of important legal questionson the unitary patent by the Court of Justice of the EU (CJEU),” theEPO said, referring to a CJEU ruling from earlier this year that rejectedchallenges to the legality of the proposed framework put forward bySpain (Generics bulletin, 22 May 2015, page 13). Following the ruling,Italy said acceding to the framework was “a priority”.

Calling Italy’s decision “very good news for Europe”, EPOpresident Benoît Battistelli said “the addition of this important andlarge market to the new patent scheme will reinforce the attractivenessof the European market”. Italy’s under secretary of state to theministry of economic development, Simona Vicari, said the countrywould seek to “define the operational procedures more suitable tothe needs of the Italian industrial fabric” as part of the “front line,together with other European partners and the EPO”.

Portugal recently became the eighth EU member state to officiallyratify the unified patent court agreement, following Austria, Belgium,France, Denmark, Luxembourg, Malta and Sweden (Generics bulletin,11 September 2015, page 12). G

MARKET NEWS


Developing generics. [email protected]

INTELLECTUAL PROPERTY

Italy is preparing tojoin unitary patent

Avoiding duplication of assessments and improving the authorisationand safety of medicines are among the goals of a “new working

arrangement” between the European Medicines Agency (EMA) andthe World Health Organization (WHO) that will allow the two bodiesto “step up cooperation to better protect global public health”.

According to the EMA, the “timely sharing of non-publicinformation” will “strengthen communication between the respectiveorganisations and make it easier and quicker to take action to protectpublic health”. The information will relate to “the safety, quality andefficacy of medicines already authorised or under review in theEuropean Union (EU), or pre-qualified or under review by WHO”.The arrangement was also expected to “accelerate patients’ access tonew and innovative medicines in the EU”, the EMA said.

Noting that the EMA and WHO – along with the EuropeanCommission – had “a long history of scientific and technicalcollaboration”, the EMA said the “strengthened cooperation” hadofficially come into effect from the start of September.

Under the confidentiality arrangement, the agency pointed out,the organisations may share information including post-authorisationpharmacovigilance data – “particularly relating to adverse drugreactions as well as safety concerns” – as well as information inapplications and data related to inspections, manufacturingfacilities and research activities. G

REGULATORY AFFAIRS

EMA and WHO willexpand cooperation


Staff spending by the US Food and Drug Administration (FDA) onfull-time equivalents (FTEs) related to biosimilars has leapt in

2015, according to Janet Woodcock, director of the agency’s Centerfor Drug Evaluation and Research(CDER).

Addressing a US Senate committee on health, education, labourand pensions, Woodcock said the agency’s spending on FTEs relatedto biosimilars in the first two quarters of the fiscal year ending 30September 2015 had been “equivalent to the total expenditures in theprevious two fiscal years”. Total FTE spending would be “significantlygreater in fiscal 2015 than in previous fiscal years”, Woodcock noted,adding that the FDA was “working to recruit additional staff and hascontinued to allocate increasing resources for the critical biosimilarreview programme”.

“The increase in FTE expenditure is a direct reflection of thechange and increase in workload in fiscal 2015,” Woodcock said,noting that four firms had publicly announced submissions of fivebiologics license applications for biosimilars to the FDA. Moreover,she revealed, as of 31 July 2015 there were “57 proposed biosmilarproducts to 16 different reference products enrolled in the biosimilarproduct development (BPD) programme”.

“Sponsors of an additional 27 proposed biosimilar products havehad a biosimilar initial advisory meeting with the FDA, but have notjoined the BPD programme to pursue development,” she added. G

MARKET NEWS


REGULATORY AFFAIRS

FDA ups investmentas biosimilars boom

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More than 80 active ingredients across 127 bidding lots are coveredby the latest tender launched by Germany’s SpectrumK consortium

of 63 statutory health insurance funds covering 7.3 million Germans.Among the drugs with combined annual sales of around C400

million (US$447 million) are antihypertensives such as amlodipine,bisoprolol, metoprolol and ramipril, as well as analgesics includingibuprofen and tilidine/naloxone.

Blockbusters like the diabetes drug metformin, the ulcer treatmentomeprazole and the cholesterol-lowering agent simvastatin will also becovered by two-year supply deals running from 1 January 2016. Thedeadline for bids in SpectrumK’s 16th tender round is 15 October.

A further 10 lots are listed only for supplying the BKK fund.Of the 137 total number of bidding lots, nearly half – 62 – will begranted to up to three suppliers, with the rest due to go to anexclusive partner.

Separately, the consortium is offering non-exclusive, two-yearsupply contracts for rasagiline 1mg that will start on 1 October 2015.

According to Germany’s federal ministry of health, savings forstatutory health insurance funds through rebates given by pharmaceuticalcompanies increased by a tenth to C770 million in the first quarter ofthis year. Nevertheless, the country’s drugs bill rose by 5% to C9.17billion – or 17% of total expenditure through the funds – due in partto paying C430 million for patented hepatitis C treatments. G


German SpectrumKseeks tender offers


Final guidance issued by the US Food and Drug Administration(FDA) over physical attributes for generics “imposes arbitrary

requirements even in the absence of known safety issues” and couldrestrict access, according to the US Generic Pharmaceutical Association(GPhA). “The premise of the guidance, that generic drugs must mimicthe reference listed drug (RLD) in size and shape, has no basis in law,”the association insisted in a letter to the US agency.

The guidance document – published by the FDA in June (Genericsbulletin, 26 June 2015, page 16) – advises generics firms developingoral tablets and capsules to ensure that their products are of a similarsize and shape to the RLD. It does not apply to abbreviated newdrug applications (ANDAs) that are already approved, and does notapply to differentiated oral dosage-forms such as chewable, orally-disintegrating and sublingual tablets.

“As the FDA is aware, generic manufacturers may propose tomanufacture a tablet or capsule that in some cases is larger than theRLD,” the letter states. “This may not be a matter of choice.”

Due to patent protection for the RLD’s formulation or modified-release technology, the GPhA points out to the agency, “a genericmanufacturer may be required to develop a dosage unit that differsin dimensions, which will not be protected by patent, in order tomake available lower-cost generics”.

“A generic version of a product that differs from the size and/orshape recommendations set forth in the guidance does not automaticallyraise safety issues,” the GPhA insists, pointing out that the FDA hadbeen “unilaterally rejecting proposed differences” that did not complywith the guidance, thus making it a “de facto regulatory requirement”.

“Member firms report that controlled-correspondence inquiries[to the FDA] have not been subject to any scientific evaluation, andrather are rejected regardless of the level of deviation from theguidance,” the GPhA reveals. “When the generic product dimensionsdiffer from the RLD, the proposed size and/or shape should be evaluatedon a case-by-case basis to assess actual risks,” the association urged.

Moreover, the GPhA warns, the guidance “creates a new life-cyclemanagement tool for new drug application (NDA) sponsors to stifleand delay access to lower-cost generic medicines based on inflexiblecriteria that are not necessarily applicable to a proposed deviation insize and/or shape”. As a result, the letter suggests, “NDA sponsorswill have even greater incentives to prevent generic competition, anddesign patent strategies to achieve this objective”, including obtainingpatents to cover ranges of sizes, shapes and other characteristics.

Furthermore, the guidance’s size requirements “are particularlyproblematic in that they do not provide generic manufacturers sufficientflexibility”, the GPhA insists. Size requirements for tablets “significantlylimit generic manufacturers’ options to design non-patent infringingproducts even when the proposed dimensions do not raise safetyconcern for the intended patient population”, the association states,while for capsules the FDA fails to define its recommendation thatlarger capsule sizes should only be considered when “adequatejustification can be provided for the size increase.”

“By requiring generic products to more closely resemble the drugsthey reference, generic manufacturers will unnecessarily encounterintellectual-property barriers that they have long sought to avoid,”the letter concludes, urging the FDA not to hold ANDAs that werereceived or pending agency review prior to the issuance of the finalguidance to the new requirements, “unless there are specificscientifically supported safety concerns”. G

MARKET NEWS


REGULATORY AFFAIRS

GPhA rebuts FDA onsize and shape guide

Least developed countries (LDCs) should be given “an indefiniteexemption” from implementing intellectual-property rules for

pharmaceuticals, the European Commission has stated. By supportingLDCs’ call to be exempted from patent-term extensions, data exclusivityand other intellectual-property provisions included in the World TradeOrganization’s (WTO’s) agreement on trade-related aspects ofintellectual-property rights (TRIPS), the Commission says suchcountries will have “easier access to cheaper medicines”.

Trade Commissioner Cecilia Malmström said she was confidentthat the European Council of Ministers would support the Commission’sapproach “and that the European Union (EU) will take the lead withinthe WTO in this field”. The WTO’s TRIPS Council is set to take adecision on an indefinite exemption for least developed countriesduring a session on 15-16 October.

Médecins Sans Frontières (MSF) applauded the “important changein the EU position since the last time this issue was discussed at theWTO”, urging other countries such as the US and Switzerland to“follow the lead of the EU and also fully support the request as putforward by the LDCs as soon as possible”.

Earlier this year, an extension to a waiver that allows LDCs toavoid obligations to protect intellectual property on pharmaceuticals alsoreceived the backing of global health initative UNITAID as well asnon-profit body IDA (Generics bulletin, 10 April 2015, page 11).G


EU voices support onexemptions to TRIPS


Lawmakers in the US should introduce legislation to protect themechanisms of the Hatch-Waxman framework and Biologics Price

Competition and Innovation Act (BPCIA) from being underminedthrough abuses of the inter partes review (IPR) procedure, an allianceof healthcare lobbying groups has urged in a letter to the chairs andranking members of the US House and Senate judiciary committees.

Since its introduction on 16 September 2012, parties such as genericsfirms have been able to use the IPR procedure to ask the US PatentTrial and Appeal Board (PTAB) to review the patentability of claimsin patents issued on or after that date on the basis of prior art.

“The IPR proceedings were intended to be a more efficient wayto address patent challenges,” the letter states, “but IPR opened thedoor to abuses that threaten the unique and specialised mechanismsunder [the Hatch-Waxman framework] and the BPCIA.” While theexisting framework “generally works well”, the letter acknowledges,“current abuses in the IPR proceedings could ultimately undermine theability to raise capital and recoup development costs needed to fundfuture research”, causing a “chilling effect” on innovation.

“Congress never intended for the IPR proceedings to undermine thepatent dispute resolution frameworks in Hatch-Waxman and BPCIA,”the letter insists. It urges Congress to “preserve the highly-detailedand sophisticated systems designed by Hatch-Waxman and BPCIA toavoid weakening the patents that sustain medical research”. G

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REGULATORY AFFAIRS

US action urged oninter partes review

Indian players will “grab at least 20%-25% of the global market sharein biosimilars in the next five years”, according to a report published

by the India Brand Equity Foundation. The government-backed bodyestimates India’s domestic and export pharmaceuticals markets to bevalued at US$15 billion each, with supplies of intermediates and activepharmaceutical ingredients (APIs) to Japan a particular area of focus.

Separately, the Associated Chambers of Commerce & Industryof India (Assocham India) expects the country’s domestic genericsmarket to grow by 16.3% per year to reach US$27.9 billion by 2020.Generics will account for 85% of India’s pharma market. G

MARKET RESEARCH

India eyes biosimilars share

US SENATORS Amy Klobuchar and Chuck Grassley havereintroduced a bill that would crack down on reverse-payment or‘pay-for-delay’ patent-litigation settlements. If passed, the PreserveAccess to Affordable Generics Act would make it illegal fororiginators to use pay-off agreements to keep generics off the market.The two senators unsuccessfully introduced similar legislation inthe previous Congress.

EUROPEAN supplementary protection certificate (SPC) Regulation469/2009’s reference to a product’s date of first authorisationshould be interpreted as referring to the date on which a product’smarketing authorisation is first notified in the European Union’s(EU’s) Official Journal, according to an opinion published by theEU Court of Justice’s advocate general. This date should be usedrather than the earlier date of the marketing authorisation itself, theadvocate general concluded.

GERMAN shortages of intravenous ampicillin-based antibioticsare forcing hospital doctors to turn to broader-spectrum drugs,thereby increasing the risk of antibiotic resistance and endangeringpatients, according to the German society for infectology, the DGI.In a joint statement issued with the association of German hospitalpharmacists, the ADKA, the DGI urged manufacturers to informthem of production and supply difficulties as soon as possible andcalled for a “comprehensive strategy” to improve the availabilityof critical off-patent drugs in Germany.

IRELAND’s health minister, Leo Varadkar, has met with China’sminister responsible for the China Food and Drug Administration(CFDA), Bi Jingquan, as part of efforts to “deepen relationshipsbetween the two countries” and “improve contact and interactions”in sectors including pharmaceuticals.

ROMANIAN generics industry association APMGR has pointed toother European pricing and reimbursement policies as “successfulmodels” as it renewed its call for a differentiated pharmaceuticalclawback for generics in Romania at the organisation’s second annualconference. The event was held with the support of the EuropeanGeneric and Biosimilar medicines Association (EGA).

FTC – the US Federal Trade Commission – has signed an antitrustmemorandum of understanding with the Korea Fair TradeCommission (KFTC) to promote “increased cooperation andcommunication” between the two bodies. Similar deals were struckby the FTC in China in 2011 and in Japan in 1999.

EMA – the European Medicines Agency – plans to finalise guidanceon its policy to publish clinical data following a series of meetingswith industry stakeholders. A July meeting with patient organisationsand regulators was followed by an event in September at which theagency presented technical guidance on procedural aspects ofsubmitting clinical reports. In October the regulator will consult withthe European Ombudsman and European Data Protection Supervisor.

GWQ SERVICEPLUS – the group of 43 German health insurancefunds – has awarded a total of 256 individual supply contracts for122 active ingredients to 41 different companies. Of the 256 contracts,87 are exclusive, while the other 169 are split between up to threesuppliers per molecule. GWQ’s 12th tender round covers drugs withcombined annual retail sales through the funds of C422 million(US$471 million). Noting that it had found partners for drugsincluding filgrastim and leucovorin, GWQ said it had failed to attractoffers for 11 bidding lots. G

IN BRIEF


MARKET NEWS


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Four firms – Accord, AMCo, Alvogen and Walgreens Boots Alliance– have been nominated for the Corporate Social Responsibility

(CSR) Initiative of the Year Award sponsored by humanitarian charityInternational Health Partners (IHP) at the Generics bulletin GlobalGenerics & Biosimilars Awards 2015. The winner will be announcedduring the Awards ceremony in Madrid, Spain, on 13 October.

“While CSR has been seen to be the preserve of the brandedindustry,” IHP acknowledged, “there are many ways that genericsfirms of all sizes can immediately act more responsibly.”

These included fund-raising for causes that help increase access;donating surplus stock; taking part in co-ordinated industry-wideresponses to emergencies; and helping to build good manufacturingpractice (GMP) capacity in the developing world. G

INDUSTRY AWARDS

Four will vie for CSR Award

A“constructive discussion on what can be done to keep prescriptiondrugs affordable while balancing innovation and competition” is

needed, according to the US Generic Pharmaceutical Association(GPhA), in the wake of rising US prescription drug costs.

The association’s comments come after Turing Pharmaceuticalsreportedly increased the price of its off-patent Daraprim (pyrimethamine)antiparasitic agent – which the US firm recently acquired from Impaxfor US$55 million (Generics bulletin, 1 September 2015, page 21) –from US$13.50 per tablet to US$750 per tablet, a rise of almost 5500%.

The generics association pointed out that Turing “was not a GPhAmember and has no relationship with the GPhA”. “No single companyand no single product represents the entire generic drug industry, whichhas an undeniable record of patient savings and access,” the groupnoted, observing that recent data showed falling generics costs.

In response to Turing’s announced price increase, US Presidentialhopeful Hillary Clinton released a four-point plan to tackle rising drugcosts in the US, including requirements that companies spend aminimum on research and development, and are able to justify priceincreases, and a stipulation that health insurance schemes place amonthly limit of US$250 on covered out-of-pocket drug costs. G


GPhA urges dialogueover US pricing plans

Enhancing patient access to medicines and improving operationalefficiency to ensure the “sustainable, long-term development” of

the generics industry are the central focus of the European Generic andBiosimilar medicines Association’s (EGA’s) wide-ranging RegulatoryEfficiency report (see front page).

The report sets out a series of proposals “to identify how additionaloptimisation can be applied”, in a manner that is “resource-neutral orresource-saving for both regulatory agencies and pharmaceuticalcompanies”. While this will “ideally avoid the need for legislativechanges”, the EGA states, it also proposes “some more ambitiousimprovements, probably needing legislative amendment”.

To overcome research and development (R&D) duplication bymoving into a single development programme, the report recommendsan official confirmation that sourcing of a reference product from a“non-EU territory with high regulatory standards” is accepted forsingle R&D programmes of generic medicines.

Meanwhile, Europe’s centralised procedure (CP) should have itseligibility criteria reinterpreted “to broaden access for genericmedicines”, the EGA suggests, while increased use of the CP forgenerics could also be promoted by addressing “areas of inflexibility”that have limited generics applicants from fully using the CP.

Improving the decentralised procedure (DCP) by enhancingflexibility could be achieved through a ‘backbone DCP’, with a singleharmonised assessment enabling marketing authorisations (MAs) tobe obtained quickly and only when needed; by a ‘basket DCP’ throughwhich one reference member state (RMS) would assess a full basketof elements for a given product and the MA holder choosing a “tailoredoption” for each member state; or through a ‘worksharing DCP’ thatwould see one RMS assess applications on behalf of several RMSs,with concerned member states being added later.

The current DCP could be improved by completing validation in14 days through automatic validation by the RMS, and mandating aday-106 clock-restart within a month after applicants answer questions,the report suggests. National phases could be accelerated through “fasttrack processing” and dropping compulsory translations of patientinformation if no immediate launch is foreseen in a given country.

The EGA also recommends modernising Europe’s fee structurewith a flat annual fee per product – covering all maintenance costsincluding variations – and introducing a fee structure for productregistrations that “fairly reflects the workload of the assessment”.

Variations fees should be restructured “so that maintenance fees, inthe first renewal period after MA grant, are lower than initial submissionfees”, the report recommends, along with a host of adjustments tofees and timelines to make the process more accessible and efficient.

“Excessive active pharmaceutical ingredient (API) goodmanufacturing practice (GMP) and supply-chain information in theregulatory dossier” must also be addressed, the report states. Meanwhile,pharmacovigilance processes should be modified to stop duplication ofsignal detection in the Eudravigilance database, introduce the singlesubmission of periodic safety update reports (PSURs) per activesubstance, and simplify risk-management plans for standard generics.

Finally, the report recommends, European regulators should“maximise the opportunity of the Article 57 database by using thesingle data collection to serve many purposes, including by connectionto regulatory procedures”. This database could be used for “manyType 1A changes instead of variations to maintain oversight butsimplify procedures”. G

REGULATORY AFFAIRS

EGA report focuseson added efficiency


Connect with Alvogen on www.alvogen.com

MEET US AT CPHI

At Alvogen we value partnerships and collaboration because we know that ourfuture is largely determined by our strategic selection of people and successful

alliances around the world. We are looking forward to linking up with oldpartners and new contacts, as well as current and potential customers at

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famous St. Andrews course, where the whole tradi-tion of golf was born – a course that has dazzled

many of the world’s top players for centuries.

We look forward to seeing you in Madrid.

Madrid, Spain, 13-15 October – Hall 10, booth F10

Alvogen is a global, privately ownedpharmaceutical company focused ondeveloping, manufacturing and sellinggeneric, brand, over-the-counterbrands and biosimilar products forpatients around the world.

The company has commercial opera-tions in 35 countries with 2,300employees and operates five manu-facturing and development hubs inthe U.S., Romania, Korea and Taiwan.North America is Alvogen’s singlelargest market and other key marketsinclude: South Korea, the WestBalkans, Poland, Romania, Bulgaria,Hungary, Taiwan, Thailand, Ukraine,Russia, Japan and China.

Connect with Alvogen on www.alvogen.com

Abasaglar, the biosimilar version of Sanofi’s Lantus (insulin glargine)original developed by Eli Lilly and Boehringer Ingelheim, is now

available in Germany.Launched in Germany around the same time as the diabetes drug

made its debut in the UK (Generics bulletin, 11 September 2015,page 17), Abasaglar is being marketed in Germany in packs of five or10 cartridges or KwikPen ready-filled pens. The 3ml cartridges arefor use with Lilly’s reusable pens, such as HumaPen Savvio.

Launch list prices for Abasaglar are C69.34 (US$77.13) andC123.75 for five and 10 cartridges, while the KwikPen is listed atC71.07 and C127.06 for packs of five and 10 devices. The discountsto pharmacy retail prices for Lantus cartridges are C10.00 and C20.00respectively, representing savings of 13% and 14%. The KwikPenvariant offer discounts to Sanofi’s Solostar original of 10% and 13%.

Deals struck with health fundsIn a list posted on the brand website at www.abasaglar.de, Lilly –

which is handling marketing – said it had by mid-September struckpricing and reimbursement deals with the majority of German healthinsurance funds, while negotiations were continuing with AOK Baden-Württemberg. Long-acting insulin analogues are fully reimburseablein Germany for patients with type-1 diabetes, as well as for type-2patients who are allergic to human insulin or are at high risk ofserious hypoglycaemia.

Lilly is also responsible for manufacturing the biosimilar at itsfacility in Fegersheim, France.

Following a positive opinion from the European Medicines Agency,the European Commission last year granted a centralised marketingauthorisation for Abasaglar (Generics bulletin, 19 September 2014,page 1). Other than Germany and the UK, the partners have launchedthe brand in the Czech Republic, Estonia, Slovakia and Japan.

Boehringer and Lilly said data from secondary analyses ofPhase III clinical trials showed that the biosimilar “demonstrated safetyand efficacy outcomes similar to Lantus” in patients with type 1 and2 diabetes who received pre-study treatment with the original.

Data presented at the 51st European Association for the Studyof Diabetes (EASD) annual meeting in Stockholm, Sweden, usedchange in glycated haemoglobin, or HbA1c, from baseline to 52weeks in type 1 patient and to 24 weeks in type 2 patients. G

PRODUCT NEWS


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

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

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

[email protected].

BIOLOGICAL DRUGS

Abasaglar arrivesinto German market

AUS district court did not err last year in ruling that four US patentsprotecting Shire’s Vyvanse (lisdexamfetamine dimesylate)

blockbuster until 2023 were valid and infringed by abbreviated newdrug applications (ANDAs) filed by Allergan’s Actavis, Amneal,Mylan, Roxane and Sandoz, the US Court of Appeals has decided.

New Jersey District Court Judge Stanley Chesler last year ruledthat compound claims in US patents 7,655,630, 7,659,253 and 7,662,787– which expire on 24 February 2023 – and a method-of-use claim inUS patent 7,105,486 that covers the attention deficit hyperactivitydisorder (ADHD) treatment until 29 June 2023 were not obvious andnot anticipated (Generics bulletin, 11 July 2014, page 21).

In their appeal, the firms maintained that a prior-art Australianpatent application – AU54,168/65 – had “actually disclosed”lisdexamfetamine, rendering the patents obvious. But the appeals courtfound that “the prior art did not disclose or make obvious the mesylatesalt of lisdexamfetamine”.

“AU’168 discloses combining amphetamine, in any of itsstereochemical forms, with numerous amino acids, in variousstereochemistries and with many potential protecting groups. Nothing inAU’168 specifically suggests combining d-amphetamine with L-lysine,”ruled the appeals court.

However, the court reversed and remanded for further proceedingsChesler’s ruling that drug master file (DMF) holder Johnson Matthey –which has supplied the generics firms with lisdexamfetamine dimesylateactive pharmaceutical ingredient (API) – had through this actioninduced infringement of the asserted claims. Johnson Matthey, as anAPI supplier, has thus far “done nothing more than provide materialfor use by the ANDA defendants in obtaining [US] approval,” thecourt concluded, so were subject to the Bolar safe harbour. G

ATTENTION DEFICIT HYPERACTIVITY DISORDER DRUGS

Five fail with appealon US Vyvanse rival

Mylan has secured the first US approval for rivals to Jazz Pharma’sFazaClo ODT (clozapine) 25mg and 100mg orally disintegrating

tablets. However, the firm holds only tentative approval for the 12.5mgstrength due to another applicant’s first-to-file abbreviated new drugapplication (ANDA) that is eligible for 180-day exclusivity.

Litigation in a Delaware district court over alleged infringement ofUS patents 6,024,981 and 6,221,392 – both of which expire on 9 April2018 – was settled and dismissed in July this year. Jazz had alreadysettled similar litigation with Novel in a deal that gave the generics firma licence to enter the market with the antipsychotic agent on 1 May2017, or earlier under certain circumstances. Teva has been marketingan authorised generic of FazaClo since the end of August 2012.

Meanwhile, Mylan has also secured final approval for and launchedfluvastatin 80mg extended-release tablets that are equivalent to Novartis’Lescol XL cholesterol-lowering brand. As Generics bulletin went topress, Mylan held the only final ANDA approval, while Par and Tevahad tentative approvals. Citing IMS Health data for the 12 monthsended June 2015, Mylan said US sales of fluvastatin 80mg extended-release tablets were US$37.6 million. Paediatric exclusivity attachedto the only patent listed against Lescol XL in the Orange Bookmaintained by the US Food and Drug Administration (FDA) – USpatent 6,242,003 – expires on 13 October 2020. G

SCHIZOPHRENIA DRUGS

Mylan gains a clozapine first


Apotex has convinced a Canadian Federal Court that a formulationpatent protecting Eli Lilly’s Cialis/Adcirca (tadalafil) brands

until April 2020 is obvious and not infringed by the generic firm’sabbreviated new drug submission (ANDS).

Judge Mary Gleason found that using tadalafil in its ‘free drugform’, reducing its particle size and formulating it with excipientsclaimed in Canadian patent 2,379,948 were “obvious steps to try” toimprove the active ingredient’s solubility in water. Furthermore, shesaid, Apotex’ generic formulation did not include the proportions ofwater-soluble diluent or hydrophilic binder described in the ‘948 patent.

Discussing Lilly’s failure to prove that Apotex’ tadalafil candidateinfringed the ‘948 patent, Gleason determined that Lilly expertDr. Bodmeier had shown a “general lack of credibility” after confusingthe definition of the words “guarantee” and “expectation” in his affidaviton a claim-construction meaning of the word “about”.

“I believe that the change [from guarantee to expectation] wasan attempt to adjust his evidence to avoid a conclusion unfavourableto Lilly, which is not how an independent expert ought to conducthimself,” she stated. “If I am wrong in this and Dr. Bodmeier’s Englishis so poor that he cannot distinguish between “guarantee” and“expectation”, then his command of the language is such that it is notsuitable for him to be providing expert testimony to this court.”

However, Gleason ruled, the Canadian firm’s allegation that thepatent was invalid due to lack of utility were not justified. “While itis true, as Apotex notes, that Lilly did not test all the formulationsclaimed in the ‘948 Patent, I find it is not necessary for them to havedone so to establish utility,” she commented.

Earlier this year, Federal Court Judge Yves de Montigny describedas “unjustified” Mylan’s allegations that Canadian Cialis patent2,226,784, which expires in July 2016, was invalid due to lack of utilityand obvious-type double patenting (Generics bulletin, 6 February 2015,page 19). Gleason noted that Mylan had appealed against the ruling,and the case was currently pending. G

PRODUCT NEWS


The “cliff” has passed for pharma but has justbegun for generics companies that have benefitedfrom the high number of drugs going off patent.Generics developers are turning to the 505(b)(2)approval pathway, through which new drugsand products that offer differentiated benefitscan gain approval in a fraction of the time andcost required by traditional pathways.

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ERECTILE DYSFUNCTION DRUGS

Tadalafil patent ruledas obvious in Canada

Zentiva’s rivals to Actelion’s Tracleer (bosentan) 62.5mg and 125mgtablets have been added to France’s répertoire of substitutable

generic equivalents following a decision by local medicines agencyANSM. Mylan’s valganciclovir 450mg tablets have also been addedwith Roche’s Rovalcyte brand as the reference product, while Pfizerhas had listed an authorised generic for its Inspra (eplerenone).

Hospira’s rocuronium version of Merck, Sharp & Dohme’sEsmeron 10mg/ml injectable has also been added to the répertoire,along with Panpharma’s rival to Prostrakan’s Droleptan (droperidol)1.25mg/2.5ml injectable, Banner Pharmacaps’ 400mg ibuprofen softcapsule – listed against Reckitt Benckiser’s Nurofen brand – andFresenius Kabi’s version of AbbVie’s Chirocaïne (levobupivacaine)solution in 0.625mg/ml, 1.25mg/ml, 2.5mg/ml and 5mg/ml strengths.

Synthon has seen listed its version of Lundbeck’s Ebixa(memantine) as 5mg, 10mg, 15mg and 20mg tablets, while Biogaran’sversion of Bioprojet’s Tiorfan (racecadotril) 100mg capsules has alsobeen added. Stada’s rival to GlaxoSmithKline’s Requip (ropinirole) 3mgprolonged-release tablets has also been added to the répertoire. G

GENERIC SUBSTITUTION

France adds to its répertoire


Visit us at the 2015 GPhA FallTechnical Conference – Booth 1

Amneal may introduce a generic version of Namenda XR(memantine) extended-release capsules almost a decade ahead of

patent expiry after settling litigation over its abbreviated new drugapplication (ANDA) with brand owner Allergan. The privately-owned US player is understood by Allergan to be the first firm tohave filed a complete ANDA with a paragraph IV patent challenge.

Under the terms of the settlement, which is subject to US FederalTrade Commission (FTC) review, Amneal will be able to launch itsgeneric memantine extended-release capsules, if approved, on 31January 2020, or alternatively “under certain circumstances” anauthorised generic exactly 12 months later, on 31 January 2021.Namenda XR’s latest-expiring US patent 8,039,009 expires with sixmonths of paediatric exclusivity on 24 September 2029.

“Similar patent-infringement litigations against certain othercompanies that have filed ANDAs remain pending in a [Delaware]District Court,” Allergan commented.

Allergan has been looking to shift patients to Namenda XR aftergeneric versions of predecessor Namenda immediate-release (IR)flooded the market earlier this year pursuant to settlement agreements(Generics bulletin, 7 August 2015, page 25). The firm – which hadfailed in its attempt to immediately remove Namenda IR from themarket to hasten the transition process – has also introduced a novelmemantine/donepezil combination under the Namzaric name. G

PRODUCT NEWS


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ALZHEIMER’S DISEASE TREATMENTS

Amneal has date forrival to Namenda XR

Canadian players could receive notices of compliance (NOCs), ormarketing authorisations, for generic versions of Alcon’s Vigamox

(moxifloxacin) 0.5% eye drops in early November following a rulingby the country’s Federal Court of Appeal.

The court found no fault in a lower court judge’s finding last yearthat Canadian patent 2,342,211 – which had been due to expire on29 September 2019 – should be declared invalid due to obviousness(Generics bulletin, 6 June 2014, page 19).

The judge had been correct to conclude that the ‘211 patent relatedto “the known compound moxifloxacin being used for a known useat a concentration known to be effective”, the Court of Appeal panelstated, adding that hearing Alcon’s attempt to re-argue its case andpresent again its evidence was “not the role of a Court of Appeal”.

Utility was predictedHowever, the Court of Appeal refused Actavis’ petition to set

aside an NOC prohibition order that prevents authorisation ofgenerics until after Canadian patent 1,340,114 expires on 3 Novemberthis year. The appeals panel supported the lower court judge’s findingthat the utility of the ‘114 patent had been soundly predicted.

Alcon did not appeal against the lower court’s ruling that Canadianpatent 2,192,418 – which expires on 9 December 2016 – was notinfringed by the formulation used by Actavis’ Cobalt affiliate. G

OPHTHALMIC DRUGS

Canada cuts downmoxifloxacin term


Biosimilar monoclonal antibody developer (mAb) EpirusBiopharmaceuticals is expanding its pipeline and “vertically-

integrated product development capabilities” by acquiring Dutchpre-clinical mAb developer Bioceros in a cash-and-shares deal valuedat US$14.1 million. Through the deal, Epirus will pick up threebiosimilar assets, including proposed versions of Alexion’s Soliris(eculizumab), and Janssen’s Stelara (ustekinumab) and Simponi(golimumab) brands. “As we move forward, Bioceros will becomeEpirus Pharmaceuticals Netherlands,” revealed Epirus’ president andchief executive officer, Amit Munshi.

Citing Bioceros’ “specific focus on biosimilars” and its status asa “leader in cell-line and process development”, Epirus noted that thedeal gave it access to a 560 sq m development laboratory for mAbsas well as a “small-scale bioreactor for rapid iteration to optimiseproduct characteristics”. Bioceros also boasted an “experienceddevelopment team of around 20 scientists with extensive experiencein cell-line and antibody development”, Epirus observed.

The US-based firm anticipates starting global filings for its‘BOW080’ eculizumab candidate in 2020, with its ‘BOW090’ustekinumab candidate to follow in 2021 and ‘BOW100’ version ofgolimumab in 2022. “Over the next year, we will be evaluating potentialpartnerships for clinical development and commercialisation of ourexpanded pipeline in markets globally,” Munshi noted.

According to data from EvaluatePharma, Epirus said it expectedthe three biosimilar assets by 2020 to have combined “innovatorpeak sales” of around US$12 billion.

“Having worked with Epirus as a partner over the last severalyears, we believe strongly in the company’s vision,” commentedBram Bout, Bioceros’ chairman and chief executive officer. G

PRODUCT NEWS


BIOLOGICAL DRUGS

Epirus buys Biocerosto bolster its pipeline

HOSPIRA has received approval from Japan’s Ministry of Health,Labour and Welfare (MHLW) for its 30mg/5ml and 100mg/16.7mlpresentations of paclitaxel.

TARO has introduced its Keveyis (dichlorphenamide) 50mgtablets in the US through its specialty pharmacy partner,Diplomat. The brand is the first treatment approved in the US forprimary hyperkalemic and hypokalemic periodic paralysis.

ROXANE has failed to persuade Delaware District Judge GregorySleet to accept its interpretation of claims in US patent 8,586,610,which protects Vanda’s Fanapt (iloperidone) antipsychotic agentuntil November 2027. Sleet rejected Roxane’s proposed constructionof terms including ‘CYP2D6 genotype’ and agreed with Vanda thatthe term ‘internally administering the iloperidone to the patient’should be given its “ordinary meaning”.

GLENMARK says its GBR 1302 bi-specific antibody is ready toenter Phase I clinical trials after pre-clinical evaluation suggestedthe novel biological drug had “demonstrated superiority over currentantibody therapies against most HER2-positive cancers”.

MYLAN has introduced ampicillin/sulbactam 1g/0.5g, 2g/1g vialsand 10g/5g vials in the US as alternatives to Pfizer’s Unasyninjectable antibiotic.

DR REDDY’S has struck a deal with Australian innovator Hatchtechthat will allow the Indian firm to market Hatchtech’s in-developmentprescription headlice product Xeglyze (abametapir) lotion inAustralia, Canada, India, New Zealand, Russia and theCommonwealth of Independent States (CIS), the US and Venezuela.Dr Reddy’s will pay Hatchtech US$10 million upfront and up toUS$50 million “based on pre-commercialisation milestones”, as wellas undisclosed milestones, linked to sales targets.

BRECKENRIDGE has obtained tentative US approval for dutasteride0.5mg soft-gelatin capsules. The US firm intends to launch thetreatment for benign prostatic hyperplasia once US patent 5,565,467protecting GlaxoSmithKline’s Avodart expires in November.

FRESENIUS KABI has expanded its US anti-infectives portfolio byintroducing moxifloxacin in its proprietary Freeflex infusion bag.

APOTEX has convinced Ontario’s Superior Court of Justice that acase based on a 400-year-old statute covering costs and damagesshould proceed to trial. The court rejected Eli Lilly’s motion todismiss Apotex’ claim for treble damages due to delays to enteringthe market caused by Lilly having listed an invalid patent againstits Strattera (atomoxetine) attention deficit hyperactivity disorder(ADHD) brand. It was not obvious, the court said, that a Statuteof Monopolies enacted in 1624 in England was not still in force.

ENDO has voluntarily recalled allopurinol and lisinopril tabletsin the US due to failed specifications and reports of oversized anddiscoloured tablets.

ANI Pharmaceuticals has agreed to pay Merck, Sharp & DohmeUS$75 million in cash for the new drug applications (NDAs) forcorticotropin gel and corticotropin-zinc hydroxide. The transaction– which includes an undisclosed percentage of future net sales, andis subject to certain customary closing conditions – is to be struckthrough a newly-created foreign subsidiary, “enabling ANI to achievea lower over-all tax rate for its operations”. G

IN BRIEF

Celltrion has filed inter partes review petitions urging the US PatentTrial and Appeal Board (PTAB) to review US patents protecting

Roche’s Rituxan (rituximab). The South Korean firm insisted thatcertain claims of US patents 7,976,838 and 7,820,161 – respectivelycovering methods of treating rheumatoid arthritis with rituximab andwith both rituximab and methotrexate – should be found unpatentable.

The ‘838 patent’s claims were “anticipated by at least two separateprior-art references”, Celltrion argued, while treating rheumatoidarthritis with methotrexate was “also well known in the prior art”. G

BIOLOGICAL DRUGS

Celltrion challenges Rituxan

Spanish firm Normon has embarked on redesigning packaging forits entire line of generics, starting with the apripirazole 5mg, 10mg

and 15mg tablets that it has just launched domestically. The overhaulis aimed at enabling “easy identification by colour coding” of a drug’sactive ingredient, therapeutic category and strength.

“Starting with aripiprazole, Normon will incorporate this designinto all future launches of generic drugs,” the company said. G

PACKAGING

Spain’s Normon has redesign


Amgen and its partner Allergan have announced positive top-linePhase III safety and efficacy data for the firms’ ‘ABP-215’

biosimilar rival to Roche’s Avastin (bevacizumab) in adult patientswith advanced non-squamous non-small cell lung cancer. The resultsof the study follow similar positive data Amgen reported from aPhase III trial for its biosimilar Humira (adalimumab) candidate earlierthis year (Generics bulletin, 6 February 2015, page 21).

As well as bevacizumab, Allergan and Amgen are collaboratingon the development and commercialisation of three more oncologybiosimilars: trastuzumab – which is also in a Phase III clinical trialin patients with breast cancer – rituximab and cetuximab. “Amgenhas a total of nine biosimilars in development,” the firms commented,noting that Allergan was “also independently developing biosimilars”.

Allergan’s biosimilars development programmes are being retainedby the company despite it having agreed to sell its Actavis genericsbusiness to Teva in a deal worth US$40.5 billion (Generics bulletin,7 August 2015, page 1). G

PRODUCT NEWS


BIOLOGICAL DRUGS

Allergan and Amgenadvance on Avastin

TARO has agreed to settle litigation in the US with Horizon Pharmarelated to the originator’s Pennsaid (diclofenac) 2% topical solution,securing a non-exclusive license to manufacture and market ageneric version of the analgesic from 10 January 2029 at the latest.This is around 19 months ahead of Pennsaid 2%’s longest-runningUS patent 8,546,450 expiring, on 9 August 2030.

AUROBINDO has expanded its US portfolio with approval formethadone and telmisartan tablets as well as for omeprazoledelayed-release capsules.

TEVA has received approval from Japan’s Ministry of Health, Labourand Welfare (MHLW) for its 20mg Copaxone (glatiramer acetate)once-daily injectable treatment for multiple sclerosis.

IMPAX has filed litigation to defend its Rytary (carbidopa/levodopa)extended-release capsules after Allergan filed an abbreviated newdrug application (ANDA) containing a paragraph IV patent challengewith the FDA for the Parkinson’s disease treatment. Allergan said itbelieved itself to be “a first applicant” to file a Rytary ANDA, andtherefore should be entitled to 180 days of exclusivity.

ACTAVIS and Perrigo have together received US Food and DrugAdministration (FDA) approvals for rivals to Reckitt Benckiser’sMucinex (guaifenesin) 1,200mg and Mucinex DM (guaifenesin/dextromethorphan) 600mg/30mg and 1,200mg/60mg extended-release cough and cold treatments.

MORE THAN TWO-FIFTHS of German rheumatologists andgastroenterologists surveyed by Decision Resources Group said theyhad prescribed biosimilar infliximab for one or more of their patients.Less than a quarter had experienced any pressure from healthcareauthorities to switch patients from the Remicade reference brandto a biosimilar, while less than a third of physicians were aware thatHospira’s Inflectra and Mundipharma’s Remsima had been approvedfor the same indications as Remicade.

DR REDDY’S has agreed to settle US litigation with BioMarinPharmaceutical concerning the US-based originator’s Kuvan(sapropterin dihydrochloride) 100mg tablets. The Indian firm hasunder the settlement been granted a non-exclusive US license tolaunch the hyperphenylalaninemia treatment in patients withphenylketonuria from an undisclosed date, “which is more than fiveyears from today, or earlier under certain circumstances”.

PERRIGO will compete with its proposed buyer Mylan for USmarket share of generic clindamycin/benzoyl peroxide 1%/5% gelafter launching an AB-rated generic version of Valeant’s BenzaClinbrand following final approval from the US Food and DrugAdministration (FDA). Mylan introduced its rival to the topicalantibiotic – which had combined branded and generic sales ofUS$231 million for the 12 months ended July 2015 – more than sixyears ago through a deal with the Canadian firm (Generics bulletin,4 September 2009, page 20).

MYLAN has introduced through its Famy Care partner a genericversion of Bayer’s Yasmin (ethinylestradiol/drospirenone)following final US Food and Drug Administration (FDA) approval.Branded and generic sales of the oral contraceptive – which is theUS firm’s 13th currently on the US market – were around US$138million for the 12 months ended June 2015, according to IMS Healthdata. The firm has also launched a rival to Janssen’s Invega(paliperidone) extended-release tablets in four strengths. G

IN BRIEF

The European Medicines Agency (EMA) says it has recently startedreviewing single generic applications for two antiviral agents for

systemic use – darunavir and tenofovir disoproxil. The former is theactive ingredient in Janssen’s Prezista HIV drug, while the latter is thebasis of Gilead’s Viread treatment for chronic hepatitis B. The EMA isalready reviewing a generic application for tenofovir disoproxil incombination with emtricitabine as an equivalent to Gilead’s Truvada.

A list of non-orphan generics and biosimilars under centralisedprocedure review that was updated by the agency on 8 Septemberincludes six pemetrexed applications as well as two each foraripiprazole, enoxaparin sodium, fluticasone/salmeterol, methotrexateand palonosetron. Single centralised marketing authorisation dossiersare under review for amlodipine/valsartan, atazanavir, bortezomib,caspofungin, cinacalcet, docetaxel and eptifibatide, as well as foretanercept, infliximab, human insulin, lopinavir/ritonavir, miglustat,rasagiline and zonisamide.

Zentiva has obtained a pan-European centralised marketingauthorisation for duloxetine 30mg and 60mg gastro-resistant capsules.G

ANTIVIRALS

EMA reviews antiviral agents

Aceto has completed the purchase of three ophthalmic abbreviatednew drug applications (ANDAs) from Nexus Pharmaceuticals and

bought another three drugs from Endo International in the US.The three Nexus drugs – ciprofloxacin 3% solution, diclofenac

sodium 0.1% solution and levofloxacin 0.5% solution – have beenmarketed by Aceto’s Rising subsidiary under licence from Nexussince 2008, with “robust shares in each market”, Aceto said.

Meanwhile, the Endo ANDAs – for methimazole tablets,glycopyrrolate tablets and meclizine tablets – were acquired by Acetofollowing the former’s acquisition of Par (see page 8). G

OPHTHALMIC DRUGS

Nexus and Endo sell to Aceto


Hikma should not be able to use the US 505(b)(2) hybrid pathwayfor its Mitigare (colchicine) rival to Takeda’s Colcrys brand to

sidestep the requirements of the Hatch-Waxman abbreviated new drugapplication (ANDA) process, according to local brand industryassociation PhRMA. An amicus brief has been submitted by theassociation as part of Takeda’s appeal against a District of Columbiadistrict court ruling that earlier this year found that there was nothingin the US Food and Drug Administration’s (FDA’s) procedural rulesthat would force Hikma’s West-Ward subsidiary to reference Colcrysand to certify to its patents.

“Mitigare is not a duplicate of Colcrys, and West-Ward did notrely upon Colcrys data or FDA’s findings of safety and effectivenesswith respect to Colcrys in order to support the Mitigare 505(b)(2)new drug application,” the district court found (Generics bulletin,6 February 2015, page 20).

But PhRMA insisted that the ruling “undermines Hatch-Waxman’sgrand bargain by permitting 505(b)(2) applicants to obtain the Act’sbenefits without shouldering any of the corresponding burdens”.

Insisting that the district court had “concluded that a 505(b)(2)applicant may obtain approval of a follow-on drug – without providingthe required patent certification – by omitting any mention of thepioneer drug in its application and relying on the FDA to fill in theblanks”, PhRMA said that interpretation “cannot be squared with the[Hatch-Waxman] Act’s structure and purpose”.

“There would be little reason for pioneer manufacturers to makesuch enormous investments if FDA could turn around and use theresulting data to approve competitors’ 505(b)(2) applications withoutaffording pioneer manufacturers any of the Hatch-Waxman Act’sprotections,” PhRMA insisted. “In short, the district court ignored theHatch-Waxman Act’s structure and purpose, as well as importantaspects of the FDA’s regulatory framework.” G

PRODUCT NEWS


Korea’s Ministry of Food and Drug Safety (MFDS) has approveda biosimilar rival to Amgen’s Enbrel (etanercept) developed

through a collaboration between Merck, Sharp & Dohme (MSD) andSamsung Bioepis under the name Brenzys. The biosimilar is indicatedfor the treatment of rheumatoid arthritis, psoriatic arthritis, axialspondyloarthritis and psoriasis in adult patients.

“The approval of Brenzys in Korea represents the first productapproval under Merck’s collaboration with Samsung Bioepis,” MSDnoted, adding that it “plans to launch Brenzys in South Korea by theend of this year or early next year”.

The approval was supported by “rigorous analytical structural andfunctional testing”, MSD said, “as well as a Phase I crossoverpharmacokinetics study and a Phase III clinical study comparingBrenzys to the originator medicine”. Dora Bibila, general manager ofMerck Biosimilars, called the approval “a key milestone”.

MSD and Samsung’s collaboration – first announced in early 2013(Generics bulletin, 8 March 2013, page 23) – was expanded in 2014to cover insulin glargine along with candidates for etanercept,infliximab, adalimumab and trastuzumab (Generics bulletin, 14February 2014, page 17). “Additional regulatory filings for each of thesefive biosimilar candidates are expected to occur in the 2015-2016timeframe,” MSD said, with the firm’s ‘MK-1293’ insulin glarginecandidate to be submitted “within the next six months”. G

BIOLOGICAL DRUGS

Merck and Samsungrival Enbrel in Korea

GOUT TREATMENTS

US hybrids must notsidestep ANDA route

US-based biopharmaceutical firm Catalyst Pharmaceuticals saysit is using its knowledge of rare debilitating diseases to rapidly

develop a generic version of Lundbeck’s Sabril (vigabatrin) for thetreatment of infant spasms and complex partial seizures. Sales of Sabril,which is formulated as either 500mg tablets or 500mg powder for oralsolution, were about US$120 million last year, the firm noted.

Catalyst currently has a vigabatrin candidate in its pipeline,‘CPP-109’, using it as a ‘research surrogate’ to support the developmentof a novel GABA aminotransferase inhibitor as an advancement onLundbeck’s brand. “We believe our substantial previous experiencewith vigabatrin will contribute to the rapid development and filing ofan abbreviated new drug application (ANDA),” Catalyst said.

Hitherto, Catalyst said it had completed numerous steps indeveloping its generic Sabril candidate – which Lundbeck licensesin the US from Sanofi – including entering into an exclusive supplyagreement for vigabatrin API with a drug master file (DMF) holder.According to the firm, several US exclusivities attached to the brandare scheduled to expire in 2016 and 2017. Meanwhile “there are nolisted patents [for Sabril], and Catalyst does not believe that itsprocesses infringe on any patents that may still be unexpired”. G

EPILEPSY TREATMENTS

Catalyst develops vigabatrin


PARAGRAPH IV WATCH


Under the patent-linkage provisions of the US Hatch-Waxman Act,there is the potential for a lucrative 180 days of generic drug

exclusivity for the first company to file an abbreviated new drugapplication (ANDA) with a paragraph IV certification that a patentis invalid, unenforceable or not infringed. In their efforts to secure theexclusivity, generics firms race to be the first to file patent challenges.

Reference products subject to a five-year New Chemical Entity(NCE) exclusivity are protected from paragraph IV challenges forfour years from the date of first approval, so potential challengersknow the specific date upon which an ANDA may be submitted inorder to secure first-filer status. This date, the so-called NCE -1 date,is exactly one year before the expiration of the NCE exclusivity. Insuch cases, all applicants filing on the first day are eligible to sharethe 180-day exclusivity, the value of which is drastically diminishedif there are many applicants. Even so, time and time again we seenumerous ANDAs submitted on the NCE -1 date. Challenges toJanssen’s blockbuster prostate-cancer treatment Zytiga (abirateroneacetate) tablets are just the latest example of this.

The NCE exclusivity for abiraterone will expire on 28 April 2016.Unsurprisingly, the US Food and Drug Administration (FDA) reportsthat the first ANDA, or ANDAs, with a paragraph IV certificationfor a generic version of Zytiga tablets was submitted on 28 April2015, the NCE -1 date (Generics bulletin, 10 April 2015, page 20).

In late June and early July 2015, Janssen Biotech receivedparagraph IV notification letters from several ANDA applicants. Inresponse, on 31 July 2015 Janssen and its partner BTG Internationalfiled a patent infringement suit against Actavis, Amneal, Apotex,Citron Pharma, Dr. Reddy’s, Hikma, Mylan, Par, Sun, Teva andWockhardt in a New Jersey district court. The suit asserted Janssen’sUS patent 8,822,438 – which expires on 24 August 2027 (see Figure1) – against all of the defendants and BTG’s earlier-expiring US patent5,604,213 against only Actavis. Similar suits were subsequently filedagainst some defendants in other courts for jurisdictional purposes.

“Given that 12-month US sales of Zytiga top US$1 billion, andthat the brand is an oral solid formulation of a widely available activeingredient, it seems unlikely that any of the applicants would havebeen naïve enough to expect anything other than numerous ANDAssubmitted on the NCE -1 date,” comments Thomson Reuters, whichcompiles a database of paragraph IV challenges and resulting litigation.

“The price erosion of a multi-generic market and difficulty ofgaining market share in a fiercely competitive environment make itsomewhat unlikely that any one company will make good on thebig profits one imagines when thinking of the 180-day exclusivity,”Thomson Reuters comments. “On the other hand, the market forgeneric abiraterone acetate tablets will still be large, and the firstentrants will certainly have an advantage in gaining market shareover companies reaching the market after supply agreements arealready in place. It may well be that the many filers for genericZytiga were simply looking for a place in that competitive initialmarket, rather than hoping for a big first-filer’s payout.”

Companies vying to achieve first-filer status have several targetsat which to aim over the next few months as NCE -1 dates arrive forbrands including ApoPharma’s Ferriprox (deferiprone) iron chelatorand Incyte’s Jakafi (ruxolitinib) myelofibrosis drug (see Figure 2). G

Abiraterone attracts ANDA rush in USKEY DETAILS: ZYTIGA

Brand: Zytiga

Active ingredient: abiraterone acetate

Delivery form: 250mg tablets

Brand owner: Janssen Biotech

Annual brand sales: US$2.24 billion globally in 2014

First paragraph IV 28 April 2015filing submitted to FDA:

Known paragraph IV Actavis, Amneal, Apotex, Citron Pharma,filers: Dr Reddy’s, Hikma, Mylan, Par, Sun

Pharma, Teva and Wockhardt

Orange Book patents: 5,604,213 – 13 December 20168,822,438 – 24 August 2027

District court locations: New Jersey, Delaware, SouthernDistrict of Florida, Northern Districtof West Virginia

Litigation references: Janssen Biotech et al. vs Amneal –(Delaware)1:15-cv-00679

BTG International et al. vs Actavis –(Florida)9:15-cv-81076

BTG International et al. vs Actavis –(New Jersey)2:15-cv-05909

Janssen Biotech et al. vs Mylan –(West Virigina)1:15-cv-00130

Figure 1: Paragraph IV challenges to Janssen Biotech’s Zytiga (abirateroneacetate) tablets in the 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

Deferiprone Ferriprox 14 October 2015Clobazam Onfi 21 October 2015Ruxolitinib phosphate Jakafi 16 November 2015

Ingenol mebutate Picato 23 January 2016Axitinib Inlyta 27 January 2016Vismodegib Erivedge 30 January 2016Ivacaftor Kalydeco 31 January 2016Tafluprost Zioptan 10 February 2016Pancrelipase Ultresa, Voikace 1 March 2016

Figure 2: Active ingredients subject to new chemical entity (NCE) exclusivitiesfor which abbreviated new drug applications (ANDAs) can be submitted betweenOctober 2015 and March 2016 (Source – Thomson Reuters)


Legislators and administrators in the UK must find a “suitable system”for upholding second medical-use patents whilst allowing generic

competition on unpatented indications, according to the High Courtjudge who ruled on a dispute between Pfizer and generics firmsActavis and Mylan over Lyrica (pregabalin).

Noting that he had “lived with this case for nine months” (seeopposite), Justice Richard Arnold maintained that the National HealthService (NHS) in England and devolved governments in Scotland,Wales and Northern Ireland had “the necessary power and authority”to give prescribers “centralised and authoritative guidance” on whenthey should prescribe specific products by brand name.

“The best solution to the problem of protecting the monopolyconferred by a second medical-use patent while allowing lawful genericcompetition for non-patented indications of the substance in question,”Arnold argued, “is to separate the patented market for the substancefrom the non-patented market by ensuring that prescribers writeprescriptions for the patented indication by reference to the patentee’sbrand name and write prescriptions for non-patented indications byreference to the generic name of the substance, the internationalnon-proprietary name (INN)”.

“It behoves patentees who want their second medical-use patentsenforced,” Arnold continued, “to provide NHS England with all theinformation and assistance it requires to enable it to issue appropriateguidance.” It was not in the interests of any party, he contended, to dealwith such issues “in the ad hoc manner in which they were addressedin [the Lyrica] case”. G

PRODUCT NEWS



UK should devise asecond-use system

Six key claims of the UK part of Pfizer’s European method-of-usepatent 0,934,061 that protects its Lyrica (pregabalin) brand until

July 2017 are invalid for insufficiency, Justice Richard Arnold hasruled. And even if key claims were valid, they were not infringed byActavis’ Lecaent (pregabalin) capsules, he said, adding that Pfizer was“liable for making groundless threats of patent-infringement proceedings”.

On insufficiency, Actavis and co-plaintiff Mylan contended thatnine of the ‘061 patent’s claims were invalid because the patent’sspecification did not make it plausible that pregabalin was effectivefor treating neuropathic pain, idiopathic pain or fibromyalgia.

Arnold said the “extremely broad” claim 1 was invalid because“there is simply no basis for saying that it was plausible that pregabalinwould be effective for all types of pain”, while there was “no reasonablebasis for predicting that pregabalin would be effective for treatingcentral neuropathic pain”, so claim 3 was also invalid.

Four claims covering specific types of pain were also invalid,but Arnold upheld three claims on the basis that they were types ofperipheral neuropathic pain that could plausibly be covered by thepatent’s specification.

Pfizer’s case was ‘wholly unpersuasive’Addressing infringement of claims 1 and 3 in his 174-page

ruling, Arnold – who earlier this year ordered England’s NationalHealth Service (NHS) to issue guidelines demanding that prescriptionsfor pregabalin to treat neuropathic pain should be limited to the Lyricabrand name (Generics bulletin, 13 March 2015, page 19) – describedPfizer’s contention that Actavis intended Lecaent to be prescribed forthe patented pain use as “wholly unpersuasive”.

Estimating that around 70% of UK prescriptions for pregabalin,which had 2013 sales of US$310 million, were for treating pain,Arnold issued declarations of non-infringement covering not onlyActavis but also any wholesalers who supplied, doctors who prescribed,pharmacists who dispensed or patients who used the branded generic.

However, Arnold said an obviousness argument brought by Actavisand Mylan around the use of pregabalin to treat neuropathic pain – ascovered by claim 3 of the patent – “suffers from the basic difficultythat none of the prior art relied on discloses both pregabalin and theuse of the treatment of neuropathic pain, or any kind of pain”.

Turning to Pfizer’s threats of suing for patent infringement,Arnold said the originator had “presented a continually evolving setof demands as to the steps Actavis should take”. After the NHS issuedguidance on prescribing by brand name, the level of brandedprescriptions for pregabalin had risen from almost none to about 30%by May 2015, he observed.

“It is reasonable to expect that, if it has not already happened bynow, in the fairly near future most prescriptions for pregabalin for painwill be written by reference to the brand name Lyrica,” Arnoldconcluded. However, he noted, the NHS might change its guidancein light of his finding that claims 1 and 3 of the patent were invalid.

Pfizer’s evidence that generic pregabalin had been dispensed fortreating pain was “completely unconvincing”, not least as Lecaent,Dr Reddy’s Alzain and Consilient’s Rewisca branded generics hadcaptured only 17.4% of the UK’s pregabalin market as of 19 May 2015.

Furthermore, Arnold found, communications that Pfizer had sentto several interested parties amounted to groundless threats of patentlitigation that were “calculated to have a chilling effect” on pharmacists’willingness to stock and dispense generic pregabalin. G

ANALGESICS/EPILEPSY DRUGS

Lyrica pain patent isinvalid, UK declares


EVENTS


12-14 October

■ 12th TOPRA AnnualSymposiumBerlin, GermanyFocusing on regulatory affairs, topics coveredat this event will include biosimilars,access to medicines, new clinical trialsregulations, pharmacovigilance, patientinformation and veterinary legislation.

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

12 & 13-15 October

■ CPhI Pre-Connect Conference& CPhI WorldwideMadrid, SpainCPhI Worldwide is an exhibition andnetworking opportunity which will includethe co-located events iCSE, P-MEC andInnopack. The event will be preceded by thePre-Connect Conference.

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

27 & 28-30 October

■ Biosimilars APAC SummitSingaporePreceded by a one-day workshop, this eventwill look at the global and Asia-Pacificregulatory landscape, market access, clinicaldevelopment and legal and IP issues.

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

28-29 October

■ 8th Product & PipelineEnhancement for GenericsWashington DC, USAThis two-day conference will cover issuesincluding business development initiatives,enhancing portfolio potential, genericdrug trends and regulatory compliance.

Contact: Marcus Evans.Tel: +1 312 894 6313.E-mail: [email protected]: marcusevans-conferences.com.

2-4 November

■ GPhA Fall TechnicalConferenceMaryland, USAThis three-day event organised by the USGeneric Pharmaceutical Association (GPhA)will look at regulatory and technical issuesaffecting the generics industry. There willbe speakers from the industry, andpresentations by representatives from theUS Food and Drug Administration (FDA).

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

4-6 November

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

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

9-10 November

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

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

23-24 November

■ EuroPLX 59Athens, GreeceThis meeting provides a forum forbusiness-development decision-makers

to discuss and negotiate agreements,in-licensing, marketing and distributionof patented medicines, generics,biosimilars, OTC products, medicaldevices and food supplements.

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

27 January

■ 9th EGA PharmacovigilanceConferenceLondon, UKThis European Generic and Biosimilarmedicines Association (EGA) conferencewill look at topics includingpharmacovigilance legislation, riskmanagement and biologics.Contact: Lucia Romagnoli, GPA Conferences.Tel: +44 7562 876 873.E-mail: [email protected] online at www.egagenerics.com orwww.egaevents.org.

28-29 January

■ 15th EGA Regulatory &Scientific Affairs ConferenceLondon, UKThis two-day conference will provideupdates on regulatory developmentswithin the industry. The event will followthe EGA Pharmacovigilance Conferenceand will be held in the same venue inLondon, UK.Contact: Lucia Romagnoli, GPA Conferences.Tel: +44 7562 876 873.E-mail: [email protected] online at www.egagenerics.com orwww.egaevents.org.

22-24 February

■ GPhA 2016 Annual MeetingFlorida, USAThis is a three-day conference organisedby the GPhA. It will look at regulatoryissues and the challenges andopportunities for the US genericsindustry. There will also be networkingopportunities and social events.

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

For more information onsponsoring or attending, [email protected].

13 October 2015, Madrid, Spain

OCTOBER NOVEMBER

We also publishOTC bulletin.

Visit otc-bulletin.comfor more information.

JANUARY

FEBRUARY

Gen 2-10-15 Pg. 28_Layout 1 30/09/2015 17:59 Page 2

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


Figure 1 (above): Comparison between the periods 1-31 August and 1-23 September2015 of UK trade prices of the most recently-launched generics listed in category Mof the Drug Tariff of pharmacy-reimbursement prices. Averages calculated from at least24 data points. Figure 2 (top right) and Figure 3 (centre right): Biggest averagetrade-price changes between 1-31 August and 1-23 September 2015. Averagescalculated from at least 11 data points. Figure 4 (bottom right): Ranking of fastest-moving products subject to the most price offers made to independent UK pharmacists(one strength per ingredient; offers recorded by 23 September). Data for Figures 2,3 and 4 from a basket of about 750 commonly-dispensed generics. Recently-launchedproducts in Figure 1 excluded from Figures 2 and 3 (Source – WaveData).

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

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

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

WANT MORE LIKE THIS?

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

Amorolfine lacquer 5% 5ml £3.95 +9 £6.21 +8Aripiprazole tabs 10mg 28 £11.65 +1 £25.73 -23Atorvastatin tabs 20mg 28 £0.43 -9 £0.80 +12Candesartan tabs 8mg 28 £0.38 +9 £0.66 +6Celecoxib caps 200mg 30 £0.85 +1 £2.11 -7Cilostazol tabs 100mg 56 £3.99 ±0 £7.79 -1Cyclizine tabs 50mg 100 £7.25 +4 £9.76 +2Desogestrel tabs 75µg 84 £1.38 -8 £2.73 +3Entacapone tabs 200mg 30 £4.01 -5 £5.13 +1Eplerenone tabs 25mg 28 £14.99 -12 £26.39 -9Escitalopram tabs 10mg 28 £0.26 -7 £0.86 +7Hydroxychloroquine tabs 200mg 60£2.80 +1 £3.86 +2Irbesartan tabs 75mg 28 £0.35 -3 £0.74 +2Memantine tabs 10mg 28 £0.53 -9 £1.31 +5Montelukast tabs 10mg 28 £0.89 -1 £1.47 +4Naratriptan tabs 2.5mg 6 £1.01 -14 £1.45 -2Quetiapine tabs 25mg 60 £0.55 +12 £1.10 -1Rabeprazole tabs 10mg 28 £1.09 -4 £1.59 +1Raloxifene tabs 60mg 28 £2.93 -15 £4.84 -1Riluzole tabs 50mg 56 £13.75 -1 £24.35 +9Rizatriptan tabs 10mg 3 £0.85 ±0 £2.32 ±0Sildenafil tabs 100mg 4 £0.31 ±0 £0.75 +15Telmisartan tabs 80mg 28 £0.77 ±0 £1.76 +2Tolterodine tabs 2mg 56 £1.45 +1 £2.32 +7Zolmitriptan tabs 2.5mg 6 £0.67 +60 £1.10 +11

FAST MOVERS

Price offers as at 23 SeptemberProduct/Strength/Pack size July August September

Omeprazole caps 20mg 28 109 101 83

Phenytoin tabs 100mg 28 85 72 78

Lansoprazole caps 30mg 28 98 90 77

Atorvastatin tabs 40mg 28 87 74 74

Naproxen tabs 500mg 28 78 77 73

Ramipril caps 2.5mg 28 88 82 73

Citalopram tabs 40mg 28 76 68 72

Warfarin tabs 3mg 28 83 72 72

Allopurinol tabs 300mg 28 79 64 71

Sertraline tabs 50mg 28 81 72 71

BIGGEST FALLERSProduct/Strength/Pack size Lowest Change Average Change

price (%) price (%)

Aripiprazole tabs 30mg 28 £22.45 -6 £44.25 -36

Trimethoprim tabs 100mg 28 £1.08 -10 £3.03 -27


Metformin tabs 500mg 28 £0.22 ±0 £0.42 -26


Baclofen tabs 10mg 84 £1.50 -12 £3.22 -17

BIGGEST RISERSProduct/Strength/Pack size Lowest Change Average Change

price (%) price (%)

Celiprolol tabs 200mg 28 £3.05 -2 £14.90 +306

Cimetidine tabs 200mg 60 £0.39 +3 £2.76 +104

Ibuprofen tabs 400mg 250 £2.84 +8 £9.03 +79

Cimetidine tabs 400mg 60 £5.65 +966 £6.09 +47Oxybutynin tabs 2.5mg 84 £0.95 -4 £2.31 +43Clindamycin caps 150mg 24 £3.39 +7 £12.36 +39

Double-digit price changes were rare amongst recently-launchedgenerics last month, although there was a notable rise in the average

price of 28-tablet packs of atorvastatin 20mg. The 12% increase to £0.80(US$1.22) came despite one supplier dropping the lowest availabletrade price by 9% to £0.43 (see Figure 1).

Similarly, the average price for four-tablet packs of sildenafil100mg rose by 15% to £0.75, but one supplier was content tomaintain the lowest-price offer at £0.31. This contrasted with thetrade prices for six-tablet packs of zolmitriptan 2.5mg whose averagerose by 11% to £1.10, possibly because the lowest price availablewas raised by 60% to £0.67. This was in contrast to the average pricefor 12-tablet packs of the same strength falling by 16% to £2.00 –just outside the steepest falls in Figure 3 – as the lowest price droppedby 13% to £0.73.

Heaviest price faller continued for another month to be aripiprazole,

which featured in Figures 1 and 3. In Figure 1, the average price for28-tablet packs of the 10mg strength fell by 23% to £25.73. Themajority of suppliers, however, still have some way to go before theymatch the lowest price offer recorded by WaveData of £11.65 forthe 10mg strength, virtually unchanged during September.

Elsewhere, cimetidine was again notable among the biggestprice risers (see Figure 2). Three strengths featured in August, butthis time the 800mg presentation was absent, leaving the 200mg and400mg strengths among the leaders. Not every supplier raised theirprices for the 200mg strength, but the message seemed to have hithome for all of the 400mg suppliers with a stratospheric rise in thelowest cimetidine price.

Omeprazole maintained its leading position in Figure 4 as thefast-moving generic most heavily featured among suppliers’ pricelists and offers to independent pharmacies and dispensing doctors. G

Double-digit increase in atorvastatin prices


Less than six years have passed since RobertWessman started Alvogen with a few milliondollars of capital. “In 2009, we had US$30 million

in the bank, no products and one contract-manufacturingfacility in the US,” he observes. Nevertheless, theambitious goal that former Actavis chief Wessmanand his team set – becoming a global billion-dollargenerics player – is now clearly within reach. Andhe has set his sights on more than trebling the group’sturnover to US$3 billion over the next five years.

“Our turnover is now close to US$800 million, andour current earnings before interest, tax, depreciation andamortisation (EBITDA) margin exceeds 30%,” Wessmantold Generics bulletin during an exclusive interview.While Alvogen has made a handful of major strategicacquisitions – including of Labormed in Romania, ofKunwha and Dream Pharma in South Korea, and ofLotus in Taiwan – Wessman stressed that 59 points ofthe group’s 76% compound annual growth rate (CAGR)had been achieved organically, largely by expandingits US portfolio while setting up greenfield operationsand building critical mass in Central and EasternEurope (CEE) and the Asia-Pacific region.

Alvogen’s successes in its key markets did not gounnoticed in the financial community. Around a yearago, private-equity fund Pamplona led a majoritytakeover deal that put an enterprise value of aroundUS$700 million on the group. Just 12 months later,Pamplona was able to sell on control of Alvogen to aconsortium led by CVC Capital Partners in a dealvaluing the firm at more than US$2 billion (Genericsbulletin, 26 June 2015, page 1). That consortium –which also includes Singapore-based Temasek – hasaround US$300 billion of assets under management.

“There is a commitment from our new stakeholdersto give the company access to acquisition funds thatare far more than we have had in the past,” Wessmanexplained, adding that the group was looking at “along pipeline of targets in Asia”. While organic growthremained central to the company’s strategy, he saidacquisitions could add critical mass quickly. “Theremight be some interesting approaches in the US, andwe have been doing more product purchases in theCEE region,” he commented.

In the US – which represents around half of thegroup’s turnover – Alvogen has just expanded its nicheproduct portfolio by introducing first-to-marketrivastigmine transdermal patches following a non-infringement verdict (Generics bulletin, 11 September2015, page 17). Wessman said almost half – 28 – ofthe company’s US pipeline of around 60 abbreviatednew drug applications (ANDAs) pending approval werepotential first-to-market or first-to-file opportunities,including several in niches such as controlled substances.Near-term planned launches include generic Tamiflu(oseltamivir) next year through a partnership with Natco.

While Wessman had previously been reluctant toenter the highly competitive, low-price US injectables

arena, he explained that product shortages had changedthe market dynamics to make the sector more attractive.To augment its own licensing deals for injectables,Alvogen has just agreed to acquire four products –acetylcysteine, clindamycin, melphalan and voriconazole– as a result of Pfizer’s takeover of Hospira (Genericsbulletin, 11 September 2015, page 21).

“The endgame to have strong service levels isperhaps to have our own injectables facility in the US,”Wessman stated, revealing that he was looking at atakeover target with a factory and strong pipeline.

“Alvogen has close to 25 marketed products in theUS, and eight of our top 10 products have over 30%market share,” Wessman pointed out. The US successhad been built on strong supply levels, with no Form 483deficiencies at the firm’s Norwich facility in 38 years.

“We have been rolling the US supply model outinto all other countries to ensure we are seen as a reliablepartner with a strong portfolio,” Wessman explained,noting that the Asia-Pacific region made up around 30%of group sales, and CEE the remaining fifth.

“Asia-Pacific is a region which we see as veryprominent for us. It is growing faster than Europe, butit is still very fragmented,” Wessman said.

Alvogen’s expansion in the Asia-Pacific region hascome through a combination of organic growth andacquisitions including Kunwha and Dream Pharma inSouth Korea (Generics bulletin, 5 September 2014,page 1), as well as of Lotus in Taiwan (Genericsbulletin, 3 February 2014, page 5).

The group has now integrated Kunwha and DreamPharma under the Alvogen Korea banner, combiningthe former’s broad portfolio in the retail and hospitalchannels with Dream’s focus on supplying obesitytreatments largely to around 3,500 clinics. “We do notfeel we need more scale in Korea, as we are leveragingour global portfolio to expand our local offering,” he said.

“Lotus is progressing very well,” Wessmancontinued. The US Food and Drug Administration(FDA) had approved the Taiwanese firm’s oncologyfacility, he pointed out, opening the door to file high-potency and cytotoxic molecules in both the US andother global markets. “Many of those products havebranded sales of US$100-US$300 million,” he noted.

Through Lotus, Alvogen is building up an oncologyportfolio that it is licensing to major players in Japan’sgenerics market. “We are not building up our owninfrastructure in Japan, we are partnering with keyplayers. Acquiring a company in Japan would be bothcostly and difficult,” he said.

In China, Alvogen has formed a joint venture withmajor local player CSPC Pharma in a deal that uses theChinese firm’s extensive distribution network to marketOTC products. “On the prescription side, we have taken asimilar approach to Japan, we are up to 10 filings in Chinanow, and we have licensed those out,” Wessman noted.

As in China, he commented, registering productsin Thailand was a difficult and lengthy process that

BUSINESS STRATEGY


By augmenting strong

organic growth with

targeted acquisitions,

Alvogen will achieve

a turnover of US$3

billion by the end

of this decade,

chief executive

Robert Wessman

told Aidan Fry.

Alvogen sets US$3bn goalfollowing fresh investment

Robert Wessman


required local studies. “We have been selling productsfrom our own pipeline in Thailand for almost threeyears, and acquiring something there would make a lotof sense,” Wessman commented.

“The Philippines and Indonesia are not easy, butare of interest,” Wessman stated. And while the grouphad a strong portfolio under registration in Vietnam,the market was becoming crowded. Wessman saidlow prices made Malaysia an unattractive option,while Alvogen had no plans to compete with Indianfirms in their home market. “Australia and New Zealandare not our cup of tea at the moment,” he added.

Given the growth potential in the 35 countries inwhich Alvogen already operates, and the need to havelocal manufacturing facilities in many markets, Wessmanis not currently looking to establish an Alvogen footprintin the Middle East and North Africa (MENA) region.He also has no plans to enter Canada or the “difficult”Turkish market, while Alvogen’s operations in WesternEurope will be limited to its second-ranked position inIceland, as well as opportunistic licensing deals.

“If we go into a new region, it will be into LatinAmerica,” Wessman revealed. Alvogen has conducteddue diligence on a potential takeover target in LatinAmerica “that would help us to cover three or fourkey countries”. “With a strong local platform andAlvogen’s pipeline, we feel we can be successful inLatin America,” he declared.

“In the CEE region, we think Russia is the placeto invest at the moment. We believe in the market’slong-term fundamentals, and transaction multiples arelower than before,” Wessman continued. Havingacquired a hormonal line from Bayer, Alvogen washunting for more product acquisitions in Russia andUkraine to augment its current strong growth. “We hadhardly any sales in Russia two years ago, but now weare at a run rate of US$10 million EBITDA,” he said.

Having acquired Romania’s Labormed over twoyears ago (Generics bulletin, 15 February 2013, page3), Alvogen has now switched most of Labormed’sportfolio to its own label. “Hungary has been aggressiveon government pricing, and we see companies pullingout,” he observed. By contrast, Alvogen has recentlyraised its holding in local player Kéri Pharma to 75%.And in Bulgaria, the group has just achieved a first-to-market launch of bortezomib under the Vortemyel brandname (Generics bulletin, 1 September 2015, page 24).

“Most of our CEE operations are at a decent scale.We have built a good name and we are growing withlaunches,” Wessman commented. “Having largely setup greenfield operations, this is the first year we areEBITDA-positive in every country in which we operate.”

A key element of growth in CEE markets such asPoland has been the biosimilar portfolio that Alvogenis offering through a regional marketing alliance forseveral markets struck with Hospira in 2012. “We haveachieved 30%-plus market share for epoetin andfilgrastim in key CEE markets, and the launch ofinfliximab has gone extremely well,” Wessman stated.“Biosimilars are already an important part of ourportfolio. In Hungary, for example, we have a leadingposition, and Poland is also a strong market for us.”

“Launching biosimilars has been a very importantexercise to build up the entire network and to understandhow to sell these products,” he pointed out. Given thelack of access to biological treatments in many CEE

countries, Alvogen’s focus had largely been on makingits lower-cost biosimilars first-line treatments with payersthrough a key-account structure, he explained.

Two years ago (Generics bulletin, 6 December2013, page 27), Alvogen announced plans to investC500 million (US$560 million) in developing andmanufacturing a portfolio of monoclonal antibodiesthrough sister company Alvotech, which develops itsown cell lines and does most of its own analytical work.

The manufacturing portion of that investment isnow bearing fruit, with a large-scale Alvotech facilityon a science park next to the University of Iceland inReykjavik largely completed.

Having already recruited around 80 staff fromaround the world – a figure that will double in comingmonths – Alvogen expects to have laboratories at thesite operating before the end of this year. “This will beone of the world’s first plants to use disposable plastictechnology,” Wessman stressed. “We will have 16,000litres of fermentation capacity, and will be able to fill-and-finish 3 to 4 million vials and pre-filled syringes.”

“We can double capacity as we have secured theblock next door, and I would not be surprised if we aredesigning an extension by the end of next year,” he said.As very few patents had been filed in Iceland, Alvogenwould be able to stockpile for supply immediately uponmarket formation, giving the firm a strategic advantage.

Discussing Alvogen’s own biosimilars pipelinethrough Alvotech, Wessman said the group had apipeline covering all major biologics coming off-patentin the next 10 years. “We are advancing well with fourin-house developed monoclonal antibodies, and we willadd two more into our own development programmeover the next 12 months,” he revealed. “Our biosimilarsfacility will be fully operational in the first quarter of nextyear, and product launches are scheduled from 2019.”

Observing trade and industry consolidation as small-molecule expiry pipelines dwindled, Wessman saidbiosimilars would play into Alvogen’s strong organicgrowth prospects as it surged past US$1 billion turnoverin the near future to strive towards US$3 billion by 2020.

“With the financial firepower our new investorshave given us for acquisitions that fit strategically andreasonable multiples, reaching US$3 billion is quitepossible.” Topline growth would be backed up by anEBITDA margin exceeding 35%, he asserted. “It is easierto scale the business to US$3 billion from where we aretoday than getting to here from where we started.” G

BUSINESS STRATEGY

“If we go into a

new region, it will be

into Latin America”


900

800

700

600

500

400

300

200

100

0

Turn

over

(US$

mill

ions

)

2009 2010 2011 2012 2013 2014 2015

Figure 1: Alvogen’s group turnover progression between 2009 and 2015 (Source - Alvogen)


In recent years, Bangladesh’s Beximco Pharma – thepharmaceuticals arm of the Beximco conglomerate –has racked up a string of key international

accreditations as part of its strategy of expanding itsglobal reach. Nods from Health Canada and Taiwan’sFood and Drug Administration (TFDA) last year joinedapprovals from European Union (EU) markets in 2011,Brazil’s Anvisa regulatory agency two years before that,and Australia’s Therapeutic Goods Administration(TGA) in 2008.

And in June this year, the Bangladeshi firmcelebrated a “major milestone”. Following an inspectionin January of its Tongi oral solid-dosage facility inDhaka, Bangladesh, by the US Food and DrugAdministration (FDA), the firm received approval fromthe agency allowing drugs to be exported to the market(Generics bulletin, 10 July 2015, page 6), makingBeximco the first pharmaceutical firm in Bangladeshto receive such clearance.

For now the firm’s international presence remainsin its infancy. In the first half of this year, Beximcoreported sales outside of Bangladesh of BDT367 million(US$4.72 million), or around 6% of total sales thatrose by 17.4% to BDT6.25 billion (see Figure 1).

Nevertheless, entering five new countries,including Australia, Indonesia and Costa Rica, andcompleting 21 registrations for 19 products across 10markets during this period, showcased Beximco’sappetite to push ahead with its overseas plans.

In an exclusive interview with Generics bulletin,Beximco’s chief operating officer, Rabbur Reza, andchief financial officer, Ali Nawaz, discussed the firm’splans to expand its overseas business, while broadeningand solidifying its presence at home.

“We have big plans for global markets,” Rezaexplained. “We would like to take that 6% [exports

proportion] to around 20% in the next five years. Weexpect around 50% of the exports total to come fromour targeted ‘tier one’ markets: Australia, Europe,South Africa and the US.”

Export sales of US$20 million are targeted fornext year, rising to US$35 million in 2017 and US$50million in 2018 – a five-fold increase within the nextthree years at Beximco’s current run-rate.

To support its international expansion plans, theBangladeshi firm is investing just over US$113 millionto expand its local facilities (see Figure 2). This wasmade possible after Beximco earlier this year struck aUS$51.6 million loan agreement with Germany’sBHF-Bank (Generics bulletin, 13 March 2015, page10), with the remaining US$61.7 million to be providedby Beximco. “This is a huge facility, which will cater toour demands for the next 20 to 25 years,” Nawaz said.

Beximco to relocate facilitiesThe bulk of that sum – around US$82.3 million –

will be spent on relocating Beximco’s oral-solid dose,liquid cream and ointment facilities, for which workis already under way.

Meanwhile, Beximco says it is constructing a“state-of-the-art research and development (R&D)laboratory,” insulin-filling lines and nasal sprayproduction. “Insulin filling, an important project, isnearing completion now, while the nasal spray upgradeis also important,” Nawaz stated.

Furthermore, the firm also plans to spend US$12.7million on a dedicated facility for cephalosporinproducts, which Nawaz said had “always been on thewish list”, while a small sum would be spent on an activepharmaceutical ingredient (API) research anddevelopment and multi-product API manufacturing line.

Aside from the cephalosporin development, whichremains in the planning stage, the entire project isslated for completion in 2017.

Of Beximco’s ‘tier one’ markets, the firmestablished a presence earliest in South Africa five yearsago. Beximco currently contract-manufactured twoproducts, and had a third on the way, Reza said.

“We have filed 13 products in South Africa, but thetimeline is long. We expect to start receiving productapprovals next year, and to start introducing our ownproducts, possibly, from 2017 onwards,” Reza said.“Upon launching in South Africa, we can take these

BUSINESS STRATEGY


Fresh from receiving

approval to import

drugs into the US,

Bangladesh’s largest

generics player,

Beximco Pharma, has

ambitious plans to

swell its international

operations, while

maintaining solid

growth at home.

Dean Rudge reports.

Beximco aims for a fifth ofits business to be overseas

2012 2013 2014 2015*(BDT bn) (BDT bn) (BDT bn) (BDT bn)

Sales 9.29 10.5 11.2 6.25EBITDA 3.15 3.32 3.60 1.85

* first six months

Figure 1: Beximco Pharmaceuticals’ turnover and earningsbefore interest, tax, depreciation and amortisation (EBITDA) inits financial years from 2012 to 2014 and in the first half of2015 (Source – Beximco)

Project Project Project coststatus (US$ millions)

Relocation of existing facility: oral-solid, ongoing 82.3liquid cream and ointment

New R&D with upgraded analytical ongoing 4.43laboratory and formulation laboratory

Insulin-filling line ongoing 6.96

Nasal-spray production facility ongoing 3.80

Physician-sample packaging and small- ongoing 1.90volume product packaging facility

API R&D and multi-product API to be undertaken shortly 1.27manufacturing unit

Facility for cephalosporin products planned 12.7

Total – 113.3

Figure 2: Breakdown of Beximco’s current manufacturing projects up to 2017 (Source – Beximco)


products to other markets as well,” he added.Beximco entered Europe in February 2013,

following approval to export for oral solids and sterileeye drops from Austria’s regulatory authority in 2011.Noting that the firm at that time launched latanoprostand latanoprost/timolol combination treatments forglaucoma in Austria and Germany (Generics bulletin,15 February 2013, page 15), Reza said Beximco wascurrently working on a third ophthalmic in Europe.“We are trying to lock in with a few partners,” he said.

Beximco is also awaiting clearance to export toPoland, and earlier this year entered Romania byintroducing an OTC multi-vitamin range.

Having received its FDA approval in June, Beximcohas amassed a pipeline of four abbreviated new drugapplications (ANDAs) in the US, although the firmactually made its first move in the US five years agowhen it acquired a generic filing from Actavis.

As Figure 3 shows, the Bangladeshi firm plans tosubmit on average five US filings a year over the nextfive years. Meanwhile, the firm would, Reza said, beinterested in using its experience with inhalers andrespiratory drugs to invest up to the development stagewith a partner.

And in Canada, Reza explained, the firm had “filedone product with Health Canada, [for which] we expectapproval by the end of the year”. “We will be filinganother product within two months, and possibly afurther product in the first quarter of next year, with thepossibility of taking some products from the US basket.”

At the beginning of this year, Beximco broke morenew ground by introducing pantoprazole under theSalpraz brand name in Australia – another of the firm’stargeted markets. Beximco has thus far supplied thegastrointestinal drug to Mylan and Sigma.

Meanwhile, Beximco plans to file a second productin October in Australia, and also file the ophthalmicproducts it has introduced in Europe.

Although not a top priority for Beximco, the firmhas also engaged in expanding into Central America,including in Costa Rica and Panama.

“Panama’s market size is like Bangladesh,” Rezaremarked, noting that it was an important market forthe firm in the region. “We have already filed 39products there, and have received a few approvals.Also, we won one tender there for four products, andwe have a local distributor in place.”

Ultimately though, Reza conceded that LatinAmerica and Mexico were “tricky” markets. “Not muchwork has been completed,” he said. “We are still trying.

As soon as we get a good partner and products we willgo from there: at this stage, we do not want too muchon our plate.”

The aforementioned Taiwanese approval last yearhad led to Beximco having 13 products under reviewin the country. Meanwhile, having introduced itshydrofluoroalkane (HFA) based Azmasol (salbutamol)inhaler in Singapore three years ago, Beximco in Aprillaunched the product in Indonesia.

Beximco is also looking to introduce pantoprazolein Malaysia and Singapore. “Volumes will not be thatbig,” Reza noted, “but pantoprazole has high potentialin both markets. It is very popular.”

Tenders are essential for Iraq marketCommenting on Iraq – which Beximco entered

earlier this year – Reza noted that it was “not a very bigmarket but we have started business”. “If you get atender business it is fine, otherwise there is no suchpotential,” he noted. Moreover, Zimbabwe’s healthauthority had conducted a successful audit of Beximco’splant in June.

Beximco’s operations in its Emerging Marketsregion include a pipeline of eight products filed inUkraine, and a further five in Kazakhstan. Meanwhile,Azerbaijan – where Beximco markets five products andhas 12 or 13 under review – had been a “good successstory for Beximco”, according to Reza. “[The country’shealth authority] is not giving any approvals to anyIndian or any Asian companies as of now,” he said.

At the same time as it looked to develop overseas,the Bangladeshi firm would, Reza commented, lookto maintain “double-digit” year-on-year growth at homeover the next five years, through “brand building andintroducing new molecules”.

With domestic sales this year on course to bearound BDT11.8 billion, following first half turnoverof BDT6.25 billion, this would put turnover in 2020at close to BDT20.0 billion – or approximatelyUS$250 million.

Boasting a domestic portfolio of more than 300branded generics in 500 presentations, Beximco hasbeen looking to vary its basket, foraying into women’shealth products, targeting high-margin therapeuticareas such as diabetes, oncology and respiratory, andinvesting in new technology including the firm’sondansetron oral soluble film.

The firm’s domestic roster does however include‘specialised’ generics, including metered-dose and dry-powder inhalers, pre-filled syringes, intravenous infusionand lyophilised injectables, as well as ophthalmics.

Earlier this year, Beximco introduced genericversions of Gilead’s Sovaldi (sofosbuvir) Hepatitis Cblockbuster in Bangladesh, capitalising on Bangladesh’slow energy and labour costs to introduce the drug atjust US$6.60 per tablet.

“Our goal is to target several thousand hepatitis Cpatients within a year,” Reza commented. The firm hadalso in September launched the first generic versionof Gilead’s Harvoni (sofosbuvir/ledipasvir) which ispriced at around US$13.00 per tablet.

“At the same time, we will also be focusing a littlebit on biogenerics,” Reza revealed. “This is one areawe thought we should venture into. The Bangladeshimarket is not that big at the moment, but we wouldlike to be a front runner and a have a presence.” G

BUSINESS STRATEGY

“We have big plans

for global markets.

We would like to take

that 6% to around 20%

in the next five years”


Market Filed Pipeline forfive years

South Africa 13 21Malaysia 6 20European Union 4 8US 4 25Canada 1 10New Zealand 1 5Singapore 1 35Australia – 20Rest of World 605 1,000

Figure 3: Breakdown by market of Beximco’s generic filingsoutside of Bangladesh, and planned pipeline of filings over thenext five years (Source – Beximco)


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PEOPLE


Lupin’s European operations president and global inhalation strategyhead, Maurice Chagnaud, has been tasked to “further accelerate

the development of Polpharma to become a regional leader in Centraland Eastern Europe, the Commonwealth of Independent States (CIS),and central Asia” following his appointment as the Polish group’schief executive officer from 8 October.

The former Teva executive – who had taken up his position withIndian firm Lupin at the beginning of last year (Generics bulletin,7 March 2014, page 31) – will succeed Markus Sieger. EntrepreneurSieger had, the firm said, been “delegated by the supervisory board”to oversee operations at the company for the past six months, andwould “remain a member of Polpharma’s supervisory board”following Chagnaud’s appointment.

Meanwhile, Joerg Windisch will step down from his role as chiefscience officer with Sandoz Biosimilars to join Polpharma from 1November as leader of the firm’s Biologics biotech division. Windisch– who also serves as chair of the European Biosimilars Group (EBG)within the European Generic and Biosimilar medicines Association(EGA) – is “expected to move Polpharma Biologics to the next stagein biologics and prepare the company for licensure, manufacturingand commercialisation of biosimilars on a global scale”.

During a near 20-year career with Sandoz, Windisch has servedin a variety of positions, taking up his most recent role in September2012 after almost nine years as global head of technical developmentwithin Sandoz Biosimilars. With the Novartis affiliate, Windisch hasoverseen the introduction of several biosimilars, including Omnitrope(somatropin), Binocrit (epoetin alfa) and Zarzio/Zarxio (filgrastim),into “highly regulated markets”.

Polpharma looking to grow biosimilar presencePolpharma said it had “for the last three years” actively sought

to advance its biosimilar presence. Earlier this year, the firm strucka marketing agreement covering three biosimilar monoclonalantibodies in the European Union (EU) with Epirus (Genericsbulletin, 7 August 2015, page 19) shortly after securing a C45 millionloan from the European Investment Bank (EIB) to support itsdevelopment projects for biosimilars. Polpharma had in 2014 enteredinto a partnership with Germany’s Strüngmann group (Genericsbulletin, 18 April 2014, page 16).

Hannes Teissl, who had “built up Polpharma Biologics over thelast three years”, including engineering those partnerships, will “nowbecome a board member for Polpharma’s newly-formed corporatestrategy”. “This is a direct response to the rapidly-changing businessenvironment and Polpharma’s ambitious mid- to long-term growthaspirations,” the Polish group explained. G

APPOINTMENTS

Chagnaud to head upPoland’s Polpharma

Stada Arzneimittel has extended the employment contract of itsexecutive chairman, Hartmut Retzlaff, by five years until 31

August 2021. Retzlaff, who has led the German group since 1993,will be responsible for functions including corporate strategy, salesand marketing, research and development, production, biotechnology,purchasing and procurement, and corporate communications. G

APPOINTMENTS

Stada chairman extends stay

International Health Partners (IHP), Europe’s largest coordinator ofdonated medical products to development projects and disaster relief

operations, has appointed Alex Harris as chief executive. Harris – whohas been with the organisation for nine years, most recently as vice-president of operations – takes over from IHP’s founder, AnthonyDunnett, who led it for 11 years.

“I am excited that Alex has agreed to lead IHP into this nextstage of its mission to eradicate suffering due to a lack of access tosafe medicine,” Dunnett stated.

Having accepted donations from over 170 healthcare companies,IHP has supplied £127 million (US$195 million) of medical aid to25 million people in 103 countries.

IHP is sponsoring the Corporate Social Responsibility (CSR)Initiative of theYear Award at the Global Generics & Biosimilars Awardsthat will take place in Madrid, Spain, on Tuesday 13 October. Fourcompanies are vying for the award (see page 17). G

APPOINTMENTS

Harris named as IHP’s leader

US President Barack Obama has nominated Robert Califf to becomethe new US Food and Drug Administration (FDA) Commissioner.

Califf currently serves as the agency’s Deputy Commissioner forMedical Products and Tobacco, a position he took up in late Februarythis year after leaving his position as vice-chancellor of clinical andtranslational research at Duke University.

The FDA has sought a permanent commissioner followingMargaret Hamburg’s resignation, after nearly six years in the role,earlier this year (Generics bulletin, 27 February 2015, page 35).Stephen Ostroff, the FDA’s chief scientist, stepped up at that time totake on Hamburg’s responsibilities on an acting basis.

The US Generic Pharmaceutical Association (GPhA) said Califf’snomination had come at a “critical time for the FDA”, noting that itwas “eager to gain clarity on several outstanding guidance documentsand continue the discussion on biosimilar naming”, as well aslooking forward to the agency’s “meaningful progress under Califf’sleadership” towards shared commitments on US Generic DrugUser Fee Amendments (GDUFA) goals. G

APPOINTMENTS

FDA commissionernominated by Obama

Albany Molecular Research Inc (AMRI) has promoted its seniorvice-president and chief commercial officer, George Svokos, to

the position of chief operating officer. Svokos – a former long-servingTeva employee who initially joined AMRI as senior vice-president ofsales and general manager for active pharmaceutical ingredients (APIs)early last year (Generics bulletin, 3 February 2014, page 27) – would“continue to lead [AMRI’s] API manufacturing business for the presenttime”, the US-based firm noted.

Meanwhile, AMRI’s senior vice-president and general counsel andsecretary, Lori Henderson, has had the position of head of corporatebusiness development added to her responsibilities. G

PROMOTIONS

Svokos named AMRI’s COO


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