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15 November 2013

Granules India plans to 2buy local API firmCFR cites support for Adcock takeover 3Sawai raises forecast on strong first half 4Hospira gets positive site signal from FDA 4Teva’s generics make just 5quarter of profitImpax provides FDA with facility answers 6Pfizer makes plans for biosimilar trials 7Concerta rival gives Mallinckrodt growth 8Perrigo shifts focus onto 9integrated APIsLupin bolstered by double-digit US rise 9Reddy’s sees surges in the US and Russia 10Aurobindo gets lift from 12US formulationsZydus’ exports top its turnover in India 13

MARKET NEWS 14

Novartis lobbies FDA 14over biosimilar INNsEGA urges EMA to adopt 16draft guidelineCanadian originators 16fail to achieve targetIreland introduces its first reference prices17Brazil’s Anvisa mulls substitution changes 17

PRODUCT NEWS 19

Pulmicort ruling puts patent 19back in playGermany sets goals for biosimilar EPO 19UK puts epilepsy risk 20into three categoriesTeva seeks stay in US Copaxone suit 21India denies licence for generic dasatinib 21Accord and Sandoz beat Spanish patent 23Mylan ‘years ahead’ onAdvair alternative 23

REGULARS

PipelineWatch – Sustiva 22Events – Our regular listing 24PriceWatch UK – Our in-depth 25look at pricing trends in the UK

People – Gioia is Glenmark’s 27North America head

COMPANY NEWS 2

US generics firms will be able to update safety information on product labelling using the same‘changes being effected’ process as originators, under a proposed rule on which the US Food

and Drug Administration (FDA) is seeking comments. Current US federal law dictates that ageneric’s label must match that of the brand and can only be updated once brand labelling is altered.

The FDA’s rule would require generics firms to inform the brand manufacturer of anyproposed changes. If, after review, the agency found the proposed change to be justified, it wouldchange generic and brand labelling at the same time. The agency had suggested introducingsuch a rule earlier this year (Generics bulletin, 12 July 2013, page 7), in the wake of USSupreme Court rulings that generics firms could use the federal law requirement to defendthemselves against claims of inadequate labelling (Generics bulletin, 30 June 2011, page 1)and design-defect claims (Generics bulletin, 28 June 2013, page 19).

Having received the rule, the US Generic Pharmaceutical Association (GPhA) said it was“in the process of careful review with our member companies”. However, the associationcommented that it was “very concerned that multiple versions of critical safety information wouldlead to unnecessary confusion and uncertainty”. G

FDA changes label update rules

Endo Health Solutions has agreed to pay US$1.6 billion to acquire Paladin Labs, theCanadian speciality pharmaceuticals company that holds a controlling 61.5% stake

in South Africa’s Litha Healthcare. The C$77.00 (US$73.84) per share offer representsa 20% premium over Paladin’s closing share price on 4 November of C$63.91.

“Paladin’s proven Canadian franchise, robust near-term pipeline and emerging marketsbusiness complement Endo’s US strengths,” the US company insisted. Highlighting the Canadianfirm’s “proven track record of acquiring and in-licensing innovative new products and developinginternational growth platforms”, Endo’s president and chief executive officer, Rajiv De Silva,said the deal would “accelerate Endo’s transformation from an integrated health solutionscompany to a top-tier global speciality healthcare leader”.

South African generics player Litha accounts for around a quarter of Paladin’s turnover,which is expected to reach C$190 million this year. The Canadian firm generates 55% of itssales from its domestic prescription operations through brands such as Pennsaid (diclofenac)and Zohydro (hydrocodone), and 11% from its domestic OTC operation. International units –including operations in Brazil and Mexico – contribute 8%. Last year, Paladin posted adjustedearnings before interest, tax, depreciation and amortisation (EBITDA) of C$79.0 million.

Under the terms of the stock-led transaction, Paladin will continue to be a separate company,operating under its own name and current management team led by president Mark Beaudet.Paladin’s chairman and founder, Jonathan Ross Goodman, will be an advisor to Endo’s board.

Endo expects to realise US$75 million in annual post-tax synergies after it closes the dealin the first half of 2014, subject to shareholder and antitrust approval. Part of these savings willcome from reducing the group’s tax rate by re-domiciling to Ireland.

In the third quarter of this year, Endo’s Qualitest generics unit increased its sales by 11% toUS$184 million on strong sales of recent launches and oral contraceptives. Qualitest representedjust over a quarter of group turnover that fell by 5% to US$715 million as prescription volumesshifted to Actavis’ generic version of the firm’s Lidoderm (lidocaine) patches more quickly thanEndo had expected. Qualitest expects to complete its US$225 million takeover of US genericsspecialist Boca Pharmacal later this year (Generics bulletin, 6 September 2013, page 3). G

Endo strikes a US$1.6bndeal for Canada’s Paladin

Gen 15/1/13 Pg. 1_Gen 18/11/05 Pg. 1 12/11/2013 21:01 Page 1

COMPANY NEWS

2 GENERICS bulletin 15 November 2013

15 November 2013 Issue 202

Editor: Aidan FryDeputy Editor: DavidWallaceBusiness Reporter: Dean RudgeProduction Controller: Debi MinalProduction Editor: Jenna LawrenceDirector of Subscriptions: Val DavisManaging Director: Mike Rice

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Granules India has signed a definite agreement to acquire fellowIndian firm Auctus Pharma, which it said was “a leading active

pharmaceutical ingredient (API) manufacturer”. Granules expects tocomplete the deal “in the next three to six months”.

Auctus boasts a portfolio of 12 APIs and related key intermediatesthat span therapeutic categories such as antihistamines, antihypertensives,antithrombotics and anticonvulsants. The firm – which generatedannual sales of Rs1.21 billion (US$19.1 million) from supplyingcustomers in 50 countries – has two Indian manufacturing facilities.An API plant in Vishakhapatnam has been approved by internationalregulators including the US Food and Drug Administration (FDA),while a factory in Hyderabad makes intermediates.

“The acquisition of Auctus fits into our strategy of being a fullyintegrated manufacturer while diversifying our product portfolio byadding high-value products with a significant market demand,” saidGranules India’s managing director, Krishna Prasad, who noted thatteams and assets from the acquisition would initially operate as aseparate division with Granules.

To facilitate vertical integration, Prasad pointed out, Granules hadopened a 930 sq m research and development facility in Hyderabad“to enable finished dosage filings for our new APIs”.

Acquiring Auctus formed part of Granules’ “three-pronged growthstrategy”, executive director Harsha Chigurupati explained. Firstly,he said, the firm would build on its leading position for products suchas guaifenesin, ibuprofen, metformin and paracetamol. Secondly, itwould improve both processes and production capacities. And thirdly,the Indian firm would develop its collaboration with contract-researchand manufacturing firm Ajinomoto OmniChem (Generics bulletin,5 August 2011, page 11).

In its financial second quarter ended 30 September 2013, higheroutput at its formulation facility in Gagillapur led Granules’ sales torise by 52% to Rs2.66 billion, while the firm’s earnings before interest,tax, depreciation and amortisation (EBITDA) moved ahead by almostthree-fifths to Rs339 million. G

MANUFACTURING/SECOND-QUARTER RESULTS

Granules India plansto buy local API firm

Jubilant Life Sciences’ board has approved a move to transfer itsoral dosage form and active pharmaceutical ingredients (APIs)

operations, as well as the Indian group’s shares in its Belgian and USsubsidiaries, into a separate holding company based in Singapore.

Having consolidated its Pharma oral-dose, semi-solid, sterileinjectable, API, radiopharmaceuticals and allergenic extract operationsinto the Singapore holding company, Jubilant says it will explore “waysof raising money, including by way of listing the Pharma business”.Raising capital in this way will, the group expects, reduce its corporatedebt (Generics bulletin, 7 June 2013, page 3).

Maintaining “market leadership” status for oral-dosecyclobenzaprine, lamotrigine and terazosin helped Jubilant to increasesales by its broader Pharmaceuticals business segment by 6% to Rs6.91billion (US$112 million) in the firm’s financial second quarter ended30 September 2013. The Indian firm also retained market leadershipfor oral-dose methylprednisolone, despite prices for the drug fallingdue to additional generic competition.

The Indian player received approval during the quarter for anadditional 29 new solid-dosage formulations worldwide, including forirbesartan, candesartan and telmisartan in Europe, and riazatriptan inCanada. Eight formulations launches included escitalopram in Canada,valsartan/hydrochlorothiazide in Europe and amlodipine in Africa, aswell as several products in the Asia-Pacific region.

Strong volume demand helped to offset lower prices for bulksartans as Jubilant’s API operation launched rizatriptan in the US andfiled for paliperidone, voricanazole and tadalafil in Europe, aripiprazolein Saudi Arabia and esomeprazole in South Korea.

Production problems hit the group’s sterile injectables andradiopharmaceuticals operations, although Jubilant said it expected“in the coming months” the US Food and Drug Administration (FDA)to lift a warning letter it had imposed on the firm’s injectables facilityin Montreal, Canada (Generics bulletin, 22 March 2013, page 8).

The Pharmaceuticals segment accounted for 48% of Jubilant’sgroup turnover that rose by 17% to Rs14.4 billion. G

BUSINESS STRATEGY/SECOND-QUARTER RESULTS

Jubilant’s directorssupport pharma split

Gen 15/11/13 Pgs. 2-13_Layout 1 12/11/2013 21:02 Page 2

Awarning letter recently issued by the US Food and DrugAdministration (FDA) over deficiencies at Agila’s injectables

facility in Bangalore, India, has not diminished Mylan’s appetite foracquiring the business from Strides Arcolab by the end of this year. Theletter listed problems including the use of non-sterile gloves with “visibleholes and flaking” (Generics bulletin, 20 September 2013, page 5).

“We believe the possibility of an import ban is very unlikely,”Mylan’s president, Rajiv Malik, assured investors. “It is not a systemicissue,” he insisted, pointing out that each of Agila’s four other Indianplants had passed FDA inspections with few ‘Form 483’ observations.

Describing the FDA’s actions as part of the agency raisingstandards around the world, “rather than a particular reflection on

Agila’s assets”, Malik said the warning letter had “changed nothingwith respect to the solid rationale we have for the transaction”. TheUS firm has agreed to pay up to US$1.85 billion for Strides’ Agilainjectables operation (Generics bulletin, 4 October 2013, page 3).

In the third quarter of this year, a 14% slide to US$707 millionin North American Generics sales led Mylan’s global Generics turnoverto fall by 6% to US$1.40 billion (see Figure 1). US sales in the prior-year quarter had been boosted by launches of escitalopram, pioglitazoneand valsartan/hydrochlorothiazide, noted Mylan.

Generics turnover in Europe, the Middle East and Africa (EMEA)improved by 11% to US$362 million, although five points of thatadvance was due to beneficial currency fluctuations. “This increasewas principally the result of a double-digit increase in revenues inItaly as a result of favourable volumes, combined with new productintroductions in France,” Mylan commented.

Local-currency growth in France on higher volumes and launcheshad offset the effects of mandatory price cuts and “an increasinglycompetitive market”, the US-based firm said, adding that its leadingmarket share in France had remained “relatively stable”. But Mylanwarned that it was anticipating “further government-imposed pricereductions” in Spain, while tenders were limiting sales in Germany.

Currency fluctuations led to a 3% sales dip to US$331 million inMylan’s Asia-Pacific region, where constant-currency sales growth was13%. Mylan’s Indian operation benefitted from higher sales of activepharmaceutical ingredients (APIs) as well as finished-dose antiretrovirals.

Higher volumes and recent launches drove double-digit local-currency growth in Japan, where Mylan’s tie-up with Pfizer “exceededexpectations”, both in terms of market share and product launches.

Mylan attributed a 2% drop to US$1.77 billion in group turnoverto adverse exchange-rate shifts. The group’s operating margin improvedby 0.6 percentage-points to 19.2%. G

COMPANY NEWS

3GENERICS bulletin15 November 2013

Business Third-quarter sales Reported Local-currencysegment (US$ millions) change(%) change (%)

North America 707 -14 -14EMEA 362 +11 +6Asia-Pacific 331 -3 +13Other 6 -24 –Generics 1,404 -6 -3

Specialty 363 +18 +18

Mylan 1,767 -2 ±0

Figure 1: Breakdown by business segment and region of Mylan’s sales in thethird quarter of 2013 (Source – Mylan)

MERGERS & ACQUISITIONS/THIRD-QUARTER RESULTS

Mylan is untroubledby warning to Agila

CFR Pharmaceuticals has “significant support” among AdcockIngram’s shareholders for its offer to acquire the South African

company, according to the Chilean firm. “Shareholders representingapproximately 45.0% of the total issued share capital of Adcock Ingramhave already pledged support for the scheme by providing eitherirrevocable commitments to vote or letters of support,” CFR stated.

Adcock and CFR had announced they were in talks over thedeal earlier this year (Generics bulletin, 12 July 2013, page 1). CFR’soffer is worth ZAR12.6 billion (US$1.23 billion), and comprisesboth cash and new CFR shares.

“CFR shareholders have passed all resolutions necessary to effectthe issue of new CFR shares to Adcock,” the Chilean firm noted,adding that it had also made deals with Baxter to continue existinglicensing, distribution and supply arrangements with Adcock if the dealwent ahead, as well as with India’s Medreich to continue with the firm’sAdcock Ingram India joint venture. “The rationale underpinning thedeal remains as compelling as ever,” stated CFR’s chief executiveofficer, Alejandro Weinstein, “and we are delighted that this is beingincreasingly recognised by shareholders.”

However, one of Adcock’s most significant shareholders – SouthAfrica’s Public Investment Corporation (PIC) – has expressed itsopposition to the deal. Acknowledging the PIC’s statement, Adcock’schairman, Khotso Mokhele, said the firm’s board nevertheless remained“strongly of the view that a combination with CFR is a unique valueproposition and would be in the best interests of all Adcock Ingramshareholders and other stakeholders, as well as South Africa at large”.Adcock would “continue to engage with the PIC regarding itsposition”, Mokhele insisted. G

MERGERS & ACQUISITIONS

CFR cites supportfor Adcock takeover

Valeant is considering expanding its generics business in the US,according to the firm’s chief financial officer, Howard Schiller.

“We now have a US$300 million or so generics business in the US,which has very attractive margins,” Schiller said, adding that the firmwould be open to considering acquisitions to build the business. “We’reexcited about some of the opportunities that are in the pipeline andwe’ll continue to grow and invest in that business,” he stated.

“Certainly, US generics are more attractive than Western Europeangenerics in our view,” commented Valeant’s chairman and chief executiveofficer, Michael Pearson. However, he stated, “not all generics are equal”.“Large primary-care products are probably the least attractive,” Pearsonsaid, suggesting generic topicals and injectables could be more “durable”.

Meanwhile, Pearson commented, in emerging markets Valeanthad been focusing on branded generics and OTC products “which tendto be increasingly cash paid” rather than reimbursed by governments.“It makes us more susceptible to economic cycles, but obviously lesssusceptible to government intervention,” he stated.

In the third quarter of 2013, the firm’s emerging markets sales roseby more than two-thirds to US$399 million, led primarily by Valeant’sUS$8.7 billion acquisition of Bausch & Lomb (Generics bulletin,7 June 2013, page 3). Developed markets contributed sales ahead by77% to US$1.14 billion, helping Valeant’s total turnover to advanceby just under three-quarters to US$1.54 billion. G

BUSINESS STRATEGY/THIRD-QUARTER RESULTS

Valeant builds on US business


Hospira believes it is beginning to put behind it manufacturingdeficiencies at its large-scale US facility in Rocky Mount, North

Carolina. “I feel by the end of this year, the bulk of the remediation[work] will be done,” chief executive officer Mike Ball told investors.

A recent meeting with the US Food and Drug Administration(FDA) about the site had been “positive and constructive”, Ball said.“A few days ago,” he revealed, “we received a written response whichconfirmed that we had made significant progress.”

While there was still work to do in addressing problems highlightedin 20 ‘Form 483’ observations issued by the FDA earlier this year(Generics bulletin, 22 March 2013, page 3), Ball said Hospira wasimproving its production and service levels at the site. “We saw nicesupply increases in products such as fentanyl, propofol, hydromorphoneand morphine sulfate,” he stated, noting that the firm had just openeda quality and analytical-testing laboratory at the facility (Genericsbulletin, 1 November 2013, page 5).

Lake Forest plant passes FDA auditHospira’s pharma plant in Lake Forest, Illinois, had passed an FDA

inspection of its quality systems and stability operations with no Form 483observations, Ball pointed out, while the firm had responded to threeobservations following an audit of its facility in McPherson, Kansas.

The injectables specialist hopes during the first half of next yearto complete a deal for Orchid’s penicillin and penem activepharmaceutical ingredient (API) business, including a plant inAurangabad, India (Generics bulletin, 14 September 2012, page 3). Andthe facility that the US group is building in Vizag, India, is scheduledfor commercial production before the end of 2014, having recentlymade exhibit batches.

Better supplies from Rocky Mount and selected price increasesoffset price erosion on docetaxel and oxaliplatin, helping Hospira toraise its Specialty Injectables (SIP) turnover in the Americas by 7.5%to US$540 million in the third quarter of this year. Ball also pointedout that two-fifths of US customers had converted to a patented pre-mix version of Precedex (dexmedetomide), ahead of potential genericcompetition to the concentrate form of the anaesthetic next year.

Price erosion of anti-infectives and oncology drugs in Europe,the Middle East and Africa (EMEA) was counterbalanced by “double-digit growth” in sales of Hospira’s Retacrit (epoetin zeta) and Nivestim(filgrastim) biosimilars. Having recently received European Unionapproval for its Inflectra (infliximab) monoclonal antibody (Genericsbulletin, 20 September 2013, page 17), Hospira has started shippingthe biosimilar to distributors in Eastern Europe. “We will move to directsales in the larger markets in 2015, as patents expire,” Ball noted.

Most of a 5.0% reported SIP sales rise to US$80.4 million in theEMEA region was due to favourable currency shifts (see Figure 1).By contrast, a reported 0.3% SIP turnover rise to US$64.8 millionin Hospira’s Asia-Pacific region equated to 9.6% constant-currencygrowth on strong paclitaxel sales in China and “continued strengthfor Precedex in Japan and South Korea”.

Group turnover – including an 11.3% sales decline to US$210million by Hospira’s struggling Medication Management devicesdivision – rose by 1.4% to US$1.01 billion.

Hospira reduced its pre-tax loss by a fifth to US$32.5 millionas higher spending on conducting biosimilar trials was offset bydevelopment funding received through a deal with NovaQuest(Generics bulletin, 17 May 2013, page 17). G

COMPANY NEWS


Third-quarter sales Reported Constant-currency(US$ millions) change (%) change (%)

Americas 540 +7.5 +8.1EMEA 80 +5.0 +0.4Asia-Pacific 65 +0.3 +9.6Specialty Injectables 685 +6.5 +7.4

Devices 210 -11.3 -10.8

Other Pharma 113 -0.7 ±0.0

Hospira 1,008 +1.4 +2.2

Figure 1: Breakdown by product type and region of Hospira’s sales in the thirdquarter of 2013 (Source – Hospira)

MANUFACTURING/THIRD-QUARTER RESULTS

Hospira gets positivesite signal from FDA

Astrong performance in the first half of its financial year ended 31March 2014 has led Sawai Pharmaceutical to increase its full-year

sales forecast to ¥88.7 billion (US$903 million), an increase of ¥1.7billion from its original forecast of ¥87.0 million. Whereas the Japanesegenerics specialist had originally anticipated annual turnover growthof 8.1%, it will require a 10.2% sales rise to reach its revised target.

Sawai had originally forecasted a modest 3.5% improvement inoperating profit to ¥18.0 billion, implying a decline in its operatingmargin of almost a percentage point to 20.7%. But buoyed by itsperformance in the six months ended 30 September 2013, the Japanesefirm now believes it will achieve an annual operating profit of ¥19.5billion, giving an operating margin rise of 0.4 points to 22.0%.

A first-half turnover increase of 11.2% to ¥42.7 billion had beenachieved, Sawai pointed out, in the absence of any major new promotionalpolicies to drive generics usage. Nevertheless, the company said it hadseen “steady growth” from products listed for reimbursement duringits current financial year. These contributed first-half sales of ¥329 million.

Sales of cardiovascular and gastrointestinal drugs enjoyed double-digit advances to ¥13.0 billion and ¥7.65 billion respectively, whileturnover from central nervous system products also increased strongly.

Sawai improved its first-half gross margin by almost a percentagepoint to 47.9%. And with selling, general and administrative costsup by just 4.0%, the Japanese firm raised its operating profit by aquarter to ¥10.1 billion, lifting its operating margin by 2.6 percentagepoints to 23.5%. G

RESULTS FORECAST/HALF-YEAR RESULTS

Sawai lifts forecaston strong first half

Improved pricing through DSM’s Sinochem Pharmaceuticals divisionand higher volumes through the firm’s Pharmaceutical Products

business both contributed to DSM’s combined Pharma division salesincreasing by 6% to C183 million (US$247 million) in the third quarterof this year. Constant-currency sales growth was 10%, the Dutch firmnoted, adding that its Pharma earnings before interest, tax, depreciationand amortisation (EBITDA) had trebled to C12 million on the backof “higher sales and cost savings”. As a result, DSM Pharma’sEBITDA margin rose by more than four percentage-points to 6.6%.Group turnover was ahead by 4% to C2.40 billion. G

THIRD-QUARTER RESULTS

Pricing and volume aid DSM


COMPANY NEWS


Teva’s global Generics business accounted for just a quarter of thegroup’s operating profit, excluding corporate general and

administrative expenses totalling US$297 million, in the third quarterof this year. Global Generics turnover was static at US$2.48 billion –or almost half of the Israeli group’s total sales that advanced by 2% toUS$5.06 billion – due to a 17% slide to US$162 million in third-partysales of active pharmaceutical ingredients (APIs).

Multiple-sclerosis brands, led by Copaxone (glatiramer acetate)accounted for nearly half of Teva’s operating profit before the corporateexpenses, other Specialty brands 22%, and OTC and other businessesthe remaining 4%.

The firm reported an operating profit of US$801 million, comparedto a loss of US$60 million in the prior-year quarter, on significantlylower legal provisions and research and development impairments.

“The operating margin of our Generics business in Europe isapproximately 15%,” stated Eyal Desheh, who is Teva’s acting chiefexecutive officer following the departure of Jeremy Levin (Genericsbulletin, 1 November 2013, page 1). The global Generics business’gross margin was 40.3%, down from 43.5% in calendar year 2012 dueto inventory reductions and write-offs. The Generics business spent 5.0%of its sales on research and development, and 17.7% of its turnoveron sales and marketing activities.

European business lacked major launchesGenerics turnover in Europe declined by 1% to US$812 million,

equivalent to a 5% constant-currency fall (see Figure 1). “There were nomajor launches of generic medications during the quarter,” Tevanoted, adding that it was focusing on sustainable, profitable activities.

Lower Generics sales contributed to an overall 6% local-currencyturnover slide in Germany. French Generics sales fell amid “competitivemarket conditions and our continued focus on sustainable business”, astotal turnover in the country fell by a tenth on a constant-currency basis.

Higher Generics sales due to “improvements in inventorymanagement” contributed to a total 42% constant-currency turnoverincrease in Italy, but Generics sales fell in Spain despite overall 1%growth on the same basis. Teva said it had remained generics marketleader in the UK, where the firm’s turnover had been flat.

The firm has 1,467 European marketing-authorisation applicationspending for 214 compounds in 423 formulations, including two via theEuropean Medicines Agency’s (EMA’s) centralised procedure. Followinga centralised approval, Teva is rolling out its Lonquex (lipefilgrastim)pegylated granulocyte-colony stimulating factor (G-CSF) in Europe.

Commenting on Teva’s decision to shelve its US dossier forlipegfilgrastim (Generics bulletin, 1 November 2013, page 15), researchand development head Michael Hayden said the firm had faced “complexintellectual-property issues”, so had decided to focus on balugrastim,which offered better commercial prospects. Re-filing lipegfilgratimin the US remained an option, he added.

The Israeli firm – which cancelled a biosimilars alliance withLonza earlier this year (Generics bulletin, 9 August 2013, page 5) –reported third-quarter sales from oncology biosimilars down by arounda quarter to US$24 million.

Meanwhile, Teva is continuing to seek a buyer for its US injectablesplant in Irvine, California, as it shifts injectables production to Europeansites in Hungary and the Netherlands.

Exclusive launches of generic Niaspan (niacin) extended-releasetablets and Temodar (temozolomide) capsules – as well as higher salesof generic Adderall IR (amphetamine salts) and Tricor (fenofibrate)tablets – helped Teva’s US Generics operation to overcome lowerturnover from escitalopram, pioglitazone and pioglitazone/metformin.

As a result, US Generics sales rose by 6% to US$1.14 billion.Other US launches during the quarter included generic rivals to

Soriatane (acitretin) capsules in July, as well as to Prevpac Kit (amoxicillin/clarithromycin/lansoprazole) extended-release tablets, Adenoscan(adenosine) vials and Zemplar (paricalcitol) capsules in September. Thefirm also secured tentative approval for an alternative to Chantix(varenicline) tablets. Out of 137 generic dossiers the firm has pendingfinal US approval, 98 include paragraph IV patent certifications, ofwhich Teva believes 57 hold first-to-file status.

A reported 11% slide to US$533 million in Generics turnover inits the Rest of World region was purely due to exchange-rate fluctuations,as this equated to a 1% constant-currency rise. Higher branded genericssales in Russia compensated for falls elsewhere.

Generics accounted for 58% of Teva’s total turnover of US$910million in the Rest of World region. This regional total comprised:US$488 million from Japan, Russia and Latin America; US$320million from the “mature generics markets” of Canada and Israel; andUS$102 million from other emerging markets.

Reported turnover fell by 21% in Japan and by a tenth in Russia,the former due solely to currency shifts and the latter largely to thetiming of Copaxone tenders. Turnover in Canada dipped slightly, butsales in Israel grew by 12%.

Latin American sales declined by a tenth, but rose by 8% in localcurrencies on higher generics sales and launching the Vicks OTC brandin Peru. Teva’s total OTC sales advanced by 13% to US$286 million,while ‘Other Revenues’ – largely from third-party distribution of drugsin Hungary and Israel – edged up by 2% to US$211 million.

Teva’s global turnover from branded Specialty Medicines rose by3% to US$2.08 billion as slightly higher sales of Copaxone and double-digit growth from Azilect (rasagiline) and Treanda (bendamustine)counteracted a 58% plunge in sales of Provigil (modafinil) due togeneric competition in the US.

The Israeli firm blamed “decreased inventory levels and a higherlevel of inventory write-off of finished goods” for its group gross marginslipping slightly to 52.0%. Research and development investment roseby 7% to US$348 million as Teva approved 13 ‘supergeneric’ newtherapeutic entities (NTEs) for development.

Meanwhile, Teva admitted that it had, during a voluntaryinvestigation into its business practices, identified issues “in Russia,certain Eastern European countries and certain Latin Americancountries” that could violate the US Foreign Corrupt Practices Act(FCPA). The Israeli group said it had brought these issues to theattention of the US Department of Justice and the Securities andExchange Commission (SEC). G


Teva’s generics make just quarter of profitThird-quarter sales Reported Local-currency

(US$ millions) change (%) change (%)

US 1,138 +6 +6Europe 812 -1 -5Rest of World 533 -11 +1Generics 2,483 ±0 –

Specialty Medicines 2,079 +3 –

OTC 286 +13 +16

Other 211 +2 –

Teva 5,059 +2 +2

Figure 1: Breakdown by product line of Teva Pharmaceutical Industries’ sales inthe third quarter of 2013 (Source – Teva)


Impax Laboratories participated in a “regulatory meeting” demandedby the US Food and Drug Administration (FDA) at the end of

October to “provide additional information and clarifications on thecompany’s responses and updates” relating to 12 ‘Form 483’ deficienciesobserved earlier this year at the firm’s US facility in Hayward, California(Generics bulletin, 8 March 2013, page 9). The site has been thesubject of an FDA warning letter since 2011.

“The FDA did not notify the company at the meeting of anyadditional enforcement actions,” stated Impax, which added that itbelieved a satisfactory re-inspection would be needed for the FDAto close out the warning letter and resolve the Form 483 observations.

Chief executive officer Larry Hsu – for whom Impax is seekinga replacement (Generics bulletin, 12 July 2013, page 23) – revealeddata-integrity issues had never arisen during discussions with the FDA.

An US$8.1 million remediation charge – along with a US$13.2million impairment to generic topical drug rights acquired fromTolmar last year (Generics bulletin, 13 July 2012, page 13) – reducedthe gross margin of Impax’ Global generics division by almost 23percentage points to 33.4% (see Figure 1).

Gross margin slips to 33.4%The Global division’s turnover increased by 15% to US$116 million

after it launched authorised Trilipix (fenofibrate) delayed-release capsulesin July (Generics bulletin, 9 August 2013, page 23), just as the firm’sexclusivity period expired for its non-substitutable rival to Endo’sOpana ER (oxymorphone) extended-release tablets.

Launching authorised generics of Impax’ own Zomig (zolmitriptan)standard and orally-disintegrating tablets also boosted the Global genericsdivision. But turnover from branded Zomig tumbled by US$27 millionfollowing generic competition (Generics bulletin, 7 June 2013, page10). This cut almost two-thirds from sales by the Impax brands division,which fell to US$16.9 million. As a result, group turnover declined by9% to US$133 million. Higher patent-litigation expenses contributedto Impax posting an operating loss of US$0.19 million. G

COMPANY NEWS


Division Third-quarter sales Change Gross(US$ millions) (%) margin (%)

Generics 116 +15 33.4Brands 17 -63 57.3

Impax 133 -9 36.4

Figure 1: Breakdown by division of Impax Laboratories’ sales and gross margin inthe third quarter of 2013 (Source – Impax)

MANUFACTURING/THIRD-QUARTER RESULTS

Impax provides FDAwith facility answers

Athlone Laboratories has opened a C5 million (US$7 million)antibiotic facility in Roscommon, Ireland, which will double its

current manufacturing capacity.The oral betalactams producer – which employs 140 people at

the Roscommon site – was acquired by the Dublin-based marketing,distribution and services group DCC as part of its deal earlier thisyear to buy companies including Kent Pharmaceuticals (Genericsbulletin, 11 January 2013, page 3). G

MANUFACTURING

Athlone opens site in Ireland

India’s Ipca generated over three-fifths of its group turnover in thesix months ended September 2013 – ahead by 17% to Rs16.3 billion

(US$265 million) – through export sales.Sales of formulations outside of India jumped by 23% to Rs6.93

billion, while turnover from exported active pharmaceutical ingredients(APIs) increased by a fifth to Rs3.22 billion.

The other Rs6.13 billion came from India. Sales of formulationsgrew domestically by just under a tenth to Rs5.27 billion, while Indianturnover from Ipca’s APIs improved by 23% to Rs861 million.

Meanwhile, the Indian firm’s pre-tax profit increased by a fifthto Rs2.65 billion in its financial first half. G

FIRST-HALF RESULTS

Exports push Ipca’s sales up

Launching the obesity treatment orlistat and the decongestantoxymetazoline under its Neo Química umbrella brand contributed

to Brazilian firm Hypermarcas increasing its Pharma division salesby 15.6% to BRL614 million (US$264 million) in the third quarter of2013. The company said it had also boosted its overall sales of generics,branded generics and OTC products.

The Brazilian company claimed to have captured a pharmaceuticalmarket share of 9.4% – the second largest in Brazil – during the quarter.The Neo Química generics operation had strengthened its market shareconsiderably, Hypermarcas added.

Higher sales of products with weaker margins offset productivityimprovements at the firm’s facility in Anápolis, Brazil. As a result, thePharma division’s gross margin slipped slightly by two-tenths of apercentage-point to 76.2%.

Pharma sales accounted for 55% of Hypermarcas’ group turnover– up by almost two percentage-points on last year’s proportion – thatgrew by 12.0% to BRL1.11 billion during the quarter. The Braziliangroup’s gross margin – including its Consumer business – improvedby two points to 64.3%, as its operating profit rose by almost a tenthto BRL222 million. G


Neo Química drugsassist Hypermarcas

Ajanta Pharma “remains focused on select specialty therapeuticsegments in India and select geographies overseas”, according to

comments made by managing director Yogesh Agrawal as the firmreported turnover ahead by 38.2% to Rs4.98 billion (US$78.0 million)in the company’s financial first-half ended 30 September 2013. TheIndian firm’s operating profit rose by over four-fifths to Rs1.17 billion.

Having recently succeeded in challenging Indian patents protectingAllergan’s Ganfort (bimatoprost/timolol) and Combigan (brimonidine/timolol) ophthalmic treatments – for which the firm markets ‘BimatT’ and ‘Bidin LS’ rivals (Generics bulletin, 6 September 2013, page19) – Ajanta announced it had also filed three abbreviated new drugapplications (ANDAs) with the US Food and Drug Administration(FDA) during its financial second quarter. G

FIRST-HALF RESULTS

Ajanta advances by two-fifths


COMPANY NEWS


Hikma has raised its full-year sales forecast for its US solid-doseGenerics business to US$260 million with an operating margin

above 40%, “given the continued strength of doxycycline sales”. Inthe first half of this year, the Jordanian group had increased its Genericsturnover to US$132 million on “exceptional sales of doxycycline”(Generics bulletin, 6 September 2013, page 11). “We maintain ourguidance for 2013 of around 20% group revenue growth,” Hikma added.

Injectables continued to “perform very well, particularly in theUS, where excellent growth is being driven by strong demand acrossour growing product portfolio”, Hikma said. “Pricing improvementsand a good performance from recently-launched, more differentiatedproducts” were also bolstering US Injectables sales, the firm added.Noting continued “steady growth in Europe” as well as stronger salesin “key markets” in the Middle East and North Africa (MENA), Hikmaforecasted “low double-digit revenue growth for the full year” inInjectables, as well as “strong profitability”.

Meanwhile, Hikma said it was still committed to resolvingmanufacturing problems at its US plant in Eatontown, New Jersey, thathad been hit by a US Food and Drug Administration (FDA) warningletter last year (Generics bulletin, 9 March 2012, page 4). “We remainfocused on the remediation of our Eatontown facility and continue togradually reintroduce products to the market,” the firm said, adding thatit expected to spend around US$45 million on the plant in 2013. G

RESULTS FORECAST

Doxycycline sales liftoutlook for Hikma

Pfizer anticipates commencing Phase III clinical trials for its biosimilarHerceptin (trastuzumab) “within the next couple of months”. Earlier

this year, the firm said its Phase II studies for the oncology drug hadproduced “positive data” (Generics bulletin, 15 February 2013, page 23).

The originator added that Phase III trials for biosimilars ofRituxan (rituximab), Remicade (infliximab) and Humira (adalimumab)were due to begin next year. At around the same time, Pfizer anticipatesstarting a Phase I trial for a biosimilar of Avastin (bevacizumab).

“We feel that we have the technology and the ability to bringbiosimilars to the market that will be very well characterised,” insistedthe firm’s chief executive officer Ian Read. Biosimilars, he added,offered “a reasonably low-cost development opportunity for productsthat have a high commercial opportunity”.

A strong contribution from its generics alliance with Mylan inJapan – where the two partners offer a combined portfolio of around250 drugs – could not prevent sales by the firm’s Established Productsdivision declining by 4% to US$2.30 billion in the third quarter of thisyear, as branded Lipitor (atorvastatin) lost ground in the US and Japan.

Pfizer is pushing ahead with plans to make its Established Productsor ‘Value’ business one of three separate commercial operations withinthe group (Generics bulletin, 9 August 2013, page 9). Another willcover ‘Innovative Pharmaceuticals’, while a third will embrace thegroup’s Vaccines, Oncology and Consumer Healthcare operations. G

BUSINESS STRATEGY/THIRD-QUARTER RESULTS

Pfizer makes plansfor biosimilar trials


Three strengths of generic Concerta (methylphenidate) extended-release tablets that Mallinckrodt introduced in the US contributed

sales of US$151 million to the firm’s turnover in its financial year ended27 September 2013. The controlled-substances specialist claims to havecaptured a 29% share of all US prescriptions for the attention deficithyperactivity disorder (ADHD) drug.

Having initially launched a 27mg strength of methylphenidate atthe end of 2012, Mallinckrodt added 36mg and 54mg versions earlierthis year (Generics bulletin, 5 April 2013, page 14). The company iscurrently awaiting approval from the US Food and Drug Administration(FDA) for an 18mg tablet so it can match all four strengths offered bythe originator, Janssen.

Mallinckrodt said its rival to Concerta had ended its financial yearstrongly, clocking up sales of US$63.0 million in the July-September

quarter as it benefited from “strong customer re-orders followingconsumption of initial product-launch quantities”.

Even though Mallinckrodt now faces competition on the ADHDdrug from Kremers Urban – which is offering the 18mg and 27mgstrengths – the firm is forecasting methylphenidate sales in its currentfinancial year ending September 2014 of “at least US$120 million”(Generics bulletin, 1 November 2013, page 4).

As Figure 1 shows, the ADHD treatment contributed just under7% to Mallinckrodt’s group turnover that increased by 7.6% to US$2.21billion in the year ended 27 September 2013. Within that total, SpecialtyPharmaceuticals sales ahead by 21.8% to U$1.22 billion more thanoutweighed a 6.1% slide to US$936 million in Medical Imaging turnover.

A 7.3% rise to US$140 million in sales of bulk and oral-dosehydrocodone compensated for slightly lower turnover from bulk andfinished oxycodone, as well as of acetaminophen active pharmaceuticalingredient (API). Mallinckrodt’s turnover from pharma brands climbedby 29.9% to US$203 million, as sales of its Exalgo (hydromorphone)extended-release tablets rose by a third ahead of imminent genericcompetition from Actavis under the terms of a patent-litigationsettlement (Generics bulletin, 8 March 2013, page 19). The firm alsogenerated US$29.2 million in sales of recently-acquired intrathecaldrugs such as Gablofen (baclofen). G

COMPANY NEWS


AcetaminophenUS$216m

-0.7%

OxycodoneUS$139m

-3.5%

HydrocodoneUS$140m

+7.3%

Other generics/APIsUS$375m

+5.2%Brands

US$203m, +29.9%

MethylphenidateUS$151m

Medical ImagingUS$936m

-6.1%

Sales to CovidienUS$51m, -5.5%

Figure 1: Breakdown by product type and business unit of Mallinckrodt’s salesthat increased by 7.6% to US$2.21 billion in the firm’s financial year ended 27September 2013 (Source – Mallinckrodt)

ANNUAL RESULTS

Concerta rival givesMallinckrodt growth

NIPPON CHEMIPHAR’S generics sales slipped by 5.9% to ¥11.6billion (US$117 million) in the Japanese firm’s financial secondquarter ended 30 September 2013. Turnover from products launchedin the previous year dropped by almost a quarter to ¥444 million,while older products launched in 2006 and earlier – which made upjust over two-fifths of Chemiphar’s generics sales – dropped by 15.1%to ¥4.83 billion. Amlodipine was the firm’s highest-selling generic,producing turnover that rose by 7.1% to ¥1.64 billion. Meanwhile,lansoprazole sales increased by more than a tenth to ¥966 millionand rabeprazole’s total advanced by 15.0% to ¥728 million.

TEVA has agreed to pay Israel’s Tax Authority ILS2.54 billion(US$718 million) “for the release of trapped profits, settling taxassessments for the years 2005-2007, and applying similar principlesthrough 2011”. The Israeli firm said it expected to incur a charge ofaround US$235 million to be reported in the fourth quarter of 2013.

HERITAGE PHARMACEUTICALS has relocated to new corporateheadquarters in Eatontown, New Jersey. Jeffrey Glazer, Heritage’spresident and chief executive officer, said the move “enables Heritagethe flexibility to continue to scale operations pursuant to our businessplan and add the human capital required for continued operationaland commercial execution and success”.

WOCKHARDT says the UK’s Medicines and Healthcare productsRegulatory Agency (MHRA) has “allowed the company tomanufacture and supply most of the products” made at the firm’sfacility in Kadaiya, India, that are “critical to public health”. Theagency had previously withdrawn good manufacturing practice(GMP) certificates for the plant, as well as a site in Chikalthana, India(Generics bulletin, 1 November 2013, page 2). Allowing the Kadaiyaplant to supply these medicines meant that the “net impact onannualised consolidated revenue is expected to be less than £1 million(US$1.59 million), out of the total annual consolidated revenue ofapproximately £18 million” from the plant, Wockhardt said.

NAVAMEDIC said its sales in the third quarter of 2013 had risen bymore than three-quarters to NOK36.7 million (US$5.92 million)following 14 product launches so far this year. Turnover from theNorwegian firm’s Pharma segment more than doubled to NOK27.5million, although Navamedic acknowledged that “slim” marginsmeant that the division generated earnings before interest, tax,depreciation and amortisation (EBITDA) of just NOK0.2 million.Sales through the firm’s Medical Nutrition unit rose by 3.5% toNOK5.8 million, while Consumer Care turnover slid slightly by2.9% to NOK3.4 million.

IGI LABORATORIES said its generic topical products contributedUS$1.4 million to total sales that doubled to US$4.0 million in thethird quarter of 2013. “We have solidified our position in our firstthree IGI-labelled topical pharmaceutical products,” said the firm’schief executive officer, Jason Grenfell-Gardner, “and we havesuccessfully launched our fourth product, econazole nitrate 1% cream– which we acquired earlier this year – during the third quarter of2013.” Having filed four abbreviated new drug applications (ANDAs)in 2013, IGI now had 12 pending US Food and Drug Administration(FDA) approval, he added. These were aimed at a combined marketworth US$300 million, Grenfell-Gardner claimed, adding that IGIplanned to file at least two further ANDAs by the end of the year.

PODRAVKA edged up its Pharmaceuticals sales by 1% to CrK586million (US$103 million) in the first nine months of this year. Exportsahead by 4% offset a 2% drop in the Croatian firm’s home market. G

IN BRIEF


Perrigo is “shifting investments” in its active pharmaceuticalingredient (API) business to concentrate on “projects that will allow

further vertical integration in our portfolio”, the company has revealed.Sales of APIs in the US firm’s financial first quarter ended 28

September 2013 rose by almost a fifth to US$43 million (see Figure 1).Although sales of existing products fell by US$11 million due toincreased competition, this was more than offset by new-product salesof US$17 million, “primarily from the recent US launch of the genericversion of Temodar (temozolomide)”. Perrigo supplies temozolomideto Teva for the US Temodar rival that the Israeli firm launched earlierthis year (Generics bulletin, 6 September 2013, page 19).

Perrigo stated, however: “We plan only limited new product launchesbeyond temozolomide”. Over the long term, the firm said, third-partyAPI sales would begin to decrease, while internal sales to the firm’sown Prescription and Consumer Healthcare units “will be ramping up”.

Meanwhile, Perrigo noted that recent batches of the guaifenesinAPI used in its store-brand rivals to Reckitt Benckiser’s Mucinex OTCcough and cold treatment had not met the firm’s “rigorous, high-qualityinternal specifications”. “We continue to work with one of our vendorsto maintain a sufficient supply of raw materials for this product,” Perrigosaid. “We are still shipping store-brand Mucinex,” Perrigo insisted,“but we will experience a gap in our ability to manufacture guaifenesin.”

In the firm’s financial first quarter, Consumer Healthcare turnoverrose by almost a fifth to US$539 million – driven partly by theguaifenesin launch – while Prescription Pharma sales rose by a quarterto US$204 million “due primarily to incremental net sales of US$23million” from acquiring the UK-based Rosemont (Generics bulletin,15 February 2013, page 1) and a range of ophthalmics from Fera(Generics bulletin, 28 June 2013, page 21), as well as new productsales of U$15 million. Meanwhile, Nutritionals sales ahead by a quartercontributed US$129 million. Other sales rose by 15% to US$19 million.

However, the Prescription Pharma segment’s operating margin hadfallen by 1.2 percentage points to 40.8%, Perrigo said, because of “higherdistribution, selling, general and administrative costs due to theinclusion of Rosemont”. The firm maintained its forecast of 25%-29%growth for the Prescription segment in its year ending June 2014, notingthat it planned to launch a rival to Valeant’s Vanos (fluocinonide)cream by the end of the financial year.

Perrigo currently has 28 abbreviated new drug applications(ANDAs) pending US Food and Drug Administration (FDA) approval,“representing US$4.2 billion in branded sales”. Of these, seven are“confirmed first-to-file ANDAs”, while a further two first-to-file ANDAsalready have final approval with date-certain launches to follow. G

COMPANY NEWS


Business Firt-quarter sales Change Operatingsegment (US$ millions) (%) margin (%)

Consumer Healthcare 539 +19.5 16.7Prescription Pharma 204 +25.0 40.8Nutritionals 129 +24.8 6.0API 43 +18.5 52.0Other 19 +15.1 6.2

Perrigo 933 +21.3 19.3*

* includes US$24.6 million of unallocated expenses

Figure 1: Breakdown by business segment of Perrigo’s sales and operatingmargin in its financial first quarter ended 28 September 2013 (Source – Perrigo)

BUSINESS STRATEGY/FIRST-QUARTER RESULTS

Perrigo shifts focusonto integrated APIs

Launching five products in the US helped Lupin push its localformulations sales up by almost a third to Rs10.3 billion (US$169

million) in the firm’s financial second quarter ended 30 September2013. Lupin received approval to market a rival to Sanofi’s Ambien(zolpidem) in the US (Generics bulletin, 20 September 2013, page 21)and struck licensing agreements for Locoid (hydrocortisone butyrate)lotion and Alinia (nitazoxanide) oral suspension (Generics bulletin,6 September 2013, page 20) during the quarter.

With the US contributing over three-fifths of total formulationsexport sales, Lupin’s total exports increased by 20.7% to Rs16.8 billion.In South Africa, turnover from Lupin’s Pharma Dynamics businessleapt by a quarter to Rs1.00 billion, while sales from Europe and theRest of World region both grew by 18% to Rs741 million and Rs1.63billion respectively. The Indian player was hit, however, by a 6% slide toRs3.09 billion in Japan (see Figure 1) as it suffered from currency shifts.

Meanwhile, domestic formulations sales rose by 9% to Rs6.64billion. Global sales of active pharmaceutical ingredients (APIs)were ahead by a fifth to Rs2.86 billion, enabling Lupin’s group turnoverto advance by 18% to Rs26.3 billion. The Indian firm, having duringthe quarter promoted its founder’s son and daughter to senior roles(Generics bulletin, 17 May 2013, page 27), posted earnings beforeinterest, tax, depreciation and amortisation (EBITDA) that were aheadby over two-fifths to Rs7.41 billion. G

SECOND-QUARTER RESULTS

Lupin bolstered bydouble-digit US rise

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

US 10,349 +32 39India 6,635 +9 25Japan 3.093 -6 12South Africa 1,004 +24 4Europe 741 +18 3Rest of World 1,631 +18 6Formulations 23,453 +17 89

APIs 2,862 +20 11

Lupin 26,315 +18 100

Figure 1: Breakdown by region and business of Lupin’s sales in its financialsecond quarter ended 30 September 2013 (Source – Lupin)

Staff and material costs increasing less steeply than turnover helpedIndoco to achieve a “significant improvement” in its earnings

before interest, tax, depreciation and amortisation (EBITDA) marginin the Indian firm’s financial second quarter ended 30 September 2013.With net sales that increased by 31.7% to Rs1.95 billion (US$30.6million) and EBITDA that rose by more than two-fifths to Rs369 million,Indoco’s EBITDA margin jumped by three percentage points to 18.9%.

Domestic sales rose by more than a fifth to Rs1.28 billion, whileexports increased by more than half to Rs675 million.

Indoco’s chairman Suresh Kare forecasted future sales growthfrom regulated markets. Issues around the implementation of a newpricing policy in India should be resolved soon, he added. G


Indoco improves profitability


Sales growth of more than 40% in the US and in Russia and theCommonwealth of Independent States (CIS) led to a 32% increase

to Rs26.5 billion (US$428 million) in Global Generics turnover byDr Reddy’s Laboratories in the Indian firm’s financial second quarterended 30 September 2013. Including non-generic operations, groupturnover advanced by 17% to Rs33.6 billion.

Launches during the quarter of azacitidine and decitabine vials –as well as of divalproex extended-release tablets and a 23mg strengthof donepezil tablets – helped to push up US Generics sales by 43%to Rs13.2 billion (see Figure 1). For both decitabine and donepezil23mg, Dr Reddy’s noted that it was the sole generic player. The Indianfirm is competing on azacitidine against Sandoz’ authorised genericof Celgene’s Vidaza (Generics bulletin, 4 October 2013, page 17).

During the quarter, Reddy’s – which said it had captured a thirdof the US fondaparinux market by volume – filed four abbreviatednew drug applications (ANDAs), leaving 62 ANDAs pending approval.

Generics turnover ahead by 44% to Rs5.52 billion in Russia andthe CIS comprised a 44% advance to Rs4.65 billion in Russia and39% growth to Rs870 million in other CIS countries, including Ukraine.Reddy’s said it had benefitted from a seasonal upturn in demand aswell as a strong performance from local OTC brands.

In its domestic market, the Indian firm overcame channel disruptionsfollowing pricing revisions to record an 8% Generics sales rise to Rs4.21billion. Follow-on biologics contributed Rs290 million to that total.

European Generics turnover dipped by 1% to Rs1.76 billion as thefirm’s German unit, Betapharm, pulled out of tender processes runby insurance funds (Generics bulletin, 9 August 2013, page 9).

But Generics sales in the Rest of World region climbed by 36%to Rs1.82 billion, aided by “volume growth in Venezuela and Australia”.

Turnover by the firm’s Pharma Services and Active Ingredients(PSAI) division fell by almost a fifth to Rs6.40 billion on lower third-party demand for active pharmaceutical ingredients (APIs) and a lackof “high-value orders” for its contract-services unit. Reddy’s is expandingthe manufacturing capacity of its PSAI division by paying Rs1.26billion for intermediates producer Ecologic Chemicals.

The group’s gross margin strengthened by 5.6 percentage-pointsto 58.0%, as the firm’s Global Generics margin reached 66.1% on therecent US launches. Reddy’s improved its pre-tax profit margin byfour points to 22.9%, even though it raised its research and developmentinvestment by 71% to Rs3.01 billion, or 9.0% of group turnover. G

COMPANY NEWS



US 13,244 +43 39Russia/CIS 5,516 +44 16India 4,207 +8 13Europe 1,761 -1 5Rest of World 1,820 +36 5Global Generics 26,548 +32 79

Pharma Services, APIs 6,403 -19 19

Proprietary Products/other 624 -25 2

Dr Reddy’s 33,575 +17 100

Figure 1: Breakdown by region and business of Dr Reddy’s Laboratories’ sales inits financial second quarter ended 30 September 2013 (Source – Dr Reddy’s)


Reddy’s sees surgesin the US and Russia

Fresenius Kabi incurred C32 million (US$43 million) of charges inthe first nine months of this year for tackling deficiencies at its

manufacturing sites in Grand Island, US, and Kalyani, India. Thecompany is continuing to produce at Grand Island, and recently resumedmanufacturing at the Kalyani oncology bulk-drugs site, following avoluntary shutdown (Generics bulletin, 8 March 2013, page 7).

Group chief executive officer Mark Schneider believed it would“not be too long” before the US Food and Drug Administration (FDA)re-inspected the two sites, but was unable to give a precise timeline.

Schneider described as “overblown” fears that the problems atGrand Island would limit the firm’s opportunities to launch injectable

generics in the US. Kabi had a strong pipeline of 40 abbreviated newdrug applications (ANDAs) pending approval, he stressed.

The facility charges – including C8 million in the third quarter– reduced the business’ nine-month earnings before interest and tax(EBIT) by 1% to C695 million on turnover that increased by 11% toC3.74 billion. Organic sales growth was 5%.

Just over a third of Kabi’s total turnover came from intravenousdrugs, sales of which advanced by 3% to C1.31 billion (see Figure 1).

Kabi’s 27% reported sales rise to C1.16 billion in North Americaequated to organic growth of 7%, allowing for the consolidation of theFenwal blood-transfusion business. Schneider said IMS Health datashowed the firm holding an 88% market share for propofol in Septemberas the firm’s shipments of the anaesthetic began to pick up followinghospital destocking.

European sales grew by 5% to C1.52 billion, even after a dropof a fifth in sales of hydroxyethyl starch (HES) blood-replacementproducts amid drug-safety concerns.

In the Asia-Pacific region – where the firm recently established ajoint venture in Indonesia (Generics bulletin, 18 October 2013, page 4)– double-digit growth in other markets helped to offset a 2% organicsales decline in China during the third quarter as Kabi suffered fromprice cuts. Asia-Pacific sales rose by 7% to C689 million, while Kabi’sturnover in Latin America and Africa grew by 2% to C371 million. G

NINE-MONTH RESULTS

Facility charges dentKabi’s profit margins

Product Nine-month sales Reported Organicline (CC millions) change (%) change (%)

Intravenous Drugs 1,308 +3 +6Clinical Nutrition 995 +1 +4Infusion Therapy 741 -2 +3Medical Devices 698 +98 +5

Fresenius Kabi 3,742 +11 +5

Figure 1: Breakdown by product line of Fresenius Kabi’s sales in the first ninemonths of 2013 (Source – Fresenius)

CANTABRIA PHARMA – the Spanish subsidiary of India’sWanbury group – has filed for voluntary insolvency in a Madridcommercial court. Wanbury had paid C42 million (US$56 million)for the Spanish operation seven years ago (Generics bulletin, 20October 2006, page 3). Cantabria markets analgesic, central nervoussystem and respiratory drugs in Spanish-speaking countries. G

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A29.5% rise in sales to Rs5.58 billion (US$88.2 million) byGlenmark’s US subsidiary, Glenmark Generics, enabled the Indian

firm to increase its group turnover by a sixth to Rs14.6 billion inthe firm’s financial second quarter ended 30 September 2013. TheIndian firm received approval for four products in the US during thequarter from the country’s Food and Drug Administration (FDA) –including desoximetasone ointment and hydrocortisone cream – andfiled six abbreviated new drug applications (ANDAs) with the agency.

In Western Europe, generics sales jumped by a third to Rs517million due to launches in Germany, Denmark and the Netherlands,as well as a successful challenge to a Dutch patent protecting Malarone(atovaquone/proguanil). Global generics sales rose by almost a quarterto Rs7.71 billion, despite turnover from active pharmaceutical ingredients(APIs) slipping by 8.5% to Rs1.01 billion (see Figure 1).

Meanwhile, increasing its domestic market share for cardiovascular,respiratory, anti-infective, gynaecology and anti-diabetic productsenabled Glenmark to drive up Indian sales through its Specialtydivision by 21.4% to Rs4.18 billion. And launching new oncologyproducts in a “stagnated” Central and Eastern Europe market helpedpush sales ahead by 38.9% to Rs527 million.

Elsewhere, Specialty sales in Africa, Asia and the Commonwealthof Independent States (CIS) – the divison’s second-biggest market –dropped by over a tenth on the back of lower sales in Kenya, Nigeriaand Sudan. Glenmark said it had become the first company to launchlornoxicam tablets in Myanmar. Sales in Latin America slid by 2.5%as local units “underperformed” in Brazil and Mexico. Turnover fromGlenmark’s Specialty Business operation increased by over a tenthto Rs7.52 billion. The Indian group’s pre-tax profit grew by 6.1%to Rs2.20 billion. G

COMPANY NEWS



US 5,579 +29.5 38Western Europe 517 +33.1 4APIs 1,011 -8.5 7Generics 7,107 +22.5 49

India 4,177 +21.4 29Africa/Asia/CIS 1,736 -10.6 12Latin America 966 -2.5 7Central/Eastern Europe 527 +38.9 4Outlicensing 118 – 1Specialty 7,524 +11.4 51

Glenmark 14,630 +16.6 100

Figure 1: Breakdown by business segment and region of Glenmark Pharmaceuticals’sales in its financial second quarter ended 30 September 2013 (Source – Glenmark)

Raising its turnover from formulations in the US by almost three-quarters to Rs7.31 billion (US$116 million) helped India’s

Aurobindo to improve its overall sales by more than a quarter toRs19.1 billion in its financial second quarter ended 30 September 2013.Along with sales in Europe and the rest of the world that advanced by17.1% to Rs2.64 billion, and antiretrovirals turnover that declinedby 7.6% to Rs2.33 billion, Aurobindo’s formulations unit grew bymore than a third to Rs12.3 billion (see Figure 1).

“The integrated business in generic formulations is auguring wellto drive the operating performance of the company,” said Aurobindo’smanaging director, N Govindarajan. At constant currencies, the firm’s

operating profit rose by three-quarters to Rs4.38 billion, giving thefirm an operating margin 6.2 percentage points higher at 22.9%.

During the quarter, the firm withdrew 10 approved abbreviatednew drug applications (ANDAs) in the US – of which two had receivedtentative approval and eight final approval – but received final nodsfor rizatriptan orally-disintegrating tablets, oxycodone/acetaminophentablets and dextroamphetamine tablets. Three approvals were alsoreceived in each of Australia, Canada and South Africa. G


Aurobindo gets liftfrom US formulations

Business/ Second-quarter sales Change Proportionregion (Rs millions) (%) of total (%)

US 7,308 +72.0 38Europe/Rest of world 2,644 +17.1 14Antiretrovirals 2,331 -7.6 12Formulations 12,283 +36.1 64

Active Ingredients 7,180 +15.4 38

Dossier Licensing 63 -46.2 –

Eliminations/other -387 -6.9 -2

Aurobindo 19,139 +27.6 100

Figure 1: Breakdown of Aurobindo Pharma’s sales in its financial second quarterended 30 September 2013 (Source – Aurobindo)


US growth providesboost for Glenmark

UNICHEM LABORATORIES said a 9.0% rise to Rs634 million(US$9.98 million) in International Formulation sales led the 2.0%group turnover rise to Rs2.70 billion in the Indian firm’s financialsecond quarter ended 30 September 2013. Domestic turnover aheadby 2.2% to Rs1.80 billion counteracted a 15.5% drop to Rs223 millionin International bulk-drug sales. G

IN BRIEF

Torrent’s exports rising by almost a third to Rs5.73 billion (US$92.5million) helped to push up the Indian firm’s overall sales by a

quarter to Rs9.72 billion in its financial second quarter ended 30September 2013. European turnover ahead by more than half joinedUS sales that advanced by 24% and a rise of 8% in Brazil. Elsewherein the world – including Canada, the Commonwealth of IndependentStates (CIS), Mexico and Russia – sales rose by 31%.

Meanwhile, the Indian company’s domestic formulations turnoverincreased by just a tenth to Rs2.97 billion due to “disruptions in themarket” caused by new government pricing measures. India’s totalpharmaceutical market had grown by just 3% over the same period,claimed Torrent, which reported total Indian turnover – includingcontract manufacturing revenues – ahead by 13% to Rs3.74 billion.Torrent improved its pre-tax profit by 9% to Rs1.52 billion despitehigher material costs, as well as staff costs that increased by 17.4%to Rs1.82 billion. G


Exports push Torrent ahead


Turnover in the US falling by more than two-fifths in dollar termsto C37 million (US$50.3 million) due to “reduced sales of the

authorised generics of Lovenox (enoxaparin) and Aprovel (irbesartan)”led Sanofi’s overall generics sales to tumble by 11.5% to C424 millionin the third quarter of 2013. In constant-currency terms, the decline was5.4%, due to the US drop as well as a constant-currency fall of 5.8%in Western Europe, “reflecting lower sales in France” (see Figure 1).

“Reduced sales in Brazil” also contributed to Sanofi’s decline asturnover from generics in the region fell by more than three-quartersfrom C76 million to C17 million, in part due to excess stocks in thesupply chain. Inventory in trade and sales volumes were now “basicallyback to normal” after the “re-order point was reached in August”, Sanofisaid, adding that an improvement should be seen in fourth-quarter sales.

Sanofi’s overall sales fell by 6.7% as reported but edged ahead by0.6% in constant-currency terms to C8.43 billion. “The third quartermarks an inflection point for Sanofi as the impact of the patent cliff endedin August,” commented chief executive officer Chris Viehbacher. G

COMPANY NEWS



Sanofi’s sales slip ondownturn in the US

Region Third-quarter sales Constant-currency Proportion of(CCmillions) change (%) total (%)

Emerging Markets 247 +2.3 58Western Europe 128 -5.8 30US 37 -42.9 9Rest of World 12 +66.7 3

Sanofi Generics 424 -5.4 100

Figure 1: Breakdown by region of Sanofi’s Generics sales in the third quarter of2013 (Source – Sanofi)

Double-digit sales rises throughout almost all of its export marketsenabled Zydus Cadila to increase its total exports by 27.9% to

Rs8.31 billion (US$135 million) in the firm’s financial second quarterended 30 September 2013. The Indian player’s pre-tax profit wasahead by nearly a third to Rs2.02 billion.

Domestically, the firm’s growth was relatively low, climbing by4.8% to Rs8.00 billion. However, this still represented 46% of Zydus’total quarterly turnover that increased by 12.5% to Rs17.4 billion.

Of its export sales, more than half came from the US (see Figure 1),where turnover jumped by almost three-tenths to Rs4.73 billion. Zydussaid it had during the quarter filed 12 abbreviated new drug applications

(ANDAs) – two of which were for injectable products – with the localFood and Drug Administration (FDA). This had come on top of receivingapproval from the agency for two products, including generic lansoprazole15mg and 30mg delayed-release tablets (Generics bulletin, 6 September2013, page 20).

Elsewhere, turnover in Europe increased by 23.6% to Rs942 million,while sales from Brazil, Emerging Markets – including Mexico – activepharmaceutical ingredients (APIs) and Animal Health were all aheadby over a quarter. Japanese sales slipping by 8.8% to Rs131 millionrepresented Zydus’ only exports decline, while turnover from jointventures also dropped by almost a fifth to Rs1.07 billion. G


Zydus’ exports topits turnover in India

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

India 7,997 +4.8 46

US 4,730 +28.8 27Europe 942 +23.6 5Brazil 622 +27.9 4Japan 131 -8.8 1Emerging markets & Mexico 1,013 +36.5 6APIs 738 +25.5 4Animal Health 134 +31.7 1Exports 8,310 +27.9 48

Joint ventures 1,068 -18.7 6

Zydus Cadila 17,375 +12.5 100

Figure 1: Breakdown by business and region of Zydus Cadila’s sales in itsfinancial second quarter ended 30 September 2013 (Source – Zydus Cadila)

More than doubling international formulations sales saw Alembic’stotal turnover rise by 20% to Rs4.88 billion (US$79.2 million)

in the firm’s financial second quarter ended 30 September 2013. TheIndian company’s formulations exports rose to Rs1.28 billion, asturnover from domestic formulations increased by just under a tenthto Rs2.75 billion (see Figure 1).

Global turnover from formulations – which accounted for overfour-fifths of total sales – rose by 28% to Rs4.03 billion. But sales ofactive pharmaceutical ingredients (APIs) fell by 14% to Rs782 million. G


Alembic improves by a fifth

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

India 2,749 +8 56International 1,280 +114 26Formulations 4,029 +28 83

APIs 782 -14 16

Export incentives 66 +118 1

Alembic 4,877 +20 100

Figure 1: Breakdown by business of Alembic’s gross sales in its financial secondquarter ended 30 September 2013 (Source – Alembic)

Turnover from active pharmaceutical ingredients (APIs) almostdoubling to Rs272 million (US$4.36 million) helped India’s JB

Chemicals & Pharmaceuticals to increase its total sales by 16.5% toRs2.53 billion in the firm’s financial second quarter ended 30 September2013. Domestic formulations sales advanced by just over a tenth toaround Rs910 million, while exports of formulations increased by thesame proportion to Rs1.20 billion, including 6% growth in Russia andthe Commonwealth of Independent States (CIS).

In the US, JB recently gained approval for tinidazole tablets, and ispreparing to launch (Generics bulletin, 1 November 2013, page 14). G


API boost aids JB’s advance


Novartis has filed a citizen petition with the US Food and DrugAdministration (FDA) urging the agency to use common

international non-proprietary names (INNs) for both biologic brandsand their biosimilar counterparts. “A modified INN for biosimilarswould impede their ability to compete fairly in the marketplace, createconfusion, and limit patient access to these critical medicines,” theSwiss company insists.

Generics associations from around the world recently used theWorld Health Organization’s (WHO’s) October consultation on INNsto reiterate their opposition to suggestions that biosimilars should useunique INNs to distinguish them from their reference brands (Genericsbulletin, 1 November 2013, page 9).

“Requiring separate INNs for biosimilars but not originator biologicswould undermine the FDA’s own approval decisions,” Novartis insists.“An inconsistent application of naming conventions would lead tomedication errors and jeopardise patient safety,” the firm adds. G

MARKET NEWS


REGULATORY AFFAIRS

Novartis lobbies FDAover biosimilar INNs

EMA – the European Medicines Agency – has launched an onlinecatalogue of medicines shortages. The publicly-available cataloguelists information on the reason for, and extent of, shortages affectingmore than one European Union (EU) member state. Initial entriesposted on 4 November are for Cerezyme (imiglucerase), Fabrazyme(agalsidase beta), Increlex (mecasermin) and Vistide (cidofovir).

IKK CLASSIC – the German statutory health insurance fund – expectsto save more than CC90 million (US$122 million) next year throughtenders. A total of 275 two-year supply contracts with 40 firms for241 medicine ‘lots’ are set to begin on 1 January 2014. Alongsideexclusive contracts, the fund is sourcing 38 of the “most prescribedmolecules and combinations” from multiple suppliers. Meanwhile,two-year contracts for 12 active ingredients awarded by Germany’sKBS fund began on 1 November. The fund awarded contracts toup to three suppliers per molecule, with Sandoz’ Hexal/1A Pharmaleading the way with six of the 21 contracts awarded.

GPhA – the US Generic Pharmaceutical Association – has urgedfurther clarity on certain aspects of draft stability guidance publishedby the US Food and Drug Administration (FDA). The draft question-and-answer document was recently published by the agency to supportfinalised stability guidance that will be implemented from June 2014(Generics bulletin, 6 September 2013, page 16).

EHFG – the European Health Forum Gastein – has been told byProfessor Nikolaos Maniadakis of the National School of PublicHealth in Athens, Greece, that demand control may be the mostefficient measure to increase the usage of generics and decreasehealthcare expenditure. “By contrast,” he said, “our findings donot support the use of pricing regulation as an effective means tocontrol expenditure.”

FDA – the US Food and Drug Administration – will requiremanufacturers of “certain medically important prescription drugs” tonotify the agency of supply interruptions under proposals publishedas part of efforts to address drug shortages. The agency has alsopublished a plan to improve its response to shortages.

EUROPEAN draft guidelines on product-specific bioequivalencehave been published for 16 molecules or combinations by theEuropean Medicines Agency’s (EMA’s) pharmacokinetics workingparty. The guidelines – all of which are open to public consultationfor three months – cover products including capecitabine, carglumicacid, dasatinib and emtricitabine/tenofovir, as well as erlotinib,imatinib, memantine and miglustat. Oseltamivir, posaconazole,repaglinide and sirolimus are also included in the guidelines, alongwith sorafenib, tadalafil, telithromycin and voriconazole.

AFRICAN quality-control testing to detect substandard and counterfeitmedicines will be conducted through a partnership between the GlobalPharma Health Fund (GPHF) and Ghana’s Center for PharmaceuticalAdvancement and Training (CePAT). “Counterfeit medications are amajor challenge in developing countries, where there are limitedresources for screening and quality assurance,” the GPHF said.

BIO – the US Biotechnology Industry Organization – has criticiseda letter sent by US senators urging the FDA to use commoninternational non-proprietary names (INNs) for biosimilars andbiologic brands (Generics bulletin, 1 November 2013, page 10).“When ultimately approved by the US Food and Drug Administration(FDA),” BIO pointed out, “biosimilars will be similar to, but notthe same as, their respective reference products.” G

IN BRIEF

Spending limits on branded medicines announced by the UK’sDepartment of Health (DoH) that are due to be implemented from

the start of 2014 have been welcomed by the British GenericManufacturers Association (BGMA).

A five-year Pharmaceutical Price Regulation Scheme (PPRS) –agreed between the DoH and brand body, the Association of theBritish Pharmaceutical Industry (ABPI) – states that UK National HealthService (NHS) spending on brands will remain flat for two years,“followed by small increases of less than 2% in the following threeyears”. NHS spending on brands was just over £12 billion (US$19.3billion) in the 2012 financial year, the DoH said, adding that any costabove the agreed threshold would have to be “absorbed by industry”.

Warwick Smith, director general of the BGMA, said theannouncement “provides clarity over the next five years”, adding thatthe “extremely efficient” UK medicines industry was able to providepatients with “a stable supply of affordable and accessible medicinesthroughout their lifecycle”. G

REGULATORY AFFAIRS

BGMA lauds cap on spending

Global pharmaceutical contract-research and manufacturing services(CRAMS) generated turnover that rose by more than a tenth to

US$72 billion in 2012, according to a report published by Italy’sChemical Pharmaceutical Generic Association (CPA).

Of contract-manufacturing activities that generated US$47 billionof the total, almost two-thirds – US$30 billion – came from contract-manufacturing of active pharmaceutical ingredients (APIs) andintermediates, the report indicates. Meanwhile, contract-manufacturingof finished-dosage forms accounted for just under a tenth, or US$4.5billion. Development of finished-dosage forms contributed 15%, orUS$7 billion, while packaging and labelling services accounted forthe remaining US$5.5 billion. G

MARKET RESEARCH

CRAMS earn US$72bn total


Brand companies in Canada have failed to meet domestic researchand development spending goals for the tenth consecutive year,

according to a report by the country’s Patented Medicine Prices ReviewBoard (PMPRB). “In 2012,” the Canadian Generic PharmaceuticalAssociation (CGPA) pointed out, “member companies of Canada’sResearch-Based Pharmaceutical Companies (Rx&D) spent only 6.6%of their Canadian revenues on research and development in Canada.”This compared to the goal of 10%.

Canada’s brand industry committed to invest at least a tenth ofdomestic turnover in local research and development when patentterms were extended in 1987. This was achieved between 1993 and2000, but since 2001 the industry has failed to reach the target.

In 2012, the PMPRB report indicates, Canadian originators spentC$783 million (US$750 million) on local research and development.This represented just 6.6% of Canadian turnover that fell by 11.5%to C$11.9 billion. Moreover, the report notes, the C$783 millioninvestment was 13.1% lower than in 2011 – when local researchand development spending represented 6.7% of Canadian turnover– and was proportionally the lowest spending figure since 1988.

“In Canada, market monopolies for brand-name drug companieshave increased no fewer than eight times since 1987,” said the CGPA’spresident, Jim Keon, “yet investments are declining toward recordlows.” The PMPRB’s report also suggests that Canadian investmentin research and development is “second worst of all countries”, with2010’s investment of 6.9% of domestic turnover comparing to figuresof 22.0% in the US, around a fifth in France and Germany, and 39.8%in the UK. Only Italy was behind Canada with a figure of 6.2%. G

MARKET NEWS


REGULATORY AFFAIRS

Canadian originatorsfail to achieve target

The “totality of evidence” derived from biosimilar comparabilityexercises, along with the safety and efficacy data from the most

sensitive indication, should be the key factors determining whetherEuropean biosimilar applicants can extrapolate safety and efficacydata between indications, according to Sandoz’ Mark McCamish.

Representing the European Generic medicines Association (EGA)during a biosimilars workshop hosted by the European MedicinesAgency (EMA) on 31 October, McCamish said extrapolation ofindications should be based on demonstrating a high level of structuraland functional similarity. The first, he said, could be shown throughphysicochemical characterisation, and the latter via biological assays.

McCamish described as “overstated” the emphasis on the samemechanism of action cited in the EMA’s draft guideline on non-clinicaland clinical issues affecting biosimilars, which is open for commentuntil 30 November 2013 (Generics bulletin, 28 June 2013, page 17).

Representing originator bodies EuropaBio and EuropeanBiopharmaceutical Enterprises at the workshop, Amgen’s RichardMarkus suggested that “data for extrapolation of indications in sensitivepopulations could be required pre-approval”. By seeking more datawhere needed, regulators would “help build confidence in biosimilarsamongst clinicians and patients”, he claimed.

The originators’ associations believe that biosimilar labelling shouldstate which studies were conducted and specify which indications wereapproved on the basis of extrapolation. G

REGULATORY AFFAIRS/BIOSIMILARS

Evidence key to extrapolation

Arevision of the European Union’s (EU) overarching biosimilarsguideline drafted by the European Medicines Agency (EMA) should

be adopted promptly, a representative of the European Genericmedicines Association (EGA) told a guidelines workshop hosted by theEMA on 31 October, the deadline for comments on the draft. “A near-term adoption of this guideline will accelerate patient access to effective,modern biological therapeutic alternatives,” stated Teva’s Karl-HeinzEmmert on behalf of the EGA’s European Biosimilars Group (EBG).

Among the provisions in the draft guideline – which is to replacethe existing overarching guideline CHMP/437/04 – is using comparatordrugs that are not authorised in the European Economic Area (EEA) toconduct clinical and non-clinical studies for comparability exercises(Generics bulletin, 17 May 2013, page 14). This, the draft says, has“the aim of facilitating the global development of biosimilars”.

Repeating studies for different jurisdictions would add C100-C150million (US$135-US$202 million) to biosimilar development costs,largely due to the expense of purchasing local reference products,Emmert commented. This extra cost, he said, would deter biosimilardevelopment, and thus limit market access and competition.

Representing originator bodies EuropaBio and EuropeanBiopharmaceutical Enterprises, Sanofi’s Eugene Corretge acknowledgedthat biosimilar applicants could use non-EEA authorised referencedrugs for in vivo clinical and non-clinical comparability studies,“provided that this is justified through an appropriate three-waycomparability exercise” involving the biosimilar as well as the EEA-approved and non-EEA-approved originals. Such a reference productshould be authorised in a member country of the International Conferenceon Harmonisation (ICH), as described in the guideline, he added.

But Emmert argued that if analytical and biological assaysdemonstrated comparability, bridging three-way pharmacokineticstudies should not be mandatory.

Addressing the draft guideline’s statement that the scientificprinciples for biosimilar comparability exercises were based on theICH’s Q5E regulations on evaluating the impact of manufacturing-process changes for biological drugs, Corretge argued that “some, but notall” ICH Q5E principles should apply to demonstrating biosimilarity.

Debate over use of ICHQ5E regulationsOriginators, he maintained, were able to compare drug substances

and products “at various steps” of their production processes to makeoriginals. Biosimilar developers, by contrast, could only compare theirversions with the finished reference product. “This distinction shouldbe further developed in the final guideline,” he insisted.

Emmert described the draft guideline’s definition of a biosimilar –a product containing “a version of the active substance of an alreadyauthorised original biological medicinal product” – as “clear, conciseand, from a scientific standpoint, well chosen”. This definition, he added,should be taken up in the EMA’s procedural advice for applicants.

However, other workshop participants objected that describing abiosimilar as a ‘version’ inappropriately implied that the biosimilarwas the same as, rather similar to, the reference drug.

In its draft overarching guideline, the EMA stresses that itsregulatory assessments “do not include recommendations on whether abiosimilar should be used interchangeably with its reference medicine”.Emmert proposed amending the draft guideline to recommend referringto the EMA’s European public assessment report (EPAR) when decidingwhether to use a biosimilar instead of its reference product. G

BIOSIMILARS

EGA urges EMA toadopt draft guideline


From 1 November, atorvastatin products have been subject to thefirst reference prices introduced by Ireland’s government under

legislation passed earlier this year. For 28-tablet packs of atorvastatintablets, Ireland’s Health Service Executive (HSE) has set prices ofC3.47 (US$4.68) for 10mg tablets; C5.46 for the 20mg strength; C9.14for the 40mg version; and C10.53 for the 80mg presentation.

Noting that the HSE would now pay “70% less for these productscompared to May 2013”, the country’s Department of Health andChildren (DoHC) said that the HSE would set reference prices foresomeprazole products by the start of December.

Introducing reference prices, the DoHC said, was a “major step”that would “ensure that generic medicine prices in Ireland will falltowards European norms”. Reference prices – being introduced on a“phased basis” – would “safeguard value for money”, the departmentadded, while at the same time set levels that would “facilitate, notjeopardise, supply of these products in Ireland”.

Under legislation published earlier this year (Generics bulletin,7 June 2013, page 12), reference prices in Ireland can be set by theHSE once the Irish Medicines Board (IMB) has designated aninterchangeable group. The legislation also introduced a frameworkfor generic substitution, including options for prescribing doctors toblock substitution or for patients to pay for a more expensive alternative.

Atorvastatin group designated in AugustAccording to plans set out by the IMB, 20 active substances “that

will achieve the greatest savings” have been marked for ‘priorityreview’. The first interchangeable group – comprising 96 atorvastatinproducts split among four sub-groups representing the four differentstrengths – was published by the agency in early August.

Once an interchangeable group has been published, an initial20% cut is implemented. After this, the HSE sets a reference price “witha view to introducing further significant price cuts”. Atorvastatin priceshad already been reduced by 20% from 1 September, while esomeprazoleand rosuvastatin prices were subjected to this reduction from 1 October.

Along with atorvastatin, the IMB’s priority list also includes othercholesterol-lowering drugs, proton-pump inhibitors and angiotensin IIreceptor antagonists, as well as ingredients such as clopidogrel andquetiapine (Generics bulletin, 28 June 2013, page 11). The IMBexpects two or three groups to be listed each month “as each of theconsultation processes are concluded”.

The DoHC also noted that separate price cuts from 1 Novemberhad seen “over 500 different presentations of various medicines” declinein price by between 5% and 29%, following agreements reached in2012 with the local generics industry group, the Association ofPharmaceutical Manufacturers of Ireland (APMI), and the brand body,the Irish Pharmaceutical Healthcare Association (IPHA).

Meanwhile, Actavis has renewed its support for an Irish informationcampaign aimed at raising public awareness of generics. A videoexplaining the nature of generics, emphasising their safety and efficacyand their potential economic benefit, as well as outlining how thenew pricing and substitution legislation functions, has been launchedas part of the ‘Just Ask’ campaign. The initiative also includes radioand print advertising, as well as a dedicated website and promotionalmaterial such as posters and leaflets for use in pharmacies.

A similar campaign, labelled ‘understanding generics’, waslaunched earlier this year in Ireland with the support of Teva (Genericsbulletin, 7 June 2013, page 13). G

MARKET NEWS


PRICING & REIMBURSEMENT

Ireland introduces itsfirst reference prices

Input from industry stakeholders is being sought by Brazil’s medicinesagency, Anvisa, over proposals to overhaul the country’s mechanism

of generic substitution. The agency noted that it was consideringmodifying the system, which currently allows brand prescriptions to besubstituted with generics but not with ‘similares’ drugs, which containthe same active ingredient but do not have proven bioequivalence.Comments on the proposals are open until 26 November.

Anvisa is asking stakeholders to comment on whether they believe“the possibility of interchangeability between reference drugs andsimilares products” would be “beneficial or detrimental”. In particular,the agency is seeking to discover whether stakeholders think thatsubstituting brands with similares products would affect areas includingaccess to medicines; pricing; competition; barriers to market entry;and the development of Brazil’s pharmaceutical industry.

Anvisa is also asking respondents to submit their opinions onsubjects including the interchangeability of reference brands withgenerics and similares products, as well as whether the agency shouldbetter communicate the technical standards that apply to genericsand to similares medicines. G

REGULATORY AFFAIRS

Brazil’s Anvisa mullssubstitution changes

Pricing measures agreed upon by Germany’s CDU/CSU and SPDpolitical parties as part of coalition negotiations threaten to place

further burdens on generics firms that are already at breaking pointdue to reference prices and tenders, the country’s generics industryassociation, Pro Generika, has warned.

Having failed to establish price controls and health-technologyassessments for many older, patented drugs, Pro Generika said, theprospective ‘black-red’ coalition partners intended to maintain a pricefreeze at 2009 levels and a mandatory 7% clawback that would preventgenerics firms from compensating for higher regulatory, salary, energyand raw-material costs through price increases.

Taking all rebates and discounts into account, generics accountedfor less than a tenth of drugs expenditure by German statutory healthinsurance funds, Pro Generika stressed. For that cost, the funds wereable to meet 73% of all prescriptions, the association added. G

PRICING & REIMBURSEMENT

Pro Generika warns coalition

Joint guidance on ‘quality by design’ has been published by theEuropean Medicines Agency (EMA) and US Food and Drug

Administration (FDA). Published as part of a three-year pilotprogramme for parallel assessments by the two agencies, that startedin March 2011, the latest question-and-answer document containsjoint recommendations as well as agency-specific guidance from thetwo bodies on ‘design space verification’. The EMA described thisas “a demonstration that the combination of the process parametersand material attributes established at pilot scale during pharmaceuticaldevelopment are capable of delivering a product of appropriate qualityon a commercial scale”. G

REGULATORY AFFAIRS

EMA and FDA guide on quality


Competition to AstraZeneca’s Pulmicort Respules (budesonide)suspension from Actavis, Apotex and Sandoz has been delayed

after the US Court of Appeals reversed an earlier patent ruling in thegenerics firms’ favour (Generics bulletin, 5 April 2013, page 12).

The Court of Appeals said a New Jersey district court had reachedan incorrect conclusion on claim construction for US patent 7,524,834,which expires on 11 May 2019, including six months of paediatricexclusivity. The issue has been remanded for further proceedings inthe New Jersey district court.

Based on its construction of the term ‘micronised powdercomposition’ in the ‘834 patent, the New Jersey district court had foundthat abbreviated new drug applications (ANDAs) filed by Actavis,Apotex and Sandoz did not infringe key patent claims.

The district court had construed ‘micronised powder composition’to mean heat-sterilised, finely-divided dry particles. But the Court ofAppeals objected that, in the plain meaning of the term, “none of thethree words imposes, or even implies, any form of sterilisation”.Noting that the patent’s specification was “confusing” on sterilisation,the appeals judges said they could not “conclude that AstraZenecadisclaimed non-heat sterilised micronised powder compositions”.

“We hold that the district court erred by adding the ‘heat sterilised’limitation into the claims at issue,” the appeals judges said. “The term‘micronised powder composition’ is construed more accurately as‘finely-divided dry particles’.”

Remanding the case back to the New Jersey court was necessary,they said, because one of the asserted claims – claim 50 – covereda sterile suspension consisting of a powder and an aqueous solution.

The Court of Appeals upheld the district court’s finding that theasserted claims of US patent 6,598,603 were invalid due to obviousnessin teaching a once-daily dosing of nebulised budesonide. A paediatricextension to the ‘603 patent expires on 23 June 2019.

Apotex failed to convince the appeals judges to increase the sizeof a bond that AstraZeneca had posted when securing an ongoingpreliminary injunction against the generics firm launching. “AstraZenecacannot be fairly informed after it obtained the benefit of the injunctionthat it must later pay more,” the judges stated, ordering that each partybear its own costs.

Teva currently offers the only US generic rival to PulmicortRespules under the terms of a patent-litigation settlement withAstraZeneca (Generics bulletin, 5 December 2008, page 19). Thisagreement allowed Teva to launch from 15 December 2009 in returnfor paying royalties to the originator. Actavis and Sandoz currentlyhold ANDA approvals for budesonide suspension, but – like Apotex –are currently enjoined from launching.

AstraZeneca reported a 7% drop in US Pulmicort sales to US$165million in the first nine months of this year.

Commenting on the Court of Appeals’ decision, Teva’s actingchief executive officer, Eyal Desheh, described generic budesonide as“more or less a US$700 million product for us”. “The gross marginis high, but the operating margin is influenced by the high level ofroyalties that we share with AstraZeneca,” he told investors.

“We believe that the resolution of these proceedings will take froma few months to a year, during which time we expect that the othergeneric manufacturers will likely continue to be enjoined from sellingtheir budesonide products,” Teva stated. “We now expect to have atleast three to 12 more months of exclusivity in the US market, andpossibly as long as through 2019,” the Israeli firm added. G

PRODUCT NEWS


RESPIRATORY DRUGS

Pulmicort ruling putspatent back in play

Biosimilar erythropoietins (EPOs) should account for at least halfof all prescriptions in Germany for erythropoiesis-stimulating

agents next year, according to a framework agreement struck betweenthe country’s insurance-fund doctors’ association, the KBV, andumbrella body of statutory health insurance funds, GKV-Spitzenverband.

While the 2014 national biosimilar EPO prescription target is atleast 50%, the proposed prescribing quotas vary significantly by federalstate. For instance, while fund doctors in Bremen are expected toprescribe biosimilar EPO in almost three out of five cases, the targetin Baden-Württemberg is just 18.9%.

The national 50% target represents an 11 percentage-point increasefrom the 39% quota set in a similar framework agreement covering 2013.

A similar minimum prescribing quota covers oral opioid drugsthat are subject to Germany’s narcotics law. The framework agreementstates that generics should account for at least 74.0% of prescriptionsfor these products, although targets for individual German states varybetween 66.8% and 86.5%.

In the opioids category, transdermal delivery forms are to accountfor no more than 48% of prescriptions within the class, including oraldrugs. Similar maximum prescribing quotas limit to 5.0% the use ofezetimibe-based drugs within the HMG-CoA reductase inhibitorscholesterol-lowering class. Glucagon-like peptide-1 (GLP-1) analoguessuch as exanatide and liraglutide, are to make up no more than 2.1%of prescriptions for diabetes drugs, excluding insulins.

Separately, the framework agreement defines ‘lead substances’that fund doctors should favour in several high-volume drug categories.By prescribing these “low-cost” active ingredients, doctors will “useeconomic resources” efficiently, the agreement states.

For example, pravastatin and simvastatin are favoured statins, whilecitalopram and sertraline are the preferred selective serotonin reuptakeinhibitors (SSRIs). Bisoprolol and metoprolol are the favoured selectivebetablockers, while doctors should look to prescribe the ACE-inhibitorsenalapril, lisinopril and ramipril over sartans (see Figure 1). G

BIOSIMILARS

Germany sets goalsfor biosimilar EPO

Drug class Lead Prescribingsubstances quota (%)

HMG-CoA reductage simvastatin, pravastatin 87.0inhibitors

Selective betablockers bisoprolol, metoprolol 88.0

Alpha-receptor blockers tamsulosin 85.0

SSRIs citalopram, sertraline 74.0

Biphosphonates alendronic acid, risedronic acid 85.0

ACE-inhibitors, sartans, enalapril, lisinopril, ramipril 75.0aliskiren

ACE-inhibitors, sartans, enalapril, lisinopril, ramipril+HCTZ, 45.0aliskiren + diuretics or amlodipine, nitrendipinecalcium antagonists

Calcium antagonists amlodipine, nitrendipine 81.0

High-ceiling diuretics furosemide, torasemide 99.0

Non-selective monoamine amitriptyline, doxepin 52.0reuptake inhibitors

Figure 1: Preferred lead substances and minimum prescribing quotas for certaindrug classes agreed by German doctors and insurance funds (Source – KBV/GKV)


New advice about switching between epilepsy medicines has beenissued by the UK’s Medicines and Healthcare products Regulatory

Agency (MHRA). Commenting that “an effect in some patients cannotbe ruled out”, the agency has divided anti-epileptic drugs into threerisk categories. These should “help prescribers and patients decidewhether it is necessary to maintain continuity of supply of a specificmanufacturer’s product”.

“Whilst there is no clear evidence of harm associated withswitching products, an effect in some patients, for some drugs, cannotbe completely ruled out,” the MHRA said, quoting the results of a formalreview by the Commission on Human Medicines (CSM). It added thatthe risks could be associated with switching between a branded originaland a generic product, or between different generic products.

Category 1 anti-epileptics are those for which doctors are advisedto ensure the patient is maintained on a specific manufacturer’s product.They are carbamazepine, phenobarbital, phenytoin, and primidone.

Category 2 anti-epileptics are those for which a continued supplyof a particular manufacturer’s product should be based on clinicaljudgement and consultation with the patient and/or the patient’s carer,“taking into account such factors as seizure frequency and treatmenthistory”. These drugs are clobazam, clonazepam, eslicarbazepine,lamotrigine, oxcarbazepine, perampanel, retigabine, rufinamide,topiramate, valproate and zonisamide.

Category 3 anti-epileptics are those for which it is “usuallyunnecessary” to ensure that patients are maintained on a specificmanufacturer’s product, “unless there are specific concerns such aspatient anxiety, and the risk of confusion or dosing errors”. They areethosuximide, gabapentin, lacosamide, levetiracetam, pregabalin,tiagabine and vigabatrin.

Commenting on the categorisation, Siu Ping Lam, the MHRA’sacting director of licensing, said it was “important new advice”. “Thecategories of anti-epileptic drugs are designed to help healthcareprofessionals decide upon whether it is necessary to maintain continuityof supply of a particular manufacturer’s product,” he said.

The latest advice from the MHRA follows earlier comments fromthe UK Department of Health when generic lamotrigine was launchedthat there was “no compelling evidence to suggest that switching fromthe originating [GlaxoSmithKline Lamictal] brand will have an adverseclinical outcome” (Generics bulletin, 20 May 2005, page 14). It added,however, that doctors could tailor prescriptions for specific patients. G

PRODUCT NEWS


EPILEPSY DRUGS

UK puts epilepsy riskinto three categories

Hospira has presented to US rheumatologists the results from twostudies conducted by its partner, Celltrion, to investigate the

safety and efficacy of the Inflectra/CT-P13 (infliximab) biosimilarversus the reference product, Janssen’s Remicade.

“The objective of these open-label extension studies was to confirmlong-term efficacy and safety of Inflectra in patients who had completedthe original 54-week European Union (EU) clinical studies, and toinvestigate switching from the reference Remicade product to Inflectra,”stated the US firm. Hospira and Celltrion recently secured EuropeanCommission approval for CT-P13 under the brand names Inflectraand Remsima (Generics bulletin, 20 September 2013, page 17). G

BIOSIMILARS

Hospira shares infliximab data

SAGENT said the antineoplastic agent carboplatin was the firstproduct made at its SCP facility in Chengdu, China, that the USinjectables specialist had launched in its home market. The oncologydrug comes in four preservative-free vial presentations.

SANDOZ has struck a deal with AstraZeneca to settle more than30 European disputes over the originator’s Nexium (esomeprazole)patents and the generics firm’s rivals to the ulcer treatment. “Theagreement resolves disputes in 20 countries,” AstraZeneca revealed.

IMPAX intends soon to launch its first-to-file generic rival to Fougera’sSolaraze (diclofenac) 3% gel after its development partner for thedrug – dermatological specialist Tolmar – received final US Food andDrug Administration (FDA) approval. Generic Solaraze was oneof two pipeline topical drugs that Impax gained rights to market– alongside nine currently-approved and marketed topical genericdrugs – under an agreement struck with Tolmar last year (Genericsbulletin, 13 July 2012, page 13).

ACTAVIS has become the latest company to settle US paragraph IVpatent litigation over Forest’s Bystolic (nebivolol) tablets. As withForest’s earlier deals with Alkem, Amerigen, Glenmark, Hetero,Indchemie and Torrent, the settlement permits Actavis to launch on thelater of three months before US patent 6,545,040 expires – includingany extensions – or the date on which the generics company securesapproval for its abbreviated new drug application (ANDA).

DR REDDY’S and MYLAN have been sued separately in a Delawaredistrict court by Takeda and Teijin Pharma after the generics firmsfiled abbreviated new drug applications (ANDAs) containing paragraphIV certifications against the originators’ Uloric (febuxostat) brand.Stating that it expected to qualify for 180-day exclusivity upon finalUS Food and Drug Administration (FDA) approval, Mylan noted thatthe brand had annual US sales of around US$261 million, accordingto IMS Health data.

ALVOGEN has acquired from Shionogi exclusive rights to marketNaprelan (naproxen sodium) 375mg, 500mg and 750mg controlled-release tablets in the US through its Almatica Pharma subsidiary. Ina separate transaction, Alvogen has acquired all rights and intereststo the Naprelan new drug application (NDA) from Stat-Trade. Nofinancial details were disclosed. Citing IMS Health data, Alvogen saidthe Naprelan analgesic achieved US sales of US$58 million last year.

WOCKHARDT has been sued by Otsuka for allegedly infringing USpatent 6,977,257, which protects the Japanese originator’s Abilify(aripiprazole) solution until 24 October 2022, including a six-monthpaediatric extension. Otsuka filed the suit in a New Jersey district court.

CENTRAFARM has introduced levocetirizine 5mg coated tabletsin the Netherlands. The Stada subsidiary is offering the allergy drugin blister packs of 30 tablets.

ACTAVIS has been sued by Ranbaxy in a New Jersey district courtafter the former filed an abbreviated new drug application (ANDA)for an equivalent to Ranbaxy’s Absorica (isotretinoin) 10mg, 20mg,30mg and 40mg capsules. Actavis believes it may be entitled to 180-day exclusivity as a first applicant to file a paragraph IV challengeto US patent 8,367,102, which expires on 21 September 2021. Bysuing, Ranbaxy has secured a 30-month stay on final approval forActavis’ ANDA, unless there is an earlier court decision. Actavissaid the Absorica acne treatment had US sales of US$97 millionin the year ended September 2013. G

IN BRIEF


An attempt by an Indian company to obtain a compulsory licenceenabling it to supply a generic version of Bristol-Myers Squibb’s

(BMS’) Sprycel (dasatinib) leukaemia drug has failed.Chaitanya Prasad, controller-general at Mumbai’s patent office,

turned down BDR Pharmaceuticals’ application on the grounds that theIndian firm had not made a sufficient effort to negotiate a voluntarylicence to Indian patent 203,937 “on reasonable terms and conditions”.

Noting that BDR had written to BMS on 4 February 2012, but notresponded to the originator’s reply – dated 13 March 2012 – that hadsought additional information, Prasad said BDR’s actions “cannot betermed as an ‘effort’”. “It is natural that the patentee may seek additionalinformation from the requesting party,” the controller-general added.

Oncology specialist BDR had submitted evidence that BMS’Sprycel worked out at Rs165,680 (US$2,651) for a month’s courseof 60 tablets, based on a price per tablet of Rs2,761. The Indian firmplanned to make its version available at Rs135 per tablet, or Rs8,100for a month’s treatment, a discount to the original of 95%. Furthermore,BDR offered to pay BMS a royalty set by the controller-general. G

PRODUCT NEWS


ONCOLOGY DRUGS

India denies licencefor generic dasatinib

Teva has petitioned the US Supreme Court to stay a Court of Appealsruling that paved the way for generic competition to the Israeli

group’s Copaxone (glatiramer acetate) blockbuster from May next year.Teva is seeking the stay while it prepares a formal application, orwrit of certiorari, for the Supreme Court to take on the case.

Earlier this year, the Court of Appeals upheld a lower court’s findingthat Teva’s US patent 5,800,808, which expires on 1 September 2015,was invalid due to ambiguities over the term ‘molecular weight’(Generics bulletin, 9 August 2013, page 1). Several valid US patentsprotect the multiple sclerosis brand until 24 May 2014.

In late October, the Court of Appeals rejected Teva’s petition fora panel rehearing or rehearing en banc, forcing the Israeli group toturn to the Supreme Court for relief.

Companies including Mylan – through an alliance with India’sNatco – Sandoz and its partner Momenta, and Synthon have filedabbreviated new drug applications (ANDAs) for rivals to Copaxone.But Teva – which is pursuing a lifecycle strategy through a three-timesper week formulation – contends that, “given the inability of even themost state-of-the-art analytical techniques to fully characterise activeingredients of Copaxone, as well as published results showing significantdifferences in gene expression between Copaxone and purportedgeneric versions, the regulatory pathway for their approval is uncertain”.

Mylan’s president, Rajiv Malik, recently said the firm was preparingto launch a US generic rival to Teva’s Copaxone (glatiramer acetate)blockbuster in May next year. “With intellectual-property hurdleslargely behind us,” he stated, “we have already produced the requisitequantity of active pharmaceutical ingredient (API) from a US Foodand Drug Administration (FDA) approved facility, and are now inthe process of building up our finished-product launch quantities.”During Mylan’s discussions with the FDA over its ANDA, “clinicaltrials have never been on the table”, Malik added.

Momenta said the FDA had acknowledged it was aware of the patentexpiry in May 2014, and added that it would be prepared to launch its‘M356’ANDA through its marketing partner, Sandoz, at that time. G

MULTIPLE SCLEROSIS DRUGS

Teva seeks a stay inUS Copaxone suit

Six generics firms – Dr Reddy’s, Kremers Urban, Lupin, Mylan, Tevaand Torrent – have received approval from the US Food and Drug

Administration (FDA) for the first generic rivals to Eisai’s Aciphex(rabeprazole sodium) 20mg delayed-release tablets. A paediatricextension to the only patent listed against the acid-reflux treatment inthe FDA’s Orange Book – US patent 5,045,552 – ended on 8 November.

Citing IMS Health data, Lupin – which launched immediately –said the drug had achieved sales of US$864 million in the year endedJune 2013. Having also entered the market, Mylan put US Aciphexsales at US$830 million in the year ended September 2013. G

GASTROINTESTINAL DRUGS

Six first with US rabeprazole

Dr Reddy’s will introduce fondaparinux in Canada “in the comingmonths”, according to the Indian firm’s development partner,

Alchemia. Earlier this year, Reddy’s obtained a notice of compliance(NOC), or marketing authorisation, from Health Canada forfondaparinux 2.5mg, 5mg, 7.5mg and 10mg syringes that are equivalentto GlaxoSmithKline’s Arixtra anticoagulant. Alchemia said the approvalsfor these strengths were “sufficient to address the whole fondaparinuxmarket in Canada”, which was worth around US$3 million last year.

Reddy’s and Alchemia already collaborate to offer a rival to Arixtrain the US (Generics bulletin, 5 August 2011, page 15). But in Europe,the Australian developer noted, Reddy’s had “decided to conductadditional technical work and re-submit its application based onfeedback from European regulators”. Approval in the EuropeanUnion (EU) was likely in late-2014 or in 2015, Alchemia believed.

Furthermore, the Australian company revealed, Reddy’s had filedgeneric applications for the injectable drug with local regulators “intwo additional emerging markets”. G

ANTICOAGULANTS

Reddy’s plans Canadian launchTender contracts for pantoprazole and fluoxetine have been awarded

to Actavis by New Zealand’s pharmaceutical management agency,Pharmac. The generics firm has been awarded a sole-supply deal for100-tablet packs of pantoprazole 20mg and 40mg tablets, with subsidiesof NZ$2.68 (US$2.22) and NZ$3.54 respectively. Actavis’ tablets willbe listed from 1 March 2014, while the currently reimbursed products– supplied by Dr Reddy’s – will adopt the same reference prices from1 May 2014, and will be delisted from reimbursement on 1 August 2014.

Meanwhile, Actavis’ fluoxetine – which will be reimbursed atNZ$1.74 for a 90-count pack of 20mg tablets and NZ$2.50 for 30orodispersible 20mg tablets – will replace Mylan’s Fluox. Actavis’products will be listed from 1 February 2014, with Mylan’s versionmatching the reference prices from April and being delisted in July.

Hospital supply deals have also been awarded to Actavis for thesame products. The firm’s fluoxetine will be listed from 1 February,while pantoprazole will be listed from 1 March 2014. Dr Reddy’s andMylan will see their versions delisted two months later in both cases. G

GASTROINTESTINAL DRUGS/ANTIDEPRESSANTS

Actavis wins Pharmac tender


November brings the expiry of supplementary protection certificates(SPCs) for Bristol-Myers Squibb’s (BMS’) blockbuster antiretroviral

agent Sustiva (efavirenz) in several major markets across Europe. Whilethe durations of SPCs obtained in Austria, Belgium, Denmark, Finland,France and Germany – as well as in Greece, Ireland, Italy, Norway,Portugal, Slovenia, Sweden and the UK – were based on a Swissmarketing authorisation for Sustiva, a Spanish SPC was obtained usingthe later European Union (EU) first marketing authorisation date, andwill therefore run until May 2014.

Patent-intelligence expert GenericsWeb notes that while efavirenzis one of the active ingredients in BMS’ fixed-dose combination Atripla– along with emtricitabine and tenofovir – additional SPCs linked tothe basic patent EP0,582,455 protect Atripla until August 2018.

In mid-November, SPCs expire in Greece and Portugal for Roche’sRituxan/MabThera (rituximab) monoclonal antibody (see Figure 1).These SPCs were granted with a zero term, meaning that they did notconfer any extra protection beyond the basic patent on which theyrelied, but they opened the door for a six-month paediatric extension.

“However,” GenericsWeb observes, “it does not appear thatRoche has finished paediatric compliance checks, so the SPCs areunlikely to be extended.”

In Austria, Belgium, Denmark, Germany, Hungary, Ireland, Italyand the UK, pending SPC applications for rituximab never enteredinto force, while similar applications were rejected in the Netherlands,Spain and Sweden. A negative-term SPC granted in Switzerlandexpired in November 2012, before the November 2013 expiry ofthe basic patent. Several companies are currently conducting clinicaltrials for biosimilar versions of Roche’s blockbuster brand.

In terms of data exclusivity (see Figure 2), November brings theexpiry of six-year protection in Canada for drugs including anidulafungin,duloxetine and raltegravir. However, generics firms will not be able tosecure notices of compliance (NOCs), or marketing authorisations, forthese molecules for another two-and-a-half years, due to a two-yearmarketing exclusivity and a six-month paediatric extension. Under thedraft terms of a comprehensive economic and trade agreement (CETA)reached with the European Union, Canada looks set to offer two-yearpatent extensions (Generics bulletin, 1 November 2013, page 1).

Among future generic-development targets (see Figure 3), theapproval of Fuki Yakuhin and Sanwa Kagaku Kenkyusho’s gout drugTopiloric/Uriadec (topiroxostat) by Japan’s Pharmaceuticals and MedicalDevice Agency (PMDA) on 28 June 2013 has led to the filing of nationalpatent-term extensions in Japan. G

PIPELINE WATCH


Want more? This data is extracted from the monthly update for Pipeline Scope, an online intelligence tool that provides fastaccess to reliable information on key patent, SPC and data-protection expiries, covering 44 countries and over 1,500 INNs.

For further information, visit www.genericsweb.com, or contact:Europe: +44 870 879 0081 North America: +1 704 665 1986

Or e-mail: [email protected]

Sustiva and Rituxan lose SPC protection

INN Country

Capecitabine Greece, Spain, Sweden

Efavirenz Austria, Belgium, Denmark, Finland,France, Germany, Greece, Ireland, Italy,Norway, Portugal, Slovenia, Sweden,Switzerland, UK

Hepatitis C antigen Italy

Rituximab Austria*, Belgium*, Denmark*,Germany*, Greece, Hungary*,Ireland*, Italy*, Portugal, UK*

Rotavirus vaccine Austria, Belgium, France, Germany,Italy, Luxembourg, Netherlands,Spain, Sweden, UK

* indicates that the SPC remained an application at expiry, so never entered into force

Figure 1: Molecules for which supplementary protection certificates (SPCs)expire in certain markets during November 2013 (Source – GenericsWeb)

SPC expiries in NovemberINN Country/Region

Aliskiren Canada*Ambrisentan AustraliaAnidulafungin Canada*Aprepitant European UnionDabigatran AustraliaDocosanol Belgium, France, Germany, Italy,

Luxembourg, Netherlands,Sweden, UK

Duloxetine Canada*Eltrombopag USInsulin detemir SwitzerlandMetformin/sitagliptin AustraliaMetformin/vildagliptin TurkeyMethyl aminolevulinic acid SwitzerlandNesiritide Canada*Nilotinib TurkeyRaltegravir Canada*Rivaroxaban AustraliaRufinamide USSugammadex AustraliaTapentadol USTemsirolimus TurkeyTulathromycin European Union

* This will be followed by a no-marketing period of two years during which a notice ofcompliance will not be granted to a generic manufacturer. In addition, a further sixmonths of data protection will be added to the eight-year term for studies of rotavirusvaccine in paediatric populations.

Data exclusivity expiries in November

Figure 2: Molecules for which data exclusivity expires in certain markets duringNovember 2013 (Source – GenericsWeb)

INN Event

Efinaconazole First Canadian patents listed in PatentRegister following Health Canada approvalof Jublia on 2 October 2013

Topiroxostat First extension applications published inJapan following the approval of Topiloric/Uriadec on 28 June 2013

Molecules in the spotlight

Figure 3: Molecules in the spotlight, based on recent regulatory or litigationevents (Source – GenericsWeb)


Accord Healthcare and Sandoz have persuaded a Court of Appealin Barcelona, Spain, that a formulation patent protecting

AstraZeneca’s Seroquel Prolong (quetiapine) extended-release tabletsis invalid due to a lack of inventive step and obviousness.

The Court of Appeal’s decision – against which AstraZeneca intendsto appeal – reverses a ruling handed down in July last year by aBarcelona Commercial Court that Spanish patent ES2,182,079 – thelocal counterpart to European patent EP0,907,364 – was valid.

Adopting a ‘problem and solution’ approach to determiningobviousness, a panel of three appeals judges noted that AstraZenecahad marketed immediate-release quetiapine in Spain since 2000,protected by the prior-art molecule patent EP0,240,228 and its Spanishcounterpart, ES2,019,379. The Seroquel Prolong extended-releasetablets followed in 2008.

Motivation to create extended-release formThe appeals judges accepted the argument brought by Accord and

Sandoz that the technical problem to be solved was precisely thatcovered by the Spanish ‘079 patent – creating an extended-releaseformulation of quetiapine. In light of prior-art references, they said, askilled person would have had a motivation to develop an extended-release formulation, and would not have faced major obstacles, asAstraZeneca had contended. Therefore, the patent must be revoked.

Accord – which was represented by Barcelona-based law firmGrau & Angulo – noted the commercial success of extended-releaseSeroquel antidepressants. In the first nine months of this year, AstraZenecaposted global Seroquel XR sales totalling US$1.00 billion. Of that,US$549 million was generated in the US – where an equivalent patentsurvived challenges (Generics bulletin, 8 March 2013, page 17) –US$312 million in Europe, and US$139 million elsewhere.

A fall of a fifth in European Seroquel XR sales came after thebrand faced generic competition in Austria, Denmark, Germany, Italy,Portugal, Romania and the UK (Generics bulletin, 3 May 2013, page21). In Canada – where Teva earlier this year launched ‘at risk’ after acourt refused to prohibit the generics firm from securing a notice ofcompliance, or marketing authorisation (Generics bulletin, 22 March2013, page 17) – AstraZeneca recently reached a patent-litigationsettlement with Sandoz that includes rights to launch a generic. G

PRODUCT NEWS


ANTIDEPRESSANTS

Accord and Sandozbeat Spanish patent

Mylan is “years ahead” of its rivals in developing a US genericversion of GlaxoSmithKline’s Advair (fluticasone/salmeterol)

respiratory drug, according to the US company’s chief executive officerHeather Bresch. Mylan is currently conducting a pharmacokineticstudy and expects to file with the US Food and Drug Administration(FDA) for a fully substitutable version during the first half of 2015,with a launch scheduled for the second half of 2016 (Genericsbulletin, 9 August 2013, page 23).

“Recent developments and competitors’ commentaries furthersupport our optimism that we will be the first into this market in 2016,”stated Mylan’s president, Rajiv Malik. The development guidelinesissued by the FDA in September were “right in line” with the firm’sexpectations, he added (Generics bulletin, 20 September 2013, page 1).

An FDA representative recently told the US GenericPharmaceutical Association’s (GPhA’s) Fall Technical Conferencethat the agency was taking the unusual step of meeting face-to-facewith abbreviated new drug application (ANDA) filers for fluticasone/salmeterol. These meetings, he said, would enable the agency to tackleissues around the combination’s complexity and its delivery device,with the aim of meeting a 10-month review cycle.

Malik revealed that Mylan had held a follow-up meeting with theFDA after the agency issued its guidelines in September. “We continueto believe that we have a clear head start,” he stated, while agreeingwith GlaxoSmithKline’s contention that ANDA developers facedsignificant manufacturing-related barriers. “We believe we are bestpositioned in this area,” Malik added.

Teva recently told investors it was “highly unlikely” that asubstitutable rival to Advair would reach the US market before 2018(Generics bulletin, 18 October 2013, page 17). The Israeli firm plans tofile its own fluticasone/salmeterol ANDA – based on “an internallydeveloped blister-based device” – in 2017.

Actavis Pharma’s president, Siggi Olafsson, also recently predictedthat generic Advair would reach the US market in 2018, based on theFDA current average ANDA review time of 33 months. If review cyclesbecame shorter as user-fee legislation was implemented, genericcompetition in 2016 might be possible, he added (Generics bulletin,1 November 2013, page 3).

“My overall opinion is that at least three companies are at a similarplace in the development of generic Advair,” Olafsson stated. Actaviswas “currently working on the pharmacokinetic parameters of ourdevice” before moving into Phase III clinical trials, he revealed. G

RESPIRATORY DRUGS

Mylan ‘years ahead’on Advair alternative

Celltrion has reported positive results from a Phase I trial for its‘CT-P10’ candidate for a biosimilar rival to Roche’s Rituxan/

MabThera (rituximab). “The safety profile for CT-P10 and rituximabwere comparable in all categories,” the South Korean companyannounced, noting that the 24-week trial had taken place in 38 hospitalsacross eight countries and had included 150 patients.

Development of CT-P10 was “going very smoothly”, Celltrion said,indicating that it was “preparing for global Phase III clinical trials”.Earlier this year, the South Korean company had “prematurely ended”a Phase III clinical trial for the product in Greece, Hungary andSpain, according to the European Union (EU) clinical trials register(Generics bulletin, 3 May 2013, page 19). G

BIOSIMILARS

Celltrion has rituximab results

Dr Reddy’s Laboratories has expanded its range of cardiovasculartherapies in the UK by launching Molita (dipyridamole/aspirin)

modified-release capsules.The 200mg/25mg hard capsules are equivalent to Boehringer

Ingelheim’s Asasantin Retard treatment for secondary preventionof ischaemic stroke and transient ischaemic attacks. But unlike theoriginator – whose product comes in 60-capsule packs – Dr Reddy’s isoffering its branded generic in packs of 100 capsules. The UK firmalready offers dipyridamole 25mg and 100mg tablets. G

CARDIOVASCULAR DRUGS

Reddy’s UK rolls out Molita


EVENTS


22 January

■ 7th EGA PharmacovigilanceDiscussion ForumLondon, UKThis European Generic medicinesAssociation (EGA) event will take theform of a discussion forum and look attopics including legislation and risk-management plans.

Contact: Cristina Romagnoli, GPA Conferences.Tel: +377 93 501 348.E-mail: [email protected] at www.gpaconferences.com/phvrac.htm.

23-24 January

■ 13th EGA Regulatory &Scientific Affairs ConferenceLondon, UKThis two-day conference will follow theEGA’s Pharmacovigilance Forum. Theevent will look at regulatory topics,generic medicines development andbioequivalence, and electronicsubmissions. Both meetings are to beheld at the same venue in London.

Contact: Cristina Romagnoli, GPA Conferences.Tel: +377 93 501 348.E-mail: [email protected] at www.gpaconferences.com/phvrac.htm.

23-24 January

■ IP Counsel Exchange forBiosimilar Applicants &SponsorsNew York, USALooking at effective strategies when dealingwith litigation, alliances and collaborations,and global challenges and risks, this two-day event is designed to provide a forumfor IP counsel dealing with biosimilars,biologics and biobetter products.

Contact: Momentum Event Group.Tel: +1 646 807 8555.E-mail: [email protected]: www.momentumevents.com.

6-7 February

■ 6th PharmeetMarrakech, MoroccoThis two-day event is designed to offerdelegates the opportunity to network aswell as the chance to strike licensingdeals for a wide range of products,including biosimilars.

Contact: PharMeet.Tel: +34 91 637 0660.E-mail: [email protected]: www.pharmeet.com.

19-21 February

■ GPhA 2014 Annual MeetingOrlando, USAThis three-day meeting of the US GenericPharmaceutical Association (GPhA) willlook at regulatory issues and the challengesand opportunities for the generics industry.There will also be networking opportunities.

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

18-19 March

■ 10th EGA LegalAffairs ForumBrussels, BelgiumThis two-day EGA event will look atissues including intellectual property,litigation, regulatory matters, patentsettlements and the European unifiedpatent court. The forum will also offernetworking opportunites.

Contact: Cristina Romagnoli, GPA Conferences.Tel: +377 93 501 348.E-mail: [email protected] online at www.gpaconferences.com.

24-27 March

■ BDP WeekSan Diego, USAConference tracks at this four-day eventwill include viral safety, contractmanufacturing and technology transfer,manufacturing efficiencies and rawmaterials/supply chain. There will be casestudies and networking opportunities.

Contact: IBC USA.Tel: +1 941 554 3500.E-mail: [email protected]: www.ibclifesciences.com/BDPWeek.

25-27 March

■ DIA 26th Annual EuroMeetingVienna, AustriaIssues covered at this three-day meeting ofthe Drug Information Association (DIA)will include clinical research, regulatory

topics, active substances, drug developmentand globalisation.

Contact: DIA.Tel: +41 61 225 5151.E-mail: [email protected]: www.diaeurope.org.

31 March – 1 April

■ EuroPLX 54Lisbon, PortugalThis event provides a forum for businessdevelopment decision makers to discuss andnegotiate collaborative agreements in licensing,marketing and distribution of patentedmedicines, generics, biosimilars, OTC products,medical devices and food supplements.

Contact: Raucon.Tel: +49 6222 9807 0.E-mail: [email protected]: www.europlx.com.

1-4 April

■ World Generic MedicinesCongress Europe 2014London, UKThis four-day conference will be co-locatedwith the Biosimilar Drug Development event.The event will look at topics includingintellectual-property developments, and willprovide global policy updates.

Contact: Health Network Communications.Tel: +44 207 608 7055.E-mail: [email protected]: www.healthnetworkcommunications.com.

3-4 April

■ 12th EGA InternationalBiosimilar MedicinesConferenceLondon, UKThis meeting, organised by the EGA, willlook at industry developments andregulatory issues for biosimilars.

Contact: Cristina Romagnoli, GPA Conferences.Tel: +377 93 501 348.E-mail: [email protected] online at www.gpaconferences.com.

9-11 December 2013

■ 16th IGPA Annual ConferenceBrussels, BelgiumThis three-day conference is being organised by the European Genericmedicines Association (EGA) and is the global event of the worldwide generics industry.It is the annual joint meeting of the Canadian, European, Japanese, South African and USgenerics industry associations, the CGPA, EGA, JGA, NAPM and GPhA. Topics to becovered at this year’s conference will include market trends and regulatory developments

Contact: Cristina Romagnoli, GPA Conferences. Tel: +377 93 501 348. E-mail: [email protected]: www.igpagenerics.com or www.gpaconferences.com/igpa13.htm.

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Figure 4: Price changes for 100-capsule packs of gabapentin 400mg, showingwhen NCSO and price concessions were granted (Source – WaveData)


Long-term product price trends or other price analyses are available.

Please specify the product and period of time you would like toinvestigate and email your request to [email protected].

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

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Figure 1: Recent changes in the trade and Drug Tariff prices for 100-capsule packsof gabapentin 300mg, showing the latest price concessions (Source – WaveData)

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Gabapentin prices have proved more difficult than most for the UKDepartment of Health to track in recent years within category M

of the Drug Tariff of pharmacy reimbursement prices. Fluctuationsin gabapentin’s trade prices have meant that its category M prices –based on actual historical trade prices and including a dispensing margin– have not always been sufficiently responsive to rapid price movements.

This has resulted in gabapentin making periodic flirtations withthe Department’s monthly ‘no cheaper stock obtainable’ (NCSO)concessions, which are brought into play when quarterly DrugTariff prices become out of step with actual trade prices. Theseconcessions are negotiated each month by the Pharmaceutical ServicesNegotiating Committee (PSNC) and only apply for the month in whichthey have been granted. At the end of last month, gabapentin 100mgand 300mg capsules were granted price concessions of £2.69 and £5.92(US$4.33 and US$9.52). These were markedly less than average tradeprices of £3.12 and £8.46, according to WaveData.

The PNSC commented that it had applied for a concession early inthe month. “After considerable pressing and numerous exchanges withthe Department,” it stated, “we were unable to reach an agreementas to what would represent a reasonable price for gabapentin and sothe Department decided to set a price that we believe is too low.”

According to the PSNC, the Department had “conveyed itsdecision” with the remark that it used “up-to-date price and volumedata from a range of suppliers”. According to the PSNC, the Departmentcontinued: “This data does indicate that stock is available at a widerange of prices for gabapentin, and we acknowledge that some is quitehigh when compared to the proposed concession prices. It also showsthat the majority of stock on the market is available at or below theproposed price from multiple suppliers. As a result, on the data availableto us, we cannot justify setting the price higher.” Recent price movementsand concessions for gabapentin 300mg are shown in Figure 1.

Noting that pharmacies in England were guaranteed annually “atleast £500 million of purchase profit income”, the PSNC said that itsaim was to “minimise the risk of dispensing at a loss and equaliseaccess to the agreed purchase margin”. It added, however, “the currentsystems make it impossible to guarantee this in all cases”. It wasworking with the Department “to try to agree new systems to deal withproducts in short supply” (Generics bulletin, 12 July, page 9).

Warwick Smith, director general of the British GenericManufacturers Association (BGMA), insists that price rises must notbe confused with product shortages and that what has happened toprices was envisaged when category M was introduced in April 2005.The NCSO system, he believes, distorts what was meant to be a freemarket in which prices could go up as well as down.

Looking back at gabapentin prices (Figures 2, 3 and 4), CharlesJoynson, managing director of WaveData, notes that capsule pricesappear to observe a three-year cycle “which seems about to repeatitself”. He also notes that back in 2010/2011, the Department preferredmonthly NCSO concessions – when pharmacists were allowed tosubstitute an original brand and were reimbursed accordingly – butmore recently has opted for fixed price concessions. G

Pharmacists object to official concessions

Gen 15/11/13 Pg.25b_Layout 1 12/11/2013 21:04 Page 3

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Glenmark has appointed Philip Gioia to become president of theIndian company’s North America operation and of its global active

pharmaceutical ingredient (API) business from 25 November. Based inMahwah, New Jersey, Gioia will report directly to Glenmark’s chairmanand managing director, Glenn Saldanha.

Gioia replaces Terrance Coughlin, who had led the firm’sGlenmark Generics business as president and chief executive officerfor the previous nine years, during what the firm called a “criticalgrowth phase”. Under Coughlin’s tenure, Saldanha noted, “the companymade considerable strategic advancements, including diversifying itsproduct line and building out its operational and distribution platform”.

Noting that Gioia had “over 25 years of experience in the USpharmaceutical industry, both in the generics and the branded space”,Glenmark said his new role would give him responsibility for both thegenerics and branded business across North America, as well as globalAPI sales and marketing. Gioia previously served as Bausch & Lomb’sglobal head of diversified products and business development, beforewhich he led the firm’s North America pharmaceutical unit. Prior tojoining Bausch & Lomb, he worked at Barr for 13 years. G

PEOPLE


APPOINTMENTS

Gioia is Glenmark’sNorth America head

Dexcel Pharma has appointed Henning Hoffmeyer to replaceMathias Pietras as managing director of the Israeli firm’s business

in Germany. Hoffmeyer – who previously held a business-developmentrole with Germany’s Axicorp – would “steer Dexcel Pharma’s publictendering activities and strengthen the company’s efforts to diversifyits German operation”, Dexcel said.

Meanwhile, Pietras has become managing director of Germany’sHormosan Pharma, the central nervous system specialist acquired byLupin in 2008 (Generics bulletin, 1 September 2008, page 3). Hehad led Dexcel’s German operations since 2010, having previouslyserved as head of sales and marketing at Canadian biotech firm AeternaZentaris (Generics bulletin, 1 October 2010, page 23).

Earlier this year, Dexcel’s senior director of business developmentand licensing, Oren Weininger, left the company after eight yearswith the Israeli firm (Generics bulletin, 6 September 2013, page 31).He had previously been responsible for the firm’s German operations. G

APPOINTMENTS

Dexcel replaces German chief

Alliance Boots and Walgreens have appointed Walgreens’ vice-president of corporate operations in the western US, Richard

Ashworth, to act as director of healthcare for Alliance Boots’ healthand beauty unit in the UK and the Republic of Ireland (ROI). Ashworthwill report to the group’s managing director for health and beautyin the UK and Ireland, Simon Roberts.

Ashworth would contribute his “extensive leadership and knowledgein healthcare and work in close collaboration with the experienced teamsin both countries to lead the development and delivery of the Bootshealthcare offer for customers in the UK and Ireland”, the firms said. G

APPOINTMENTS

Boots names director in UK

CHMP – the European Medicines Agency’s (EMA’s) committee forhuman medicinal products – has elected Pierre Demolis as its newvice-chair for a three-year mandate. Demolis has been a memberof the CHMP since 2007.

AMGEN has increased its board of directors to 13 members followingthe appointment of Greg Garland, president and chief executiveofficer of manufacturing and logistics firm Phillips 66. “At a timewhen Amgen is expanding its global presence to serve more patients,we look forward to Greg’s contributions to the board,” said Amgen’schief executive officer, Robert Bradway.

OSMOTICA PHARMACEUTICAL has named Kenneth Gayron asits chief financial officer. He will also serve as a member of thedrug-delivery specialist’s executive leadership team. Osmoticarecently named Gene Wright as vice-president and head of globalclinical development (Generics bulletin, 20 September 2013, page 27).

MEDAC has appointed InterMune’s former vice-president of sales,Terri Shoemaker, as president and chief executive officer of itsMedac Pharma US subsidiary. Shoemaker, who has over 25 yearsbiotech and pharmaceutical industry experience, also co-foundedstrategic guidance firm BioPharm Strategic Solutions. Under herleadership, privately-held Medac said it planned to focus onautoimmune diseases and oncology.

AESICA has named Baali Muganga as its east-coast business-development manager in the US, with responsibility for expandingthe firm’s contract-development and pharmaceuticals manufacturingoperations. “Specifically, Muganga will be responsible for targettingsmall- to medium-sized life science and pharmaceutical companiesrequiring product development and manufacturing support,” Aesicasaid in a statement, noting that Muganga had previously heldpositions at Reata Pharmaceuticals and AstraZeneca. Meanwhile,Julius Lodato has been made director of finance and administration.

PERRIGO has promoted Kelly Sledge to become sales and marketingproject manager at its US-based Sergeant’s Pet Care Productsoperation in Omaha, Nebraska.

McKESSON has appointed James Beer as its vice-president andchief financial officer. He replaces Jeff Campbell, who departedthe firm in June to become chief financial officer at American Express.Beer, who was previously chief financial officer at SymantecCorporation, joins the firm as it takes control of European wholesalingand pharmacy retailing group Celesio in a deal valued at US$8.3billion (Generics bulletin, 1 November 2013, page 3).

ELDER PHARMACEUTICALS’ board of directors has named AlokSaxena as the firm’s managing director and chief executive officerfor five years, subject to shareholder approval.

CELESIO has promoted Markus Georgi to become director of thefirm’s investor relations. Before taking up his former role as head ofgroup investor relations in April 2012, Georgi had previous experiencein a similar role at CompuGroup Medical AG and also worked ashead of equity capital markets at Deutsche Telekom. Celsio’s formerdirector of investor relations, Sabine Göttgens, has left the company.

VENNER SHIPLEY has added Colm Murphy and Anwar Gilani tothe law firm’s Chemical and Life Sciences group. Murphy is a partnerwith the firm and joins Venner Shipley’s London team, while Gilaniis a senior associate and joins the firm’s Cambridge office. G

IN BRIEF

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