COMPANY NEWS EMA gives backing to biosimilars of Forsteo · 2018-11-20 · market-share gains of high-value products, portfolio rationalisation and pipelineexecution”. Having completed

Biosimilar alternatives to Eli Lilly’s Forsteo (teriparatide) from both Gedeon Richterand Stada Arzneimittel were among the medicines recommended for approval by the

committee for human medicinal products (CHMP) within the European MedicinesAgency (EMA) during its November meeting.

The CHMP said the biosimilar teriparatide 20µg/80µl solutions for injection that Richterwill market under the Terrosa brand name and Stada under the Movymia label had “comparablequality, safety and efficacy” to Lilly’s Forsteo osteoporosis treatment.

Stada said it expected to receive approval for Movymia under the European Union’s (EU’s)centralised marketing-authorisation pathway in January next year. The European Commissiontypically acts upon the CHMP’s recommendations within 67 days.

The German group had in October 2014 signed a teriparatide licensing and sales agreementwith Richter-Helm BioTec, a joint venture between Hungary’s Richter and Germany’s Helm(Generics bulletin, 17 October 2014, page 23). The deal covered the EU and nine non-EUcountries. Richter – for which teriparatide marks its first CHMP positive opinion on abiosimilar – said the drug would be launched under both the Richter and Stada labels ingeographical Europe and the Commonwealth of Independent States (CIS).

“With the EU-wide launch of marketing planned to coincide with the expiration of thepatent at the beginning of 2019, Stada will report the resulting sales and make further licencepayments to Richter-Helm,” the German group stated. Lilly reported global third-quartersales of Forteo/Forsteo up by 12% to US$391 million, including US$207 million in the US,where the originator is enforcing against Teva six formulation and method-of-use patentswith expiry dates ranging from December 2018 to August 2019. G

18 November 2016

Eagle has biosimilars ambitions withArsia 3Perrigo committee to 3review generics unitSawai slashes sales and profit prospects 4Hikma cuts estimate of Generics turnover 4Cipla plots an inhaler filing 5by end of yearMeda lifts Mylan but pressures limit rise 5Belgium and Serbia stall sales at Stada 6Teva is relaxed over pricing issues in US 7Lupin advances with NorthAmerican rise 7Sun’s chief explains US metformin delay 8Wockhardt invests in its UK production 8Formulations sales rise by fifth at Ipca 9US momentum leads 10Aurobindo to growthUS and India growth gives Alkem a boost 11

MARKET NEWS 12

FDA rule will protect filings from petitions 12Agenda set by Trump as shares 12get a bumpLancet study offers advice to lift uptake13

PRODUCT NEWS 14

UK’s NHS exploring generic 14PReP optionCoherus plots a path for US pegfilgrastim 14Mylan and Mabion make rituximab pact 15Apotex tadalafil case 15is rejected on appealCHMP backs Mylan’s darunavir 17HIV tabletsAntibiotics needed for Haiti andYemen 18Cipla and Mylan will 19progress dolutegravirBiocad cleared for a Copaxone alternative19

REGULARS

Events – Our regular listing 18Price Watch UK – UK pricing trends14People – Teva appoints Stark 20as chief legal officer

COMPANY NEWS 3 EMA gives backing tobiosimilars of Forsteo

Teva’s attempt to buy its way into the Mexican generics through its US$2.3 billion takeoverof local player Rimsa has been “a failure”, chief executive officer Erez Vigodman admitted

to investors. “We believe over time we will be able to reach the targets that we set for ourselves[in Mexico], even if it will take us a number of years more than what was expected initially,”Vigodman commented, stressing the “need to learn deeply from what went wrong”.

At present, Teva and Rimsa’s former owners, the Espinosa brothers, are suing each otherin a New York court. The Israeli group claims that “systematic information manipulation” thatled to widespread product recalls was concealed during the due-diligence process. But theEspinosas have accused Teva of “a classic case of buyer’s remorse” after the Israeli firmrealised it had “substantially overpaid” (Generics bulletin, 7 October 2016, page 3).

“We did not disclose the situation in Rimsa earlier as we attempted to address the situationwith the local agencies and then negotiate a settlement with the seller,” Vigodman explained.“We have put in place a full remediation plan to address the issues identified.”

“We are committed to the Mexican market,” stated the head of Teva’s Global Genericsbusiness, Siggi Olafsson, “and we are working hard to leverage the assets from Rimsa as thebasis to drive our growth in the region.” Olafsson added that, due to the numerous recalls, Rimsahad made a “negligible” contribution to Teva’s third-quarter Global Generics sales that rose by32% to US$2.90 billion, including a two-month contribution from Actavis.

Actavis added US$887 million to group turnover that advanced by 15% to US$5.56 billion. Butthe group’s operating profit was dented by a US$520 million settlement provision (see page 7). G

Teva admits to Mexican failure

Issue No.285

Gen 18-11-16 Pg. 1_Gen 18/11/05 Pg. 1 16/11/2016 17:25 Page 1

W E U N D E R S T A N D T H E C O M P L E X I T YO F B I O S I M I L A R S .

S I M I L A R S A M E .

FOLLOW THE LEADER

Perrigo’s board of directors has formed a special subcommitteetogether with president and chief executive officer John Hendrickson

to evaluate “the market position and growth opportunities” for the firm’sPrescription US generics business. The strategic review is expected tobe completed in the first quarter of next year.

“I have had many conversations with investors over the last fewmonths about the future of our [Prescription] business,” Hendricksonrevealed. “And we continue to evaluate the business’ market dynamics,portfolio strategies, and long-range growth opportunities in order togenerate the best value.”

“Our strategic review of this segment requires an in-depth,comprehensive evaluation of the interdependencies within our business,”he noted. Areas including manufacturing, shared-service functions andtax deserved thoughtful consideration, Hendrickson added.

The Prescription evaluation falls under a larger, company-wide“strategic portfolio review” that Perrigo is on track to complete in thefirst quarter of 2017. “We have engaged a leading third-party consultingfirm to provide an outside perspective and evaluate our segments,market positions, growth opportunities and relative organisationalstructures,” Hendrickson commented.

Perrigo’s announcement came shortly after one of the firm’slargest shareholders, Starboard Value, advised Perrigo to divest its ‘non-core’ Prescription business and focus on its consumer healthcareoperations, “to reverse the trajectory of poor operating and financialperformance” (Generics bulletin, 16 September 2016, page 3).

Starboard had also suggested Perrigo divest its rights to royaltieson sales of Tysabri (natalizumab), which Perrigo has responded to byannouncing it would “review strategic alternatives” for its rights toroyalties from the multiple-sclerosis blockbuster.

Meanwhile, Perrigo plans by the end of this year to file an arbitralclaim against the sellers of Omega Pharma, after taking a US$1.68billion impairment charge in its financial third quarter ended 1 October2016 in conjunction with its acquisition of the Belgian firm.

Having tied-up a C3.8 billion (US$4.08 billion) agreement forOmega in March last year, the US firm was forced in its financialthird quarter to register a goodwill impairment charge of US$804million on top of a brand intangible assets charge of US$866 million,leading Perrigo to report an operating loss of US$1.52 billion.

Perrigo’s group turnover increased by 1% to US$1.35 billion, as“changes implemented in the [Prescription] segment”, led to salesincreasing by 3% to US$267 million (see Figure 1). “Our productivityimprovements in the quarter partially offset the effect of thecompetitive pricing environment,” Hendrickson commented. G

COMPANY NEWS

3GENERICS bulletin18 November 2016

BUSINESS STATEGY/THIRD-QUARTER RESULTS

Perrigo committee toreview generics unit

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

Consumer Healthcare 669.1 -1 +15.0Branded Consumer Healthcare 304.0 +1 -554.1Prescription 267.4 +3 +29.1Specialty Sciences 93.4 +10 +25.0Other 21.0 -7 –

Perrigo 1,354.9* +1 -111.8

* includes third quarter net sales of US$21.8 million from ‘held-for-sale’ businesses

Figure 1: Breakdown by business segment of Perrigo’s sales and operatingmargin in its financial third quarter ended 1 October 2016 (Source – Perrigo)

US injectables specialist Eagle Pharmaceuticals is set to foray intothe biosimilars arena and bolster its development capabilities after

signing a definitive agreement to acquire early-stage biotechnologycompany Arsia Therapeutics.

Founded by Massachusetts Institute of Technology professorsRobert Langer and Alexander Klibanov, in partnership with US investorPolaris Partners, Arsia will bring to Eagle a proprietary technologyplatform that “enables subcutaneous administration of high-dosebiologics through improved formulation”.

In addition to marking Eagle’s entry into biologic and biosimilardrugs, the proposed transaction will, according to the 505(b)(2) hybridproduct specialist, also allow Eagle to “apply its proven market strategyto offer ‘biobetter’ formulations, and to aid in the rapid developmentof novel biologics”.

Meanwhile, Langer and Klibanov, as well as “other key membersof the Arsia team”, have agreed to collaborate with Eagle to “developnew formulations and solve delivery challenges in the large moleculesspace”. Eagle also plans to establish a biologics innovation centrenear Arsia’s headquarters in Cambridge, Massachusetts.

Under the terms of its agreement for Arsia, Eagle has agreed topay approximately US$30 million upfront, split into a US$27.3 millioncash payment and US$2.7 million worth of Eagle common stock, aswell as up to US$48 million in certain undisclosed milestone payments.The transaction is expected to close imminently, subject to customaryclosing conditions.

“We are especially excited that Arsia’s founders are dedicated tocollaborating with Eagle, both as shareholders and researchers,”commented Scott Tarriff, Eagle’s president and chief executive officer.

“This collaboration extends beyond Arsia technology, withArsia’s team committed to helping us solve formulation challengesin areas we have yet to target.”

Significantly enhance Eagle’s capabilitiesCommenting on the deal, Tarriff said acquiring Arsia would

“significantly enhance Eagle’s formulation capabilities and greatlyexpand our product-development opportunities”.

“While large pharmaceutical companies around the world investheavily in biosimilars,” he noted, “Eagle’s and Arsia’s combined know-how and execution capabilities will allow us to improve upon thoseformulations to create biobetters, which we believe will be key toproduct differentiation, pricing power and larger market share.”

Arsia also, Tarriff pointed out, currently had several early-stagepartnerships with pharmaceutical companies.

“We plan to partner with key biosimilar companies to help altertheir existing pipelines into biobetters. This is a natural extension ofEagle’s business model, applied to the biologics space,” he observed.

Langer added that the technology developed by Arsia demonstrated“tremendous promise in solving a variety of fundamental pharmaceuticalchallenges in the delivery of high-dose biologics”.

As well as a non-alcohol docetaxel formula, argatroban, diclofenac/misoprostol and the firm’s Ryanodex (dantrolene), Eagle’sportfolio of hybrid injectables includes Bendeka (bendamustine), arapid-infusion alternative to Teva’s Treanda that the Israeli firmdistributes under the terms of a US$120 million deal signed last year.

Meanwhile, Eagle’s pipeline of in-development product includesa ready-to-use version of The Medicines Company’s Angiomax(bivalirudin) and a liquid alternative to Eli Lilly’s Alimta (pemetrexed). G

MERGERS & ACQUISITIONS

Eagle has biosimilarsambitions with Arsia

Gen 18-11-16 Pgs. 3-20_Layout 1 16/11/2016 17:24 Page 3

Market progress in Japan through measures to promote genericsthat has been “weaker than anticipated” has led local generics

specialist Sawai Pharmaceutical to cut its sales forecast for its financialyear ending in March 2017 by almost 6% to ¥134.5 billion (US$1.26billion), a reduction of ¥8.50 billion.

The Japanese firm has also reduced its full-year outlook foroperating profit by 6.0%, or by ¥1.50 billion, to ¥23.5 billion. Sawaiis now predicting that it will achieve only 1.4% operating profit growthon an 8.9% sales rise. “Market movements associated with measuresto promote generic drugs have been lower than the level anticipated,and we predict that it will be difficult to recover in the second half [ofthe financial year],” the company explained.

In the first half of its financial year that began in April 2016, Sawaisaid its sales had increased by “only 11.0%” to ¥65.4 billion due tothe relatively weak impact of pro-generic measures. During the April-September period, the firm’s operating profit declined by 2.1% to ¥11.4billion, reducing its operating margin by 2.3 percentage points to 17.4%.

Sawai attributed the weaker margin in part to increasing its researchand development spending – associated in part with developing productsfor the US market – by 41.6% to ¥4.82 billion, equivalent to 7.4% ofgroup turnover. Reduced reimbursement prices through Japan’s NationalHealth Insurance (NHI) system also dented profitability.

Drugs listed for NHI reimbursement in Sawai’s current financialyear contributed just ¥165 million, although the company is preparingfor listings in December for generic Kipres/Singulair (montelukast),Tracleer (bosentan), Co-Dio (valsartan/hydrochlorothiazide) andMirapex-LA (pramipexole) tablets. Products listed in the 2015-2016financial year added ¥2.44 billion to total turnover.

While the Japanese company continued to experience double-digitsales gains through dispensing pharmacies and drugstores, its growththrough hospitals and clinics slowed to low single-digit rates. Similarly,sales through wholesalers clearly outpaced agencies turnover. G

COMPANY NEWS

4 GENERICS bulletin 18 November 2016

18 November 2016 Issue 285

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

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RESULTS FORECAST/FIRST-HALF RESULTS

Sawai slashes salesand profit prospects

Hikma expects full-year sales for its US non-injectable Genericsbusiness to be around US$600 million in 2016, dropping from its

previous prediction in August of US$640-670 million. Driving volumegrowth for certain products in its portfolio since August had “beenmore challenging than initially expected”, the company admitted.

Forecasting 2017 Generics sales of around US$800 million, theJordanian firm said it would focus on “improving the sales mix throughmarket-share gains of high-value products, portfolio rationalisationand pipeline execution”.

Having completed its acquisition of Boehringer Ingelheim’sRoxane US business at the end of February (Generics bulletin, 4March 2016, page 6), Hikma said that although sales were “rampingup more slowly than originally anticipated”, it remained “highlyconfident in the future prospects of the business”.

Hikma estimated its group full-year sales to grow by approximately35% in constant currencies to around US$2 billion in 2016, despiteBranded sales being impacted by currency headwinds. Remaining“on track” to deliver global Injectables growth in the “mid to high-single digits” in 2016, the firm said it was “benefitting from theinvestments we have made across our geographies to broaden ourportfolio and strengthen our manufacturing capabilities”.

Slow “wrap-up” of products going to market was due to Hikma“adjusting capacity in manufacturing sites”, and “optimising” itsportfolio, including discontinuing some products.

Having “invested heavily in the US”, Hikma said it was lookingfor opportunities in emerging markets and potential acquisitions. “Bycontinuing to leverage our operations in the Middle East and NorthAfrica (MENA) region, expanding our portfolio of global Injectablesproducts and integrating the West-Ward Columbus [Roxane] businessinto our US operations,” commented Said Darwazah, Hikma’s chairmanand chief executive officer, “we are increasingly well-positioned tocapture a range of attractive future growth opportunities.” G

RESULTS FORECAST

Hikma cuts estimateof Generics turnover


Cipla intends to make its first US filing for a metered-dose inhaler(MDI) by the end of 2016. The Indian company sees submissions

for respiratory and oncology drugs as key to expanding its portfolioof differentiated generics in the US market.

While Cipla plans to target “most respiratory therapies in the US”, itacknowledges that it is unlikely to be among the initial wave of playersfor major products such as generic Advair (fluticasone/salmeterol).

Noting Sandoz’ recently-filed Advair citizen petition highlightingthe potential for pharmacokinetic batch-to-batch variability (Genericsbulletin, 28 October 2016, page 14), Cipla’s managing director andglobal chief executive officer, Umang Vohra, stressed the importanceof not only making a high-quality regulatory submission, but also beingable to sustain manufacturing standards for respiratory drugs.

“We do not expect there to be more than four to five players inthis field on a sustainable basis,” he told investors.

Vohra said developing a respiratory portfolio formed part of Cipla’sstrategy to build a differentiated US portfolio that also includedoncology drugs such as generic Abraxane (paclitaxel) using nanoparticletechnology. This “technologically complex” cancer therapy was among12 abbreviated new drug applications (ANDAs) that Cipla submittedduring the six months ended September 2016.

“Of the 12 ANDAs filed, seven were paragraph IV patentchallenges, with a couple of them being first-to-file,” Cipla revealed.

With the integration of InvaGen and Exelan “running smoothlyand label transition nearing completion”, Cipla has 131 ANDAs withfinal approval – including 50 from InvaGen – and 59 pending approval.

North American sales in Cipla’s financial second quarter ended30 September 2016 grew by 38% to Rs6.60 billion (US$100million) following six product launches during the quarter.

A first-to-market launch of Crifos (fosfomycin) for injection helpedto lift the Indian firm’s domestic turnover by 21% to Rs14.7 billion (seeFigure 1). A reported 3% rise to Rs4.59 billion in South Africa equatedto 8% local-currency growth as Cipla Medpro outpaced the overallprivate market and secured antitrust clearance to add Actavis’ portfolioto its deal with Teva (Generics bulletin, 14 October 2016, page 4).

Turnover in Europe and Emerging Markets were hit by a shift tobusiness-to-business supplies and “complexity-reduction initiatives”respectively. Vohra said the European business was now breaking even.

Raising research and development spending to around 8% of groupturnover that rose by 9% to Rs37.5 billion contributed to Cipla’spre-tax profit falling by a quarter to R4.44 billion. G

COMPANY NEWS


BUSINESS STRATEGY/SECOND-QUARTER RESULTS

Cipla plots an inhalerfiling by end of year

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

India 14,670 +21 39Emerging Markets 8,450 -1 23North America 6,600 +38 18South Africa 4,590 +3 12Europe 1,160 -27 3Global API 1,100 -50 3Others 950 +16 3

Cipla 37,510 +9 100

* rounded to nearest Rs10 million

Figure 1: Breakdown by region and business of Cipla’s sales in its financial secondquarter ended 30 September 2016 (Source – Cipla)

Incorporating Meda from 5 August helped to lift Mylan’s sales inthe third quarter of 2016 by 13% to US$3.06 billion despite pricing

pressures and lower volumes in North America conspiring to limit salesgrowth in the region to just 1%. Meda – which was acquired by Mylanin a deal worth around US$6.6 billion (Generics bulletin, 26 August2016, page 3) – contributed US$331 million to the company’s overallthird-quarter turnover, of which US$324 million were generics sales.

Meda and the topicals business that Mylan this year bought fromRenaissance (Generics bulletin, 20 May 2016, page 1) helped to liftNorth American turnover by 1% to US$1.10 billion (see Figure 1).Despite new product sales aiding the advance, these were offset by“lower volumes and pricing on existing products”, while an unfavourablecomparison to the third quarter of 2015 resulted from launchesincluding esomeprazole, lidocaine and bexarotene in that period.

In Europe, “pricing and volumes on existing products wereessentially flat”, although Meda helped the region to grow by almost

two-fifths to US$842 million. And in the Rest of the World region,“higher volumes offset lower pricing”, including in antiretrovirals,while five percentage points of positive currency effects lifted growthfrom a fifth to a quarter.

Specialty sales dropped by 4% as volumes for Mylan’s EpiPen(epinephrine) were “down due to the lack of wholesaler purchases inthe quarter, in anticipation of our upcoming generic launch”, explainedchief executive officer Heather Bresch. Following controversy overpricing for the auto-injector, Mylan recently revealed plans to launchan authorised generic (Generics bulletin, 9 September 2016, page 19),which Bresch said was now due to be introduced in early December.

Research and development costs 13.9% higher at US$199 millionresulted from the Meda and Renaissance deals, as well as Mylan’sbiosimilars collaboration with Momenta and “the continueddevelopment of our respiratory, insulin and biologics programmes”.

Combined with the higher research costs, a US$468 millionprovision for litigation settlements – largely due to a US$465 millionsettlement with the US Department of Justice over EpiPen rebates(Generics bulletin, 14 October 2016, page 3) – led Mylan to registeran operating loss of US$131 million for the quarter.

Mylan also announced plans to change from the next financialquarter its reporting segments, moving from the two Generics andSpecialty units to three segments covering North America, Europe andRest of World. This was because the firm’s portfolio would now be“effectively integrated across generic, branded and OTC products”. G

THIRD-QUARTER RESULTS

Meda lifts Mylan butpressures limit rise

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

North America* 1,099 +1 36Europe 842 +38 28Rest of World* 670 +25 22Generics 2,611 +17 85

Specialty 419 -4 14

Others 28 +45 1

Mylan 3,057 +13 100

* Brazilian sales of US$11.0 million were reclassifiedfrom Rest of World to North America

Figure 1: Breakdown of Mylan’s sales in the third quarter of 2016 (Source – Mylan)


Double-digit sales declines in both Belgium and Serbia caused salesby Stada Arzneimittel’s Generics business segment to all but stall

at C932 million (US$1.01 billion) in the first nine months of this year.The Generics segment’s sales edged up by 0.4% on growth in France,Italy, Russia and Vietnam as its operating margin strengthened by almostthree percentage points to 16.1%, aided by lower rebates in Germany.

Belgian generics sales declined by a quarter to C57.7 millionin the nine-month period, which Stada attributed to “a still hesitantpurchasing and sales strategy of our Belgian sales partner”, Perrigo’sOmega Pharma. However, the German group pointed out, the thirdquarter of this year had brought a notable recovery with 47% genericssales growth to C17 million in Belgium. “Further recovery in the fourthquarter is expected,” Stada stated.

In Serbia, “declining reimbursement prices” and high wholesalerinventories – as well as a “slightly negative currency effect” – causedgenerics sales to tumble by 28% to C37.2 million in the nine months.

Generics turnover in the German group’s domestic market slippedby 2% to C223 million, equivalent to nearly a quarter of Stada’s globalGenerics sales (see Figure 1). Chief financial officer Helmut Kraft saidthe lower sales resulted largely from the expiry of tender contractsheld by the firm’s Stadapharm sales entity, particularly the recentlyended 13th tender round of the AOK group of health insurance funds.

Italian generics turnover climbed by 3% to C117 million on“positive volume effects”. The Italian rise more than offset a 1% slip toC79.1 million in Spain amid higher discounting. Despite “strong priceand discount competition”, French sales grew by 9% to C60.5 million.

A generics sales rise of 31% to C75.5 million in Russiaequated to 51% growth at constant exchange rates, Stada said. Kraftsaid the firm’s broad portfolio of low-cost generics was helping tomaintain sales momentum as Russian consumers reacted to reducedpurchasing power by seeking cheaper alternatives to brands.

Generics sales in Vietnam rose by 9% to C49.5 million, while theArgentinian generics producer Laboratorio Vannier that Stada acquiredfor US$13.0 million at the start of this year contributed nine-monthsales of C5.6 million.

Stada’s turnover, including its Branded Products unit, edged aheadby 0.5% to C1.54 billion. But its operating profit fell by 4% to C173million as Stada recorded C29.0 million of impairment charges. G

COMPANY NEWS


NINE-MONTH RESULTS

Belgium and Serbiastall sales at Stada

Germany-2%, C223.2m

Italy+3%, C116.8m

Spain-1%, C79.1m

Russia+31%, C75.5m

France+9%, C60.5m

Belgium-25%, C57.7m

Vietnam+9%, C49.5m

Serbia-28%, C37.2m

Others+6%, C232.2m

Figure 1: Breakdown by country of Stada Arzneimittel’s Generics sales thatstalled at C932 million in the first nine months of 2016 (Source – Stada)

Unexpected additional price reductions for certain “higher-value”products within the basket of 15 marketed products that Impax

acquired from Teva in August – including budesonide inhalationsuspension and propranolol tablets – led the US firm to take an assetimpairment charge of US$251 million in the third quarter of this year.

Having closed an agreement worth US$586 million for the portfolioat the beginning of August, Impax said it had “assumed certain priceconcessions would occur”. “However, the company elected to takeadditional price reductions on certain of the acquired products inorder to retain key customers,” Impax explained.

“These reductions produced significantly lower than expectedoperating cash flows from the acquired product lines and triggeredan impairment analysis,” commented Impax, which in total took aUS$285 million impairment charge. In turn, Impax’ Generics unit

reported a US$233 million operating loss in the third quarter of thisyear, a US$281 million swing from the prior-year period.

Meanwhile, Impax has also slashed its full-year sales guidancefor the second consecutive quarter, to reflect increased competitionacross the industry and the “resulting customer pricing activities”.

The US firm now anticipates full-year sales of US$840-US$855million, down from a previously revised forecast in August of US$900-US$940 million. The latest guidance is lower than Impax’ group salesfor 2015, when Impax recorded group turnover of US$860 million.Impax’ initial guidance at the beginning of this year – several monthsbefore the Teva deal was agreed – projected group sales approachingUS$1 billion (Generics bulletin, 26 February 2016, page 6).

“It’s clearly been a very difficult and challenging year for mostof the pharmaceutical segment and, obviously, Impax was not immuneto this,” said president and chief executive officer Fred Wilkinson.

In the third quarter of this year, Impax’ generics sales slid by 3.0%to US$175 million, as the firm suffered a 62% year-over-year dip insales of generic Solaraze (diclofenac), Skelaxin (metaxalone), andAdderall XR (amphetamine salts), owing to price and volume declines.

On the other hand, the market share captured by Impax’authorised generic Adrenaclick (epinephrine) auto-injector more thandoubled, as Impax capitalised on the recent controversy surroundingMylan’s EpiPen (epinephrine). “Epinephrine auto-injector is one ofour outstanding wins of this year,” Wilkinson said, revealing thatImpax had “accelerated our efforts to build greater awareness of ourproduct”, through television, social media and print.

Having launched six products so far in 2016, Impax expects tobegin shipping an additional four products by the year end. This was,however, down from a prior forecast of 12-14 launches in 2016,Wilkinson acknowledged.

Specialty Brands sales climbing by 30.0% helped overcome thefall in generics turnover, as Impax’ group sales increased by 3.1%to US$228 million (see Figure 1). G

THIRD-QUARTER RESULTS

Impax’ profit plungesafter Teva deal bites

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

Generics 175.3 -3.0 -111.9Specialty Brands 52.6 +30.0 58.4

Impax 227.9 +3.1 -72.6

Figure 1: Breakdown by division of Impax Laboratories’ sales and gross margin inthe third quarter of 2016 (Source – Impax)


Lupin’s North American Formulations sales soared by 73.1% toRs20.0 billion (US$301 million) during its financial second quarter

ended 30 September, helping to lift the company’s overall turnover bynearly a third to Rs42.1 billion. US sales surged by 69.8% to US$292million, with two launches during the quarter. Earlier this year, Lupinacquired its first US manufacturing site after completing its US$880million acquisition of Gavis Pharmaceuticals and its Novel Laboratoriesaffiliate (Generics bulletin, 18 March 2016, page 3).

During the quarter, Lupin filed four abbreviated new drugapplications (ANDAs) and received nine approvals. Cumulative ANDAfilings stood at 338 as of 30 September, with the company havingreceived 196 approvals to date, and with 45 first-to-file opportunities.

The Indian firm’s domestic Formulations turnover rose by 12.1%to Rs9.96 billion (see Figure 1). Sales in Japan advanced by a tenth,aiding Lupin’s turnover in its Asia-Pacific region as it increased by23.7% to Rs5.52 billion, despite a 16.4% drop in sales in the Philippines.

Lupin expects a deal struck with Japan’s Shionogi for 21 ‘long-listed’off-patent brands to generate annual sales in the market of around¥9.40 billion (US$88.6 million) when it comes into effect from thestart of December (Generics bulletin, 5 August 2016, page 14).

Sales in Lupin’s Europe, Middle East and Africa (EMEA) regionmoved up by 6.2% to Rs2.36 billion, with increases in South Africaand Germany of 27.0% and 31.3% respectively. Latin Americanturnover fell by 8.9% to Rs986 million, as sales growing by a tenth inBrazil failed to balance a 31.9% decrease in Mexico. Lupin’s Restof World sales dipped by 4.3% to Rs396 million.

Global growth of almost two-fifths in Formulations sales wasslightly offset by a 12.3% drop in worldwide turnover from activepharmaceutical ingredients (APIs). The firm’s pre-tax profit rose by40.8% to Rs8.18 billion.

Lupin’s managing director Nilesh Gupta highlighted “robustgrowth across businesses”. “The company continues to invest aheadof the curve, be it research or manufacturing,” he commented.

Meanwhile, all outstanding inspections at Lupin’s plant in Goa,India, have been closed after it received an Establishment InspectionReport (EIR) from the US Food and Drug Administration (FDA). InMarch, the Indian company received nine observations following anFDA inspection at the site which identified issues involving “inadequacyand adherence to standard operating procedures” (Generics bulletin,18 March 2016, page 6). G

COMPANY NEWS


SECOND-QUARTER RESULTS

Lupin advances withNorth American rise

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

North America 19,978 +73.1 47India 9,958 +12.1 24Asia-Pacific 5,520 +23.7 13Europe/Middle East/Africa 2,355 +6.2 6Latin America 986 -8.9 2Rest of World 396 -4.3 1Formulations 39,193 +37.1 93

APIs 2,919 -12.3 7

Lupin 42,112 +31.9 100

Figure 1: Breakdown by region and business segment of Lupin’s turnover in itsfinancial second quarter ended 30 September 2016 (Source – Lupin)

Third-quarter sales Change Actavis contribution(US$ millions) (%) (US$ millions)

US 1,293 +25 538Europe* 829 +25 224Rest of World 782 +54 93Generic Medicines 2,904 +32 855

Multiple sclerosis 1,061 -2 –Other 987 -10 –Specialty Medicines 2,048 -6 –

OTC/Other 611 +38 32

Teva 5,563 +15 887

* European Union, Switzerland, Norway, Albania, Iceland, Former Yugoslavia

Figure 1: Breakdown of Teva’s sales in the third quarter of 2016, with thecontribution from the acquired Actavis generics business (Source – Teva)

Teva insists that it has nothing to fear from investigations into pricingcollusion in the US and that there has been no “fundamental change”

in a continuing trend for US generic price erosion running at around 5%.Commenting on recent media coverage of the US Department

of Justice’s investigation into potential anti-competitive generic pricingagreements, Teva’s chief executive officer, Erez Vigodman, told investors“we are not aware of any fact that will give rise to an exposure toTeva with respect to this investigation”.

Siggi Olafsson, head of Teva’s Global Generics business, said priceerosion on the firm’s US base generics portfolio had been 7% duringthe third quarter of 2016, slightly higher than the 5% trend. He attributedthis to “temporary market instability” as customers applied pressureover around 60 products for which Teva and Actavis had to divestduplicates to get Federal Trade Commission (FTC) approval.

The Actavis generics operation – which Teva acquired on 2August – contributed US$538 million to US Generics sales that rose by25% to US$1.29 billion in the third quarter of this year (see Figure 1).Olafsson said a decline of around a quarter in Teva’s legacy US Genericsbusiness was due to 11 launches failing to compensate for competitionon aripiprazole, budesonide, capecitabine and esomeprazole.

However, Olafsson stressed, 23 confirmed US first-to-fileopportunities to date this year ensured Teva had a strong US pipeline.

Actavis’ total US$887 million contribution in the two months afterclosing included US$224 million to Teva’s European Generics operationthat grew by 25% to US$829 million. Olafsson said the European unit“did not miss a beat”, with “full integration in all the Actavis markets”.

Despite a “negligible” impact from acquiring Rimsa in Mexico,Rest of the World Generics turnover rose by 54% to US$782 millionas Actavis added US$93 million and Teva’s joint venture with Takeda inJapan contributed around US$150 million. “Full distribution integration[with Takeda] was achieved by the end of quarter,” Olafsson noted.

Global Generics turnover rose by 32% to US$2.90 billion, whileActavis helped to lift the business’ operating margin by 3.7 percentagepoints to 29.9%. But Teva’s group operating margin fell by just overseven points to 13.8% on turnover that increased by 15% to US$5.56billion. The lower margin was due largely to a US$520 millionprovision for settling a US investigation into the firm’s operationsin Russia, Mexico and Ukraine between 2007 and 2013 (Genericsbulletin, 27 February 2015, page 3). G

BUSINESS STRATEGY/THIRD-QUARTER RESULTS

Teva is relaxed overpricing issues in US


Sun Pharma’s failure to launch its US Food and Drug Administration(FDA) approved generic version of Santarus’ Glumetza (metformin)

extended-release tablets is down to “technical issues”, according tothe Indian firm’s managing director, Dilip Shanghvi.

When Sun received approval for its alternative to the diabetestreatment blockbuster in August, the firm announced that it anticipatedmarket entry within weeks (Generics bulletin, 26 August 2016, page 7).

“We are working towards addressing issues [with the product],”Shanghvi told investors as Sun presented its results for its financialsecond quarter ended 30 September 2016. “Hopefully, we will be ableto solve these challenges.”

Meanwhile, in response to investor queries, Shanghvi offered nofurther updates on the timeframe or status of an anticipated FDAre-inspection of Sun’s manufacturing facility in Halol, India, and saidSun would not, at this juncture, update its full-year sales guidance inanticipation of the facility regaining compliance. The Indian firmrequested FDA inspectors revisit Halol earlier this year.

In Sun’s financial second quarter, the firm’s first generic versionof Novartis’ Gleevec (imatinib) in the US contributed towards Sun’sUS sales rising by 12.0% to Rs37.1 billion (US$547 million), evenas the firm lost its six-month monopoly in July.

The Indian firm said its US pipeline now consisted of 144abbreviated new drug applications (ANDAs) pending FDA approval,including 13 tentative approvals, after filing three ANDAs and receivingsix final approvals during the quarter.

Moreover, Sun recently bolstered its US portfolio by launchingauthorised generics of four olmesartan-based Daiichi Sankyo brandsthrough an exclusive supply and distribution deal with the Japaneseoriginator (Generics bulletin, 4 November 2016, page 12).

Sun enjoyed growth in all of its geographies and markets in itssecond quarter, including “broad-based” growth for its EmergingMarkets region, where sales rose by 25.5% to Rs11.4 billion (seeFigure 1), or by 22% to US$170 million in US dollar terms. Meanwhilein Sun’s domestic market, the Indian firm maintained its status as thecountry’s largest player, with an 8.7% market share, as turnover roseby 11.1% to Rs20.1 billion.

Including Bulk Drugs turnover that rose by 16.6% to Rs3.70billion, Sun’s group sales climbed by 13.2% to Rs77.6 billion. TheIndian firm’s pre-tax profit soared by 86.4% to Rs29.2 billion, followinga marginal increase in expenses, as Sun increased its research anddevelopment spending by 14% to to Rs5.70 billion. G

COMPANY NEWS


BUSINESS STRATEGY/SECOND-QUARTER RESULTS

Sun’s chief explainsUS metformin delay


US 37,144 +12.0 48India 20,091 +11.1 26Emerging Markets 11,411 +25.5 15Rest of World 5,281 +6.3 7Formulations 73,927 +13.2 95

Bulk Drugs 3,669 +16.6 5

Other/eliminations 45 -68.2 –

Sun Pharma 77,640 +13.2 100

Figure 1: Breakdown by region and business of Sun Pharma’s net sales in itsfinancial second quarter ended 30 September 2016 (Source – Sun Pharma)

Wockhardt is investing £10 million (US$12 million) to expandits sterile manufacturing and testing facility in Wrexham,

UK. The investment – announced in conjunction with UK PrimeMinister Theresa May’s trade mission to India – will treble capacityat the Wrexham site to 75 million ampoules and vials per year,generating 40 to 50 jobs on top of the 380 personnel already employedat the site in north Wales.

UK-based laboratory-information management systems providerBroughton Software said it was providing its LabHQ LIMS systemfor use at the Wrexham facility known as CP Pharmaceuticals.

Approved by both the UK’s Medicines and Healthcare productsRegulatory Agency (MHRA) and the US Food and Drug Administration(FDA), the CP site produces injectables in both liquid and lyophilisedforms including analgesics, heparin and insulin.

The UK facility forms part of Wockhardt’s network of 14manufacturing plants that are also located in India, Ireland and the US.

Wockhardt reported UK sales in its financial second quarter ended30 September 2016 down by 37% to Rs2.73 billion (US$40.3 million)

against an exceptionally strong prior-year quarter on a “one-timeopportunity” (Generics bulletin, 9 December 2015, page 4). The firm’sUK business made four filings and received three approvals duringthe six months ended September.

The UK slide was mitigated in part by Wockhardt achieving 13%sales growth in France to Rs170 million and a 3% rise to Rs390 millionin Ireland. Nevertheless, the Indian company’s total second-quarterturnover in Europe plummeted by more than a quarter to Rs3.66billion (see Figure 1).

Group turnover fell by 13% to Rs10.7 billion as the firm suffereda 22% decline to Rs1.82 billion in the US, where it had 84 abbreviatednew drug applications (ANDAs) pending approval as of 30 September.

A 15% advance to Rs4.32 billion in its domestic market – aidedby 10 launches during the quarter – more than compensated for theIndian company seeing its sales in emerging markets slide by aquarter to Rs840 million.

Having invested around Rs990 million, or 9% of its turnover, inresearch and development, Wockhardt saw its pre-tax profit tumbleby three-quarters to Rs260 million. G

MANUFACTURING/SECOND-QUARTER RESULTS

Wockhardt investsin its UK production

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

India 4,320 +15 41Emerging Markets 840 -26 8India/Emerging 5,160 +5 48

UK 2,730 -37 26Ireland 390 +3 4France 170 +13 2Other 370 +76 3Europe 3,660 -28 34

US 1,820 -22 17

Wockhardt 10,650 -13 100

* rounded to the nearest Rs10 million

Figure 1: Breakdown by region of Wockhardt’s sales in its financial secondquarter ended 30 September 2016 (Source – Wockhardt)


Investing heavily in research and development resulted in Nichi-IkoPharmaceutical’s operating margin sliding by three percentage points

to 5.4% in the six months ended 30 September 2016.The Japanese generics specialist’s operating profit tumbled by

30.6% to ¥4.04 billion (US$38.5 million) as it increased its researchand development spending by 29.3% to ¥3.52 billion. While theresearch and development investment was broadly in line with the firm’sfull-year forecast of ¥6.70 billion, its operating profit was only a littleover a quarter of the way to its full-year goal of ¥14.2 billion.

Nichi-Iko’s gross margin weakened by just over a point to 36.3%on turnover that increased by 8.9% to ¥75.2 billion. That total comprisedgenerics sales that advanced by 13.6% to ¥67.3 billion as turnover from‘long-listed’ off-patent brands declined by 12.3% to ¥5.49 billion.

Wholesaler growth boosts salesViewed by distribution channel, Nichi-Iko’s turnover growth was

attributable largely to a 10.7% advance through wholesalers to ¥61.7billion, equivalent to just over four-fifths of group turnover. Salesgrowth was strongest through the firm’s two largest wholesale customers.

Products listed for National Health Insurance (NHI) reimbursementduring the Japanese company’s current financial year starting in April2016 contributed sales of ¥291 million, while drugs listed by theNHI in the 2015-2016 financial year added ¥4.99 billion. G

COMPANY NEWS


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FIRST-HALF RESULTS

Research investmentcuts Nichi-Iko profit

Increasing its Formulations sales by a fifth to Rs6.68 billion (US$99.6million) pushed Ipca Laboratories’ group turnover up by 17% to

Rs8.78 billion in its financial second quarter ended 30 September 2016.Within its group total, the Indian firm’s active pharmaceutical

ingredients (APIs) turnover rose by 2% to Rs1.85 billion, solelyattributable to a 15% advance in India to Rs382 million (see Figure 1).

With operating expenses only marginally higher at Rs8.00 billion,Ipca more than quadrupled its pre-tax profit to Rs924 million. G


Formulations salesrise by fifth at Ipca


India 4,044 +23 46Exports 2,640 +16 30Formulations 6,684 +20 76

India 382 +15 4Exports 1,463 ±0 17APIs 1,845 +2 21

Others 253 – 3

Ipca 8,782 +17 100

Figure 1: Breakdown of Ipca Laboratories’ sales in its financial second quarterended 30 September 2016 (Source – Ipca)


Continued momentum in launches, approvals and filings in the UShelped Aurobindo Pharma to achieve 12.2% group turnover growth

to Rs37.8 billion (US$558 million) in its financial second quarterended 30 September 2016.

During the three-month period, the Indian company launched 11products in the US, seven oral-dose formulations and four injectables.Aurobindo said these launches, along with “volume increases”,contributed to US Formulations turnover rising by 17.8% to Rs17.4billion, or 46% of group turnover.

Aurobindo filed nine abbreviated new drug applications (ANDAs)with the US Food and Drug Administration (FDA) during the quarter,six for oral formulations and three for injectables, taking the firm’s totalnumber pending tentative or final approval as of 30 September to 128.

Four oral contraceptives were among 15 final approvals obtainedfrom the FDA during the three-month period, along with twogenitourinary drugs, methenamine tablets and darifenacin extended-release tablets. Four other oral-dose approvals in the US wereeszopiclone and rosuvastatin tablets, as well as omeprazole/sodiumbicarbonate capsules and galantamine extended-release capsules.

The Indian company also secured approval for five US injectables –esomeprazole, granisetron, linezolid, ropivacaine and zoledronic acid.

Two tentative approvals – generics of Tivicay (dolutegravir) andEpzicom (abacavir/lamivudine) tablets – added to Aurobindo’s rosterof antitretroviral HIV drugs.

Aurobindo’s global sales of Antiretroviral Formulations slippedby 0.6% to Rs2.79 billion, or around 7% of the group’s turnover (seeFigure 1). But that slide was more than compensated by EuropeanFormulations turnover rising by 6.4% to Rs8.13 billion, includingWestern European operations acquired from Actavis in 2014. “Theacquired business continues to see profitability,” Aurobindo stated.

With Emerging Markets sales ahead by 13.3% to Rs1.77 billion,the Indian firm’s total Formulations turnover climbed by 12.4% toRs30.0 billion, making up four-fifths of the group total. The other fifthcame from Aurobindo’s active pharmaceutical ingredients (APIs)operation that experienced 11.3% growth to Rs7.69 billion on strongdemand for betalactam antibiotics.

Having lifted its gross margin by 1.7 percentage points to 56.8%,Aurobindo raised its pre-tax profit by nearly a third to Rs8.30 billion. G

COMPANY NEWS



US momentum leadsAurobindo to growth

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

US 17,351 +17.8 46Europe 8,134 +6.4 22Emerging markets 1,768 +13.3 5Antiretrovirals 2,785 -0.6 7Formulations 30,038 +12.4 80

Betalactams 5,113 +19.6 14Non-betalactams 2,575 -2.3 7APIs 7,688 +11.3 20

Other 28 – –

Aurobindo 37,755 +12.2 100

Figure 1: Breakdown by business segment of Aurobindo Pharma’s sales in itsfinancial second quarter ended 30 September 2016 (Source – Aurobindo)

CIPLAQCIL – the antiretrovirals and malaria treatments manufacturerlocated in Kampala, Uganda, in which India’s Cipla holds a majoritystake – is evaluating going public through an initial public offering(IPO), and has appointed Renaissance Capital as its official book-runner. “Certain shareholders may consider selling down part or allof their stake to enable sufficient free-float and liquidity, while Ciplagroup, represented through its subsidiaries, intends to continueholding the majority stake and control,” the Ugandan company stated.

CAMBREX increased its turnover by 8% to US$99.9 million inthe third quarter of this year. Shortly after the end of the quarter, theUS-based active pharmaceutical ingredients (APIs) producer acquiredfor around US$25 million fellow US bulk-drugs specialistPharmaCore, which it has now renamed as Cambrex High Point.

ORCHID PHARMA reported turnover down by 12.5% to Rs1.88billion (US$28.2 million) in its financial second quarter ended 30September 2016. Finance and interest costs totalling Rs712 millioncaused the Indian company to post an Rs805 million pre-tax loss.

BIONICAL – the UK-based outsourcing specialist – has acquiredcontract research organisation (CRO) Emas Pharma for anundisclosed fee.

BEXIMCO PHARMACEUTICALS increased its turnover by 11%to BDT3.77 billion (US$47.8 million) in the third quarter. TheBangladeshi firm – which has just struck a US sales and distributiondeal with local generics player Bayshore (see page 15) – improved itsgross margin by 1.3 percentage points to 46.0%. As a result, Beximcoincreased its pre-tax profit by 24% to BDT710 million.

IDIFARMA – the Spanish contract developer – expects to achievea turnover this year of around C5.3 million (US$5.7 million),representing growth of more than 50% over the past two years. Notingthat it was increasingly focusing on niche generics, includinghighly-potent molecules, the Spanish firm said more than half of itsbusiness was now generated outside of its domestic market.

AARTI DRUGS is anticipating an audit of its facility in Tarapur,India, by European authorities within the next few weeks. The Indianbulk drugs producer achieved sales turnover of 15.7% to Rs3.16billion (US$46.6 million) in its financial second quarter ended 30September 2016, as volume growth of “around 25%-30%” more thanoffset lower prices. Aarti improved its pre-tax profit by 43.6% toRs326 million.

MYLAN has revealed “certain employees and a member of seniormanagement” have received subpoenas from the US Departmentof Justice seeking information on the marketing, pricing and saleof generic cidofovir, glipizide/metformin, propanolol and verapamil,including on any communications with other suppliers of these drugs.The firm said it was “fully co-operating” with the inquiry that addsto a previous probe on generic doxycycline.

IDEAL CURES is building a fourth manufacturing plant at itscampus in Sikkim, India. The film-coatings specialist expects toopen the plant early in 2017.

NATCO PHARMA almost doubled its turnover to Rs4.68 billion(US$69.1 million) in its financial second quarter ended 30 September2016, largely on its sales of finished-dose formulations rising by85% to Rs3.70 billion. The Indian company more than doubledits pre-tax profit to Rs897 million. G

IN BRIEF


Asales rise of almost a quarter to Rs3.02 billion (US$44.4 million)in the US coupled with domestic turnover that climbed by 18.4%

to Rs12.3 billion led India’s Alkem Laboratories to report a group salesrise of 18.6% in its financial second quarter ended 30 September 2016.

In the former market – which accounted for approximately a fifthof group turnover that reached Rs16.4 billion (see Figure 1) – Alkemreceived one abbreviated new drug application (ANDA) approval,taking the firm’s total US approvals to 34, including seven tentativenods, and said it had also launched an in-licensed product.

The Indian firm added that a continued focus on research anddevelopment “to accelerate ANDA filings and develop a differentiatedportfolio” was one strategy to expand Alkem’s presence in the US.

Other markets added the remaining Rs869 million to Internationalsales that rose by a fifth to Rs3.9 billion, following “strong underlyingdemand in key markets such as Australia, Chile and Kazakhstan”.

Meanwhile, in Alkem’s domestic market, the Indian firm said it had“outperformed” against a backdrop of regulatory price cuts, fuelled byhigher sales of its anti-infective, gastrointestinal and analgesic products.

With Alkem’s pre-tax profit climbing by 9.7% to Rs3.07 billionin its financial second quarter, the firm’s pre-tax margin dropped to18.7% from 20.2%. G

COMPANY NEWS



US and India growthgives Alkem a boost

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

India 12,258 +18.4 75

US 3,023 +23.9 19Other 869 +4.7 5International 3,892 +19.1 24

Other 233 – 1

Alkem 16,383 +18.6 100

Figure 1: Breakdown by region of Alkem Laboratories’ sales in its financialsecond quarter ended 30 September 2016 (Source – Alkem)

Neuland Laboratories’ board has approved a draft proposal to mergewith Neuland Health Sciences and Neuland Pharma Research,

“subject to all necessary approvals”. The combined entity would“improve relationships with customers”, the firm insisted, as it would“become an end-to-end active pharmaceutical ingredient (API)provider”. The deal is expected to close by the second quarter of 2018.

Neuland Laboratories’ joint managing director, Saharsh Davuluri,said the transaction would help “create a stronger and more sustainableentity”. “It not only reduces some redundant costs,” he stated, “butalso unlocks value by way of consolidation of businesses, optimisationof operations and improved overall capabilities.”

Launches of brinzolamide in the US and voriconazole in Europehelped Neuland Laboratories achieve double-digit turnover growth inits financial first half ended 30 September 2016. The Indian firm’soverall sales rose by 19% to Rs2.99 billion (US$44.2 million) as itenjoyed “success” across each of its business segments, “leading tobetter profitability and margins”. G

BUSINESS STRATEGY/FIRST-HALF RESULTS

Neuland merger offers more

Packaging and distribution operations can commence at XelliaPharmaceuticals’ facility in Cleveland, Ohio, after the Danish firm

received a notice from the US Food and Drug Administration (FDA),following a successful inspection by the agency.

Xellia – which acquired the former Ben Venue site late last year(Generics bulletin, 9 December 2015, page 5) – said the noticedemonstrated the “significant progress” the firm had made in bringingthe facility back to compliance. “The company can now initiate certaincommercial activities at the newer part of the Cleveland site thatinvolves labelling, secondary packaging and the distribution of drugproducts manufactured at other sites,” the anti-infective specialist stated.

As well as investing “significantly” in equipment upgrades andfacility design, Xellia said it had hired an “experienced team of over90 employees, to be expanded to around 170 employees over the next12 months as the company prepares to start the production of sterileanti-infective injectable products during 2018.”

Xellia’s Cleveland site will operate alongside the company’sexisting sterile injectables production plant in Raleigh, North Carolinaand Copenhagen, Denmark. Commercial production at the former BenVenue facility is expected to start around the end of next year(Generics bulletin, 21 October 2016, page 6).

Describing the US as an “important” market for Xellia, the firmsaid the country generated over 40% of its total sales in 2015. G

MANUFACTURING

Xellia Cleveland siteset to start packing

Marksans Pharma said pressure on its UK operation was largely toblame for group sales falling by a fifth to Rs3.74 billion (US$55.1

million) in its financial first-half that ended on 30 September 2016.“The UK-based business is witnessing higher competition, price

erosion, channel consolidation and moderation in volume off-takes,”the Indian company commented, adding that it had also been impactedby the devaluation of the British pound. Earlier this year (Genericsbulletin, 25 March 2016, page 5), the UK’s Medicines and Healthcareproducts Regulatory Agency (MHRA) withdrew a good manufacturingpractice (GMP) certificate for the firm’s oral-dose facility in Goa, India.

Marksans’ total formulations sales in UK and the rest of Europetumbled by 43.6% to Rs1.37 billion (see Figure 1).

Formulations sales in North America rose by 5.2% to Rs1.66billion despite a “short-term slowdown in sales of existing products”as the group integrated its acquisition of Time Cap Labs (Genericsbulletin, 10 July 2015, page 2). G

FIRST-HALF RESULTS

UK pressure hurts Marksans

First-half sales Change Proportion of(Rs millions) (%) total (%)

North America 1,658 +5.2 44UK/Europe 1,373 -43.6 37Australia, New Zealand 548 +21.2 15Rest of World 160 -26.9 4

Alkem 3,739 -20.1 100

Figure 1: Breakdown by region of Marksans Pharma’s sales in its financial firsthalf ended 30 September 2016 (Source – Marksans)


Afinal rule governing the handling of citizen petitions that ask theUS Food and Drug Administration (FDA) to take action relating

to abbreviated new drug applications (ANDAs), 505(b)(2) hybridapplications or 351(k) biosimilar petitions has been published by theagency in the US Federal Register.

The rule – which comes into effect from 9 January 2017, andfinalises a proposed rule set out almost five years ago (Genericsbulletin, 13 January 2012, page 17) – amends regulations to enact therequirement of the Federal Food, Drug, and Cosmetic (FD&C) Act thatthe FDA “must not delay approval of a pending application becauseof any request to take any form of action relating to the application”unless the agency determines “that a delay is necessary to protectthe public health”.

“Over the years,” the agency explained, “the FDA has receivednumerous petitions asking the agency not to approve a particular ANDAor 505(b)(2) application – or classes of these applications concerninga particular drug product or active ingredient – unless certain criteriaset forth in the petition are met.” These had in many cases raisedscientific or legal issues “relating to the standards or approval of anapplication”, the FDA acknowledged, such as suggesting that particularmethods are used to demonstrate bioequivalence.

“When submitted early – such as when we are making decisionsabout the bioequivalence requirements for a generic drug product orbefore we have received the first ANDA, 505(b)(2) application or 351(k)application for a drug or biological product,” the agency stated, “apetition may contain information that can contribute towards ourevaluation of an application.” However, “when petitions are submittedlate in the review process for challenged applications and do not raisevalid scientific and/or legal issues, they may have the effect ofimproperly delaying the approval of an application”.

The FDA pointed out that it may “deny a petition at any point ifit determines that a petition or a supplement to the petition was submittedwith the primary purpose of delaying the approval of an application andthe petition does not on its face raise valid scientific or regulatory issues”.

Having received a submission containing “several comments” frombrand industry association PhRMA during the comment period, theFDA declined the body’s request that the agency revise the proposedrule to limit its application to “cases in which there is evidence thata relevant ANDA or 505(b)(2) application is pending”.

“Normally, the existence of a pending application is not madepublic by the FDA,” the agency stated, adding that it was making thesection added by the new rule “apply to all petitions that request anaction that could delay the approval” of a filing, “regardless of whetheran application subject to the petition’s requested action is pending atthe time the petition is submitted”. Otherwise, the agency observed,“the filing of petitions could become a way for individuals to uncoverthe existence of certain pending applications”.

Other comments submitted by PhRMA – including concerns thatthe new rule could be read as retroactively imposing requirements onpetitions, queries over the clarity of language in the rule, and a requestthat the agency introduce a mechanism for notifying petitioners ifthe agency determines that delaying a filing is not necessary to protectpublic health – were dismissed by the FDA.

PhRMA had also asked the FDA to “abandon its practice of notproviding a substantive response” to petitions “regardless of the reviewstatus of a pending ANDA 505(b)(2) application”. But the agencysaid this issue was “outside the scope of this rulemaking”. G

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REGULATORY AFFAIRS

FDA rule will protectfilings from petitions

Reforming the US Food and Drug Administration (FDA), modernisingthe country’s Medicare health insurance framework and allowing

individual US states greater flexibility in administering the Medicaidprogramme for low-income beneficiaries are among the healthcarepriorities set out by US President-elect Donald Trump following hissuccess in the country’s recent presidential election.

One of the key goals set out by Trump’s administration, as thepresident-elect prepares to take office early next year, is to “reformthe FDA, to put greater focus on the need of patients for new andinnovative medical products”. He also plans to repeal the ‘Obamacare’Affordable Care Act (ACA) that created the framework underpinningthe US biosimilars pathway.

Trump also intends to “modernise Medicare, so that it will be readyfor the challenges with the coming retirement of the ‘baby boom’generation and beyond”. And the administration has also announcedits intention to “maximise flexibility for states in administeringMedicaid, to enable states to experiment with innovative methods todeliver healthcare to low-income citizens”.

In the wake of Trump’s election, shares for numerous companiesengaged in the pharmaceutical sector experienced an immediate spike,including for generics manufacturers worldwide. Aurobindo, Dr Reddy’sand Hikma were among those to see a lift following the US election,as well as Lupin, Mylan and Sandoz parent company Novartis. G

REGULATORY AFFAIRS

Agenda set by Trumpas shares get a bump


Prescribing by international non-proprietary name (INN), enablingpharmacy-level generic substitution and using procurement and

reimbursement decisions to promote the use of generics are among the“pro-generic policies” recommended by a study on access to essentialmedicines published in medical journal The Lancet. The “EssentialMedicines for Universal Health Coverage (UHC)” report focuses on thedevelopment of essential medicines policies over the past 30 years, afterthe landmark Nairobi conference on the rational use of drugs in 1985.

Patent pooling and voluntary licensing also have “great potential”to expand access to essential medicines, according to the study, whichwas welcomed by the Medicines Patent Pool (MPP). Further strategieshighlighted to reduce prices and increase competition includeincentivising market authorisations, assuring the quality of genericsthrough bioequivalence testing requirements, and publishing lists ofinterchangeable medicines.

Established in July 2014, the Lancet’s Commission on EssentialMedicines Policies sets out to “explore the progress achieved, thechallenges that remain, and the lessons learnt”. Five “core challenges”,the report outlined, must be “addressed by every country” to secureaccess to essential medicines: “paying for a basket of essential medicines;making medicines affordable, ensuring quality of medicines; promotingquality medicines; and developing new and missing medicines”.

The Commission – which is made up of 21 independent experts –offers “actionable recommendations” in the report to “make essentialmedicines a central pillar of the global health agenda”. It suggestsexpanding the current MPP into an “essential MPP”, which would“create an opportunity for companies to licence patents for the purposeof creating a competitive generic market of essential medicines”.

Using brands instead of generic alternatives leads to “unnecessarilyexpensive use”, the report noted. “In the US between 1999 and 2010,substituting generic products for their brand-name counterparts savedthe health system more than US$1 trillion,” the study observed.Furthermore, the World Health Organization (WHO) estimated that“if 18 common medicines were sold as lowest-price generics ratherthan originator brands, between 9% and 89% of costs could be savedacross 17 countries”. “It has been estimated that Chinese hospitalpurchasers could save a total of US$1.4 billion by switching fromoriginator brand antihypertensives and antidiabetics to domesticallyavailable generic equivalents,” the report stated.

The Commission said the WHO’s prequalification programmeshould evolve to address a wider range of essential medicines, andshift its focus to other priority medicines, including biosimilars. G

MARKET NEWS


MARKET RESEARCH

Lancet study offersadvice to lift uptake

India and the UK have signed a memorandum of understanding toestablish bilateral co-operation in the field of intellectual property

(IP). Establishing a “broad and flexible framework”, the memorandumwas struck between India’s Department of Industrial Policy andPromotion and the UK’s Intellectual Property Office.

Priority initiatives include collaborating on training programmesand exchanging best practices and knowledge on IP awareness, aswell as on application processes for patents, trademarks, industrialdesigns and geographical indications. G

INTELLECTUAL PROPERTY

India and UK sign deal on IP

GBMA – Australia’s Generic and Biosimilar Medicines Association– has submitted its response to a discussion paper on pharmacyremuneration and regulation. The association claimed that thecountry’s premium-free dispensing incentive (PFDI) was “notachieving its intended purpose of increasing the uptake of genericmedicines”, as it provided pharmacists with “no incentive to dispensea generic” when there was no brand price premium on another brandof the same item. “A specific improvement to the PFDI would beto link it to a measurable generic substitution target of 85%,” theGBMA suggested. Meanwhile, the association supported separateconsumer incentives such as a lower co-payment, or disincentivesfor consumers to choose a brand when generics are available, alsoproposing mandatory prescribing by active ingredient, which couldbe facilitated through changes to prescribing software. Registeringits objection to pharmaceutical tenders, the association also suggestedthat placing the onus for delivering medicines to pharmacies onmanufacturers could be considered anti-competitive.

QUINTILESIMS has insisted that protecting the £60 billion (US$75billion) life sciences contribution to the UK economy “must bea priority in forthcoming Brexit negotiations”. Marking the releaseof a Public Policy Projects report on ‘Getting the Best Brexit Dealfor Britain’s Life Sciences’ based on QuintilesIMS data, industryexperts debated its findings at an event chaired by Stephen Dorrell,chair of the country’s National Health Service (NHS) Confederation.

EAST AFRICA’s US$5 billion pharmaceutical market is expected togrow by more than 12% per year for the next five years, accordingto the United Nations Conference on Trade and Development(UNCTAD), as lifestyle changes in the region lead to higher rates ofnon-communicable diseases. “So far, the region’s 65 manufacturershave only been able to satisfy about 30% of market demand, leavingthe other 70% to be captured by imports,” UNCTAD said.

APMGR – Romania’s generics industry association – has pennedan open letter to the country’s prime minister, reiterating its requestfor the “immediate introduction” of a differential for generic medicinesto be applied to the country’s pharmaceutical clawback tax.

FDA – the US Food and Drug Administration has released guidancefor industry on non-inferiority clinical trials to establisheffectiveness for applicants submitting investigational drug applications(INDs), new drug applications (NDAs), biologics licensing applications(BLAs), or supplemental applications on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectivenessof the drug or biologic, usually because a superiority study designcannot be used. This finalises draft guidance published in 2010.

IRELAND will formally bid to host the European Medicines Agency(EMA) in the aftermath of Brexit, the country’s health minister SimonHarris has confirmed. Having received the “go ahead” from thegovernment, the bid proposes relocating the agency’s headquartersfrom London to Dublin. A group will be established “immediately”to develop a detailed proposal by early 2017, as the governmentworks to promote the selection of Dublin as the new location forthe EMA, in discussion with the European Commission and otherEuropean Union member states.

HHS – the Department of Health and Human Services – has set out aproposed notice in relation to the Medicaid National Drug RebateAgreement (NDRA), which has been updated to incorporate legislativeand regulatory changes that have occurred since the agreement waspublished in 1991, as well as editorial and structural revisions. G

IN BRIEF


National Health Service (NHS) England says it will “explore optionsfor using generics” after a Court of Appeal ruling that the NHS

is able to provide the antiretroviral drugs emtricitabine and tenofovirfor pre-exposure prophylaxis (PReP) in people at relatively high riskof contracting an HIV infection.

The National AIDS Trust had challenged NHS England’s positionthat local authorities should fund such prophylactic treatment as apublic-health service and that paying for such drugs could leave theNHS open to legal challenges from proponents of other treatmentsthat required national funding.

But the panel of three appeal judges found the NHS England couldfund PReP, not least because it already paid for post-exposureprophylaxis (PEP). “If NHS England has the function of commissioningtreatment for HIV,” Justice Andrew Longmore commented, “thedischarge of that function will be greatly helped by reducing thenumbers of persons infected with HIV.”

Highlighting a finding by Justice Nicholas Underhill that NHSEngland was empowered, but not obliged, to provide PReP treatment,the NHS said it was now considering whether to fund such drugs. Thepublicly-funded health service said it would immediately ask Gileadto “reconsider its currently proposed excessively high pricing” for itsTruvada (emtricitabine/tenofovir) combination brand while it exploredoptions for using generic alternatives. G

PRODUCT NEWS


PRICE WATCH ....... UK

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

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

Zolmitriptan prices zoom upAverage UK trade prices for zolmitriptan 2.5mg tablets in packs

of six quadrupled in November, according to the latest figuresprovided by WaveData.

Comparing UK trade prices between the periods 1-31 October2016 and 1-15 November 2016, the average trade price for themigraine treatment rose to £5.93 (US$7.37) from just £1.17 in theprevious month, despite the lowest available offer dropping slightlyby 5% to £0.85.

Meanwhile, 30-count packs of buspirone 5mg tablets saw theiraverage price soar by 240% to £10.29 – based on averages calculatedfrom at least 29 data points – as the lowest price jumped by atenth to £2.55.

Mirtazapine tablets in several strengths continued to experiencerises, following certain strengths seeing their averages more thandouble in mid-October (Generics bulletin, 21 October 2016,page 14). Increases of between 45% and 50% were registered for28-tablet packs in 15mg, 30mg and 45mg strengths, with the averageprice for the lowest strength rising to £3.63, 30mg tablets increasingto £1.61, and the 45mg strength hitting £3.61.

Conversely, the average price for a pack of 28 ropinirole 2mgtablets plummeted by around 91% to £1.25, while temazepam20mg tablets in a 250-count pack saw their average price almosthalved to £20.06. G

HIV/AIDS DRUGS

UK’s NHS exploringgeneric PReP option

Sandoz could launch its Glatopa (glatiramer acetate) 40mg multiple-sclerosis drug in the US “early in 2017”, according to the firm’s

development partner, Momenta. Noting that a regulatory exclusivityperiod for Teva’s Copaxone 40mg reference brand expires on 28January 2017, Momenta’s president and chief executive officer, CraigWheeler, said he expected a district court decision at around the sametime on four Copaxone 40mg patents, three of which had beeninvalidated by Mylan through an inter partes review (Generics bulletin,9 September 2016, page 16).

Wheeler said he was not concerned by Teva’s recent insistencethat draft FDA guidelines for glatiramer were “not sufficient to establishactive substance sameness” between generics and Copaxone (Genericsbulletin, 4 November 2016, page 11). “We have a good chance ofgetting a tentative approval and being able to launch early next year,”he maintained. Sandoz estimated that Glatopa 20mg had capturednearly 40% of the daily US glatiramer market, with over 7,500 patientstreated since the drug’s launch in June 2015, Wheeler noted.

Having regained from Shire commercial rights to its M923biosimilar Humira (adalimumab) candidate (Generics bulletin, 7October 2016, page 9), Momenta is planning regulatory filings from“mid-2017” and “a commercial launch as early as 2018” as it explorespotential licensing deals with commercial partners.

Through its collaboration with Mylan, Momenta expects by theend of next year to report top-line data from a Phase I single-dose studyinto the partners’ M834 biosimilar Orencia (abatacept) candidate(Generics bulletin, 11 November 2016, page 12). Wheeler said thetwo firms were working towards launching the rheumatoid arthritistreatment “in the 2020 timeframe”. G

MULTIPLE SCLEROSIS DRUGS

Glatopa 40mg months away

Coherus BioSciences has begun preparing its commercial strategyfor its CHS-1701 rival to Amgen’s Neulasta (pegfilgrastim) after

the US Food and Drug Administration (FDA) accepted the biosimilarfor review and set an action date of 9 June 2017 (Generics bulletin,14 October 2016, page 17). The US-based developer expects the FDAto host an advisory committee on the product.

“We believe that we will be the first biosimilar pegfilgrastimcandidate to be approved and to compete with Neulasta,” statedCoherus’ president, chief executive officer and chairman, DennyLanfear. Sandoz, he noted, had received a FDA complete responseletter outlining problems with its pegfilgrastim candidate and planned tosubmit more data in 2018 (Generics bulletin, 28 October 2016, page 1).

“We expect to staff a small specialty oncology salesforce ofapproximately 50 representatives and perhaps a dozen key-accountspecialists,” Lanfear revealed, adding that Coherus was “building outour value chain” by securing state licences and securing third-partylogistics partners while establishing a “commercial vendor base”.

Observing that Sandoz’ Zarxio (filgrastim-sndz) had capturedaround 40% of the market from Amgen’s Neupogen reference brand,Lanfear said “our research data suggest that there is much greater pent-up demand for a long-acting biosimilar pegfilgrastim than for a short-acting filgrastim like Zarxio”. “We would expect biosimilar pegfilgrastimpenetration in the US to approach the 70% to 80% level.” G

BIOLOGICAL DRUGS

Coherus plots a pathfor US pegfilgrastim


Mylan has struck a deal with Poland’s Mabion that will give Mylan“exclusive rights” to sell Mabion’s proposed biosimilar rival

to MabThera (rituximab) in all European Union (EU) countries andnon-EU Balkan states.

Under the terms of the deal, “Mylan will pay Mabion an upfrontpayment of US$10 million and additional milestone payments in theaggregate of up to US$35 million, subject to filing and approval ofmarketing authorisations and commercial launch in key countries”,Mabion said. The Polish firm will also receive royalties on net sales.

Mabion’s rituximab candidate – known as CD20 – is currentlyundergoing clinical trials in 887 rheumatoid arthritis patients and38 lymphoma patients. The firm says it “intends to register CD20 onmarkets in all countries where the reference drugs are sold”. It willbe produced at Mabion’s plant in Konstantynow Lodzki, Poland.

“Mylan will support Mabion in Mabion’s efforts to secure approvalof CD20 by the European Medicines Agency (EMA),” the Polish firmstated, citing Mylan’s “strong experience in generics and biosimilars”.

The deal comes shortly after Mylan announced that it hadsubmitted an application with Biocon to the US Food and DrugAdministration (FDA) for biosimilar trastuzumab (Generics bulletin,11 November 2016, page 1). The firms believe the filing could be thefirst submission of a proposed biosimilar version of the drug in theUS. Applications for trastuzumab, pegfilgrastim and insulin glarginehave already been accepted for review by the EMA (Generics bulletin,11 November 2016, page 15).

“Through various collaborations, we have access to a combinedportfolio of 16 biosimilar and insulin analogue generic products indevelopment, which gives Mylan one of the industry’s largest andmost diverse portfolios,” said Mylan president Rajiv Malik. G

PRODUCT NEWS


BIOLOGICAL DRUGS

Mylan and Mabionmake rituximab pact

Canada’s Federal Court of Appeal has again closed the door on agenerics company seeking a notice of compliance, or marketing

authorisation, for a generic version of Eli Lilly’s Cialis (tadalafil) brand,after dismissing Apotex’ appeal against a lower court ruling.

In April, a Canadian appeals court rejected Mylan’s appeal againsta Federal Court ruling that found Lilly’s Canadian patent 2,226,784was ‘patentably distinct’ to prior-art Canadian patent 2,181,377, andthus was not invalid due to obviousness-type double-patenting. Theappeals court also upheld a prior ruling that the ‘784 patent coveringthe erectile-dysfunction treatment did not lack utility (Genericsbulletin, 29 April 2016, page 11).

In the Canadian firm’s appeal, Apotex argued that Mylan’s FederalCourt case and appeals case, and therefore Apotex’ own Federal Courtcase, were wrongly decided, on the grounds that they did not followthe Canadian Supreme Court’s priority-date ruling on patent-claimconstruction and double-patenting in Whirlpool Corp v Camco Inc.

“On the basis of my conclusion as to what Whirlpool decided,I find that Apotex’ argument that Mylan’s Federal Court of Appeal casewas wrongly decided fails,” the appeals court decided.

Moreover, Apotex’ separate argument that the federal court haderred in finding that the ‘784 patent was sufficient to teach the inventionwas, the appeals court found, “without merit”. G

ERECTILE DYSFUNCTION DRUGS

Apotex tadalafil caseis rejected on appeal

Biosimilars in oncology indications are as safe and effective as theirreference drugs, based on a decade of experience with biosimilars

in Europe and other markets, according to a paper published in TheLancet Oncology periodical journal. According to the article writtenby researchers including Professor Huub Schellekens from UtrechtUniversity, advances in analytical methods are reducing the need forcomparative clinical trials for biosimilars.

However, McKesson’s US Oncology Network – which wasrepresented among the researchers by Dr Robert Rifkin – maintainedthat “significant retooling is needed if these oncology drugs are tobe safe, effective and affordable choices for patients here in the US”.

Another paper on generic oncology drugs states that “empiricalstudies did not identify safety concerns in the US, Canada, the EuropeanUnion (EU) and Japan, where regulations and enforcement are strong”.G

ONCOLOGY DRUGS/BIOLOGICAL DRUGS

Cancer biosimilars work well

Using Biogen’s Flixabi (infliximab) instead of the reference brand,Janssen’s Remicade, in France, Italy and the UK could save more

than C200 million (US$215 million) over three years, according toresearch presented by the biosimilars provider.

Biogen modelled two different uptake rates for Flixabi – marketshares of either 10%, 20% and 30% or 20%, 40% and 60% over thethree-year period – and two different discount rates to Remicade. Basedon these models, the company calculated potential savings of C41.5-C104 million in France, C9.3-C31.4 million in Italy and £19.8-£66.0million (C23.0-C76.7 million) in the UK.

“This would allow for savings equivalent to 19,641 to 69,983patient-years in all three countries,” Biogen commented. G

BIOLOGICAL DRUGS

Flixabi could save C200mn

EGIS says it has generated US$110 million in royalty revenues fromActavis’ sales of generic Crestor (rosuvastatin calcium) in the USsince the cholesterol-lowering generic was launched in May this year(Generics bulletin, 6 May 2016, page 11). Hungary’s Egis also holdsa US patent on an alternative rosuvastatin zinc salt for which the USFood and Drug Administration (FDA) has granted tentative approval. G

IN BRIEFPrivately-owned US generics specialist Bayshore Pharmaceuticalshas teamed up with Bangladesh’s Beximco Pharmaceuticals to

launch carvedilol 3.125mg, 6.25mg, 12.5mg and 25mg tablets in theUS under the Bayshore label.

Having secured US approval for carvedilol late last year, Beximcorecently obtained clearance for sotalol that it plans to launch during thefirst quarter of next year (Generics bulletin, 28 October 2016, page 19).“Additional approvals and product launches from our collaborationare imminent,” revealed Bayshore’s president, Mark Moshier. G

CARDIOVASCULAR DRUGS

Bayshore links with Beximco


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Mylan’s darunavir tablets for treating HIV infections and tadalafilfilm-coated tablets for pulmonary arterial hypertension have been

recommended for pan-European approval by the committee for humanmedicinal products (CHMP) within the European Medicines Agency(EMA). The European Commission will now act on the proposals.

The CHMP said Mylan should be given a centralised marketingauthorisation for its generic of Janssen-Cilag’s Prezista (darunavir)tablets in six strengths – 75mg, 150mg, 300mg, 400mg, 600mg and800mg. The committee also issued a positive opinion on Mylan’sTadalafil Generics 20mg film-coated tablets as bioequivalent to EliLilly’s Adcirca (tadalafil) cardiovascular brand. Mylan has held acentralised marketing authorisation for tadalafil 2.5mg, 5mg, 10mgand 20mg film-coated tablets for treating erectile dysfunction sinceNovember 2014 (Generics bulletin, 3 October 2014, page 13).

During its November meeting, the CHMP also granted a positiveopinion to Merck, Sharp & Dohme’s (MSD’s) Lusduna (insulinglargine) 100 units/ml solution for injection. The committee’s backingfor the biosimilar alternative to Sanofi’s Lantus diabetes drug comesafter the European Commission granted a centralised approval toLilly’s Abasaglar (insulin glargine) in September 2014. G

PRODUCT NEWS


STADA ARZNEIMITTEL has filed an opposition with the EuropeanPatent Office (EPO) to AstraZeneca’s European patent EP2,736,895protecting the originator’s Tagrisso (osimertinib) lung-cancertreatment. The ‘895 patent was granted earlier this year and coverspyrimidine derivatives as epidermal growth factor receptor (EGFR)modulators for treating cancer.

WOCKHARDT UK anticipates resuming supplies of its Migril(ergotamine/cyclizine/caffeine) migraine tablets by December thisyear following a technology-transfer process. “There still remain anumber of logistical and quality assessments before supply to marketcan commence,” the firm stated.

MYLAN claims the Gabrielle (desogestrel/ethinylestradiol) 150µg/20µg and 150µg/30µg contraceptive pills that it is marketing in Germanyoffer a discount of up to 38% over Hexal’s Lamuna equivalent.

BRECKENRIDGE says it has entered the US injectables market byintroducing a generic rival to Edison’s Methergin (methylergonovinemaleate) 0.2mg/ml brand for preventing and controlling post-partumhaemorrhage. The US-based firm – which has partnered on thelaunch with the abbreviated new drug application (ANDA) holder,Ergoject – said it planned to follow up with several more injectables“in the near future”. These launches will be overseen by the firm’sdirector of institutional sales and trade relations, David Giering,who was previously with Teva.

ELPEN is promoting its Pulmelia (budesonide/formoterol) dry-powder inhaler in Germany through pharmacy-press advertising. Theadvertising highlights the directly visible evidence of dose deliveryenabled by the Greek firm’s patented Elpenhaler device that it alsouses for its Rolenium (salmeterol/fluticasone) respiratory brand.

AMNEAL has failed in its appeal against US Patent and TrademarkOffice (USPTO) decisions on inter partes reviews of Endo’s USpatent 8,329,216 covering oxymorphone. The US Court of Appealsupheld without comment earlier decisions by the USPTO’s patenttrial and appeal board (PTAB).

FRESENIUS KABI has introduced a generic alternative to TheMedicines Company’s Angiomax (bivalirudin) single-dose 250mgvials in the US.

RAFARMA has entered into a production contract with fellow Russiancompany JSC F-Synthesis for imatinib. Rafarma said the deal wouldboth increase production volumes and reduce cost of goods, enablingit to capture more market share for the cancer treatment.

COHERUS intends during the first half of next year to start apharmacokinetic study of a biosimilar adalimumab formulationthat is “not impacted” by AbbVie’s US formulation patent9,114,166. The biosimilars developer plans to appeal against arefusal by the US patent trial and appeal board (PTAB) toinstitute an inter partes review of the ‘166 isotonic formulationpatent (Generics bulletin, 11 November 2016, page 13).

MYLAN should face a US Federal Trade Commission (FTC) probeinto potential anti-competitive practices over EpiPen (epinephrine)auto-injectors, according to leading members of the Senate judiciarycommittee. The senators allege that Mylan entered into contractsthat precluded schools from purchasing alternatives to the EpiPentreatment for anaphylactic shock, and also misclassified thedevice for the purposes of Medicaid rebates. G

IN BRIEF HIV DRUGS/CARDIOVASCULAR DRUGS

CHMP backs Mylan’sdarunavir HIV tablets

Giving naive or established patients Celltrion’s CT-P13 biosimilarinfliximab rather than Janssen’s Remicade reference brand leads

to “higher rates of treatment discontinuation”, according to studies basedon Turkish data that the originator presented during the 2016 AmericanCollege of Rheumatology/Association of Rheumatology HealthcareProfessionals (ACR/ARHP) annual meeting in Washington DC, US.

Drawing on data from the Turkish national ministry of healthdatabase, Janssen first analysed medical-billing records for 1,044patients starting treatment for rheumatoid arthritis between 1 July 2014and 30 June 2015. Of those, four-fifths or 831 started on Remicade,and the other fifth or 213 on CT-P13 that Celltrion and its partnersmarket under brand names including Remsima and Inflectra.

In the Remicade cohort, 55% of patients, or 453, discontinuedtreatment, whereas the rate for CT-P13 was slightly higher at 63%, or134 patients. Janssen said the Remicade discontinuations included64 patients, or 8% of the total, who switched to the CT-P13 biosimilar.

Looking at 3,018 patients who were already being treated withRemicade, Janssen identified 148, or 5%, who switched to CT-P13.“In the patients who were switched, 70% discontinued treatment withCT-P13 within six months,” the originator stated. “In comparison, only24% of patients who maintained treatment with Remicade discontinued.”

“This real-world evidence raises important questions regardingthe impact to patients and their healthcare professionals when patientswho are stable on Remicade are switched to a biosimilar,” arguedJanssen’s vice-president of medical affairs, Andrew Greenspan.

During the same meeting, Norwegian researchers presented theNOR-Switch study showing that CTP13 is “not inferior” to Remicade(Generics bulletin, 21 October 2016, page 1). Dutch researchers alsoreported that “the majority of rheumatoid arthritis, psoriatic arthritisand spondylarthritis patients can be switched to biosimilar infliximabwithout changes in efficacy, safety and immunogenicity”. G

BIOLOGICAL DRUGS

Infliximab switching studied


PRODUCT NEWS


25 January

■ 10th Pharmacovigilance ConferenceLondon, UKThis conference is organised by Medicines for Europe and willlook at topics including legislation and biologics.

Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.medicinesforeurope.com/events/phv-2017.

26-27 January

■ 16th Regulatory & Scientific Affairs ConferenceLondon, UKThis event will follow the Pharmacovigilance Conference at the samevenue in London. Updates on regulatory developments will be covered.

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

7-8 February

■ World Affordable Medicines CongressBarcelona, SpainThis event brings together two conferences – World Generic MedicinesCongress and Biosimilar Drug Development World. There will beinsights into commercial strategies, pricing, and development challenges.

Contact: Health Network Communications. Tel: +44 (0) 207 092 1000.E-mail: [email protected]: healthnetworkcommunications.com.

13-15 February

■ GPhA 2017 Annual MeetingOrlando, USAThis conference, organised by the Generic PharmaceuticalAssociation (GPhA), will look at regulatory issues and challengesfor the US generics industry.

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

2-3 March

■ 2nd Business Development & InnovationOpportunities in Consumer Healthcare/OTCLondon, UKOrganised jointly by the Pharmaceutical Licensing Group andOTCToolbox, this event will focus exclusively on businessdevelopment and innovation in the consumer healthcare/OTC market.Contact: OTCToolbox. Tel: +44 121 314 8757.E-mail: [email protected]: plg-group.com/events/2nd-otctoolbox-plg-otc-conference-and-networking-event/.

22-23 March

■ 13th Legal Affairs ConferenceLondon, UKThis Medicines for Europe conference will cover legal andintellectual-property developments regarding generics and biosimilars.

Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.medicinesforeurope.com/events/13th-legal-affairs-conference/.

EVENTS – January, February & March

Save the date ...24 October 2017Frankfurt, Germany

Antibiotics and analgesics are among the drugs most urgently neededby International Health Partners (IHP), Europe’s largest co-ordinator

of donated medicines, as it responds to health emergencies in Haitiand Yemen. In particular, IHP needs all formulations and strengths ofamoxicillin, azithromycin, ceftriaxone, ciprofloxacin, doxycyclineand erythromycin. Beyond these antibiotics, the charity is looking forsupplies of analgesics and anti-inflammatory agents such as diclofenac,ibuprofen, naproxen and paracetamol.

Other medicines that are urgently required include fluconazole,folic acid, furosemide, lactulose and metronidazole, as well as ranitidine,salbutamol and simvastatin. Adult and paediatric multivitamins, oralrehydration salts and saline are also in demand.

Donated stocks need to be dated until at least December 2017,with packaging in French or English preferred for Haiti, and Englishor Arabic for Yemen.

In Haiti, IHP has already shipped medicines and supplies to itspartner International Medical Corps (IMC), which is runningprogrammes that include mobile medical units, cholera treatment andprevention, and water, sanitation and hygiene activities following thedevastation caused by Hurricane Matthew. “We have agreed to continuesourcing additional medicines for IMC in Haiti as the situation remainsdesperate and our medicines have had a huge impact on the servicesthey have been able to deliver,” Adele Paterson, IHP’s associatedirector of corporate partnerships, told Generics bulletin.

In Yemen, IHP is working with “local partners on the ground,including the World Health Organization (WHO), to respond to thecrisis and strengthen the remaining community health systems throughmedical aid to front-line health workers and facilities”. The continuingconflict in the Middle-Eastern country had destroyed much of thelocal infrastructure and left an estimated 14 million people in need ofmedical assistance amid a complex environment in which only a smallnumber of humanitarian agencies were able to actively deliver assistance,the donations specialist stated. “IHP is working with Yemen’s Ministryof Health, which has recently published a request of essential medicinesand supplies that it needs,” Paterson explained.

While many of the medicines required in Haiti and Yemen aretypical of those most sought by IHP – such as antibiotics, antifungals,analgesics, and multivitamins – the charity encourages donors withstock of other products they could donate to make contact, as suchproducts could be used in other areas. G■ For more information, visit www.ihpuk.org or contact Adele Patersonon +44 20 7014 2815.

ANTIBIOTICS/ANALGESICS

Antibiotics neededfor Haiti and Yemen

Icos’ European patent EP1,200,092, which covers tadalafil compoundswith specific particle sizes, is invalid as it lacks an inventive step,

a Dutch court has ruled.Finding in favour of Actelion – which intends to launch tadalafil

in the Netherlands once a supplementary protection certificate (SPC)linked to European patent EP0,740,668 expires on 11 November nextyear – a district court in The Hague said it would have been routinefor a skilled person to seek to improve the dissolution of the erectile-dysfunction drug by micronising tadalafil particles within the sizesdescribed in the ‘092 patent. G

ERECTILE DYSFUNCTION DRUGS

Netherlands rules on tadalafil


PRODUCT NEWS


Cipla and Mylan are the first companies to apply to the World HealthOrganization (WHO) for pre-qualification of generic dolutegravir,

the Medicines Patent Pool (MPP) has announced. The two firms – bothof which are manufacturing partners of the MPP – applied to the WHOfor generic dolutegravir 50mg tablets, which the MPP noted was a“necessary step in allowing international procurers such as the GlobalFund to Fight AIDS Tuberculosis and Malaria, UNICEF and UNITAIDto purchase and distribute the treatment in developing countries”.

ViiV Healthcare in 2014 granted the MPP two non-exclusivelicences for manufacturing generic dolutegravir covering adult andpaediatric formulations respectively (Generics bulletin, 18 April 2014,page 16). “Both licences permit generic pharmaceutical companiesbased anywhere in the world to manufacture dolutegravir and to combinethe treatment with other drugs to develop fixed-dose combinationsof regimens recommended by the WHO,” the MPP added.

Earlier this year, the two parties extended the adult licence to “alllower middle-income countries”, (Generics bulletin, 29 April 2016,page 13), allowing the sale of dolutegravir in “more than 130 countries”.

Considered a “significant improvement” in antiretroviral therapy,dolutegravir was recently recommended as an “alternative first-linetreatment” by the WHO. “The treatment does not require boosting andhas a good barrier to resistance, as well as high efficacy and tolerabilityat a relatively low dose,” the MPP noted. “As part of a daily regimen,the 50mg tablet is currently prescribed for patients that have never takenHIV therapy, as well as for the many that have developed resistanceto current treatment.”

ViiV is currently facilitating applications for tentative approvalby the US Food and Drug Administration (FDA) of dolutegravirmanufactured by MPP’s generics partners by waiving the originator’sright to a five-year new chemical entity (NCE) exclusivity.

“We have worked closely with our partners on rapid productdevelopment to ensure the availability of generic dolutegravir in low-and middle-income countries shortly after its rollout in high-incomenations,” commented Greg Perry, the MPP’s executive director. G

HIV/AIDS DRUGS

Cipla and Mylan willprogress dolutegravir

Russia’s Biocad is set to expand its local portfolio of complexproducts after receiving a marketing authorisation from Russia’s

Ministry of Health for its generic version of Teva’s Copaxone (glatirameracetate). The Russian firm plans to offer its alternative to the multiple-sclerosis treatment at a 30% discount to the cost of Teva’s brand.

Having begun development on its Copaxone generic four yearsago, Biocad said its application had included the results of a two-yearPhase III clinical trial in patients with multiple sclerosis, testing theequivalence, efficacy and safety of the Russian firm’s candidate againstTeva’s original. In total, Biocad had invested “about RUB400 million(US$6.20 million) for the development of the drug”, the firm revealed.

“We are not dependent on suppliers and guarantee the quality ofthe substance,” commented Biocad’s vice-president of research anddevelopment, Roman Ivanov, pointing out that Biocad would handlethe full cycle of developing and marketing the drug, includingsynthesising the substance. This was “especially important given thehigh level of complexity of the process and characteristics of the activesubstance”, Ivanov added.

Moreover, the Russian firm noted, Biocad would compete forshare versus Teva, as well as local firms JSC F-Synthesis and Rafarma.

Biocad’s portfolio of complex generic products and biosimilarsin its domestic market currently includes the biosimilar monoclonalantibodies (mAbs), trastuzumab and bevacizumab and rituximab(Generics bulletin, 29 January 2016, page 13). G

MULTIPLE SCLEROSIS DRUGS

Biocad cleared for aCopaxone alternative

AMassachusetts district court’s decision to dismiss Amphastar’santitrust allegations against Momenta over testing standards for

enoxaparin should be reversed, the US Federal Trade Commission (FTC)has argued in an amicus brief filed with the US Court of Appealsfor the First Circuit.

Stressing that it was supporting neither Amphastar nor Momentain the underlying case, the FTC argues in its brief that the district courtincorrectly applied the ‘Noerr-Pennington’ doctrine that exempts genuineactions to influence government bodies, such as the US Food and DrugAdministration (FDA), from antitrust prosecution. G

ANTICOAGULANTS

FTC files enoxaparin opinion

Canada’s Supreme Court is currently considering its position on theextent to which patents must prove or predict the innovations that

they promise. Having heard on 8 November oral arguments inAstraZeneca’s appeal against a Court of Appeal verdict that invalidateda Nexium (esomeprazole) patent, the Supreme Court is now weighingoral and written submissions from parties including the CanadianGeneric Pharmaceutical Association (CGPA).

Midway through last year, a Canadian Court of Appeal upheld aprevious ruling in favour of Apotex, finding that AstraZeneca’s Canadianpatent 2,139,653 was invalid because it lacked utility (Genericsbulletin, 7 August 2015, page 20). G

GASTROINTESTINAL DRUGS

Canada ponders promise case

Hospital drugs specialist Laboratoire Aguettant says it is “goingglobal” with its range of emergency injectables in pre-filled syringes.

The French firm has just rolled out its sulfite-free adrenaline syringesin Austria, Belgium, France and Portugal, having launched the drugearlier this year in Germany, Ireland, the Netherlands and the UK.

Aguettant’s adrenaline formulation uses an oxygen absorber and afoil pouch, rather than sulfite preservatives, to minimise oxidisation.Sulfites, it claims, “can trigger broncho-constriction and life-threateninganaphylactic shock”. Adrenaline takes to four the number of emergencymedicines in pre-filled syringes that the firm offers, adding to ephedrine,atropine and phenylephrine.

Having recently invested C40 million (US$43 million) in its facilityin Lyon, France, Aguettant believes innovations such as a patentedopening mechanism for syringes will enable the company to increaseits turnover from C107 million last year to C120 million within thenext five years. The French firm operates six subsidiaries in Belgium,Germany, Italy, Spain, the UK and Vietnam. G

INJECTABLE DRUGS

Aguettant now ‘going global’


Momenta has appointed Scott Storer to become senior vice-president and chief financial officer from 28 November. Storer

will replace Momenta’s retiring chief financial officer, Rick Shea.Also serving as a member of the executive committee, Storer will

report to Craig Wheeler, the company’s president and chief executive.Prior to joining Momenta, Storer was the senior vice-president

of finance at Baxalta following its spin-off from Baxter Internationalin July 2015. He had also held several positions with Baxter, mostrecently as vice-president of BioScience finance. G

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APPOINTMENTS

Storer is Momenta’schief financial officer

Perrigo has added to its board of independent directors by appointingGeoffrey Parker and Theodore Samuels. Parker has already joined

the board and Perrigo’s audit committee from 7 November, whileSamuels will join the board on 4 January.

Parker is currently a member of the board of directors of GenomicHealth, Sunesis Pharmaceuticals and ChemoCentryx, and previouslywas chief financial officer for Anacor Pharmaceuticals. Samuels hasserved as president of Capital Guardian Trust Company since 2010. G

APPOINTMENTS

Perrigo adds two to its board

Teva has promoted David Stark to join its executive leadershipteam as he becomes the Israeli firm’s chief legal officer, replacing

Richard Egosi, who is “taking a leave of absence”.With “over 20 years of legal experience”, Stark joined Teva in

2002, serving in various roles in Teva North America and Teva Americasincluding senior director, deputy general counsel, vice-president andgeneral counsel .

Teva’s president and chief executive officer, Erez Vigodman, saidStark had led the legal team on a “number of key achievements” inhis most recent position of deputy chief legal officer, including the“successful negotiation and close of [acquiring] Actavis Genericsand Anda, and a series of key legal wins”.

Egosi had been “invaluable throughout his 21-year tenure with thecompany” Vigodman added. “We are pleased he will continue hiscareer at Teva and look forward to his continued contribution.” G

APPOINTMENTS

Teva appoints Starkas chief legal officer

IPRF – the International Pharmaceutical Regulators Forum – on 6-7November in Osaka, Japan, held its first management committee underits new chair, Joan Blair from the US Food and Drug Administration(FDA), and co-chair Patrícia Pereira Tagliari from Brazil’s Anvisa.G

IN BRIEF


Documents

COMPANY NEWS EMA gives backing to biosimilars of Forsteo · 2018-11-20 · market-share gains of high-value products, portfolio rationalisation and pipelineexecution”. Having completed