gen 30-3-18 pgs.1-16 › ...on the agenda for the management team of amneal and its merger partner...

30 March 2018

COMPANY NEWS 3Teligent’s US site will 3fill first batch by June

Sandoz on high after lighting 3up joint dealHovione reveals three plant 4expansion plans

Malladi and Labocont 4receive FDA warnings

Krka sets up a dedicated 5biosimilars unit

Stada’s owners start 6squeeze-out offering

MARKET NEWS 7England counts cost of 7respiratory drugs

Third of payers prefer 7biosimilars in the US

Vancocin FTC case 8is dismissed for now

UK may turn to FDA 9with no EMA deal

PRODUCT NEWS 10Orion moves forward with 10Easyhaler in EU

Alvogen succeeds in US 10Suboxone lawsuitCipla rivals Teva and Reddy’s 12on US Aloxi

Hikma launches US 12ritonavir exclusively

Momenta and Sandoz fail 13on US enoxaparin

FEATURES 14Amneal plans to partner 14on path to US top tableForming strategic partnerships for bothcommodity generics and biosimilars is highon the agenda for the management teamof Amneal and its merger partner Impax.Aidan Fry reviews the company’s plans tocompete with the leading US players.

REGULARSEvents – Our regular listing 6Price Watch UK – Our regular listing 12People – Lannet names heads 16of ops and marketing

Issue No.347

Financial incentives for French healthcare establishments to prescribe biosimilarversions of etanercept and insulin glargine have been set out in an instructionpublished by the country’s government. Specifically aimed at biological medicines thatare prescribed by hospitals but dispensed by community pharmacies, the incentives willreward establishments that achieve a “strong progression” in the usage rate of thesebiosimilars, for which “accompanying measures have not been sufficiently developed”.Biogen’s Benepali and Sandoz’ Erelzi are the two etanercept biosimilars targeted by theinstruction, and Eli Lilly’s Abasaglar the sole insulin glargine biosimilar.

Noting that more frequent use of biosimilars instead of reference brands was an “importantissue in improving prescribing practices” in France, the document acknowledges that a changein French prescribing conditions brought in at the start of 2017 – which allowed originalbiologics to be replaced with biosimilars at any point during a course of treatment – “has notyet led to a sufficient increase in their market share”.

France’s Biogaran noted last year a significant disparity in uptake between biosimilarsdispensed in the hospital context and the community pharmacy context in France. CitingDecember 2016 figures from French industry association Gemme and market researcherGERS, the firm noted that biosimilars had by that point achieved just 0.2% penetration of theFrench etanercept market by volume, and insulin glargine biosimilars just 0.8%. This comparedto 18% for epoetin alfa, more than a fifth for infliximab, 45% for somatropin and 87% forfilgrastim (Generics bulletin, 26 May 2017, page 15).

More recently, the instruction notes, French authorities had recommended “systematicprescription of biosimilars”, and urged doctors to initiate treatment with a biosimilar in at least70% of cases for 11 ‘similar biologic groups’, including etanercept and insulin glargine (Genericsbulletin, 10 November 2017, page 11). And at the start of this year, France’s government seta goal of 80% biosimilar penetration by 2022 (Generics bulletin, 12 January 2018, page 1).G

Further biosimilar competition to Roche’s Herceptin (trastuzumab) and Janssen’sRemicade (infliximab) looks to be on the way in European markets. The EuropeanMedicines Agency’s (EMA’s) committee for human medicinal products (CHMP) hassimultaneously recommended the granting of marketing approvals for Amgen’s Kanjinti(trastuzumab) 150mg and 420mg powders for concentrate for solution for infusion, as wellas Sandoz’ Zessly (infliximab) 100mg powder for concentrate for solution for infusion.

For both biosimilars, the CHMP positive opinion will now be reviewed by the EuropeanCommission (EC), which will decide whether to grant a centralised marketing authorisationvalid in all 28 European Union (EU) member states. Norway, Iceland and Liechtenstein, asmembers of the European Economic Area (EEA), will take corresponding decisions on the basisof the EC’s decision. The EC typically acts on the CHMP’s recommendation within 67 days.

Infliximab biosimilars currently available in Europe include Celltrion’s Remsima, Pfizer’sInflectra and Samsung Bioepis’ Flixabi. Celltrion’s Herzuma and Samsung’s Ontruzant areapproved biosimilars of Herceptin, although neither player holds an approval for the 420mgstrength. Merck Sharp & Dohme launched Ontruzant in the UK earlier this month.

Roche also markets a 600mg subcutaneous injectable formulation of Herceptin inEurope, which has not yet received a biosimilar recommendation or approval. G

France takes action onetanercept and insulin

CHMP backs two EU biosimilars

3GENERICS bulletin30 March 2018

COMPANY NEWS

Teligent is aiming to fill its first batches at its US manufacturingfacility in Buena, New Jersey, by the end of June, according topresident and chief executive officer Jason Grenfell-Gardner. Notingthat the sterile injectables suite was “largely finished”, he added thefirm was “on track” to sell its first injectable product during thesecond quarter. “We’re keen to move from constructing and installingto manufacturing and selling,” he declared.

Water validation tests at the site were being “worked through[from] now into April, or the beginning of May”, Grenfell-Gardnerstated. Anticipating that the US$60 million expansion project wouldbe completed next quarter, he said he expected that the facility wouldbe “generating revenue from the new filling line in early 2019”.

Grenfell-Gardner detailed that the filling line – which is “primarilyfocused on liquid-fill” injectables – has the ability to produce vialsfrom 2ml up to 50ml. “In fact, if we wanted to, we could probablyproduce them up to 100ml,” he added, noting that vials could be“aseptically filled, as well as terminally sterilised”. The line willalso manufacture ampoules.

“We start with between four million and eight million units ofcapacity depending on size and shifts in line one,” Grenfell-Gardner stated,“with the idea of eventually moving to around 40 million in capacitywhen we get to line two, but that’s a little bit further down the road.”

Summarising Teligent’s pipeline progress last year, he admittedthat “after a bumpy ride in the middle of 2017” the firm “finally sawthe pipeline approval engine re-engage with three approvals in thefourth quarter”. The firm had been “working through review issuesrelated to US Food and Drug Administration (FDA) inspections ofsome of our raw material suppliers”, Grenfell-Gardner explained.“These have now been cleared and approvals are flowing again.”

In addition to nine abbreviated new drug application (ANDA)approvals last year, Teligent also launched 12 products in the US.Four Health Canada approvals were granted, while there were fivelaunches in the country. In 2017, the firm had 28 products availablein the US and 30 in Canada.

One of Teligent’s “larger growth opportunities”, hydrocortisonebutyrate 0.1% lotion, was launched during the current quarter followingapproval late last year (Generics bulletin, 8 December 2017, page13). “Between now and 30 June [2018], I believe we have eightpotential action dates,” Grenfell-Gardner revealed.

In response to an investor query on research and development(R&D) investments this year, Teligent’s chief said there was acombination of both new and reactivation products on the injectablesside”, while “there are still topical submissions that are expected tohappen in 2018 as well”.

In 2017, the US firm’s group sales inched up by 1% to US$67.3million, aided by turnover from Teligent-labelled products, whichgrew by nearly a fifth to US$58.0 million. The remaining US$9.3 millionwas generated by contract manufacturing, partner products and product-development fees, which slumped overall by 48%. Gross marginslid by 12 percentage points to 41%, which the firm said was“dueprimarily to price declines, particularly with lidocaine 5% ointment,operational challenges and increased distribution fees”.

Forecasting 2018 sales of between US$70-US$78 million, Teligentsaid it plans to invest US$13-US$15 million in its R&D pipeline. “Weview 2018 as a year of shifting gears from investment to profitability,”Grenfell-Gardner asserted. Gn [email protected]

MANUFACTURING/ANNUAL RESULTS

Teligent’s US site willfill first batch by June

Xellia Pharmaceuticals says the company “will continue to makesignificant investments in its US business during 2018, inpreparation for the commercialisation of its innovative product pipeline”,including its novel liquid-dosage form of vancomycin in a ready-to-use infusion bag. The value-added anti-infective was recentlygranted Qualified Infectious Disease Product (QIDP) status from theUS Food and Drug Administration (FDA), and a new drug application(NDA) for the product is expected to be submitted “during 2018”.

To support Xellia’s anti-infectives pipeline, the company saidthat since 2014 it had “significantly expanded its manufacturingcapabilities for sterile injectables in the US”, including site acquisitionsin Raleigh, North Carolina, and Cleveland, Ohio (Generics bulletin,8 August 2014, page 9; 9 December 2015, page 5).

Facilities at the Cleveland site “have subsequently receivedsubstantial upgrades”, the Danish anti-infectives specialist noted.

In 2017, Xellia’s group turnover rose by 23% to US$317 million,which is the “highest reported sales since the company was establishedas an independent business in 2008”. The firm stated that the “strongfinancial result builds on an increased supply of several key products,and was, in particular, driven by continued growth in US sales”, whichaccounted for 60% of turnover, compared to 54% of sales in 2016. G

BUSINESS STRATEGY/ANNUAL RESULTS

Xellia to invest in US business

Sandoz Canada is joining forces with local medical cannabisproducer Tilray to “accelerate innovation and increase availabilityof high-quality medical cannabis products”, in what Tilray claims isthe first alliance between a federally-licensed producer of medicalcannabis and a local affiliate of a global pharmaceuticals company.

Having signed a binding letter of intent with Sandoz, Tilray saysa number of subsequent anticipated definitive agreements, which areyet to be formally executed and are subject to regulatory approval, willsee the firms collaborate on a number of initiatives, including leveragingSandoz Canada’s “best-in-class knowledge” to educate Canadianpharmacists and physicians about Tilray’s range of medical cannabis.

Meanwhile, Nanaimo-based Tilray will become the “exclusivepartner” of Sandoz for its non-smokable and/or non-combustiblemedical cannabis products, and will also partner with the Novartisaffiliate to develop “new and innovative” medical cannabis productsthat offer an alternative to smokable and/or combustible products.

“Sandoz Canada, known for its supply reliability, will wholesaleand distribute non-smokable/non-combustible Tilray products toCanadian hospitals and pharmacies,” noted Tilray, pointing out thatthis agreement was subject to future regulatory changes.

Tilray claims to be a global pioneer in medical cannabis research,production and distribution, “and was the first medical cannabiscompany to obtain current good manufacturing practice (cGMP)certification in accordance with the European Medicines Agency’s(EMA) standards”. With this standard of quality behind it, Tilray saysit currently supplies “tens of thousands of patients with high-quality,cGMP-certified products in 10 countries spanning five continents”.

Brendan Kennedy, Tilray’s chief executive officer, said theagreement was a major milestone on the “long road” to legitimisingmedical cannabis as conventional medicine. G

STRATEGIC ALLIANCES

Sandoz on high afterlighting up joint deal

4 GENERICS bulletin 30 March 2018

COMPANY NEWS

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Issue 347 l 30 March 2018

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Published by OTC Publications Ltd, 4 Poplar Road, Dorridge, Solihull B93 8DB, UK.Tel: +44 (0) 1564 777550 Fax: +44 (0) 1564 777524Company registered in England No 02765878.© OTC Publications Ltd. All rights reserved.Generics bulletin® is registered as a trademark in the European Community.Printed by Warwick Printing Company Ltd. ISSN 1742-0784

Hovione has unveiled plans to increase its capacity in “existingtechnologies, like spray-drying”, as well as to “grow in newareas of business”, as it offered an update on its capacity expansionsin Portugal, Ireland and the US. Hovione’s expansion program isdue to “continue in the coming five years”.

The Portuguese firm stated that over the last two years, it hadrelocated its development services to a new local centre in Lisbon,near to its Loures manufacturing site. Noting that the new buildingwas fully equipped to handle potent and highly-potent compounds,Hovione observed that the facility employed 200 staff.

Since 2016, the Loures site has “expanded its drug-substancereaction vessel capacity with a small-scale production area and a newpilot plant”, adding 30 cubic metres of capacity. “One pilot and twolarge-scale spray-dryers were installed at the site, and started theoperation of a new drug-product centre equipped with oral-dosageform and inhalation manufacturing capabilities,” Hovione stated.

Over the next three years, the active pharmaceutical ingredient(API) supplier will add to the Loures site a new chemical synthesisand spray-dryer building for contract manufacturing, as well as twolarge spray-drying units, new formulation facilities for bigger batchsizes, and an additional 1,200 sq m of analytical laboratories.

Meanwhile, the firm has “doubled the size of its development andmanufacturing operations” in New Jersey, US, in the past two years(Generics bulletin, 24 June 2016, page 3), enhancing chemical andanalytical development, spray-drying and formulation capabilities.

Turning to its site in Cork, Ireland, Hovione said it was “reinstatingand renewing a production building with 157 cubic metres of chemicalsynthesis capacity devoted to contract manufacturing”. “About halfof this capacity will be ready for operation by May 2018.” G

MANUFACTURING

Hovione reveals threeplant expansion plans

India’s Malladi Drugs & Pharmaceuticals and the DominicanRepublic’s Labocont Industrial have received separate warningletters from the US Food and Drug Administration (FDA) regardingtheir manufacturing facilities. Inspections at the sites identified“significant” deficiencies from current good manufacturing practice(cGMP), relating to active pharmaceutical ingredients (APIs) andfinished-dosage forms respectively.

In September 2017, the FDA inspected Malladi’s Indian plantin Tamil Nadu. Noting that part of the facility was “open to theoutdoors”, the agency found that the firm “failed to take adequateprecautions to prevent the risk of contamination while producingdrugs using open equipment”. “Our inspector observed vermin, suchas birds and insects, in the facility.”

Furthermore, the company’s cleaning processes were deemed“insufficient”, with equipment “difficult to reproducibly clean”.Malladi did not “adequately validate” its API production process, with“24 batches yielding out-of-specification test results for an unspecifiedimpurity over approximately two years”. “Your firm rejected thesenon-conforming batches and reprocessed some of them,” the FDAsaid. The company was placed on import alert in December last year.

Meanwhile, an audit in June 2017 at Labocont’s Santo Domingosite in the Dominican Republic found that the company “does notcompletely and comprehensively separate production facilities, whichpresents an unacceptable risk of contamination”. Moreover, Labocontdid not ensure that complete assay-testing data of finished-dosageforms and APIs were maintained and reviewed by the quality unit,and analytical methods to determine assay of such products were“not validated and lack specificity”. The FDA placed the firm onimport alert in February this year. G

MANUFACTURING

Malladi and Labocontreceive FDA warnings

LONZA has entered into an exclusive partnership with Orkilathrough the Switzerland-based firm’s Capsule Delivery Solutionsbusiness, which enables Orkila to promote Lonza’s Capsugel rangein Egypt. “By leveraging Orkila’s extensive logistics network anddeep industry expertise,” Lonza stated, “we will be able to serveour Egyptian customers faster and more efficiently.” G

IN BRIEFTHERMO FISHER SCIENTIFIC is set to expand its footprint in theEuropean Union (EU), by investing US$35 million in a pharmaservices supply-chain facility in Rheinfelden, Germany. The new sitewill “significantly increase European capacity for cold and ambientclinical trial materials in support of complex clinical research”.Construction is due to begin in the final quarter of 2018. G

IN BRIEF


COMPANY NEWSBUSINESS STRATEGY/ANNUAL RESULTS

Krka has set up an “independent organisational unit” dedicated tobiosimilars as part of its stated intention to “embark on the areaof similar biological medicines”. Noting that a separate unit had beenset up “due to the scale and complexity of content in this field”, theSlovenian firm said it would place a “priority focus on treatmentsfor autoimmune diseases and diabetes”.

“When entering into new and technologically demanding areassuch as biosimilar medicines,” a Krka spokesperson told Genericsbulletin, “we establish connections with other companies andactivities.” Observing that the firm has “a special group of expertson recombinant technologies and products”, the spokesperson saidthese experts “actively follow products and technologies in differentdevelopment phases at potential partners”.

Although Krka declined to highlight specific molecules, the firmsaid it would “examine prospects for medicines from various therapeuticsegments, especially medicines for the treatment of diabetes andautoimmune diseases, and conduct diligent expert and business reviews”.

At the same time, Krka – as it reported sales ahead by 8% to C1.27billion (US$1.57 billion) in 2017 – has unveiled a five-year strategythat the company expects will enable it to achieve turnover growthof “at least 5% per annum on average” between 2018 and 2022. Italso plans to achieve an earnings before interest, tax, depreciation andamortisation (EBITDA) margin of 21%-25% over the period, buildingon the 24.2% margin achieved in 2017 with EBITDA that rose by athird to C307 million.

To achieve the target levels of profitability, Krka said it wouldpursue “carefully thought-out investments and an increased scope ofcontract manufacturing”. “In addition to organic growth, Krka intends toexpand by means of acquisitions and long-term business combinations,”the firm said, “including joint ventures in the case of commerciallyappealing and available acquisition targets”. “The primary objectivesare to acquire new products and to enter new markets,” Krka stated.

“Particular focus will be placed on the Chinese market in thecoming five-year period,” Krka said, “where major opportunities arearising in view of the increasing use of modern generic medicinesand changes in the regulatory environment”. The Slovenian firmrecently established a joint venture with Chinese player Ningbo MenovoPharmaceutical in which Krka holds a 60% share (Generics bulletin,24 November 2017, page 3). “The company will initially focus onregistering Krka’s products in China,” Krka said, noting that itexpects “the first major sales results” in two or three years.

China, Europe and central Asia are focusAlong with China, Krka says it will focus on European markets

and territories in central Asia, “striving to better utilise the salespotential of all sales regions”. The firm plans to “strengthen theprofessional and cost synergies within the Krka group, maximisingthe utilisation of competitive advantages in the business environmentsof Krka companies abroad”.

Russia remains Krka’s largest market, with sales that grew by afifth to C271 million in 2017, helping to boost turnover in the firm’sEast Europe region by 17% to C388 million (see Figure 1). Elsewherein the region, Krka said it remained the largest foreign supplier ofgenerics in Ukraine, where the pharmaceutical market had “started togrow again after years of decline and stagnation”, helping the firmto increase its local sales by 14% to C45.2 million.

“Stabilisation of the business environment” in Kazakhstan liftedKrka’s sales by 22% to C15.6 million, while the Slovenian firm notedthat double-digit increases were also achieved in Armenia, Azerbaijan,Belarus, Georgia and Tajikistan. Meanwhile, in Uzbekistan a 7%

rise produced turnover of C14.5 million.In Central Europe, 3% growth to C145 million in Poland –

where Krka ranks fourth among foreign generics firms – contributedto an overall 6% rise to C304 million in the region. In the second-largest individual market, the Czech Republic, an increase of 21%to C45.8 million made Krka the third-largest foreign generics player,while in Hungary 3% growth led the company to a C45.1 million totaland a second-placed ranking among non-domestic generics firms.

German tenders dent salesWest Europe saw Krka’s lowest regional increase, inching ahead

by just 1% to C286 million. This was achieved despite a 13% dropin Germany “due to lower sales of products through public tenders”.In the UK, Krka’s sales rose by 36% while double-digit growth wasalso achieved in France, Ireland, Italy, Portugal and Scandinavia.

Stagnant Romanian sales contributed C54.2 million, and Croatiansales ahead by 12% added C31.1 million to the total in South-EastEurope, which grew by 6% to C161 million. “Sales growth wasrecorded in all markets in the region, except for Romania and Bosniaand Herzegovina,” Krka observed.

Along with domestic sales that rose by 3% to C88.0 million –cementing the Slovenian firm’s leading position in its local medicinesmarket, with a 9% market share – Krka enjoyed sales in the rest ofthe world that rose by more than a tenth to C39.5 million. “The biggestcontribution was made by individual markets of the Middle East, theFar East and Africa,” Krka noted, “especially Iran and South Africa.”

In 2017, Krka noted that it had obtained marketing authorisationsfor 23 new products – including 17 prescription pharmaceuticals –in 46 presentations. New products included combinations ofamlodipine with olmesartan, candesartan and perindopril, while thefirm also obtained European marketing authorisations for erectile-dysfunction drugs including its Viavardis and Vardegin vardenafiltablets, as well as its Tadilecto and Tadagis tadalafil tablets.

New products – defined as those launched within the past fiveyears – made up a third of group sales.

More recently, the committee for human medicinal products(CHMP) within the European Medicines Agency (EMA) has justadopted a positive opinion recommending granting a marketingauthorisation for Krka’s pemetrexed 100mg and 500mg powder forconcentrate for solution for infusion, a rival to Eli Lilly’s Alimta. Gn [email protected]

Krka sets up a dedicated biosimilars unit

Figure 1: Breakdown by region and product group of Krka’s sales in 2017(Source – Krka)

East Europe 388.2 +17 31Central Europe 303.6 +6 24West Europe 286.1 +1 23South-East Europe 160.9 +6 13Slovenia 88.0 +3 7Overseas markets 39.5 +11 3

Krka 1,266.4 +8 100

Prescription 1,046.1 +9 83Non-prescription 119.2 +7 9Animal Health 63.2 +1 5Other 37.9 +3 3

Annual sales Change Proportion(C millions) (%) of total (%)


COMPANY NEWS

17-19 Apriln DIA Europe 2018

Basel, SwitzerlandIssues including policy and regulations, research and development,marketing and access will be covered at this three-day event.

Contact: Drug Information Association. Tel: +41 61 225 5151.E-mail: [email protected]. Website: www.diaglobal.org.

25 Apriln 14th Legal Affairs Conference

London, UKThis one-day conference organised by Medicines for Europe willcover legal and intellectual-property developments regardinggenerics and biosimilars. This event will be followed by the 16thBiosimilar Medicines Conference, at the same venue.

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

26-27 Apriln 16th Biosimilar Medicines Conference

London, UKThis Medicines for Europe conference will look at the latestregulatory topics, market access and procurement, andinternational developments within the biosimilars industry.


23-24 Mayn World Biosimilar Congress USA 2018

San Diego, USAThe agenda for this two-day meeting includes pricing,pharmacovigilance, bioanalytics and patent issues.

Contact: Terrapinn. Tel: +1 212 379 6320.E-mail: [email protected]. Website: www.terrapinn.com.

13-15 Junen Joint Medicines for Europe and

IGBA Annual ConferenceBudapest, HungaryThis joint Medicines for Europe and IGBA three-day conferencewill look at the latest developments within the industry.


24-28 Junen DIA 2018

Boston, USAThis is a four-day event which will cover topics including clinicaltrials, the biosimilars landscape, and regulatory issues.

Contact: Drug Information Association. Tel: +41 61 225 5151.E-mail: [email protected]. Website: www.diaglobal.org.

EVENTS – April, May, June

Tuesday 9 October 2018,Madrid, Spain

SAVE THE DATE...

Indian generics players Alembic Pharmaceuticals and Cipla have eachreceived ‘Form 483’ observations of good manufacturing practice(GMP) deficiencies from the US Food and Drug Administration(FDA), following inspections of plants in their home country.

Alembic said an FDA audit this month of its formulations facilityin Panelav, India, had resulted in three Form 483 observations. “Noneof the observations are related to data integrity or are repetitive innature,” stated the company, adding that it would shortly submit itsresponse on the observations to the agency.

Cipla said it had already responded to “certain observations whichare procedural in nature” following an inspection at its factory in Goathat was conducted in January prior to the approval of a specific,undisclosed product. “We do not foresee any impact on the otherproducts being manufactured and filed from the plant,” the Indianfirm stated, adding that it had already received two approvals forproducts linked to the site since the inspection. G

MANUFACTURING

Indian duo receive FDA 483s

Indian formulations and active pharmaceutical ingredients (APIs)supplier Bal Pharma has expanded its bulk drugs activities byacquiring all shares in privately-owned Golden Drugs. Bal paidRs20.66 (US$0.32) per share for the Udaipur-based firm, which hasnow become a wholly-owned subsidiary.

Bangalore-based Bal has also launched a joint venture withAustralia’s Akaal Pharma to develop veterinary drugs, including anoral treatment for atopic dermatitis in dogs. G

MERGERS & ACQUISITIONS

India’s Bal Pharma bulks up

Stada Arzneimittel’s controlling shareholders, the Bain Capitaland Cinven private-equity firms, have started a procedure tosqueeze out majority shareholders. A domination profit and loss transferagreement (DPLA) approved by the German firm’s extraordinarygeneral meeting in early February was entered into the company’scommercial register by a Frankfurt district court on 20 March,triggering a two-month window in which minority shareholders cantender their holdings to Bain and Cinven’s Nidda Healthcare holdingcompany in return for C74.40 (US$91.94) per share.

However, the offer period can be extended beyond May by apetition for a court ruling. Any minority shareholders who turn downthe C74.40 per share offer will be eligible for an annual gross payment

of C3.82 per share in lieu of an annual dividend.Stada – which recently slashed its 2017 dividend by 85% to

C0.11 per share as it looks to fund ambitious geographic expansion anda push into more complex products, including biosimilars (Genericsbulletin, 16 March 2018, page 1) – ended 2017 with Bain and Cinvenholding 65% of its 62.3 million shares. Institutional shareholders held33% of the firm’s shares, and private investors the remaining 2%. During2017, Stada’s share price rose by 79%, adding more than C2.4 billionto its market capitalisation that reached C5.50 billion at year-end. G

MERGERS & ACQUISITIONS

Stada’s owners startsqueeze-out offering


MARKET NEWS

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Just under a third of commercial payers in the US gave preferenceto biosimilars over their reference products in 2017, while morethan a quarter of payers required members to follow a step-therapyprotocol placing the biosimilar before the original reference brand.This is according to the eighth annual Medical Pharmacy TrendReport that has just been published by Magellan Rx Management.

Meanwhile, of payers who did not require a step therapy, “only31% planned to implement step therapy in the future”. “Payersindicated that a significant cost differential of 27% would be necessaryfor them to implement a step therapy protocol”.

The report also claims that last year, for biosimilars on the market,commercial payers used the Medicare national social insuranceprogram reimbursement model “for 53% of lives”.

Payment for biosimilars under this model – which provide pass-through ‘transitional’ reimbursements for products in the MedicarePart B programme – is made at wholesale acquisition cost (WAC)plus 6% for the first two quarters the product is available, and thenat average sales price (ASP) plus 6% of the reference product’s ASPwhen ASP data for the biosimilar becomes available.

“Although 67% of plans that manage both commercial and Medicarelines of business utilised the same models, suggesting ‘ASP plus x%’would be the dominant model in Medicare, 41% of Medicare liveswere under a Medicare reimbursement model,” the report notes. G

MARKET RESEARCH

Third of payers preferbiosimilars in the US

Fluticasone propionate inhalers represented the largest NationalHealth Service (NHS) spending on prescriptions through communitypharmacists and dispensing doctors or dentists in England last year,according to a prescription cost analysis conducted by NHS England.And fellow respiratory drugs beclometasone dipropionate and budesonidewere also among the top-five molecules measured by net ingredient cost(NIC) excluding value-added tax (VAT), while tiotropium ranked eighth.

According to the NHS Digital figures, dispensing 5.99 millionitems of fluticasone propionate led to an NIC of almost £272 million(US$385 million) in 2017, giving a net cost per item dispensed of£45.38. Beclometasone ranked fourth with an NIC of £209 millionfrom 12.4 million units, just ahead of a budesonide NIC of £182 million.

Enteral nutrition products came second in the list, ahead ofpregabalin in third with an NIC last year of nearly £216 million,implying an average cost for each of 6.25 million items dispensed of£34.48. Pfizer’s Lyrica (pregabalin) reference brand has faced genericcompetition in the UK for several years, and midway through 2017lost patent protection for its pain indication.

Measured by the number of items dispensed in the UK – excludingproducts dispensed through hospitals or on private prescription –atorvastatin led the way, ahead of levothyroxine sodium, omeprazole,ramipril and amlodipine. Simvastatin, aspirin, lansoprazole, colecalciferoland bisoprolol fumarate rounded out the top 10 by volume. G

MARKET RESEARCH

England counts costof respiratory drugs


MARKET NEWS

The US Federal Trade Commission (FTC) has fallen short inlitigation alleging Shire’s ViroPharma waged a “campaign ofserial, repetitive, and unsupported filings” with the US Food andDrug Administration (FDA) and US courts, notably FDA citizenpetitions, to unlawfully delay generic competition to the originator’sVancocin (vancomycin) capsules by two years, after a US districtcourt granted ViroPharma’s motion to dismiss the complaint.

However, Delaware District Court Judge Richard Andrews foundthe FTC had identified potential antitrust violations committed byViroPharma, and therefore gave the Commission leave to amend itscomplaint “in reasonable time”.

In February last year, the FTC sued ViroPharma for allegedlyviolating Section 5(a) of the FTC Act, which prohibits “unfair ordeceptive acts or practices in or affecting commerce” (Genericsbulletin, 17 February 2017, page 15). Specifically, the FTC allegedthat ViroPharma “harmed competition and consumer welfare” by“inundating the FDA with regulatory and court filings – 46 in all – todelay the FDA’s approval of generic Vancocin capsules”. The FTCsought a permanent injunction and “other equitable relief”.

In a two-part decision, Andrews was ultimately persuaded byViroPharma’s argument that the FTC had not sufficiently pleadedthe facts necessary to invoke its authority under Section 13(b) of theFTC Act. Relating to judicial enforcement, this section of the Actempowers the FTC to obtain preliminary and permanent injunctiverelief “for any provision of law that the FTC enforces”.

ViroPharma had put this argument forward in its oppositionopening brief to dismiss the case that was filed in April last year(Generics bulletin, 21 April 2017, page 14).

ViroPharma not ‘about to violate’ a lawThe FTC’s ability to seek a permanent injunction was dependent

on it having reason to believe ViroPharma “is violating, or is aboutto violate a law”, Andrews stated, concluding that, with regards to thesecond part, the FTC’s 45-page complaint “contains nothing by way offacts that plausibly suggest ViroPharma ‘is about to violate’ any law”.

Shire acquired ViroPharma in January 2014, and divestedVancocin seven months later, according to the originator, whichhas claimed to “played no role in ViroPharma’s challenged petitioning,which took place between 2006 and 2012”.

However, Andrews disagreed that ViroPharma’s petitioningconduct before the FDA was protected under the US Noerr-Penningtondoctrine, which extends immunity under antitrust laws to businesseswhen they petition for government action that may have anticompetitiveeffects. A so-called ‘sham-exception’ to this immunity is tied to thedoctrine, where petitioning is a pretense “to interfere directly withbusiness relationships of a competitor”.

“I think the allegations in the complaint, taken as true, are sufficientat this stage to overcome ViroPharma’s ‘presumptive antitrustimmunity under the Noerr-Pennington doctrine’,” Andrews found.

He agreed with the FTC that whether ViroPharma’s petitioningwas “in fact a sham” under differing standards – depending onwhether there is a single petition or a series of petitions at issue, whichthe parties disagreed over – was a “factual inquiry, which cannot beresolved at the motion to dismiss stage”. “Thus, I will not dismissthe FTC’s complaint on the basis that ViroPharma’s petitioningactivity is immune under Noerr-Pennington,” Andrews noted. Gn [email protected]

LITIGATION

Vancocin FTC caseis dismissed for now

BELGIUM has become the latest European Union (EU) memberstate to issue a clarification on calculating and correcting theduration of supplementary protection certificates (SPCs) in thewake of the Court of Justice of the EU’s (CJEU’s) Seattle Geneticsdecision. The country’s intellectual-property office has released acircular stating that the relevant date for a centralised marketingauthorisation is the date on which the approval was published inthe EU’s Official Journal, while the respective date for nationalauthorisations is the date of notification. Where there is no officialnotification date for a national approval, the office intends to applythe date of the marketing authorisation. France and Sweden recentlyissued similar clarifications (Generics bulletin, 9 March 2018, page 10).

TMMDA – Turkey’s Medicines and Medical Devices Agency – isdrawing industry’s attention to requirements that drug packagingfor human medicines must include embossed Braille letteringfrom the end of this year.

AAM – the US Association for Accessible Medicines – insistsrestricting or banning patent-litigation settlements would “keepbiosimilar and generic drugs off the market with no patient benefit”.Such a move, it contends, would help originators to abuse thepatent system. Rather, the trade body argues, Congress shouldaddress brand firms’ tactics to delay competition by restrictingaccess to samples. The AAM is calling on legislators to pass thebipartisan Creating and Restoring Equal Access to EquivalentSamples (CREATES) Act that would allow firms to sue originatorsthat withhold the samples needed for bioequivalence and biosimilaritytesting or that refuse to negotiate shared safety protocols.

TRIPS – trade-related aspects of intellectual-property rights –flexibilities under the terms of the World Trade Organization (WTO)agreement are used more frequently “than is commonly assumed”,according to a paper published in the World Health Organization(WHO) bulletin. Having identified 176 instances of the possibleuse of TRIPS flexibilities by 89 countries – of which 100 examples,or 56.8%, included compulsory or non-commercial use licences –the Dutch authors suggest these offer a “practical legal pathway”to provide access to lower-cost generics.

ESTONIA’S MEDICINES AGENCY “welcomes requests to actas the reference member state (RMS) for medicines authorisedin mutual-recognition or decentralised procedures” that currentlyhave the UK as the RMS. The Estonian agency said it would notcharge fees for changing the RMS, but stressed that Estonia wouldhave to already be a concerned member state (CMS) in the relevantprocedure and that all ongoing regulatory procedures, such asvariations and renewals, would have to be completed before aswitch could take place. According to the agency, Estonian humanmedicines sales at wholesaler level exceeded C300 million (US$370million) for the first time last year, growing by 3.8% to C301 million.Of that total, 69% or C209 million came through communitypharmacies and another 30% or C89.7 million through hospitals.Other outlets contributed C2.7 million.

THE NETHERLANDS’ ACM – the Authority for Consumers andMarkets – has named prescription drug prices as one of its“four key priorities” to address this year and next. Insisting that“competition in the pharmaceutical sector contributes to innovationand the affordability of medicines”, the watchdog pledged tocollaborate with the Dutch healthcare authority, the NZa, as wellas with equivalent bodies abroad, and to “enter into a dialogue”on drug pricing with stakeholders. G

IN BRIEF


MARKET NEWS

The UK may seek to align with the US Food and Drug Administration(FDA), if the country fails to secure full regulatory alignmentwith the European Union (EU) on medicines as part of negotiationsover its ‘Brexit’ withdrawal from the EU, according to a UK Houseof Commons health and social care committee report on the impactof Brexit on medicines.

Negotiators have just agreed the terms of a transition period ina move that has been approved by the European Council. Welcomingthe development, industry associations including Medicines forEurope and the British Generic Manufacturers Association (BGMA)have urged clarity over a future trading and regulatory relationship“as soon as possible”.

Stressing that it should be a priority for both the UK and EU tosecure “the closest possible regulatory alignment” as part of the nextround of negotiations over the terms of Brexit, the committee reportemphasises that “the overriding message from almost all of theevidence received in this inquiry is that the UK should continue toalign with the EU regulatory regimes for medicines”.

However, the report acknowledges, “at the same time, the UKgovernment should also be open to exploring other potential tradeand regulatory agreements with the wider international life sciencescommunity”. If full regulatory alignment with the EU is not secured,it suggests, “a distant second-best option for the life science industryand patients in the UK would be alignment with another large marketsuch as the FDA in the US”.

“While this form of alignment would raise significant financialand patient safety issues, it remains preferable to the UK endeavouringto create a standalone regulatory system after leaving the EU,” thecommittee’s report states.

“Rather than undermining the UK’s negotiating position, clarityabout contingency planning to guarantee patient safety and continuedhealth supplies will strengthen the UK’s negotiating position bydemonstrating that we have a credible fall-back position,” thecommittee insists in its report.

“The European Medicines Agency (EMA) has published itsguidance on what is necessary for the UK to maintain continuedaccess to medicines in a ‘no deal’ scenario,” in the event that EUand UK negotiators fail to reach an agreement, the committee notes,“and we believe that this one-sided picture may harm confidence ifit is not possible to compare it to the government’s planned approach.”“Calming the fears of life science companies to prevent them frominvesting in a ‘no deal’ scenario should be considered a priority inthe next round of negotiations.”

Nevertheless, the report makes clear that securing collaborationand close regulatory alignment with the EU remains the mostdesirable outcome. “In order to minimise harm to their citizens, bothsides should look to secure the closest possible regulatory alignmentas a priority in the next round of negotiations”, as well as “mutualrecognition of pharmacovigilance mechanisms”, it recommends.

“Brexit poses huge challenges to the life science sector andcarries a number of unintended consequences for patients and the UKNational Health Service (NHS),” the report warns. “Failure to achievean ongoing collaboration would signal the triumph of politicalideology over patient care.”

Responding to the committee’s report, BGMA director generalWarwick Smith said maintaining close ties with the EU after Brexitwas of “the utmost importance”.

“Continued regulatory alignment, along with free and frictionlesstrade, will be the best way of ensuring that UK patients can continueto access a safe and secure supply of generic and biosimilar medicines,”

Smith stated. “We strongly support the committee’s recommendationsof maintaining regulatory alignment with the EMA, and of seekingmutual recognition of standards and pharmacovigilance arrangementsand qualified persons.”

Cautioning that “any divergence from current arrangements oradditional costs of bringing medicines to market are likely to resultin delays in the NHS and UK patients accessing generic medicines”,Smith said this was “especially crucial for biosimilar medicines”.If the UK ceased to be part of the EU regulatory framework, hepointed out, “a new route of authorisation would need to be createdto allow UK patients to benefit from these medicines”, which hesaid had the potential to save the NHS up to £300 million (US$425million) annually by 2021.

In its report, the committee suggests that “the nature and levelof UK ‘regulatory drift’ in the life science sector from the EU besystematically assessed at regular intervals by current and future UKgovernments, in order to prevent issues over a lack of harmonisationoccurring in the future”. The UK should also “aim to have a seat atthe International Council on Harmonisation of Technical Requirementsof Pharmaceuticals for Human Use (ICH) in its own right”, thereport suggests, urging the UK government to apply for full ICHmembership “at the earliest opportunity”.

Specifically referring to generics, the report notes that “if theUK diverges from EU regimes in a manner that adds to the cost andtimeliness of existing supply chains”, patients could “stand to waitlonger to access generic drugs coming off-patent”.

Fewer generics firms in the marketIt cites evidence given by Smith as part of the inquiry, indicating

that adverse effects on supply chains leading to higher costs would riskgenerics firms “relinquishing their licences and marketing authorisations,so there could be fewer manufacturers in the marketplace”.

Generic competition “at the moment, in normal times, keepsthe market pretty resilient”, Smith told the committee, observingthat “the more manufacturers there are of the same molecule, themore options we have if there are supply difficulties”. “That is a keyobjective for the generic industry in keeping that competitive multi-source market going.”

While the UK had stated an intention to maintain regulatoryalignment with the EMA (Generics bulletin, 9 March 2018, page 1),the report acknowledged, the European Council had stated that – inlight of the UK ruling out continued membership of the EU singlemarket and customs union – “preserving the integrity of the singlemarket excludes participation based on a sector-by-sector approach”.

Moreover, the report states, “it is not just prudent, but essential,that scrutiny is undertaken of the UK Department of Health andSocial Care’s contingency planning for a ‘no-deal’ situation”. “Wealso recommend that the government undertake further contingencyplanning on the impact on the supply chain in the event of failure toachieve free and frictionless trade in pharmaceutical products.”

“The committee is right to consider the consequences of a‘no-deal’ scenario,” Smith commented, “and it is vital that theUK has sufficient contingency plans in place.” The BGMA, heemphasised, would “continue to work with the government tominimise the risk of any negative impact on patients”.

Meanwhile, the Brexit Health Alliance – which brings togetherthe NHS along with industry, medical researchers as well as patientand public health organisations – said that both the UK and EUnegotiators “need urgently to address the future co-operation model”.Gn [email protected]

REGULATORY AFFAIRS

UK may turn to FDA with no EMA deal


PRODUCT NEWS

Orion says it has “received positive conclusions” in a decentralisedmarketing-authorisation procedure for its salmeterol/fluticasoneEasyhaler dry-powder inhaler, after submitting a marketing-authorisation application in April last year. The firm chose Swedenas its reference member state for the decentralised procedure thatcovers 22 European Union (EU) member states.

Noting that the combination drug was “the sixth member of theEasyhaler product family intended for the treatment of asthma andchronic obstructive pulmonary disease (COPD)”, Orion pointed outthe firm had completed trials for the product in December 2016.

“We are satisfied with the favourable results in a challengingdevelopment area,” commented Christer Nordstedt, the company’ssenior vice-president of pharmaceutical research and development.“The salmeterol/fluticasone combination product will strengthenOrion’s Easyhaler product family that utilises the same inhalertechnology and offers diverse treatment options.”

Last year, the Finnish firm revealed it was expanding its localEasyhaler facility in Espoo (Generics bulletin, 16 June 2017, page 15),in order to support approval for its salmeterol/fluticasone combination,and also to prepare for the anticipated demand from expanding thegeographic footprint of its Bufomix (budesonide/formoterol) combination.

Orion recently revealed it was developing a tiotropium formulationfor European markets, noting that a bioequivalence study was “ongoing”.

In 2017, turnover from Easyhaler products – which form part ofOrion’s Proprietary Products division – rose by a fifth to C77 million(US$94.8 million), mainly due to sales of Bufomix. ProprietaryProducts turnover stagnated at C351 million, and accounted foralmost a third of group sales, which inched up by 1% to C1.08 billion.G

RESPIRATORY DRUGS

Orion moves forwardwith Easyhaler in EU

Alvogen is one step closer to introducing a generic sublingual filmformulation of Indivior’s Suboxone (buprenorphine/naloxone)in the US, after a Delaware district court ruled that the Icelandicfirm’s abbreviated new drug application (ANDA) does not infringeasserted claims in three US patents protecting the opioid dependencetreatment. Indivior plans to appeal, but admits that any genericlaunch “could potentially result in a rapid and material loss of marketshare for Suboxone film in the US”. Alvogen had agreed not to launchbefore the earlier of a favourable district court ruling or 19 April 2018.

The patents in question – 8,017,150, 8,603,514 and 8,900,497,with expiry dates ranging from February 2023 to March 2030 – areall owned by US oral-film technology specialist MonoSol RX andlicensed to Indivior. Alvogen did not challenge the validity of anyof the asserted claims. As Generics bulletin went to press, the USFood and Drug Administration (FDA) had not approved anybuprenorphine/naloxone sublingual film formulation ANDA products.

Noting that Indivior had not presented any evidence at trial withrespect to the ‘150 patent and had agreed that it was not infringedunder the court’s claim construction, Delaware District Judge RichardAndrews summarised that “at issue in this case is the process fordrying the sublingual film”. Alvogen’s “conventional” drying processdid not infringe the drying limitations of the ‘514 and ‘497 patent,nor the ‘visco-elastic film’ limitation of the ‘497 patent, he concluded.

Last year, Andrews had found that Dr Reddy’s ANDA productdid not infringe the same three patents (Generics bulletin, 8September 2017, page 13). Furthermore, Endo’s Par and Teva’sWatson were found not to infringe asserted claims in the ‘497 patent,but Andrews rejected the three firms’ obviousness attacks against allthree patents. Shortly afterwards, Indivior reached a patent-litigationsettlement with Mylan (Generics bulletin, 29 September 2017, page 12).

Alvogen is also among the ANDA filers against which Indivioris asserting its newly-listed US patents 9,855,221 and 9,687,454,that expire in February 2022 and August 2029 respectively (Genericsbulletin, 16 February 2018, page 14). G

OPIOID-DEPENDENCE THERAPIES

Alvogen succeeds inUS Suboxone lawsuit

Nippon Kayaku is able to manufacture and sell biosimilartrastuzumab in Japan after obtaining a marketing approval for thecancer treatment that it developed jointly with South Korea’s Celltrion.The partners had struck a co-development and marketing deal forthe rival to Roche’s Herceptin branded original in November 2010.

In July 2015, Nippon Kayaku announced that it would useits local expertise to extend a global Phase III clinical trial for thebiosimilar trastuzumab – also known as CT-P6 – to Japan. Thecompany submitted a marketing authorisation application for the drugto Japan’s Ministry of Health, Labour and Welfare (MHLW) arounda year ago (Generics bulletin, 21 April 2017, page 13).

Covering 60mg and 150mg strengths of the monoclonal antibody,Nippon Kayaku’s marketing authorisation for CT-P6 is indicated foradvanced or recurrent gastric cancer overexpressing HER2. The firmsaid it anticipates “early launch” of the product. Nippon Kayakunoted that Celltrion “has already received approvals in the EuropeanUnion (EU) and Korea” for biosimilar trastuzumab.

Trastuzumab is the second biosimilar monoclonal antibody forNippon Kayaku, and its third biosimilar overall. Having in 2013introduced filgrastim into its domestic market through an alliance withTeva (Generics bulletin, 17 May 2013, page 16), the Japanese firmfollowed up a year later by launching infliximab (Generics bulletin,5 December 2014, page 31). G

ONCOLOGY DRUGS

Kayaku advances trastuzumab

Apotex has failed to convince a Canadian federal court that it isentitled to damages for losses suffered while the firm was keptoff the market by patent-infringement procedures started by AstraZenecato protect the Nexium (esomeprazole magnesium) brand. FederalJudge George Locke ordered Apotex to pay the originator’s costs,having found that Apotex’ production process using a titaniumcatalyst infringed Canadian patent 2,193,994.

Furthermore, Locke decided, there was “no evidence to supportApotex’ assertion” that the company would have marketed an Apo-Esomeprazole generic that did not infringe Canadian patent 2,139,653in the period between Health Canada having completed a review ofApotex’ abbreviated new drug submission (ANDS) on 11 December2009 and a patent hold on generic approval ending on 16 June 2010.

A decision by Canada’s Supreme Court on 30 June 2017 tooverturn a finding that the ‘653 patent was invalid for lack of utilitymeant that any sales of the generic during the patent-hold period wouldhave infringed the ‘653 patent that “is, and always was, valid”. G

GASTROINTESTINAL DRUGS

Apotex is denied on Nexium


PRODUCT NEWS

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].

Pregabalin capsules continued to see their average UK tradeprices tumble in late March, according to the latest figuresreported by WaveData.

Comparing average UK trade prices between 1-28 February2018 and 1-26 March 2018, WaveData found that pregabalincapsules in eight presentations experienced average declines ofbetween a quarter and around two-fifths. A pack of 84 pregabalin25mg capsules cost 41% less than in February at £7.44 (US$10.56),despite the cheapest available price climbing by 15% to £3.39.Similar declines of between 33% and 39% were seen for 84-capsulepacks of the 50mg, 100mg and 200mg strengths, as well as for56-count packs of 225mg capsules.

Meanwhile, 56-capsule packs of pregabalin 25mg and 75mgcapsules saw average price drops of 27% to £4.38 and £3.77respectively, while the same pack size of 300mg capsules fell by 25%to £6.00. All averages were calculated from at least 35 data points.

Separately, 28-count packs of pioglitazone tablets in 15mg,30mg and 45mg strengths continued to reflect the steep increasesseen earlier in the month (Generics bulletin, 23 March 2018,page 9). The lowest strength saw the biggest rise of 964% to£7.69, while the 30mg presentation jumped by 835% to £8.88and the 45mg tablets soared by 804% to £10.20. G

PRICE WATCH ....... UK

The availability of biosimilar rituximab in India has significantlyincreased access for patients since its launch in 2007, althoughthe efficacy of such complex products remains problematic tounderstand without Phase III clinical trial data, according to a recentstudy published in the Indian Journal of Cancer.

More than a decade ago, in April 2007, Dr Reddy’s Laboratoriesannounced the availability of the company’s Reditux (rituximab)biosimilar. Roche’s MabThera (rituximab) original “has been in usein India since 2000”, a separate report notes.

“Biosimilar products have greatly increased the accessibility tocostlier antibodies in low- and middle-income countries like India.However, these drugs are often approved for use without large Phase IIIefficacy trials comparing them to the innovator molecules.”

According to the study, which was financially supported byIndian cancer-treatment and research centre, The Cancer Institute,the biosimilar was licensed in India based on a single-arm study inpatients with diffuse large B-cell lymphoma (DLBCL), meaning aretrospective analysis featured as part of the study “is often the onlymeans to understand the efficacy of these drugs”.

“Although these results are not a substitute for randomisedPhase III trials, these can increase confidence among physicians usingthe biosimilar molecule when it is not possible – due to economicconsiderations – to use the innovator product,” the report claims.

“At our centre, [greater than] 90% of patients of DLBCL treatedin 2014–2015 received rituximab, and this has been possible due tothe availability of biosimilars,” the report notes. “A randomisedblinded trial comparing the innovator and biosimilar rituximab…hasbeen now completed and the results are awaited.” G

ONCOLOGY DRUGS

Indian rituximab helps access

Hikma has through its US West-Ward Pharmaceuticals subsidiarylaunched “the first AB-rated generic” version of AbbVie’s Norvir(ritonavir) 100mg tablets. According to the US Food and DrugAdministration (FDA) approval letter, the Jordanian firm was the“first applicant to submit a substantially complete abbreviated newdrug application (ANDA) for ritonavir 100mg [tablets], with oneor more paragraph IV certifications”. Therefore, the agency noted,Hikma was eligible for 180-days of exclusivity.

“We will be launching ritonavir with additional patient supportand co-pay assistance to ensure more people are able to access thislife-saving medicine,” commented Brian Hoffman, president ofHikma’s Generics division. West-Ward was “engaging with advocacygroups to better understand how to communicate and support patientsand healthcare providers”, Hikma stated. Furthermore, the subsidiarywas set to launch an education and awareness campaign, including“a website and direct communication”.

As Generics bulletin went to press, West-Ward was the onlyfirm to hold a final approval for a generic version of Norvir, whileMylan, Cipla, Hetero Labs and Aurobindo had tentative approvals.

According to the FDA’s Orange Book, six patents protect theHIV drug, with expiry dates ranging from January 2020 to March2027, including six months of paediatric exclusivity. Citing Iqvia data,Hikma said US Norvir sales in 2017 were around US$209 million.G

HIV DRUGS

Hikma launches USritonavir exclusively

Dr Reddy’s and Sandoz, as well as Teva at-risk, have launchedthe first generics of Helsinn Healthcare’s Aloxi (palonosetron)0.25mg/5ml intravenous injectable in the US. The Swiss-basedoriginator has responded by licensing an authorised generic of thechemotherapy-induced nausea treatment to Cipla.

Regarding Teva’s generic, the originator is currently petitioning theUS Supreme Court for a writ of certiorari to review and reverse an earlierUS Court of Appeals decision that invalidated patents shielding theantiemetic brand – a landmark interpretation of the America Invents Act’s(AIA’s) on-sale bar provision (Generics bulletin, 5 May 2017, page 11).

Helsinn is asking the Supreme Court to consider whether, underthe AIA, “an inventor’s sale of an invention to a third party that isobligated to keep the invention confidential is an act that can invalidatea patent”. A response to the petition is due on 2 April.

Reddy’s and Sandoz’ launches resulted from separate patent-litigation settlement agreements, which were both announced in 2015.

According to the FDA’s Approved Drug Products database, Reddy’s,Sandoz and Teva currently hold abbreviated new drug application(ANDA) approvals for the 0.25mg/5ml strength, while the Indian andIsraeli firm also hold approvals for the 0.075mg/1.5ml strength. Nichi-Iko’sSagent has a tentative approval for the 0.25mg/5ml strength.

Citing Iqvia data, Teva said Aloxi injectable sales in the US werearound US$459 million for the 12 months ended November 2017. G

ANTIEMETICS

Cipla rivals three onAloxi generics in US

Pregabalin prices plummet


PRODUCT NEWS

Momenta and Sandoz face the prospect of paying treble damagesto Amphastar over allegations the two firms “restricted tradeand prevented competition in the manufacture and sale of genericenoxaparin” in the US, after a district judge denied Momenta’s bidto dismiss the US-based specialty company’s antitrust lawsuit.

The antitrust case revolves around Momenta and Sandoz’ allegedinvolvement in the US Pharmacopeia (USP) approving and adoptingUSP Method 207 – the process for establishing a drug standard totest enoxaparin products – in December 2009, and the subsequentalleged use of steps in USP Method 207 that are protected byMomenta’s US patent 7,575,886. Momenta and Sandoz representativesare alleged to have participated in USP panel discussions that culminatedin USP Method 207, and coerced Sanofi to abandon a pending patentapplication containing claims that would read on the method.

The case was initially dismissed, in July 2016, a decision latercriticised by the US Federal Trade Commission (Generics bulletin,18 November 2016, page 19), before being revived in March last year.

Sandoz received US Food and Drug Administration (FDA)approval for its Lovenox (enoxaparin) generic in July 2010, holdinga monopoly in the generics market for around 14 months untilAmphastar’s approval in September 2011. However, “two days afterreceiving approval” Momenta sued Amphastar for infringing the‘886 patent, preventing the firm from marketing generic enoxaparin.

According to Amphastar, the FDA required generic enoxaparinmanufacturers to “comply with USP Method 207 as a condition ofapproval”, meaning that the ‘886 patent “excluded unlicensedcompetitors from receiving FDA approval”, and, ultimately, preventednew entrants to the market. Amphastar added that Sandoz was theexclusive licensee of the ‘886 patent under a “profit-sharing,contractual relationship with Momenta”.

“Amphastar alleges that defendants violated the Sherman[antitrust] Act by (1) entering into an agreement in restraint of tradewhich blocked it from selling generic enoxaparin and (2) wrongfullyacquiring monopoly power by deceiving the USP into adopting astandard which they later claimed was covered by defendants’patent,” summarised Massachusetts District Judge Nathaniel Gorton.

And siding with Amphastar, Gorton found that the firm “hassufficiently alleged that defendants’ actions before the USP, whilethat organisation was considering the proposed standards forenoxaparin, were a material cause of Amphastar’s antitrust injury”.

“Amphastar has plausibly alleged that it was required to use USPMethod 207 to obtain and maintain its generic enoxaparin approvalfrom the FDA,” Gorton found. “The existence of alternatives is afactual question inappropriate for resolution on a motion to dismiss.”Gorton also found plausible the plaintiff’s argument that the collaborationagreement between Sandoz and Momenta “created financial incentives”for the companies to exclude enoxaparin rivals.

A jury trial in the case has been set for 9 September 2019, 21days earlier than initially scheduled. Jack Zhang, Amphastar’s chiefexecutive officer, said the company could “proceed to assert ourtreble damages under antitrust law”.

Meanwhile, in the linked patent invalidity and infringement caseinvolving the ‘886 patent, Gorton has entered final judgement infavour of Amphastar, following a US federal jury ruling from Julylast year, that claims of the patent are invalid for lack of enablementand written description (Generics bulletin, 28 July 2017, page 18). Gn [email protected]

ANTICOAGULANTS

Momenta and Sandozfail on US enoxaparin

SANDOZ has resolved US patent litigation with Amag Pharmaceuticalsover Feraheme (ferumoxytol) 30mg/ml, 17ml single-dose vials.Under the terms of the settlement, Sandoz may launch a genericon 15 July 2021, “or earlier under certain circumstances”, and willpay a royalty on sales of the generic to Amag until the last OrangeBook patent for Feraheme expires. “If Sandoz is unable to secureapproval by such date,” Amag noted, “Sandoz will launch anauthorised generic version of Feraheme on 15 July 2022 for up to12 months.” Six US patents shield Feraheme, five of which expirein March 2020 and one in June 2023.

MYLAN has launched in the US a generic version of Bristol-MyersSquibb’s Mutamycin (mitomycin) 5mg, 20mg and 40mg single-dose vials, shortly after receiving approval from the US Food andDrug Administration (FDA). The product is used in combinationwith other drugs to treat stomach and pancreatic cancers.

SAWAI has received approval from Japan’s ministry of health,labour and welfare (MHLW) for its rival to Boehringer Ingelheim’sSifrol (pramipexole hydrochloride) 0.125mg and 0.5mg tablets tobe used for mild-to-moderate restless legs syndrome, in additionto treating Parkinson’s disease. The approval therefore expandsthe indication “to include the same uses as their brand equivalents”.

AMERIGEN has received approval from the US Food and DrugAdministration (FDA) for the first generic version of Hikma’sWest-Ward Pharmaceutical’s cyclophosphamide 25mg and 50mgcapsules. Noting that its generic capsules were manufactured byStason, Amerigen said it expected to launch in “the near future”.

TELIGENT has secured US approval for its halobetasol propionate0.05% ointment, the company’s second approval this year. Teligentsaid the product was due for launch in “the second quarter of 2018”.

SUN PHARMA has obtained approval from the US Food andDrug Administration (FDA) for Ilumya (tildrakizumab-asmn),used to treat moderate-to-severe plaque psoriasis. The approvalwas supported by data from two Phase III studies.

EXELTIS has acquired the Gynotran (metronidazole/miconazole)brand from Bayer “to be marketed throughout Latin America”. Theagreement “projects a transition period of two years” for the vaginalinfection treatment, covering countries in Central and South America.Women’s Health specialist Exeltis said the deal was “part of Exeltis’specific strategy to increase its presence in the Latin American market”.

GRANULES has received approval from the US Food and DrugAdministration (FDA) for its metformin 500mg and 750mgextended-release tablets, which are equivalent to Bristol-MyersSquibb’s Glucophage XR. The firm expects to launch imminently.

ZYDUS CADILA has secured final approval in the US for metroprololextended-release tablets, available in 25mg, 50mg, 100mg and200mg strengths. The drug to treat hypertension will be manufacturedat the Indian firm’s formulations facility in Ahmedabad, India.

PERRIGO has received final approval from the US Food and DrugAdministration (FDA) for the store brand OTC equivalent of ReckittBenckiser’s Mucinex DM maximum strength (guaifenesin/dextromethorphan hydrobromide) 1,200mg/60mg extended-releasetablets. Noting that the drug would be packaged and marketed as astore brand or retailer ‘own label’ brand, Perrigo said it was finalisingplans to launch the tablets “for the 2018 cough-cold season”. G

IN BRIEF

BUSINESS STRATEGY


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Figure 3: Reported and forecasted annual sales by standalone Impax and Amnealbetween 2014 and 2021 based on figures included in a definitive proxy statement(Source – Impax)

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Figure 4: Reported and forecasted annual adjusted earnings before interest, tax,depreciation and amortisation (EBITDA) by standalone Impax and Amneal between2014 and 2021 (Source – Impax)

By 9 April, Impax Laboratories believes it couldhave completed its merger with Amneal andadopted the latter’s name, subject to approval fromshareholders and the US Federal Trade Commission(FTC). If completed, the merger – first announced inmid-October last year (Generics bulletin, 20 October2017, page 1) – will create “the fifth-largest US genericscompany” by value with a pro forma turnover in 2017of US$1.81 billion, and gross US generics sales, as perIqvia data, of US$2.6 billion last year (see Figure 1).

But while the combined company expects to see“tangible benefits from increased scale”, including astronger relationship with customers through a broaderproduct portfolio, it will still be considerably smallerthan the US ‘big three’ of Teva, Mylan and Sandoz.

Questioned about how the new Amneal would beable to compete against larger players as the US drug-distribution environment evolved and consolidated,Impax’ president and chief executive officer, PaulBisaro – who will take on the role of executive chairmanof the combined group – highlighted the opportunityto form strategic alliances.

“Because of the portfolio we bring to the table,and the uniqueness of that portfolio, we can partnerwith companies that have more commodity-likeproducts to help us get to that scale,” he told delegatesto a Barclays healthcare conference held in Miami, US.The new Amneal, he said, could form a “sort of jointventure to get ourselves in a position where we can beof the same scale” as the three US market leaders.

Bisaro maintained the “real challenge” was how tonavigate in the evolving marketplace to be able to reachthe patient. “This is a very new idea for generic firms.”

Bisaro said firms needed to find ways to makethemselves relevant to patients. This, he suggested,could be achieved not just through launching generics,but also by establishing “a branded OTC franchise”.

Customer consolidation that had led to three buyingconsortia accounting for 85% to 90% of all retail genericpurchasing in the US had, he said, “changed the overalldynamic and forced us to think about new ways to

deal with that new environment”. He noted that Amnealwas watching closely developments such as Amazon’shealth insurance partnership with Berkshire Hathawayand JP Morgan, or CVS’ US$69 billion bid for Aetna.

Stressing that the combined company wouldcontinue to work closely with the three key consortiaof ClarusOne, Red Oak and Walgreens Boots AllianceDevelopment (WBAD), Bisaro believed that “we haveto prepare for a future that is probably going to haveadditional players in it”. “And we have to decidewhether we are going to be one of those players or weare going to be supporting one of those players, andhow do we best position ourselves for that,” he stated,adding that “we want to be a leader in that space”.

Moving “up the food chain” from generics intospecialty brands was not the only option. “We maylook to go a different route into different adjacencies.”

Bisaro acknowledged that the “playbook” that heand incoming Amneal chief executive officer BobStewart had followed at Watson and Actavis/Allergan

Injectable17%

IR Tablets36%

Capsules/Soft Gels11%

Oral Liquid7%

ER Tablets13%

Topical8%

Nasal Spray1%

Transdermal3%

Other3%

Ophthalmic1%

Figure 2: Breakdown by product type of Amneal’s and Impax’combined pipeline of approximately 173 abbreviated new drugapplication (ANDA) filings (Source – Amneal/Impax)

Amneal plans to partneron path to US top tableForming strategic

partnerships for both

commodity generics

and biosimilars is high

on the agenda for the

management team

of Amneal and its

merger partner Impax.

Aidan Fry reviews

the company’s plans

to compete with the

leading US players.

15GENERICS bulletin

BUSINESS STRATEGY

30 March 2018

“does not really necessarily work in this newenvironment” as distribution, purchasing and insurancemodels changed rapidly. “Looking to adjacencies inthe space is probably a place where we will start,” hesaid, stressing that the company would continue toexplore deals for assets that would strengthen its existinggenerics and specialty brands franchises.

Reflecting on the same theme, Stewart noted that“the way we built Watson all the way up throughAllergan was basically to have a core generics business,then go for international scale, move up into higher-margin products, and then start shifting to brands, doubledown on brands... and then do the large transaction”.

“In this case, that still could be part of it,” hecontinued, “but also we need to think about do we getinto branded OTCs, do we start thinking about adjacenciesother than just having a core generics business thatthen branches up into specialty. We are going to haveto play in all of those arenas, and the core of what wehave to do is make sure that we have a differentiatedportfolio, no matter what adjacency we are playing in.”

Any push into the OTC arena would be basedaround niche brands rather than a store-brand offering,Stewart revealed. “I do not necessarily want to rushout to build a plant to produce ibuprofen tablets,” hestated. Impax’ existing specialty brands franchise had,he pointed out, recently been strengthened by theissuance of a US patent protecting Rytary (carbidopa/levodopa) extended-release capsules until 2028.

In the generics arena, the combined company –which will also have a presence in the US biosimilarsarena through Amneal’s licensing deal for two productswith Adello Biologics (see box entitled ‘Amneal willbe biosimilars fast follower’) – will boast around 200product families and a pipeline of around 173 filedabbreviated new drug applications (ANDAs), as well asmore than 140 projects in the development pipeline.

As Figure 2 shows, immediate-release and extended-release tablets make up almost half of the filed ANDAs,with the other half coming from an array of deliveryformats. But immediate-release and extended-releasetablets represent less a quarter of the combined company’spre-filing development pipeline of around 143 projects,with a fifth of projects covering injectables, andophthalmics and oral liquids each accounting forabout a tenth. Furthermore, 5% of development projectsare for inhalation drugs, supported by Amneal’spurchase from Adello in October 2017 of a facility formetered-dose inhalers (MDIs) and dry-powder inhalers(DPIs) in Cashel, Ireland.

Observing that legacy Amneal had historically“over-invested” in product development relative toits size – the privately-owned US company last yearspent US$158 million, or more than 15% of itsUS$1.03 billion turnover on research and development –Stewart said the combined group would devote about10% of its sales to building out its pipeline. “There isno shortage of opportunities to work on,” he insisted.

With legacy Amneal benefitting from recentlaunches such as busulfan vials and budesonide capsulesin January, isotretinoin capsules and methylphenidateextended-release tablets in February, and oseltamivirsuspension as well as tiagabine and erythromycintablets in March – and having drugs including genericCopaxone (glatiramer acetate) in its pipeline – theprivately-owned company is set to be the key sales

growth driver for the combined group through to 2021(see Figure 3). And as Figure 4 demonstrates, legacyAmneal also anticipates a notable step-up in its adjustedearnings before interest, tax, depreciation andamortisation (EBITDA) over the next few years.

Stewart said the combined company would, likeits industry peers, partner on biosimilars. But otherwise,the firm had the capabilities and capacities “to developand produce every dosage form that is out there”,from nasal sprays and topical patches to ophthalmics,respiratory drugs and injectables. Acquiring rights toproducts such as OTC brands or hospital injectablescould accelerate the firm’s growth, he noted. “But asI look across the infrastructure, there is not anythingthat we are in need of.”

And even after Impax sold its plant in Taiwan forUS$18.5 million (Generics bulletin, 12 January 2018,page 4), the company believes it has “[production]capacity to support growth for the foreseeable future”,capable of making around 20 billion units per year.Utilisation rates at several of the group’s sites in the US,Ireland and India are currently at less than 50%. G

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Figure 1: The top 20 US generics players, based on reported and pro forma gross sales in 2017(Source – Amneal/Impax/Iqvia)

Amneal intends to be “a fast follower, not necessarily a trailblazer” in thebiosimilars arena once it merges with Impax, according to the company’srecently appointed chief executive officer, Bob Stewart. And the firm intends toadopt a “partnership approach” to broaden its pipeline beyond the two productsthat it has licensed in the US from privately-owned developer Adello Biologicsthat had filgrastim accepted for filing by the US Food and Drug Administration(FDA) in September last year. That deal includes future milestone payments toAdello ranging between US$99 million and US$181.5 million, as well as Amnealpaying half of net profits after manufacturing and marketing costs.

Predicting that it would take “a little bit longer” for US biosimilars uptaketo develop in “a meaningful way”, Stewart said Amneal would be “selective interms of where we place bets” as it struck deals. “We will probably err moretowards the institutional side of things, as opposed to trying to go after a morespecialty kind of model,” he explained. “We will look at making sure that wehave got a portfolio in which we can be competitive and that fits our overallsales model, complementing our other institutional business, like injectables.”

While Amneal intended to possess internal expertise in biosimilar developmentand commercialisation, Stewart said he saw no pressing need to invest inmanufacturing capabilities. Observing how titre yields had improved such thatlarge-scale stainless steel reactors were largely redundant, he said any productioninvestment was likely to be into flexible bag technologies. G

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Lannett is strengthening its management team with two appointments.Grant Brock has joined the US-based player as vice-presidentof operations, while Alicia Evolga will take up the position of vice-president of marketing from 2 April.

Brock was formerly vice-president of operations for US-baseddrug-delivery technology firm Aprecia Pharmaceuticals, havingpreviously served in manufacturing and engineering roles with Teva.

“Grant brings expertise that will improve operational efficienciesthroughout the company,” commented chief executive officer TimothyCrew, who joined Lannett at the turn of last year (Generics bulletin,12 January 2018, page 20). “He will be responsible for ensuring thatwe continue to provide a reliable high-quality supply of medicinesmanufactured in full compliance with current good manufacturingpractice (cGMP).”

Evolga is a “creative and savvy marketing strategist and leader”,noted Crew, boasting “more than 10 years of marketing experiencewith expertise leading effective strategy, product management, cross-functional team management and revenue growth in the genericpharmaceutical industry”. Most recently she served with Cipla USAand previously worked for Lupin, Apotex and Impax.

John Kozlowski has served as Lannett’s chief operating officersince October 2017, while Kevin Smith – a 16-year veteran of thecompany – is currently senior vice-president of sales and marketing. G

APPOINTMENTS

Lannett names headsof ops and marketing

AMNEAL – along with Impax, ahead of their combined merger –have provided an update on the new firm’s “leadership identificationprocess”. Allergan’s chief operating officer, Rob Stewart – whorecently joined the current standalone Amneal business as companypresident (Generics bulletin, 22 December 2017, page 3) and isset to transition to president and chief executive officer of the newAmneal (Generics bulletin, 9 February 2018, page 16) – “recentlymet with the proposed senior leadership team”. “Over these weeks,Rob has met with these leaders to discuss his high-level visionand strategy for the new Amneal post-close,” the firms divulged.“The senior leaders [have] began the process of designing theirfunctional organisations, aligned to the strengthened capabilities,talents and goals of the combined company.” Stewart had also beenworking to finalise leadership selections for both the Tech Ops andCorporate Development functions, the companies noted. “We aremaking good progress in both areas and expect to communicatemore details shortly.” The firms expect to complete their mergerimminently (see page 14).

MERCK & CO has appointed Jennifer Zachary as generalcounsel, effective from 16 April. She will be responsible for thefirm’s global legal, security and aviation, and environmental, healthand safety organisations, and will also be a member of Merck’sexecutive committee. She succeeds in the role Michael Holston.Currently, Zachary is a partner at law firm Covington & Burling,in the company’s food, drug and device practice group.

CVS HEALTH has named Derica Rice as the president of itspharmacy benefit management (PBM) business, CVS Caremark,effective from 30 March. In the role, he will have “day-to-dayleadership and oversight of the PBM business, including sales andaccount management, operations, mail-service pharmacy andspecialty pharmacy”. He will also focus on driving PBM strategy,new business development and client relationship management andretention. Rice joins from Eli Lilly, where he most recently servedas executive vice-president of global services and chief financialofficer of the originator.

ORION has re-elected seven board members following its recentannual meeting, including Sirpa Jalkanen, Ari Lehtoranta,Timo Maasilta and Hilpi Rautelin. The other members are EijaRonkainen, Mikael Silvennoinen and Heikki Westerlund.Westerlund has also been re-elected as chairman.

FEBELGEN has welcomed Antoon Daneels as the Belgian genericsand biosimilars industry association’s pharmaceutical policy officer.He joins FeBelGen from Krka, where he held the role of regulatoryaffairs manager for the Slovenian organisation.

PFENEX director Dennis Fenton “will not stand for re-election atthe company’s next annual meeting”, the firm has revealed. Pfenexinsisted that Fenton’s decision was “not the result of a disagreementwith the company on any matter relating to the company’s operations,policies or practices”. He will continue to serve as a director ofthe board “until the expiration of his term”.

CPHA – the US Consumer Healthcare Products Association – haselected Gary Downing as chair of its board of directors followingits annual executive conference this month. The CPHA has alsore-elected 10 members to its board, including Milan Kalawadia,vice-president and head of OTC and Specialty Generics at Dr Reddy’s.Among the five newly-elected board me

gen 30-3-18 pgs.1-16 › ...on the agenda for the management team of amneal and its merger partner...

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