UKexpectstos ave75% fromadalimumabrivals - Generics Bulletin · l...

30 November 2018

UK expects to save 75%from adalimumab rivalsSavings of around 75% on the cost of adalimumab are expected by the UK’s National

Health Service (NHS) “after negotiating deals with five manufacturers on low-costversions of the health service’s most costly drug”. The NHS said it had “moved swiftly todrive strong competition between biosimilar manufacturers and the manufacturer of theoriginator brand, resulting in huge cost discounts”.

“The deal should mean hospitals pay around a quarter of the more than £400 million(US$513 million) each year they currently spend on adalimumab,” the NHS said, meaningthat NHS England was “on course on its ambition to cut £300 million from the nation’s annualmedicines bill by 2021 through greater use of best value biological medicines a year early”.More than 46,000 patients are currently prescribed AbbVie’s Humira original.

Acknowledging that the saving – “the biggest inNHS history from a single drug negotiation”– was unlocked by the introduction of biosimilar adalimumab following four European launchesin October (Generics bulletin, 26 October 2018, page 1), the NHS added that the £300 millionfigure was “double previous estimates”, having recently forecasted savings of £150 millionfrom its tenders (Generics bulletin, 26 October 2018, page 14). NHS England said it hadaccepted bids from the four biosimilar suppliers – Amgen, Biogen, Mylan and Sandoz – as wellas AbbVie. Biosimilars are expected to be available from December, while “the ongoing use ofHumira may also continue where clinically appropriate or where it is the best value”.

“Harnessing the power of competition between drug companies, NHS England has now freedup hundreds of millions of pounds of savings to reinvest in patient care,” NHS chief executiveSimon Stevens said. “This is another example of how the smarter approach to biosimilar medicinesin the UK and Europe gives patients and taxpayers a much better deal than they get in the US.”NHS England guidance to trusts and clinical commissioning groups (CCGs) directs that nine outof 10 new patients should be started on the “best value” biological medicine within three monthsof a biosimilar launch, with at least 80% of existing patients switched within 12 months. G

Generics bulletin gets even betterFrom December, Generics bulletin is evolving to provide our subscribers with even greater

and more timely insight into the global generics, biosimilars and value-added medicinesindustries. As Generics bulletin joins the Informa Pharma Intelligence portfolio of industry-leading news and information services, we will soon bring you a digital-first offering allowingyou to access the same dedicated industry insights that you have come to expect fromGenericsbulletin for more than 15 years, but with all the advantages that an online news serviceprovides, along with an updated look for the print edition from our next issue on 14 December.

Generics bulletin will provide up-to-the-minute continuous coverage of stories as theyhappen, through a new online platform that you can customise to meet your specific needs,supported by free newsletter alerts delivered to your inbox daily. Subscribers who currentlyreceive a weekly print copy of Generics bulletin will continue to do so, as well as so muchmore – including a content archive that gives you searchable access to old stories as well as new.We will also offer access to a broader network of dedicated analysts and journalists – includingour colleagues at Scrip, Pink Sheet and In Vivo – bringing you a greater connection to industryexperts, more content and coverage of market events and their impacts from around the globe.

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COMPANY NEWS 3Mylan gets warning for Morgantown site 3

Indoco expects audit to end FDA warning 3

Cambrex to expand by acquiring Avista 4

European hopes were too high, says Orion 4

Krka firms up its focus on global footprint 5

Doc Generici’s share climbs by almost 1% 6

Pharmathen launches will bolster its profits 7

Weininger controls Fair-Med via MBO 7

MARKET NEWS 8German draft offers firms pro and cons 8

Key to added value is continuous innovation 9

Substitution target is set at 90% in France 10

UK providers call for more biosimilar data 10

Chinese cities team for national tender 12

Biosimilars Canada picks patient provider 12

PRODUCT NEWS 13Three firms in EU get nods on pegfilgrastim 13

US court vacates Suboxone injunction 13

Actavis Quillivant XR finding is overturned 14

Krka is victorious on Danish esomeprazole 14

US appeals refuses to grant a bar on Zytiga 15

FEATURES 18Industry must evolve to adopt 18hybrid model for future growth

Polpharma Group expanding 22its capacity for biologicals

Olafsson seeking to stretch 24results of Hikma’s spending

REGULARSEvents – Conferences and meetings 8

Price Watch UK – Our regular listing 14

Pipeline Watch – Emend 16

People – MHRA chief Hudson 27quits ahead of Brexit

Issue No.378

The next issue ofGenerics bulletin willbe published on

Friday 14 December 2018.

Gen 30-11-18 Pgs.1-32.indd 1 27/11/2018 17:00

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3bulletin30 November 2018

COMPANY NEWS

MANUFACTURING

Mylan gets warningfor Morgantown siteMylan has suffered a further manufacturing setback at its flagship

facility in Morgantown, US, after the US Food and DrugAdministration (FDA) issued the site with a warning letter concerningits finished-dosage forms. Following an inspection at the plant from19 March to 12 April, the agency identified “significant violations” ofcurrent good manufacturing practice (cGMP) and said it may withholdnew approvals linked with the site.

The FDA said that Mylan’s cleaning validation and verificationprogram for manufacturing equipment “is inadequate to prevent crosscontamination”. “Your firm has had many recurring incidents in whichvisible drug residues were found on non-dedicated equipment after theequipment was deemed clean by multiple staff,” the agency observed.In January, Mylan opened an investigation after a technician found“visible residues of nitrofurantoin in the form of a yellow powder”on the encapsulation machine, after producing batches of verapamilextended-release capsules, a white-powdered drug product. The FDAalso described Mylan’s cleaning program as “insufficient”, and saidthat the firm “continued to experience cleaning swab failures related todetergent residue across numerous pieces of non-dedicated equipment”.

Mylan’s investigations into out-of-specification results andprocess deviations were deemed “inadequate” by the agency, as“root causes did not consistently include scientifically supportedconclusions”. “Changes in blend size, formulation, and manufactureof your drug products were not evaluated consistently, appropriately,or thoroughly before execution,” the FDA continued. “In many cases,you failed to use your change management system for significantchanges.” Numerous batches with “major process changes” were notincluded in Mylan’s stability program.

Similar deficiencies at Mylan’s Indian injectables facility inBangalore, as well as at its Agila Specialties formulation and sterileproduct division sites, also in Bangalore, were cited in a warning letterin August 2015, and at its Maharashtra plant in India in April 2017.“These repeated failures at multiple sites demonstrate that Mylan’smanagement oversight and control over the manufacture of drugs isinadequate,” the FDA concluded, recommending a cGMP consultant.

Earlier this year, Mylan received a 32-page ‘Form 483’ reportfrom the FDA that listed 13 observations citing issues with quality-control procedures, equipment cleaning and maintenance, laboratorycontrols and reviews of batch failures (Generics bulletin, 6 July 2018,page 7). This led the firm to implement a “comprehensive restructuringand remediation plan” at the plant, discontinuing several products andcutting staff (Generics bulletin, 31 August 2018, page 3).

The restructuring and remediation issues were partly responsiblefor Mylan’s North American sales sliding in both the second and thirdquarters of this year, which slumped by over a fifth to US$1.00 billionand by 14% to US$1.01 billion respectively.

In response to the warning letter, Mylan stated that the issuesraised by the FDA“are being addressed within the context of [Mylan’srestructuring and remediation] plan”. “We have been in regular contactwith the FDA,” the US firm commented, “and will continue to workto ensure that the agency is satisfied with the steps we have taken toresolve all the points raised in the warning letter.”

Noting that the facility “continues to supply products for the USmarket while we are executing on our commitments to the FDA”,Mylan said that the company “did not expect to have any significantnew product launches from the site in 2019”. Gn [email protected]

BUSINESS STRATEGY

Intellipharmaceutics has dealsIntellipharmaceuticshasentered intoexclusive licensinganddistributionagreements with distributors in Malaysia, Vietnam and the Philippines– for several of its extended-release generic drugs. Each deal requiresthe distributor to purchase a minimum yearly quantity of all productsincluded in the agreements, and is subject to regulatory approval andearly termination. No financial details have been disclosed.

A Malaysian company has been granted the exclusive right toimport and market locally Intellipharmaceutics’ generic Seroquel XR(quetiapine), available in four strengths: 50mg, 200mg, 300mg and400mg. Intellipharmaceutics said it was also in discussions with thedistributor to include other products in the agreement.

The Canada-based firm has entered a similar deal with aVietnamese company, but this also includes exclusive rights to genericsof Glucophage XR (metformin) 500mg and 750mg and Keppra XR(levetiracetam) 500mg, in addition to generic Seroquel XR in 50mg,150mg and 200mg strengths.

Intellipharmaceutics has also agreed a deal with a pharmaceuticaldistributor in the Philippines, to import and market in the countrygeneric versions of Seroquel XR, Glucophage XR and Keppra XR, aswell as generic Focalin XR (dexmethylphenidate) and the group’s firstnovel drug formulation, abuse-deterrent oxycodone ER. G

MANUFACTURING

Indoco expects auditto end FDA warningIndoco Remedies expects in the near future to receive a clean bill ofhealth from the US Food and DrugAdministration (FDA) for its sterileand solid-dose facilities in Goa, India. The Indian company anticipatesthe FDA issuing an establishment inspection report (EIR) that willremove a warning letter sent by the agency last year and will enable thefirm to secure abbreviated new drug application (ANDA) approvals.

On 14-21 November, Indoco revealed, the FDA had inspectedboth its Plant II steriles and Plant III solid dosage sites situated onthe Verna industrial estate in Goa. “The inspection concluded withIndoco receiving two minor observations, none of which are repeat innature,” the company disclosed, adding that it would respond to theFDA’s observations “within the stipulated time of 15 days”.

In the warning letter that the FDA sent to Indoco at the endof March last year (Generics bulletin, 14 April 2017, page 3), theagency had highlighted a repeat observation of leakages from solutionproducts and had recommended that the company retain a currentgood manufacturing practice (cGMP) consultant. Deficiencies listedin the letter included failing to establish and follow adequate writtenprocedures for handling complaints and failing to ensure procedureswere followed by the firm’s quality control unit.

Insisting that the firm was committed to the “highest quality inmanufacturing, operations, systems integrity and cGMP culture”,Indoco’s managing director, Aditi Kare Panandikar, said the positiveoutcome of the FDA’s latest inspection “will now pave the way forapproval of our pendingANDAs, with a consequent boost to revenues”.

In May this year, Indoco’s active pharmaceutical ingredient (API)plants in Patalganga and Rabale also passed FDA audits. Shortlyafterwards, the Indian firm announced that it had set up a manufacturingcompliance cell, supported by third-party consultants, to improve itsdata-integrity procedures (Generics bulletin, 15 June 2018, page 5).G

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4 bulletin 30 November 2018

COMPANY NEWS

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ISSN 1742-0784

BUSINESS STRATEGY

European hopes weretoo high, says OrionThere is “no question that the overall biosimilar industry was too

optimistic on the pricing of biosimilars, at least in the Europeancontext”, according to Orion’s president and chief executive officer,Timo Lappalainen.

“The US may be a different story, but I think in Europe whatwe’ve seen in the biosimilars being recently introduced, especially inthe tenders environment, we see very low price levels. That means thatyou have to have a cost-effective supply chain, and there may be pointswhen there’s not enough money for the middle man,” Lappalainen said.

Speaking to investors during the recent Jefferies 2018 HealthcareConference, held in London, UK, the Finnish firm’s chief made hiscomments in light of reports – “our understanding and in the press” –that AbbVie had bid at an 80% discount for its Humira (adalimumab)original in a tender in Norway.

Acknowledging that Orion had recently struck a sales andmarketing collaboration with Amgen for the US firm’s Amgevita(adalimumab) biosimilar in Finland, Lappalainen made clear: “We arenot in the Humira business at all outside of Finland, where it is not atender product. It is not a hospital product in Finland.”

Amgevita, “Finland’s first adalimumab biosimilar,” would belaunched “in the very near future,” Lappalainen revealed. Earlier thisyear, Orion estimated Finnish sales of Humira to be around €50 million(US$57 million) per year at present.

Through sales and marketing deals with Celltrion in the Nordicregion and certain Eastern European markets, Orion has built upa portfolio of biosimilars that includes Remsima (infliximab) andRitemvia (rituximab), as well as Herzuma (trastuzumab). “The launchschedule of trastuzumab remains open,” Orion noted earlier this year,“and depends on the patent situation and on the timing of tenderingcompetitions, among other things.”

Exemplifying the challenges for biosimilar players in tender-driven markets, Orion’s combined biosimilar sales tumbled by 57.1%to €19.1 million in the first nine months of this year, after Orion failedto win national winner-takes-all infliximab tenders in Denmark latelast year and in Norway earlier this year.

“Luckily, the profitability of our biosimilar business is at thelower end of our business,” Lappalainen acknowledged at theJefferies conference, implying that it would not weigh too heavilyon the group’s overall profitability. G

MERGERS & ACQUISITIONS

Cambrex to expandby acquiring AvistaCambrex has entered into a definitive agreement to acquire Avista

Pharma Solutions for approximately US$252 million, addingearly-stage active pharmaceutical ingredient (API) and finished-dosage form development and testing services to its global contractdevelopment and manufacturing network.

Contract development, manufacturing and testing organisationAvista is a portfolio company of Ampersand Capital Partners, ahealthcare-focused private equity firm, that offers “a broad suiteof scientifically differentiated services”. These services range fromAPI and drug-product development and production to standaloneanalytical, microbiology testing and solid-state sciences.

Avista operates four facilities, including three in the US – one inDurham, North Carolina, another in Longmont, Colorado, and onein Agawam, Massachusetts – along with a UK site in Edinburgh,Scotland. The firm has “worked on more than 200 small moleculesfor approximately 180 customers so far in 2018”. “Including themicrobiological testing business,Avista has over 400 active customers,and is expected to generate approximately US$65 million in annualrevenue in 2018,” Cambrex observed. Avista’s 330-person workforceis set to join Cambrex’ 1,700 employees across the US and Europe.

“The acquisition is expected to be funded with a combination ofcash in hand and borrowings under Cambrex’ existing revolving creditfacility, which in conjunction with this transaction, will be increasedthrough the accordion feature,” Cambrex stated. The firm has “securedcommitted financing for the proposed increase”. Noting that theacquisition was subject to customary closing conditions, Cambrex saidthe deal was slated to close by the end of this year. The firm expectsthe transaction to be accretive to adjusted earnings per share in 2019.

In September, Cambrex acquired contract development andmanufacturing organisation (CDMO) Halo for US$425 million(Generics bulletin, 21 September 2018, page 4). This included addingHalo’s US facility in Whippany, New Jersey, and its Canadian site inMirabel, Québec. “Like the Halo transaction,” commented the bulk-drugs producer’s president and chief executive officer Steve Klosk,“this acquisition opens up an exciting new segment of the market andbrings a large number of new customer relationships to Cambrex.”

“We are very excited to be joining the Cambrex team,” addedPat Walsh, Avista’s chief executive officer, “and believe the growthsynergies as a result of this combination will be significant.” G

Issue 378 l 30 November 2018

Managing Editor: David WallaceExecutive Editor: Aidan Fry

Gen 30-11-18 Pgs.1-32.indd 4 27/11/2018 17:00


COMPANY NEWS

BUSINESS STRATEGY/NINE-MONTH RESULTS

Krka firms up its focus on global footprintKrka is keen to expand its geographic presence beyond its stronghold

in Europe, especially by capitalising on the “huge opportunity” inChina. But it has no immediate plans to build a major presence inthe Americas, according to the Slovenian group’s management boardmember David Bratoz.

Bratoz told delegates to the Jefferies London HealthcareConference earlier this month that expanding the role of Krka’sOverseas Markets region – which, in the first nine months of this year,accounted for just 3.4% of group turnover that advanced by 5% to €972million (US$1.10 billion) – would be “a very strong focus for Krka inthe years to come. This our smallest region, but also the region with thehighest potential,” he insisted.

Revealing that the Slovenian group was “doing well in marketssuch as Iran and Iraq”, Bratoz said Krka was working with a networkof local distribution partners not only in the Middle East and NorthAfrica (MENA) region, but also in Africa and Asia through marketssuch as Ghana, SouthAfrica, Malaysia and Vietnam, as well as China.

Towards the end of last year, Krka – which had set among itsstrategic goals to 2022 prioritising “European, Chinese and centralAsian markets” – formed a joint venture with its existing Chinesepartner Ningbo Menovo Pharmaceutical through a deal that saw theSlovenian group take a controlling 60% share in return for a €30millionequity investment (Generics bulletin, 24 November 2017, page 3).

Bratoz explained that the venture would give Krka a pathway into“the second-largest generics market worldwide” that was increasinglyapplying quality standards in line with those in the European Union(EU) and the US. Given the requirement to manufacture or to conductbioequivalence trials locally, he argued that it made sense to form aventure with a local player. The venture’s goal, he outlined, was toregister locally as much of Krka’s existing portfolio as possible andto produce locally, with the first sales expected in 2020. “We aretalking here about sales in the tens of millions,” he told delegates tothe Jefferies conference.

Nine-month Overseas Markets turnover that grew by 9% to €32.8million (see Figure 1) included sales in Africa and the Far East thatclimbed by 23% to €15.8 million, more than compensating for a 2%slip to €16.2 million in theMiddle East. TheAmericas – predominantlycountries in Central America – contributed just €0.8 million to theOverseas markets total.

Responding to a question about Krka’s ambitions in theAmericas,Bratoz argued that “it makes no sense for us” to target a US genericsmarket that had been flooded by companies from Asia, includingIndia. Pointing out that Krka had briefly led the US market forenalapril before “prices got destroyed in a couple of months”, he saidthe Slovenian group already had plenty of room to expand within itsexisting footprint of around 70 countries. The US was “not a priority”.

Similarly, he described as “not the most important area forus” building up Krka’s existing presence in the OTC arena. Non-prescription product sales ahead by 5% to €87.4 million made up 9.0%of group turnover in the first nine months of 2018 (see Figure 2).WhileOTC played a significant role for the group’s operations in Russia,Ukraine and the former Yugoslav republics, Bratoz acknowledged, hesaid Non-Prescription sales would have to be “three times larger” forthe group to justify pouring large sums into mass-market advertisingto build international brands. “We see much better margins in thePrescription business, and even in Animal Health,” he commented.

Prescription Pharmaceuticals sales grew in line with the nine-monthgroup performance by increasing by 5% to €804 million, driven by 15%growth in Krka’s South-East Europe region, a 12% rise in OverseasMarkets, a 7% increase in East Europe and a 6% gain in Central Europe.Viewed by country, sales shot up by 75% in Finland, by a third inScandinavian countries, and by about a fifth in Italy and Ukraine.

Within total turnover in Krka’s West Europe region that slippedby 3% to €211 million, a 6% rise in sales under its own label throughlocal Krka subsidiaries almost made up for sales through third-partydistributors that tumbled by nearly a fifth to account for 30% ofturnover in the region. Prescription sales in West Europe generatedalmost €188 million.

The weaker West Europe performance was due to a 21% slideto €51.0 million in Germany as the local Tad Pharma operationsurrendered tender deals for gastrointestinal and metabolic treatments.The German fall was offset to a significant degree by sales inScandinavia climbing by 39% to €29.5 million.

Sales growth of 13% in Spain and of 24% in Italy more thancancelled out an 11% fall in France on weaker third-party turnover.

Launches including Co-Dalneva (perindopril/amlodipine/indapamide), Dilaxa (celecoxib) and Telmista (telmisartan) helped tolift Russian sales by 2% as reported, but by 16% on a local-currencybasis, to €189 million, making up the bulk of turnover in Krka’s EastEurope region that rose by 6% to €288million. Central Europe turnoveralso grew by 6% to €240 million, aided by a 4% rise to €113 million inPoland and 14% growth to €37.9 million in the Czech Republic.

Sales growth of more than a third in Bulgaria and Serbia pushedup turnover in South-East Europe by 14% to €132 million. LaunchingRasalsya (rosuvastatin/valsartan) and Parnido (paliperidone) helpedto lift the Slovenian group’s domestic turnover by 3% to €68.6million, of which €29.0 million came from Prescription drugs. Gn [email protected]

East EuropeC287.6m+6%

Central EuropeC239.6m+6%

West EuropeC211.0m-3%

South-East EuropeC132.3m+14%

SloveniaC68.6m+3%

Overseas marketsC32.8m+9%

Figure 1: Breakdown by region of Krka’s group turnover that rose by 5% to €972million in the first nine months of 2018 (Source – Krka)

Figure 2: Breakdown by product group of Krka’s group turnover that rose by 5% to€972 million in the first nine months of 2018 (Source – Krka)

Product GroupNine-month

sales(C millions)

Change(%)

Proportionof total(%)

Prescription Pharma 804.3 +5 83

Non-Prescription Pharma 87.4 +5 9

Animal Health 50.4 +4 5

Resorts/Tourist Services 28.3 +4 3

Other 1.5 -10 -

Krka 971.9 +5 100

Gen 30-11-18 Pgs.1-32.indd 5 27/11/2018 17:00


COMPANY NEWSBUSINESS STRATEGY

Doc Generici’s shareclimbs by almost 1%Italian branded generics specialist Doc Generici had obtained a15.9% share of the Italian retail generics market as of the end ofthe third quarter of 2018, up marginally from 15.1% in the prior year.

Revealing the figures to attendees to the recent Jefferies 2018Healthcare Conference, held in London, UK, Doc Generici’s chiefexecutive officer, Gualtiero Pasquarelli, pointed out that only fiveplayers commanded between them an 87% share of the market: Teva,Mylan, Doc Generici, Stada and Sandoz.

The privately-owned firm – which was swallowed up by privateequity and investment advisory firm CVC Capital Partners in 2016 –said for the 12 months ended 30 September 2018, its sales had risenby 13% to C202.3 million (US$230 million). Over the same period oftime, the Milan-based firm’s earnings before interest, tax, depreciationand amortisation (EBITDA) had climbed by more than a fifth – 22%– to C77.5 million.

Discussing market conditions for players in the Italian retailmarket, Pasquarelli noted that with generics having achieved arounda 22.3% share by volume of the market, penetration was “far below”other major European markets; nevertheless, he underlined, marginson such products were typically much higher in Italy.

Earlier this year, Italian industry associationAssogenerici reportedthat off-patent brands continued to dominate the Italian market byvolume, holding a share of around 52%. Patent-protected brands madeup the remaining quarter (Generics bulletin, 29 June 2018, page 7).

Pointing out that the average penetration figure for genericproducts in major European markets was around 55% – “anywherebetween 40-60%, depending on your definition of generic”, he said –Pasquarelli opined that for Italy it would take a “large period of timeto reach the average penetration figure in Europe”.

Nevertheless, Pasquarelli was optimistic about Doc Generici’sprospects in the coming years. He pointed to a patent cliff that wouldtake place between 2022-2024, when a “whole class” of type 2diabetes drugs and oral anticoagulants will lose protection in Italy. G

STRATEGIC ALLIANCES

Zentiva and Phoenix team upSanofi’s Zentiva has formed a “strategic partnership” with European

wholesaler Phoenix, through which the companies will work on“commercial opportunities to provide better access to Zentiva productsfor the benefit of patients across Europe”.While Zentiva noted that thefirst projects were being rolled out in Central and Eastern European(CEE) markets, the firm did not provide further details about thecollaboration, nor any financial details.

“In Phoenix, we are confident that we have found the right partnerfor distribution and commercial activities,” commented Robert Storch,Zentiva’s head of trade and revenue. “We are looking forward toexpanding our collaboration to benefit even more markets in future.”

Nemanja Jankovic, head of partnerships at Phoenix’ CorporatePharma Services and Sourcing, stated: “We believe that Zentiva is anexcellent fit for partnering at European level, thanks to their strongheritage, broad portfolio of generics and OTCmedicines, and presencein a large number of European markets.” Headquartered in Mannheim,Germany, Phoenix “considers itself to be a link between manufacturerand patient” and is active in 27 countries. G

STRIDES PHARMA SCIENCE’S board of directors hasapproved the Indian firm’s participation in the Series B fundraiserof its former subsidiary, Stelis Biopharma, with a commitment ofUS$15 million in a US$100 million fund raise. Currently, Stridesowns a 36.25% stake in Stelis, which “in the last 24 months hasadvanced significantly, with two of its lead assets now ready forfiling in the regulated markets”. “The first close of the currentfund raise is US$35 million, of which Strides will commit US$15million and US$20 million is from other existing shareholders,” thefirm explained. Strides noted that Stelis has completed constructionat its biopharma manufacturing facility in Bengaluru, India. Thedrug-product block is “in the final stages of validation” and isexpected to go commercial for manufacturing and high-end contractdevelopment and manufacturing organisation (CDMO) services inthe fourth quarter of the 2019 financial year. The drug-substanceblock will be commercially online by the first quarter of 2020.

ALKEM has revealed that the US Food and Drug Administration(FDA) conducted an inspection at its Indian bioequivalence facilityin Taloja, Maharashtra, from 8-14 November, with no ‘Form 483’observations issued.

PILATUS COMPARATOR SOLUTIONS has announced that itsUS facility in Long Island “is now fully licensed and operational”.“This move will greatly strengthen Pilatus Comparator Solutions’global position and has already enhanced access to manufacturersand suppliers in the US,” stated the sample-sourcing specialist. Thisfollows the company’s opening of its facility in Germany earlierthis year, which “has greatly enhanced sourcing capabilities of thegroup and has ensured stability of service provision post Brexit”.

PIRAMAL PHARMA SOLUTIONS says its new current goodmanufacturing practice (cGMP) kilo lab suite at its activepharmaceutical ingredient (API) site in Ennore, Chennai, in India,will formally open on 1 December 2018. The facility – whichhas capabilities from early development through commercialmanufacturing, with an available capacity of over 300kl – supplieskey starting materials, registered starting materials, advancedintermediates and APIs for both large pharmaceutical and biotechfirms in North America, Europe and Rest of World markets.

ROQUETTE has appointed Barentz as its preferred distributionpartner for its plant-based pharmaceutical product range in Europe.The firms had “been successfully working together for many yearsin several European countries by developing distribution channelsbacked by a strong technical expertise”, the companies noted ina joint press release. The collaboration is expanding to includeAustria, Cyprus, France, Ireland, Malta, Switzerland and the UK, inaddition to countries includingBelgium, Croatia, Finland, Germany,Hungary, Macedonia, Poland and Turkey. This means that Barentz“will soon be able to offer and supply Roquette’s extensive productrange to customers in most European countries”. “Between nowand the end of 2018,” the firms stated, “both companies will worktogether to ensure alignment in all countries with the exception ofthe UK, Ireland and France, where co-operation will officially startfrom 1 July 2019.”

LUPIN has launched in India a chatbot named ‘ANYA’ that is“specifically designed to provide medically verified informationfor health-related queries”. “ANYA is the first bot of its kind tobe launched in India for disease awareness,” noted the Indiancompany, adding that the chatbot would start by addressing queriesrelated to diabetes. G

IN BRIEF

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BUSINESS STRATEGY

Pharmathen launcheswill bolster its profitsLaunching a wave of generic long-acting injectables from next

year followed by value-added, 505(b)(2) injectables will seePharmathen deliver annual earnings before interest, tax, depreciationand amortisation (EBITDA) of more than C100 million (US$114million) in the “near term”, the Netherlands-based firm believes.

Addressing delegates to the recent Jefferies 2018 LondonHealthcare Conference, deputy chief executive officer Dimitris Kadissaid the company’s research and development investments – “over C150million over the past five years in drug delivery platforms” – would seethem launch a series of long-acting injectables “in the coming years”the first one in the US “expected to be launched in 2019, and we haveanother eight products lined up for launch between 2020 and 2022”.

From 2023, Kadis disclosed, Pharmathen would begin deliveringon “our second wave of products – not generics, but 505(b)(2),specialty, lifecycle-management products. These are the products thatwill drive Pharmathen’s growth post 2023.” Overall, Pharmathen was“sitting on a pipeline of more than 35 products that have passed thedevelopment stage and are ready for approval and launch”, Kadis said.

“Wehavebeengrowing,withanannualgrowthrateofapproximately9%, and we intend to keep it like that,” Kadis revealed. “Our objectivethis year is for our top line to be north of C185-C190 million, with anEBITDA margin of 30%.” But, he said, with the firm’s planned futureprojects, the near-term EBITDA target was C100 million.” G

COMPANY NEWS

BUSINESS STRATEGY

Weininger controlsFair-Med via an MBOFair-Med Healthcare Group, including its Australian affiliate Eris

Pharma, is now under the sole ownership of its chief executiveofficer, Oren Weininger, following a management buy-out (MBO).

Weininger, who joined the Fair-Med group as chief executivefour years ago, told Generics bulletin that the group had built upan extensive portfolio of prescription generics, OTC medicines,dermocosmetics and dietary supplements. Products are marketedunder its own labels through a global network of distributors. These,he said, formed the basis of an attractive sales and marketing platformfor potential partners that lacked a presence in Europe, and potentiallythe Middle East and North Africa (MENA) region. Sales had grownfrom zero to €16 million (US$18 million) within four years.

While Fair-Med has its headquarters in Zug, Switzerland, its mainoperational and regulatory hub for Europe is located in Hamburg,Germany. Having enjoyed considerable success in both the local tendermarket with prescription generics, and in the OTC sector by providingown-label ranges of high-volume products, Germany currently accountsfor more than two-thirds of Fair-Med’s European turnover.

Weininger explained that the group – which uses contractmanufacturers – was present in 10 EuropeanUnion (EU)markets throughlocal distributors, targeting particularly tender-led markets such as theNetherlands and the Nordic countries. And through Eris in Australia, thegroup had built a sizeable operation supplying the MENA region. G

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MARKET NEWS

30 Januaryn 12th Pharmacovigilance Conference

London, UKThis is a one-day Medicines for Europe conference which will lookat latest trends and the future direction of pharmacovigilance.Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.medicinesforeurope.com/events.

31 January-1 Februaryn 18th Regulatory & Scientific

Affairs ConferenceLondon, UKThis conference will follow the Pharmcovigilance event at the samevenue and will provide updates on regulatory developments.Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.medicinesforeurope.com/events.

4-6 Februaryn Access 2019! AAM Annual Meeting

New Orleans, USAThe Association for Accessible Medicines annual meeting will lookat the future of the generics and biosimilars industry.Contact: Association for Accessible Medicines. Tel: +1 202 249 7100.E-mail: [email protected]. Website: www.accessiblemeds.org/events.

25-26 Februaryn EuroPLX 69

London, UKThis two-day meeting provides an opportunity to discuss andnegotiate agreements, development, in-licensing, marketing,promotion and distribution.Contact: RauCon. Tel: +49 6221 426296 0.E-mail: [email protected]. Website: www.europlx.com.

3-5 Marchn World Biosimilar Congress USA

San Diego, USAThis meeting is co-located with a multi-streamed conferenceand technology exhibition. Topics covered will include marketaccess, clinical trials, legal considerations, development andmanufacturing and biosimilar regulatory guidelines.Contact: Terrapinn. Tel: +44 207 092 1210.E-mail: [email protected]. Website: www.terrapinn.com.

26-27 Marchn 15th Legal Affairs Conference

Amsterdam, The NetherlandsThis Medicines for Europe event will cover the latest developments inIP, legal affairs, biosimilars and the SPC Regulation.Contact: Lucia Romagnoli. Tel: +44 7562 876 873.E-mail: [email protected]. Register online atwww.medicinesforeurope.com/events.

EVENTS – January – March 2019

SAVE THE DATE.....The Global Generics & Biosimilars Awards 2019

will be held on 5 November 2019 in Frankfurt, Germany

LEGISLATION

German draft offersfirms pro and consPositive measures including a drive to increase uptake of biosimilars

are offset by more negative aspects, such as promoting pharmacysubstitution of biologics and exposing cytostatic cancer therapiesto tender processes, under draft medicines legislation unveiled byGermany’s ministry of health.

Local industry association Pro Biosimilars welcomed thelegislation’s move to compel regional doctors’ and insurance funds’authorities to agree usage quotas for biosimilars. But it was lessimpressed by the medicines safety, or GSAV, bill’s plan to have thecountry’s federal joint committee, the G-BA, draw up a guideline tostate which reference biologics could be substituted with biosimilarsat pharmacy level.

Observing that biosimilar uptake was accelerating in Germany asconfidence among doctors increased, Pro Biosimilars said the healthministry was following “the wrong path” by taking the decision onwhich biologic drug to use out of the hands of doctors and putting inthe hands of the G-BA committee. Rather, the industry associationargued, it would be better to encourage the positive biosimilaruptake trend “with level-headedness instead of dirigism”. “Throughsubstitution, no trust is built in new product groups,” it warned.

Pro Biosimilars’ sister association, Pro Generika, took issuewith moves to subject cytostatic cancer drugs to competitive tenderprocesses. “These medicines are too important to haggle over,” theindustry body maintained.

For cytostatics, “insurance funds will take over price negotiationswith the pharmaceutical industry”, with pharmacists receiving “theactual purchase price” in a move expected to save around €300 million(US$340 million) annually. However, around €120 million of thosesavings will be used up by paying pharmacists a fixed sum of €110 forcompounding cancer drugs. The frequency of surprise inspections forcompounders is to be increased.

Several of the health ministry’s planned measures relate to thevalsartan impurities problem. Health insurance funds are to get a“right to redress” from their pharmaceutical industry suppliers whereproducts are found to be deficient and may be recalled. In turn,funds will be required to “take joint responsibility” for providing anuninterrupted supply to patients of medicines covered by tenders,with patients being excused co-payments in cases where they have toswitch to an alternative medicine due to product recalls.

“States must inform the responsible federal authorities aboutplanned inspections of drug and raw-material producers in thirdcountries,” the ministry said.

The association of the German pharmaceutical industry, the BPI,which represents particularly local producers, welcomed steps to holdinsurance funds accountable for the supply decisions that made inawarding tender contracts. “If a fund cannot demonstrate that it haskept the risk of supply problems as low as possible in choosing itstender partner, it should bear the responsibility and additional coststhat result from supply disruptions through tenders,” the BPI insisted.Germany’s medicines manufacturers’ association, the BAH, regrettedthat the draft did not compel funds to award tender contracts to at leastthree suppliers per molecule.

Other measures contained in the draft legislation include: betterco-ordination of recalls between state and federal entities; feweradministrative hurdles to prescribing medicinal cannabis; changes toparallel import regulations; and measures to introduce e-prescribing.Gn [email protected]

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MARKET NEWS

VALUE ADDED MEDICINES are a “global phenomenon”,according to Aurelio Arias, Iqvia’s senior consultant for Europeanthought leadership. Addressing Medicines for Europe’s secondannual Value Added Medicines Conference in Brussels, Belgium,Arias pointed out that variation in the top products in each marketstemmed from differences in local demand as well as variation inpayer approaches. While US pricing pressure was stalling overallmarket growth in 2018, he said, injectables and devices – such asinhalers, pens and patches – were leading the “high value, low-volume segments”, with oral solids making up over half the market.Iqvia was also continuing to evolve its definition of value addedmedicines, he revealed, to “chip away at what is not a value addedmedicine”. This included removing Mylan’s EpiPen (epinephrine)from the market definition, as well as adding US branded genericsregistered through the new drug application (NDA) pathway as aproxy for 505(b)(2) products.

LABORATORIOS OJER PHARMA has been named as one ofthe winners of Medicines for Europe’s two value added medicinesawards for 2018, for its innovative Keramod (imiquimod) 5%gel. The film-forming formulation is designed to enhance patientcompliance by reducing side effects. Also receiving an awardwas the Hungarian Transplant Federation for its Be Educatedand Empowered Patient (BEEP) education program for organ-transplanted patients. The awards are aimed at recognising programsthat “improve patient quality of life and/or adherence, and/ordemonstrate relevant value added benefits on existing treatments”.

PATIENT ADHERENCE is “not about taking your medication,it’s about finding the correct medication to adhere to”, accordingto Bernard Vrijens, chief executive of advanced analytical researchon drug exposure and invited professor of biostatistics at Belgium’suniversity of Liège, Belgium. “We need to individualise adherence,”he maintained. “The big problem is one-size-fits-all,” Vrijenscontended, urging a more personalised, tailored approach tomedicines. “That’s where digital health may have a big impact,”he suggested, acknowledging that digital tools needed to be closelyintegrated with care. Everyday changes could provide importantbenefits, he emphasised, stating that there were “hundreds of littlethings we can do today to make changes” and urging “small steps”rather than only pursuing big changes.

BELGIUM has adopted a “pragmatic approach” to value addedmedicines, according to Francis Arickx, head of the directorate ofreimbursement ofmedicines and pharmaceutical policy at local healthinsurer INAMI. Noting that a recent royal decree had introduced areimbursement pathway for value added medicines (Genericsbulletin, 18 May 2018, page 8),Arickx urged the healthcare industryto have a “more honest” conversation around value added medicines.It was “not exactly true” that payers were looking for savings,Arickx observed. Rather, he said, they were “looking for headroomto pay for everything”, which meant making choices about spendingacross the board. “We have been trying to sow the seeds for a newway of thinking about added value in the minds of those who makethe decisions,” Arickx said. But while it would be a positive stepto adopt a holistic view of healthcare budgets and break the ‘silo’mentality of savings in one area of healthcare only being re-investedinto that same area, Arickx suggested, “I don’t think the politicalclimate is ready for that yet”.

MEDICINES FOR EUROPE has welcomed Arun Narayan asits new value added medicines sector chair, replacing UmbertoComberiati. For full details, see page 27. G

IN BRIEF VALUE ADDED MEDICINES

Key to added value iscontinuous innovationPursuing “continuous innovation” around known molecules was the

key goal emphasised by European off-patent industry associationMedicines for Europe at its second annual Value Added MedicinesConference in Brussels, Belgium.

Medicines for Europe president Marc-Alexander Mahl said thatwell-known challenges to healthcare systems such as demographicchanges were being exacerbated by a stagnating number of newinnovative medicines, with certain treatment areas now largely beingabandoned by ‘big pharma’.

It was therefore important forMedicines for Europe to focus on thepotential of knownmolecules, he said, with “continuous innovation” onvalue added medicines representing “a major opportunity to improvehealthcare system efficiency by addressing major priorities for patientssuch as patient adherence, quality of life and health outcomes”.

“Value addedmedicines deliver patient-centred gains from both theclinical and economic perspective,” Mahl emphasised. “To capture thisinnovation, we have to integrate value added medicines in healthcaresystems and seize opportunities in digital healthcare.”

To bring value added medicines to patients, the association said,it would be important to achieve adjustments in the healthcare process“such as adjustments on purchasing and procurement processes,acceptance of adequate evidence, and, where needed, adjustment ofpricing and reimbursement barriers”. Stakeholder collaboration shouldalso be “maximised”, the association recommended.

“As patients, healthcare practitioners and payers grapple with thechallenges of sustainable access,” Medicines for Europe concluded,“value addedmedicines canmeaningfully address core patient concernsand ensure better health returns at costs that society can afford.” G

VALUE ADDED MEDICINES

Drug efficacy is not everythingEfficacy of treatment is not necessarily the primary consideration

that patients have for their medicines, according to Donna Walsh,executive director of the European Federation of NeurologicalAssociations (EFNA).

Delivering a keynote speech at off-patent industry associationMedicines for Europe’s second annual Value Added MedicinesConference in Brussels, Belgium, Walsh suggested that in some cases,patients may be willing to take a drug that is less effective than another,if other secondary factors linked to their illnesses were better addressed.

As an example, she highlighted that secondary symptomsexperienced by patients with neurological disorders often affectedquality of life even more than primary symptoms, such as insomnia forParkinson’s disease sufferers or nausea and vomiting for those sufferingfrom migraine. While new drugs were desirable for neurologicaldisorders, she acknowledged, “in the meantime, I think we need tosee improvements in the current treatments”, including around factorssuch as safety, adherence, ease of use and tolerability.

Improvements could be achieved,Walsh suggested, by prioritisingthose factors that were truly important to patients and clearlypositioning the added value offered by alternative treatments, therebyreaching a consensus that was reflective of patient needs. Withcollective will and clear political support, she suggested, the benefitsof such value-added medicines could be recognised. G

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MARKET NEWSMARKET RESEARCH

UK providers call formore biosimilar dataReal-life data and financial incentives will increase healthcare

professionals’ (HCPs) biosimilar use in the UK, according to astudy published in the British Medical Journal (BMJ).

Five “major themes” emerged from the semi-structured interviewswith 22 HCPs – consultants, nurses and pharmacists – from acrossfive hospitals in the West Midlands, UK. The first theme, ‘perceptionof biosimilars’, found that all HCPs “expressed an understanding ofthe concept of biosimilars”.

Secondly, the ‘attitude towards biosimilar prescribing’ themediscovered that the majority of HCPs were content to initiatebiosimilars. “Aminority of rheumatology HCPs and diabetology HCPsfelt that they were under pressure from their organisation to initiatenew patients on biosimilars,” the study detailed. All gastroenterologyHCPs and a minority of rheumatology HCPs were content to switchpatients from a reference biologic to a biosimilar, while the majority ofdiabetology HCPs were reluctant to switch for cost reasons.

A third theme, ‘HCPs views on evidence base for biosimilars’,identified that gastroenterology HCPs “expressed more confidenceand/or fewer concerns than other specialists”. Their main source ofhesitance about biosimilar uptake was indication extrapolation, butthis “had been overcome”.

“Gastroenterology HCPs believed that the guidance from theBritish Society of Gastroenterology and the National Institute forCare Excellence (NICE), experience from other trusts and thenational registry are enough for using biosimilars,” the study noted,highlighting its fourth theme, ‘facilitators to prescribing biosimilars’.“Half of diabetology, rheumatology and some gastroenterology HCPsvalued the availability of more supportive evidence on the efficacyand safety of biosimilars from other trusts.”

Lastly, ‘barriers to prescribing biosimilars’ found that the majorityof HCPs indicated that the development of an unexpected adverseeffect or the increase in the rate of side effects among patients locallyor nationwide would inhibit them from prescribing biosimilars.“Safety and efficacy concerns, patients’ opinion and how cost savingswere shared were the identified barriers to considering prescribingbiosimilars,” the study concluded. G

REGULATORY AFFAIRS

Substitution target isset at 90% in FranceAn overall target of 90% has been set for the generic substitution of

eligible molecules by pharmacists in France for 2018. Legislativetext published in the country’s journal officiel setting out the targetobserves that, as of November 2017, the overall average substitutionrate achieved by French pharmacists had been 87.5%.

The 2017 figure excludes levothyroxine, which is also excludedfrom the 2018 target. Also excluded from the target are buprenorphineand mycophenolate, as well as five epilepsy treatments: lamotrigine,levetiracetam, pregabalin, sodium valproate and zonisamide.

Basing the 90% objective on the substitution of molecules withinFrance’s répertoire list of generic equivalents as it stood on 30 June2017, the text also sets out the possibility of sanctions for pharmacistswhose substitution rate falls below 75%.

A list of molecule-specific substitution targets is also set outin the text. The highest target of 95% has been set for atorvastatin,lercanidipine, metformin, omeprazole and pantoprazole, as well aspravastatin, ramipril, simvastatin and valaciclovir. Meanwhile, a 90%target applies to escitalopram, gliclazide, montelukast, repaglinideand tramadol/paracetamol.

For duloxetine and esomeprazole, an 85% target applies, whilean 81% goal has been set for rosuvastatin. Clopidogrel and quetiapinehave an 80% substitution target, while ezetimibe and ezetimibe/simvastatin have a 65% target and oxycodone has a goal of just 25%.

The substitution goals have been published as legislationimplementing the French healthcare budget for 2019 is making itsway through the country’s parliament. Government proposals for thebudget included introducing a list of objective medical criteria thatmust be used when marking prescriptions as non-substitutable, and aprovision that would only reimburse at the generic price patients whorefuse generic substitution without valid medical grounds (Genericsbulletin, 5 October 2018, page 1).

While the French Senate has passed a version of the budgetlegislation that removes these provisions, local generics associationGemme suggested it was likely that the deleted articles would bere-introduced during the second reading of the text in the country’sAssemblée Nationale. G

PRICING & REIMBURSEMENT

BGMA disappointed on pricingAUK pricing scheme for branded medicines agreed between the

country’s Department of Health and Social Care (DHSC) and theAssociation of the British Pharmaceutical Industry (ABPI) has metwith disappointment from the local generics industry. Warwick Smith,director general of the British Generic Manufacturers Association(BGMA) criticised the deal, which runs from 2019 to 2023.

“It is disappointing that the new branded medicines voluntarypricing scheme fails to exclude from its scope products that are alreadysubject to competition and therefore offer significant savings, suchas branded generics and biosimilars,” Smith said. “This means thatthe true cost of new medicines will be obscured, as will the savingsdue to competition from branded generics and biosimilars. Thislack of transparency is likely to lead to ineffective decision making,increasing costs to the National Health Service (NHS) and reducingpatient access to medicines.” G

CORPORATE SOCIAL RESPONSIBILITY

IHP seeks donations of drugsCommonly used off-patent drugs including analgesics, antacids,

antibiotics andACE-inhibitors are urgently needed by humanitariancharity International Health Partners (IHP) for its essential andcommunity health kits. Drugs available for donation by the end ofFebruary 2019 should have a minimum of 20 months of dating, belabelled in English, and be accompanied by a certificate of analysis.

IHP is asking generics firms for their help in providing over200,000 treatments needed to meet projected demand in 2019. Theessential health kits are used by healthcare professionals visitingunder-served communities to provide 800 treatments as part of short-term outreach or in the aftermath of a disaster. The community kits areused by local community health workers to provide care at a villagelevel. “Both kits provide essential medicines, but also enable educationand disease-prevention training,” IHP told Generics bulletin. Gn For more information, visit www.ihpuk.org or e-mail [email protected].

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REGULATORY AFFAIRS

EU bodies ponder e-leafletsPaving the way for European Union (EU) member states to introduce

electronic patient information (ePI) was the goal of a workshopheld on 28 November by the European MedicinesAgency (EMA), theHeads of MedicinesAgencies (HMA) and the European Commission.This covers both the package leaflet for patients and the summary ofproduct characteristics (SmPC) for healthcare professionals.

The workshop held in London, UK, followed a Commissionreport which highlighted that “despite efforts to make the PI easy toread and useful, there is still a need to improve how information onmedicines is conveyed to patients and healthcare professionals”. Thereport found that the main “room for improvement” was with thepackage leaflet rather than with the SmPC (Generics bulletin, 28April2017, page 7). However, it concluded, more evidence would be neededbefore considering a proposed key information section in the PI.

Delivering package leaflets through digital platforms would, theEU bodies suggest, “enhance access to up-to-date information andoffer new opportunities to better tailor this information to the needsof patients”, including those with visual impairments or low literacy.

Based on the outcome of the workshop, the bodies intend to draft“key principles for the use of ePI in the EU” that they will releasefor a six-month public consultation in January 2019. While an actionplan published by the agency in 2017 laid out several PI initiatives,proposed timelines may be affected by the agency’s move fromLondon to Amsterdam, the Netherlands. G

MARKET NEWSINFORMATION CAMPAIGNS

Biosimilars Canadapicks patient providerBiosimilars Canada has revealed that local specialty pharmaceuticals

service provider Innomar Strategies has been selected as thepreferred provider for the association’s Patient Support Program (PSP)platform for patients treated with biosimilars.

Innomar Strategies, a part of AmerisourceBergen, delivers “end-to-end commercialisation solutions to improve product access, increasesupply-chain efficiency and enhance patient care”.

The group’s “key areas of specialisation” include strategicconsulting, patient support programs, nursing and clinical services, andspecialty pharmacy and logistics.

Creating a “seamless and simple process for patients”, theplatformwill provide a “common suite of PSPservices for BiosimilarsCanada members going forward that can be customised to meet theindividual needs of the therapy, the biosimilar sponsor and payers”.The PSP platform is due to launch in 2019.

Jim Keon, president of Biosimilars Canada, pointed out thatCanada was “recognised internationally as having high barriers tomarket entry for sponsors of biosimilars”. He said the platform was“an important solution in ensuring biosimilar sponsors can provide thehigh-quality patient support services required by payers, physiciansand patients while providing value to the Canadian healthcare system”.

“As more biosimilars come into the market, patients will needservices built around these products to support themwith their illness,”commented Kevin West, vice-president of Innomar Strategies. “Byutilising a centralised PSPmodel, healthcare providers, manufacturersand patients will experience efficiencies, while still having a best-in-class experience.” G

REGULATORY AFFAIRS

UK calls for Brexit plan clarityClarity is needed on the UK government’s contingency preparations

to ensure the country has continued access to medicines in theevent that no ‘Brexit’ deal is reached by 29 March 2019 – when theUK is currently due to leave the European Union (EU) – according tothe House of Lords EU Home Affairs Sub-Committee.

In a letter to UK health minister Matt Hancock, the Committeehas outlined questions amid concerns that “a no-deal Brexit may limitthe availability of medicines and medical products in the UK”. TheHouse of Lords contended that there has been “little sign to date ofpotential delays on the border being addressed”.

Hancock has been asked to clarify contingency measures securingmedicine supply beyond the first six weeks after Brexit, as well as toprovidemore detail on a tender being run for additional storage capacity.The Committee also wants to know what plans the government has tosecure and prioritise airborne routes for medical products, as well ashow it will encourage drug companies to prioritise UK launches.

“The government’s current guidance is to stockpile six weeks’worth of medicines and medical products in the event of blockagesat borders,” the House of Lords noted, “however medicines withshort-shelf lives cannot be stockpiled and would have to be flownin.” Mike Thompson, chief executive of the Association of the BritishPharmaceutical Industry (ABPI), recently highlighted that medicineswith short shelf-lives or temperature-control requirements “cannot bestockpiled” (Generics bulletin, 2 November 2018, page 10). G

PRICING & REIMBURSEMENT

Chinese cities teamfor national tenderMillions of tablets of 31 commonly-used drugs such as amlodipine,

atorvastatin, clopidogrel and imatinib will, for the first time, besubject to a nationwide tender process under a pilot scheme plannedto be implemented from 6 December.

Under the ‘4+7 Program’, 11 cities – including the four vastconurbations of Beijing, Tianjin, Shanghai and Chongquing – willparticipate in a centralised bidding process for the 31 drugs. Under apilot scheme, representatives from each region will form a centralisedjoint procurement office, with Shanghai’s Pharmaceutical CentralizedBidding Services Management Agency having overall oversight.

Bidding companies will be expected to commit to volumessufficient for one year of supply, in some cases running to around 30million tablets. The tender covers a wide array of therapeutic classes,including: cardiovascular agents such as amlodipine, atorvastatin,losartan, rosuvastatin; the antiviral entecavir; the central nervoussystem (CNS) drugs paroxetine and risperidone; and the oncologytherapies gefitinib, imatinib and pemetrexed.

The seven second-tier cities covered by the pilot scheme are:Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu andXi’an.

In a recent report on improving patient access to innovativemedicines in China, the RDPAC originator pharma committee of theChina Association of Enterprises with Foreign Investment (CAEFI)highlighted the inefficiencies of medicines having to go throughmultiple layers of pricing and reimbursement negotiations at national,provincial and hospital level before patients gained access. GPresented in conjunction with our sister publication, Scrip.Original reporting by Brian Yang.

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PRODUCT NEWS

ARTHRITIS DRUGS

Reddy’s and Mylan beat VimovoTwo US method-of-treatment patents protecting Horizon Pharma’s

Vimovo (naproxen/esomeprazole) delayed-release tablets up to2031 are invalid on the ground of indefiniteness, Dr Reddy’s andMylan have convinced New Jersey District Judge Stanley Chesler.

Granting summary judgement of invalidity on US patents9,393,208 and 9,220,698, which expire on 3 September 2029 and10 March 2031 respectively, Chesler noted that both patents claimedmethods of treating conditions such as osteoarthritis and rheumatoidarthritis by administering an ‘AM’ unit dose of naproxen andesomeprazole followed by a ‘PM’ dose 10 hours later, with these unitdoses to “target” a steady state of intragastric pH.

Referring to the court’s previous ‘Markman’ claim-constructionopinion, Chesler said it had construed ‘target’ to mean ‘set as agoal’. “The fundamental difficulty is that both key phrases here areincomprehensible: ‘the AM and PM unit dose forms target’ and ‘theAM and PM unit dose forms further target’,” Chesler summarised. “Itis not possible to comprehend what these phrases mean, because pillscannot be said to set goals.”

And because the target clauses were incomprehensible, hedecided, Reddy’s and Mylan were correct that the patents provided“no discernible standard for drawing the line that distinguishesinfringing acts from non-infringing ones”. Thus, the two patents wereindefinite in that that they failed to “inform, with reasonable certainty,those skilled in the art about the scope of the invention”. G

BIOLOGICAL DRUGS

Three firms in EU getnods on pegfilgrastimThree firms – Mundipharma, Mylan and Sandoz – have received

final pan-European marketing authorisations from the EuropeanCommission for biosimilar rivals toAmgen’sNeulasta (pegfilgrastim).The nods for Mundipharma’s Pelmeg, Mylan’s Fulphila and Sandoz’Ziextenzo followed positive recommendations from the EuropeanMedicines Agency’s (EMA’s) committee for human medicinalproducts (CHMP) towards the end of September (Generics bulletin,28 September 2018, page 15).

Other pegfilgrastim biosimilars approved in the European Union(EU) include Accord’s Pelgraz – which was launched immediatelyupon approval two months ago (Generics bulletin, 5 October 2018,page 18) – as well as Coherus BioSciences’Udenyca. Coherus has notyet announced launch plans, although earlier this year it said it wasengaged in discussions with “various parties” for marketing the drugin Europe (Generics bulletin, 31 August 2018, page 21).

While Mundipharma, Mylan and Sandoz did not immediatelycommentonplansto launchtheirversions,MundipharmaInternational’shead of biosimilars, Philippe Bastide, said “the availability of thisbiosimilar represents an important opportunity to reduce healthcarecosts while increasing access to an effective treatment option”.

Mundipharma’s rival toAmgen’sNeulastawasoriginallydevelopedby Cinfa Biotech, which was acquired by Mundipharma in October foran undisclosed price (Generics bulletin, 19 October 2018, page 3), aspart of a transaction that Mundipharma said gave it “global reach andexpanded development capabilities”. The firm insisted its version wasbased on “a robust regulatory submission of key biosimilarity data fromanalytical, biofunctional and clinical study comparisons”. G

OPIOID-DEPENDENCE TREATMENTS

US court vacatesSuboxone injunctionDr Reddy’s Laboratories plans to resume its launch activities of

the first generic of Indivior’s Suboxone (buprenorphine/naloxone)sublingual film formulation “as soon as permitted” after a US Court ofAppeals vacated and remanded a district court’s preliminary injunctionin a majority 2-1 decision.Appeals court judge Pauline Newman offereda dissenting opinion. As Generics bulletin went to press, Dr Reddy’shad not announced a launch.

ANew Jersey district court had awarded Indivior the preliminaryinjunction earlier this year on the basis that it was likely to succeedon the merits of its infringement case against Reddy’s over US patent9,931,305 that expires in February 2022. However, in granting theinjunction, the district court had erroneously interpreted the scope ofclaims in the patent, the appeals court found.

“Based on the record with the proper interpretation of claim scope,we conclude that Indivior has not shown that it is likely to succeedon the merits of its infringement claim,” the appeals court concluded.“The district court thus abused its discretion in granting the preliminaryinjunction. Accordingly, we vacate the preliminary injunction andremand to the district court for further proceedings.”

Dr Reddy’s urges actionFollowing the ruling, Reddy’s has filed a motion requesting that the

appeals court either issue a mandate immediately – a formal filing thatreturns the case to the district court – or alternatively, stay the preliminaryinjunction pending issuance of the mandate. The originator plans tooppose Reddy’s motion and also file a petition for both panel rehearingand rehearing en banc of the ruling vacating the preliminary injunction.

Indivior has also warned that any Reddy’s launch would be‘at risk’, with litigation involving other Suboxone patents currentlyongoing. This includes an appeal launched by the originator against aDelaware district court’s finding that the Indian firm’s abbreviated newdrug application (ANDA) product does not infringe Suboxone patents8,603,514 and 8,017,150 (Generics bulletin, 8 September 2017, page13), as well as ongoing litigation in a New Jersey court involving USpatents 9,855,221 and 9,687,454.

“Should generic buprenorphine/naloxone sublingual film enterthe market in 2018, the result would most likely be a rapid andmaterialloss of market share for Suboxone,” the originator acknowledged.

InJunethisyear,Reddy’sreceivedUSFoodandDrugAdministration(FDA) approval for four strengths of generic Suboxone and launchedthe product immediately thereafter. However, the Indian player’scommercial activities were stopped soon after by a court-imposedtemporary restraining order (Generics bulletin, 22 June 2018, page 11).

The district court then in July granted Indivior’s motion for apreliminary injunction, with Reddy’s being enjoined from using, sellingor importing its generic Suboxone. However, the Indian firm notedin announcing that the injunction had been vacated, the temporaryrestraining order had not included a bar on commercial manufacturing.

In reaching its decision to vacate the injunction, the appealscourt held that ‘305 patent claims at-issue in the case are “patentablyindistinct” from those in the ‘514 patent – an earlier Suboxonepatent related to the ‘305 patent, sharing the same specification –overturning the district court’s prior finding. Therefore, the appealscourt found, “claim preclusion is likely to apply. As a result,Indivior has not shown that it is likely to succeed on the merits of itsinfringement claim against [Reddy’s]”. Gn [email protected]

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PRODUCT NEWSGASTROINTESTINAL DRUGS

Krka is victorious onDanish esomeprazoleKrka’s Swedish subsidiary, Krka Sverige, has claimed victory in long-

running patent litigation over a European Nexium (esomeprazole)patent, reversing an earlier adverse decision and reversing an award ofdamages. The lawsuit revolves aroundAstraZeneca’s European patentEP1,020,461, which protects the active pharmaceutical ingredient(API) esomeprazole with an optical purity exceeding 99.8% ofenantiomeric excess.

Having in 2016 been ordered by a Danishmaritime and commercialcourt in Copenhagen to pay AstraZeneca DKK50 million (US$7.6million) in damages (Generics bulletin, 4 March 2016, page 13) –after the originator failed to secure an injunction preventing Krka frommarketing or importing esomeprazole into Denmark – the generics firmappealed this first instance ruling to an eastern high court in Copenhagen.

While the maritime and commercial court had found in favour ofAstraZeneca due to the presence of optically-pure crystals in Krka’sreaction mixture, the Slovenian firm argued that the verdict wentbeyond the scope of the patent and was “in contradiction with well-established jurisprudence in relation to Swiss-type claim patents”.

“After the trial, the eastern high court in Copenhagen reversedthe first-instance decision,” Krka stated. “The court found thatKrka Sverige had not infringed the patent and rejected the claim fordamages.” While the Copenhagen court’s decision was final, Krkaacknowledged that AstraZeneca had the option of filing an applicationfor leave to appeal the decision to the Danish Supreme Court. G

ATTENTION DEFICIT HYPERACTIVITY DISORDER DRUGS

Actavis Quillivant XRfinding is overturnedActavis has suffered a setback in its attempts to bring a generic of

Tris Pharma’s Quillivant XR (methylphenidate) extended-releasesuspension to market ahead of patent expiry, after a US Court ofAppeals vacated and remanded a favourable district court ruling onnumerous patent claims due to “inadequate fact-findings”.

In September last year, Delaware District Judge Gregory Sleetinvalidated as obvious 21 claims from fivepatents shielding the brandedattention deficit hyperactivity disorder drug: US patents 8,465,765;8,563,033; 8,778,390; 8,956,649; and 9,040,083. Furthermore, Sleetalso rejected Tris’ secondary considerations of non-obviousness.

On appeal, Tris requested a reversal of judgement for sevenclaims across three of the patents – the ’765, ’033, and ’390 patents– all directed to pharmacokinetic (PK) and pharmacodynamic (PD)properties of the Quillivant XR extended-release formulation.

Siding with the originator, in an at-times withering rebuke, thepanel of three appeals court judges concluded that Sleet’s conclusionsof law were “based on inadequate fact-findings”. Meanwhile, theydecided, Sleet also erred in rejecting Tris’ evidence of objective indiciaof non-obviousness.

“The district court failed to make the necessary factual findingsand provide sufficient analysis of the parties’ arguments to permiteffective appellate review,” appeals court judge Raymond Chen wrotefor the court’s unanimous decision. “Specifically, the district court’sopinion merely recites the parties’ arguments but fails to explain oridentify which arguments it credits or rejects. We thus cannot reachthe merits of whether the Quillivant XR formulation would have beenobvious over the prior art.”

Sleet, the appeals court wrote on several occasions, failed toarticulate whether he credited testimony or explain why and howtestimony supported the court’s conclusion. His analysis of a specificPK issue disputed by the two parties, for example, was described as“very cursory”, while testimony provided by Tris’ experts on the issuewas neither discussed nor cited by the court, despite Actavis’ expertresponding to this in his testimony. “We identify gaps in the districtcourt’s opinion,” the appeals court underlined, “and remand for thedistrict court to conduct further fact findings and detailed analysis.”

The appeals court also backed Tris’ arguments over evidence ofobjective indicia of non-obviousness that Sleet had rejected. It agreedthat the district court had incorrectly rejected Tris’ experts’ testimonyon unexpected results, because “they purportedly failed to comparethe Quillivant XR formulation with the closest prior art”. “The districtcourt should have considered Tris’ evidence that its claimed inventionenjoyed unexpected properties compared to the known, extended-release formulations,” the appeals court noted.

And Sleet was also wrong to dismiss Tris’ argument that QuillivantXR satisfied a long-felt need compared to prior art, the appeals courtstated. None of the prior-art methylphenidate products identified by thedistrict court, Tris successfully contended on appeal, satisfied a long-feltneed because none of them possessed all three desired properties listedby Tris; a 45-minute onset of action, a 12-hour duration of effect, and aliquid methylphenidate product that does not require swallowing a tablet.

The appeals court did not address other indicia of non-obviousnessthat Sleet had also dismissed, namely commercial success andcopying. However, it wrote: “In view of the errors we identifiedabove, we invite the district court to reconsider all the evidence ofobjective indicia in its overall determination of obviousness.” Gn [email protected]

Up to the minute live retail market pricing is available for the UK and Eire onWavedata Live at wavedata.net.

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

Price hikes prompt concessionsTreble-digit average UK trade price rises for molecules such

as dosulepin and naproxen have prompted the country’sDepartment of Health and Social Care (DHSC) to grant priceconcessions in November, according to the latest lists publishedby the Pharmaceutical Services Negotiating Committee (PSNC).

Comparing UK trade prices to independent pharmacists in theperiods 1-31 October 2018 and 1-26 November 2018, WaveDatareported that the average price for a pack of 28 dosulepin 25mgcapsules rose by 420% to £6.36 (US$8.11) as the lowest availableoffer more than trebled from £0.47 to £1.64. In response, theDHSC granted a concession price of £5.10. However, a 287% riseto £11.71 in the average price of the 75mg strength had not beenmet with a concession price as Generics bulletin went to press.

Meanwhile, a 142% increase in the average price of 56naproxen 500mg enteric-coated capsules to £10.86 – as thelowest price rose by almost a third to £3.64 – prompted a £10.99concession from the DHSC. But an even steeper 188% average riseto £6.38 for the 250mg version did not provoke a similar reaction.

Separately, olanzapine tablets featured among both thesteepest rises and steepest falls for average UK trade prices inNovember, with rises of as much as 262% affecting orodispersiblepresentations as the standard tablets slipped by as much as half.G

PRICE WATCH ....... UK

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PRODUCT NEWS

ONCOLOGY DRUGS

US appeals refuses togrant a bar on ZytigaGenerics of Janssen’s Zytiga (abiraterone acetate) blockbuster could

enter the US market imminently, after a US Court of Appealsrefused twice in quick succession to grant the originator injunctionsblocking such launches.

An emergency motion for an injunction pending appeal of adistrict court’s decision to invalidate a key patent shielding Zytiga wasfiled by Janssen and partner BTG International on 1 November. Thiswas denied by the appeals court on 20 November.

Later that same day, Janssen filed another emergency motion for atemporary injunction, to stay in place until the US Supreme Court ruledupon the originator’s application for an injunction pending appeal. Thenext day, 21 November, the appeals court denied this motion also.

In denying the motion for an injunction the first time aroundon 20 November, the appeals court stated: “Without prejudicing theultimate disposition of these cases by a merits panel, we concludebased upon the papers submitted that appellants [Janssen and BTG]have not established that an injunction is warranted here.”

At the same time, the appeals court scheduled a date of 24 January2019 for oral argument in Janssen’s appeal. The same court thensaid in its 21 November order again denying Janssen’s motion: “On20 November 2018, this court denied the appellants’ motion for aninjunction pending appeal. This court expedited the briefing scheduleand oral argument. The appellants have not shown that any furtherrelief is warranted.”

ANew Jersey district court opened the door for generic competitionto Zytiga on 26 October by ruling that the originator’s key method-of-use patent 8,822,438 was obvious over prior art (Generics bulletin, 2November 2018, page 2018, page 13).

The patent was scheduled to expire on 24 August 2027, andwas the only patent listed against Zytiga in the US Food and DrugAdministration’s (FDA’s) Orange Book.

On 31 October, the FDA approved the first Zytiga abbreviatednew drug applications (ANDAs), submitted byApotex, Hikma, Mylanand Teva. The latter three players are all serving as defendants in thecase; Apotex settled litigation and entered into a license agreement forthe ‘438 patent in April 2018.

Other generics firms serving as defendants in the case areAceto’s Rising Pharmaceuticals, Amneal, Dr Reddy’s, Endo’s Parand Wockhardt.

In January this year, the US Patent Trial andAppeal Board (PTAB)issued three inter partes review decisions invalidating all claims ofthe ‘483 patent, favouring a multitude of generics players, includingMylan and Teva, as well as Amerigen and Argentum (Genericsbulletin, 26 January 2018, page 11). Janssen has filed a motion for arehearing of these decisions.

In its 20 November denial of injunction, the appeals court orderedparties to “notify the court as soon as the PTAB issues its reconsiderationdecisions [in the three inter partes reviews] and whether any partyintends to appeal those decisions”.

The appeals court also invited the director of the US Patent andTrademark Office (USPTO), Andrei Iancu, for his view on severalissues related to the overlapping district court and PTAB cases. Anamicus brief running no more than 14,000 words must be submittedby 19 December 2018.

US sales of Zytiga, which is used to treat prostate cancer, leaptby 72% to US$1.42 billion in the first nine months of 2018. Gn [email protected]

STRIDES PHARMA SCIENCE has struck an exclusive USdevelopment, licensing and supply agreement with Suda Pharmafor the latter’s SUD-001H (sumatriptan) oral spray for treatingmigraine headaches. Developed using Suda’s OroMist hydrotropetechnology, the SUD-001H “first-in-class, mint-flavoured oral spray”is slated for filing through the US hybrid 505(b)(2) regulatory pathwayas an alternative to GlaxoSmithKline’s Imitrex (sumatriptan) tabletsand nasal spray. Strides will fund Suda’s development work, payingUS$0.4 million in cash up-front and a further US$0.6 million onreaching certain developmentmilestones, including a pilot first-in-manclinical study, submission and approval in the US. Strides, which willpay Australia’s Suda royalties and a handling fee on sales, also hasright of first refusal on the drug in territories including the EuropeanUnion (EU), Australia and New Zealand, Canada, South Africa andJapan. The Indian firm said filings through the 505(b)(2) pathwayformed part of its strategy to develop a portfolio of complex andspecialty products to complement the more than 150 abbreviated newdrug application (ANDA) filings it anticipates submitting by 2021.

INDIVIOR has introduced its Perseris (risperidone) once-monthlysubcutaneous injectable in theUS for treating schizophrenia in adults.“Clinically relevant levels were reached after the first injection ofPerseris without use of a loading dose or any supplemental oralrisperidone,” the firm claimed.While the UK-based firm had preparedfor “a full promotional launch” through its Perseris salesforce inFebruary next year, it said that investment was contingent on theUS Court of Appeals upholding an injunction against Dr Reddy’sintroducing a generic version of its Suboxone (buprenorphine/naloxone) sublingual film. A day later, the US court dropped theinjunction (see page 13).

PULMATRIX has presented data from its recently completed PhaseI clinical trial for its PUR1900 Pulmazole (itraconazole) inhaleddry-powder formulation at the 2018 annual scientific meeting of theAmerican College of Allergy, Asthma and Immunology (ACAAI).TheUS firm plans to start a Phase II study for the pulmonary diseasesdrug imminently. At the same ACAAI conference, Glenmarkpresented data for its Ryaltris (olopatadine/mometasone) nasalspray for seasonal allergic rhinitis that has a US Prescription DrugUser Fee Act (PDUFA) target action date of 21 March 2019.

CAMURUS has secured European Commission approval for itsBuvidal (buprenorphine) prolonged-release weekly and monthlytreatments for opioid dependence. “This marks the first approvalof a long-acting treatment for opioid dependence in the EuropeanUnion (EU),” the Swedish company asserted. An “initial waveof country launches” is scheduled for the first quarter of 2019.“Formulated with Camurus’ proprietary FluidCrystal injectiondepot technology, Buvidal is a lipid-based solution which, onceinjected, transforms into a gel-like depot,” the firm explained. “Thedepot slowly biodegrades over time, releasing the buprenorphinewhich blocks the drug-liking effect of opioids in the brain andreduces withdrawal, craving and patient’s use of illicit opioids.” TheUS Food and Drug Administration (FDA) has issued a PrescriptionDrug User Fee Act (PDUFA) goal date of 26 December 2018 forthe CAM2038 formulation to Camurus’US partner Braeburn, whilethe Swedish firm also has the formulation under regulatory reviewin Australia and the US.

FORESEE PHARMACEUTICAL has announced that all patientshave completed participation in its Phase III, multinational, multi-center trial of leuprolide mesylate injectable suspension 25mg, athree-month ready-to-use subcutaneous depot formulation. G

VALUE ADDED MEDICINES IN BRIEF

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PIPELINE WATCH

This monthly update of key patent, SPC and data exclusivity data is extracted from IQVIA’s Ark PatentIntelligence Expiry Database. Covering 130 countries and over 3,000 INNs, Ark Expiry Databasecontains watertight data teamed with the ultimate in generic launch analysis.For further information, visit www.arkpatentintelligence.com or e-mail: [email protected].

Emend’s end comes quicker in SwitzerlandEarly December 2018 will bring the expiry of a Swiss supplementary

protection certificate (SPC), granted on the basis of Europeanpatent EP0,734,381, that protects Merck’ Sharp & Dohme’s Emend(aprepitant) capsules. According to IQVIA’s Ark Patent Intelligencedatabase, the ‘381 patent and its associated SPC is the only significantpatent protecting the antiemetic brand in Switzerland.

In the European Union (EU), the normal SPC term ended inNovember this year, exactly 15 years after the European MedicinesAgency (EMA) granted a pan-European centralised marketingauthorisation for Emend. However, several EU countries designatedin the ‘381 patent have granted six-month pediatric extensions to thelocal SPCs, conferring protection on Emend until mid-May 2019.

“Pediatric extension is currently not available in Switzerland,”IQVIA observes. “However, in 2016 the Swiss parliament allowedfor changes to the Swiss patent law and approved pediatric extensions

by extending the SPC by six months or through a new pediatric SPClinked directly to the patent and extending the term by six months”(Generics bulletin, 8April 2016, page 6). This amendment will comeinto force on 1 January 2019, the country’s Federal Council decidedin September this year.

In the first nine months of 2018, Merck reported InternationalEmend sales outside of the US that crept up slightly to US$157million. Global turnover for the brand slipped by 4% to US$396million on a weaker performance in the US, where Sandoz claimeda first-to-market launch of aprepitant capsules at the start of 2017(Generics bulletin, 20 January 2017, page 15). Glenmark securedapproval from the US Food and Drug Administration (FDA) foraprepitant 40mg, 80mg and 125mg capsules in October 2017.

Merck’s Emend franchise also includes the intravenous prodrugfosaprepitant that is protected in Europe until February 2020 bysupplementary protection certificates that reference European patentEP0,748,320, entitled ‘prodrugs of morphine tachykinin receptorantagonists’. In the US, a six-month pediatric extension to the solepatent listed against the intravenous 150mg powder format in the FDA’sOrange Book – US patent 5,691,336 – expires in September next year.

Gilead’s Sovaldi (sofosbuvir) loses its new chemical entity(NCE) data exclusivity in the US in December 2018. However, thetablets benefit from protection from nine Orange Book-listed patentswith expiry dates ranging between March 2028 and December 2030.

The oral single-drug hepatitis C treatment has, IQVIA points out,enjoyed considerable market success, since it is a direct-acting antiviralwith zero virus detection after 12 weeks of therapy in 80-90% patients.“However, Gilead has faced some backlash from drug users andinsurers on the pricing of Sovaldi at US$84,000 for the 12-week course,earning Sovaldi the name ‘the US$1,000 pill’,” IQVIA observes.“Gilead defended the pricing by mentioning that the average price ofSovaldi was discounted by more than 60% off US public list prices.”

The US-based originator reports Sovaldi sales as part of itshepatitis C (HCV) franchise, alongsideEpclusa (sofosbuvir/velpatasvir),Harvoni (sofosbuvir/ledipasvir) and Vosevi (sofosbuvir/valpatasvir/voxilaprevir). In the third quarter of 2018, Gilead reported global HCVfranchise sales that tumbled by 59% to US$902 million. “The declinewas primarily due to lower sales of Harvoni, Epclusa and Sovaldi acrossall major markets as a result of increased competition,” Gilead revealed.

“As a first step towards making HCV products more affordable,Gilead announced in September 2018 the launch of low-costauthorised generics of Epclusa and Harvoni in early 2019,” IQVIAcommented. Both drugs are to be made available in January next yearat a list price of US$24,000 for “the most common course of therapy”,thereby pricing them “to more closely reflect the discounts that healthinsurers and government payers receive today” (Generics bulletin, 28September 2018, page 15).

In February this year, Gilead received notifications from Natcoand Teva that they had submitted abbreviated new drug applications(ANDAs) for generic Sovaldi, leading the originator to sue for allegedinfringement in both Delaware and New Jersey district courts. Gileadsaid that while Teva had asserted that nine Sovaldi patents were invalid,unenforceable and/or not infringed by its proposed generic, Natco hadchosen not to all challenge all the Orange Book patents, having filed aparagraph IV certification to just two Sovaldi patents. G

Figure 1: Molecules for which supplementary protection certificates (SPCs)expire in certain markets in December 2018 (Source – Ark Patent Intelligence)

SPC expiries in DecemberINN Country

Aprepitant Switzerland

Data exclusivity expiries in December

INN Country

Amlodipine/Olmesartan medoxomil/Hydrochlorothiazide 1

European Union

Blinatumomab 2 US

Brentuximab vedotin Australia

Bromelains Turkey

Fesoterodine Switzerland

Fexofenadine/Pseudoephedrine Japan

Gardasil 9 2 US

Nebivolol 3 Canada

Nivolumab 2 US

Rivaroxaban Switzerland

Sofosbuvir US

Stiripentol 4 Canada

Temsirolimus Switzerland

Ticagrelor 1 European Union

Tocilizumab Switzerland

Umeclidinium bromide US

Umeclidinium bromide/Vilanterol US

Umeclidinium bromide/Vilanterol/Fluticasone furoate

US

1 This will be followed by two years of market exclusivity, where a generic will not beplaced on the market

2 This will be followed by eight years of biosimilar application approval exclusivity,during which a biosimilar will not be approved

3 This will be followed by a no-marketing period of two years, during which a notice ofcompliance will not be granted to a generic manufacturer

4 This will be followed by a no-marketing period of two and a half years, during which anotice of compliance will not be granted to a generic manufacturer

Figure 2: Molecules for which data exclusivity expires in certain markets duringDecember 2018 (Source – Ark Patent Intelligence)

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Gen 30-11-18 Pgs.1-32.indd 17 27/11/2018 17:00


BUSINESS STRATEGY

With over 30 years of experience in the globalgenerics industry, Claudio Albrecht has seenjust about every peak and trough experienced

by the sector since its earliest days. Having started hispharmaceutical career at Sandoz in 1987, he ran theNovartis division’s operations in countries includingthe US in the early days of the Hatch-Waxman legaland regulatory framework that has since taken genericpenetration in the US to over 90%.

In 2000, Albrecht left Sandoz to become chiefexecutive officer of Ratiopharm, a role in which hedrove the privately-ownedGerman group’s internationalexpansion, was an early investor in biosimilarinfrastructure and pipeline, and developed a highlysuccessful OTC umbrella brand. Having subsequentlyfounded a strategy consulting firm with long-timebusiness partner Peter Prock, Albrecht was then askedto assume the role of chief executive and executivechairman of Actavis, sharpening the multinationalgenerics player’s focus toward becoming a ‘one-stop-shop’ for diabetes products before the business wasbought by Watson for US$6 billion.

Speaking exclusively to Generics bulletin as hecompleted a period during which he led Stada notonly through a turbulent change of ownership, but alsothrough an extensive reform of its market strategy,supply chain and corporate culture,Albrecht expoundedon his vision for the future of the industry, coveringissues including portfolio management and corporatestructures, manufacturing and supply-chain structures,opportunities in the OTC and value-added medicinessectors, and biosimilar strategies.

And as he considers the current opportunities andchallenges with which companies are contending, hebelieves the industry faces a fundamental shift in bothits structure and the mentality required to succeed.

“I strongly believe that for pure-play genericscompanies, essentially showing equivalence to easy-to-copy molecules, their time is somehow over,” Albrechtasserted. “Everybody is trying to become a hybridcompany,” he observed, pointing to the high level ofinterest in 505(b)(2) and similar regulatory routes in abid to bring differentiated small-molecule products tothe market.

“Then you have this large field of biosimilars,which will to a certain extent be limited to thoseplayers which operate in a large enough territory to earnback their investment,” Albrecht continued. “Even ifdevelopment becomes easier, it will still be a significantinvestment, so you will probably not see nationalplayers have any important role in this arena.”

Highlighting the example of Mylan’s moves forAbbott’s established products basket and the US firm’spurchase of Meda, as well as Teva’s now defunct OTCjoint venture with Procter & Gamble, Albrecht saidanother way in which traditional generics firms werelooking to diversify and de-risk was by pushing intoconsumer-driven brands.

“This is going to be a question of balance, andI believe you have to play in all of these fields,” hemaintained. For many major companies, he believed,prescription generics and biosimilars would continueto act as growth drivers, while the brands and OTCbusinesses would potentially be driven by acquisitions.

At the heart of such strategies,Albrecht contended,lay questions about how to define the industry in whichtraditional generics suppliers now played. “How do wedefine our industry?” he wondered. Taking the exampleof industry leader Teva, he pointed out that the Israelifirm had for many years seen its Copaxone (glatirameracetate) brand be a major component of group turnover,and even with the multiple-sclerosis blockbuster nowfacing generic competition, novel drugs such as Teva’sfremanezumab monoclonal antibody for migraineswere coming through.

“Everything that Teva, Sandoz and Mylan do, Ialso in theory could do,” he argued, recognising thatsmaller players may not be able to match the big three’sinvestment levels. But below the top three, he observed,it remained an open question as to who would emergeas the closest challengers.

During his time with Stada,Albrecht had laid out aplan to cement the German group’s place in the top fiveindustry players globally, and the top three in Europe,through a broad strategy designed to produce top-linegrowth well above the market average. This includedbuilding out a pan-European hospital sales networkthrough which to distribute the firm’s promisingpipeline of biosimilars and associated drugs, as wellas internationalising its strong local OTC brands andfilling in geographical gaps by seeking acquisitionsin the UK, in Central and Eastern European countriessuch as Poland, and in the Middle East and NorthAfrica (Generics bulletin, 16 March 2018, page 1).

No pure-play generics anymore“I think you have to compare on a company level,

not so much on an industry or sector level, becauseeverybody is trying to do their own thing. But itis definitely not going to be just pure-play genericsanymore,” he contended. “And the company that showsthe highest creativity, has the best ideas on how tosustain profitability, will probably be the winner.”

Discussinghowcompanies couldmeet this creativitychallenge, Albrecht stressed the importance of buildingand maintaining a strong network of industry contactsand partners. “For me, the biggest business developeris always the chief executive officer (CEO),” he opined.“The CEO has to have the ideas and the network,supported by people who can make things happen.”

Creativity and a strong business-developmentteam really came into its own in supporting portfoliomanagement that would give access to differentiatedproducts through partnerships and alliances, Albrechtasserted. As the industry pivoted towards specialtyproducts –which he defined as “everything that requires

Industry must evolve to adopthybrid model for future growthTo find sustainable

growth and profits,

traditional ‘pure-play’

generics companies

will have to become

hybrid entities that

span the spectrum

from OTC brands to

biosimilars, industry

veteran Claudio Albrecht

told Aidan Fry in an

exclusive interview.

Claudio Albrecht

Gen 30-11-18 Pgs.1-32.indd 18 27/11/2018 17:00


BUSINESS STRATEGYmore than an affordable price” – the complexity andexpense not only of developing and manufacturing,but also of marketing and detailing, these complexchemical and biological medicines would increase.Nevertheless, he believed, “the move into the specialtyarea is a logical one”.

But given the complexities involved, it wasimportant not to try to compete on every specialtyfront, but rather to build around “strongholds” and leadproducts that were alreadywithin a company’s portfolioor pipeline. As an example, he cited the strategy he andhis team had elaborated at Stada that focused aroundfour therapeutic categories: oncology, including severalbiosimilars; ophthalmology, incorporating chemicaldrugs as well as the Lucentis (ranibizumab) biosimilarbeing developed through an alliance with Sweden’sXbrane; central nervous system (CNS); and diabetes(Generics bulletin, 16 March 2018, page 5).

A strong lead brand, like Teva’s Copaxone orStada’s Apo-Go (apomorphine) Parkinson’s diseasedrug, provided a strong platform from which to furtherdevelop hard-to-make injectable CNS products, heexplained. “Oncology is an area of obvious differentiationpossibilities: a biosimilars oncology pipeline wouldcombine with small-molecule cancer therapies to createa strong oncology offering that includes numerousdifferentiation opportunities such as ready-to-useformulations, liposomal deliveries and devices,” headded. “Disease management will more strongly come toEurope one day, and oncology and diabetes will be at theforefront of the debate.”

“If you look at diabetes, I believe there are not manygeneric players who are trying to go into this field,” heremarked. “But for payers, diabetes is a tremendouslyexpensive area, and its prevalence is growing in a verydynamic way, so it is becoming more expensive everyday. There will have to be a way of containing thesetreatment costs.

“You need to think in a broad sense, because inmany countries you can build a competence at the levelof the key decision-maker, most of all with the payers,”Albrecht continued. “You want to have a productportfolio that shows that you have that competence,and then you can create a kind of one-stop-shop. Thisis also the competitive advantage you have over theinnovators. A generics company can offer a wide rangeof products for type 1 and type 2 diabetes and all itscollateral diseases, providing wide treatment conceptsat significantly reduced costs.”

The appeal of this approach, and identity of thedecision-maker, would vary from country to country,he recognised. But in regions such as the MiddleEast, where diabetes was one of the fastest-growingmorbidities, building a therapeutic franchise in this areacould provide a strong foothold. In highly developedmarkets such as Germany, working closely withhealth insurance funds to support disease-managementprograms could prove successful, he suggested.

Local management within a company should beexpected to follow the central strategy, but alsobe allowedto adapt and implement details to meet local needs,Albrecht argued. “It is a toolbox approach, whereby youtake what is good for you,” he explained. This approach,he suggested, could allow local operations to tailor theiroffering in sectors such as the OTC market (see boxentitled ‘Digital offers up OTC options’).

Within Europe, Albrecht observed, “you have verydifferent channels for the same product, so you haveto adjust your sales structures”. Citing the exampleof pegfilgrastim, which is just seeing biosimilarcompetition in Europe for the first time, he pointedout that the neutropenia treatment was exclusivelya hospital-administered drug in certain countries,but in others there was a significant retail element.“Therefore, what you need are flexible and agilecountry organisations which understand where thedeciders sit and are able to build strong relationships.”

Having lead products in key therapeutic areasmade it easier to license-in associated products in thesame therapeutic category, he believed. “The aim,”he explained, “is to backfill the portfolio in the mosteffective way that helps to dilute the cost of your salesand marketing infrastructure.”

Partner to fill portfolio blanksPartnering could prove a viable way to fill in blank

spaces in portfolios, particularly for complex productsthat commanded prices which allowed margins to besplit, Albrecht argued, noting the raft of implant andextended-release opportunities coming in the CNSspace, such as the long-acting ‘Consta’ formulation ofrisperidone. “The central challenge is how can I bring aproduct to market that commands returns far exceedingaverage development costs? And that is really whereyour business-development team is key.”

“There are several ways of doing it,” Albrechtelucidated. “There are several small companies thathave know-how in-house and it is always interestingto team up with them, inject some money and do ittogether so you do not have to start from scratch.”Having found a co-development partner, one option wasto fund the project in return for owning the intellectualproperty, he suggested.

In the oncology arena, adding value to infusionsystems by making them safer and easier to handlepresented challenges in healthcare systems thatfocused primarily on sourcing the cheapest availableproduct, Albrecht acknowledged. Considering the totalcost of care, rather than just the cost of an individualdrug treatment, was primarily a concept accepted in theEnglish-speaking world, he pointed, out. Elsewhere,he surmised, safety features that protected nurses andhealthcare professionals from cytotoxic substancesmight gain more traction in the hospital market.“Total cost of care is probably not the right argument,especially in non-Anglican markets, but safety throughfeatures such as needle guards is a better one.”

Looking from a sales and marketing perspective,Albrecht does not feel it makes sense to delineateproducts by their regulatory pathway or delivery form,but rather by their key target group.

“I do not believe in splitting products by nature,”he explained. “I believe more in separating businessesby who makes the buying decision. There should be acustomer-centric focus to how you sell your portfolio,based on whatever each customer needs. For example,how often do cancer patients also need support productsfor the side-effects of their treatments?”

Therefore, managing separately biological andchemical products was not the best course. “If you talkto key opinion leaders in oncology, they need not onlybiologics like monoclonal antibodies, but also small-

“If you look at

diabetes, I believe

there are not

many generic

players who are

trying to go into

this field”

Gen 30-11-18 Pgs.1-32.indd 19 27/11/2018 17:00


BUSINESS STRATEGYmolecule cytotoxics,” he stressed. “Sending somebodyto talk to a key opinion leader about just one product,rather than four or five, is often a waste of resources.”

Turning his attention to the biologics sector,Albrecht highlighted the significant advantage conferredby being first to market with a biosimilar of a givenmolecule. For example, he admitted, gaining sharein the filgrastim market as a late entrant had provenchallenging. “You should really try to be in the firstwave,” he commented.

Nevertheless, he believed that large markets, suchas for pegfilgrastim, still offered opportunities evenfor companies that were not in the vanguard. “Intotal, I foresee seven or eight players coming to thepegfilgrastim market,” he revealed, noting that theinitial launch dynamics in both Europe and the US werestill playing out.

Acknowledging Accord’s ability to secure afilgrastim market share of over 15% in Europe as thefifth or sixth entrant (Generics bulletin, 5 October2018, page 24), Albrecht said this reflected the valueof strong partnerships and competitive cost structuresin the biosimilars arena. And with Accord leading thechargewith pegfilgrastim in Europe (Generics bulletin,5 October 2018, page 18), it would be interesting to seehow market share and pricing dynamics evolved.

“For pegfilgrastim,” he observed, “several tenderswill run before the end of this year for supplies in 2019.The big question is which players will be able to buytheir way into these hospital contracts.” And while

latecomers could potentially gain traction throughrepeat tenders, such access would clearly come at aprice. “And then the question is: what does your coststructure look like, and can you afford it? And youhave to hold that against the model of how much it costyou to bring the product to market.”

In certain markets, such as Germany, avoidinghighly competitive hospital tenders and focusing on thesizeable retail market for pegfilgrastim could be a viablecommercial strategy, he proposed.Where a company hadan existing hospital sales and marketing team, bundlingproducts around therapeutic franchises, such as addingdialysis and nephrology products around erythropoietin,in a ‘scheme-selling’model often made sense.

“If youwant toplay in thebiosimilars field, youneedto be a multinational player. You cannot be a nationalplayer, because the risk is too high that somethingadverse will happen in your market,” Albrecht argued,pointing to the example of the dramatic price erosion oninfliximab in Norway. “Individual markets are usuallytoo small to earn back your investment.”

“One of the big trends, I believe, in the future ofthe industry over the mid-term will be that biosimilarsgo down a similar road that generics went down 30years ago,” he expounded. “We will see developmentand regulatory barriers down, making it less expensiveto bring biosimilars to market,” he predicted, pointingto discussion around clinical trial requirements and theability to use global comparator products.

“If authorities really want to stimulate pricecompetition, they need to make the development andregulatory hurdles more affordable,” he argued. “Ibelieve the market will go in a direction where productsbecome more interchangeable.”

With lower cost barriers to entry and greaterinterchangeability, Albrecht foresees the biosimilarsmarket mirroring the generics sector in evolving towardsa model in which players compete hard to obtain amargin above cost of goods. “It will probably not bequite as aggressive on price as quickly as with small-molecule generics,” he conceded. But with Albrechtanticipating there will eventually be “more than 15”firms offering biosimilar adalimumab, pricing pressurewill be severe.

In this environment, he says it will be importantto be brave enough to kill biosimilar developmentprojects when they will not give a sound return oninvestment. “You have to look at how many people aredeveloping it, and how fast will you be to market.”Andif it seemed likely that a company would be late intoa crowded market, it would be best to cut investmentas soon as possible, especially for drugs that wouldrequire broad sales and marketing support. For moreniche biosimilars, such as in the ophthalmic sector,competition would potentially be less fierce.

“Usually, originators are fairly prudent when itcomes to killing prices,” he observed. Discussingoriginators’ defensive tactics for their reference brands,Albrecht saidmuchwould depend on the approach takenby health technology assessment (HTA), reimbursementand procurement authorities. “If these bodies wantto achieve their savings goals,” he cautioned, “theywill have to take a critical approach to incrementalinnovations and assess whether they really add improvesafety or quality of life versus the biosimilar. In manycases, we see that these steps do not add all that much

Digital offers up OTC optionsThere is no shortage of generics companies that regard the OTC sector as a

potentially promising arena in which to leverage their expertise in off-patentmolecules. What is in shorter supply is the considerable capital and resourcesneeded to create global brands through massive media campaigns and expensivetelevision commercials.

But that may be changing, according to former Stada,Actavis and Ratiopharmhead Claudio Albrecht. In an increasingly digital world, he sees several newopportunities to build consumer healthcare brands through more targeted, lessexpensive media channels such as Facebook and Google. “These days, peoplespend more time looking at their mobile phones than they do watching thetelevision,” he observes.

Not only do digital media resonate more efficiently and effectively with thenext generation of consumers, Albrecht argues, they also lend themselves morereadily to international application than traditional mass-media campaigns. Butwhile he recognises the potential for apps to improve health, he questions howeasy it will be to link such technologies to specific product portfolios of off-patentcompanies and to make a return on investment. “Our job is to provide morecost-effective medicines that help healthcare systems save money,” he points out,highlighting the danger that investing in an expensive technology could driveconsumers to use a competitor’s interchangeable product.

Recalling how he at Ratiopharm led a team that created an umbrella OTCbrand that, surveys showed, German consumers considered to be the most trustedand innovative pharma brand, Albrecht admits that the concept – built around theimage of twins to imply equivalence – would not necessarily be as successful inother countries.

“If I were starting afresh now in the OTC arena,” he reveals, “I would probablycreate an umbrella brand. And as a company with a few non-prescription generics,I would look to have pharmacists and their assistants pushing my products, ratherthan try to pull in consumers. This strategy may not give you a huge market share,but it will give you a reasonable relation between your advertising and promotionspend and the returns you generate.” G

Gen 30-11-18 Pgs.1-32.indd 20 27/11/2018 17:00


BUSINESS STRATEGYvalue.” In ensuring potential biosimilar savings wererealised, Albrecht suggested prescribing quotas couldbe a useful tool.

And as in the small-molecule generics space,biosimilars players would have to be prepared to takeon fights against blocking intellectual property, hecontended. “The bigger you are, the easier it will beto attack or to launch at risk,” he said, noting that thethreat of damages was typically higher in the US thanin Europe.

“For a smaller company, it would be much moredifficult to gamble and have that level of uncertaintyfor two or three years. But I believe it is important totake on some level of risk, and it is important that theauthorities recognise that we need sufficient margins toenable us to fight through these issues.”

SPC waiver would boost EuropeStressing that while it should battle against patent

abuse, the industry must respect valid intellectualproperty, Albrecht said the prospect of EuropeanUnion (EU) producers being able to stockpile duringthe term of the supplementary protection certificate(SPC) – under a proposed SPC manufacturing waivercurrently being evaluated by the EU Council (Genericsbulletin, 2 November 2018, page 8) should trigger areassessment of where European companies made theirmost strategically important products.

“If we could produce drugs to launch immediatelyupon SPC expiry, I believe several companies wouldlocate much of their activities in Europe, rather thanbeing forced to import from outside of the EU,” heforecasted. This would reduce the complexity of thesupply chain whilst creating high-quality jobs, butwould not adversely impact originators that would, inany case, face competition from generics produced inAsia or elsewhere.

According to Albrecht, the current discussionaround impurities found in sartan ingredientsproduced in China should include a review of howan SPC waiver could improve supply-chain securityfor medicines in the EU. It was vital, he argued, thatpolicy-makers take a “holistic view” and not bow topressure from vested interests based in the US. “Asan industry, we tend to forget problems very quickly,but we should really make the case of reliability andquality of supply, even if producing in Europe will notavoid every issue.”

Security of supply should be one the major topicson the industry’s agenda, Albrecht argued.

“For strategic products, it is particularly importantthat you control the supply chain and understand theprocesses of your suppliers. The ideal situation isto have a few strategic suppliers for which you canconduct regular audits and where they share with youall the variations and other changes they do.” Suchopen relationships and transparency contributed mosttellingly to supply-chain security, he believed.

Albrecht was sceptical that backward integrationinto active pharmaceutical ingredients (APIs) was theright approach for commodity products. “If it comesto certain strategic products where you have long-termvalue creation, such as in biologics, the drug substanceis a driver. But for chemically-derived products, Iwould rather depend on a limited number of supplierswho are willing to look beyond solely cost.”

What was critical in collaborating with bulk-drugpartners was working closely on quality parametersand understanding what was contained in the closedpart of the drug master file (DMF), he maintained. Andwhile quality issues could still arise, close collaborationcould help to establish “early warning signals” for anyproblems. Having a second API source identifiedin dossiers mitigated against the risk of recalls andmarket shortages that could cost companies dearthrough failure-to-supply clauses built into tenders andprocurement contracts, he added.

“It is not a great strategy to have 150 suppliers inyourAPI horizon. It is a great strategy to concentrate onmaybe 10 suppliers who have maybe a broad portfolioto offer and with whom you have a clear understandingon quality and what you want to see,” he asserted. “Yougive them the volume, and they give you security, evenif it is not always the very lowest price available in themarket. You have to concentrate on fewer partners, butgive them more business.”

With a network of preferred API suppliers inplace, Albrecht argued that it was perfectly possibleto manufacture dosage forms in Europe for the localmarket. Citing his experience at Ratiopharm, Actavisand Stada, he said the facilities in geographical Europewere not only cost-competitive on a global basis, theyalso conferred advantages in terms of duties whenexporting to Russia or speed of release. “In terms ofsupply-chain complexity, it was better for us to supplyout of Europe than out of India,” he stated.

Within Europe, Albrecht remarked, companieswere able to drive considerable volumes throughGerman tenders that generated economies of scale andcost-of-goods benefits for the rest of the region.And fora similar reason, he felt the UK generics market couldalso be an attractive opportunity, albeit one complicatedby the current uncertainty around the country’s ‘Brexit’withdrawal from the UK. “If the UK emerges fromBrexit with a regulatory system similar to that of theSwissmedic agency in Switzerland, I think we can livewith that,” he remarked.

By contrast, relatively low-penetration Europeancountries like France and Spain did not offer the samescale benefits, while Italy and Spain were largelydominated by powerful, local players that were oftenunder family ownership.

In France, he recognised, competing in the coreprimary-care generics segment was tough. “With anuanced approach, it is possible to find attractiveniches, but the system as such makes life for pure-playgenerics very difficult.”

Describing the way to win in tender-led Nordicmarkets as “the art of the supply chain”, Albrecht saidmany Central European markets were like France inthat they offered attractive niches, particularly in theOTC arena. Furthermore, consumer healthcare brandscould also serve as a spearhead to push into the MiddleEast and North Africa (MENA) region.

Discussing his plans after finishing his term atStada, Albrecht told Generics bulletin he was lookingforward to taking on new challenges and projects withhis Albrecht, Prock & Partners consultancy based inZug, Switzerland. “We have quite a queue of peoplewaiting,” he revealed. But for now, he has set himselfan even steeper challenge – mountain-biking across thelength of Bhutan. G

“If the UK emerges

from Brexit with a

regulatory system

similar to that of the

Swissmedic agency

in Switzerland, I think

we can live with that”

Gen 30-11-18 Pgs.1-32.indd 21 27/11/2018 17:00


BUSINESS STRATEGY

Polpharma Group expandingits capacity for biologicals

Around seven years ago, Polpharma Grouptook a major strategic decision to compete inthe booming biosimilars and biologics arena.

Having invested heavily into its development andproduction infrastructure in Poland, the group has notonly started to advance its own biosimilars pipeline.It is also positioning itself as an attractive contractdevelopment and manufacturing organisation (CDMO)for partners around the world.

Discussing the group’s biologics strategy withGenerics bulletin, vice-president of Polpharma’smanagement board and head of the PolpharmaBiologicsdivision, Hannes Teissl, described the decision to moveinto biologics as “a game-changer for the group,because we have created a truly global offering out of aregional geographic footprint”. Inmoving into the sectorseven years ago, the group was, he acknowledged,too late to compete effectively on the first waveof monoclonal antibodies such as adalimumab andrituximab. “We therefore decided to look at potentiallaunches from 2020 onwards,” Teissl revealed, addingthat the firm had selected targets – including biosimilarsof Lucentis (ranibizumab), Tysabri (natalizumab) andStelara (ustekinumab) – that appeared to have attractedrelatively little biosimilars competition.

To support that pipeline, Polpharma has capitalisedon the industrial expertise of its owner, Jerzy Starak,and a team of experienced international biologicsmanagers to build a fully-integrated value chain ofbiological assets that range from cell-line developmentto commercial fill-and-finish manufacturing.

Having already invested around US$350 millioninto facilities and biologics operations, Polpharmacurrently has two operational sites for biologic drugs,with a third under construction. The first is the formerBioceros cell-line development laboratory in Utrecht,the Netherlands – which the group acquired from Epirustwo years ago (Generics bulletin, 24 June 2016, page2) – that houses more than 30 experienced scientistsworking on research and early-stage development.“Bioceros has proprietary technology which allowsefficient modulation of cell lines to really boost theyields while retaining fingerprint-like biosimilarity –our team also has decades of experience in generatinginnovative antibodies,” Teissl explained, adding that thisDutch affiliate was also offering highly productive cell-lines and antibody generation services to third parties.

The group has started to further invest into theUtrecht site so that it can move projects to an even moreadvanced stage, thereby “providing third-party clientswith biosimilars candidates they can trust to meet thestringent similarity criteria of regulators”. When thegroup was starting at its Gdansk cell-culture site, Teisslrevealed, it had to buy and work on commercially-available cell lines. “But Bioceros made us fullyintegrated, and we can now see a big difference,” he said.

“Right now, at Gdansk we have 270 highly skilledpeople drawn from eight different nationalities, along

with everything you need to develop biologics, performupscale development and do pilot and commercialmanufacturing up to 2,000 litres,” Teissl stated. Thefacility already had good manufacturing practice(GMP) clearance for mammalian projects, and has nowbeen complemented by a microbial section. “In early2019, we will add a flexible fill-finish line that can dovials and syringes, liquid and lyophilized, both for ourown products and for third parties. Companies tendto underestimate the fill-finish side of the business;they focus on drug substance, but then often run intoformulation and quality issues,” Teissl commented,adding that the Gdansk site was ideal for producingclinical materials as well as commercial batches ofsmaller-volume products.

Entering biologics CDMO arenaThe group’s Gdansk facility, Teissl explained,

was helping the group to enter the biologics CDMOarena beyond cell-line work. Today, the Gdansk siteis engaged in performing CDMO activities for theFYB201 program, a biosimilar rival to Genentech’sLucentis (ranibizumab) that – based on the recentpositive read-out of top-line data from a pivotal‘Columbus-AMD’ Phase III trial – has just showncomparable efficacy to Lucentis, with positive 48-weekdata. Global commercial rights for this program werelicensed from Formycon and belong to Bioeq, a 50-50joint venture that Polpharma has formed with theStrüngmann Group’s Santo Holding.

Teissl, who was instrumental in establishingthe Bioeq joint venture, said it had been formed in2014 with the purpose of jointly developing andcommercializing globally FYB201. The decision toalso locate commercial manufacturing of this programat the group’s Gdansk facility allowed Bioeq to takeadvantage of the favourable local intellectual-propertyenvironment, he pointed out.

Formycon is targeting a US market entry withranibizumab upon patent expiry for Lucentis in June2020 (Generics bulletin, 8 December 2017, page 14).European patent expiry will follow in 2022.

With Formycon and Bioeq having just completedtheir Phase III trial ahead of a planned dossiersubmission to the US Food and Drug Administration(FDA), Bioeq seemed to be “in a favorable competitivesituation for this program”, he believed.

Polpharma has already enjoyed early successin several countries, including in the Netherlandsand the UK (Generics bulletin, 11 August 2017,page 23) as well as Germany on another of its leadbiosimilar candidates, an alternative to Biogen’s Tysabri(natalizumab). Teissl said the group – which is alsoworking on biosimilar ustekinumab, along with “threeother projects” – has started to move natalizumab intothe clinical phase of development work.

Commenting on the group’s biologics portfolioselection, Teissl said: “We don’t need to have multiple

Extensive biological

development and

production capabilities

that Polpharma Group

is establishing in Poland

are intended not only

to support its own

biosimilars pipeline.

The group is also

creating a significant

contract development

and manufacturing

organisation (CDMO),

vice-president Hannes

Teissl told Aidan Fry.

Hannes Teissl

Gen 30-11-18 Pgs.1-32.indd 22 27/11/2018 17:00


BUSINESS STRATEGYprograms in one and the same therapeutic area, becausewe always pick the best commercial partner for eachof them whatever category”. While ranibizumabcommercialization would be managed through theBioeq venture, he said the company was open to discusscollaborations on other molecules. Polpharma’s priorityin any commercial collaboration would be to do theright deal for the product, be it on a local, regional orglobal scale, he outlined.

Commercial production for both drug substanceand fill-and-finish will be augmented by a large-scalebiologics facility that Polpharma is currently buildingin Duchnice, Poland, near to Warsaw’s internationalairport (Generics bulletin, 8 December 2017, page3). Slated to be fully operational by 2020, the 30,000sqm Duchnice plant will initially house four 2,000-litresingle-use bioreactors on its first floor, but the facilityis designed to handle up to 12 such disposable reactors.Fill-and-finish suites on the ground floor will havean initial capacity of 15 million vials and pre-filledsyringes per year, scalable up to above 30 million units.

While competition might not be as fierce as insmall-molecule generics, Teissl said cost of goods forbiosimilars would become increasingly important asentrants reached the market.

Observing that several multinationals had alreadyput developments on hold as their pipeline programmesdisappointed, markets did not yet play out as expectedand corporate strategies changed, he stressed theabsolute and long-term commitment of the groupto becoming a major, fully integrated player in thebiologics space.

With the Gdansk site gearing up to support its firstbiologic product launches, the biosimilars of Lucentisand Tysabri – and the large-scale Duchnice site set tostart operations within the next two years – the groupwould, Teissl argued, be in a strong position of beingable to offer CDMO services having already provenits capabilities with its own pipeline projects. “Weare using the knowledge and experience that our teamhas applied to bring our own biosimilars to market tosupport third-party clients,” he outlined.

“We’ve seen CDMOs do it the other way round– they try to forward integrate into biosimilars. Ourapproach is to offer to clients only what has worked wellfor us. One of these success factors is a limited numberof interfaces along the value chain and insofar we’re notdriven by offering certain time slots of ourmanufacturingcapacity, but a truly modular one-stop-shop servicescope from A to Z: cell line generation, process andanalytical development, clinical and commercial supply,mammalian and microbial, fill and finish.”

Retain full controlAnother crucial element of that strategy, he

explained, was our industrial focus and being ableto retain full control on research and developmentand manufacturing in the group and with that quality,supply reliability and cost of goods. “A large shareof our industry’s issues is directly related to workwhich has been outsourced to multiple different serviceproviders,” Teissl contended.

Quite often clients find themselves confrontedwith priorities of service providers, which do not matchtheir own plans. Our teams are dedicated, trained andexperienced to understand our client’s problem in full,

to jointly generate tailored solutions and finally deliveron time in full,” he summarised.

Teissl stressed that developing and manufacturingfor third-party clients was not tactical or a short-termdecision for Polpharma Group, but was rather “animportant strategic element of our group”. Nor was ita new approach.

“Our chairman has a heritage of partnering andbeing passionate about manufacturing for clients, bothfor small molecules and biologics,” Teissl continued.“Obviously we are a new player in the biologics space,but we have pulled together a truly international teamwith an unparalleled track record in serving customersfor many decades. Our CDMO director used to headthe largest microbial facility worldwide, has built large-scale mammalian plants and serve multinational clientsfor over 20 years” he stated.

Last year, Teissl was reunited with former Sandozcolleague Jörg Windisch – “a legend in the biosimilarsindustry” – who took the role of chief operating officerof Polpharma Biologics.

Set up biologics academyFurthermore Polpharma has set up its own

biologics academy that will work with universitieswith an aim of producing 40-50 qualified staff eachyear. While the company had been putting togethera young, international biologics team, it was keen tostrengthen the local biotech base in Poland and becomerecognised as an attractive employer in the biotech arena,Teissl explained. To achieve, this, he acknowledged,Polpharma needed to become more visible and generateevidence of its progress on biologics.

Teissl acknowledged that Polpharma Biologicshad, until now, largely been operating under the radar.But that, he promised, would change as the groupprepared both to bring biosimilars to market and tobring its production capacity online.

“We now have our capacities and certifications,making us an attractive CDMO for partners who areeither looking for a better solution for their currentproducts, who do not feel comfortable with movingtheir programs to Asia or who are seeking broaderstrategic alliances,” he maintained, highlighting thatPoland was a great place for manufacturing biologics.

“There is a new player that is offering capacityand quality, is located in Europe and is ready tocollaborate,” Teissl proclaimed. G

A 30,720sq m biologics facility that Polpharma Group is constructing in Duchnice, Poland, will befully operational in 2020

Gen 30-11-18 Pgs.1-32.indd 23 27/11/2018 17:00


BUSINESS STRATEGY

Olafsson seeking to stretchresults of Hikma’s spending

CelebratingHikmaPharmaceuticals’40thanniversaryduring a recent investors’ day, the Jordaniangroup’s executive chairman, Said Darwazah, was

in reflective mood. The vision of his father, SamihDarwazah, of creating a truly global business improvinglives around the world had been well and truly deliveredthrough a company operating in about 50 countries,making 7 billion doses annually and generating globalsales of almost US$2 billion per year (see Figure 1).

“We realised that we had done all of this withthe same team,” he recalled. Acting on a belief thatit was time to bring fresh talent into the business,the management team had started to recruit acrossseveral functions, including research and development,manufacturing and commercial. “To head all of this, weneeded somebody with experience who could take us tothe next level,” Darwazah explained, praising Hikma’schoice – former Actavis and Teva chief Siggi Olafsson(Generics bulletin, 23 February 2018, page 1) – forhitting the ground running.

Having conducted a thorough review of Hikma’soperations over the past nine months or so, Olafssonearlier this month laid out to investors a strategy basedaround strengthening the group’s base, maximisingreturns on investments and reviving the firm’s flaggingpipeline,whilst capitalising on the group’s “differentiatedbusiness model”. Hikma’s global Injectables businesssegment had, he recognised, been “the driver of ourgrowth over the past five years”, propelled through asteady launch roster to account for more than two-fifthsof group turnover. By contrast, the US non-injectableGenerics segment – which generates a third of groupturnover – was “a turnaround business”, working hard torestoremargins after a couple of lean years.AndHikma’sBranded operation in the Middle East and North Africa(MENA) region was “really what differentiates us”,offering a range of in-licensed novel drugs, brandedgenerics and OTC products in 18 MENAmarkets.

The Injectables segment, Olafsson pointed out,had been launching around 15 products per year andhad built up a pipeline of about 120 candidates. Andwith a total capacity of 1 billion units spread acrossfacilities around the world, the segment was “extremelywell positioned, not only today, but also for the future”.

With the Injectables business having produced14% sales growth to US$414 million in the first halfof 2018 on a strong performance from recent launches(see Figure 2), Hikma has raised the segment’s full-yearforecast to US$825-US$850 million, producing a ‘core’adjusted operating margin of 39% to 40%. Olafsson saidthe segment was continuing to benefit from competitors’supply problems in the injectables arena. “Shortagesper se are not one-off,” he argued, highlighting howintermittent supply disruptions had long been a featureof many markets. Therefore, it was vital to be nimbleenough in terms of manufacturing schedules and addingshifts to meet sudden surges in demand.

Through its strongmanufacturing base inColumbus,

US, and in Jordan, the US non-injectable Genericsbusiness was recovering well from a difficult period inwhich margins had been eroded. Stressing the segment’sability to develop and make several complex productsincluding nasal sprays and oral oncology drugs, Olafssonsaid the business was working hard to differentiate itsportfolio. “In an environment where our competitors areshrinking their product offering, our special offering ishelping our customers,” he insisted. “We are getting tobe more important.”

“If you do not differentiate,” he warned, “you willjust be one of the 170 generic companies competing inthe US, and you will not stand out.”

But challenges remain for the Generics segment,not least in obtaining more sustainable margins. “Theweakness where we need to improve is on the pipeline,”he admitted. “The quality of the pipeline we have isvery good – I just need more of it.”

Developing Hikma’s pipeline is one of three keystrategic pillars underpinning Olafsson’s strategy fordelivering sustainable growth. The other two pillarsare ‘focusing on the foundation’ by making the baseUS$2 billion business more efficient, and ‘leveragingpartnerships andmergers and acquisitions’, supported bythe group’s strong balance sheet that saw it end the firstsix months of 2018 with a net debt to earnings beforeinterest, tax, depreciation and amortisation (EBITDA)leverage ratio of 1.0.

Partnerships that capitalised on Hikma’s positionas the fifth-largest pharma company in the MENAregion – and as the leading local player – had beeninstrumental in enabling the group’s Branded segmentto build a broad portfolio of novel drugs, brandedgenerics and consumer healthcare products, Olafssonobserved. As an example, he cited the OTC partnershipthat the firm had struck with Perrigo’s Omega Pharmaunit for more than 30 consumer healthcare products(Generics bulletin, 13 July 2018, page 3).

Clear opportunities in MENABut while “the opportunities are clearly there” in

the MENA region as “the only global, local player inthis part of the world”, Olafsson acknowledged thatthe Branded segment had been growing only modestly,with sales ahead by 4% to US$232 million in the firsthalf of this year. “We are finding a way to reignite thegrowth in this business going forward,” he promised.

“We want to work with partners where we do nothave all the information or the technology ourselves,”Olafssoncontinued.Thegroup’s track recordasa“reliablepartner” of choice was one of six “unique strengths” thathe had identified at Hikma, along with: a “strong balancesheet” that gave the firm the “firepower to do bothmergers and acquisitions and business development”while returning cash to investors via dividends; theright “people and culture” through a blend of expertisefrom a family-led firm with an influx of fresh talent;“commercial excellence” via key account managers and

Vastly stepping up

returns from research

and development

investment whilst

stripping costs out of

the base business and

filling gaps through

business-development

deals are central to

the strategy laid out

by Hikma’s new chief

executive, Siggi Olafsson.

“The quality of the

pipeline we have is

very good – I just

need more of it”

Gen 30-11-18 Pgs.1-32.indd 24 27/11/2018 17:00


BUSINESS STRATEGYsalesforce representatives; a “broad product portfolio”in each of the three business segments; and a record of“high-quality” manufacturing and supply over 40 yearsthat few competitors could rival.

But significant challenges also faced the group, notleast in reversing a trend over the past four or five yearsfor Hikma’s core operating margin to slide from 30% in2013 down to 20% in 2017. Pointing out howHikma hadover this period transitioned from being a “one-productcompany” that relied on exclusive product opportunitiesin the US to a diversified global operator, Olafssonacknowledged that the company’s pipeline had beeninadequate to compensate for competition and pricingpressures in the US. “We didn’t compensate for the700 to 800 abbreviated new drug application (ANDA)approvals that the US Food and Drug Administration(FDA) started to deliver, up from 300 ANDA approvalsthree or four years ago,” he admitted.

Set four key objectivesTo tackle this issue of a declining operating margin,

Olafsson has set the group four objectives: firstly,maximising returns from its existing product portfolioby offering customers more differentiation and elevatedservice levels; secondly, leveraging its commercialcapabilities, such as by realising synergies betweencustomer serviceof theGenericsand Injectables segmentsin the US or between the Branded and Injectablesoperations in the MENA region; thirdly, reducing costs,a program that is well underway with activities at thedefunct Eatontown production andMemphis distributioncentres in the US being centralised into the campus atColumbus, Ohio; and fourthly by improving internalprocesses by aligning local systems that had not keptpace with the rapid sales expansion of the group.

“The margins that we are dealing with, and thecompetition in the market, mean we need to think aboutcosts at every point in time,” Olafsson insisted.

With a view to controlling costs and staying inline with peers, Olafsson intends to limit researchand development spending over the next five yearsto around the current range of 6% to 7% of groupturnover (Generics bulletin, 23 March 2018, page14). But he believes “the return on the investment iscurrently too low”, as only around 3% of group salesin 2017 were the result of new launches, an inadequateamount to compensate for the typical high-single-digitprice erosion in the generics industry. “This is thefundamental challenge we have,” he recognised.

To “compensate for this tough operatingenvironment”, Olafsson has set Hikma the goal ofraising its research and development return oninvestment to new launches accounting for about 10%of group turnover within five years (Generics bulletin,16 November 2018, page 1).

For the firm’s Injectables segment, Olafsson saidthis would require “increasing the complexity ofprojects” in its development pipeline. But for the non-injectable US Generics unit, it was “more about thenumbers”, because the short-term launch prospectswere insufficient to offset the competitive pressures.

And for the Branded MENA segment, Olafssonwants the unit to prioritise projects to maximise theirlaunch potential. “The days when we could take ageneric product, put a brand name on it, give it to oursalespeople and it would be a success, those are gone,”he contended. “We need to have something differentto offer.” In each of Hikma’s 18 MENA markets, heexplained, local players were poised to compete onprice. “We need to move our business model a littleaway from being a purely branded generics companyto being a real brand company that offers differentiatorsfor patients.”

Hikma’s own pipeline efforts will be augmentedby both partnerships and mergers and acquisitionsactivities. “The focus of our merger and acquisitionactivities is more about growing in our current marketsand building scale,” Olafsson stated. “The returnon investment in our current market footprint issignificantly more than entering new markets.”

Streamlining MENA footprintWhileHikmawould continue to be opportunistic in

entering new markets – such as through the injectablesdeal that it had just struck in Vietnam with MedlacPharma (Generics bulletin, 16 November 2018, page7) – Olafsson said he was keen to streamline the group’sgeographic spread. “Where we are de-emphasising ismaybe the number of countries we are operating in,” heexplained. Rather than operating in 50-plus countries,Hikma would, he said, focus on allocating resourcesto, and growing faster in, core markets such as Algeria,Egypt and Saudi Arabia in the MENA region.

At the same time, he said, Hikma would invest intechnologies for delivering more complex dosage formsand “knowledge around devices”. And the firm wouldalso look for opportunities tomove into adjacent businessareas to complement its three business segments. G

n In-depth analyses of Hikma’s Injectables, Generics andBranded business segments will appear on Generics bulletin’snew online-first platform – coming soon!

0

500

1000

1500

2000

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

262 317449

581 637731

918

1,109

1,489 1,440

1,950 1,936

1,365

Group

turn

over

(US$millions

)

2005Listed on LSE

2007Expanded intoinjectableoncology marketin Germany andentered Egyptianmarket

2010Grewfootprintin MENAwithacquisitionsin TunisiaandAlgeria

2011Became a top 3generic injectablesmanufacturer inUS with Cherry Hillacquisition

2014GrewinjectablespipelinethroughBedfordacquisition

2015Increased presence in USGenerics market byacquiringColumbus

Figure 1: Hikma Pharmaceuticals’ annual turnover between 2005 and 2017, with key landmark events(Source – Hikma)

Figure 2: Breakdown by business segment of Hikma’s sales andgross margin in the first half of 2018 (Source – Hikma)

Businesssegment

First-half sales(US$ millions)

Change(%)

Grossmargin (%)

Injectables 414 +14 62.8

Generics 338 +11 36.3

Branded 232 +4 50.0

Other 5 ±0 20.0

Hikma 989 +11 50.6

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PEOPLE

APPOINTMENTS

Narayan is value-added chairEuropean off-patent industry association Medicines for Europe has

appointed Arun Narayan as chair of its value-added medicinessegment, taking over from Umberto Comberiati.

Speaking as Medicines for Europe held its second annual ValueAdded Medicines Conference in Brussels, Belgium (see page 9),Narayan said a key question for the sector to address was how tocreate a pathway that incentivised continuous innovation aroundknown drugs, as well as how to ensure that healthcare systems did notmiss out on the benefits of such innovation.

“Wemust demonstrate to payers and governments that continuousinnovation can provide more value than new chemical entities (NCEs)alone,” Narayan declared, insisting that there was “significant scope”to bring the benefits of such innovation to patients.

Emphasising the importance of putting patients at the heart of theevaluation process for value added medicines – as well as maximisingthe integration of such drugs in healthcare systems by includingregulators in the conversation and providing them with adequateevidence of the benefits – Narayan said that value-added drugs shouldbecome “a cornerstone for a patient-centric health continuum”. G

RESIGNATIONS

MHRA chief Hudsonquits ahead of BrexitThe UK’s Medicines and Healthcare products Regulatory Agency

(MHRA) is preparing to recruit a new chief executive officer, aftercurrent chief Ian Hudson announced plans to step down from the rolein September 2019 “following almost two decades with the agency”.The move comes as the UK is preparing its ‘Brexit’ departure fromthe European Union (EU) in March next year.

“Recruitment for his successor will begin early in 2019, so thatan orderly handover can be arranged once an appointment has beenmade,” the MHRAannounced, noting that Hudson had served as chiefexecutive for six years.

Citing both personal and professional reasons for his departure– including reducing his work commitment and pursuing “more ofa portfolio career” upon turning 60 – Hudson said, “I feel the time isright for a new person to guide the agency and our work through itsnext phase, following the UK’s departure from the EU next year.”

“Although I will be standing down in the Autumn,” Hudsonacknowledged, “my focus remains on ensuring the agency delivers itsessential contribution to public health, and I look forward to continuingto lead our work until September 2019.”

Details of how the MHRA will interact with the EuropeanMedicines Agency (EMA) and the European medicines frameworkafter the UK leaves the EU – currently scheduled for 29 March 2019– remain unclear.

A formal Regulation has just been published by the EuropeanParliament and Council amending existing legislation to reflect thechange in location of the EMA from London, UK, to Amsterdam, theNetherlands, as of 30 March 2019. According to the Regulation, theDutch competent authorities should ensure that all measures are in placeto allow the EMA to move to its temporary location in Amsterdam “nolater than 1 January 2019”, and to its permanent location “no later than16November 2019”. Progress reports to the Parliament and Council willbe submitted every three months from 17 February 2019. G

LITIGATION

Teva loses US caseover age and nationAUS jury has found in favour of a former Teva employee who sued

the company on the basis that he had been fired after complainingabout discrimination linked to his age and American nationality.

Stephen Middlebrooks was 58 when Teva terminated hisemployment, in February 2016, as the company’s senior director ofNorth American facilities management. The role, which includedresponsibility for both the US and Canada, was based out of NorthWales, Pennsylvania, US. As Generics bulletin went to press, courtdocuments revealing Middlebrooks’ payout as part of the favourableruling were unavailable. Unconfirmed media reports suggest that hehas been awarded more than US$6 million.

According to the complaint filed in a Pennsylvania district court lastyear, Middlebrooks, following his promotion to his latest role in 2013,began reporting to Nir Aharoni, an Israeli who was based in Israel asTeva’s global senior director of facilities management, in early 2014.

Of thefivesenioremployeeswhoreported toAharoni,Middlebrookswas the oldest, longest-tenured with Teva and “the one with the greatestlevel of responsibilities and staff”, overseeing around 70 employees. Hewas also allegedly one of only twoAmericans reporting to the Israeli.

Aharoni’s team allegedly pushed Middlebrooks for informationabout the ages of his own team members, with Aharoni claiming thatin “Israel they make decisions based on age”. Despite Middlebrookscomplaining to both Aharoni and human resources, he continued tobe pressed for information. He was also later not paid an equity bonusthat he was eligible to receive.

The complaint also claims that Aharoni had openly criticisedAmericans in front of a member of Middlebrooks’ team, “regardingAmericans’ narrow-minded perceptions of Israelis”. Aharoni alsoallegedly “ranted” to Middlebrooks “that Americans had done a verypoor job supporting Israel in its military actions in the Middle East”.

The jury verdict in favour of Middlebrooks also allows forconsideration of “reasonable attorneys’ fees and costs”. G

MUNDIPHARMA has named Arnaud Breabout as senior vice-president and chief financial officer, reporting to Alberto Martinez,president and chief executive officer, in Europe. Having recentlyserved as chief financial officer for global functions and investmentsat GlaxoSmithKline (GSK), Breabout has more than 20 years ofexperience in the pharmaceutical industry. Before joining GSK in2002, he held roles at Procter & Gamble, Bristol Myers Squibb andPrice Waterhouse in the UK and France.

FORESEEPHARMACEUTICALShasappointedThomasWeitaoSun as senior vice-president of pharmaceutics and manufacturing forthe Taiwan-based company. Citing Sun’s “over 20 years of experiencein all aspects of pharmaceutical development”, Foresee pointed outthat this included discovery pharmaceutics, manufacturing, andsupply-chain management for phases 1 to 3 studies. Research anddevelopment efforts are currently focused on a “unique stabilizedinjectable formulation (SIF) depot delivery platform and deriveddrug products targeting specialty markets”, as well as “transformativepre-clinical and clinical first-in-class new chemical entity (NCE)programs targeting disease areas with highly unmet needs”. G

IN BRIEF

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