Generics ulletin nforma · 2019. 2. 20. · Februar No. harma ntelligence ulletin nforma Generics genericsbulletin.pharmaintelligence.informa.com LANNETT Levothyroxine Is No More

22 February 2019No.387

Pharma IntelligenceInformaBulletin

Genericsgener icsbul let in .pharmaintel l igence . informa.com

LANNETT

Levothyroxine Is No More For Lannett: Here’s How The Company Aims To Replace It p. 14

ADVAIR

Mylan Launches US Advair Rival, Wixela Inhub, At A 70% Discount, p. 5

GERMANY

Germany Rows Back On Plans For Biosimilar Substitution, p. 10

Deal On European SPC Manufacturing Waiver Is An Acceptable CompromiseDAVID WALLACE [email protected]

A compromise deal reached be-tween the European Council, Parliament and Commission on a

proposed waiver for manufacturing dur-ing the term of supplementary protec-tion certificates (SPCs) - for both export and stockpiling for ‘day-one’ launch with-in the European Union (EU) - has been broadly welcomed by the European off-patent industry, albeit with reservations over certain alterations that have been made to key aspects of the mechanism.

While the final version of the deal has not yet been published in full, the Com-mission has confirmed that the compro-mise agreement reduces the period during which generics and biosimilars firms can stockpile for day one launch within Europe

from a previous suggestion of two years to six months. (Also see “Two-Year Stockpiling Provision ‘Vastly Improves’ European SPC Waiver” - Generics Bulletin, 25 Jan, 2019.)

It also foresees implementing the waiver from 2022 – rather than the pre-viously mooted 2020 or 2021 – and re-tains notification requirements that will force generics firms to publish commer-

cially-sensitive information.Applauding the compromise deal, Euro-

pean off-patent industry association Medi-cines for Europe said it “thanks the EU for addressing many of its proposals for a com-prehensive waiver, including the possibil-ity to manufacture for export and day-one launch, and a balanced date of applicability”.

“Recognising the complex legal nature of the SPC manufacturing waiver, we thank the many European Parliamentary, Council, Commission and national representatives who engaged thoughtfully with our in-dustry and with stakeholders to move this legislation to a conclusion based on the benefits for Europe,” the industry associa-tion commented.

STOCKPILING PERIOD OF SIX MONTHSHowever, speaking to Generics Bulletin, Medicines for Europe director general Adrian van den Hoven acknowledged the reduction of the stockpiling period to six months was not ideal. While he said this period was just about adequate for the measure to be effective, he suggested that “for a lot of complex products, this is going to be challenging”.

It would also be a challenge for manu-facturers who were producing only for local European markets – rather than also producing for export to countries where SPC protection does not exist – to ramp up production in such a short period of time, van den Hoven observed.

Even a compromise period of a year would have been preferable for the ge-nerics industry, he added.

Nevertheless, Medicines for Europe pointed out that “the compromise foresees a review in five years, specifically of the day-

“For a lot of complex products, this is going to be challenging.” – Adrian van den Hoven, Medicines for Europe

CONTINUED ON PAGE 4

scripintelligence.com

2 | Generics Bulletin | 22 February 2019 © Informa UK Ltd 2019

I N T H I S I S S U E

from the [email protected]

This week saw the latest decisive step in the long process of bringing to fruition one of the European generics and biosimilars industry’s biggest wishlist items: a waiver to allow manu-facturing of generics and biosimilars during the brand’s supplementary protection certifi-cate (SPC) period, as well as to allow stockpil-ing within the EU for ‘day one’ launch.

With the European Council, Parliament and Commission having reached a compromise deal on the shape that the waiver will take (see front cover), the reaction from the off-patent industry has been positive, even though cer-tain key provisions have been altered as part of the back-and-forth that has seen the proposed Regulation pass through many different sets of hands just to get to this point.

Nevertheless, as the waiver gets closer and closer to being formally adopted, there is a sense of momentum building, even in the face of staunch opposition from the brand

industry both in Europe and elsewhere.Also this week we saw Mylan deliver on its

promise to launch a US rival to GlaxoSmith-Kline’s Advair, at a steep 70% discount to the respiratory brand’s wholesale acquisition cost (p.5). Mylan’s launch will be watched closely to see how the dynamics of the market play out, especially given that other generic versions in development are still awaiting US approval.

It has been a big week for generic debuts: as well as Mylan’s Advair launch, Alvogen has introduced the first European generic version of Celgene’s Revlimid with launches in cen-tral and eastern Europe (p.6), while Teva has brought to the US market the first generic rival to Lundbeck’s Sabril (p.7).

Meanwhile, in the deal-making arena, Sam-sung Bioepis has followed up on January’s Chinese biosimilars licensing agreement with 3SBio by striking another biosimilars deal in the region, this time with C-Bridge Capital (p.14).

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COVER / Deal On European SPC Manufacturing Waiver Is An Acceptable Compromise

5 Mylan Launches US Advair Rival, Wixela Inhub, At A 70% Discount

6 Alvogen Claims Lead On Lenalidomide In Europe

6 ‘Astronomical’ Anti-Counterfeiting Costs Threatean Industry Sustainability

7 Teva Introduces First Sabril Rival In US

8 Gedeon Richter Predicts Two-Year Wait To Refile Pegfilgrastim, But Teriparatide Is In The Wings

9 Bangladesh’s Beximco Sees Exports Boom As It Expands In North America

10 Germany Rows Back On Plans For Biosimilar Substitution

11 Neuraxpharm Strengthens French Business By Appointing Brun As General Manager

12 Price Watch UK: Candesartan Climbs As Temazepam Tumbles In UK

13 Basaglar Follow-On Insulin Booms For Eli Lilly

14 Samsung Bioepis And C-Bridge Capital Deal Eyes ‘Next-Generation’ Biosimilars In China

14 Levothyroxine Is No More For Lannett: Here’s How The Company Aims To Replace It

ANDA Litigants Join Forces To Cut Costs And Cope With CompetitionGenerics firms challenging patents in the US are seeing benefits through teaming up, according to Kent Walker of Brinks Gilson & Lione.

https://bit.ly/2tBDWRL

One EU Pegfilgrastim Pulled As Another LaunchesAs Stada and Gedeon Richter withdraw their applications for a pegfilgrastim biosimilar that the pair have been jointly developing, Mundipharma has pushed ahead with a European roll-out for its Pelmeg version starting in Germany, Ireland and the Netherlands.

https://bit.ly/2DUQhox

Dr Reddy’s Brings In Kikuchi To Lead North America GenericsDr Reddy’s has added to its senior leadership team by appointing Marc Kikuchi as CEO of North America Generics. With a record number of US launches in Q3, potentially more in store and now a new leader to steer things through, the firm has improved its outlook for a significant revival in earnings. But risks of delays and competition on certain key anticipated launches in 2019 could dull prospects.

https://bit.ly/2S7NUE9

CHMP Knocks Back TLC’s Doxorubicin HybridAs the CHMP refuses to recommend granting approval for TLC’s doxorubicin hybrid, the committee within the EMA has given the nod to Teva’s Ajovy monoclonal antibody migraine remedy as well as two small-molecule generics from Krka.

https://bit.ly/2SciGvn

exclusive online content

ASTRONOMICAL COSTS TO IMPLEMENT ANTI-COUNTERFEITING MEASURES ARE HARD TO BEAR FOR MANY EUROPEAN GENERICS SUPPLIERS

6

MYLAN CAN BREATHE EASY AFTER GETTING WIXELA INHUB TO MARKET

4

LANNETT IS ATTEMPTING TO BRIDGE THE GAP LEFT BY AMNEAL SNAPPING UP DISTRIBUTION RIGHTS TO LEVOTHYROXINE

14



R E G U L AT I O N

one launch duration, which provides us with an opportunity to assess its benefits”.

On the move to implement the waiver from 2022 – rather than 2020 or 2021, as had been suggested earlier in the negoti-ating process – van den Hoven said that one benefit of the compromise deal was that it adopted the proposed language of the European Council on implementa-tion, which was the preferred wording of Medicines for Europe.

NOTIFICATION MEANS LITIGATIONHowever, the off-patent industry associa-tion pushed back harder against the no-tification requirements envisaged by the compromise deal, that will require gener-ics and biosimilars firms to publicly dis-close commercially-sensitive information about their manufacturing and launch plans to the SPC holder.

“We deeply regret that the manufac-turing waiver includes unnecessary and redundant notification requirements,” Medicines for Europe said. “This will re-quire generic and biosimilar medicines manufacturers to publish commercially confidential information to allegedly pre-vent our industry from circumventing the rules of the waiver – notably the re-im-port of medicines manufactured under the export waiver for day-one launch.”

The association pointed out that such a measure was “obviously redun-dant now that the manufacturing waiv-er also authorises its use for day-one launch manufacturing”.

“Medicines for Europe therefore calls on authorities to closely monitor any potential misuse of the notification sys-tem for frivolous litigation which could delay competition from generic and bio-similar manufacturers in markets where SPCs have expired.”

Expanding on industry’s opposition to the notification requirements, van den Hoven told Generics Bulletin that the con-cern was that notification would be used as a trigger for automatic legal challenges from the SPC holder.

“Where we see notification, it means au-tomatic litigation,” he indicated, suggesting that originators would seek to find grounds for injunctions against generics and biosim-ilars manufacturers by claiming deficiencies in the notification information provided.

Medicines for Europe had lobbied to limit these notification requirements, but to no avail, he conceded. However, he was hopeful that the final version of the text would offer some protections for the off-patent industry against frivolous litigation.

COMMISSION POSITIVE ON BENEFITS OF WAIVER

Commenting on the agreement, the Euro-pean Commission said the waiver would “preserve the strong existing intellectual property (IP) rights in order to encourage innovation and research in the EU, but will make it easier to for EU companies to ex-port generic and biosimilar medicines to third countries where IP protection has expired or never existed”.

Commissioner Elżbieta Bieńkowska, responsible for internal market, industry, entrepreneurship and small-to-medium-sized enterprises (SMEs), called the waiver mechanism a “well-calibrated adjustment to IP rules” that would help European pharmaceutical companies to “tap into fast-growing global markets and foster jobs, growth and investments in the EU”.

“We are removing a major competitive disadvantage of EU manufacturers who

will soon be able to compete on equal terms on global markets where competi-tion is fierce,” she summarized.

“The waiver will support Europe’s phar-maceutical manufacturing base and Eu-rope’s pioneering role in research and development of biosimilars,” the Commis-sion highlighted. “It is expected to gen-erate extra growth of at least €1 billion (US$1.1 billion) per year in net additional export sales, creating up to 25,000 extra high-skilled jobs over 10 years.”

MORE CRITICISM FROM ORIGINATORSNot all parties have expressed satisfaction with the compromise deal, however, with European brand industry body EFPIA taking the opportunity to once again assert its op-position to what it sees as “Europe’s gamble with the future of medical innovation”.

“If adopted in the final text,” EFPIA claimed, “the amendments risk impacting on Euro-pean patients living with unmet medical needs. They will significantly weaken Eu-rope’s research and development (R&D) of-fering, risking investment and jobs from our SMEs, our companies, our academic institu-tions and our healthcare systems.”

The originator association criticised the compromise deal for “unbalanced and disproportionate amendments allowing the stockpiling of generic medicines for six months, an early implementation date and a lack of safeguards”, suggesting that the framework for the mechanism “reca-librates the European economy from a knowledge-based region at the cutting edge of research, development and medi-cal innovation to a Europe that is not com-petitive on the global R&D stage and fails to attract future investments for the ben-efit of patients”.

EFPIA director general Nathalie Moll warned that “stockpiling without ade-quate safeguards risks the further erosion of IP rights beyond the waiver itself, send-ing the wrong signal to global investors and innovators”. “The need for adequate safeguards should be of paramount im-portance to anyone that believes in medi-cal innovation in Europe,” she insisted.

But Medicines for Europe reiterated that “the SPC manufacturing waiver will con-tribute to better patient access, to create manufacturing opportunity and jobs and to increase Europe’s capacity to manufac-ture and supply its own medicines”.

CONTINUED FROM PAGE 1

“The waiver will support Europe’s pharmaceutical manufacturing base and

Europe’s pioneering role in research and

development of biosimilars. It is expected to generate extra growth of at least

€1 billion per year in net additional export sales, creating up to 25,000 extra high-skilled jobs

over 10 years”


R E G U L AT I O N

“We now call on the Parliament and the Council to rapidly adopt the SPC manu-facturing waiver,” Medicines for Europe stated, “and look forward to strengthen-ing Europe’s pharmaceutical manufactur-ing for access, jobs and growth.”

NEXT STEPS INCLUDE APRIL VOTEThe agreement reached by the co-legis-lators is now subject to formal approval by the European Parliament and Council.

Noting that a key European Parliament vote to approve the text was due in April – allowing time for the text to be translat-ed into multiple EU languages – van den Hoven emphasized that Medicines for Europe was “not resting on our laurels” and would continue to lobby hard on the waiver as it made its way towards an ulti-mate approval by the European Council after being passed by the Parliament.

Recently, the industry association has hit back at “foreign vested interests” that are still seeking to derail the process. (Also see “For-eign Vested Interest Must Not Sway Away From SPC Waiver” - Generics Bulletin, 7 Feb, 2019.)

Van den Hoven told Generics Bulletin that the “clear signals” from the three European institutions in favour of the SPC manufac-turing waiver had sent a strong message that the long-awaited mechanism would make it to fruition, giving Medicines for Eu-rope confidence that it would be realised.

“We’ve been fighting for this for years,” he concluded, “and we’re not going to lose it now.”

Published online 15 February 2019

Generics Bulletin

Visit https://pharmaintelligence.

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Mylan Launches US Advair Rival, Wixela Inhub, At A 70% DiscountDAVID WALLACE [email protected]

A ll three strengths of Mylan’s Wixe-la Inhub (fluticasone/salmeterol) generic rival to GlaxoSmithKline’s

(GSK’s) Advair Diskus are now available in the US at a 70% discount to the brand, the generics firm has announced.

“The wholesale acquisition costs of Wix-ela Inhub 100μg/50μg, 250μg/50μg and 500μg/50μg are US$93.71, US$116.44 and US$153.14, respectively,” Mylan announced, noting that this represented a 70% discount to Advair Diskus and 67% less than GSK’s authorized generic version that the origina-tor launched on 8 February.

DEMONSTRATES SAVINGS POTENTIAL“We’ve had numerous discussions with customers about the need for a unique launch strategy for the first substitutable generic of Advair Diskus that increases af-fordability to all in our healthcare system,” noted Mylan chief commercial officer Tony Mauro. “We trust that by launching Wixela Inhub at a significantly discount-ed list price, we will demonstrate the sav-ings that generics can deliver for patients through reduced out-of-pocket costs, as well as the US healthcare system overall.”

Alongside its launch, Mylan has also rolled out patient services to provide training and education about Wixela In-hub and its device.

FOLLOWS LATE- JANUARY APPROVAL

Mylan received approval from the US Food and Drug Administration (FDA) for the first US substitutable generic rival to Advair Diskus towards the end of January, put-ting it around a year ahead of its closest generic competitors. (Also see “Mylan’s Nod For US Advair Rival Puts It A Year Ahead Of The Pack” - Generics Bulletin, 31 Jan, 2019.)

Shortly after the approval, Mylan con-firmed that it planned to launch its version – in which the generics company has in-vested more than US$700 million – by the end of this month. (Also see “Mylan Gears Up To Launch US Advair Rival This Month” - Generics Bulletin, 1 Feb, 2019.)

Wixela Inhub, Mylan pointed out, in-corporated “the latest safety information” required by the FDA, “which prompted an amendment to the label for certain inhaled corticosteroids, including Advair Diskus and any generic versions”, thus slightly de-laying Mylan’s approval. (Also see “Mylan Draws Hope From FDA’s Fluticasone Label-ling Update” - Generics Bulletin, 11 Jan, 2019.)

In 2018, GSK saw its US Advair sales fall by 30% at constant exchange rates to £1.097 billion (US$1.41 billion), at the same time as US sales of its Ellipta respira-tory portfolio grew by 27% on the same basis to £1.245 billion.


“We trust that by launching

Wixela Inhub at a

significantly discounted list

price, we will demonstrate

the savings that generics can

deliver for patients through

reduced out-of-pocket costs,

aswell as the US healthcare

system overall”

MYLAN CAN BREATHE EASY AFTER GETTING WIXELA INHUB TO MARKET



S T R AT E G Y

Alvogen Claims Lead On Lenalidomide In EuropeDAVID WALLACE [email protected]

A lvogen has launched a generic version of Celgene’s Rev-limid (lenalidomide) in “a range” of central and eastern Eu-ropean (CEE) markets including Bulgaria, Croatia, Roma-

nia and the Baltic states. Alvogen’s version – developed in-house by its Lotus Pharmaceuticals subsidiary – will be available as 2.5mg, 5mg, 7.5mg, 10mg, 15mg, 20mg and 25mg hard capsules.

“Following the launch into CEE,” Alvogen said, “the generic and bioequivalent version of Revlimid will be launched globally in 2019.” The firm added that the oncology brand’s global market was currently worth around US$9.8 billion.

Hacho Hathcikian, Alvogen’s vice-president for the CEE region, said the launch of lenalidomide was “a major landmark for Alvogen in the CEE region as we successfully become the first generic pharmaceuti-cal company to launch the generic of Revlimid in our major markets”.

“Patients now finally have access to an affordable and high-quality treatment for the various oncology indications the prod-uct is targeted at,” Hathcikian commented, adding that “having lenalidomide in our portfolio also enhances our drive to be one of the key oncology players in the CEE region”.

Alvogen had last year indicated that it had received the first Eu-ropean approvals in “several European countries” after successfully completing “multiple registration procedures” for its generic Rev-limid capsules. Iceland acted as the reference member state in the decentralized marketing-authorization procedure. (Also see “Alvo-gen is first with Revlimid rival in EU” - Generics Bulletin, 4 May, 2018.)

ACCORD SETTLED WITH CELGENE IN EUROPEAccord received a centralized nod from the EMA for its version of Revlimid in the same seven strengths last year. (Also see “Mylan’s adalimumab wins CHMP backing” - Generics Bulletin, 3 Aug, 2018.)

However, the Intas subsidiary has settled litigation with Cel-

gene over intellectual property barriers in the UK and elsewhere in Europe, including a UK supplementary protection certificate (SPC) linked to the local part of European composition-of-matter patent EP0,925,294 which expires in June 2022.

“Accord has agreed to vacate its challenges to Celgene’s patents and Celgene has granted Accord the ability to market a generic lenalidomide product for certain conditions prior to expiry of Cel-gene’s patent and SPC rights in the UK, beginning on 18 January 2022, and in various other European countries where Celgene’s SPC is in force beginning on 18 February 2022,” the originator stated.

IPR CHALLENGES FAIL IN THE USMeanwhile, in the US – where Celgene several years ago struck a deal with Natco that gives the firm “a volume-limited license” to sell generic lenalidomide commencing in March 2022 – inter partes review (IPR) petitions by Dr Reddy’s challenging three Revlimid patents have just been denied by the US Patent Trial and Appeal Board (PTAB).

The three US patents – 7,189,740; 8,404,717; and 9,056,120 – are all currently listed in the US Food and Drug Administration’s (FDA’s) Orange Book with expiry dates of 11 April 2023.

Dr Reddy’s had challenged the patents via the IPR process at the same time as parallel litigation over the patents is ongoing. In all three IPR challenges, Dr Reddy’s had relied upon Celgene press releases as prior art that demonstrated unpatentability.

But the PTAB refused to institute IPRs as the firm had “not estab-lished that the Celgene press releases were available as prior art printed publications”, meaning that Reddy’s had “not shown a rea-sonable likelihood of prevailing in its unpatentability challenges”.


‘Astronomical’ Anti-Counterfeiting Costs Threaten Industry SustainabilityAIDAN FRY [email protected]

T he huge costs to Europe’s generics companies of imple-menting the anti-counterfeiting provisions of the EU’s Fal-sified Medicines Directive (FMD) represent a severe threat

to the entire sector, off-patent trade body Medicines for Europe is warning. Anti-tampering devices and 2-D data matrices on packs of essentially all prescription, and some non-prescription, medicines became mandatory in the EU from 9 February.

“The industry-funded system has required an investment of over €1 billion (US$1.1 billion) from manufacturers to update production and packaging lines, and will require a further €100-€200 million an-nually to maintain the information-technology (IT) infrastructure,” Medicines for Europe highlighted. “These costs simply cannot be

ASTRONOMICAL COSTS TO IMPLEMENT ANTI-COUNTERFEITING MEASURES ARE HARD TO BEAR FOR MANY EUROPEAN GENERICS SUPPLIERS


R E G U L AT I O N

absorbed for the majority of generic medicines on the EU market.”Noting that the EU’s pharmaceutical industry had committed to

serializing 10-14 billion packs of medicine each year, the trade body stressed that the project had been “a massive undertaking from a manufacturing, IT and regulatory perspective” for an EU generics in-dustry that supplied over two-thirds of Europe’s prescription medi-cines. It called on national authorities to review whether having to invest in huge regulatory compliance projects such as FMD endan-gered supplies of essential medicines “at very low cost”.

“The financial investment by our members has been astro-nomical and this poses a particular challenge to the sustain-ability of the generic medicines sector,” warned Medicines for Europe’s director general, Adrian van den Hoven.

CALL FOR DIALOGUE ON PATIENT ACCESS TO ESSENTIAL MEDICINES

“Industry and authorities need to have a focused dialogue to ensure patient access to essential medicines is not jeopardized in the future,” van den Hoven suggested. “This kind of dialogue should urgently take place for our members to be able to sup-port long-term sustainability of European healthcare systems and continue to deliver on better health for patients.”

On 8 February, a day before the statutory deadline, the Euro-pean Medicines Verification Organisation (EMVO) announced that its European Medicines Verification System (EMVS) had gone live, representing “a world first”.

“The new system is a world first for its stakeholder model, its scale and its use of new technologies,” elucidated the consortium of supply-chain stakeholders. “The EMVS has a unique structure that really makes it one of a kind,” the EMVO observed. “It will connect: around 2,000 pharmaceutical companies; around 6,000 wholesale distribution authorization holders; 140,000 pharma-

cies; 5,000 hospital pharmacies; and around 2,000 dispensing doctors in 28 European Economic Area (EEA) countries.”

PREVALANCE OF COUNTERFEITS IN EU LEGAL SUPPLY CHAIN IS JUST 0.005%

However, the EMVO announcement also hinted that the vast in-vestment required to set up the system to verify the authenticity of medicines at the point of dispensing was dedicated to address-ing events that very rarely occurred. “The European Commission estimated in an impact assessment accompanying the FMD that the prevalence of counterfeit medicines in the legal supply chain in Europe is approximately 0.005%,” it acknowledged.

Nevertheless, UK branded drugs body the Association of the British Pharmaceutical Industry (ABPI) warned as the EMVS came online that “in the event of a ‘no deal’ Brexit, the UK will drop out of the new system, leaving National Health Service (NHS) patients more exposed to the dangers of fake medicines than other patients in the EU”.


“The financial investment by our members has been astronomical and

this poses a particular challenge to the sustainability of the generic medicines

sector” - Adrian van den Hoven, Medicines for Europe

Teva Introduces First Sabril Rival In USGRACE MONTGOMERY [email protected]

T eva has launched in the US the first generic rival to Lund-beck’s Sabril (vigatrabin) 500mg tablets, three weeks after receiving approval from the US Food and Drug Adminis-

tration (FDA) for the product.No other company currently holds an approved abbreviated

new drug application (ANDA) referencing Sabril tablets.The Israeli firm’s vigabatrin tablets are FDA-approved for the

treatment of refractory complex partial seizures as an adjunctive therapy in patients 10 years of age and older who have respond-ed inadequately to several alternative treatments. Teva’s generic is part of a single shared-system Risk Evaluation and Mitigation Strategy (REMS) Program with other drug products containing vi-gabatrin to ensure safe use of the product.

“This launch represents a notable addition to our generics port-folio and underscores our commitment to ensuring that patients with complex, chronic conditions have more treatment options,” stated Brendan O’Grady, executive vice-president and head of North America commercial at Teva.

Citing data from IQVIA, the company observed that Sabril tablets

had annual sales of US$180 million in the US, as of November 2018.When giving the green light for Teva’s vigatrabin tablets in

January, the FDA reiterated its focus on “prioritizing the ap-proval of generics to compete with medicines that face little or no competition”.

In 2018, the agency included vigatrabin tablets on a list of off-patent, off-exclusivity branded drugs without approved generics, to “clarify that there were no patents or exclusivities that should im-pede its approval”.

Teva is also one of five companies to currently hold ANDA approv-al for vigabatrin 500mg solution, for which Endo’s Par led the way. Like the tablets, the vigabatrin solution format is not covered by any unexpired patents or exclusivities listed in the FDA’s Orange Book.

ANNOUNCES LAUNCH OF ADCIRCA RIVAL Teva has also launched in the US Alyq, a generic version of Eli Lilly’s Adcirca (tadalafil) 20mg tablets, for the treatment of pul-monary arterial hypertension to improve exercise ability.

Aurobindo has just received final approval from the FDA for



S T R AT E G Y

its AB-rated generic version of Adcirca. The agency concluded in a tentative approval letter sent to the Indian firm in November 2017 that “adequate information has been presented to demon-strate that the drug is safe and effective for use as recommended in the submitted labeling”.

FOLLOWS DEBUT OF CIALIS RIVALIn August 2018, Mylan launched the first generic of Adcirca 20mg tablets with 180 days of marketing exclusivity in the US

(Also see “Mylan has head start on US Adcirca rival” - Generics Bul-letin, 31 Aug, 2018.).

Teva late last year introduced its first-to-file generic version of Lilly’s other tadalafil-containing brand, Cialis, for the treatment of erectile dysfunction and signs and symptoms of benign pros-tatic hyperplasia (Also see “Teva first in the US with a rival to Cialis” - Generics Bulletin, 5 Oct, 2018.).


Gedeon Richter Predicts Two-Year Wait To Refile Pegfilgrastim, But Teriparatide Is In The WingsDEAN RUDGE [email protected]

G edeon Richter says its attempts to secure a European marketing authorization for biosimilar pegfilgrastim have demonstrated that the highest-quality biosimilars

must be supported by a data package of equal quality if they are to make it through the approval process.

The Hungarian firm’s management made the observation as Richter announced that it will take “another two years” for itself and development partner Stada to refile their proposed biosimi-lar Neulasta (pegfilgrastim) candidate that Richter has once again withdrawn, after questions were raised over the risk-benefit as-sessment for the biosimilar. (Also see “One EU Pegfilgrastim Pulled As Another Launches” - Generics Bulletin, 11 Feb, 2019.)

“We are convinced that the quality of the product is outstand-ing. There are no uncertainties around the quality of the product,” stated chief executive officer Gábor Orbán. “But the quality of the filing is a different thing and it’s especially different when it comes to a biosimilar, when both authorities and companies have limited experience with biosimilar registration.

“So, the reason we had to pull the filing again was that it be-came clear that some of the shortcomings in the validity of the data – validity meaning not the integrity of the data, but the clinical validity, scientific validity of the data – could be subject to doubt with the authorities.”

Orbán insisted, “We’ll have to work on this and we will; because we have a good product and there’s no reason why we should not get it to the patients who need cheaper, more affordable biosimi-lar products than what they have today.”

RICHTER PLANS FOR TERIPARATIDE LAUNCHES In a more positive development for Richter, the company con-firmed that it is “ready for launch” with its biosimilar to Eli Lilly’s Forsteo (teriparatide) in the EU when the US-based originator’s local patent expires on 21 August.

“We have all the permits for the EU, so we are expecting in the EU big sales, around the €30 million (US$34 million) level,” re-vealed chairman of the board Erik Bogsch. “And we are working on other markets, including the Middle East, and others.”

Jointly developed by Richter and Stada, Richter’s Terrosa (teriparatide) was granted a pan-European marketing authoriza-

tion in January 2017, around the same time as the German firm’s Movymia (teriparatide) biosimilar.

Richter explains, “According to the relevant license agreement, [biosimilar teriparatide] is expected to be launched under both Richter and Stada labels in geographical Europe following the patent expiry of the original product.”

Asked by an investor if the company had any other biosimilar programs in development, Bogsch replied, “We are at the early stages. It would be too early to talk about [that].”

ESMYA DECLINE HURTS RICHTER Sales of the Esmya (ulipristal acetate) uterine fibroid therapy plummeting by 72.2% to €25.9 million dragged Richter to a 3.0% Pharmaceutical sales decline last year.

The slump in sales for Esmya pertains to the European Medi-cines Agency’s pharmacovigilance risk assessment committee (PRAC) in 2018 implementing temporary measures that includ-ed stopping new patients being started on Esmya, and halting new courses of therapy being given, due to a potential associa-tion between the drug and liver injury.

Richter began to relaunch Esmya across EU markets in August and September last year. Around the same time, however, part-ner Richter’s partner Allergan received a complete response let-ter from the US Food and Drug Administration (FDA) pertaining to its new drug application (NDA) filing for ulipristal acetate.

In all, Pharmaceutical turnover stood at €1.14 billion, buoyed by royalty income from the Vraylar (cariprazine) antipsychotic agent leaping by 68.3% to €75.9 million. Meanwhile, sales of the Bemfola (follitropin alfa) fertility treatment biosimilar rose by more than a fifth to €41.9 million, after Richter acquired the US rights in July 2018.

Broken down by global region, Richter suffered from sales fall-ing in its two major geographies, the European Union and Com-monwealth of Independent States, declining by high single digits.

In the former, Richter was hurt by sales slumps in all of its five leading EU markets: Germany, France, Spain, Italy and the UK, on the back of lower Esmya sales. The total fall in these markets was a fifth to €147.8 million.

Over in the Commonwealth of Independent States, turnover dropped by 8.5% to €381.8 million, in light of a 6.3% drop to €290


S A L E S & E A R N I N G S

million in Russia. Richter said a lower average exchange rate of the rouble against the euro – 12.3% – “impacted significantly our sales performance in Russia when reported in euros.”

The growth seen in the US was thanks to royalty income from Vraylar.

Richter’s group operating profit more than doubled to €137.9 million, as impairment charges linked to Esmya fell significantly – from €157.6 million to €75.5 million – year-on-year. This rise pushed Richter’s operating margin from 4.7% to 9.9%. Gross margin did not change materially during the year, Richter pointed out.


Breakdown By Region Of Gedeon Richter'sPharmaceuticals Sales In 2018

The EMA's actions over Esmya hurt Gedeon Richter's Pharmaceutical sales considerably in 2018,causing a 3.0% decline to €1.14 billion. It was better news, however, for Richter in its native Hungary,where sales increased by 6.2% to €121.6 million, amounting to a tenth of total Pharmaceuticals sales,

"primarily due to regulatory related preshipments." Meanwhile, the US leapt to third place in the list ofRichter's largest pharmaceutical markets by value, on the back of US$38.7 million worth royalty

income from Vraylar.

10.62%

32.04%

33.35%

9.87%

7.23%1.59%

5.29% Hungary

European Union

Commonwealth ofIndependent States

USA

China

Latin America

Rest of World

Breakdown by geographical region of Gedeon Richter's Pharmaceutical sales converted into Euros in 2018 (source: GedeonRichter)

Breakdown by geographical region of Gedeon Richter's Pharmaceutical sales converted into Euros in 2018 (source: Gedeon Richter)

Bangladesh’s Beximco Sees Exports Boom As It Expands in North AmericaAIDAN FRY [email protected]

B eximco Pharmaceuticals more than doubled its export sales in the first half of its financial year running until 30 June 2019 as the Bangladeshi generics and active phar-

maceutical ingredients (APIs) specialist continued to expand its offering in North America.

Having launched its fourth product in the US, metformin 500mg and 750mg extended-release tablets, the company also secured US Food and Drug Administration (FDA) approval for two generic cardiovascular drugs: nadolol 20mg, 40mg and 80mg tablets; and sotalol 80mg, 120mg and 160mg tablets.

Beximco – which already exports carvedilol, sotalol and metho-carbamol to the US – markets its US portfolio through an alliance with local partner Bayshore. (Also see “Alliances, An Acquisition And Investments Drive Beximco” - Generics Bulletin, 10 Dec, 2018.)

In Canada, the Bangladeshi producer has followed up its ex-ports of olopatadine eye drops by introducing both cyprohepta-dine allergy tablets and moxifloxacin antibiotic eye drops.

ENTERED GEORGIA, LAOS AND MOZAMBIQUEDuring the six months ended 31 December 2018, Beximco entered three new countries – Georgia, Laos and Mozambique – and in to-tal completed 39 registrations for 30 products in 16 countries.

Launching eight products in its home market helped the Bangla-deshi company to increase its domestic sales by 22.5% to BDT9.874 billion (US$118 million), accounting for 89% of group turnover that grew by 28.6% to BDT11.110 billion. Half-year export sales shot up by 113.0% to BDT1.236 billion, but the rise in group pre-tax profit was a more modest 12.0% to BDT1.936 billion.

Managing director Nazmul Hussain noted that the Bangla-deshi group’s domestic growth had been bolstered by consoli-dating its acquisition of the Nuvista Pharma women’s health business. (Also see “Beximco acquires Nuvista stake” - Generics Bulletin, 26 Jan, 2018.) He also highlighted Beximco’s receipt of the Community Partnership of the Year prize at the 2018 Scrip Awards held late last year.


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R E G U L AT I O N

Germany Rows Back On Plans For Biosimilar SubstitutionAIDAN FRY [email protected]

P lans to allow German pharmacists to substitute biological medicines have been significantly watered

down in a version of healthcare reforms agreed by the country’s federal cabinet. Provided that the reform package passes muster with the country’s upper house of parliament, the Bundesrat, the legislation is slated to come into effect around the middle of this year.

Initial drafts of the GSAV medicines safe-ty bill had foreseen biosimilar substitution at pharmacy level, based on a list of which reference biologics could be switched that was to be drawn up by the country’s fed-eral joint committee, the G-BA. However, that proposal drew considerable criticism from several parties, including doctors, pharmacists and industry in the form of local trade association Pro Biosimilars. (Also see “German draft offers firms pro and cons” - Generics Bulletin, 30 Nov, 2018.)

An explanatory note to the version of the legislation now approved by the fed-eral cabinet states that, while biosimi-lars are not identical to their reference products, they can “in many cases be dispensed or used instead of the origi-nal product”. However, it acknowledges, there is no current legal framework in Germany for automatic substitution at

pharmacy level along the lines of the ‘aut idem’ provision for substituting small-molecule generics.

While the latest draft of the legislation retains the requirement that the G-BA determine which reference biologics are suitable for substitution, it pushes back any pharmacy-level switching of biologics for at least three years. “In this period,” the note explains, “substitution on the basis of the G-BA’s determinations can only occur at the physician’s level under the super-vision of the treating doctor”. The three-year moratorium on pharmacy switching should, it contends, enable scientific data to be gathered on the extent to which bi-osimilars can be substituted for reference brands as well as on clinical experiences with biosimilars.

REVISED LEGISLATION RETAINS FIXED-USAGE QUOTAS

A measure that met with industry ap-proval – obliging payers and prescribers to collaborate on setting “fixed usage quotas” for biosimilars – is retained in the revised version of the legislation.

Other provisions in the draft aim to tack-le quality issues and drug shortages, trig-gered in part by a response to the sartans impurity issues around the world. The Ger-

man cabinet wants greater transparency around raw-material supply chains and in-tends to compel regional inspectorates to inform federal authorities when they audit production plants in third countries.

COMPANIES TO BE HELD ACCOUNTABLE FOR PRODUCT DEFICIENCIES

German statutory health insurance funds are to be given the ability to seek financial redress from manufacturers experiencing product deficiencies, such as those that lead to recalls. “Compa-nies also have an economic interest in ensuring that their medicines are safe,” Germany’s ministry of health insisted in outlining the draft legislation. In turn, funds are to be held jointly accountable for ensuring that medicines covered by rebate contracts under tenders remain available, and patient co-payments are to be removed for drugs that are substi-tutes for medicines that have been re-called due to quality defects.

Among the other provisions in the GSAV bill are drawing up regulations for e-pre-scriptions and amendments around rules and quotas for parallel imports to provide greater incentives to import cheaper ver-sions of higher-priced brands.

According to Insight Health data cited German biosimilars' share stuck in single digitsDespite signi�cant inroads on molecules such as �lgrastim, in�iximab and etanercept, biosimilarscaptured less than 10% of the German biologics market by value and volume in 2018

Volume (DDD)

Volume (DDD)

310.8m

58.7m

826.5m

Download data

Patented Biologics

Biosimilars

Off-Patent BiologicOrginals

Value (retail prices)

Value (retail prices)EUR4.18bn

EUR0.67bn

EUR4.36bn

Download data

Patented Biologics

Biosimilars


Pro Biosimilars/Insight Health data for calendar 2018, measured in dened daily doses (DDDs) and at pharmacy retail listprices less any statutory rebates and discounts

German biosimilars' share stuck in single digitsDespite signi�cant inroads on molecules such as �lgrastim, in�iximab and etanercept, biosimilarscaptured less than 10% of the German biologics market by value and volume in 2018

Volume (DDD)

Volume (DDD)

310.8m

58.7m

826.5m

Download data

Patented Biologics

Biosimilars


Value (retail prices)

Value (retail prices)EUR4.18bn

EUR0.67bn

EUR4.36bn

Download data

Patented Biologics

Biosimilars


Pro Biosimilars/Insight Health data for calendar 2018, measured in dened daily doses (DDDs) and at pharmacy retail listprices less any statutory rebates and discounts

Pro Biosimilars/Insight Health data for calendar 2018, measured in defined daily doses (DDDs) and at pharmacy retail list prices less any statutory rebates and discounts

German biosimilars’ share stuck in single digitsDespite significant inroads on molecules such as filgrastim, infliximab and etanercept, biosimilars captured less than 10% of the German biologics market by value and volume in 2018


P E O P L E

“Substitution on the basis of the G-BA’s

determinations can only occur at

the physician’s level under the

supervision of the treating doctor” - German health

ministry

by Pro Biosimilars, less than 5% of all pre-scriptions for biologic drugs in Germany last year, measured by defined daily dose (DDD), were for biosimilars. Off-patent biological brands made up seven-tenths of the market by volume, and patented brands just over a quarter.

On a value basis, biosimilar sales totalled around €520 million (US$588 million) at ex-factory list prices and €670 million at retail prices, accounting for 7.3% of Ger-many’s biologics market in both cases.

The Insight Health data shows a wide disparity in biosimilar uptake by mol-ecule. In terms of DDD, biosimilar fil-grastims’ share of the market reached just over three-quarters, almost a decade after they first entered the market. Rather more quickly, biosimilar infliximabs have gained almost two-thirds of the German market by volume.

Biosimilar rituximabs captured just un-der three-fifths of the German market by volume last year, etanercepts just over half, and trastuzumab biosimilars a fifth. By contrast, biosimilar insulin lispro bare-ly made a mark, taking just 1.6% of the DDD market.


Neuraxpharm Strengthens French Business By Appointing Brun As General ManagerGRACE MONTGOMERY [email protected]

Neuraxpharm has appointed Pierre-Hervé Brun as general manager of the European central nervous sys-

tem (CNS) specialist’s French affiliate, Neur-axpharm France.

With 30 years in the pharmaceutical in-dustry, Brun “brings extensive experience in business development, market access and commercial operations manage-ment”, Neuraxpharm stated.

Brun started his career in research and development (R&D) at Sanofi predecessor Rhone-Poulenc Rorer, and held various management roles at Negma-Lerads and Therabel. He also previously worked at Aptalis Pharma, formerly Axcan Pharma, serving successively as senior European business development director and depu-ty general manager in charge of commer-cial operation and market access.

Most recently, Brun assisted pharma and biotech companies to “strengthen their com-mercial, business development and market access strategies” in a consultancy role.

Located in Paris, Neuraxpharm France was formerly known as Laboratoire Bio-dim. Neuraxpharm acquired the company from Weinberg Capital Partners’ Pharma Omnium International in July 2018.

Biodim was Pharma Omnium Interna-tional’s commercial division, selling and marketing brands including anti-anxiety drugs Seresta (oxazepam) and Temesta (lorazepam), with “one of the largest drug portfolios for treating CNS diseases, with more than 100 molecules”.

“We are very pleased Pierre-Hervé has joined the team at Neuraxpharm France,” commented Neuraxpharm’s chief execu-tive officer Jörg Thomas Dierks. Noting that France was “one of the top five markets in Europe”, he added that Brun’s appointment was “in line with our strategy to further strengthen the senior management team with new country manager appointments”.

Dierks remarked that selecting Brun as Neuraxpharm France’s general manager

“will enable us to leverage and fully utilize the platform we have in the French market and grow our position in this target country”.

“I am pleased to join Neuraxpharm at this exciting stage as the company looks to the French market for growth and expansion,” stated Brun.

SPANISH SUBSIDIARY QUALIGEN REBRANDED

Separately, Neuraxpharm has rebranded its Spanish subsidiary Qualigen to Neur-axpharm Spain, in a move that “completes the Spanish company’s integration into the European group of the same name”.

Headquartered in Sant Joan Despí in Bar-celona, Neuraxpharm Spain has two pro-duction plants in Spain and over 400 staff, including 80 R&D specialists. Founded in 2008, the group has “launched more than 40 molecules for the treatment of CNS pa-thologies with both branded and generic pharmaceuticals”. “It continues to develop its range with a growing portfolio of drugs for other CNS indications and launches a new product every month,” Neuraxpharm noted.

The European CNS specialist used to be called NuPharm, up until October 2018 when it rebranded to Neuraxpharm, in an “exciting new chapter” for the company that “positions Neuraxpharm as a single and differentiated CNS-oriented firm with-in the European pharmaceutical industry”. Neuraxpharm also rebranded its Italian subsidiary FB Health to Neuraxpharm Italy.

Created in 2016, NuPharm combined five companies – Spain’s Qualigen, Labo-ratorios Lesvi and Inke; Germany’s Neur-axpharm, which also operates in Poland; and Italy’s FB Health – with investment group Apax Partners.

Neuraxpharm recently expanded its Eu-ropean reach by acquiring CNS specialty pharmaceutical company Farmax which has been renamed ‘Neuraxpharm Bohemia’.




P R I C E WAT C H U K

Candesartan Climbs As Temazepam Tumbles In UKDAVID WALLACE [email protected]

C andesartan tablets in multiple presentations saw their average UK trade prices to independent pharmacists rocket upwards in January, according to the latest fig-

ures from market researcher WaveData.Of the top eight biggest risers in January, five spots were taken

by candesartan tablets, with 28-count packs of the 8mg strength topping the list with an average rise of 439% to £3.61 (US$4.65).

Other presentations of candesartan saw rises of between 87%, for seven 2mg tablets, and 386% for 28-count packs of 16mg tablets.

Responding to the rises, the UK Department of Health and So-cial Care (DHSC) issued price concessions for two presentations of candesartan. The 8mg and 16mg strengths received conces-sions of £4.57 and £4.22 respectively, according to the UK Phar-maceutical Services Negotiating Committee (PSNC), exceeding the trade prices recorded by WaveData of £3.61 and £4.03.

However, for carvedilol 25mg tablets that saw a 74% average rise to £3.03, the concession fell far short, at just £1.38.

Turning to the fastest-falling UK trade prices, WaveData re-ported that temazepam 10mg and 20mg tablets in 28-count

packs had seen steep declines in January, with the average price of the higher strength falling by almost two-thirds to £1.56 as the lower strength fell by three-fifths to £1.89.

Propranolol 10mg and 40mg tablets also saw drops of around two-fifths, while slightly less steep declines were seen for molecules including pioglitazone, risperidone, dosulepin and metronidazole.

Among recently-launched generics, the biggest average price movement in WaveData’s basket of recent launches was seen for nortriptyline 10mg tablets, with a 41% rise to £8.94 for 100 tablets despite the cheapest offer in the market remaining stable at £1.51.

Celecoxib 200mg tablets saw their average price jump by more than a quarter to £1.82, while zonisamide 100mg capsules increased by a tenth to £5.59. At the same time, double-digit average falls were seen for memantine 10mg tablets and tadalafil 10mg tablets.

Leading the ‘fast movers’ in January – those molecules with the most offers in the marketplace – were omeprazole and lansoprazole, closely followed by atorvastatin, bisoprolol and amitriptyline.


RECENT LAUNCHES

PRODUCT/STRENGTH/PACK SIZE

JAN 2019

MINIMUM

MINIMUM

CHANGE

(%)

JAN 2019

AVERAGE

AVERAGE

CHANGE

(%)

Aripiprazole Tabs 10mg 28 £0.69 -5% £1.46 2%

Carbimazole Tabs 5mg 100 £15.99 5% £22.53 -2%

Celecoxib Caps 200mg 30 £0.89 7% £1.82 26%

Cilostazol Tabs 100mg 56 £3.18 0% £5.22 9%

Duloxetine Caps 30mg 28 £0.77 -3% £1.47 3%

Eplerenone Tabs 25mg 28 £2.70 -2% £4.42 -1%

Escitalopram Tabs 10mg 28 £0.44 -2% £0.87 -3%

Etoricoxib Tabs 90mg 28 £2.18 -1% £2.86 0%

Ezetimibe Tabs 10mg 28 £1.20 -5% £1.65 -7%

Frovatriptan Tabs 2.5mg 6 £2.75 -7% £4.44 -7%

Ivabradine Tabs 5mg 56 £3.73 -1% £4.82 -6%

Memantine Tabs 10mg 28 £0.61 0% £0.93 -10%

Nefopam Tabs 30mg 90 £4.15 0% £5.44 -7%

Comparison between the periods 1-31 December 2018 and 1-31 January 2019 of UK trade prices of the most recently-launched generics listed in category M of the Drug Tariff of pharmacy-reimbursement prices. Averages calculated from at least 19 data points. (Source - WaveData)

Up to the minute live retail market pricing is available at wavedata.net and historical prices at https://www.bppi.co.uk

Alternatively, contact WaveData at [email protected] or +44 (0)1702 425125

ANALYZE

Further information related to this story is available here: https://bit.ly/2TVRRNK

RECENT LAUNCHES

PRODUCT/STRENGTH/PACK SIZE

JAN 2019

MINIMUM

MINIMUM

CHANGE

(%)

JAN 2019

AVERAGE

AVERAGE

CHANGE

(%)

Nortriptyline Tabs 10mg 100 £1.51 0% £8.94 41%

Olmesartan Medoxomil Tabs 10mg 28

£0.61 0% £1.21 6%

Pregabalin Caps 150mg 56 £2.25 -6% £3.69 -1%

Rasagiline Tabs 1mg 28 £1.00 5% £1.96 -5%

Rizatriptan Tabs 10mg 3 £3.31 0% £6.29 1%

Rosuvastatin Tabs 5mg 28 £0.65 -4% £1.07 5%

Sevelamer Tabs 800mg 180 £23.15 1% £120.62 1%

Sildenafil Tabs 100mg 4 £0.24 4% £0.43 8%

Tadalafil Tabs 10mg 4 £0.75 -9% £1.27 -11%

Telmisartan Tabs 80mg 28 £8.99 -5% £13.06 -5%

Travoprost Eye Drops 40mcg/ml 2.5ml

£2.03 -3% £3.44 9%

Zonisamide Caps 100mg 56 £2.74 0% £5.59 10%


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Basaglar Follow-On Insulin Booms For Eli LillyAIDAN FRY [email protected]

E li Lilly’s Basaglar follow-on version of insulin glargine was among the US-based originator’s fastest-growing brands last year, registering an 85% sales gain to US$801 million.

At the current rate of rise, the diabetes drug will soon be a bil-lion-dollar blockbuster.

The main driver of this growth was sales in the US – where Basaglar was approved through the hybrid 505(b)(2) regulatory pathway – doubling last year to US$623 million. This progress, Lilly explained, had been “driven by increased demand, partially offset by lower realized prices due to increased volume in Medi-care Part D”.

The same factors lay behind a 59% turnover advance to US$182 million in the fourth quarter. Lilly – which reports total sales of the drug developed through its diabetes alliance with Boehringer Ingelheim, with payments to its partner for its por-tion of the gross margin reported as cost of sales – said Basa-glar’s total share of prescriptions in the US market had reached around 18% by the end of 2018.

Outside of the US, sales – including under the Abasaglar name in markets including the EU – climbed by 48% to US$179 million, “primarily driven by increased volume”. That growth rate was restricted by a relatively modest 27% increase to US$49.9 million in the fourth quarter of 2018, Lilly reported, as the vol-

ume gains were tempered by “lower realized prices” and unfa-vorable exchange-rate fluctuations.


Global Basaglar sales have passed US$200 million per quarter

Global sales of Eli Lilly's Basaglar insulin glargine hybrid have risen sharply, driven by volume gains in the US

260240220200180160140120100806040200

Q1 Q2 Q3 Q4

46

166

87

202

146

201

154

232

Qua

rter

ly s

ales

(US$

mill

ions

)

2017 2018

Eli Lilly's quarterly global sales of its Basaglar insulin glargine brand (Source - Eli Lilly)

Global Basaglar sales have passed US$200 million per quarter

Global sales of Eli Lilly’s Basaglar insulin glargine hybrid have risen sharply, driven by volume gains in the US

Eli Lilly’s quarterly global sales of its Basaglar insulin glargine brand (Source - Eli Lilly)



D E A L S

Samsung Bioepis And C-Bridge Capital Deal Eyes Up ‘Next-Generation’ Biosimilars In ChinaDEAN RUDGE [email protected]

W ith the ink barely dry on a li-censing agreement to expand its biosimilars business into

mainland China, Samsung Bioepis has signed a new deal to increase its presence in the region, this time for its third-wave biosimilars including rivals to Lucentis (ra-nibizumab) and Soliris (eculizumab).

A licensing agreement signed with C-Bridge Capital will see the Chinese healthcare venture capital firm establish a new biopharmaceutical company, Af-faMed Therapeutics, which will collabo-rate with Samsung Bioepis across areas including clinical development, registra-tion and commercialization in China.

AffaMed describes itself as a company focused on identifying and licensing late-

stage candidates for commercialization in emerging Asia Pacific markets and globally.

Samsung Bioepis, which noted that the agreement will also include its Herceptin (trastuzumab) biosimilar candidate, will receive an upfront payment, as well as royalties on sales. Further financial details were not disclosed.

Christopher Hansung Ko, Samsung Bioepis’ president and chief executive of-ficer, commented, “We want to play an important role in widening access to high-quality healthcare for patients throughout China. C-Bridge is the right partner for this mission as evidenced in its exceptional track record of successfully turning portfo-lio companies like AffaMed Therapeutics into leading biopharmaceutical compa-

nies in China and beyond.”At the beginning of the year, Samsung

Bioepis announced its expansion into mainland China through a licensing deal with China’s 3SBio, covering biosimilar can-didates including Avastin (bevacizumab). (Also see “Samsung Bioepis Eyes China With 3SBio Deal” - Generics Bulletin, 7 Jan, 2019.)

Avastin was also at the crux of a licensing agreement Cipla signed with China’s Bio-Thera Solutions last month, which Cipla will have exclusive rights to distribute and mar-ket the drug in select emerging markets. (Also see “Cipla Partners With Bio-Thera For Bevacizumab In Select Emerging Markets” - Generics Bulletin, 15 Jan, 2019.)


Levothyroxine Is No More For Lannett: Here’s How The Company Aims To Replace ItDEAN RUDGE [email protected]

L aunching approximately 37 prod-ucts across calendar 2018 and cal-endar 2019 will add at least US$160

million to Lannett’s top line during the company’s next financial year ending June 2020, the Philadelphia-based com-pany anticipates, as it continues efforts to rebuild in the wake of losing its lucrative US supply agreement for levothyroxine.

These launches, combined with the net savings from the company’s previously-an-nounced cost-cutting plan until Lannett’s 2020 financial year, should also go a signifi-cant way towards filling the US$100 million annual gross profit gap left by the absence of levothyroxine, according to Lannett.

With Lannett’s cash balance continu-ing to increase – “comfortably more than US$200 million” as of early February – and “virtually all key actions” pertaining to the cost-cutting plan being “completed or in process,” chief executive officer Tim Crew remarked to investors during the compa-

ny’s second-quarter earnings call, “To para-phrase Mark Twain, news of our company’s travails has been greatly exaggerated.”

He continued, “More to the point, we are feeling quite good about the cur-rent state of our business, the progress we’ve made over the last several quar-

ters and our future prospects.”Net sales rose by 5% to a “record”

US$193.7 million in the three months end-ed 31 December 2018; although these gains were aided by sales of Lannett’s thyroid de-ficiency treatments – i.e. levothyroxine – ris-ing by almost three-tenths to US$88.5 mil-

LANNETT IS ATTEMPTING TO BRIDGE THE GAP LEFT BY AMNEAL SNAPPING UP

DISTRIBUTION RIGHTS TO LEVOTHYROXINE


S T R AT E G Y

lion as customers stocked up ahead of the transition of supplies to Amneal.

A sharp rise in cost of sales cut Lan-nett’s gross profit by a fifth to US$69.8 million; while cutting US$7.2 million in operating expenses year-on-year still saw Lannett’s operating profit drop by 22% to US$36.7 million.

Launching approximately 20 products in calendar 2019 will generate net sales of around US$75 million during Lannett’s 2020 fiscal year; while the introduction of 17 new products during calendar 2018 will add the same amount during the company’s current 2019 fiscal year, “with at least 35% of gross margin.”

According to Crew, those same 17 prod-ucts generated approximately US$40 mil-lion of net sales with a gross margin of about 37% during the six months ended 31 December 2018.

Key planned launches currently with no generic competition include generic Vesicare (solifenacin) tablets and Tha-lomid (thalidomide) capsules, for which the company has provided an update on its application.

“We are increasingly confident about our future,” Crew said. “With approximate-ly 60 products in various stages of op-erational readiness and development, of which we plan to launch 10 over the next several months, we expect to regularly bring new products to market for the fore-seeable future at a similar pace and value as we have in the recent past.”

COST-CUTTING PLAN IN PROGRESS In November last year, Lannett unveiled a broad cost-cutting initiative geared to-wards reducing company expenses by US$66 million a year by its 2020 fiscal year, of which US$33 million will be reinvested into the company. (Also see “Lannett will axe 250 under savings scheme” - Generics Bulletin, 16 Nov, 2018.)

“To date, virtually all key actions in the plan have been completed or are in pro-cess,” Crew said. “The completed actions in-clude the closure of both our long-standing manufacturing facility and distribution site in Philadelphia; the initial restructuring of Cody Labs; and reduced staffing and other expenses throughout the organization.

“The main in-process item is the transi-tion of Cody Labs, which we expect to final-ize before the end of the current fiscal year,”

Crew said. “We thus expect to realize the substantial cost savings of the plan over the next several quarters. These changes are never easy but important to support our future growth plans.”

Increasing financial flexibility and bet-ter positioning the company to capitalize on growth opportunities, Lannett late last year brokered an amendment to its credit agreement.

As a result of these development, Crew said, Lannett has raised its financial guid-ance for fiscal 2019: net sales are expect-ed to be US$615-US$635 million, up from US$585-US$615 million. However, group gross margin is anticipated to fall, from 38-39% to 37-38%.

INSULIN GLARGINE CLINICAL TRIAL FILED Crew also provided the following corpo-rate updates concerning Lannett’s devel-opment pipeline:

• Lannett’s partner Andor Pharmaceu-ticals received a “minor” complete response letter for its Concerta ER (methylphenidate) abbreviated new drug application (ANDA). With Andor having already responded, Crew said, “We believe that we will launch that product before the end of the [cur-rent] fiscal year.”

• “Second, we received a complete re-

sponse letter on thalidomide, primar-ily around the associated active phar-maceutical ingredient (API) supplier,” Crew noted. “While we are still assess-ing the situation, a launch later in the current calendar year is still planned.”

• The biosimilar to Lantus (insulin glargine) being developed with Chi-nese partner HEC is “continuing to progress,” according to Crew. “We have completed an encouraging pharmacokinetic and pharmacody-namic animal comparability study. As a result, a clinical trial application for the first normal healthy volun-teer study with HEC insulin glargine versus US Lantus has been filed with South African health authorities.”

• Finally, he said, Lannett’s business development teams are continuing to evaluate a pipeline of transactions to expand the group’s portfolio. “The success we have had launching new products, combined with our talented teams and strong customer relation-ships, makes us an impactful partner,” Crew said. “And while our internal pipeline continues to progress, we certainly expect we’ll transact many more partnership deals.”


Lannett's Sales By Product Category In Its FinancialSecond Quarter Ended 31 December 2018

Lannett's sales rose by 5% to a "record" US$193.7 million. As this gure shows, thyroid deciencytreatments made up slightly less than half of group sales, underlining its importance to the group.Lannett insists, "The 17 products launched during calendar year 2018 were key contributors to the

growth in the quarter and are expected to contribute approximately US$75 million in scal 2019 netsales with at least 35% of gross margin."

Antibiotic 2.16%Anti-Psychosis 7.22%

Cardiovascular 13.26%Central Nervous System 3.19%

Gallstone 1.28%

Gastrointestinal 5.16%Glaucoma 0.26%

Migraine 6.50%

Muscle Relaxant 1.61%

Pain Management 4.63%Respiratory 0.60%

Thyroid Deciency 45.67%

Urinary 0.83%Other 3.52%

Contract Manufacturing 4.08%

Breakdown by product category of Lannett's sales in the three months ended 31 December 2018 (source: Lannett)

Breakdown by product category of Lannett’s sales in the three months ended 31 December 2018 (Source - Lannett)

Lannett’s Sales By Product Category In Its Financial Second Quarter Ended 31 December 2018

Lannett’s sales rose by 5% to a “record” US$193.7 million. As this figure shows, thyroid deficiency treatments made up slightly less than half of group sales, underlining its im-portance to the group. Lannett insists, “The 17 products launched during calendar year 2018 were key contributors to the growth in the quarter and are expected to contribute approximately US$75 million in fiscal 2019 net sales with at least 35% of gross margin.”


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Generics ulletin nforma · 2019. 2. 20. · Februar No. harma ntelligence ulletin nforma Generics genericsbulletin.pharmaintelligence.informa.com LANNETT Levothyroxine Is No More