En­do los­es Va­sostrict patent bat­tle as sales take a hit from gener­ics

It’s been just two days since En­do In­ter­na­tion­al filed for bank­rupt­cy in an at­tempt to dig it­self out of thou­sands of opi­oid law­suits. Now one of its top sell­ers is in trou­ble.

A fed­er­al ap­peals court on Thurs­day af­firmed a Delaware judge’s de­ci­sion that Ea­gle Phar­ma­ceu­ti­cals’ gener­ic ver­sion of En­do’s va­so­pressin in­jec­tion Va­sostrict does not in­fringe on the com­pa­ny’s patents. Ea­gle’s ver­sion won ap­proval back in De­cem­ber, and al­ready, the gener­ic and oth­ers like it have dri­ven down Va­sostrict sales.

Va­sostrict is man­u­fac­tured by En­do’s Par Phar­ma­ceu­ti­cal unit, and raked in a whop­ping $900 mil­lion last year, more than dou­bling the earn­ings of En­do’s sec­ond high­est-sell­ing prod­uct, Xi­aflex for men with Pey­ronie’s dis­ease.

Even though va­so­pressin has been mar­ket­ed as a ther­a­peu­tic agent for al­most a cen­tu­ry, Par won ap­proval back in 2014 as part of an FDA ini­tia­tive to en­cour­age man­u­fac­tur­ers to get ap­proval for old, un­ap­proved drugs. The drug is ap­proved to in­crease blood pres­sure in adults with va­sodila­to­ry shock who re­main hy­poten­sive de­spite flu­ids and cat­e­cholamines.

How­ev­er, sales last quar­ter took an 85% dive from Q2 2021 due to “low­er price and mar­ket share re­sult­ing from gener­ic com­pe­ti­tion,” the com­pa­ny said.

In ad­di­tion to Ea­gle, Dr. Red­dy’s and Am­phastar have al­so swung ap­provals for their own gener­ic ver­sions.

Par filed suit against Ea­gle back in 2018, around the same time that Ea­gle sub­mit­ted its AN­DA. Plain­tiffs ar­gued that the gener­ic would in­fringe on two patents, which ex­pire in 2035 and re­quire va­so­pressin to have a round­ed pH be­tween 3.7 and 3.9. How­ev­er, a Delaware court ruled last Au­gust that Ea­gle’s prod­uct doesn’t over­step be­cause its pH range is be­low that cov­ered by the Par patents.

While ac­knowl­edg­ing the low­er pH of Ea­gle’s gener­ic, Par point­ed to ev­i­dence that the pH of Ea­gle’s prod­uct would drift up over time, in­fring­ing on the patents.

A fed­er­al ap­peals court main­tained the ini­tial court’s de­ci­sion on Thurs­day, not­ing:

The dis­trict court’s find­ing that there was no up­ward pH drift in Ea­gle’s post-re­lease pH da­ta was not clear er­ror. The court thor­ough­ly con­sid­ered the post-re­lease pH da­ta Par cites, along with Ea­gle’s ex­pert tes­ti­mo­ny as­sess­ing that da­ta, and found that, while the pH mea­sure­ments fluc­tu­at­ed over time, there was no dis­cern­able trend — and cer­tain­ly not an in­evitable up­ward trend — in the fluc­tu­a­tions.

En­do has de­clined to com­ment.

The news comes days af­ter En­do filed for bank­rupt­cy un­der a moun­tain of opi­oid law­suits, fol­low­ing in the foot­steps of Pur­due Phar­ma and Mallinck­rodt. The com­pa­ny faced a litany of com­plaints over its for­mer opi­oid pain med Opana ER, which was tak­en off the mar­ket in 2017 at the FDA’s re­quest.

En­do filed for a Chap­ter 11 on Wednes­day, while al­so reach­ing a $450 mil­lion opi­oid set­tle­ment with sev­er­al states.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.