Mer­ck cel­e­brates an­oth­er win in Janu­via patent bat­tle against Vi­a­tris

Vi­a­tris has suf­fered its sec­ond sting­ing loss in as many weeks in its at­tempt to chal­lenge Mer­ck’s Janu­via and Janu­met patents.

A fed­er­al ap­peals court on Thurs­day up­held Mer­ck’s patent rights re­lat­ed to the di­hy­dro­gen phos­phate salt of sitagliptin — an ac­tive in­gre­di­ent in the block­buster di­a­betes drugs Janu­via, Janu­met and ex­tend­ed-re­lease for­mu­la­tion Janu­met XR — call­ing Vi­a­tris’ claims “un­per­sua­sive.”

The lat­est rul­ing pro­tects Mer­ck’s patent through May 2027, in­clud­ing six months of pe­di­atric ex­clu­siv­i­ty, ac­cord­ing to the com­pa­ny.

Vi­a­tris had pre­vi­ous­ly chal­lenged the va­lid­i­ty of the salt patent, dubbed No. 7,326,708 or ‘708 for short. When the US Patent Of­fice sided with Mer­ck in May 2021, the com­pa­ny took the case to a fed­er­al ap­peals court, which af­firmed the Patent Of­fice’s de­ci­sion on Thurs­day.

It’s a tough blow for Vi­a­tris, which lost a sep­a­rate patent suit against Mer­ck’s sitagliptin just last week. Judge Irene Kee­ley of West Vir­ginia up­held two key patents, in­clud­ing the salt patent and an­oth­er one cov­er­ing the co-for­mu­la­tion of sitagliptin and met­formin in Janu­met, which ex­pires in 2029.

Janu­via and Janu­met are both oral drugs de­signed to low­er pa­tients’ blood sug­ar, but Janu­met al­so con­tains met­formin, which helps the body re­spond bet­ter to in­sulin. To­geth­er, they raked in $1.2 bil­lion last quar­ter, up 3% from Q2 2021.

Vi­a­tris is look­ing to go to mar­ket with gener­ics for both Janu­via and Janu­met. While the com­pa­ny has the op­tion to ap­peal last week’s de­ci­sion up­hold­ing the salt and met­formin patents, it’s un­clear if there are any plans to do so. The com­pa­ny has not re­spond­ed to a re­quest for com­ment as of press time.

Mer­ck said in an email to End­points News on Fri­day that it is “pleased” with the ap­peals court de­ci­sion, adding, “We look for­ward to con­tin­u­ing to pro­vide these im­por­tant prod­ucts to pa­tients who need them through 2027.”

Mer­ck has set­tled with sev­er­al oth­er ri­vals who have agreed not to launch their own gener­ics un­til 2026 “or ear­li­er un­der cer­tain cir­cum­stances,” the com­pa­ny said in a news re­lease.

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:

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.

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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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.