Mer­ck pulls a patent win for di­a­betes fran­chise in West Vir­ginia fed­er­al court

Mer­ck doesn’t have to sweat Janu­via and Janu­met com­peti­tors — at least for now.

A fed­er­al judge award­ed Mer­ck a win in its patent bat­tle against Vi­a­tris, the phar­ma gi­ant an­nounced Thurs­day, putting the freeze on a po­ten­tial Vi­a­tris gener­ic un­til at least 2026, bar­ring an ap­peal.

Judge Irene Kee­ley of West Vir­ginia up­held two key patents sur­round­ing sitagliptin, an ac­tive in­gre­di­ent in the block­buster di­a­betes drugs. The first patent, No. 7,326,708, cov­ers the di­hy­dro­gen phos­phate salt of sitagliptin and is valid through 2026, with pe­di­atric ex­clu­siv­i­ty un­til 2027. The sec­ond, No. 8,414,921, cov­ers the co-for­mu­la­tion of sitagliptin and met­formin in Janu­met and ex­pires in 2029.

While it isn’t im­me­di­ate­ly clear if Vi­a­tris will chal­lenge the de­ci­sion, the com­pa­ny has fought Mer­ck’s di­a­betes patents in the past and is cur­rent­ly in a sep­a­rate ap­peals case over the va­lid­i­ty of the salt patent. Vi­a­tris is look­ing to go to mar­ket with gener­ics for both Janu­via and Janu­met, which to­geth­er raked in $1.2 bil­lion last quar­ter, up 3% from Q2 2021. Last year, the drugs earned more than $5.2 bil­lion. Vi­a­tris did not re­spond to a re­quest for com­ment as of press time.

Janu­via and Janu­met are oral drugs de­signed to low­er blood sug­ar, but Janu­met al­so con­tains met­formin, which helps the body re­spond bet­ter to in­sulin.

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. The com­pa­ny has pre­vi­ous­ly said it ex­pects sales in the US “will de­cline sig­nif­i­cant­ly” once gener­ics reach the mar­ket.

While Janu­via was orig­i­nal­ly set to lose patent ex­clu­siv­i­ty next year, Mer­ck not­ed that if the salt patent was found to be valid, cer­tain rights could be ex­tend­ed to 2027.

Just last month, reg­u­la­tors an­nounced that they dis­cov­ered a ni­trosamine im­pu­ri­ty in some Janu­via sam­ples but al­lowed the tem­po­rary dis­tri­b­u­tion of sam­ples con­tain­ing the im­pu­ri­ty above ac­cept­able lev­els to avoid a short­age of the drug.

“It could be dan­ger­ous for pa­tients with this con­di­tion to stop tak­ing their sitagliptin with­out first talk­ing to their health care pro­fes­sion­al. FDA rec­om­mends pre­scribers con­tin­ue to use sitagliptin when clin­i­cal­ly ap­pro­pri­ate to pre­vent a gap in pa­tient treat­ment,” the agency said.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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New in­fla­tion-linked drug re­bates go in­to ef­fect on Sat­ur­day

Beginning tomorrow, biopharma companies can be charged rebates for any new drug price increases rising faster than the rate of inflation.

The new rebates are part of the newly signed Inflation Reduction Act, which introduces this new requirement that manufacturers pay rebates to Medicare for Part D drugs whose price increases exceed inflation, and in January 2023, the same will occur with Part B drugs.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

#AAO22 conference in Chicago (Photo credit: Associate editor Kyle LaHucik)

#AAO22: In bid for first FDA nod in ge­o­graph­ic at­ro­phy, Apel­lis claims an­oth­er first in eye dis­ease field

CHICAGO — Eight weeks before patients and industry find out if the FDA approves the first treatment for geographic atrophy, an advanced form of age-related macular degeneration, the biotech behind the drug is out with some new data on a secondary endpoint.

In what study investigator Charles Wykoff called the “first direct evidence of function preservation by slowing GA growth” in an investigational treatment, Apellis Pharmaceuticals’ drug pegcetacoplan led to less loss of retinal sensitivity versus sham  within 250 microns on either side of the GA lesion over 24 months.

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BioCryst's new website for its HAE unbranded campaign encourages patients to take charge of treatment decisions.

BioCryst launch­es aware­ness cam­paign around man­age­ment of rare vas­cu­lar dis­ease

While hereditary angioedema (HAE) is rare, treatment options for the condition have become much more common. So BioCryst Pharmaceuticals is taking a new angle in its recently launched HAE awareness campaign encouraging patients to take control of their disease management.

“Hereditary angioedema (HAE) isn’t the author of your story — you are … #cHAEngetheplan. Not the goal,” the US campaign website advises.

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