Thomas Kuhn, Poxel

Vivek Ra­maswamy’s Meta­vant hits a brick wall, aban­don­ing a lead pro­gram for di­a­betes. And there’s noth­ing vis­i­ble left to see here

Just a few years af­ter Vivek Ra­maswamy’s epic Alzheimer’s fail, an­oth­er one of his star­tups is cut­ting its loss­es be­cause of a high-risk en­deav­or — this time on the di­a­betes front — didn’t pan out.

Meta­vant, Ra­maswamy’s biotech #7, has de­cid­ed not to ad­vance its lead can­di­date imeglim­in in­to Phase III, in­stead of look­ing for a quick sell-off. If it doesn’t se­cure a deal with­in 60 days, the rights go back to Mer­ck KGaA spin­out Pox­el, which li­censed the drug to Roivant — the par­ent com­pa­ny to Ra­maswamy’s suite of “vants” —  back in 2018 for $50 mil­lion in cash and up to $600 mil­lion in mile­stones.

A spokesper­son for Meta­vant tells End­points News there are cur­rent­ly no “dis­closed” drugs in the pipeline, and didn’t rule out that pos­si­bil­i­ty. But for now, bar­ring some stealth pro­grams or deals in the works, the com­pa­ny looks dor­mant.

Pox­el says Meta­vant’s de­ci­sion wasn’t based on ef­fi­ca­cy, safe­ty, or oth­er da­ta. “We con­duct­ed an in­ter­nal re­view and de­ter­mined that ad­vanc­ing imeglim­in was not strate­gi­cal­ly ap­pro­pri­ate for us,” Meta­vant said in a short email state­ment to End­points.

In a sep­a­rate part­ner­ship with Sum­it­o­mo Dainip­pon Phar­ma, the drug suc­cess­ful­ly com­plet­ed a Phase III pro­gram and is cur­rent­ly un­der reg­u­la­to­ry re­view for Type 2 di­a­betes in Japan. Pox­el CEO Thomas Kuhn said the drug could hit the mar­ket next year, adding that the com­pa­ny is “ful­ly com­mit­ted” to fu­ture de­vel­op­ment and com­mer­cial­iza­tion.

“To­day’s an­nounce­ment does not im­pact the agree­ment for Imeglim­in with Sum­it­o­mo Dainip­pon Phar­ma. Mov­ing for­ward, we are prepar­ing to ex­plore var­i­ous op­tions to ad­vance Imeglim­in in­to a Phase 3 de­vel­op­ment pro­gram in the US, Eu­rope and oth­er coun­tries cur­rent­ly cov­ered un­der the Meta­vant agree­ment,” Kuhn said in a state­ment.

Meta­vant’s on­ly oth­er pro­gram was a di­a­betes drug li­censed from Lig­and, for which it re­turned the rights ear­li­er this year. Roivant paid $20 mil­lion in cash and promised up to $513.8 mil­lion in mile­stones for the glyco­gen re­cep­tor in­hibitor, called LGD-6972.

In its Q2 2019 fi­nan­cial re­port, Lig­and said con­tin­ued de­vel­op­ment of the pro­gram was “high­ly un­like­ly” due to changes in FDA re­quire­ments.

Meta­vant has been work­ing with FDA to de­ter­mine a path for­ward for the glucagon re­cep­tor an­tag­o­nist or GRA pro­gram now known as RVT-1502 in di­a­betes. Lig­and be­lieves that con­tin­ued de­vel­op­ment of RVT-1502 for di­a­betes in the U.S. is high­ly un­like­ly based on pre­clin­i­cal and clin­i­cal tri­als now re­quired by FDA for any drug in the GRA class in­tend­ed for long-term use. Meta­vant may choose to ex­plore cer­tain oth­er in­di­ca­tions and/or ge­o­gra­phies for RVT-1502 and ex­pects to make a de­ci­sion lat­er this year.

Ear­li­er this month, Ra­maswamy’s Ax­o­vant changed its name to Sio Gene Ther­a­pies in a com­plete re­brand, mark­ing its three-year shift away from Alzheimer’s dis­ease. “We’re not a vant any longer,” CEO Pa­van Cheru­vu said, adding that Roivant is no longer a ma­jor­i­ty stake­hold­er.

The im­plo­sion of the Meta­vant deal un­der­scores just how rare it is for a biotech com­pa­ny to at­tempt to try any­thing on the di­a­betes front, a field dom­i­nat­ed by a hand­ful of gi­ant play­ers that can af­ford to cov­er the im­mense cost of huge late-stage stud­ies — of­ten in pur­suit of mar­gin­al med­ical gains for pa­tients. And with this lat­est fail­ure, it’s even less like­ly we’ll see more in small com­pa­nies any­time soon.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Thomas Gad, Y-mAbs Therapeutics founder and interim CEO

FDA re­jects Y-mAbs’ neu­rob­las­toma drug af­ter tak­ing is­sue with clin­i­cal tri­al de­sign

Uncertainty about clinical trial evidence has led the FDA to hand down a complete response letter for Y-mAbs’ neuroblastoma drug, casting a cloud on the future of a candidate that had gone through a long development journey in a rare pediatric cancer.

Y-mAbs said it’s disappointed “but not surprised” given that the agency’s oncology drug advisory committee had voted 16-0 against its drug’s approval a few weeks ago.

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Tim Pearson, Carrick Therapeutics CEO

Pfiz­er backs $60M in­fu­sion in­to Car­rick, teams up on breast can­cer treat­ment

In a big week for Carrick Therapeutics, the company announced $60 million in funding for its lead breast cancer drug and development of a second program, as well as a collaboration with Pfizer for combo development.

The $35 million from Pfizer comes with an agreement under which Pfizer will support Carrick’s Phase II study of samuraciclib in combination with Pfizer’s Faslodex for advanced breast cancer. Along with the investment, Adam Schayowitz, vice president and development head of breast cancer, colorectal cancer and melanoma at Pfizer global product development, will join Carrick’s scientific advisory board.

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

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with Rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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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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