Jim Robinson, Urovant CEO

Urovant hops across the pond, out-li­cens­ing over­ac­tive blad­der drug to Pierre Fab­re for $75M

Urovant Sci­ences, the for­mer sub­sidiary of Vivek Ra­maswamy’s Roivant Sci­ences, is branch­ing out across the At­lantic in a new li­cens­ing deal.

The Cal­i­for­nia biotech and French multi­na­tion­al phar­ma and cos­met­ics com­pa­ny Pierre Fab­re joint­ly an­nounced Tues­day that they are pair­ing up, with Urovant giv­ing Pierre Fab­re the rights to reg­is­ter and com­mer­cial­ize over­ac­tive blad­der drug vibegron, known as Gemte­sa in sev­er­al mar­kets, in­clud­ing the en­tire EU, Ice­land, Liecht­en­stein, Nor­way, the UK and Switzer­land. The deal al­so in­cludes a few op­tion ter­ri­to­ries which, ac­cord­ing to a state­ment, in­clude “French-speak­ing coun­tries of Sub-Sa­ha­ran Africa, Turkey and cer­tain East­ern Eu­ro­pean coun­tries.”

Urovant will re­tain full rights in the US and oth­er un­named mar­kets, ac­cord­ing to the state­ment. As part of the deal, Urovant will al­so re­ceive up to $75 mil­lion in com­bined up­front pay­ments plus reg­u­la­to­ry and sales mile­stones, and top­ping that off with po­ten­tial roy­al­ties.

Urovant CEO Jim Robin­son ex­pressed ex­cite­ment at the deal, adding that the French phar­ma’s “ex­pe­ri­ence in the glob­al OAB and Be­nign Pro­sta­t­ic Hy­per­pla­sia (BPH) mar­ket make them unique­ly suit­ed to de­liv­er vibegron to more pa­tients.”

The pair will al­so be work­ing to­geth­er on con­duct­ing pe­di­atric tri­als in Eu­rope for the drug, which was bagged by Ra­maswamy from Mer­ck for $25 mil­lion. Urovant will al­so be “pro­vid­ing man­u­fac­tur­ing ser­vices” to Pierre Fab­re.

Gemte­sa orig­i­nal­ly hit the mar­ket in late 2020 af­ter the FDA gave it the green light. The for­mer Ra­maswamy out­fit, which was sold to a Sum­it­o­mo Dainip­pon sub­sidiary for $584 mil­lion in an all-cash deal, had pre­vi­ous­ly laid out a pos­i­tive Phase III read­out, show­ing that the drug can­di­date had hit its co-pri­ma­ry end­points and sev­en sec­ondary end­points com­pared to place­bo af­ter three months of treat­ment and a one-month safe­ty fol­low-up.

How­ev­er, Urovant had test­ed the drug along­side toltero­dine, a cheap gener­ic that al­so achieved sta­tis­ti­cal sig­nif­i­cance over place­bo. Re­searchers said at the time that even though Gemte­sa achieved “nu­mer­i­cal­ly bet­ter ef­fi­ca­cy than toltero­dine,” they did not run a p-val­ue out­lin­ing the sta­tis­ti­cal sig­nif­i­cance of the treat­ment ef­fect.

Af­ter that saga, the drug then passed a safe­ty study in Sep­tem­ber, show­ing that it had no clin­i­cal­ly rel­e­vant ef­fect on blood pres­sure and heart rate.

End­points News has reached out to Urovant and will up­date ac­cord­ing­ly.

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Dave Marek, Myovant CEO

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Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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

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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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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

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The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

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Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Hervé Hoppenot, Incyte CEO

In­cyte pays out $70M to get hands on Medicxi-backed vi­tili­go biotech

The M&A wheels keep on turning in biotech — and this time it’s Incyte that gets to do the dealmaking.

The Delaware biotech put out word on Monday morning that it will be shelling out $70 million in cash to acquire Villaris Therapeutics. Incyte will not only acquire Villaris, but also exclusive global rights for Villaris’s lead candidate auremolimab.

Auremolimab, currently in IND-enabling studies, is an anti-IL-15Rβ monoclonal antibody being investigated in vitiligo, with a possibility of other autoimmune and inflammatory indications. Villaris says it is targeting that pathway after a mouse study showed that doing so could be effective at reversing the disease.

Kelly Ganjei, AmplifyBio CEO

Am­pli­fy­Bio scoops up lab space and oth­er as­sets from PACT Phar­ma as cell ther­a­py biotech read­justs

The West Coast cell therapy biotech PACT Pharma was facing some challenges after several employees got the axe from the company and execs put the kibosh on its only clinical trial. Now, the company has sold some of its assets to an Ohio-based contract research organization.

AmplifyBio has acquired a 46,280 square-foot lab in South San Francisco, CA, with around 40 employees specializing in cell and gene therapy development and access to technology platforms that can be applied to “product characterization.”