Vivek Ramaswamy’s ‘vant’ brainchildren keep bearing fruit with Urovant’s FDA nod for incontinence med vibegron

Max Gelman

Associate Editor

Christ­mas has come ear­ly for Urovant Sci­ences as the for­mer Vivek Ra­maswamy out­fit scored an FDA ap­proval for its lead pro­gram.

James Robin­son

The biotech’s over­ac­tive blad­der can­di­date vibegron will be the newest drug to hit the mar­ket, the agency said Wednes­day, giv­ing Urovant its first ap­proved prod­uct. Vibegron, a be­ta-3 ag­o­nist that’s tak­en as a once-dai­ly pill, will be sold as Gemte­sa. The drug is like­ly to launch in ear­ly 2021, CEO James Robin­son has pre­vi­ous­ly said.

The FDA based Gemte­sa’s ap­proval on da­ta from a Phase III tri­al that raised near­ly as many ques­tions as it an­swered back in March 2019. The drug hit both co-pri­ma­ry end­points and sev­en sec­ondary end­points com­pared with place­bo af­ter three months of treat­ment and a one-month safe­ty fol­low-up. Gemte­sa cut av­er­age in­stances of in­con­ti­nence every 24 hours by 2 from a base­line of 3.43, achiev­ing a clear win over the 1.4 drop in the place­bo arm.

But Urovant test­ed the drug along­side a cheap gener­ic called toltero­dine, which al­so achieved sta­tis­ti­cal sig­nif­i­cance over place­bo at a 1.8 drop from base­line, com­ing close to Gemte­sa’s re­sults. Re­searchers said at the time that even though vibegron achieved “nu­mer­i­cal­ly bet­ter ef­fi­ca­cy than toltero­dine,” they did not run a p-val­ue for the Urovant drug against the gener­ic.

That left an­a­lysts to make the com­par­isons on their own and sent Urovant’s stock price down 17% af­ter an ini­tial 20% spike. Ra­maswamy orig­i­nal­ly bagged the drug in a small $25 mil­lion deal from Mer­ck, and it’s one of mul­ti­ple drugs he pre­dict­ed would reach ap­proval by 2022.

It’s a big win for the biotech, com­ing just over a month af­ter its par­ent com­pa­ny, a sub­sidiary of Sum­it­o­mo Dainip­pon, bought Urovant out in full to bring the biotech clos­er in­to its own net­work of com­pa­nies and for­mer Vants.

Urovant was ac­quired for $584 mil­lion in an all-cash deal, valu­ing the biotech at $16.25 per share. The fig­ure rep­re­sent­ed a 96% pre­mi­um on the biotech’s clos­ing price a day ear­li­er, and the tim­ing proved fruit­ful giv­en Wednes­day’s an­nounce­ment.

Vivek Ra­maswamy

Fo­cus­ing on uri­nary dis­eases, Urovant was one of five biotech Ra­maswamy sold to Sum­it­o­mo Dainip­pon about 15 months ago. The group in­clud­ed My­ovant, which last week saw an ap­proval of its own in prostate can­cer; En­zy­vant (pe­di­atric rare dis­eases); Al­ta­vant (res­pi­ra­to­ry rare dis­eases) and Spirovant (pul­monary dis­eases). Ra­maswamy brought in $3 bil­lion with the move, and it in­clud­ed the op­tion of buy­ing an­oth­er 6 of his star­tups.

Ra­maswamy al­so re­mains on the board of Sum­i­to­vant, the ex-Vant um­brel­la owned by Sum­it­o­mo Dainip­pon.

The com­pa­ny is fur­ther eval­u­at­ing vibegron in OAB in men with be­nign pro­sta­t­ic hy­per­pla­sia and for ab­dom­i­nal pain as­so­ci­at­ed with ir­ri­ta­ble bow­el syn­drome. Fur­ther down the pipeline, Urovant has a gene ther­a­py pro­gram called hMaxi-K, which is be­ing re­searched for pa­tients with OAB symp­toms who have failed oral phar­ma­co­log­ic ther­a­py.