Vivek Ra­maswamy’s Urovant claims a big win in PhI­II — but ques­tions linger about a cheap gener­ic and their brand­ed ri­val

Af­ter the great Ax­o­vant im­plo­sion that swept away its high­ly tout­ed Alzheimer’s drug, Roivant chief Vivek Ra­maswamy need­ed one of the biotechs in his fast-grow­ing league of drug de­vel­op­ers to win a big Phase III tri­al. Based on to­day’s top-line re­lease for Urovant’s Phase III uri­nary in­con­ti­nence drug vibegron, the team is claim­ing that vic­to­ry and prep­ping an ap­pli­ca­tion for the FDA.

But there are some lin­ger­ing ques­tions about the cheap gener­ic that was used as an ac­tive com­para­tor in the study, and it’s dri­ving the biotech’s stock in­to the red Tues­day morn­ing.

Urovant’s drug hit sta­tis­ti­cal sig­nif­i­cance for both co-pri­ma­ry end­points and all 7 sec­on­daries when com­pared against a place­bo. But the drug was al­so test­ed along­side an old gener­ic drug called toltero­dine. And there the re­search showed that vibegron “achieved nu­mer­i­cal­ly bet­ter ef­fi­ca­cy that toltero­dine.”

In the slide show pre­sen­ta­tion this morn­ing, the com­pa­ny went on to il­lus­trate the specifics of the com­para­tor arms ver­sus place­bo, but re­searchers did not run a p val­ue for the Urovant drug against the gener­ic. But they were rel­a­tive­ly close, as you can see here:

Source: Urovant

Urovant’s drug cut in­stances of in­con­ti­nence by 2 from a base­line of 3.43, achiev­ing a clear win over the 1.4 drop in the place­bo arm. Toltero­dine, though, came much clos­er at 1.8. Both drugs beat the place­bo with sta­tis­ti­cal sig­nif­i­cance.

For uri­na­tion fre­quen­cy, there was a sim­i­lar spread. The place­bo arm hit a drop of 1.3, with a neg­a­tive 1.8 for vibegron and -1.6 for toltero­dine. Vibegron hit sta­tis­ti­cal dif­fer­ence ver­sus place­bo, toltero­dine did not. But there was no di­rect com­par­i­son of the ex­per­i­men­tal drug and the cheap place­bo.

In their an­nounce­ment back in 2012, Astel­las post­ed these re­spons­es for Myr­be­triq.

Myr­be­triq 25 mg, in­con­ti­nence episodes were re­duced by 1.36 episodes from a base­line of 2.65, a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of 0.40 vs. place­bo in 12 weeks. The num­ber of uri­na­tions was re­duced by 1.65 uri­na­tions from a base­line of 11.68, a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of 0.47 vs. place­bo in 12 weeks.

Myr­be­triq 50 mg, in­con­ti­nence episodes were re­duced by 1.49 episodes from a base­line of 2.71, a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of 0.40 vs. place­bo in 12 weeks.  Num­ber of uri­na­tions was re­duced by 1.75 uri­na­tions from a base­line of 11.70, a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion of 0.55 vs. place­bo in 12 weeks.

You can be sure that an­a­lysts will al­so be fill­ing in the blanks by ex­trap­o­lat­ing the head-to-head com­par­isons them­selves.

Urovant’s pitch is built around demon­strat­ing a bet­ter safe­ty and ef­fi­ca­cy pro­file than the an­ti­cholin­er­gics — like toltero­dine, where there’s been a link with de­men­tia — and the block­buster drug Myr­be­triq (mirabegron), which was launched by Astel­las back in 2012. Vibegron is a be­ta-3 drug, like Myr­be­triq, which is backed by patents that ex­pire in 2023 — about 3 years af­ter Urovant could ex­pect an ap­proval.

Giv­en that this drug is in­tend­ed for a mass mar­ket with mil­lions of pa­tients, teas­ing out the specifics of how a new, brand­ed drug com­pares to well es­tab­lished mar­ket­ed drugs would be cru­cial to its longterm suc­cess or fail­ure on the mar­ket. 

Biren Amin

Urovant, which has a mar­ket cap of $442 mil­lion, is let­ting it all ride on this Phase III. Ra­maswamy nabbed the drug from Mer­ck with a small, $25 mil­lion up­front — one of a slate of deals he struck ear­ly on as he grabbed ther­a­pies that had been side­lined at the ma­jors and aimed them for quick cat­a­lysts.

Big gam­ble? Jef­feries’ Biren Amin not­ed that a clear win here would be worth a 100% spike in the stock, with a neg­a­tive out­come elim­i­nat­ing up to half of its mar­ket cap.

That’s not what hap­pened, though. Af­ter pop­ping up 20% be­fore the bell, the stock turned south, plung­ing to a mi­nus 17% as in­vestors tried to sort out the re­sults for them­selves.


Im­age: Vivek Ra­maswamy at the US-Chi­na Bio­phar­ma In­no­va­tion & In­vest­ment Sum­mit, 2018. PHARM­CUBE, END­POINTS

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

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President Donald Trump and FDA Commissioner Stephen Hahn (AP Images)

FDA is­sues fi­nal rule al­low­ing im­por­ta­tion of drugs from Cana­da — but al­so keeps the pow­er to re­voke it

Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.

On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.