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

06 Jul 2022
endpts.com
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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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