Urovant Sciences and Pierre Fabre Médicament have entered into an exclusive license agreement allowing the French pharma/cosmetics company to register and commercialize vibegron for the treatment of overactive bladder in the European Economic Area, UK and Switzerland.
The deal also includes some optional territories, such as the French-speaking countries of Sub-Saharan Africa, Turkey and certain Eastern European countries. California-based Urovant — a subsidiary of Sumitovant Biopharma — will retain full rights in the U.S. and other select markets.
Urovant will receive up to $75 million in an upfront payment, regulatory and sales milestones as well as sales royalties from Pierre Fabre.
The drug, branded as Gemtesa, won the U.S. FDA nod in Dec 2020. Gemtesa is a selective beta-3 adrenergic agonist that affects the muscles in the bladder.
The partners will share responsibility for vibegron clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant will also provide manufacturing services to Pierre Fabre.