Urovant Sciences Expands European Footprint Through Strategic Partnership with Pierre Fabre on Vibegron Therapy

Urovant Sciences has announced a significant licensing deal with pharmaceutical giant Pierre Fabre Médicament to bring vibegron treatment to European markets. Under this collaborative arrangement, Pierre Fabre will take on registration and commercialization responsibilities across the European Economic Area, United Kingdom, Switzerland, and select territories including French-speaking Sub-Saharan Africa, Turkey, and parts of Eastern Europe.

Financial Framework and Milestone Structure

The agreement outlines compensation reaching up to USD $75 million for Urovant Sciences, structured through upfront payments combined with regulatory and sales-based milestones. Beyond these fixed payments, Urovant Sciences will receive royalties tied to actual sales performance, creating a performance-linked revenue model that aligns both parties’ interests.

Notably, Urovant Sciences retains complete commercialization rights within the United States and select other markets, preserving its direct market access for its lead therapeutic candidate.

Product and Clinical Context

Vibegron, marketed as GEMTESA® in the U.S., represents an oral, once-daily 75 mg small molecule beta-3 agonist designed for adults experiencing overactive bladder symptoms. The drug received FDA approval in December 2020 and launched commercially in the American market during April 2021.

Overactive bladder affects approximately 546 million individuals globally aged 20 and above, with roughly 33 million U.S. adults experiencing its bothersome manifestations including urge incontinence, urgency, frequent urination, and nocturia. GEMTESA addresses the significant unmet medical need in this therapeutic space.

Manufacturing and Development Collaboration

As part of the partnership arrangement, Urovant Sciences will provide manufacturing support services to Pierre Fabre. Additionally, both organizations will share clinical development responsibilities for pediatric populations within European territories, demonstrating a commitment to comprehensive patient care across age groups.

The arrangement also reflects Urovant Sciences’ strategy for global market penetration while maintaining focus on U.S. market dominance for its urology-focused portfolio.

About the Companies

Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., specializes in developing innovative urology therapies addressing unmet medical needs. Beyond vibegron, the company is advancing URO-902, a novel gene therapy for overactive bladder patients unresponsive to oral medications.

Pierre Fabre Médicament brings five decades of urology and women’s health expertise to the partnership. As the second-largest private French pharmaceutical group and a global dermo-cosmetics leader, Pierre Fabre generated €2.5 billion in revenues during 2021, with approximately 66% derived from international operations. The organization manufactures over 95% of its products in France while serving approximately 115 countries worldwide.