On July 5, 2022 Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., and Pierre Fabre Médicament reported they have entered into an exclusive license agreement for Pierre Fabre to register and commercialize vibegron for the treatment of Overactive Bladder (OAB) in the European Economic Area, UK, and Switzerland, with some option territories, which notably include French-speaking countries of Sub-Saharan Africa, Turkey, and certain Eastern European countries (Press release, Pierre Fabre, JUL 5, 2022, View Source [SID1234616481]). Urovant will retain full rights in the United States and other select markets.
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"We are thrilled to partner with Pierre Fabre, a leader in the international biopharmaceutical space," said Jim Robinson, Chief Executive Officer of Urovant Sciences. "Their experience in the global OAB and Benign Prostatic Hyperplasia (BPH) market make them uniquely suited to deliver vibegron to more patients who need it across Europe and surrounding areas."
Under the terms of the agreement, Urovant Sciences will receive payments up to USD $75 million, based on upfront, regulatory, and sales milestone payments. Additionally, Urovant will receive royalties based on sales performance.
Urovant Sciences and Pierre Fabre will share responsibility for vibegron clinical trials in the pediatric populations in Europe. As part of the transaction, Urovant Sciences will also provide manufacturing services to Pierre Fabre.
"We are delighted to enter into this partnership with Urovant, which will bring effective treatment and improved quality of life to all patients suffering from Overactive Bladder (OAB) in Europe. This partnership confirms Pierre Fabre’s extensive expertise in urology and in women’s health for five decades and the group’s ambitions to offer therapeutic solutions to chronic diseases that are very disabling in everyday life," said Eric Ducournau, group CEO at Pierre Fabre.
About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), frequent urination (usually eight or more times in 24 hours), and nocturia (waking up more than two times in the night to urinate).1
While 33 million US adults experience the bothersome symptoms of OAB, approximately 546 million people ≥ 20 years are affected by OAB worldwide. 1,2