Yamanouchi Pharmaceutical Co. Ltd. and GlaxoSmithKline announced an agreement in the United States to co-promote Vesicare (solifenacin succinate; development number: YM905), an investigational compound for overactive bladder (OAB).
Under the co-promotion agreement, Vesicare in the U.S. will be co- promoted by Yamanouchi Pharma America (YPA) and GSK.
Vesicare is an investigational muscarinic antagonist that is thought to act on the receptors in the smooth muscle of the bladder. The compound was discovered and developed by Yamanouchi, and its New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration by YPA in December 2002. The application is currently under review by FDA and contains clinical trial data on the use of Vesicare for the relief of symptoms associated with OAB such as urinary frequency, urinary incontinence or urgency.
A market authorization application for Vesicare was submitted in Europe in January 2003, and Yamanouchi has initiated Phase III clinical trials for Vesicare(R) in Japan.
Yamanouchi is preparing for the establishment of an independent sales network in the United States focusing on the field of urology. Vesicare will be the first product in the United States to be marketed through YPA with its own independent sales and marketing organization. This U.S. co-promotion agreement will accelerate the preparation of the launch and will help ensure an expeditious and efficient entry of Vesicare into the U.S. market.
For GSK, this agreement with Yamanouchi represents a further strengthening of the company's late stage product development pipeline and offers an opportunity to bring a new treatment option to the estimated 17-20 million people in the U.S. with overactive bladder.