Esmya has completed European clinical studies and will enter U.S. Phase III trials in 2011.
Watson Laboratories exclusively licensed Esmya™, a treatment for uterine fibroids, from PregLem for $17 million. The deal allows Watson to develop and market this treatment for uterine fibroids in the U.S. and Canada. The product is currently in late-stage development in Europe, and Watson expects to initiate U.S. Phase III studies next year.
Esmya is an orally active selective progesterone receptor modulator that reversibly blocks the progesterone receptors in target tissues. Under the terms of the agreement, Watson will make payments based on the achievement of certain regulatory milestones. Additionally, PregLem will pay royalties based on sales in the U.S. and Canada. The companies will also collaborate on additional Esmya formulations, jointly sharing those development costs.
“Esmya represents a significant strategic addition to our portfolio of women’s health products and is potentially the first effective treatment for uterine fibroids in more than 20 years,” remarks Paul Bisaro, Watson’s CEO. “The agreement enables us to maximize our expertise in developing, registering, and commercializing significant therapeutic advances in diseases treated by OB/GYNs. It also forms the foundation for us to further develop a franchise of products and indications in the uterine fibroid category.”