Watson Pharmaceuticals, Inc. (NYSE: WPI) ("Watson") and Gedeon Richter Plc ("Richter") today announced that Watson's subsidiary, Watson Laboratories, Inc. has entered into an exclusive licensing agreement with PregLem, S.A., ("Preglem") the wholly owned subsidiary of Richter, to develop and market Esmya™ (ulipristal acetate) in the U.S. and Canada. In European studies, Esmya™ has been shown to be an effective and safe treatment for uterine fibroids (myoma), a condition that affects millions of women worldwide. The product is currently in late stage development in Europe and Watson expects to initiate U.S. Phase III clinical studies in 2011.
Under terms of the agreement, Watson will pay PregLem a $17 million license fee and will pay royalties based on sales in the U.S. and Canada. Watson will make additional payments based on the achievement of certain regulatory milestones. The companies will also collaborate on additional Esmya™ formulations, jointly sharing the 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," said Paul Bisaro, Watson's Chief Executive Officer. "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. We look forward to further expanding our relationship with PregLem and Gedeon Richter for future opportunities between our companies."
"I am pleased with the agreement concluded with Watson, as their specialty knowledge and marketing strength are expected to contribute to the successful development and marketing of Esmya™ in North America. I am convinced that via the acquisition of PregLem and the commercialisation of Esmya™, we will create increasing value for our investors", said Erik Bogsch, Managing Director of Gedeon Richter Plc.
"Esmya™ has successfully completed clinical trials in Europe, so we have significant clinical knowledge and confidence in the development requirements as we move to late-stage trials in the U.S. and Canada," said Ernest Loumaye, CEO and Co-Founder of PregLem.
Uterine fibroids (myomas) are the most common benign, solid tumors of the female genital tract, affecting between 20 and 25 percent of women of reproductive age. The condition is characterized by excessive uterine bleeding, anemia, pain, frequent urination or incontinence, and occasional interruption of fertility. Approximately 300,000 surgical procedures are performed annually to address uterine fibroids, including approximately 230,000 hysterectomies. GnRH agonists are the only approved treatment for uterine fibroids when associated with anemia but their use has been relatively limited due to side effects resulting from the suppression of estrogen to castration levels (hot flushes, depression, mood swings, loss of libido, vaginitis and loss of bone mineral density).
Watson Pharmaceuticals, Inc.