Watson Pharmaceuticals (NYSE: WPI) this morning revealed that it has entered into an exclusive licensing agreement with PregLem SA, the wholly-owned subsidiary of Hungary’s largest drugmaker Gedeon Richter (RICHT: HB), to develop and market Esmya (ulipristal acetate) in the USA and Canada.
Under terms of the agreement, Watson will pay PregLem a $17 million license fee and royalties based on sales in the USA 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.
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 US Phase III clinical studies in 2011.
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