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news.Watson Laboratories has entered into an agreement with PregLem for the development and marketing of Esmya (ulipristal acetate) in the US and Canada.
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In European studies, Esmya has been shown to be an effective and safe treatment for uterine fibroids (myoma).
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 $17m license fee and will pay royalties based on sales in the US and Canada and will also 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.
Watson CEO Paul Bisaro said the agreement enables us to maximize their expertise in developing, registering and commercializing significant therapeutic advances in diseases treated by OB/GYNs.
PregLem co-founder and CEO Ernest Loumaye said Esmya has successfully completed clinical trials in Europe, so they have significant clinical knowledge and confidence in the development requirements as they move to late-stage trials in the US and Canada.