MORRISTOWN, N.J., and BUDAPEST, HUNGARY, Dec. 16, 2010
/PRNewswire-FirstCall/ — 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
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