Sunday, April 02, 2017 7:35:26 PM
Our main competitors for the treatment of uterine fibroids and endometriosis are GnRH agonists, especially Lupron®, the current therapeutic standard of care for uterine fibroids. Lupron® is marketed by AbbVie, which has far greater resources and marketing capabilities than we have. Recently AbbVie has licensed a Phase 3-ready molecule from Neurocrine Biosciences for the treatment of endometriosis. Gedeon Richter and Allergan have also entered into an exclusive license agreement to develop and market Esmya™ (an orally active selective progesterone receptor modulator) in the U.S, Canada and Europe. In addition, Bayer AG is also developing an oral selective progesterone receptor modulator, vilaprisan, which is anticipated to enter phase 3 clinical trials later this year. Surgical treatment of both uterine fibroids and endometriosis continues to compete with Proellex® by removing uterine fibroids and by removing misplaced tissue in women with endometriosis. We believe we can potentially compete with Lupron® and other GnRH agonists because we believe that Proellex® will not present the same side effect of a decrease in bone mineral density given its specific focus on progesterone inhibition, which differentiates it from GnRH agonists that create a low estrogen state. There are additional companies developing similar progesterone-blocking technology.
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