Repros Therapeutics Inc. is an advanced development stage bio-pharmaceutical company focusing on the treatment of hormonal/endocrine-related disorders. The major focus of the company’s diseases includes secondary hypogonadism, endometriosis and uterine fibroid. The company’s lead value driver, Androxal, recently completed Phase III clinical trials in secondary hypogonadism and met study endpoints. Both studies are with a Special Protocol Assessment (SPA) designation. The FDA recently also suggested the company potentially to conduct comparative pivotal studies vs. marketed testosterone gel for potential approval and the company plans to start the trials in 1Q14 with potential completion in 4Q14 and NDA filing shortly after. According to this timeline, Androxal could potentially enter the market in 2016. Overall, although risks for the development has increased modestly due to the uncertainty of clinical path and slight increase of development time, we believe the accumulative robust clinical data that support the notion of Androxal is potentially superior to testosterone gels has not changed.
The second product, Proellex, with a vaginal delivered version (Proellex-V) and a low dose oral regimen are about to undergo two separate Phase II studies in uterine fibroids, while a low dose orally administrated form is undergoing Phase II in endometriosis study and data from all studies