Repros Submits New Drug Application to FDA for Androxal

Repros Therapeutics Inc.®

today reported that it has electronically submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Androxal®, the Company's lead product candidate. Androxal® is a single isomer of clomiphene citrate and an orally active proprietary small molecule compound. The Company is developing Androxal® for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. Androxal® is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism. Secondary hypogonadism due to being overweight or obese is the single greatest cause of hypogonadism in general. The NDA for Androxal® includes a significant collection of data on safety and efficacy from over 20 studies. It is supported by four Phase 3 efficacy studies, two of which compared Androxal® to a leading FDA approved topical gel in addition to placebo. In the two active-comparative studies, Androxal® met the primary efficacy endpoints and demonstrated the reproducibility of the previous Phase 3 study results. Analyses found Androxal® to be superior to the topical gel in both co-primary endpoints: percent change from baseline in average sperm concentration and percent of subjects considered to be responders. A responder is defined as an individual achieving a 24 hour average testosterone in the normal range with associated average sperm concentration ≥ 10 million/mL. Androxal® exhibited no negative effects on sperm concentration compared to placebo but exhibited highly significant effects on normalizing testosterone levels compared to placebo control.