FDA and Repros Reach Agreement for Androxal Registration Program

Repros Therapeutics Inc.®

today announced it has held a meeting with the Division of Reproductive and Urologic Products (DRUP) to agree upon the registration requirements for the Company's Androxal® oral therapy for the treatment of secondary hypogonadism. Repros believes secondary hypogonadism is responsible for over 90% of the incidence of low testosterone in the United States. A key element of the meeting included the overall required safety database. Unless unexpected safety issues arise, the FDA noted that safety data for 100 subjects exposed to Androxal for one year and 800 subjects exposed for 6 months would be adequate. To date, the Company has data for approximately 70 subjects for 1 year and 150 subjects for 6 months. Androxal has been well tolerated.