Zacks_Analysts' Blog : Repros Schedules Meeting with FDA - Analyst Blog

Biopharmaceutical company Repros Therapeutics Inc. (RPRX) recently announced that it intends to conduct a type B meeting with the US Food and Drug Administration (FDA) regarding the phase III protocol for the company’s lead pipeline candidate, Androxal. Earlier this month, the company had received a feedback from the FDA regarding the company’s plans to conduct two phase III studies with Androxal.

Repros is developing Androxal for the treatment of secondary hypogonadism in men, who want to maintain their fertility while undergoing treatment for low testosterone. Androxal could provide an advantage over existing therapies mainly due to its convenience of use - Androxal is an oral treatment whereas existing products need to be injected or are available in the form of nasal sprays, creams or gels.

Hypogonadism Market Highly Competitive

According to the Urology Channel, about 13 million men in the US experience testosterone deficiency with less than 10% receiving treatment. The company believes that approximately 70% of men having low testosterone suffer from secondary hypogonadism. This represents significant commercial potential. However, we note that the hypogonadism market is pretty crowded with Abbott Laboratories’ (ABT) AndroGel holding a major share of the market.

Other currently marketed therapies include Auxilium Pharmaceutical’s (AUXL) Testim. Additional competition could be just round the corner in the form of Eli Lilly’s (LLY) Axiron, which is currently under FDA review. By the time Androxal gains approval, the market could be crowded with additional competitors like Endo Pharmaceutical’s (ENDP) Aveed, and BioSante Pharmaceuticals (BPAX)/Teva Pharmaceutical Industries Ltd.’s (TEVA) Bio-T-Gel.

Meanwhile, Androxal has the potential to be developed for the treatment of type II diabetes as well. The company’s investigational new drug (IND) application for the diabetes indication was accepted by the FDA and Repros is now looking to commence a phase II study in hypogonadal men with type II diabetes.

Our Take

We currently have a Zacks #3 Rank (short-term “Hold" rating) on Repros. Our short-term Hold rating is based on the company’s progress in moving Androxal into phase III development. We are also encouraged to see that the FDA is allowing the company to conduct an escalating dose study that will evaluate the safety and efficacy of Proellex, Repros’ second pipeline candidate. Proellex, which is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis, was placed under full clinical hold by the FDA.

Longer-term, we have an Underperform recommendation on Repros. We are concerned about the company’s financial position and believe the company will need to raise funds shortly in order to proceed with the development of its pipeline candidates. We believe Repros will seek a development partner for Androxal, which should bring in the necessary funds.