Repros ($RPRX) has again swung southward in its up-and-down development of the testosterone drug Androxal, pushing back its proposed NDA filing and revealing that the FDA is taking a hard look at its Phase III results, news that hammered its shares by about 30%.
The company is now targeting the third or fourth quarter of next year for an NDA submission, walking back its earlier plan to file for approval by mid-2014 as it deals with regulatory uncertainty over Androxal. The drug, a testosterone-replacement pill designed to treat secondary hypogonadism without harming sperm count, has had a roller coaster trip through mid- and late-stage trials, dragging Repros' stock to peaks and nadirs since 2009.
Now, in a fairly byzantine release, Repros explains that the FDA has taken issue with its two pivotal studies, ZA-301 and ZA-302, and the agency wants to discuss whether the company should include men referred from a fertility clinic in its final analysis of whether Androxal beat out placebo in maintaining healthy sperm counts.
If the FDA tosses those patients, ZA-301's endpoint-meeting results could be put in jeopardy, and Repros' special protocol assessment requires it to pass both pivotal trials to merit approval. The agency is willing to consider different sperm-count endpoints than those initially set forth, the company said, but it would demand new prospective studies before doing so, which would likely push back an NDA even further.
But at least one aspect of the delay could work in Repros' favor, the company said, as the FDA has agreed to let it study Androxal head-to-head against approved testosterone replacement therapies, and, if the drug outperforms its would-be rivals, Repros can slap that on its label. The company is finalizing two such study designs, figuring it can wrap them up and deliver results to the agency by the fourth quarter of next year.
Of course, none of that will matter much if the FDA throws out a chunk of Repros' pivotal data and forces it to start all over again, and the Wall Street response to Androxal's latest hurdle could mean investors are running out of patience for a drug that has already endured falsified clinical data, last-minute changes of plans and a patent dispute.
- read Repros' statement