Close to three years ago, Clarus Therapeutics pulled its bid to mount an $86 million IPO, bowing to the chilly markets freezing out most biotechs at the time. But now Clarus, which has been moving ahead with venture cash from the likes of Thomas McNerney and H.I.G. BioVentures, has brushed off its IPO pitch designed to back the launch of a new drug for low testosterone which is now under regulatory review.
Back in 2011, Clarus was boasting that it was one short step away from completing a late-stage study on its lead therapy for low testosterone. Now its IPO states that its drug, Rextoro, has run the gamut on two Phase III studies and was submitted to the FDA in January. But it still faces what could be a grueling review of safety issues as the FDA grows increasingly alarmed about the potential safety risks associated with low-testosterone therapies.
Low testosterone--or hypogonadism--has become a hot field in medicine, driven by the growing ranks of aging men suffering from a natural weakening process. It's also a well-served field, with a number of existing therapies to pick from. That's something that Clarus CEO Robert Dudley, who has the development of the AndroGel topical formulation on his resume, understands well. This new drug from Clarus is an oral therapy which could help circumvent some of the common problems associated with a gel, provided it's approved, including accidental exposure to women and children.
"Only 31% and 14% of men continued taking T-gels six and twelve months, respectively, after commencing therapy, according to a peer-reviewed study of more than 15,000 men with T deficiency," states the new Clarus IPO. "We believe these low adherence rates result from inconvenient application and safety concerns about T-gels. In addition, T-gels carry a "black box warning" because of their risk of unsafe transference of T to children."
On the other hand, Clarus also notes that it has already run a Phase IV trial of its drug to evaluate potential safety issues. The agency has grown increasingly leery of the risk of stroke, heart attack and death in men taking these drugs, and Clarus notes that there were four serious cardiovascular incidents in their clinical studies, including two heart attacks.
Clarus's PDUFA date is November 3. Before then, the Chicago-area biotech plans to use its IPO cash to start building a commercial operation that can launch the first product in a portfolio of men's health products. But it faces a lukewarm market among biotech investors, who appear to be flagging after a long, frenzied IPO boom.
- here's the S-1