Ventrus Biosciences (NASDAQ:VTUS) recently hired JP Benya as its new VP of Commercial Operations and Business Development, with the intent that Benya will play a significant role in preparing for the commercial launch of VEN-307. The company estimates that it could launch VEN-307, a treatment candidate for anal fissures (AF) in early 2014, if successfully developed. Notably, Benya is an industry veteran with a strong track record for commercializing drugs. He has been instrumental in launching and growing blockbuster therapies like Intron A. and Sanofi’s (NYSE:SNY) Ambien. After VTUS’ hemorrhoid treatment (VEN-309) failed in a Phase III clinical trial and the program was terminated in June, shares plummeted and have since been underpriced for a company that has a late-stage compound with one successful Phase III trial in hand. As VEN-307 advances toward approval, shares of VTUS are likely to increase in value and better reflect the opportunity for this asset. The company recently met with the FDA to discuss the VEN-307 data from its first Phase III trial, and while management has said that it won’t opine on how successful the meeting was, we view the hiring of a commercial officer as a good sign that the FDA discussions went well. The company plans to speak about the FDA meeting later this year, which could serve as a catalyst for the shares.
In May, the company reported that VEN-307 met primary and secondary endpoints in a Phase III trial for the treatment of AF. In the trial, the treatment demonstrated a statistically significant improvement in pain on defecation (POD) vs. placebo, with a favorable tolerability profile. Additionally, VEN-307 showed positive results in reducing average daily pain, as well as a shortening of the time for fissures to heal. VEN-307 is a topical formulation of diltiazem hydrochloride, which is commonly used as an oral vasodilator. Existing topical treatments for AF, cream-based nitroglycerin for example, can cause severe headaches, and VEN-307’s efficacy and benign safety and tolerability profile, make this potential treatment highly competitive.
Important to a development-stage biotech company, Ventrus has enough cash to continue operating through a second Phase III trial and FDA review of VEN-307 without the need to raise additional financing; the company completed an extensive capital raise in 2011. Ventrus also expects marketing expenses for VEN-307 to be relatively low given the unique concentrations of gastrointestinal specialists that would prescribe VEN-307, if approved. You can read our original report on this GI-focused company here, or read about some other plays in the field of gastrointestinal disorders here.
Head over to our Interviews section to see discussions with Biotech management and, more specifically, PropThink’s interview with Ventrus CEO Russel Ellison.