Ventrus Biosciences (NASDAQ: VTUS, StockTwits: $VTUS), a company specializing in developing and bringing late-stage prescription drugs to market, with a focus on drugs for gastrointestinal disorders, may get a boost from challenges faced and recently overcome by competitor Uroplasty Inc. (NSDQ: UPI). Uroplasty had fought a lengthy battle to secure third-party reimbursement from regional HMO, PPO, and Medicare insurers, which it recently won.
Though the Uroplasty struggle was over its device for urinary incontinence, instead of fecal incontinence control like Ventrus’ product line, it brings to the forefront the importance of coverage for both. In addition, Uroplasty has just indicated its intent to enter the fecal incontinence arena at the FDA level and received notification that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) issued guidance on percutaneous tibial nerve stimulation (PTNS) for the treatment of fecal incontinence.
There is, however, a key difference between the two companies’ approaches to treating incontinence. Uroplasty’s UrgentPC urinary incontinence device is just that- a device- while the Ventrus approach is topical drug-based indication.
The Uroplasty UrgentPC delivers an electrical stimulus to the posterior tibial nerve, a nerve trunk running mainly along the back of the leg down behind the medial ankle. This means ‘batteries required’ and wearing a device which some users may find uncomfortable. It appears that Uroplasty intends to use a similar approach for fecal incontinence.
While the Ventrus’ first-in-class, drug-based method avoids these issues, this is not a debate over one product being superior to the other. It is notable that Uroplasty is bringing fecal incontinence into the spotlight with third-party reimbursers, a fact that can only strengthen Ventrus’ hand in dealing with them too upon Ventrus’ therapies making it to market.
Ventrus currently has three important FDA-pipelined candidate drugs to treat fecal incontinence, anal fissures, and hemorrhoids. The company notes on its website that at present there are “no approved prescription treatments for these conditions”. It also points out that a major market exists to treat them, citing 2004 data showing that there were 3.2 million clinical visits for hemorrhoid complaints ranging from bleeds to itching to pain, an estimated 12.5 million Americans afflicted by hemorrhoids, seven million by fecal incontinence, and more than four million by anal fissures. The drug most commonly used for some of these problems is Salix’ brand Anusol cream, which Ventrus describes as “having limited clinical benefits”. The company estimates a revenue stream from this, for it and partner S.L.A. Pharma AG, at about $563 million per month, based on a monthly population of 750,000 patients.