BioWorld Today Assistant Managing Editor

Ventrus Biosciences Inc., a year-old start-up firm founded by Paramount Biosciences to focus on late-stage opportunities in the gastroenterology space, recently introduced itself with the in-licensing of its third compound, a topical ointment for hemorrhoids.

The Greenwood Village, Colo.-based company had "maintained a modest profile during its initial in-licensing and development activities," said President and CEO Thomas Rowland, who heads the firm's three-person executive team, which includes Chief Medical Officer Terrance Coyne and Vice President of Clinical Operations John Dietrich, and together they bring "more than 50 years of collective drug industry experience."

Ventrus also gets infrastructure support and received some of its early funding from Paramount, an investment firm with a reputation for starting firms from scratch. To date, more than 40 start-ups have emerged from the Paramount model, including two West Coast firms, Pacific Beach Biosciences Inc., which focuses on anti-infectives, and cancer drug company Coronado Biosciences Inc., both of which were formed in the last couple of years.

Ventrus is targeting the gastroenterology space — in fact, its name comes from the Latin word for stomach — and its focus is late-stage development and commercialization of in-licensed gastrointestinal assets, Rowland said.

The company brought in the most recent addition to its pipeline earlier this week, picking up worldwide rights to a new chemical entity, designated VEN309, from Sam Amer & Co. in exchange for undisclosed up-front, milestone and royalty payments. VEN309, a topical gel, is designed to inhibit venous constriction and platelet aggregation while providing local anesthetic activity to treat hemorrhoids.

Rather than simply treating the symptoms, VEN309 aims to treat the underlying cause of hemorrhoids, a condition that affects about 13 million people in the U.S. The drug will be entering Phase III shortly, Rowland said, and "we currently expect to finish clinical trials" and submit a new drug application by 2011.

"There's been no new product [for hemorrhoids] in more than 30 years," he told BioWorld Today. "So we have the opportunity to bring an innovative and novel product into a large market."

It's Ventrus' goal to address those types of large, unmet medical needs, and "it's unique for a company to start out with this level of advanced pipeline," Rowland said.

The company's portfolio also includes VEN307, its most advanced product, which is set to start Phase III testing for anal fissures. That product is a topical formulation of diltiazem, a calcium channel blocker approved in an oral form to treat hypertension. A third product, VEN308, a topical form of phenylephrine, which is approved as an oral treatment for nasal decongestion, has completed proof of concept in fecal incontinence and is set to start dose-ranging studies.

Both of those programs first emerged from discoveries at St. Mark's Hospital and Research Institute in London, which "looked at gastroenterology uses of those drugs and found that they had a therapeutic effect," Rowland said. S.L.A Pharma AG, a privately held UK firm that "specializes in taking academic ideas into commercial development," then licensed rights to those products to Ventrus.

"What S.L.A. has done is taken these oral products and [reformulated them] for topical use," Rowland said, adding that both VEN307 and VEN308 are expected to advance on the 505(b)(2) regulatory pathway.

Over the next year, Ventrus plans to get all its planned trials "up and running," he said. After that, "we expect to start reporting Phase III data."

Pending positive results, Ventrus anticipates filing NDAs for VEN307, VEN309 and VEN308 in 2010, 2011 and 2012, respectively.