Virgin Trains USA Inc. (VTUS)

Description:

Ventrus biosciences inc were incorporated in Delaware in October 2005 under the name South Island Biosciences, Inc. and changed name to Ventrus Biosciences, Inc. in April 2007. The company is a development stage specialty pharmaceutical company currently focused on the development of late-stage prescription drugs for gastrointestinal disorders, specifically hemorrhoidal disease, anal fissures and fecal incontinence. Its lead product VEN 309 (iferanserin) is a new chemical entity, or NCE, for the topical treatment of symptomatic internal hemorrhoids. In seven clinical studies between 1993 and 2003 involving 359 patients, VEN 309 demonstrated good tolerability and no severe adverse events, and statistically significant improvements in bleeding, itchiness and pain. Beginning in 2008, the company has had extensive discussions with the FDA under a Special Protocol Assessment, or SPA, process, for its first pivotal U.S. trial of VEN 309 for the treatment of symptomatic internal hemorrhoids. Its additional product candidate portfolio consists of two in-licensed late-stage drugs. VEN 307 (diltiazem) is intended to treat pain associated with anal fissures and VEN 308 (phenylephrine) is intended to treat fecal incontinence. These candidates are two molecules that were previously approved and are currently marketed for other indications and that have been formulated into its proprietary topical treatments for these new gastrointestinal indications. Its objective is to develop and commercialize differentiated products to address unmet medical needs of the lower gastrointestinal tract. The company is developing its product candidates to treat hemorrhoids, anal fissures and fecal incontinence. Currently, there are no FDA-approved prescription drugs in the U.S. for the treatment of hemorrhoids. One product (Rectiv, a topical nitroglycerin) was approved by the FDA in June 2011 and it expects this product to be launched by Aptalis in 2012. There are no FDA-approved prescription drugs for the treatment of incontinence, but Solesta, a hyaluronic acid dermal filler, was approved as a device by the FDA in 2011 for intra-anal injection for fecal incontinence. The company expects Salix Pharmaceuticals to launch this product in 2012.The production, distribution, and marketing of products employing its technology, and its development activities, is subject to extensive governmental regulation in the U.S. and in other countries.