Like other start-up companies working to develop drugs for GI disorders, Ventrus Biosciences was attracted to the sector not only by unmet clinical needs and the focused sales opportunities, but also by the potential for creating a cross-over success: a drug that launches as a prescription product but eventually leaps over the counter to become a blockbuster, á la Claritin. Ventrus has two drug candidates ready for Phase III testing: a topical gel formulation of diltiazem, a generic vasodilator, as a treatment for anal fissures, and a novel compound it hopes will become the first new product approved for hemorrhoids in 30 years.

Meritage Pharma was built by serial biotech entrepreneur Cam Garner around a viscous formulation of budesonide designed to coat the inflamed throat. It is now in Phase II trials for an orphan indication, pediatric eosinophilic esophagitis, an inflammation of the esophagus that appears to be triggered by allergies. Meritage's decision to reformulate a compound with a well-established safety record is, like the choice to pursue an orphan drug designation, a risk- and cost-reducing maneuver that has helped other biotech companies achieve success.

Alvine Pharmaceuticals aims to treat celiac disease-a common hereditary autoimmune disorder in which the intestinal lining reacts to wheat, barley or rye gluten, leading to pain, bloating, and damage to the gut--with an orally available drug meant to degrade gluten in the stomach into peptide fragments too small to stimulate an immune response. Generally, antigens need to be at least nine amino acids long to rouse an immune response, but Alvine expects its lead compound to chop up gluten into peptide fragments a third that size or smaller.