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Biotechs Target the GI Tract

This article was originally published in Start Up

Executive Summary

Regulatory risk and a mature market for some indications have driven Big Pharma players from the gastrointestinal space. That signals possible biotech opportunity. In this issue, we profile Alvine Pharmaceuticals, Genetic Analysis, Meritage Pharma and Ventrus Biosciences.

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Genetic Analysis AS

A number of diseases are associated with or influenced by imbalances in gut bacteria, including autism and GI disorders such as ulcers, Crohn's disease, inflammatory bowel disease, irritable bowel syndrome, colon cancer, and necrotizing enterocolitis in preterm infants. Many other conditions not obviously associated with the gastrointestinal tract also seem to be influenced by imbalance in the gut, such as allergies, eczema, depression and obesity. Genetic Analysis is developing the G-MAP, a microbiota array technology that analyzes and profiles the gut microflora and associates the resulting profile with various diseases.

Ventrus Biosciences Inc.

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 Inc.

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.

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