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Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
Date:9/26/2007

ntamicin Topical

CollaRx GENTAMICIN TOPICAL is a biodegradable collagen-based dressing that delivers the broad-spectrum antibiotic, gentamicin, directly to the infected wound environment for localized action. The product is already approved and marketed in countries outside the US as GENTAMICIN SURGICAL IMPLANT where a number of published clinical case studies and anecdotal reports from clinicians have pointed to its effectiveness in the treatment of infected chronic wounds of various etiologies. Innocoll plans to develop the topical indication for the global market. Initially the product will be investigated for the treatment of diabetic foot infections across the full range of severities in a series of phase 2 trials and has appointed the full-service Clinical Research Organization, Premier Research Group, to co-ordinate these studies. The lead indication is the treatment of diabetic ulcers having a mild infection where the safety and efficacy of CollaRx GENTAMICIN TOPICAL will be compared to an orally administered antibiotic. In subsequent phase 2 trials, Innocoll will investigate the product as an adjunct to systemic antibiotic therapy for treating diabetic foot infections of higher severity and also as a method to prevent diabetic ulcers from becoming clinically infected.

Currently, there are no topically applied antibiotics marketed in the US that are specifically indicated for the treatment of infected diabetic foot ulcers and recent market research independently performed by L.E.K. Consulting forecast peak annual revenues for CollaRx GENTAMICIN TOPICAL approaching US$270 million, when limiting the sales projections to diabetic foot indications only.

About Bupivacaine Surgical Implant

BUPIVACAINE SURGICAL IMPLANT is a biodegradable and fully bioresorbable matrix of purified fibrillar collagen impregnated with the local anesthetic, bupivacaine. It has been specifically developed and formulated using Innocoll's proprietary CollaRx sponge
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SOURCE Innocoll, Inc.
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