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

ual sales of approximately $800 million in the US alone."

About Gentamicin Surgical Implant

GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It was developed using Innocoll's proprietary collagen-based technology, CollaRx(R), and is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) at the target tissue while maintaining low systemic levels well below the toxicity threshold. The product is indicated as an adjunct to systemic antibiotic therapy for the prevention of surgical site infections and for the treatment of deep, localized infections in both hard and soft tissues. There are more than 60 prospective clinical trials and published case reports totalling over 7,500 patients documenting safety and efficacy over a broad range of orthopaedic, colorectal, cardiothoracic, vascular, and neurosurgical procedures. The product is already approved in 49 countries spanning Europe, Latin America, Middle East, Africa and Asia and is marketed by EUSA Pharma under the following trade names; COLLATAMP(R) G, COLLATAMP(R) EG, SULMYCIN(R) IMPLANT, GARAMYCIN(R) SCHWAMM, DURACOL(R), DURACOLL(R), GENTACOL(R), GENTACOLL(R), GARACOL(R), GARACOLL(R) and CRONOCOL(R).

GENTAMICIN SURGICAL IMPLANT is under development in the US for the prevention of surgical site infections. An IND has been approved by the FDA and Innocoll plans to conduct two US multi-centered phase 3 clinical trials; one in cardiac surgery patients at higher risk of surgical site infection and the other in patients undergoing open colorectal surgery. Innocoll has appointed Duke University's Duke Clinical Research Institute (DCRI) as the Study Co-ordinating Center for both trials. Independent market research recently performed by L.E.K. Consulting projected peak US sales of greater than US$200 million per annum.

About CollaRx(R) Ge
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SOURCE Innocoll, Inc.
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