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Innocoll Announces Dosing of First Patient in Second US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections
Date:2/19/2008

ute (DCRI) as the Study Coordinating Center for both trials. Approximately 50 sites will be recruited for the trial in patients undergoing cardiac surgery and 35 sites for the colorectal surgery trial.

Open colorectal surgery is widely considered to be the most prone to surgical site infection and the design of the trial is based upon an approved and well established use of GENTAMICIN SURGICAL IMPLANT for this indication in Europe. The results of several such studies have been published, including one prospective, randomized, controlled clinical trial in 221 patients which demonstrated a 70% decrease in surgical site infections from 18.4% in the control group to 5.6% in the patients treated with the implant.

According to the latest statistics published by the Pennsylvania Health Care Cost Containment Council (PHC4), one of the few U.S. States mandated to collect such data, patients that contracted a surgical site infection spent an average of 14.5 days in hospital at an average hospital charge of $132,110 compared to 4.7 days and $33,267 for patients that had no hospital-acquired infection. Independent market research recently performed by L.E.K. Consulting has conservatively projected peak US sales of GENTAMICIN SURGICAL IMPLANT to be greater than US$200 million per annum.

Dr. Michael Myers, Innocoll's President and CEO commented, "As an already approved product in Europe and elsewhere with proven safety, efficacy and pharmacoeconomics, we believe that the development of our Gentamicin Implant for the US market represents an excellent commercial opportunity and value proposition for our shareholders. With the commencement of this second phase 3 trial, our sights are now well and truly set on NDA filing once these trials are complete."

About Innocoll, Inc.

Innocoll is a privately held, specialty pharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. It develops and manufactures
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SOURCE Innocoll, Inc.
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1. Innocoll Announces Dosing of First Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-operative Pain
2. Innocoll Announces Dosing of First Patient in US Phase 3 Clinical Trial to Investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the Prevention of Surgical Site Infections in Cardiac Surgery Patients
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