ASHBURN, Va., Feb. 19 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that the second of two phase 3 clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies Ltd, to investigate CollaRx(R) GENTAMICIN SURGICAL IMPLANT for the prevention of surgical site infections, has commenced dosing.
GENTAMICIN SURGICAL IMPLANT is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It is designed to provide a high concentration of gentamicin (which has a concentration-dependent mechanism of action) directly to the target tissue for localized action, while maintaining low systemic levels well below the toxicity threshold. The product was developed using Innocoll's proprietary collagen-based drug delivery technology, CollaRx, and (outside of the US) is indicated as an adjunct to systemic antibiotic therapy for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues. GENTAMICIN SURGICAL IMPLANT is already approved in 49 countries spanning Europe, Latin America, Middle East, Africa and Asia and there are more than 60 prospective clinical trials and published case reports totaling over 7,500 patients documenting its safety and efficacy over a broad range of orthopedic, colorectal, cardiothoracic, vascular, and neurosurgical procedures.
According to advice from FDA received at both pre-IND and post-IND meetings held in 2007, Innocoll will conduct two multi-centered phase 3 clinical trials in the US to support the planned New Drug Application (NDA). The first trial in cardiac surgery patients at higher risk of surgical site infection commenced in December 2007. The second trial, which has now enrolled its first patient, is in general surgery patients undergoing open colorectal surgery. Innocoll has appointed Duke University's Duke Clinical Research Institute (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 a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). Innocoll 's lead product, Gentamicin Surgical Implant for the treatment and prevention of surgical site infections, is approved for sale in 49 countries in Europe, Latin America, Middle East, Africa and Asia and is marketed 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). In 2005, Innocoll acquired the worldwide marketing rights for this product from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP) and in August 2007 sold its marketing rights, with the exception of the US, to EUSA Pharma. Gentamicin Surgical Implant is currently in phase 3 development in the US for the prevention of surgical site infections. Other late stage pharmaceutical products in Innocoll's development pipeline include CollaRx Gentamicin Topical for the treatment and prevention of infected diabetic foot ulcers and CollaRx Bupivacaine Implant for the management of post-operative pain, both of which are currently in Phase 2 development. For more information, please visit http://www.innocollinc.com.
|SOURCE Innocoll, Inc.|
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