ASHBURN, Va., April 24 /PRNewswire/ -- Innocoll, Inc., a privately-held specialty pharmaceutical company, announced that following a pre-Investigational New Drug (IND) application meeting, the U.S. Food and Drug Administration (FDA) has accepted Innocoll’s proposal to commence the development of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT in the U.S. at phase 3. In consideration of the positive outcome to this meeting, Innocoll plans to file an IND within the second quarter 2007 for the target indication of prevention of surgical site infection in patients undergoing open chest or abdominal surgery as an adjunct to standard infection prophylaxis.
Innocoll has appointed Duke University’s Duke Clinical Research Institute (DCRI) as the Study Coordinating Center for two planned U.S. multi-centered phase 3 clinical trials in open heart and colorectal surgeries. The design of the first of these two trials in patients undergoing open heart surgery will be based upon a recently published 2,000 patient clinical trial demonstrating that Innocoll’s Gentamicin Implant reduced the incidence of sternal wound infection (SWI) by 53% when used as an adjunct to standard infection prophylaxis. This was a prospective, randomized, controlled clinical study performed at two hospital centers in Sweden and led by Dr. Orjan Friberg, Cardiothoracic Surgeon at Orebro University Hospital. Patients in the treatment group had two Gentamicin Implants (260 mg total dose) placed between the sternal halves before closure. The primary endpoint (total incidence of SWIs after 2 months post-surgery) was 9.0% in the control group and 4.3% in the treatment group (p<0.001). Sub-population analysis of known high-risk groups showed even greater treatment effect, including a 68% reduction from 17.3% in the control group to 5.6% in the treatment group for patients with diabetes. Using the data generated in this cardiac surgery trial, a health economic analysis was performed and published showing that routine prophylactic use of the Gentamicin Implant resulted in a net cost saving per patient.
According to the latest (2005) 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. The same official report states that “surgery performed on the large and small intestines represented the largest percentage of surgical site infections at 9.0% followed closely by surgery for blockages in blood vessels, including blood vessels of the heart, which accounted for 8.9%".
Dr. Michael Myers, Innocoll’s President and CEO commented “We are pleased that the Agency shares our opinion that there is adequate safety and efficacy data gathered outside of the U.S. to open the IND for the Gentamicin Implant at phase 3. Combating the growing and costly problem of surgical site infections is a poorly met medical need in the U.S. and represents a significant commercial opportunity. We are committed to filing the IND this quarter and targeting NDA submission in 2008. Taken together with our two INDs that are already approved for the topical use of our Gentamicin product in the treatment of infected diabetic foot ulcers and for our Bupivacaine Implant in the management of post-operative pain, we have established a firm foundation for the long-term, sustainable growth of the business.”
About CollaRx(R) GENTAMICIN SURGICAL IMPLANT
GENTAMICIN SURGICAL IMPLANT is a biodegradable leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. The product was developed using Innocoll’s proprietary collagen- based technology, CollaRx(R), and is indicated for the treatment and prevention of post-operative acquired infections in both hard and soft tissues. There are more than 50 prospective clinical trials and published case reports totalling over 7,500 patients that document the safety and efficacy across a broad variety of orthopaedic, abdominal, colorectal, cardiothoracic, vascular, and neurosurgical procedures. The product has been approved in 49 countries and is currently marketed in Europe, Latin America, Middle East, Africa and Asia 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).
About Innocoll, Inc.
Innocoll is a privately held, fully integrated, global, hospital specialty pharmaceutical company specializing in surgical and dermatological products. It develops and markets internationally a range of medical products using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). Innocoll, Inc. acquired the product rights for Gentamicin Surgical Implant from Essex Chemis AG, an affiliated company of Schering-Plough Corporation and has since assumed all sales, marketing and distribution activities for the product. For more information, please visit www.innocoll.com.
Innocoll, Inc.
CONTACT: Martha Clancy, Corporate Communications Officer, Innocoll, Inc.,+353 (0) 906 634902, mclancy@innocoll-tech.com
Web site: http://www.innocollinc.com/
