ASHBURN, Va., April 11 /PRNewswire/ -- Innocoll, Inc. announced its wholly-owned subsidiary, Innocoll Pharmaceuticals Ltd., has submitted a class III medical device application for its CollaRx(R) GENTAMICIN SURGICAL IMPLANT to the Australian Therapeutics Goods Administration (TGA).
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 has been approved in 49 countries as either a medicinal product for the treatment and prevention of surgical site infections or as a medical device. There are more than 50 prospective clinical trials and published case reports which document the safety and efficacy of the product over a broad variety of orthopaedic, abdominal, colorectal, cardiothoracic, vascular and neurosurgical procedures totaling over 7,500 patients. It 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).
According to the National Surveillance of Healthcare Associated Infection in Australia (2001), it was estimated that surgical site infections occur in 2% to 13% of patients, depending on the type of surgery, and representing an annual healthcare burden of AU$268 million (US$220 million).
Commenting on the announcement, Dr. Michael Myers, President and CEO of Innocoll, Inc., said "The official estimates of costs associated with the treatment of surgical site infections are quite staggering, even for a country like Australia with a population of only 20 million. We further believe that official estimates of infection rates grossly underestimate the true extent of the problem when patients are properly followed in well-controlled trials. Our product is clinically proven to prevent such infections. This filing in Australia follows hot on the heels of our recent Canadian submission and shows our commitment to growing the worldwide sales of our leading Gentamicin Implant through launches in new international markets and appointment of local distribution partners."
About CollaRx(R)CollaRx is Innocoll's lead technology platform for the site specific targeted delivery of a wide variety of drugs with particular emphasis on antibiotics and anesthetics. The CollaRx technology also forms the basis of Innocoll's lead product, Gentamicin Surgical Implant, a biodegradable leave- behind implant indicated for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues.
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, +353 (0) 906634902, mclancy@innocoll-tech.com
Web site: http://www.innocollinc.com/
