Healthcare Industry News: GENTAMICIN SURGICAL IMPLANT
News Release - April 26, 2006
Innocoll Announces Launch of a New Version of its CollaRx GENTAMICIN SURGICAL IMPLANT Specially Designed for Use in Cardiac SurgeryASHBURN, Va., and ATHLONE, Ireland, April 26 (HSMN NewsFeed) -- Innocoll, Inc. announced its sales and marketing subsidiary, Innocoll Pharmaceuticals Ltd., has launched a new version of its CollaRx GENTAMICIN SURGICAL IMPLANT that is specially designed for maximum convenience and ease of use in cardiac surgery.
Post-operative sternal wound infection is a serious, potentially life- threatening complication of cardiac surgery. It remains a major cause of morbidity and adds significantly to the length of a hospital stay and associated cost of care. A recently published clinical study involving 2000 patients undergoing a sternotomy during cardiac surgery has demonstrated that Innocoll's GENTAMICIN SURGICAL IMPLANT reduced the incidence of sternal wound infection (SWI) by 53% when used as an adjunct to standard infection prophylaxis (intravenously administered isoxazolyl-penicillin).
The LOGIP (Local Gentamicin for Sternal Wound Infection Prophylaxis) trial 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 SURGICAL IMPLANTS placed between the sternal halves before closure. Each implant was 10cm x 10cm in dimension and contained 130mg of gentamicin, corresponding to a total dose of 260mg. Immediately prior to placement between the sternal halves, the implants were cut to fit the dimensions of the sternum.
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 group patients having either diabetes or increased body mass index (BMI>25 kg/m squared) and representing 71% of the total study population showed a decrease in infections from 11.1% to 4.4%.
Of particular interest was the reduced risk of SWIs found in diabetic patients. For this group, representing 18% of the total study population, the incidence of infections decreased by 68% from 17.3% in the control group to 5.6% in the treatment group.
Based upon these findings, a health economic analysis was performed and published. This analysis demonstrated that routine prophylactic use of CollaRx GENTAMICIN SURGICAL IMPLANT in conjunction with systemic therapy reduced the number of SWI and produced a net saving per patient. This saving was most substantial for the diabetic subgroup.
As a direct result of the LOGIP trial and subsequent recommendation by Dr. Friberg, Innocoll has developed a new product size of the implant, which has the same surface area (100cm squared) and gentamicin dose (130mg), but with modified dimensions of 20cm x 5cm to better fit the sternum and hence more convenient to use.
Commenting on the launch and findings from the LOGIP trial, Dr. Michael Myers, President and CEO of Innocoll, Inc., said, "The prevalence of diabetes and its risk factors has become alarming. It is now the fourth leading cause of death in the world's most developed countries, and the incidence of the disease is expected to continue to increase at an astonishing rate. Of the approximate 2,000,000 patients undergoing cardiac surgery annually 25% are diabetic. This group is at higher risk for surgical complications including SWI. The Friberg study clearly demonstrates that our product significantly reduces the risk of a patient developing a sternal wound infection following cardiac surgery, the results being even more pronounced for high-risk, diabetic patients. We believe that the medical and economic benefits of our product are both important and significant."
Denise Carter, President of Innocoll Pharmaceuticals Ltd., stated, "Cardiac surgery represents a new surgical application for our product. We are planning an extensive marketing campaign around the launch of this new version as we introduce it throughout Europe via our direct sales force and through our various worldwide distribution partners."
About GENTAMICIN SURGICAL IMPLANT
GENTAMICIN SURGICAL IMPLANT is a biodegradable leave-behind implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin, and is indicated as an adjunct to systemic antibiotic therapy for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues. The product was developed using Innocoll's proprietary collagen-based technology, CollaRx(TM), and has been approved in over 50 countries. It is marketed under the following different trade names: (COLLATAMP® G, COLLATAMP® EG, SULMYCIN® IMPLANT, GARAMYCIN® SCHWAMM, DURACOL®, DURACOLL®, GENTACOL®, GENTACOLL®, GARACOL®, GARACOLL® and CRONOCOL®) in Europe, Central and South America, Middle East, Africa and Asia.
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(TM) and LiquiColl®. Innocoll, Inc. acquired the product rights for GENTAMICIN SURGICAL IMPLANT from Essex Chemis AG, an affiliated company of Schering-Plough Corporation (NYSE: SGP ) and has since assumed all sales, marketing and distribution activities for the product. For more information, please visit http://www.innocoll.com. For product or pipeline information, please visit http://www.innocoll-pharma.com.
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