Healthcare Industry News:  GENTAMICIN SURGICAL IMPLANT 

Devices Surgery Regulatory

 News Release - February 5, 2007

Innocoll Receives BfArM Approval for a New Version of its CollaRx(R) Gentamicin Surgical Implant in Germany

ASHBURN, Va., and ATHLONE, Ireland, Feb. 5 (HSMN NewsFeed) -- Innocoll, Inc. announced its sales and marketing subsidiary, Innocoll Pharmaceuticals Ltd., has received approval from The Federal Institute for Drugs and Medical Devices (BfArM) for marketing a new version of its CollaRx® GENTAMICIN SURGICAL IMPLANT in Germany, where it is sold under the trade name Sulmycin® Implant E.

Previously available in 10cm x 10cm and 5cm x 5cm sizes, the new version of Sulmycin Implant E is 20cm x 5cm in dimension, and is the only product of its type available in this size. Innocoll developed the new size to provide optimal flexibility to the surgeon as the product is used across a broad range of surgical specialties.

Innocoll's GENTAMICIN SURGICAL IMPLANT was the first gentamicin-collagen sponge on the market and is the only such product approved as a medicinal (drug) product in the world. 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 totalling over 7,500 patients.

One such clinical trial (known at the Local Gentamcin Infection Prophylaxis or LOGIP trial) involving 2,000 patients undergoing a full median sternotomy during cardiac surgery 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). 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.

The LOGIP trial was a prospective, randomized, controlled clinical trial performed at two hospital centers in Sweden and led by Dr. Organ 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 contained 130mg of gentamicin, corresponding to a total dose of 260mg. 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 a body mass index more than 25 kg/m squared (the WHO definition of overweight) 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 GENTAMICIN SURGICAL IMPLANT as an adjunct to systemic antibiotic therapy reduced the number of SWIs and produced a net saving per patient. This saving was most substantial for the diabetic subgroup.

Commenting on the approval, Dr. Michael Myers, President and CEO of Innocoll, Inc., said "There is a substantial body of compelling evidence showing that our product can significantly reduce post-operative surgical site infections in open heart as well as many other surgical procedures, especially for those patients at increased risk. Surgical site infection can be a severe and potentially devastating complication after surgery and we believe that the medical and economic benefits of our product are both important and significant."

Denise Carter, President of Innocoll Pharmaceuticals Ltd., added "Germany is a key market for us. The product was first invented and developed in Germany and continues to be manufactured at our production plant in Bavaria. We are pleased to have received our first drug approval for the new product size in Germany, and we look forward to subsequent drug approvals in other European countries."

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®, and has been approved in 49 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® 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 www.innocoll.com.


Source: Innocoll

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