Healthcare Industry News:  GENTAMICIN SURGICAL IMPLANT 

Devices Regulatory

 News Release - August 8, 2007

Health Canada Approves Innocoll's CollaRx(R) GENTAMICIN SURGICAL IMPLANT

ASHBURN, Va., Aug. 8 (HSMN NewsFeed) -- Innocoll, Inc. announced its wholly- owned subsidiary, Innocoll Pharmaceuticals Ltd., has received a class IV medical device licence for its CollaRx® GENTAMICIN SURGICAL IMPLANT from the Canadian regulatory authority, Health Canada.

Innocoll's 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®, 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. It is currently in phase 3 clinical development in the US for the prevention of surgical site infections.

There are approximately 60 prospective clinical trials and published case reports which document the safety and efficacy of the GENTAMICIN SURGICAL IMPLANT 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 a 53% reduction in the incidence of sternal wound infection (SWI) 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 in infection from 17.3% in the control group to 5.6% in the treatment group for patients with diabetes. 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. From the findings of the LOGIP trial, a health economic analysis was performed and published, which concluded that routine prophylactic use of the Gentamicin Implant resulted in a net cost saving per patient.

This announcement follows an announcement earlier this year that Innocoll's German manufacturing subsidiary, Syntacoll GmbH, received Canadian Medical Device Conformity Assessment System (CMDCAS) certification awarded by the American division of TUV SUD Group. Having successfully obtained both the CMDCAS certification and the product licence, Innocoll is now in a position to commercialize its GENTAMICIN SURGICAL IMPLANT in Canada where it has been registered under the trade name, COLLATAMP G.

Commenting on the announcement, Dr. Michael Myers, President and CEO of Innocoll, Inc., said "We are delighted to receive Canadian approval for our lead product, the Gentamicin Implant, which we believe will be of benefit to the many patients undergoing surgeries in Canada that are at risk of post- operative infection. We are currently finalizing plans for early commercialization in Canada and anticipate the product will be available later this year."

About CollaRx®

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. This product has been approved in almost 50 countries in Europe, Latin America, Middle East, Africa and Asia and is marketed under the following trade names; COLLATAMP® G, COLLATAMP® EG, SULMYCIN® IMPLANT, GARAMYCIN® SCHWAMM, DURACOL®, DURACOLL®, GENTACOL®, GENTACOLL®, GARACOL®, GARACOLL®, and CRONOCOL®.

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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