Healthcare Industry News:  CollaRx 

Devices Regulatory

 News Release - March 22, 2007

Innocoll Files CollaRx(R) GENTAMICIN SURGICAL IMPLANT in Canada and Receives Canadian Medical Devices Conformity Assessment System (CMDCAS) Certification

ASHBURN, Va., March 22 (HSMN NewsFeed) -- Innocoll, Inc. announced its German manufacturing subsidiary, Syntacoll GmbH, has received Canadian Medical Devices Conformity Assessment System (CMDCAS) certification for its ISO 13485:2003 Quality System as awarded by the American division of TUV SUD Group. Upon receipt of the CMDCAS accreditation certificate, Innocoll Pharmaceuticals Ltd., the sales and marketing subsidiary of Innocoll, Inc, submitted a class IV medical device application for its CollaRx® GENTAMICIN SURGICAL IMPLANT to the Canadian regulatory authority, Health Canada.

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. 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® G, COLLATAMP® EG, SULMYCIN® IMPLANT, GARAMYCIN® SCHWAMM, DURACOL®, DURACOLL®, GENTACOL®, GENTACOLL®, GARACOL®, GARACOLL® and CRONOCOL®.

Commenting on the announcement, Dr. Michael Myers, President and CEO of Innocoll, Inc., said, "Achieving CMDCAS accreditation is a further endorsement of Innocoll's manufacturing capabilities and approach to quality management. This has enabled us to move forward with the registration and commercialization of our lead product in Canada, the eighth largest and fourth fastest growing pharmaceutical market in the world. We plan to appoint a local marketing and distribution partner and anticipate launching later this year."

About CollaRx®

CollaRx is Innocoll's lead collagen-based drug delivery platform for the site specific targeted delivery of a wide variety of medicines with particular emphasis on antibiotics and anesthetics. The CollaRx technology also forms the basis of Innocoll Pharmaceuticals' 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® 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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