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AMRI To Fill Excellagen for Cardium

Burlington site to handle sterile pre-filled syringes

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Cardium Therapeutics and its subsidiary, Tissue Repair Company have contracted Burlington, MA site of AMRI to manufacture sterile pre-filled syringes in support of the U.S. introduction of Excellagen, a professional-use, formulated collagen-based product for the management of diabetic foot ulcers, pressure ulcers and other dermal wounds.

Excellagen is a highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound-care management. According to a Cardium statement, “Its unique high molecular weight bovine Type I collagen formulation is topically applied through easy-to-control, pre-filled, single use syringes.” Excellagen is intended for physician use following debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen was introduced to the U.S. market by Cardium Therapeutics on March 30, 2012.

“We are pleased to be supporting Cardium’s U.S. marketing introduction of Excellagen,” said Thomas E. D’Ambra, Ph.D., chairman, president and chief executive officer of AMRI. “As a growing number of healthcare companies like Cardium face technically rigorous product manufacturing needs, we believe they will look to AMRI given our enhanced quality, proven experience, and scientific excellence to successfully address these challenges and ensure the highest manufacturing standards. We congratulate Cardium on the commercialization of Excellagen, a product that will address an unmet market need and provide a benefit to a growing patient population.”

Dr. D’Ambra noted that the Excellagen launch “is a good illustration of further opportunities ahead and a validation of the market potential for AMRI’s participation in the aseptic dosage form business.”

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