AMRI announced today that its Burlington site was contracted by Cardium Therapeutics and its subsidiary, Tissue Repair Company (“Cardium”) 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. AMRI’s highly collaborative approach to technical transfer enabled Cardium to meet its commercial introduction timeline and overall business needs.
(Logo: http://photos.prnewswire.com/prnh/20120229/NY61160LOGO)
Excellagen is a new, FDA-cleared, highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound-care management. 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 CEO 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 continued, “Supporting the Excellagen commercial market entry 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.”
“We are pleased to have AMRI as the aseptic fill manufacturer of our Excellagen sterile easy-to-use, pre-filled syringes,” stated Christopher J. Reinhard, Chairman and CEO of Cardium. “We look forward to an ongoing and collaborative relationship with AMRI as we continue to introduce Excellagen to the U.S. market.”
AMRI’s commitment to quality has been enhanced by the recent addition of key personnel at the AMRI Burlington site, including the recent hire of Thomas McGrath, Director of Quality for Aseptic Services. In addition, AMRI SMARTSOURCING™, an approach to providing services to the pharmaceutical and biotechnology industries focused on better customer outcomes, reaffirms AMRI’s commitment to customer value and ensures customers will have access to high quality scientific performance and experienced project management with the accountability of delivering results in a cost-competitive manner at all stages of the product pipeline.
Let us hear your thoughts below.
