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news.Tissue Repair Company, a wholly-owned subsidiary of Cardium Therapeutics, has entered into a multi-year supply agreement with Devro Medical, part of Scotland-based Devro plc, for the supply of highly-refined fibrillar bovine Type I collagen, an important component of Cardium's new Excellagen formulated collagen product candidate, which is pending FDA 510(k) clearance.
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Excellagen is a fibrillar bovine Type I collagen-based topical gel (2.6% collagen concentration) that is formulated to include structural stabilizers, hydrolytic enzyme inhibitors, and bacteriostatic agents.
Cardium said that, based on the 510(k) FDA submission, Excellagen will be indicated for the management of wounds, including partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers and certain other wounds, such as surgical and trauma wounds.
Excellagen’s initial marketing focus will be directed to the care of diabetic ulcers based on experience and clinical findings from the Matrix Study.
Under this supply agreement, the collagen component of Excellagen will be manufactured at Devro’s new cGMP manufacturing facility which is currently undergoing final process validation activities and awaiting a formal accreditation audit for ISO certifications.
Devro also plans to establish a Device Master File with the FDA following completion of ISO certifications of other component manufacturing processes.
In addition, Cardium has also entered into a clinical manufacturing and supply agreement with its US-based fill and finish contract manufacturer to provide final processing and assembly of the market ready Excellagen product.
Christopher Reinhard, chairman and CEO of Cardium, said: “After a detailed review of potential commercial suppliers of medical-grade collagen fiber formulations for our Excellagen product candidate, we believe that Devro Medical is uniquely qualified to ensure a timely supply of highly-refined material of a quality and consistency designed for use in treating diabetic wounds and other important medical applications.”
“With our commercial supplier now in place, we expect to have market-ready material finalized and tested within the next quarter so that we can be in position for final FDA clearance and commercial launch. In parallel, we are now initiating activities associated with launch, including packaging and other final product requirements, and are in discussions with potential commercialization partners for the marketing and sale of Excellagen in the US and internationally.”