May 15, 2012
/PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced an agreement with UK-based Angel Biomedical Limited, a subsidiary of Angel Biotechnology Holdings plc (AIM: ABH), a global biopharmaceutical contract manufacturer, covering the manufacture of formulated collagen for Cardium's Excellagen® product, which was recently cleared for marketing by the U.S. Food and Drug Administration (FDA). Excellagen is a professional-use high molecular weight fibrillar bovine Type I topical gel (2.6%) specifically engineered as an adjunct to debridement for the management of diabetic foot ulcers and other dermal wounds.
In addition to the manufacturing of Excellagen's formulated collagen, Angel Biomedical Ltd will assist Cardium to facilitate filing for a CE Mark of Excellagen for marketing and sale in the European Union and in other countries recognizing CE Mark approval. Additionally, Angel Biomedical will assist Cardium in establishing its own Device Master File with the FDA's Center for Devices and Radiological Health covering the process for manufacturing the Company's Excellagen formulated fibrillar collagen gel.
"We are pleased to announce the agreement with Angel following Angel's recent asset purchase of our current collagen manufacturing facility located in
. This new agreement is a logical next step that provides for ongoing and future supply of the specialized formulated collagen used to support Excellagen's commercialization activities, and also positions Cardium for the planned expansion of Excellagen commercialization into European and other markets," stated
Christopher J. Reinhard
, Chairman and CEO of Cardium Therapeutics.
"The team at Angel is excited by this new partnership to provide Cardium's formulated high molecular weight collagen. We look forward to the commercial manufacture of Cardium's Excellagen advanced wound care product and to facilitate its CE marking to assist Cardium expand its global distribution opportunities," stated Dr.
, Acting Chief Executive Officer of Angel Biotechnology.
Excellagen is an FDA-cleared highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound care management. Excellagen's unique high molecular weight sterile collagen formulation is topically applied through easy-to-control, pre-filled, single use syringes. Excellagen is intended for physician use following surgical debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen's viscosity-optimized biocompatible gel formulation requires application at only one or two week intervals. It is recommended that Excellagen be applied following surgical debridement in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors.