Earlier this morning, Cardium Therapeutics announced that it has signed an agreement with Advanced Biosciences Research, an affiliate of bioRASI, for the planned commercialization of Cardium’s professional-use Excellagen® topical wound care management product in Russia and the nine additional member countries comprising the Commonwealth of Independent States (CIS). According to today’s press release, bioRASI will be responsible for the registration and approval for the marketing and sales of Excellagen in the Russian Federation, and will assist Cardium to develop an infrastructure plan for the marketing, sales, and distribution of Excellagen in Russia and the CIS following final market approval.
“We are pleased to broaden our relationship with bioRASI, the sponsor and development partner responsible for the management and regulatory compliance of our Generx® DNA-based cardiovascular angiogenic biologic Phase 3 / registration study for the treatment of patients with myocardial ischemia due to coronary disease which is currently underway in Russia,” commented Christopher J. Reinhard, Chairman and CEO of Cardium Therapeutics. “We recently announced plans for the expansion of Excellagen into the European Union consisting of 27 member countries through the CE Mark registration process and a marketing and distribution agreement with BL&H Co. for South Korea. The Russian market represents another important step forward in our international commercialization strategy for Excellagen.”
bioRASI is a full-service, global contract research organization (CRO) that provides clinical development to optimize its sponsors scientific, clinical, and business results. bioRASI facilitates obtaining drugs, biotherapeutics, and medical devices marketing approvals by delivering high quality regulatory and clinical strategies, solutions, and services. The company’s access to the largest facilities and patient populations all over the world saves their clients critical time. bioRASI’s services include program optimization, project management, regulatory, clinical, data management and analysis, compliance, and audit.
Excellagen is an FDA-cleared highly-refined formulated fibrillar collagen-based topical gel (2.6%) engineered for debridement and platelet activation and to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic ulcers and other dermal wounds. Excellagen’s unique high molecular weight sterile collagen formulation is topically applied through easy-to-control, pre-filled, single use syringes and its viscosity-optimized biocompatible gel formulation requires application at only one or two week intervals. Excellagen is intended for physician use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Following FDA clearance, Cardium conducted additional studies showing that Excellagen can activate human platelets to trigger the release of Platelet-Derived Growth Factor (PDGF), which is recognized as an important wound healing facilitator.
Cardium’s market research indicates that physicians seek easy-to-use products to reduce preparation time and facilitate product application. Excellagen’s unique, ready-to-use syringe-based collagen gel requires no thawing or mixing. Because of its specialized formulation, only a thin layer needs to be applied over the wound area, and one syringe containing 0.5 cc of Excellagen covers wounds up to 5cm(2) in size using the supplied 24-gauge sterile, single-use flexible applicator tip. To learn more about new Excellagen, visit Cardium’s website at www.CardiumTHX.com
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