Cardium Therapeutics today announced that it has entered into its first international agreement for the commercialization of Excellagen™ in the South Korean market. Cardium entered into a marketing and distribution agreement with BL&H Co. Ltd., an established pharmaceutical company based in Korea, for the commercialization of Excellagen Formulated Fibrillar Collagen Gel in the South Korean market under a transfer price arrangement as further described below.
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“With our successful regulatory clearance of Excellagen by the FDA, and production of commercial supplies in process, we look forward to initiating commercialization of Excellagen with strategic and distribution partners having access to podiatrists and other wound care specialists,” stated Christopher J. Reinhard, Chairman and CEO of Cardium Therapeutics. “In that regard, we are pleased to announce the first of what we plan to be a series of marketing and distribution agreements with commercialization partners in the U.S. and other markets consistent with Cardium’s business model.”
Under the BL&H agreement, Cardium will manufacture and supply Excellagen to BL&H at an up-front transfer price which will be 40% of the sales price based on reimbursement pricing to be established for the South Korean market. BL&H will be responsible for all costs related to regulatory filings, as well as sales, marketing and distribution activities. The Korea Food and Drug Administration registration process is adaptive to products that have received U.S. FDA clearance and the registration and reimbursement pricing process can typically be completed within about a year from application. As part of the regulatory process in Korea, BL&H plans to provide the health authorities with the findings of Cardium’s Matrix clinical study, which showed that formulated collagen can significantly accelerate reductions in wound radius immediately following application compared to standard of care therapy in diabetic foot ulcers, and can support platelet activation and release of the wound healing protein, Platelet-Derived Growth Factor (PDGF). These findings were published in the peer-reviewed official journal of the Wound Healing Society, Wound Repair and Regeneration, (2011) 19: 302-308, available at www.cardiumthx.com/pdf/ExcellagenPaper_WoundRepair.pdf.
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