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MediWound Announces an Additional $10 Million Award from BARDA
Funding to support emergency stockpiling replenishment, pediatric indication submission, and expanded access treatment protocol extension YAVNE, Israel, May
About this update from Mediwound Ltd.
[{"type":"text","content":"Funding to support emergency stockpiling replenishment, pediatric indication submission, and expanded access treatment protocol extension\nYAVNE, Israel, May 09, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), has awarded an additional $10 million to MediWound. The supplemental funding will support a $3 million replenishment of expired product previously procured for emergency preparedness, the pediatric indication sBLA submission to the U.S. Food and Drug Administration (FDA), and enrollment of an additional 50 patients in the ongoing expanded access treatment protocol (NEXT). \"Our long-standing partnership with BARDA has been instrumental in NexoBrid’s successful development. We are thrilled at the prospect of making it available in the U.S. market,\" said Ofer Gonen, Chief Executive Officer of MediWound. “Replenishment of the NexoBrid emergency stockpile highlights the critical importance of the product and ensures that in the event of a mass casualty burn incident, patients in the U.S. will have access to this lifesaving agent in a timely manner. We remain committed to advancing innovative solutions that will meet medical needs and improve patient outcomes.\" The NexoBrid® indication expansion will include treatment of pediatric burn victims, which comprises more than 30% of the total burn population. NexoBrid is particularly relevant to the pediatric population as the current surgical standard of care (SOC) is extremely traumatic. NexoBrid enables clinicians to provide a safe, fast, and highly effective non-surgical debridement option that addresses the unmet need in the pediatric population. The NEXT protocol provides for continued access to NexoBrid for up to 250 patients (in both the pediatric and adult populations), while maintaining physician skills until NexoBrid is commercially available in the U.S. for adults, and prior to receiving FDA approval for the pediatric indication. MediWound was awarded its first BARDA contract for treatment of thermal burn injuries in 2015. This ...