Israeli severe burns and wound management developer MediWound Ltd. (Nasdaq: MDWD) has announced that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.
MediWound's share price rose 11.24% on Nasdaq yesterday on the news, giving a market cap of $80.82 million. The share price of Clal Biotechnology Industries Ltd. (TASE: CBI), controlled by Len Blavatnik, which has a 35% stake in MediWound, is up 6% today, giving a market cap of NIS 139 million.
The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal US Phase III (DETECT) study of NexoBrid in adult patients with deep partial and full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints, with a comparable safety profile. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the US, EU and other international markets. Vericel Corp. (Nasdaq: VCEL) holds an exclusive license for North American commercial rights to NexoBrid.
Funding and technical support for the development of NexoBrid is being provided by the US Biomedical Advanced Research and Development Authority (BARDA), including the ongoing expanded access protocol (NEXT) in the U.S., which allows for the continued clinical use of NexoBrid during FDA’s review of the NexoBrid BLA. In addition, BARDA has made a $16.5 million commitment to procure NexoBrid for emergency stockpile as part of its mission to build national preparedness for public health medical emergencies.
MediWound CEO Sharon Malka said, "The NexoBrid BLA submission is a major milestone in our unique long-term partnership with BARDA, and we believe that upon approval, NexoBrid will benefit severe burn victims in routine care and serve as a critical medical countermeasure in case of a U.S. mass casualty incident. Submitting the BLA has been a collaborative effort of many dedicated parties and we thank all of our investigators and their teams, studies participants, our employees and our partners, especially BARDA and Vericel, for their commitment to the program." The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing. MediWound is eligible to receive a milestone payment from Vericel upon BLA approval.
Published by Globes, Israel business news - en.globes.co.il - on July 1, 2020
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