MediWound and Vericel Announce Acceptance of the First Delivery of NexoBrid to BARDA for Emergency Response Preparedness

YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ: VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million.

“This first shipment of NexoBrid is another major milestone in our longstanding partnership with BARDA, and we look forward to delivering the full procurement by the end of 2021,” said MediWound Chief Executive Officer Sharon Malka. “The acceptance of the first delivery by BARDA during the ongoing COVID-19 pandemic underscores the importance of NexoBrid to U.S. national preparedness for the potential emergency treatment of large numbers of patients with severe thermal burns injuries.”

“The procurement of NexoBrid for our nation’s response preparedness is one of many key NexoBrid activities occurring in 2020,” said Nick Colangelo, President and Chief Executive Officer of Vericel. “This shipment, combined with the recent BLA submission and growing number of burn centers enrolled in the NexoBrid expanded access treatment protocol, bring us a step closer to ensuring that healthcare providers have both the supply and training needed to enzymatically debride burn patients, whether the need is due to individual accidents or a burn mass casualty event.”

On June 30, 2020, a Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. While the BLA is being reviewed by the FDA, burn centers across the U.S. are treating burn patients under the NexoBrid expanded access (NEXT) protocol.

The procurement is a key milestone of the Project BioShield (PBS) contract between MediWound and BARDA which was signed in September 2015 with procurement initiated in January 2020. Under the PBS contract, BARDA provides funds and support for the advancement of the development and manufacturing of NexoBrid, as well as the procurement of NexoBrid as a medical countermeasure for mass casualty emergencies involving thermal burns. In May 2019, Vericel entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. As part of the license agreement, Vericel and MediWound will equally split gross profits generated by BARDA’s initial $16.5 million procurement.