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MediWound Ltd. (NASDAQ: MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ: VCEL) today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Assistant Secretary for Preparedness and Response (ASPR), a part of the U.S. Department of Health and Human Services (HHS), has begun procuring NexoBrid® for emergency stockpile as part of the HHS mission to build national preparedness for public health medical emergencies. BARDA purchased inventory will be managed by MediWound under vendor managed inventory. The initial BARDA procurement is valued at $16.5 million, with the first delivery of NexoBrid expected by the end of the first quarter of 2020 and additional deliveries occurring over the subsequent five quarters. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million. The submission of the Biologics License Application (BLA) for NexoBrid to the U.S. Food & Drug Administration (FDA) is planned for the second quarter of 2020.
“The initiation of the NexoBrid procurement by BARDA is a significant milestone in our partnership with BARDA,” said MediWound Chief Executive Officer Sharon Malka. “We have been working with BARDA since 2015 on multiple development and training initiatives with the mutual goal of adding NexoBrid to ASPR’s portfolio of medical countermeasures for mass casualty emergencies. The initiation of the procurement while NexoBrid is at the pre-BLA stage underscores the importance of NexoBrid to U.S. national preparedness for treatment of large number of severe thermal burns injuries.”
“Our country faces a multitude of evolving threats that could result in an overwhelming number of people suffering from burn injuries,” explained BARDA Director Rick Bright, Ph.D. “Today’s purchase is part of our ongoing efforts to provide first responders and other medical professionals with fast access to the products they will need to save as many lives as possible. The progress of NexoBrid to date is a testament to how much can be accomplished in a relatively short time through public-private partnership.”
“We believe that availability of NexoBrid for emergency response will significantly increase U.S. readiness for burn mass casualty incidents,” said Nick Colangelo, President and Chief Executive Officer of Vericel. “The increasing number of burn centers enrolling in the NexoBrid expanded access treatment protocol will help ensure that major burn centers across the country are trained and experienced in the use of NexoBrid should such an event take place.”
The procurement is a key milestone of the Project BioShield (PBS) contract signed in September 2015 between MediWound and BARDA. 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.
Recently, MediWound initiated the NexoBrid expanded access treatment protocol (NEXT), which is supported and funded by BARDA and enables the continued clinical use of NexoBrid for U.S. patients during the preparation and review of the NexoBrid BLA. NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial- and full-thickness thermal burns up to 30 percent of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers are anticipated to participate.
MediWound received FDA concurrence that patients can be treated under the NEXT protocol in a burn mass casualty incident that is not a declared national emergency. MediWound has submitted documents for consideration by the FDA supporting the use of NexoBrid in a declared national medical emergency contingent upon the FDA issuance of an Emergency Use Authorization (EUA). The EUA is a mechanism by which the FDA can allow an unapproved medical product that qualifies as a mass casualty medical countermeasure to be used in a public health emergency.
