MediWound Ltd (NASDAQ: MDWD) has announced that the Biomedical Advanced Research and Development Authority (BARDA) has expanded its granted contract with the company by offering additional funding of$9 million.
BARDA is part of the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The supplemental funding will support NexoBrid BLA resubmission with the FDA and the current expanded access treatment protocol (NEXT).
MediWound receives additional funding for NexoBrid
CEO Sharon Malka said, “We are greatly appreciative that BARDA is providing additional funds to develop NexoBrid, and support NexoBrid’s potential approval to enhance U.S. preparedness. We look forward to continuing our long-lasting collaboration with BARDA and our U.S. commercial partner Vericel in order to make NexoBrid available to U.S. burn patients, as we continue to advance the preparation of the BLA resubmission anticipated in mid-2022.”
In 2015, MediWound received its initial BARDA award for thermal burn injuries treatment. The initial BARDA contract, worth approximately $168 million, funded further design and production and the acquisition of NexoBrid as a medical protective measure as part of the United States’ mass casualty preparedness. BARDA offered technical support and around $91 million for NexoBrid development initiatives required to pursue FDA marketing approval in the United States under the initial BARDA contract. The NexoBrid Phase 3 (DETECT) trial and accompanying BLA resubmission procedures, as well as the current third Phase pediatric (CIDS) trial and the NexoBrid extended access treatment program, are among these initiatives.
BARDA pledged another $16.5 million to buy NexoBrid
As part of the HHS aim to develop national readiness for healthcare medical emergencies, BARDA pledged an extra $16.5 million in January 2020 to buy NexoBrid. The arrangement also involves a $10 million alternative to support the development of other possible NexoBrid indications, as well as a $50 million option to purchase more NexoBrid.
BARDA has an additional agreement with MediWound to assist NexoBrid development as a debridement solution sulfur mustard injuries (chemical burns) treatment, in addition to the initial BARDA contract.