MediWound announced the U.S. Biomedical Advanced Research and Development Authority (BARDA) has expanded its awarded contract with MediWound providing supplemental funding of $5.5 million to support emergency readiness for NexoBrid deployment upon request of use of NexoBrid in mass casualty situation.
“BARDA’s expanded commitment is further validation of NexoBrid’s importance to U.S. national preparedness for treatment of large number of severe thermal burns injuries. We greatly appreciate BARDA’s continued support and contribution over the years to the development of NexoBrid,” said Sharon Malka, CEO of MediWound. “We have started to build a NexoBrid emergency stockpile and designing processes for emergency deployment upon request of use of NexoBrid in mass casualty situation. In addition, the increasing number of burn centers enrolling into the NexoBrid expanded access treatment (NEXT) protocol will ensure that major burn centers across the U.S. are trained and experienced in the use of NexoBrid should such an event take place. In parallel, we continue to advance the preparation of the BLA and anticipating submission to the FDA in mid-year and subject to approval, commercial launch by our partner Vericel in 2021.”
Under the modified contract including this supplemental amount, BARDA will provide technical assistance and a total of $82 million in funding for NexoBrid development activities towards U.S. marketing approval from the Food and Drug Administration (FDA). The additional $5.5 million of supplemental funding is to support emergency readiness for a potential deployment of NexoBrid upon request of use in mass casualty situation, following the initiation of NexoBrid procurement for emergency stockpile as part of the U.S. Department of Health and Human Services (HHS) mission to build national preparedness for public health medical emergencies. This modified contract maintains a $10 million option to fund development of other potential NexoBrid indications, and an option to fund up to $50 million for additional NexoBrid procurement. In addition to this modified contract, BARDA also has a separate independent contract with MediWound to support the development of NexoBrid as a debridement product to treat sulfur mustard injuries. This contract provides $12 million in funding to support research and development activities up to pivotal studies in animals with options for additional funding of up to $31 million for additional development activities through BLA submission.
The cumulative non-dilutive funding under both contracts with BARDA is now valued at up to $202 million. As of December 31, 2019 the Company has received approximately $43 million from BARDA.