CAMBRIDGE, Mass., May 29, 2019 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has agreed to fund the NexoBrid® expanded access treatment (NEXT) protocol. The NEXT protocol is being conducted under the U.S. Food and Drug Administration’s (FDA) expanded access program, which allows access to investigational products to treat patients with serious or immediately life-threatening diseases or conditions outside of clinical trials when no comparable or satisfactory alternative treatment options are available. U.S. burn surgeons participating in the NEXT protocol will be able to treat up to 150 patients during the preparation and review of the NexoBrid Biologics License Application (BLA).
On May 7, 2019, Vericel announced that it had entered into exclusive license and supply agreements with MediWound Ltd. to commercialize NexoBrid in North America. NexoBrid is a topically-administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial- and full-thickness thermal burns within four hours of application without harming viable tissue. MediWound will receive the additional funding from BARDA under an amendment to an existing BARDA contract. Under the terms of the License Agreement, MediWound will continue to conduct all development activities under the supervision of a Central Steering Committee comprised of members of each party until the BLA is approved and subsequently transferred to Vericel.
The NEXT protocol 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% of total body surface area. Up to 30 sites will participate in the NEXT protocol. The protocol has been designed to be consistent with current real-life burn treatment practices in the U.S. The increased number of burn centers trained and familiar with NexoBrid prior to FDA approval and commercial availability will improve national readiness for potential burn mass casualty events. To further promote national readiness, the FDA has agreed that in the event of a burn mass casualty event that is not a nationally declared emergency, additional patients could be treated under the NEXT treatment protocol.
“We are very pleased with BARDA’s commitment to make NexoBrid available to patients under an expanded access protocol,” said Nick Colangelo, president and CEO of Vericel. “It is a reflection of the significant need for improved burn treatments and the compelling body of clinical data supporting the use of NexoBrid. The NEXT protocol will further extend the number of NexoBrid-trained physicians and healthcare providers in the United States and generate additional awareness, advocacy, and use at U.S. centers of excellence prior to commercialization of NexoBrid.”
