MediWound (NSDQ:MDWD) said today that the U.S. Biomedical Advanced Research and Development Authority (BARDA) upsized a contract with the company to provide a supplemental $21 million in funding.
The newly acquired funding will be used to help launch the NexoBrid expanded access treatment protocol with the company’s NexoBrid product.
The NexoBrid is a topically-administered product intended to enzymatically remove nonviable burn tissue in patients with deep partial and full-thickness thermal burns. The product has already received CE Mark approval in the European Union and has been designated as an orphan biologic in the U.S.
Through the modified contract, BARDA will now supply a total of $77 million in funding for NexoBrid development, supporting it towards FDA approval in the U.S., according to a press release. This includes an ongoing NexoBrid Phase 3 study and other requirements or a Biologics License Application submission, the company said.
The contract also includes a $16.5 million commitment for the procurement of NexoBrid upon FDA approval, a $10 million option to fund NexoBrid for other indications and an option to fund up to $50 million for additional NexoBrid procurement, the company said.
MediWound said that as of March 31 this year, it has received approximately $31 million from BARDA.
The NEXT protocol is intended to allow MediWound to increase the number of burn centers trained in the use of NexoBrid to improve preparedness for burn mass casualty events, the company said. The protocol allows for the treatment of up to 150 burn patients with deep, partial and full thickness burns covering up to 30% total body surface area.
“We are very pleased with BARDA’s continued commitment towards the development of NexoBrid, allocating supplemental funds to support multiple indications. BARDA’s continuous support underscores its endorsement of our breakthrough therapy for treatment of severe burns and its mission for building mass casualty event preparedness. BARDA’s significant continuous support and our recently announced commercial agreement with Vericel for rights within North America further validate NexoBrid’s role as an important treatment for patients with severe burns. We look forward to continuing our collaboration with BARDA and Vericel in order to make NexoBrid available to U.S. burn patients. We plan to initiate the NEXT expanded access treatment protocol in the third quarter of 2019, in tandem with our preparation of the NexoBrid BLA, which is planned for submission in the fourth quarter of this year, subject to FDA concurrence. The NEXT protocol allows for the continued clinical use as well as non-declared emergency use of NexoBrid on U.S. patients, prior to NexoBrid approval by the FDA. We believe the NEXT treatment protocol will further extend the NexoBrid user-base across the U.S. and generate further awareness, advocacy, and use at U.S. centers of excellence, potentially facilitating significant market penetration,” CEO Sharon Malka said in a press release.
Earlier this month, Vericel (NSDQ:VCEL) said it inked an exclusive U.S. licensing and supply agreement with MediWound for its NexoBrid biological product.
