MediWound said today it has been awarded a contract of up to $112 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to advance development, manufacturing, and procurement of the company’s Phase III pharmaceutical NexoBrid®.
NexoBrid would be developed as a medical countermeasure as part of BARDA preparedness for mass casualty events, MediWound said.
NexoBrid is indicated for enzymatic removal of eschar in adults with deep-partial and full-thickness thermal burns. MediWound is carrying out a Phase III study of NexoBrid in the U.S. to evaluate its effectiveness in such burns—the same indication for which the product has E.U. approval, and has been commercially launched in the E.U. and Israel.
In earlier clinical studies, according to MediWound, NexoBrid has shown its ability to non-surgically and rapidly remove in a single, four-hour application the dead, or the damaged tissue, earlier than other modalities, without harming viable tissue. Longer-term, NexoBrid has also shown a significant reduction in surgical burden with outcomes comparable to current surgical treatment.
BARDA’s five-year base contract consists of $24 million to support development activities to complete the FDA approval process for NexoBrid for use in thermal burn injuries; and $16 million for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization (EUA) and/or FDA marketing authorization for NexoBrid.
The contract also includes options for further funding of up to $22 million for expanding NexoBrid's indications; and of up to $50 million for additional procurement of NexoBrid.
“This non-dilutive funding provides important recognition of the potential merits of NexoBrid and the therapeutic impact of our technology, as well as provides significant support for our ongoing clinical development and manufacturing programs,” MediWound president and CEO Gal Cohen said in a statement.
Cohen added that the BARDA contract will free up a portion of MediWound’s $71.7 million in net proceeds from its IPO last year. That portion, he said, was initially intended for use in clinical development of NexoBrid, but can now be used to further advance the company’s pipeline.
MediWound said in its IPO prospectus that it would spend “approximately “$25 million to $30 million” of its net proceeds on research and development, and an equal range of amounts to expand sales and marketing infrastructure. The company’s management estimated that the majority of its R&D and sales/marketing proceeds “will be spent on the ongoing expansion of NexoBrid.”
Israel’s Office of the Chief Scientist is supporting development of NexoBrid and MediWound’s Phase II biopharmaceutical EscharEx® EscharEx through a $1 million grant awarded in June. Last fall, the Disaster Committee of the International Society for Burn Injuries (ISBI) recommended inclusion of NexoBrid in its draft plan for mass casualty events.
“We look forward to working with various international agencies and governments to advance the use of NexoBrid for mass casualty and disaster preparedness, as well as in military medicine,” Cohen added.