Clal Biotechnology Industries Ltd. reported to the Tel Aviv Stock Exchange Today that its wound and burn care solutions unit MediWound Ltd. has been awarded a $112 million contract by the US Biomedical Advanced Research & Development Authority (BARDA).
Investment group Clal Biotechnology, which has a 45 percent stake in MediWound, said that the five-year deal is for NexoBrid, which removes dead tissues from medium to severe burns, and will be used by the US authorities following incidents with many injured.
The U.S. body would also help MediWound get approval for its drug NexoBrid, a topical treatment that removes damaged tissue, from the Food and Drug Administration, Clal said in a statement.
The deal includes a $24 million payment by BARDA towards the development required in order to win US Food and Drug Administration (FDA) approval for NexoBrid.
In addition, BARDA is committing to buying $16 million worth of NextoBrid subject to FDA approval and using it in emergency situations (Emergency Use Authorization). The deal also includes an option for $22 million in financing expanded use of NexoBrid in other approved indications, and up to $50 million in additional purchases of the burns treatment.
BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.
Following this US federal funding, some of the $70 million raised on Nasdaq by MediWound in March 2014, can now be used for the development of other products.