Mallinckrodt PLC said it will receive an additional $26 million from the U.S. government to study its burn therapy StrataGraft in children.
The additional award from the U.S. Biomedical Advanced Research and Development Authority, or BARDA, pushes total government funding for the therapy to $86 million. The U.K.'s Mallinckrodt can secure up to an additional $160 million for StrataGraft, which is being developed by its subsidiary Stratatech Corp. as a medical countermeasure for large-scale burn incidents.
StrataGraft is a human skin substitute that is yet to be approved by the U.S. Food and Drug Administration. The regulator has designated StrataGraft as a regenerative medicine advanced therapy, which will allow for an accelerated review process.
StrataGraft, which is designed to work like natural skin, is being studied in a phase 3 trial for adults.
BARDA is a division of the U.S. Department of Health and Human Services tasked with the procuring and developing countermeasures against bioterrorism, including chemical, nuclear and radiological threats, as well as pandemic influenza and emerging diseases.