Neumedicines Inc. Wins U.S. federal government contract for up to $273 million to fund late-stage development of HemaMax(TM)
Contract worth up to $273 million to fund advanced development of Neumedicines’ HemaMax™ (recombinant human interleukin 12; rhuIL-12) for treatment of Hematopoietic Syndrome of Acute Radiation Syndrome (HSARS).
The contract was awarded on September 15, 2011 by the Biomedical Advanced Research & Development Authority (BARDA) of the U.S. Department of Health and Human Services (DHHS).
BARDA provides an integrated, systematic approach to the development and purchase of necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
Neumedicines will initially receive approximately $17 million from BARDA over 18 months to speed the development of HemaMax.
Additional financing over the next 3.5 years is available in milestone-based options to be exercised by BARDA, potentially bringing the total value of the award to approximately $273 million.
Funds from this award will be used to advance the late-stage development of HemaMax toward BLA submission under the U.S. Food and Drug Administration’s Animal Rule (21 CFR 601.90-95).
The new contract, one of the largest awarded by BARDA for advanced product development, will support the company's clinical and commercial strategy, including scaling up manufacturing, expanded human safety trials and pivotal, non-clinical efficacy studies in animals, through FDA licensure.