HHS Announces Contract to Fund Development of Ebola Drug
BARDA will provide funding and access to subject-matter expertise and technical support toward the goal of FDA approval for ZMapp, an experimental medication.
The U.S. Department of Health and Human Services announced that its Office of the Assistant Secretary for Preparedness and Response has entered into a contract to support the development of a drug to treat Ebola patients. The $24.9 million, 18-month contract with Mapp Biopharmaceutical Inc., of San Diego, Calif., can be extended to a total of $42.3 million, according to the Sept. 2 news release.
ASPR's Biomedical Advanced Research and Development Authority will provide funding and access to subject-matter expertise and technical support for manufacturing, regulatory, and non-clinical activities. Work under the contract supports the development and manufacturing of an experimental medication named ZMapp toward the goal of U.S. Food and Drug Administration approval.
"While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy," said Dr. Nicole Lurie, assistant secretary for preparedness and response. "Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today's agreement represents an important step forward."
Mapp Biopharmaceutical will manufacture a small amount of the drug for early-stage clinical safety studies and nonclinical studies needed to demonstrate ZMapp's safety and efficacy in people, and the company will work with BARDA on the manufacturing process, increasing production yields, and the scale of manufacturing.