San Diego biotech Mapp Biopharmaceutical was awarded a federal contract Tuesday worth up to $42.3 million to develop its promising ZMapp drug for treating patients infected with the deadly Ebola virus.
The contract with the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, supports the development and manufacturing of ZMapp with a goal of 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.”
The Department of Defense and other federal agencies supported initial work on ZMapp. The drug was apparently successful in treating two Americans stricken with the disease in August amid the outbreak in West Africa.
As part of the new contract, Mapp Biopharmaceutical will manufacture a small amount of the drug for early stage clinical safety studies and nonclinical studies needed to demonstrate the drug’s safety and efficacy in people. The company will also focus on the manufacturing process, increasing production yields and the scale of manufacturing.
As an experimental drug, ZMapp currently is available only in very limited quantities and these steps will contribute to increasing the amount of product potentially available to treat patients with Ebola, officials said.
ZMapp is a combination of three monoclonal antibodies manufactured in tobacco plants. Monoclonal antibodies bind certain virus proteins and neutralize the virus, decreasing the amount of the virus in the body that the patient’s immune system has to fight. ZMapp has been shown to reduce mortality in mice and nonhuman primates exposed to Ebola viruses.
BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.
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