Tuesday, September 02, 2014

HHS Contracts With Mapp Bio To Develop Experimental Ebola Drug

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Although it is far from certain that the experimental monoclonal antibody cocktail called ZMapp is both safe, and effective against Ebola infection, early animal studies (see Nature: 100% Of Ebola Infected Macaques Recovered With ZMapp) have been highly encouraging, and we’ve seen anecdotal reports of improvement in some of the humans who have received the drug. 

 

Today the HHS has announced that BARDA (Biomedical Advanced Research and Development Authority) would provide funds, expertise, and technical support to help the manufacturer (Mapp Biopharmaceutical) to ramp up the production, and testing of the drug. 


On August 12 the manufacturer announced `The available supply of ZMapp™ has been exhausted’. At the time, reports indicated it could take several months to produce more. Hopefully this contract will help speed up that process.


This from the HHS Press Office.

 

FOR IMMEDIATE RELEASE
September 2, 2014

Contact: HHS Press Office
202-690-6343

HHS contracts with Mapp Biopharmaceutical to develop Ebola drug

Work will accelerate drug development and testing

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). This contract supports the government-wide response to the Ebola outbreak in West Africa.

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide funding as well as access to subject matter expertise and technical support for manufacturing, regulatory, and nonclinical activities through a $24.9 million, 18-month contract with Mapp Biopharmaceutical Inc., of San Diego, California. ASPR can extend the contract up to a total of $42.3 million.

Work under the contract supports the development and manufacturing of the medication 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,” explained 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.”

(Continue . . .)