U.S. Regulators Ask Three Labs For Mapp Biopharmaceutical's ZMapp Ebola Plans

U.S. Regulators Ask Three Labs For ZMapp Ebola Plans

October 17, 2014

By Riley McDermid, BioSpace.com Breaking News Staff

The U.S. government is getting serious about stockpiling drugs that can fight the deadly Ebola virus, with health officials asking three advanced laboratories to submit plans for the ramped-up production of previously successful drug ZMapp, Reuters reported Friday.

As such, a "task order" has been issued by the Biomedical Advanced Research and Development Authority (BARDA) in Texas, a lab designed for high-end experimental research that operates in conjunction with GlaxoSmithKline .

“[U.S. regulators are] working with partners around the world as quickly as possible to advance the development of multiple vaccine and therapeutic candidates for clinical evaluation and future use in preventing or treating Ebola virus disease," BARDA Director Robin Robinson said in a statement.

ZMapp, which is produced by Mapp Biopharmaceuticals, is an experimental antiviral drug that was given to two medical aid workers who were repatriated to America after contracting Ebola in West Africa. Both recovered from the disease and their plasma is currently being used to help treat other critically ill patients with Ebola.

Supplies of ZMapp ran out in August, which had been manufactured in tobacco plants by Kentucky Bioprocessing, a unit of Reynolds American Inc.

Though there is no conclusive evidence that ZMapp was helpful in the patients’ recovery—it had been administered unsuccessfully to a Spanish priest who still died of Ebola—there is enough hope in its potential that authorities are racing to find new ways to supercharge production of the drug.

They have asked the nation’s three Centers for Innovation in Advanced Development and Manufacturing to submit proposals for how they could produce supplies of ZMapp. The centers are Emergent Biosolutions in Baltimore, a lab owned by Swiss drugmaker Novartis AG in North Carolina and BARDA. All three were created in 2012 under a $440 million seed grant.

Reuters reported that once proposals are submitted on Nov. 10, BARDA will select which facilities work best for producing the most ZMapp the quickest.

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