U.S. requests production plans for Ebola drug ZMapp

By Sharon Begley NEW YORK (Reuters) - U.S. officials have asked three advanced biology laboratories to submit plans for producing the experimental Ebola drug ZMapp, which ran out after it was given to a handful of medical workers who contracted the disease in West Africa, government and lab officials said on Friday. The "task order" issued on Thursday by the Biomedical Advanced Research and Development Authority (BARDA) asks that detailed plans, including budgets and timetables, be submitted by Nov. 10. Separately, Amgen Inc said on Friday that it will help create production lines for ZMapp using mammalian cells, a more traditional technique than the tobacco plants used to produce previous doses of ZMapp. Amgen will assign 12 to 14 employees to the effort, said spokeswoman Kristen Davis, and they will work on the project through the end of 2014. ZMapp was given to American medical workers Dr. Kent Brantly and Nancy Writebol, who recovered after contracting Ebola in Liberia, and to at least one Spanish priest, who died. It is impossible to know whether ZMapp helped because it has not been studied in a rigorous clinical trial, but the drug has been held out as a promising therapy during the worst Ebola outbreak on record. The U.S. government "is 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," BARDA Director Robin Robinson said in a statement. The three advanced labs, called Centers for Innovation in Advanced Development and Manufacturing, were established by the U.S. government in 2012 with $440 million in seed money. They are required to develop flexible manufacturing capabilities to allow them to produce countermeasures against chemical, biological, and other threats. One of the three, run by Texas A&M Health Science Center in partnership with Britain's GlaxoSmithKline Plc, "is swiftly responding" to the government request, Dr. Brett Giroir, chief executive officer of the health science center, said in a statement, and will submit detailed proposals for scaling up production of ZMapp. The other two centers are a facility led by Emergent Biosolutions in Baltimore and another in Holly Springs, North Carolina, led by Swiss drug company Novartis AG. Adam Havey, president of Emergent's biodefense division, said the company has been in discussions with plant-based manufacturers to develop a response to the task order. "We look forward to leveraging our manufacturing capabilities to expand production of this experimental therapeutic and to find other ways to support the U.S. government's fight against Ebola," Havey said in a statement. Novartis said it was evaluating the request from BARDA. Elizabeth Power, a company spokeswoman, said the company is "unable to provide any additional details at this time." Once proposals are submitted, BARDA will select one or more labs to produce ZMapp, which is currently manufactured in tobacco plants by Kentucky Bioprocessing, a unit of Reynolds American Inc. "We believe there are substantial opportunities to increase the yield of ZMapp" in plants while keeping the product the same, Giroir said in an interview. The compound needs to be identical to what Mapp has already vetted in animals "or you would have to go back to the beginning for safety testing," he said. Giroir said the Texas center "is very familiar" with plant-based antibody production. If it wins a government contract for ZMapp production, it would likely tap Caliber Biotherapeutics, which specializes in tobacco-plant-based drug production and shares the Texas campus, as a subcontractor. It is not yet clear how many doses of ZMapp Texas could produce in what amount of time, Giroir said. San Diego-based Mapp Biopharmaceutical has said it ran out of its limited supply of ZMapp in August. Mapp officials were not available for comment. (Additional reporting by Toni Clarke and Deena Beasley; Editing by Michele Gershberg and Jonathan Oatis)