The U.S. Department of Health and Human Services (HHS) signed a $24.9 million, 18-month contract with Mapp Biopharmaceutical to support the development, manufacture, and FDA approval of the medication ZMapp for the treatment of Ebola disease. The deal can be extended up to a total of $42.3 million.
“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,” Nicole Lurie, M.D., 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.”
To speed the development of ZMapp, officials at the Biomedical Advanced Research and Development Authority (BARDA) said they will work closely with the Defense Threat Reduction Agency within the Department of Defense and the National Institute of Allergy and Infectious Diseases. BARDA also will work with the company to optimize and accelerate the manufacturing of ZMapp so testing can be done as soon as possible.
As part of the project, 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. Mapp Biopharmaceuticals also will work with BARDA 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, pointed out Dr. Lurie.
In a speech delivered at the U.N. on Tuesday Joanne Liu, M.D., president of Doctors Without Borders/Médecins Sans Frontières (MSF) referred to the Ebola outbreak in West Africa and denounced the lack of deployment of resources, which has to date relied on overstretched ministries of health and private nongovernmental organizations to tackle the exceptionally large outbreak. Despite repeated calls by MSF for a massive mobilization on the ground, the international response has been lethally inadequate, she emphasized.
Transmission rates have reached levels never before reported in past Ebola outbreaks, and the further spread of the virus will not be prevented without a massive deployment of specialized medical units to bolster epidemic control efforts in affected countries, according to Dr. Liu, who requested that states with biological-disaster response capacity, including civilian and military medical capability, must immediately dispatch assets and personnel to West Africa.
“Six months into the worst Ebola epidemic in history, the world is losing the battle to contain it,” noted Dr. Liu. “Leaders are failing to come to grips with this transnational threat. The WHO announcement on August 8 that the epidemic constituted a ‘public health emergency of international concern’ has not led to decisive action, and states have essentially joined a global coalition of inaction.”