BARDA Awards up to $143 Million for Advanced Development of a New Drug to Treat Anthrax
News Dec 24, 2009
The HHS Biomedical Advanced Research and Development Authority (BARDA) has awarded a contract to Elusys Therapeutics, Inc. of Pine Brook, N.J., for the advanced development of a medication to treat inhalational anthrax, one of the top bioterrorism threats facing the nation.
The first year of the contract, called the base year, is valued at $16.8 million. The federal government has the option to continue the contract if the company meets performance milestones, so the contract’s potential total is up to $143 million over a five-year period.
Under the contract, Elusys Therapeutics will continue development of a medication called Anthim, specifically for inhaled anthrax. The potential medication would be a monoclonal antibody, produced in the laboratory by a single group of genetically identical cells.
To date, Anthim has been developed under a National Institutes of Health contract since 2007 utilizing the BARDA Biodefense Medical Countermeasures Development Fund.
The advanced product development supported by the new BARDA contract includes scaling up manufacturing, formulation chemistry studies to determine how much of the drug is needed to be effective, additional human safety trials, and pivotal, non-clinical effectiveness studies in animals toward licensure through the Food and Drug Administration.
Anthim received FDA fast track and orphan drug designations, which assisted in expediting its development. Elusys used funds from BARDA and the private sector to manufacture Anthim, conduct two Phase 1 safety trials in humans, and conduct numerous studies demonstrating safety and effectiveness in animal models.
Under the new BARDA contract, Elusys will continue with a long-term strategy to license Anthim to treat people who have become sick from inhaled anthrax, with additional studies to further evaluate the effectiveness of the drug to prevent illness from anthrax. If Anthim is licensed by the FDA, the federal government could buy the product for the Strategic National Stockpile under Project Bioshield.