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.
Discovery Provides Hope for New Vaccine Against Flesh-eating BacteriaNews
Researchers at Houston Methodist have solved a 100-year-old mystery, providing them a possible key to unlock a pathway for treating diseases caused by flesh-eating bacteria.READ MORE
Hits for a Novel Drug Target Identified for Depression and PainNews
Novel small molecules have been identified that might be transformed into a new medical treatment of depression and/or even the potential in the treatment of pain.READ MORE
Autism Risk Higher if Pregnant Mothers Have Infection Requiring HospitalizationNews
Studies have shown that mothers who experience an infection severe enough to require hospitalization during pregnancy are at higher risk of having a child with autism.READ MORE