Public Health Emergency - Leading a Nation Prepared
Date: Augsut 30, 2011
Company: Elusys Therapeutics, Inc., Pine Brook, NJ
Contract amount: two-year base period valued at $26.5 million with options based on performance milestones totalling up to $68.9 million over a five year period
About the contract: This contract supports the continued development of a humanized monoclonal antibody, Anthim, which binds to the anthrax Protective Antigen. Under the contract, Elusys will develop a formulation for intramuscular administration and perform studies that will evaluate the efficacy of Anthim for pre- and post-exposure prophylaxis for anthrax. The intramuscular formulation should facilitate the administration of Anthim in emergency settings. Anthim has been under development by BARDA since 2009, building on previous investments by the Department of Defense and the National Institutes of Health. Anthim has received Fast-Track and Orphan Drug designations from the FDA, which have further expedited its development. To date Elusys has successfully manufactured Anthim using current good manufacturing practices and conducted two Phase 1 safety trials in humans and numerous studies demonstrating safety and efficacy in animal models.
Additional information: The contract is funded through the BARDA Broad Agency Announcement (BAA) (CBRN-BAA-10-100-SOL-00012) and falls under the Biodefense Medical Countermeasures Development Fund (BMCDF) established by the Pandemic and All-Hazards Preparedness Act of 2006. The BMCDF is used to support the development of technologies that the federal government needs for emergency preparedness. Products that mature under this program may later be considered for purchased through the Project BioShield Special Reserve Fund. BARDA is seeking additional proposals for peptide or small molecule antitoxins that could potentially treat or prevent anthrax. Proposals are accepted through the Broad Agency Announcement BARDA-CBRN-BAA-11-100-SOL-00009 at www.fbo.gov.
Press Release: Novel anthrax vaccine and antitoxin being developed with federal support
Procurement Announcement: Contract Awarded under BARDA-CBRN-BAA-10-100-SOL-00012
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