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Biosecurity News in Brief
BARDA, NIAID Award Anthrax Monoclonal Antibody Contract; NIAID Awards Botulinum Antitoxin ContractBy Kunal Rambhia, September 15, 2008 On September 3, 2008, Emergent BioSolutions, Inc., announced that it had been awarded a $24.3 million contract to develop its anthrax monoclonal antibody AVP-21D9. The contract was awarded jointly by the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The funds will be disbursed over 4 years, with $20 million coming in the first 2 years for increasing manufacturing capacity and completing phase I clinical trials. The final 2 years of the contract will involve non-clinical studies.1 Anthrax monoclonal antibody is a fully human antibody that has shown potential as a post-exposure anthrax therapeutic and has “demonstrated very high affinity to the anthrax toxin in animal studies.”1 Emergent also owns BioThrax—the only anthrax vaccine currently approved by the FDA. The company is also developing 2 new anthrax vaccines and another post-exposure therapeutic. In related news, on September 9, XOMA Ltd. announced that it received a $65 million, 6-year contract from NAIAD to develop botulinum antitoxins for clinical trials.2 This contract increases XOMA’s total awards for development of botulinum antitoxins to $100 million (divided among 3 contracts). XOMA intends to begin human safety and animal efficacy trials of its first drug candidate by 2009. In order to support filing for an Investigational New Drug (IND) with the U.S. Food & Drug Administration (FDA) and to conduct preclinical studies to prepare for human clinical trials, XOMA has identified the following goals:
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