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Emergent Biosolutions Acquires Monoclonal Anthrax Product CandidateAcquisition represents important addition to company’s portfolio of anthrax countermeasures AVP-21D9 is a human monoclonal antibody product candidate that is being developed as an intravenous treatment for patients who present with symptoms of anthrax disease following exposure to Bacillus anthracis. In non-clinical studies, this candidate demonstrated an ability to protect animals challenged with a lethal dose of inhaled anthrax spores. AVP-21D9 is being developed with funding support from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID), including a grant to establish a cGMP manufacturing process and to test efficacy in additional inhalation studies. “The acquisition of Avanir’s monoclonal anthrax antibodies rounds out our anthrax countermeasure program nicely. In addition to our FDA-approved product, BioThrax? (Anthrax Vaccine Adsorbed), which is indicated for pre-exposure prevention of anthrax in individuals at high risk of exposure to anthrax spores, we are developing a polyclonal anthrax immune globulin therapeutic, which is a human plasma-derived product candidate. Now, as a result of this acquisition, we have another anthrax therapeutic in our product portfolio – a new monoclonal anthrax antibody product candidate that has performed well in proof-of-concept studies,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This transaction reflects our ongoing commitment to develop a full portfolio of countermeasures to strengthen our country’s preparedness in the event of future anthrax attacks.” The U.S. government is funding the development of, and seeking to procure, two types of treatments for inhalational anthrax disease: polyclonal antibody products, also known as immune globulins, and monoclonal antibody products. Emergent BioSolutions currently is developing a polyclonal anthrax immune globulin (AIG) product, which is being manufactured by Talecris Biotherapeutics, Inc., at its FDA-approved production facilities. Two full-scale lots of this product candidate have been manufactured under current good manufacturing practices at Talecris, and we plan to conduct pivotal human and animal studies in 2008 and 2009, which could position us for a procurement contract as early as next year. NIAID has provided us grant funding of up to $13.4 million for a combination of initiatives relating to our AIG product candidate, including non-clinical efficacy studies and a human safety and pharmacokinetics study. We intend to pursue additional NIAID development funding for both of our anthrax therapeutic product candidates, and we believe that both therapeutics would be eligible to be procured by the U.S. Department of Health and Human Service for inclusion in the SNS prior to receiving marketing approval, provided that they are deemed to be licensable under Project BioShield. About Emergent BioSolutions Inc. Safe Harbor Statement Related posts:
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Submitted by admin on Fri, 08/14/2009 - 05:03.
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