ROCKVILLE, Md. —Emergent BioSolutions Inc. announced that on March 6, 2008, it completed the acquisition of a group of anthrax monoclonal antibodies from AVANIR Pharmaceuticals, including Avanir’s lead product candidate, AVP-21D9.
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, 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,” said Fuad El-Hibri, chairman and CEO of Emergent BioSolutions.
“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,” he said. “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.
“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 is developing a polyclonal anthrax immune globulin product, which is being manufactured by Talecris Biotherapeutics Inc., at its FDA-approved production facilities. The company said it intends to pursue additional NIAID development funding for its anthrax therapeutic product candidates.
Emergent BioSolutions, formed in 2004, is dedicated to the research, development and manufacture of products that harness the immune system to treat and prevent disease. These include vaccines and related products for prophylactic and therapeutic use against common infectious diseases and biological weapons of mass destruction.