GAITHERSBURG, Md. — Emergent BioSolutions announced Aug. 31, 2006, that it has been awarded two grants from the National Institute of Allergy and Infectious Diseases totaling $3.8 million to support the development of the company’s anthrax immune globulin (AIG) therapeutic product.
The company is developing its AIG product as a single-dose intravenous therapeutic for post-exposure treatment of patients with manifest symptoms of anthrax disease resulting from the release of anthrax toxins into the body. The company anticipates that, if successfully approved, its AIG product will be prescribed for administration under these circumstances either as a monotherapy or in conjunction with antibiotics.
The first grant award will provide up to $3.7 million in funding through 2009 to support non-clinical studies aimed at assessing the tolerability, pharmacokinetics and efficacy of the company’s AIG product in animal models, as well as development and validation of product assays.
The second grant will fund the preparation of materials needed by NIAID for project feasibility assessment and the preparation of documentation required for applying for a NIAID Clinical Trial Implementation Cooperative Agreement.
The company’s AIG program is focused on using antibodies produced by healthy donors immunized with BioThrax (Anthrax Vaccine Adsorbed) for the treatment of anthrax. BioThrax, which is manufactured by the company, is the only FDA approved vaccine for prevention of anthrax infection.
The company recently completed a plasma donor collection program in which plasma was obtained from healthy individuals who had been vaccinated with BioThrax. The amount of plasma resulting from this program was sufficient to produce the first full-scale commercial production batch of the AIG product candidate, as well as for non- clinical efficacy studies.
The company is designing a healthy donor stimulation program in order to obtain additional quantities of plasma for the production of future commercial production batches.
Emergent BioSolutions works to develop, manufacture and commercialize Immunobiotics, which are novel products that direct the immune system to prevent and treat life-threatening diseases. These include products for use against serious diseases where there exists significant unmet or underserved medical needs and against biological agents that may potentially be used as weapons of bioterrorism.