Emergent BioSolutions submits anthrax IND to FDA

The drug is an anthrax immune globulin (AIG) therapeutic treatment for patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body. The company expects to initiate a pivotal clinical trial in 2007 in order to evaluate AIG safety and pharmacokinetics in 105 healthy volunteers.

During 2006, the National Institute of Allergy and Infectious Diseases (NIAID) agreed to provide funding to the company of up to $3.7 million to support pivotal animal studies and for the development and validation of product assays.

Fuad El-Hibri, chairman and CEO of Emergent BioSolutions, said: “Our AIG product, which we are developing in part with grant funding from the NIAID, is an important element of our efforts to develop safe and effective medical countermeasures to help protect the nation against biological attack.”