emergent biosolutions

Emergent BioSolutions Submits Biologics License Application to FDA for Anthrax Immune Globulin Intravenous (Human)

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emergent biosolutions

August 7th, 2014

Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has submitted a Biologics License Application to the U.S. Food and Drug Administration (FDA) for Anthrax Immune Globulin Intravenous (Human) [AIGIV] as part of a development contract with the Biomedical Advanced Research and Development Authority (BARDA). AIGIV, which was acquired in the Cangene acquisition completed earlier this year, is being developed as an intravenous therapeutic treatment for inhalation anthrax.

“This accomplishment is a testament to the diligent work of our employees within the recently acquired Cangene operations and their years of successful collaboration and partnering with the U.S. government,” said Adam Havey, executive vice president and president biodefense division at Emergent BioSolutions. “We commend BARDA for their steadfast commitment to advancing this key anthrax countermeasure program and remain dedicated to supporting their mission to protect our civilian and military population.”

AIGIV is a sterile solution of purified human immune globulin G (IgG) containing polyclonal antibodies that targets the anthrax toxins of Bacillus anthracis, the bacteria that causes anthrax disease. It is prepared using plasma collected from healthy, screened donors who have been immunized with BioThrax® (Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine for the prevention of anthrax disease. AIGIV was evaluated through studies conducted in animal models of inhalation anthrax and was granted Orphan Drug designation by FDA in 2008.

AIGIV is being developed as part of a $160 million contract with the Biomedical Advanced Research and Development Authority, within the office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. Under this contract, which was awarded in 2005, 10,000 doses of AIGIV have been delivered to the U.S. Strategic National Stockpile and the company will receive a $7 million milestone payment upon FDA approval of AIGIV.

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