|[August 07, 2014]
Emergent BioSolutions Submits Biologics License Application to FDA for Anthrax Immune Globulin Intravenous (Human)
ROCKVILLE, Md. --(Business Wire)--
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 thei 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.
About Emergent BioSolutions
Emergent BioSolutions is a global specialty biopharmaceutical company
seeking to protect and enhance life by offering specialized products to
healthcare providers and governments to address medical needs and
emerging health threats. Additional information about the company may be
found at www.emergentbiosolutions.com.
Follow us @emergentbiosolu.
[ Back To TMCnet.com's Homepage ]