Emergent BioSolutions Receives Health Canada Approval for Botulism Antitoxin
12 December 2016 - 11:00PM
Emergent BioSolutions Inc. (NYSE:EBS) today announced that Health
Canada has approved the company’s New Drug Submission (NDS) for its
botulism antitoxin, BAT® [Botulism Antitoxin Heptavalent (A, B, C,
D, E, F, G) - (Equine)]. BAT is indicated for the treatment of
symptomatic botulism following documented or suspected exposure to
botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and
pediatric patients. BAT was approved under the Extraordinary Use
New Drug (EUND) Regulations, which provide a regulatory pathway for
products for which collecting clinical information for its intended
use in humans is logistically or ethically not possible.
“Emergent is pleased that Health Canada has approved this
critical countermeasure against botulinum toxin, which has been
identified by the U.S. Centers for Disease Control and Prevention
and Public Health Agency of Canada as one of the more likely
biological threat agents,” said Adam Havey, executive vice
president and president, biodefense division at Emergent
BioSolutions. “As a leading global provider of medical
countermeasures that address CBRNE threats and emerging infectious
diseases, Emergent is committed to helping allied governments
fulfill their preparedness needs. We expect to expand upon our
longstanding relationship with the Canadian government and develop
similar relations outside of North America as a key strategic
objective for the organization.”
Emergent has an existing ten-year contract, executed in 2012, to
supply BAT to the Canadian Department of National Defense as well
as the Public Health Agency of Canada and individual provincial
health authorities. In addition, Emergent has been supplying BAT to
the U.S. Strategic National Stockpile as part of a $450 million
contract with the Biomedical Advanced Research and Development
Authority (BARDA), within the Office of the Assistant Secretary for
Preparedness and Response in the U.S. Department of Health and
Human Services. BAT, which was licensed by the U.S. Food and Drug
Administration in 2013, is the only botulism antitoxin available in
the U.S. for treating naturally occurring, non-infant botulism, and
for administering to patients under emergency conditions.
About Emergent BioSolutionsEmergent
BioSolutions is a global specialty biopharmaceutical company
dedicated to one simple mission—to protect and enhance
life. We develop, manufacture, and deliver a portfolio of
medical countermeasures for biological and chemical threats as well
as emerging infectious diseases. Through our work, we envision
protecting and enhancing 50 million lives with our products by
2025. Additional information about the company may be found at
www.emergentbiosolutions.com. Follow us @emergentbiosolu.
Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
burrowsr@ebsi.com
Media Contact:
Tracey Schmitt Lintott
Senior Vice President, Global Public Affairs
240-631-3281
SchmittT@ebsi.com
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