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Emergent BioSolutions Receives Health Canada Approval for Botulism Antitoxin

GAITHERSBURG, Md., Dec. 12, 2016 (GLOBE NEWSWIRE) — 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 BioSolutions
Emergent 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.