Last week, Gaithersburg, MD based biopharmaceutical company, Emergent BioSolutions Inc. announced the signing of a nearly $1 billion contract with the Centers for Disease Control and Prevention (CDC) to supply the Strategic National Stockpile (SNS) approximately 29.4 million doses of BioThrax anthrax vaccine through September 2021.
BioThrax is the only anthrax vaccine licensed by the U.S. Food and Drug Administration(FDA) and is indicated for both pre-exposure prophylaxis and post-exposure prophylaxis of anthrax disease.
In addition, the Biomedical Advanced Research and Development Authority (BARDA), a division within the Office of the Assistant Secretary of Preparedness and Response at HHS, issued a notice of intent to procure approximately $100 million of BioThrax for delivery into the SNS within 24 months from the date of contract award, which the company anticipates will be in the first half of 2017.
“Emergent believes these actions reflect the U.S. government’s continued assessment of anthrax as a high-priority threat and its firm commitment to protect the nation against bioterrorism,” said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. “We are pleased to be able to make meaningful contributions to helping the government execute its strategy to achieve its preparedness goals.”
In Canada, the company announced Monday 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.
LISTEN: Bioterrorism: An interview with Lawrence Roberge, PhD