Emergent BioSolutions Receives Health Canada Approval of BioThrax® (Anthrax Vaccine Adsorbed)
December 17 2018 - 3:10PM
Emergent BioSolutions Inc. (NYSE:EBS) today announced that Health
Canada has approved the company’s New Drug Submission (NDS) for its
anthrax vaccine, BioThrax® (Anthrax Vaccine Adsorbed). BioThrax is
indicated for active immunization for the prevention of disease
caused by Bacillus anthracis, in individuals 18 through 65 years of
age, whose occupation or other activities place them at risk of
exposure, regardless of the route of exposure. BioThrax is
administered in a three-dose primary schedule (0, 1 and 6 months)
with boosters at three-year intervals recommended thereafter.
BioThrax was approved under the Extraordinary Use New Drug
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.
“With the growing awareness of biological and chemical threats
around the globe, Emergent is committed to partnering with allied
governments and providing preparedness solutions to meet their
national security needs,” said Abbey Jenkins, senior vice president
and vaccines and anti-infectives business unit head, at Emergent
BioSolutions. “We are pleased to receive Health Canada licensure of
BioThrax, fulfilling our commitment to the Canadian government, and
enabling future procurement of this critical medical
countermeasure. We look forward to continuing our decades-long
partnership in our quest to fulfill our mission – to protect and
enhance life.”
BioThrax is designated by Health Canada as an innovative drug
giving it market exclusivity for eight years. Earlier this year,
Emergent completed the Mutual Recognition Procedure for BioThrax
expanding licensure of BioThrax in five European countries, namely,
the U.K., Poland, France (marketed as BaciThrax), Italy, and the
Netherlands, in addition to Germany, where BioThrax received market
authorization in 2013.
About BioThraxBioThrax is also licensed by the
U.S. Food and Drug Administration for the active immunization for
the prevention of disease caused by Bacillus anthracis in persons
18 through 65 years of age for both pre-exposure and post-exposure
prophylactic use. Please follow links for full U.S. prescribing
information and for full Canadian prescribing information in
English or in French.
BioThrax has also received market authorization from the Health
Sciences Authority in Singapore and the Paul-Ehrlich Institut in
Germany.
Where approved in Europe, BioThrax is indicated for prevention
of disease caused by Bacillus anthracis in adults at risk of
exposure. BioThrax should be used in accordance with official
recommendations, where available. BioThrax is administered in a
three-dose primary schedule (0, 1 and 6 months) with boosters at
three-year intervals recommended thereafter. Please follow link for
full details of EU prescribing information.
The safety and efficacy of BioThrax have not been established in
pediatric or geriatric populations. Individuals are not considered
protected until they have completed the three-dose primary
immunization series. Vaccination with BioThrax may not protect all
individuals.
BioThrax is manufactured from a culture filtrate, made from a
non-virulent strain of Bacillus anthracis. Over 14 million doses of
BioThrax have been administered to more than three million
individuals.
About Emergent
BioSolutionsEmergent BioSolutions Inc. is a global life
sciences company seeking to protect and enhance life by focusing on
providing specialty products for civilian and military populations
that address accidental, intentional, and naturally occurring
public health threats. We aspire to be a Fortune 500 company
recognized for protecting and enhancing life, driving innovation,
and living our values. Additional information about the company may
be found at www.emergentbiosolutions.com. Find us on LinkedIn and
follow us on Twitter @emergentbiosolu and Instagram
@life_at_emergent.
Investor Contact:Robert G.
BurrowsVice President, Investor
Relations240-631-3280burrowsr@ebsi.com
Media Contact:Lynn KiefferVice
President, Corporate
Communications240-631-3391KiefferL@ebsi.com
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