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Reduced Dosage and Intramuscular Administration ApprovedROCKVILLE, Md., Dec 19, 2008 (BUSINESS WIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food
and Drug Administration (FDA) has approved Emergent's
supplemental Biologics License Application (sBLA) for Anthrax Vaccine
Adsorbed (BioThrax(R)), the only FDA-licensed vaccine to
prevent disease caused by Bacillus anthracis. The supplement
provides for a change in the route of administration and a reduction in
the total number of vaccinations. The new schedule for BioThrax is five
intramuscular (IM) doses at 0, 1, 6, 12 and 18 months, compared with the
former schedule of six subcutaneous (SC) doses at 0, 2 weeks and 1, 6,
12, 18 months.
The sBLA was based on results from a planned interim analysis of data
from a large multicenter study initiated by CDC in 2002. This study is
designed to evaluate whether as few as three doses of BioThrax
administered over six months, with booster doses up to three years
apart, will confer an adequate immune response. CDC will complete
further data analysis in 2009, and Emergent may submit a new sBLA to
allow for further reduction in the number of required doses if supported
by the data.
Daniel Abdun-Nabi, chief operating officer and president of Emergent
BioSolutions said, "Today's announcement is an exciting milestone in our
continued mission to advance BioThrax. We are pleased that the U.S.
Government shares our commitment to enhancing this critical
countermeasure. The CDC is to be applauded for their hard work and
diligence throughout this important effort."
About BioThrax(R) (Anthrax Vaccine Adsorbed)
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax
infection. It is licensed by the FDA as a pre-exposure prophylaxis for
use in adults who are at high risk of exposure to anthrax spores.
BioThrax is manufactured from a culture filtrate, made from a
non-virulent strain of Baccillus anthracis and contains no dead or live
bacteria. BioThrax is administered by intramuscular injection in five
doses, with an annual booster dose recommended thereafter. Since 1998,
the U.S. government has procured nearly 32 million doses of BioThrax.
During that time period, nearly 7.9 million doses have been administered
to more than two million military personnel. BioThrax cannot cause
anthrax infection. Please visit http://www.emergentbiosolutions.com/pdf/emergent_biothrax_us.pdf
for full prescribing information.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of immune-related
biologic products, consisting of vaccines and therapeutics that assist
the body's immune system to prevent or treat disease. Emergent's
marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only
vaccine approved by the U.S. Food and Drug Administration for the
prevention of anthrax infection. Emergent's clinical pipeline includes
programs focused on anthrax, botulism, typhoid, tuberculosis, hepatitis
B and chlamydia.
Safe Harbor Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management, including any potential future securities
offering, and any other statements containing the words "believes",
"expects", "anticipates", "plans", "estimates" and similar expressions,
are forward-looking statements. There are a number of important factors
that could cause the company's actual results to differ materially from
those indicated by such forward-looking statements, including
appropriations for BioThrax procurement; our ability to obtain new
BioThrax sales contracts with the U.S. government; our plans to pursue
label expansions and improvements for BioThrax; our plans to expand our
manufacturing facilities and capabilities; the rate and degree of market
acceptance and clinical utility of our products; the timing of and our
ability to obtain and maintain regulatory approvals for our other
product candidates; our commercialization, marketing and manufacturing
capabilities and strategy; our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing; and
other factors identified in the company's quarterly report on Form 10-Q
for the quarter ended September 30, 2008 and subsequent reports filed
with the SEC. The company disclaims any intention or obligation to
update any forward-looking statements as a result of developments
occurring after the date of this press release.
SOURCE: Emergent BioSolutions Inc.
Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media Contact:
Tracey Schmitt
Director, Corporate Communications
301-795-1800
SchmittT@ebsi.com
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