Emergent BioSolutions Inc. (NYSE:EBS) announced today that its
investigational anthrax vaccine, NuThraxTM (Anthrax Vaccine
Adsorbed with CPG 7909 Adjuvant), has been granted Fast Track
Designation by the U.S. Food and Drug Administration (FDA). The vaccine
candidate, also known as AV7909, consists of BioThrax®
(Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory
oligodeoxynucleotide compound, CPG 7909, and is currently being
evaluated in a Phase 1b clinical trial for safety, tolerability, and
immunogenicity. The FDA's Fast Track Development Program provides for
expedited regulatory review of drugs and biologics that treat serious or
life threatening diseases and that demonstrate the potential to address
unmet medical needs.
“Emergent is pleased to receive Fast Track Designation for NuThrax,”
said Daniel J. Abdun-Nabi, president and chief operating officer of
Emergent BioSolutions. “Expedited regulatory review could mean more
frequent communications with FDA, priority review of Biologics License
Applications (BLA) for our vaccine, and a rolling BLA submission, which
allows FDA to review sections of the BLA in advance of receiving the
complete submission.”
The Phase 1b trial for NuThrax is being conducted with support from a
development contract that is jointly administered under contract number
HHSN272200800051C by the National Institute of Allergy and Infectious
Diseases (NIAID), a component of the National Institutes of Health
(NIH), and the Office of the Biomedical Advanced Research and
Development Authority (BARDA) of the Department of Health and Human
Services (HHS).
About Emergent BioSolutions Inc.
Emergent BioSolutions protects and enhances life by developing and
manufacturing vaccines and therapeutics that are supplied to healthcare
providers and purchasers for use in preventing and treating disease.
Emergent’s marketed and investigational products target infectious
diseases, oncology, and autoimmune disorders. Additional information
about the company may be found at .
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, our expected revenue growth and net earnings for 2011, and any
other statements containing the words “believes”, “expects”,
“anticipates”, “plans”, “estimates”, “may”, “would”, “will”, 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 the success of our preclinical studies and
clinical trials of our product candidates and post-approval clinical
utility of our products; the rate and degree of market acceptance of our
products; the success of our ongoing and planned development programs;
the timing of and our ability to obtain and maintain regulatory
approvals for our other product candidates; our plans to pursue label
expansions and improvements for BioThrax; 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 March 31, 2011 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.

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