Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has
secured two grants totaling over $4.5 million from The National
Institute of Allergy and Infectious Diseases (NIAID) to fund the
continued development of the company’s rBOT
and NGAV vaccine candidates.
The rBOT grant is for the continued development, over a three-year
period, of a serotype A and B recombinant botulinum vaccine. This is the
first grant that Emergent BioSolutions has received for its botulinum
vaccine program, and such support signals the U.S. government’s
confidence in the candidate.
The NGAV grant provides important funding, over a five-year period, for
animal model development and cGMP manufacturing of clinical lots of
alternative formulations of a next generation anthrax vaccine, which may
then be tested in a subsequent clinical trial. Data from a completed
Phase I trial indicate that this vaccine candidate may be the most
potent anthrax vaccine ever tested in humans with the potential of
providing protection with one or two doses. These results indicate that
this vaccine is a promising next-generation anthrax vaccine candidate,
particularly for possible use for post-exposure prophylaxis (PEP).
"We are very pleased that the NIAID, with
these grants, has elected to support the continued development of both
our rBOT and NGAV candidates,” said Daniel J.
Abdun-Nabi, president and chief operating officer of Emergent
BioSolutions. "These are both important
countermeasures that address critical biopreparedness requirements of
the U.S. government. Our progress to date on both vaccine candidates has
been impressive and we believe that, with continued government support,
we will be able to successfully advance these product candidates towards
commercialization.” About the NGAV candidate
AV7909, one of Emergent’s next generation
anthrax vaccine candidates, is composed of Emergent’s
FDA-approved BioThrax® (Anthrax Vaccine
Adsorbed) and the immunostimulatory oligodeoxynucleotide compound CPG
7909 (VaxImmuneTM) developed by Coley
Pharmaceutical Group (purchased by Pfizer Inc. in 2007). AV7909 has been
successfully tested in multiple non-clinical studies and in a Phase 1/2
clinical trial. In the Phase 1/2 clinical trial evaluating the safety
and immunogenicity of a first generation AV7909 vaccine, the addition of
CPG 7909 to BioThrax increased peak anti-protective antigen (PA) titers
6-fold and reduced the time to peak titer by 21 days compared to
BioThrax alone. Additionally, only two doses of AV7909 were required to
elicit the same serum anti-PA IgG levels achieved by three doses of
BioThrax alone. These results indicate that AV7909 is a promising
next-generation anthrax vaccine candidate, particularly for possible use
for post-exposure prophylaxis.
About the rBot candidate
Emergent’s recombinant botulinum vaccine is
composed of multiple serotypes of botulinum toxin, which have been
detoxified through genetic engineering. The active ingredients in the
vaccine are produced in E. coli using recombinant technology, and
the vaccine formulation includes an aluminum-based adjuvant. With the
addition of the serotype E toxin fragment to the botulinum AB vaccine
last year, Emergent is now poised to provide a botulinum vaccine
designed to protect against toxin types that represent the greatest
bioterrorism threat. The bivalent AB and trivalent ABE botulinum
vaccines have demonstrated efficacy against toxin challenge in animals
when administered in a single dose. The commercial manufacturing
processes have been established and ongoing stability studies show that
the vaccine has a promising stability profile.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a leading biopharmaceutical company
dedicated to one simple mission—to protect
life. We develop, manufacture and commercialize vaccines and
therapeutics that assist the body’s immune
system to prevent or treat disease. Our products target infectious
diseases and other medical conditions that have resulted in significant
unmet or underserved public health needs. Our marketed product, BioThrax®
(Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S.
Food and Drug Administration for the prevention of anthrax infection. www.emergentbiosolutions.com.
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 our expected revenue growth and net
earnings for 2008, 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 the timing of, and the potential
for successful outcomes resulting from future product development
efforts related to rBOT Vaccine Candidate and NGAV Candidate; and our
ability to obtain additional funding from the U.S. government for rBOT
Vaccine Candidate and NGAV Candidate; and other factors identified in
the company’s current report on Form 10-Q for
the quarter ended March 31, 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.
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