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The rBOT Grant is the First Government Award in Support of the
Company's Botulinum Vaccine Program
ROCKVILLE, Md.--(BUSINESS WIRE)--July 24, 2008--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(R)
(Anthrax Vaccine Adsorbed) and the immunostimulatory
oligodeoxynucleotide compound CPG 7909 (VaxImmune(TM)) 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(R) (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.
CONTACT: 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
SOURCE: Emergent BioSolutions Inc.
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