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|Emergent BioSolutions Awarded Two Grants from NIAID to Support Development of the Company's Recombinant Botulinum Vaccine (rBOT) and Next Generation Anthrax Vaccine (NGAV) Candidates|
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.