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|Emergent BioSolutions Gains Rights To VaxImmune(TM) From Coley Pharmaceutical Group to Expand Its Anthrax Franchise|
Coley's VaxImmune is a proprietary Toll-like receptor 9 (TLR9) agonist designed to induce both an enhanced antibody response and a potent killer T cell immune response to infections in order to achieve and sustain a clinical response without compromising safety.
"As a leading developer of both biodefense and commercial vaccines and therapeutics, we continually assess novel adjuvant technologies as a critical component of our development strategy," stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "We believe that gaining access to a promising adjuvant technology like VaxImmune provides us a distinct advantage. This adjuvant has the potential to significantly enhance immune responses. Securing rights to VaxImmune demonstrates our commitment to developing our anthrax franchise, which includes BioThrax(R) (Anthrax Vaccine Adsorbed), the only FDA licensed vaccine against anthrax infection, as well as development programs focused on improvements to BioThrax, an enhanced anthrax vaccine and an anthrax immune globulin (therapeutic)."
The agreement allows the company to build on promising data from a Phase I clinical study funded by the Defense Advanced Research Projects Agency (DARPA) of the DoD. This double-blind Phase I clinical trial was designed to evaluate the safety and immunogenicity of a combined product candidate using BioThrax and VaxImmune compared to BioThrax alone and VaxImmune alone. This human trial, developed through a collaboration among DARPA, Coley and Emergent BioSolutions, and completed in 2005, involved 69 healthy volunteers and used a three-dose regimen and intramuscular route of administration. The immunogenicity results from this trial were promising. Specifically, the mean peak concentration of antibodies to anthrax protective antigen in participants who received BioThrax plus VaxImmune was approximately 6.3 times higher than in participants who received BioThrax alone. In addition, this mean peak concentration of antibodies to anthrax protective antigen was achieved in approximately three weeks after first injection in participants who received BioThrax plus VaxImmune, which is approximately 21 days sooner than in those participants who received BioThrax alone.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immunobiotics, such as vaccines and therapeutics that induce or assist the body's immune system to prevent or treat disease. The company's biodefense business is focused on developing and commercializing immunobiotics for use against biological agents that are potential weapons of bioterrorism. The company's commercial business is focused on developing immunobiotics for use against infectious diseases which pose significant unmet or underserved public health needs. More information on the company is available at 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, our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management 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 our performance under existing BioThrax(R) sales contracts with the U.S. government, including the timing of deliveries under these contracts; our ability to obtain new BioThrax sales contracts with the U.S. government; our plans for future sales of BioThrax; 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; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company's Registration Statement on Form S-1 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.