Emergent BioSolutions Bags VaxImmune License Agreement

Written by Staff Writer

Sunday, 18 March 2007

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Coley Pharmaceutical Group, Inc revealed that it has signed a license agreement with Emergent BioSolutions Inc according to which Emergent can make use of its VaxImmune vaccine adjuvant compound in the development of new anthrax vaccines.

Announcing the deal, Emergent BioSolutions' CEO and Chairman Fuad El-Hibri said, "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. 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."

El-Hibri added that this deal shows that his company is committed to the development of Anthrax vaccines. 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)", he said.

VaxImmune is a proprietary Toll-like receptor 9 (TLR9) agonist which induces 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.

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.

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.