GAITHERSBURG, Md.—Emergent BioSolutions, a privately-held biopharma­ceutical company, in June signed an agree­ment with sanofi pasteur, the vaccines busi­ness of the sanofi-aventis Group, giving the company exclusive, worldwide rights to Emergent BioSolutions' proprietary pro­teins and related technology to develop a novel vaccine against Neisseria meningitidis serogroup B bacterial infections.

 

While there are effective purified polysac­charide and conjugate vaccines available to protect against the other major meningococ­cal serogroups, currently there is no vaccine to protect against Neisseria meningitidis serogroup B infections. Even with intensive medical treatment, meningococcal infection has a fatality rate of up to 10 percent, and approximately 15 percent of survivors are left with serious disability, such as loss of limbs, deafness or brain damage.

 

"Our agreement with sanofi pasteur is an important step forward in the development of a critically needed vaccine to prevent one of the world's deadliest childhood diseases," says Fuad El-Hibri, chairman and CEO of Emergent. "This agree­ment is also consistent with our strategy of selectively establishing relationships with leading phar­maceutical and biotechnology companies for the commercializa­tion of certain of our product can­didates."

 

It is also an opportunity that might not have presented itself had Emergent not acquired U.K.-based vaccine company Microscience just over a year ago.

 

"Microscience had already initi­ated discussions with sanofi before the acquisition," recalls Kyle Keese, senior VP, marketing and commu­nications for Emergent. "So that acquisition, in addition to bring­ing us a significant commercial pipeline of preclinical and clinical-stage vaccines, also brought in the collaboration with sanofi."

 

The two companies will joint­ly evaluate and develop a pool of four antigen candidates that could serve as the basis of a multivalent subunit vaccine against Neisseria meningitidis infection. Emergent BioSolutions identified these pro­tein candidates using its patented Signature-Tagged Mutagenesis functional genomics technol­ogy—another inheritance from the Microscience acquisition—in combination with functional pro­teomics techniques.

 

Under the terms of the agree­ment, Emergent will have primary responsibility for product devel­opment activities from the current preclinical testing through Phase I clinical trials, Keese reports. Then sanofi pasteur will have pri­mary responsibility for product development activities from ini­tiation of Phase 2 studies through to regulatory approval, and for all commercialization activities including world- wide sales and marketing.