Covalent, Emergent BioSolutions sign Anthrax immune globulin development contract

By Angela McDaniels

Seattle, Dec. 5 - Covalent Group Inc. and Emergent BioSolutions Inc. said they have signed a contract under which Covalent will provide Emergent with operational support in the development of an anthrax immune globulin product for the treatment of anthrax infection.

Under the $1.2 million contract, Covalent will support Emergent's anthrax immune globulin development program by providing project management, study site management, field operations, data management, biostatistical services and medical writing services.

The Emergent anthrax product is anticipated to be an intravenous formulation with high titers of antibodies to protect against anthrax infection Immune globulins are being used increasingly in the treatment of diseases mediated by circulating toxins, such as tetanus, and specific infections, such as hepatitis B, the companies said.

Emergent BioSolutions has been collecting plasma containing high titer levels of anthrax antibodies over the past year from donors who have been vaccinated with BioThrax, the only anthrax vaccine licensed by the U.S. Food and Drug Administration. BioThrax is manufactured by BioPort Corp., a subsidiary of Emergent.

Anthrax disease is an infection caused by the spore-forming bacillus anthracis and is considered a likely biological warfare agent because of its ability to infect via the respiratory route, the high mortality of anthrax inhalation and its use as a bioterror agent in 2001, the companies said.

Emergent BioSolutions, based in Gaithersburg, Md., develops products that harness the immune system to treat and prevent disease.

Covalent Group is a clinical research organization that designs and manages clinical trials and Patient Disease Registries for the pharmaceutical, biotechnology and medical device industries. It is based in Wayne, Pa.

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