Emergent BioSolutions initiates Phase II trial of oral typhoid vaccine candidate

ROCKVILLE, MD. —Emergent BioSolutions Inc. announced June 5, 2008, that dosing of patients has begun in a U.S. Phase II clinical trial of the company’s single-dose oral typhoid vaccine candidate.

This randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial is being conducted in healthy adults. The company anticipates that trial results will be available by the end of the year. This U.S. study will evaluate vaccine manufactured at the large-scale facility planned for commercial launch.

This trial is designed to confirm the safety and immunogenicity of the vaccine, and Phase III trials are expected to begin in 2009. If approved, this candidate would be the first, single-dose, drinkable typhoid vaccine available for adults and children.

“In previous clinical studies, this vaccine candidate has demonstrated promising immunogenicity and safety results in both children and adults,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “We are pleased with our continued progress in the development of this important vaccine candidate, which is a cornerstone in our company’s mission of protecting life.”

Stephen Lockhart, senior vice president of product development for Emergent BioSolutions, said, “Typhoid fever continues to be a high disease burden worldwide, claiming over 200,000 lives annually, most notably children living in developing countries where the disease is endemic. In addition, there is increasing incidence of antibiotic resistant strains of the disease which would suggest an even greater need for efficient and effective vaccination.”

The vaccine is intended to be administered in a single, drinkable dose for adults and children residing in typhoid endemic regions as well as individuals traveling to these endemic regions.

For the current clinical study, approximately 200 patients will be enrolled across three sites in the U.S. Screening of patients for this study began in early May 2008. Additional trials are being designed that would address the needs of adults, children and senior citizens living in and traveling to typhoid endemic regions.

Emergent BioSolutions is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics. Its development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and Chlamydia. Its BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax.