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These oral vaccines represent Barr's first in-house biologics development initiative and demonstrate the company's ability to develop, manufacture and conduct clinical trials for biologic products, said Barr. The Prescription Drug User Fee Action date for the adenovirus biologics license application (BLA) is July 31, 2009.
The pivotal clinical data supporting the company's BLA for the adenovirus (ADV) vaccines, types 4 and 7 resulted from a large placebo-controlled Phase III study designed to evaluate the safety and efficacy of type 4 ADV oral vaccine to prevent wild type 4 adenovirus-associated acute respiratory disease (ARD) and for the type 7 ADV oral vaccine to induce neutralizing antibody to type 7 adenovirus.
The study involved over 4,000 male and female recruits at Naval and Army training facilities. The clinical trial results support the safety and tolerability of the oral type 4 and type 7 ADV vaccines, the efficacy of the oral type 4 ADV vaccine in reducing the attack rate of wild type 4 adenovirus-associated febrile ARD and the ability of type 7 ADV vaccine to produce neutralizing antibodies, said Barr.
Bruce Downey, Barr's chairman and CEO, said: "We are very pleased to have our first BLA accepted for filing by the FDA, and believe that we have achieved a significant step in building our biologics program.
"Working together with the Department of Defense (DOD) over the past six years we have made significant progress in meeting a critical unmet medical need for our armed forces. DOD's efforts to efficiently execute the clinical trial have enabled us to achieve this clinical milestone."
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