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This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Barr's adenovirus vaccines constitute its first biologics BLA: Barr's adenovirus types 4 and 7 live oral vaccines carry an FDA user fee date of July 31, 2009, making it the company's first in-house biologics to reach FDA review. Barr, through its Duramed subsidiary, entered into a multi-year agreement in 2001 to develop the vaccines for the U.S. Department of Defense. The vaccine product is administered as an oral enteric-coated tablet with an inner tablet core containing live adenovirus - type 4 or type 7 - surrounded by an outer tablet coat and a final enteric coat. The type 4 and type 7 vaccine tablets are taken together to prevent wild type 4 adenovirus-associated acute respiratory disease and to induce neutralizing antibody to type 7 adenovirus. The BLA is supported by a Phase III placebo-controlled study in more than 4,000 male and female Navy and Army recruits

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