Barr Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has accepted for review Duramed Pharmaceuticals, Inc.'s Adenovirus Types 4 and 7 Live Oral Vaccines Biologics License Application (BLA).
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. The Prescription Drug User Fee Action (PDUFA) date for the Adenovirus BLA is July 31, 2009.
"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," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer. "Working together with 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."
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 3 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.
Barr/DOD Project Summary
In 2001, Barr entered into a multi-year agreement with the U.S. Department of Defense (DOD) for clinical development of the Adenovirus Vaccines, Type 4 and 7. As part of the agreement, Barr constructed a dedicated facility to support the production of supplies necessary to complete the approval process and support projected needs of the DOD. The Company completed the Phase I study in April 2006, and completed the Phase III clinical program in April 2008.
The finished dosage form is an orally administered 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 coating. The vaccines are administered as individual oral tablets taken together.