Barr Pharmaceuticals undertakes first biologic drug initiative

MONTVALE, N.J. The Food and Drug Administration will review a generic drug maker’s application for a biologic drug.

Barr Pharmaceuticals announced Thursday that the FDA would review subsidiary Duramed Pharmaceuticals’ biologics license application for a Adenovirus Types 4 and 7 Live Oral Vaccines. Barr said this represents its first in-house biologics initiative.

“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,” Barr chairman and chief executive officer Bruce Downey said in a statement. “Working together with Department of Defense over the past six years, we have made significant progress in meeting critical unmet medical needs for our armed forces.”

The vaccines are designed to fight against wild type 4 and type 7 adenovirus-using antibodies. Both viruses cause respiratory infections, and type 4 can cause acute respiratory disease, which often affects military recruits. Barr and the DoD conducted a Phase 3 study that involved more than 4,000 male and female recruits at Navy and Army training facilities. The DoD and Barr entered an agreement to develop the vaccines in 2001.