Under the terms of a Project BioShield contract, the government is stockpiling 20 million doses of IMVAMUNE in case of a smallpox emergency. The modification of the contract brings its total value to $544 million.
“This additional $32 million from the Department of Health and Human Services will allow Bavarian Nordic to move forward with our phase 3 trial of IMVAMUNE smallpox vaccine,” Anders Hedegaard, the president and CEO of Bavarian Nordic A/S, said. “This study will greatly expand our already promising database and further demonstrate the safety of this important bioterrorism medical countermeasure.”
Bavarian Nordic anticipates that the phase 3 trial will begin enrollment during the first half of 2013, will include 4,000 subjects and could support a Biologics License Application to submit to the U.S. Food and Drug Administration. The modification of the contract is the result of a more expanded design of the study than was initially proposed. Bavarian Nordic has delivered more than eight million doses of IMVAMUNE to the Strategic National Stockpile and anticipates that it will deliver the remainder of the 20 million doses in 2012 and 2013.