Imvamune is a MVA-BN (a strain of the Modified Vaccinia Ankara) based third-generation smallpox vaccine candidate that has been shown to be well tolerated in healthy subjects in clinical trials.
With the government support, the company’s procurement contract was modified, increasing the total value of the contract by $32m to $544m.
The pivotal Phase 3 trial will begin enrollment of 4,000 subjects in the first half of 2013 to support a Biologics License Application (BLA) submission to the Food and Drug Administration.
Bavarian Nordic president and CEO Anders Hedegaard said the additional $32m from the Department of Health and Human Services will allow Bavarian Nordic to move forward with the Phase 3 trial of Imvamune smallpox vaccine.
"This study will greatly expand our already promising database and further demonstrate the safety of this important bioterrorism medical countermeasure," Hedegaard added.
Till date, the company has delivered more than 8 million doses of Imvamune to the Strategic National Stockpile, and the rest 20 million doses are expected to be delivered in 2012 and 2013.