ARTICLE | Company News

Bavarian Nordic, U.S. Department of Health and Human Services infectious news

September 15, 2014 7:00 AM UTC

Bavarian Nordic said HHS's Biomedical Advanced Research and Development Authority (BARDA) exercised an option valued at up to $118 million to supply 4 million doses of Imvamune smallpox vaccine to the U.S. Strategic National Stockpile. Bavarian Nordic will receive an upfront payment of $18 million, while the remaining $100 million will be recognized pro rata with the deliveries of the doses. The company said this is the second option exercised to purchase additional doses of Imvamune to maintain the stockpile.

Bavarian Nordic has been delivering a liquid-frozen formulation of the vaccine to the stockpile since 2010 under a 2007 and 2013 contract. The company has a separate contract with BARDA to develop the freeze-dried formulation, which could have a longer shelf life than the liquid-frozen formulation. Bavarian Nordic plans to submit the data from a Phase II trial evaluating the freeze-dried formulation to FDA next year for potential production and supply to begin in 2016, which would require a new government contract (see BioCentury, June 11, 2007 & April 22, 2013). ...