US govt extends Imvamune smallpox vaccine trial

The US government-owned National Institutes of Allergy and Infectious Diseases has extended an existing contract (RFP-2) with Danish firm Bavarian Nordic to include the initiation of a larger Phase II study with Imvamune, the company's investigational smallpox vaccine, in people diagnosed with atopic dermatitis. The extension will prolong the original contract to 2010 and has a value of $15.0 million, with the majority of revenue expected at the end of 2008 and beginning of 2009.

Anders Hedegaard, chief executive of Bavarian Nordic, welcomed the move, saying that "this is an important step in our efforts to develop a safe next-generation smallpox vaccine for the entire population, and it builds further on our long-term partnership with the US government."

The original RFP-2 contract, awarded in 2004 by the NIAID, included a Phase II study with Imvamune in people diagnosed with atopic dermatitis. However the need for more clinical safety data in this population has increased due to requirements from the Food and Drug Administration to generate data to support an Emergency Use Authorization for the vaccine, the firm noted.