Bavarian Nordic A/S received $37 million from Biomedical Advanced Research and Development Authority as part of a contract for freeze-dried smallpox vaccine.
The total contract with the U.S. federal agency is for up to $539 million.
The biotechnology company will use the funding to meet development costs associated with the phase 3 study required for the approval of the vaccine called Imvamune. The study will be a lot consistency study in healthy volunteers across several production lots of freeze-dried Imvamune, similar to the earlier completed phase 3 study of liquid-frozen Imvamune.
The vaccine is approved in the EU, where it is marketed under the brand name of Imvanex, and in Canada. Although not yet approved in the U.S., Imvamune is currently stockpiled by the U.S. government for emergency use in people for whom replicating smallpox vaccines are contraindicated.
The freeze-dried formulation has a potential shelf life of more than five years and would simplify the storage and shipping logistics compared to liquid-frozen vaccine.