With the awarding of a contract from the Biomedical Advanced Research and Development Authority (BARDA), Bavarian Nordic A/S will be the sole source for the freeze-dried IMVAMUNE smallpox vaccine to the U.S. government.
The contract with BARDA, which operates as part of the U.S. Department of Health and Human Services (HHS), is valued at an initial $100 million for the manufacturing and storage of the vaccine. There are options in the contract that are split into two areas. First is the filling and freeze-drying of IMVAMUNE, and second is the clinical development, regulatory commitments and validation of fill/finish activities. The latter has a potential value of up to $140 million. With these factored in, the contract could be worth as much as $539 million in the end.
“We are proud to be part of a long-standing and successful partnership with BARDA and this latest contract starts a new chapter, as we supply an improved formulation of our vaccine as part of the U.S. government commitment to protect the nation from a smallpox outbreak “ Paul Chaplin, president and CEO of Bavarian Nordic, said. “Our latest strategic investment that will expand our manufacturing capacities will add value, not only to our partnerships but also to our proprietary pipeline.”
To guarantee they can meet production capacity, Bavarian Nordic is, in turn, investing $75 million in a new fill/finish manufacturing line in its Denmark facility–a process which could be aided by a $33 million award from BARDA from the potential $140 million from the second part of the contract.