Bavarian Nordic A/S was awarded a sole source contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), for the procurement of freeze-dried Imvamune smallpox vaccine. The potential value of the initial base and optional awards is in excess of $539 million.

The initial award in the contract calls for the manufacturing and storage of $100 million of Imvamune bulk. This is the third such award to manufacture vaccine bulk; with the two prior orders totaling $233 million. The initial options in the contract are divided between two distinct areas, the first of which is the filling and freeze-drying of Imvamune from the three bulk awards, with total potential value of $299 million. The second part of the contract contains provisions for clinical development, regulatory commitments, and parts of the establishment and validation of fill/finish activities, with potential value of up to $140 million. The award also contains options to acquire additional vaccine bulk and/or freeze-dried doses of Imvamune in the future.

To ensure the production capacity to secure the future Imvamune stockpile at the U.S. Strategic National Stockpile, Bavarian Nordic will invest approximately $75 million over the coming years in the construction of a fill/finish manufacturing line at its facility in Denmark. As part of Bavarian Nordic’s long-standing partnership with BARDA, a potential optional award of up to $33 million (part of the $140 million mentioned above) is dedicated to process transfer, and validation of the new manufacturing line. This strategic investment will allow Bavarian Nordic to recognize the full value chain of the manufacturing process, to maintain control of the product cycle throughout, and the potential to provide these services to third parties in the future.

“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 ” said Paul Chaplin, president and chief executive officer, Bavarian Nordic. “Our latest strategic investment that will expand our manufacturing capacities will add value, not only to our partnerships, but also to our proprietary pipeline.”