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The Danish biotechnology company has been awarded a sole-source BARDA contract valued at more than $539 million for a freeze-dried smallpox vaccine.
On Sep. 27, 2017, Danish biotechnology company Bavarian Nordic announced that it has been awarded a sole-source contract from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services (HHS), for the procurement of freeze-dried Imvamune smallpox vaccine. The initial base award and optional awards are valued at potentially more than $539 million.
The initial award in the contract calls for the manufacturing and storage of $100-million worth of vaccine bulk. This marks the third award from BARDA to manufacture vaccine bulk following two prior orders totaling $233 million. The initial options in the contract are divided into two parts. The first part has a total potential value of $299 million and entails filling and freeze-drying the vaccine from the three bulk awards. The second part has a potential value of up to $140 million and contains provisions for clinical development, regulatory commitments, and parts of the establishment and validation of fill/finish activities. The award also contains options to acquire additional Imvamune vaccine bulk and/or freeze-dried doses in the future.
For its part, Bavarian Nordic will invest approximately $75 million over the next few years to construct a fill/finish manufacturing line at its facility in Denmark to ensure production capacity for securing future Imvamune stockpile at the US Strategic National Stockpile. As part of the company’s long-standing partnership with BARDA, a potential optional award of up to $33 million-part of the $140 million previously mentioned-is dedicated to process transfer and validation of the new manufacturing line.
“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 US government commitment to protect the nation from a smallpox outbreak, “ said Paul Chaplin, president and CEO of Bavarian Nordic, in a company press release. “Our latest strategic investment that will expand our manufacturing capacities will add value, not only to our partnerships, but also to our proprietary pipeline.”
Source: Bavarian Nordic