Bavarian Nordic A/S this week announced that the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health & Human Services, has ordered a bulk supply of IMVAMUNE non-replicating smallpox vaccine, valued at USD 133 million.
Under this new order, which is an extension of an existing contract, Bavarian Nordic will manufacture and store a bulk supply of IMVAMUNE. This bulk material could be converted into freeze-dried IMVAMUNE at a later date, once the freeze-drying manufacturing process has been transferred to a commercial line, and is approved by the U.S. authorities.
“This order was made possible by previous BARDA funding, which allowed us to identify a new process to extend the shelf-life of the bulk vaccine. This process now offers greater flexibility for stockpiling our vaccines by Governments,” said Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic. “The bulk supply could represent the initial transition to a freeze-dried formulation of IMVAMUNE, once an Emergency Use Authorization has been granted.”
The freeze-dried version of IMVAMUNE is expected to reduce the life cycle management costs based on a longer shelf life and will replace the liquid-frozen version that is currently stockpiled in the U.S. Strategic National Stockpile (SNS). The freeze-dried version is well positioned to fulfill the U.S. Government’s long-term requirements for sufficient non-replicating smallpox vaccine to protect 66 million Americans, comprising those for whom a replicating smallpox vaccine is not recommended and their household contacts.
Bavarian Nordic recently reported positive results from a pivotal Phase 2 study, which demonstrated that the freeze-dried and the liquid-frozen versions of the vaccine induced an equivalent immune response in people. With the clinical development now completed, the only outstanding activity to support the stockpiling of this next-generation of the vaccine by the U.S government is the finalization of the transfer of the manufacturing process, which is expected by the end of the year.
This bulk vaccine order will be produced and revenue recognized in 2016 and into 2017, and thus does not affect the Company’s expectations for the financial results for 2015.