Bavarian Nordic A/S. a biotechnology company developing immunotherapies headquartered in Kvistgaard Denmark with operations in Germany and the US, reports that the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health & Human Services, has ordered a bulk supply of Imvamune, a non-replicating smallpox vaccine, in a deal valued at $100 million.

Under this new order, Bavarian Nordic will manufacture and store a bulk supply of Imvamune. This bulk material can 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 US authorities. This new bulk vaccine order will be produced and revenue recognized in 2017. This order follows a $133 million order for bulk Imvamune in 2015 resulting in a total current investment of $233 million to date. A contract for the eventual delivery of finished product to the US government is still required prior to determining a dose price of the freeze-dried formulation.

The freeze-dried version of Imvamune is expected to reduce the lifecycle management costs based on a longer shelf life and will replace the liquid-frozen version that is currently stockpiled in the US Strategic National Stockpile (SNS). The freeze-dried version is well positioned to fulfill the US government's long-term requirements for sufficient non-replicating smallpox vaccine to protect 66 million Americans, comprised of those individuals for whom a replicating smallpox vaccine is not recommended and their household contacts.

Imvamune is being developed as a smallpox vaccine for individuals for whom traditional replicating vaccines are contraindicated, such as people with atopic dermatitis and HIV. Imvamune is the company's most advanced commercial program.

Source: Bavarian Nordic