Bavarian Nordic: €30m loan to support smallpox vaccine fill/finish plant

The loan will support construction of a facility aimed at bringing the full production of Imvamune in-house. The news comes a year after Bavarian Nordic won a US$539 (€472) million contract to supply the freeze-dried smallpox vaccine to the US government.

Danish biotech Bavarian Nordic secured the loan from the European Investment Bank. During its second quarter results, CEO Paul Chaplin said the loan both secures the firm’s cash position and supports investments in its manufacturing network.

This includes production of Imvamune, a non-replicating smallpox vaccine set to be filed for approval in the US later this year.

While the vaccine is produced in-house, the fill/finish is carried-out by a third-party manufacturer. But in September 2017, Bavarian Nordic announced construction of a fill/finish plant at its site in Kvistgaard, Demark, after winning a contract from the Biomedical Advanced Research and Development Authority (BARDA) – part of the US Department of Health and Human Services (HHS) – to supply the smallpox vaccine as part of the US Strategic National Stockpile (SNS).

The contract is “the single largest Imvamune order that we have in [our] history,” Chaplin said on the investor call, being worth $539 million, and so the firm is increasing output to supply this.

“In parallel to producing the bulk, we are investing $75 million expanding our manufacturing facility to include our own fill/finish line, capable of producing freeze-dried IMVAMUNE as well as other products,” he said. “This line will come onboard in 2020, whereby $300 million or $299 million of the award will be used to convert all the bulk from this contract and previous contracts into freeze-dried doses.”

Moving in-house

In its 2017 annual report, Bavarian Nordic said: “Since starting deliveries of IMVAMUNE to the SNS [US Strategic National Stockpile] in 2010, Bavarian Nordic has relied on a contract manufacturer for final drug production and filling of the vaccines.

“Now, with the transition to a new and improved version, that requires a different manufacturing process, the Company is preparing to take upon this task itself; the current facility in Denmark is being expanded with a fill/ finish manufacturing line, which will be able to serve both large- and small scale production orders in the future.”

The vaccine is based on Bavarian Nordic’s vaccine platform technology, which uses the inability of its Modified Vaccinia Ankara (MVA) virus to replicate in a vaccinated individual, in contrast to the original smallpox vaccines.

In the Europe and Canada, the vaccine is approved under the name Imvanex.