Bavarian Nordic is constructing a US$75 million fill & finish facility in Denmark on the back of future US government contracts to supply smallpox vaccine Imvamune.
Last September, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded Danish vaccine manufacturer Bavarian Nordic a contract for the manufacturing and storage of its smallpox vaccine Imvamune.
The deal, worth more than $539 million (€460 million), is the third such award to manufacture vaccine bulk to the US Department of Health and Human Services (HHS).
And to support the agreement, Bavarian Nordic is building a fill & finish plant, something CEO Paul Chaplin said was encouraged by the potential for increased demand from the US government.
“There is precedent to expect that additional doses either of bulk or of final doses will come from the US government,” he told investors during a financial call this week.
“So there is great business in the short term and really great business in the long term. And we have been encouraged by the US government to build this fill/finish plant not for these initial orders, but for the future orders to come.”
He added the plant will come online in 2021, when the firm will begin converting the bulk substance into freeze-dried doses.
BLA and Imvamune Revenues
For the first quarter 2018, the firm generated revenues of around $2 million but expects this to rise to around $83 million for the full year.
“A very minor part of the revenues in Q1 was related to a rest of world delivery of Imvamune, but none to the US government. All the US government deliveries or invoicing will occur later in the year,” said Chaplin.
Imvamune is approved in Canada and in the European Union (marketed under the trade name Imvanex). Bavarian Nordic anticipates filing a Biologics License Application in the US in the second half of this year.
“In terms of the BLA, all the data is set and completed. We’ve already had discussions with the FDA last year in terms of some of the datasets and the like. And we’re currently planning to have a couple more meetings with the FDA to clarify some of the CMC or manufacturing and some of the clinical issues.”