In 2017, the US government extended its long-running relationship with Bavarian Nordic by entering into a contract worth up to $539 million. More than half of the total is tied to the production of 13 million freeze-dried doses of a smallpox vaccine.
Bavarian Nordic won US Food and Drug Administration (FDA) approval of a liquid-frozen formulation of the vaccine, sold as Jynneos, almost one year ago. Phase 2 results suggested the liquid-frozen and freeze-dried formulations are bioequivalent but Bavarian Nordic needed more data to bring the latter version to market.
Denmark-based Bavarian Nordic may now have that data. In a phase 3 trial funded by a $37 million deal with the US government, Bavarian Nordic showed three lots of the smallpox vaccine induced equivalent antibody responses, causing the pivotal study to meet its primary endpoint.
Bavarian Nordic is yet to share data from the 1,129-subject clinical trial but, with no study subjects suffering serious adverse reactions, said it is in a position to file a supplement with the FDA to seek approval of the freeze-dried formulation. The approval is expected to cover the use of the vaccine in the protection of people against both smallpox and monkeypox.
The filing will move Bavarian Nordic a step closer to realizing the bulk of the revenues covered by its 2017 agreement with the US government. Bavarian Nordic has spent the years since it landed the contract preparing its infrastructure to support the supply agreement.
Upon landing the contract, Bavarian Nordic outlined plans to invest $75 million to build a fill-finish facility in Denmark. The US government provided $44 million last year to support qualification of the facility and transfer and validation of the freeze-drying process.
Bavarian Nordic expects to handle up to 8 million doses of freeze-dried vaccines at the plant once it comes online. The plant will also have capacity to fill and finish up to 40 million doses of liquid vaccines. Bavarian Nordic may make some capacity available to third parties.
“We would be potentially interested in filling up excess capacity for other customers, and we're currently exploring that as we speak,” said Bavarian Nordic CEO Paul Chaplin on a quarterly results conference call with investors earlier this year.
Freeze drying of live virus vaccines, such as Jynneos, can result in a longer shelf life than is achieved by other approaches. The dried product created through the process is reconstituted before use.
Jynneos is currently sold in a liquid-frozen form that is kept at at -25°C to -15°C before being thawed for use. The expiration date for liquid-frozen Jynneos is 36 months from the date of manufacture. The freeze-dried version is expected to have a longer shelf life and could be used to replace expiring doses of other smallpox vaccines in the US stockpile.