The U.S. Biomedical Advanced Research and Development Authority (BARDA) have exercised another option under the ongoing contract for freeze-dried MVA-BN smallpox vaccine.
The option, valued at USD 44 million, will cover qualification of the new fill-finish facility, currently being established at the company’s manufacturing site in Denmark, as well as transfer and validation of the freeze-drying process. The majority of this contract option is expected to be revenue recognized in 2019 and 2020, reports the company.
The second option under the contract
This is the second option exercised under the contract. In 2017, BARDA exercised an option of USD 37 million to cover development costs associated with the Phase 3 study required for the eventual approval of the freeze-dried MVA-BN smallpox vaccine. This Phase 3 will be initiated in the first half of 2019.
“We are well underway in the establishment of our new fill-finish facility, which will not only unlock the full value of our smallpox vaccine contracts with the U.S. Government, but will also strengthen the commercial foundation of our company in the future as we become a fully-fledged vaccine manufacturer. The option awarded will support the final stages of bringing the facility into operations, and we look forward to continuing our successful partnership with BARDA in the development and production of biological countermeasures to protect the U.S. population, ” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.
A new fill-finish facility
Bavarian Nordic is currently constructing a 3,200 sqm fill-finish facility in extension of its existing large-scale vaccine manufacturing facility in Denmark. Utilizing isolator technology, and with large-scale lyophilization, labelling and packaging line. The new facility has been designed with a potential annual capacity of up to 40 million doses of liquid vaccines and 8 million doses of freeze-dried vaccines.
The company is investing approximately USD 75 million in the project, and the newly awarded option from BARDA will support the process transfer and validation activities, required for finalizing the production of freeze-dried MVA-BN smallpox vaccine.
The construction began in March 2018, and the facility is expected to be fully operational in 2020, upon which qualification and validation of the process for freeze-dried MVA-BN will begin, before initiating commercial manufacturing in 2021.
Image: Bavarian Nordic