- Option of 119 million USD exercised for the manufacture of freeze-dried JYNNEOS® in 2023 and 2024
- This is the first set of options worth a total of $299 million to convert existing bulk vaccine, previously purchased by BARDA, into approximately 13 million freeze-dried doses of JYNNEOS.
COPENHAGEN, Denmark, May 18, 2022 – Bavarian Nordic A/S (OMX: BAVA) today announced that the US Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, has exercised the first options under the contract to provide a freeze-dried version of JYNNEOS® smallpox vaccine, thus allowing the manufacture and billing of the first doses of this version in 2023 and 2024.
The options are worth $119 million and represent the first options exercised to convert bulk vaccine, which has already been manufactured and priced under previous contracts with BARDA, into freeze-dried doses of JYNNEOS smallpox vaccine. Additional options on the contract worth $180 million, if exercised, support the conversion of a total of approximately 13 million freeze-dried doses of JYNNEOS smallpox vaccine which are expected to be manufactured in 2024 and 2025. The majority bulk vaccine for these doses has already been manufactured and invoiced.
The transfer of the freeze-drying process to our new fill and finish facility in Kvistgaard was initiated last year and, following an FDA inspection in 2022, will lead to commercial manufacturing in 2023. An addition to liquid JYNNEOS BLA existing frozen will be realized including the Phase 3 data, which has already been completed and reported, as well as the manufacturing data to support the approval of the freeze-dried version of JYNNEOS in 2024. Alongside these activities, we will, with the allocation of this first option, start manufacturing and invoicing doses of freeze-dried JYNNEOS in 2023 and 2024.
Paul Chaplin, President and CEO of Bavarian Nordic, said: “We are pleased to announce the exercise of the first options under our contract with the US government to supply a freeze-dried version of the smallpox vaccine with improved shelf life, which can be manufactured in our new fill and finish plant. This marks an important milestone in our longstanding partnership with the US government to ensure the availability of lifesaving vaccines for everyone.
The content of this announcement does not affect the Company’s expectations regarding financial results for 2022.
This project was funded in part by federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract no. HHSO100201700019C.
About our smallpox vaccine contracts with the U.S. government
Since 2003, Bavarian Nordic has worked with the US government on the development, manufacture and supply of a non-replicating smallpox vaccine to ensure that all populations can be protected against smallpox, including people with immune systems is weakened and are at high risk of adverse reactions to traditional smallpox vaccines, which are based on replicating vaccinia virus strains. To date, the company has provided nearly 30 million doses of the frozen liquid version to HHS, with the vast majority delivered for emergency use ahead of the vaccine’s FDA approval in 2019.
Since 2009, BARDA has supported the development of a freeze-dried version of the vaccine with a longer shelf life to replace stock and in 2017 awarded the company a ten-year contract worth $539 million for the supply of freeze-dried vaccines. Part of this contract (37 million USD) funded the phase 3 study. In addition, under this contract, Bavarian Nordic produced bulk vaccines worth 253 million dollars, which s will add to the existing stock of bulk vaccines manufactured under previous orders, which will collectively translate into approximately 13 million doses to be delivered later. The bulk of the contract (US$299 million), however, will be completed upon delivery of the freeze-dried doses, which will be manufactured in the company’s new fill-finish plant.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company focused on developing, manufacturing and marketing life-saving vaccines. We are a world leader in smallpox vaccines and have long provided the US government with a non-replicating smallpox vaccine, which has been approved by the FDA, also for protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe and Canada. Our commercial product portfolio also contains market-leading vaccines against rabies and tick-borne encephalitis. Through our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unleashing the power of the immune system, including an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also engaged in the development of a next-generation COVID-19 vaccine. For more information, visit www.bavarian-nordic.com.
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are beyond our control, that could cause actual results to differ materially from those discussed in the forward-looking statements. Forward-looking statements include statements regarding our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements that may accompany the forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances after the date of publication, except as required by law.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, tel. : +45 61 77 47 43
United States: Graham Morrell, Paddock Circle Advisors, [email protected]Such. : +1 781 686 9600
Company announcement no. 17 / 2022