31.05.2024 16:33:50 - dpa-AFX: GNW-Adhoc: Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine
COPENHAGEN, Denmark, May 31, 2024 - Bavarian Nordic A/S (OMX: BAVA) today
announced the submission of a supplemental Biologics License Application (sBLA)
to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-
dried formulation of JYNNEOS(®) for prevention of smallpox and mpox disease in
adults 18 years of age and older.
The liquid-frozen formulation of JYNNEOS(®) was approved by the FDA in September
2019. It remains the only approved mpox vaccine anywhere in the world and the
only non-replicating smallpox vaccine approved in the U.S. This formulation of
JYNNEOS(®) has specific cold-chain requirements, while the freeze-dried
formulation provides more flexibility in terms of transportation, storage
conditions and shelf life, thus being more suitable for long-term stockpiling.
The sBLA submission is based on clinical data from a Phase 3 lot consistency
study and data from a Phase 2 study that showed bioequivalence between the
freeze-dried and liquid-frozen formulations, as well as other clinical and non-
clinical data, including process development and manufacturing data. Following a
standard review time of 10 months for the sBLA, approval of the freeze-dried
formulation could be obtained in the first quarter of 2025.
"We are pleased to finalize this submission, marking a significant milestone in
our development of this next generation of our smallpox/mpox vaccine and in our
partnership with the U.S. government on developing a vaccine suited for
addressing public health challenges, now and in the future. The licensure of
this new formulation, which is ideally suited for long-term stockpiling, should
ensure future orders beyond the current contract valued at almost USD 300
million with the U.S. government" said Paul Chaplin, President and Chief
Executive Officer of Bavarian Nordic.
Bavarian Nordic has an ongoing contract with the U.S Biomedical Advanced
Research and Development Authority (BARDA) valued at USD 299 million to supply a
freeze-dried doses of JYNNEOS(®) for stockpiling. This contract allows the
production of freeze-dried doses prior to the licensure of the formulation and
the Company has started to manufacture vaccines under this contract in the first
quarter of 2024, aiming to fulfil the first USD 119 million contract option
during this year. This has already been included in the Company's financial
guidance for 2024, which therefore remains unchanged. Additional options valued
at USD 180 million are pending exercise by BARDA. The bulk vaccine for
manufacturing the freeze-dried vaccines were initially manufactured under
previous contracts, however a significant part of this inventory was repurposed
for manufacturing of liquid-frozen doses during the mpox outbreak in 2022-2023
and would thus need to be replaced via new orders to enable fulfilment of the
remaining freeze-dried option.
About the smallpox/mpox vaccine
MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox
vaccine and the only mpox vaccine approved in the U.S. and Switzerland (marketed
as JYNNEOS(®)), Canada (marketed as IMVAMUNE(®)), the EU/EAA and United Kingdom
(marketed as IMVANEX(®)). Originally developed in collaboration with the U.S.
government to ensure the supply of a smallpox vaccine for the entire population,
including immunocompromised individuals who are not recommended vaccination with
traditional replicating smallpox vaccines, MVA-BN has been indicated for use in
the general adult population in individuals considered at risk for smallpox or
mpox infection.
Bavarian Nordic has been a long-term supplier of the vaccine to the U.S. and
Canada, as well as numerous other countries as part of their national biological
preparedness. During the 2022-2023 mpox outbreak, Bavarian Nordic has
furthermore supported governments and supranational organizations by expanding
access to the vaccine to more than 70 countries worldwide.
Federal funding acknowledgements
This project has been funded in whole or in part with federal funds from the HHS
Office of the Assistant Secretary for Preparedness and Response, Biomedical
Advanced Research and Development Authority, under Contract No.
HHSO100201700019C.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company with a mission to protect
and save lives through innovative vaccines. We are a global leader in smallpox
and mpox vaccines, supplied to governments to enhance public health preparedness
and have a strong portfolio of vaccines for travelers and endemic diseases. For
more information visit www.bavarian-nordic.com (http://www.bavarian-nordic.com).
Forward-looking statements
This announcement includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control, that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning 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 which may accompany the forward-looking statements. We
undertake no obligation to publicly update or revise forward-looking statements
to reflect subsequent events or circumstances after the date made, except as
required by law.
Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, rss@bavarian-
nordic.com (mailto:rss@bavarian-nordic.com), Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com
(mailto:graham@paddockcircle.com), Tel: +1 781 686 9600
Company Announcement no. 17 / 2024
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