Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine
31 Mayo 2024 - 9:33AM
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
vaccineMVA-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
acknowledgementsThis 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 NordicBavarian
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.
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.
ContactsEurope: Rolf Sass
Sørensen, Vice President Investor Relations,
rss@bavarian-nordic.com, Tel: +45 61 77 47 43US: Graham Morrell,
Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686
9600
Company Announcement no. 17 / 2024
Bavarian Nordic AS (TG:BV3)
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De May 2024 a Jun 2024
Bavarian Nordic AS (TG:BV3)
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