29.04.2024 15:03:43 - dpa-AFX: GNW-Adhoc: Bavarian Nordic Initiates Rolling Submission of Biologics License Application with FDA for its Chikungunya Vaccine Candidate
COPENHAGEN, Denmark, April 29, 2024 - Bavarian Nordic A/S (OMX: BAVA) today
announced that it has initiated the rolling submission process with the U.S.
Food and Drug Administration (FDA) for a Biologics License Application (BLA) for
the licensure of its CHIKV VLP vaccine candidate for immunization against
chikungunya virus infection in individuals 12 years of age and older.
Bavarian Nordic will submit additional data over the coming months, aiming to
complete the BLA submission before the end of the first half of 2024 to support
a potential FDA approval of the vaccine in the first half of 2025.
"We are pleased to advance our chikungunya vaccine candidate into the
registration phase and look forward to working with the regulators in our
efforts to bring this novel product to the market. We have generated robust data
in adolescents, adults and older adults, suggesting a strong and durable
antibody response against the chikungunya virus and a fast onset of protection,
which supports our belief that we can establish our vaccine as the preferred
choice in this emerging market," said Paul Chaplin, President and CEO of
Bavarian Nordic.
The CHIKV VLP vaccine candidate received Breakthrough Therapy designation and
Fast Track designation from the FDA in October 2020 and April 2018,
respectively, and PRIME designation from the EMA in September 2019. These
designations are designed to facilitate the development or expedite review of
medicines that either target an unmet medical need or may demonstrate
substantial improvement over available therapy. In February 2024, the Committee
for Medicinal Products for Human Use (CHMP) under EMA granted accelerated
assessment for the MAA for the CHIKV VLP vaccine candidate, which Bavarian
Nordic plans to submit by mid-2024.
About chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV). CHIKV disease typically presents with acute symptoms, including fever,
rash, fatigue, headache, and often severe and incapacitating joint pain. While
mortality is relatively low, morbidity is high; nearly 50% of individuals with
CHIKV disease have debilitating long-term symptoms that can intensify with age.
In the past 20 years, the CHIKV has emerged in several previously non-endemic
regions in Asia, Africa, southern Europe, and the Americas, often causing large
unpredictable outbreaks.
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. 09 / 2024
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