* First regulatory submission completed for CHIKV VLP seeking approval of the
vaccine candidate for immunization against chikungunya virus infection in
individuals 12 years of age and older
* Represents first BLA for a chikungunya vaccine for adolescents
COPENHAGEN, Denmark, June 17, 2024 - Bavarian Nordic A/S (OMX: BAVA) today
announced the completion of the rolling submission process which was initiated
in April 2024 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. Pending acceptance from the FDA, the BLA could support a
potential approval of the vaccine in the first half of 2025.
The BLA submission includes results from two phase 3 clinical trials in more
than 3,600 healthy individuals 12 years of age and older, demonstrating that the
CHIKV VLP vaccine was highly immunogenic, as demonstrated by the strong
induction of chikungunya neutralizing antibodies against chikungunya 21 days
after vaccination, with antibody titers equal to or above the threshold agreed
with authorities as a marker of seroprotection. The CHIKV VLP vaccine was well-
tolerated across both studies and vaccine-related adverse events were mainly
mild or moderate in nature.
Bavarian Nordic also intends to submit a Marketing Authorisation Application
(MAA) with the European Medicines Agency (EMA) by the end of the first half
2024. The MAA has already been granted accelerated assessment, which means the
CHIKV VLP vaccine could potentially obtain approval by the European Commission
in the first half of 2025.
"The completion of the BLA submission marks a significant milestone in the
development of our CHIKV VLP vaccine and represents an important contribution to
the development of preventative solutions for individuals 12 years of age and
older at risk of chikungunya virus from bites by infected mosquitos. With the
near-term anticipated MAA submission to EMA, we are looking towards potential
approval of the vaccine in the first half of 2025 and subsequent launch in both
the US and EU," said Paul Chaplin, President and CEO of Bavarian Nordic.
About CHIKV VLP
CHIKV VLP is an adjuvanted VLP-based vaccine candidate for active immunization
against chikungunya disease. Pending regulatory approval, the single-dose
vaccine will be made in a pre-filled syringe, designed to ease administration by
saving vaccinators' time and reducing the risk of administrative errors.
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.
About chikungunya
Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), which belongs to the group of arboviruses like dengue virus. 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. Recent data(1) suggest that chikungunya is severely
underreported and often misdiagnosed as dengue fever due to lack of proper
testing.
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. 18 / 2024
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(1) Ribas Freitas AR, Pinheiro Chagas AA, Siqueira AM, Pamplona de Góes
Cavalcanti L. How much of the current serious arbovirus epidemic in Brazil is
dengue and how much is chikungunya? Lancet Reg Health Am. 2024 Apr
30;34:100753. doi: 10.1016/j.lana.2024.100753. PMID: 38711542; PMCID:
PMC11070701.
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