Saint Herblain (France), July 1, 2024 – Valneva
SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announced that the European Commission (EC) has
granted marketing authorization in Europe for Valneva’s single-dose
vaccine, IXCHIQ®, for the prevention of disease caused by the
chikungunya virus in individuals 18 years of age and older. The
approval was unanimously endorsed by Member States following a
stringent assessment by the European Medicines Agency (EMA)1. The
EC decision marks the third approval the Company has received for
IXCHIQ® following approval from the U.S. Food and Drug
Administration (FDA) in November 2023 and Health Canada last
month2. The Company expects to deliver the first doses in Europe in
the fourth quarter of 2024.
IXCHIQ® is the world’s only licensed chikungunya
vaccine available to address this unmet medical need. In accordance
with the International Recognition Procedure (IRP)3, Valneva has
also submitted a Marketing Authorization Application (MAA) to the
UK Medicines and Healthcare products Regulatory Agency (MHRA). An
additional marketing authorization application is under review by
the Brazilian Health Regulatory Agency (ANVISA) to make the vaccine
available in certain Low- and Middle-Income Countries (LMIC), with
potential approval in 2024.
Juan Carlos Jaramillo, M.D., Chief
Medical Officer of Valneva, commented, “The EC approval
marks a crucial milestone toward making this vaccine available to
as many European citizens as possible. In recent years, climate
change has caused the Aedes mosquito, a known carrier of
chikungunya and dengue viruses, to spread to areas in Europe that
were previously unaffected. It is critical to provide a vaccine
solution not only to European travelers going to endemic
chikungunya areas, such as South America or Africa, but also to the
local European populations experiencing invasive mosquito attacks.
We would like to thank our partner, CEPI, for supporting us in this
endeavor.”
Dr. Richard Hatchett, Chief Executive
Officer of the Coalition for Epidemic Preparedness
Innovations (CEPI), commented, “Supported
by CEPI and EU funding, IXCHIQ is the world’s first vaccine
offering protection against the debilitating Chikungunya virus. The
EU’s rapid approval of the vaccine, following recommendation by the
European Medicines Agency, is a historic moment to help protect the
lives and livelihoods of European populations against Chikungunya
outbreaks, which are becoming more frequent and widespread in the
region. But the fight is not over – as a matter of priority CEPI is
working with Valneva and the EU to expand access to the vaccine to
those living in endemic countries who are greatest risk from the
disease.”
The EC marketing authorization follows the
European Medicines Agency’s (EMA) positive opinion a month ago4 and
is supported by data from the pivotal Phase 3 study which were
published in The Lancet, and showed a 98.9% seroresponse rate at 28
days with a single vaccination. This immune response was sustained
for 24 months by 97% of participants and was equally durable in
younger and older adults5. Last month, Valneva reported further
positive pivotal data in adolescents six months after a single
vaccination, which are intended to support filing for potential
label extension for use in adolescents aged 12 to 17 years6. The
data are also expected to support licensure of IXCHIQ® in Brazil,
which would be the first potential approval for use in an endemic
population.
Valneva partnered with CEPI 7 and Instituto
Butantan in Brazil8 to make the vaccine more accessible to LMIC.
The collaboration falls within the framework of the agreement
signed between CEPI and Valneva in July 20199, which provides
funding of up to $24.6 million with support from the European
Union’s Horizon 2020 program.
About ChikungunyaChikungunya
virus (CHIKV) is a mosquito-borne viral disease spread by the bites
of infected Aedes mosquitoes which causes fever, severe joint pain,
muscle pain, headache, nausea, fatigue and rash. Joint pain is
often debilitating and can persist for weeks to years.10In 2004,
the disease began to spread quickly, causing large-scale outbreaks
around the world. Since the re-emergence of the virus, CHIKV has
now been identified in over 110 countries in Asia, Africa, Europe
and the Americas.11 Between 2013 and 2023, more than 3.7 million
cases were reported in the Americas12 and the economic impact is
considered to be significant. The medical and economic burden is
expected to grow with climate change as the mosquito vectors that
transmit the disease continue to spread geographically. As such,
the World Health Organization (WHO) has highlighted chikungunya as
a major public health problem.13
About Valneva SEWe are a
specialty vaccine company that develops, manufactures, and
commercializes prophylactic vaccines for infectious diseases
addressing unmet medical needs. We take a highly specialized and
targeted approach, applying our deep expertise across multiple
vaccine modalities, focused on providing either first-, best- or
only-in-class vaccine solutions.We have a strong track record,
having advanced multiple vaccines from early R&D to approvals,
and currently market three proprietary travel vaccines, including
the world’s first and only chikungunya vaccine, as well as certain
third-party vaccines.Revenues from our growing commercial business
help fuel the continued advancement of our vaccine pipeline. This
includes the only Lyme disease vaccine candidate in advanced
clinical development, which is partnered with Pfizer, as well as
vaccine candidates against the Zika virus and other global public
health threats. More information is available at
www.valneva.com.
Valneva
Investor and Media ContactsLaetitia Bachelot-FontaineVP
Global Communications & European Investor RelationsM +33 (0)6
4516
7099laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking Statements
This press release contains certain
forward-looking statements relating to the business of Valneva,
including with respect to the progress, timing, results and
completion of research, development and clinical trials for product
candidates, to regulatory approval of product candidates and review
of existing products. In addition, even if the actual results or
development of Valneva are consistent with the forward-looking
statements contained in this press release, those results or
developments of Valneva may not be sustained in the future. In some
cases, you can identify forward-looking statements by words such as
“could,” “should,” “may,” “expects,” “anticipates,” “believes,”
“intends,” “estimates,” “aims,” “targets,” or similar words. These
forward-looking statements are based largely on the current
expectations of Valneva as of the date of this press release and
are subject to a number of known and unknown risks and
uncertainties and other factors that may cause actual results,
performance or achievements to be materially different from any
future results, performance or achievement expressed or implied by
these forward-looking statements. In particular, the expectations
of Valneva could be affected by, among other things, uncertainties
and delays involved in the development and manufacture of vaccines,
unexpected clinical trial results, unexpected regulatory actions or
delays, competition in general, currency fluctuations, the impact
of the global and European credit crisis, and the ability to obtain
or maintain patent or other proprietary intellectual property
protection. Success in preclinical studies or earlier clinical
trials may not be indicative of results in future clinical trials.
In light of these risks and uncertainties, there can be no
assurance that the forward-looking statements made in this press
release will in fact be realized. Valneva is providing this
information as of the date of this press release and disclaims any
intention or obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
1 Commission authorises Chikungunya vaccine (europa.eu)2 Valneva
Announces Health Canada Approval of the World’s First Chikungunya
Vaccine, IXCHIQ® - Valneva3 International Recognition Procedure -
GOV.UK (www.gov.uk)4 Valneva Receives EMA’s Positive CHMP Opinion
for its Chikungunya Vaccine - Valneva5 Valneva Reports Positive
24-Month Antibody Persistence Data for its Single-Shot Chikungunya
Vaccine IXCHIQ® - Valneva6 Valneva Reports Further Positive Pivotal
Phase 3 Data in Adolescents for its Single-Shot Chikungunya Vaccine
- Valneva7 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine8
Valneva and Instituto Butantan Sign Final Agreement on Single-Shot
Chikungunya Vaccine for Low and Middle Income Countries9 CEPI
awards up to $23.4 million to Valneva for late-stage development of
a single-dose Chikungunya vaccine10
https://jvi.asm.org/content/jvi/88/20/11644.full.pdf11
https://cmr.asm.org/content/31/1/e00104-1612 PAHO/WHO data: Number
of reported cases of chikungunya fever in the Americas (Cumulative
Cases 2018-2023 and Cases per year 2013-2017).
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 01 Aug 2023.13 Geographical expansion of cases of
dengue and chikungunya beyond the historical areas of transmission
in the Region of the Americas (who.int)
- 2024_07_01_IXCHIQ_EC_Approval_PR_EN_Final
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