Health Canada Accepts Valneva’s Chikungunya Vaccine License
Application for Review
Saint-Herblain
(France), August
29,
2023 – Valneva
SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announced that Health Canada has completed screening
validation of the Company’s regulatory application for marketing
approval of its single-shot chikungunya vaccine candidate VLA1553
in persons aged 18 years and above, and has determined that the New
Drug Submission (NDS) application is sufficiently complete to
permit a substantive review. Based on Health Canada’s performance
standard to process an NDS application, the Company believes the
regulatory review could be completed by mid-2024.
This is the second regulatory application for
VLA1553 filed by Valneva, and the Company intends to make
additional regulatory submissions in 2023. A Biologic License
Application (BLA) is currently under priority review1 by the U.S.
Food and Drug Administration (FDA)2.
VLA1553 is currently the only chikungunya
vaccine candidate worldwide for which regulatory review processes
are underway and, if approved, it could become the first licensed
chikungunya vaccine available to address this unmet medical need.
It would also represent the third vaccine Valneva3 has brought from
early R&D to approval.
Juan Carlos Jaramillo,
MD, Chief Medical Officer of Valneva, commented,
“Chikungunya represents a major threat for people traveling to or
living in areas where chikungunya virus and the mosquitos that
transmit it are present, including popular destinations for U.S.
and Canadian travelers. This threat continues to grow as shown by
the recent epidemiological alert issued by the Pan American Health
Organization (PAHO)4. No vaccine or specific treatments are
currently available for this debilitating disease, and we will
continue to work diligently to make VLA1553 available in different
territories as quickly as possible.”
The regulatory submissions with Health Canada
and the FDA follow final pivotal Phase 3 data in March 20225, final
lot-to-lot consistency results in May 20226 and positive
twelve-month persistence data in December 20227. The Company’s
pivotal Phase 3 results were published in the Lancet in June
2023.
A clinical study of VLA1553 in adolescents aged
12 to 17 years is ongoing in Brazil8, for which Valneva reported
initial Phase 3 safety data in adolescents yesterday9. This study,
conducted by Valneva’s partner Instituto Butantan and funded by the
Coalition for Epidemic Preparedness Innovations (CEPI), is intended
to support label extension in this age group following a potential
initial regulatory approval in adults from the FDA. The study is
also expected to support licensure of the vaccine in Brazil, which
would be the first potential approval for use in endemic
populations, as well as regulatory submission in Europe.
The vaccine was granted PRIority MEdicine
(PRIME) designation by the European Medicines Agency (EMA) in 2020
and also received FDA Fast Track, Breakthrough Therapy and Priority
Review designations in 2018, 2021 and 2023 respectively.
About ChikungunyaChikungunya is
a mosquito-borne viral disease caused by the chikungunya virus
(CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.
Infection leads to symptomatic disease in up to 97% of humans after
four to seven days following the mosquito bite. While mortality
with CHIKV is low, morbidity is high, and the global market for
vaccines against chikungunya is estimated to exceed $500 million
annually by 203210. Clinical symptoms include acute onset of fever,
debilitating joint and muscle pain, headache, nausea, rash and
chronic arthralgia. Chikungunya virus often causes sudden large
outbreaks with high attack rates, affecting one-third to
three-quarters of the population in areas where the virus is
circulating. The high-risk areas of infection for travelers are
places where chikungunya virus-carrying mosquitos are endemic,
including the Americas, parts of Africa, and Southeast Asia, and
the virus has spread to more than 110 countries11. As of July 2022,
more than three million cases have been reported in the Americas12
and the economic impact is considered to be significant. The
medical and economic burden is expected to grow as the CHIKV
primary mosquito vectors continue to spread geographically. There
are no preventive vaccines or effective treatments available and,
as such, chikungunya is considered to be a major public health
threat.
About
VLA1553VLA1553 is a live-attenuated,
single dose investigational vaccine candidate targeting the
chikungunya virus, which has spread to over 110 countries13. It has
been designed by deleting a part of the chikungunya virus
genome.Valneva reported final data from the pivotal Phase 3 trial
of VLA1553 in March 202214, final lot-to-lot consistency results in
May 202215 and positive twelve-month persistence data in December
202216.If approved, VLA1553 would expand Valneva’s existing
commercial vaccines portfolio and as such, Valneva intends to
commercialize this vaccine, leveraging its existing manufacturing
and commercial operations. To make VLA1553 more accessible to Low-
and Middle-Income Countries (LMIC), Valneva and Instituto Butantan
in Brazil signed an agreement in January 2021 for the development,
manufacturing and marketing of VLA155317. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 201918, which provides funding of up to $24.6
million with support from the European Union’s Horizon 2020
program.VLA1553 received FDA Fast Track, Breakthrough Therapy
designations and Priority Review in 2018, 2021 and 2023,
respectively. VLA1553 was also granted PRIority MEdicine (PRIME)
designation by the European Medicines Agency (EMA) in 2020.
About Valneva SEValneva is a
specialty vaccine company focused on the development, manufacturing
and commercialization of prophylactic vaccines for infectious
diseases with significant unmet medical need. The Company takes a
highly specialized and targeted approach to vaccine development and
then applies its deep understanding of vaccine science to develop
prophylactic vaccines addressing these diseases. Valneva has
leveraged its expertise and capabilities both to commercialize
three vaccines and to rapidly advance a broad range of vaccine
candidates into and through the clinic, including candidates
against the chikungunya virus and Lyme disease.
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 during this
presentation will in fact be realized. Valneva is providing the
information in these materials as of this press release and
disclaim 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 FDA Accepts Valneva’s Chikungunya Vaccine License Application
for Priority Review - Valneva2 Valneva Announces PDUFA Date
Extension for Chikungunya Virus Vaccine Candidate - Valneva3 This
statement refers to Valneva and its predecessor
Intercell4https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas5
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate6 Valneva Successfully Completes
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate7 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva8 Valneva Announces Initiation of Adolescent Phase 3 Trial
for its Single-Shot Chikungunya Vaccine Candidate – Valneva9
Valneva Reports Positive Initial Phase 3 Safety Data in Adolescents
for its Single-Shot Chikungunya Vaccine Candidate - Valneva10
VacZine Analytics Chikungunya virus vaccines Global demand
analysis. February 202011
https://www.who.int/news-room/fact-sheets/detail/chikungunya12
PAHO/WHO data: Number of reported cases of chikungunya fever in the
Americas (Cumulative Cases 2018-2022 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 25 Jul 2022.13
https://www.who.int/news-room/fact-sheets/detail/chikungunya14
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate15 Valneva Successfully Completes
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate16 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva17 Valneva and Instituto Butantan Sign Final Agreement on
Single-Shot Chikungunya Vaccine for Low and Middle Income
Countries18 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine
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2023_08_29_Health_Canada_Filing_Review_Acceptance_PR_EN_Final
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