Valneva Files for Chikungunya Vaccine Authorization with Health
Canada
Saint-Herblain
(France),
May 30,
2023 – Valneva
SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announces the filing of a regulatory application
with Health Canada for marketing approval of the Company’s
single-shot chikungunya vaccine candidate, VLA1553, in persons aged
18 years and above. If accepted, Health Canada will provide
additional information on the potential approval timeline.
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) with a Prescription Drug User
Fee Act (PDUFA) review goal date at the end of August 2023.
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 Valneva 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 of the Pan American Health Organization
(PAHO)2. No vaccine or specific treatments are currently available
for this debilitating disease, and we will continue to work
diligently to bring VLA1553 to different territories as soon as
possible.”
The regulatory submissions with Health Canada
and the FDA follow final pivotal Phase 3 data in March 20223, final
lot-to-lot consistency results in May 20224 and positive
twelve-month persistence data in December 20225. A clinical study
of VLA1553 in adolescents is ongoing in Brazil6, for which Valneva
reported enrollment and vaccination completion in February 20237.
This trial, conducted by Valneva’s partner Instituto Butantan and
funded by the Coalition for Epidemic Preparedness Innovations
(CEPI), may support future regulatory submissions in this age
group, if VLA1553 is initially approved in adults, as well as
licensure of the vaccine in Europe and Brazil, which would be the
first potential approval for use in an endemic population. First
results are expected mid-2023.
VLA1553 received FDA Fast Track and Breakthrough
Therapy designations in 2018 and 2021, respectively. The program
was also granted PRIority MEdicine (PRIME) designation by the
European Medicines Agency (EMA) in 2020, and Valneva plans to make
regulatory submissions for VLA1553 in Europe in the second half of
2023.
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 72-92% 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 20328. 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 countries9. As of July 2022,
more than three million cases have been reported in the Americas10
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 countries11. 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 202212, final lot-to-lot consistency results in
May 202213 and positive twelve-month persistence data in December
202214.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 VLA155315. The collaboration falls
within the framework of the agreement signed between CEPI and
Valneva in July 201916, 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 SEWe are a
specialty vaccine company focused on the development, manufacturing
and commercialization of prophylactic vaccines for infectious
diseases. We take a highly specialized and targeted approach to
vaccine development by focusing on vaccine solutions addressing
unmet medical needs to ensure we can make a difference to peoples’
lives. We apply our deep understanding of vaccine science,
including our expertise across multiple vaccine modalities, and our
established vaccine development capabilities, to develop vaccines
against diseases which are not yet vaccine-preventable, or for
which there are limited effective treatment options. Today, we are
leveraging our expertise and capabilities to rapidly advance a
broad range of vaccines into and through the clinic, including
candidates against the chikungunya virus and Lyme disease.
Media
& Investor ContactsLaëtitia Bachelot-FontaineVP Global
Communications & European Investor RelationsM +33 (0)6 4516
7099
laetitia.bachelot-fontaine@valneva.com |
Joshua
Drumm, Ph.D.VP Global Investor RelationsM +001 917 815
4520joshua.drumm@valneva.com |
Forward-Looking StatementsThis
press release contains certain forward-looking statements relating
to the business of Valneva, including with respect to regulatory
approval of VLA1553 and timing and plans for clinical programs and
clinical trials. 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 indicative of future results. 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 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
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, the ability to obtain or
maintain patent or other proprietary intellectual property
protection and the impact of the COVID-19 pandemic. 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 the information in this press
release as of the date hereof 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 FDA Accepts Valneva’s Chikungunya Vaccine License Application
for Priority Review -
Valneva2https://www.paho.org/en/documents/epidemiological-alert-chikungunya-increase-region-americas3
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate4 Valneva Successfully Completes
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate5 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva6 Valneva Announces Initiation of Adolescent Phase 3 Trial
for its Single-Shot Chikungunya Vaccine Candidate – Valneva7
Valneva Completes Enrollment for Adolescent Phase 3 Trial of
Single-Shot Chikungunya Vaccine Candidate - Valneva8 VacZine
Analytics Chikungunya virus vaccines Global demand analysis.
February 20209
https://www.who.int/news-room/fact-sheets/detail/chikungunya10
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 2022.11
https://www.who.int/news-room/fact-sheets/detail/chikungunya12
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate13 Valneva Successfully Completes
Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya
Vaccine Candidate14 Valneva Reports Positive 12-Month Antibody
Persistence Data for Single-Shot Chikungunya Vaccine Candidate -
Valneva15 Valneva and Instituto Butantan Sign Final Agreement on
Single-Shot Chikungunya Vaccine for Low and Middle Income
Countries16 CEPI awards up to $23.4 million to Valneva for
late-stage development of a single-dose Chikungunya vaccine
- 2023_05_30_VLA1553_HealthCanada_filing_PR_EN_Final
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