Valneva Submits Chikungunya Vaccine Marketing Application to EMA
and Announces CHMP Accelerated Assessment
Saint-Herblain (France), October 25, 2023 –
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine
company, today announces the submission of a marketing application
with the European Medicines Agency (EMA) for approval of the
Company’s single-shot chikungunya vaccine candidate, VLA1553.
Valneva was also granted accelerated assessment1 for the
application by EMA’s Committee for Medicinal Products for Human Use
(CHMP) based on the vaccine candidate’s “major interest for public
health and therapeutic innovation”.
VLA1553 is currently the first and only
chikungunya vaccine candidate worldwide for which regulatory review
processes are underway. A Biologic License Application (BLA) is
currently under priority review by the U.S. Food and Drug
Administration (FDA)2 with a Prescription Drug User Fee Act (PDUFA)
action date planned for the end of November 20233. Additionally, a
marketing application is under review by Health Canada4.
If approved, VLA1553 could become the first
licensed chikungunya vaccine available to address this unmet
medical need.
Juan Carlos Jaramillo, MD, Chief Medical
Officer of Valneva, commented, “We welcome EMA’s
accelerated assessment and will work closely with them to bring
this vaccine to market. Chikungunya virus, or CHIKV, is a serious
and debilitating mosquito-borne viral infection that poses a
significant unmet need and the risk of chikungunya spreading in
Europe is relatively high due to the possibility of infected
travelers5. No vaccine or specific treatments are currently
available for this debilitating disease. We will continue to work
diligently to bring VLA1553 to different territories as soon as
possible.”
The regulatory submissions with the EMA, FDA and
Health Canada follow final pivotal Phase 3 data in March 20226
(Lancet article), final lot-to-lot consistency results in May
20227, twelve-month persistence data in December 20228 and positive
initial Phase 3 safety data in adolescents9.
VLA1553 was granted PRIority MEdicine (PRIME)
designation by EMA in 2020 and received FDA Fast Track and
Breakthrough Therapy designations in 2018 and 2021,
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, positive twelve-month
persistence data in December 202216 and positive initial Phase 3
safety data in Adolescents17. The pivotal Phase 3 data were
published in The Lancet18(article link), the world’s leading
peer-reviewed medical journal, in June 2023.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
VLA155319. The collaboration falls within the framework of the
agreement signed between CEPI and Valneva in July 201920, which
provides funding of up to $24.6 million with support from the
European Union’s Horizon 2020 program.
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 two proprietary travel vaccines as well as
certain third-party vaccines leveraging our established commercial
infrastructure.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, potentially
the world’s first vaccine against the chikungunya virus, as well as
vaccine candidates against the Zika virus and other global public
health threats.
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 Accelerated assessment | European Medicines Agency
(europa.eu)2 FDA Accepts Valneva’s Chikungunya Vaccine License
Application for Priority Review - Valneva3 Valneva Announces PDUFA
Date Extension for Chikungunya Virus Vaccine Candidate - Valneva4
Health Canada Accepts Valneva’s Chikungunya Vaccine License
Application for Review - Valneva5
https://www.ecdc.europa.eu/en/chikungunya/threats-and-outbreaks/risk-assessment-chikungunya-eu6
Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot
Chikungunya Vaccine Candidate7 Valneva Successfully Completes
Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate8
Valneva Reports Positive 12-Month Antibody Persistence Data for
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 Reports Positive Initial Phase 3 Safety Data in
Adolescents for its Single-Shot Chikungunya Vaccine Candidate -
Valneva18 Valneva Announces Publication of its Chikungunya Vaccine
Candidate Phase 3 Data in The Lancet - Valneva19 Valneva and
Instituto Butantan Sign Final Agreement on Single-Shot Chikungunya
Vaccine for Low and Middle Income Countries20 CEPI awards up to
$23.4 million to Valneva for late-stage development of a
single-dose Chikungunya vaccine
- 2023_10_25_EMA_Submission_PR_EN_Final
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