Saint-Herblain (France), October 16, 2020 –
Valneva SE (“Valneva” or “the Company”) a specialty vaccine company
focused on prevention of diseases with major unmet needs, today
announced that the European Medicines Agency (EMA) has granted
PRIority MEdicines (PRIME) designation for its single-shot Phase 3
chikungunya vaccine candidate VLA1553. This new designation from
the EMA complements the Fast Track designation received by the U.S.
Food and Drug Administration (FDA) in December 20181.
The PRIME designation is awarded by the EMA to
promising medicines that demonstrate the potential to address
substantial unmet medical need based on initial clinical data. The
EMA considers PRIME designations a priority and provides medicine
developers with special support, including enhanced interactions
and dialogue, as well as a pathway for accelerated evaluation and
review2.
Juan Carlos Jaramillo, M.D., Chief
Medical Officer of Valneva, commented, “We are very
pleased to receive PRIME designation for our chikungunya vaccine
candidate. It provides further validation of our clinical data and
recognition of the significant unmet medical need for chikungunya.
We look forward to working closely with the EMA to expedite the
availability of our single-shot vaccine to people living in the
European Union.”
On September 8, 2020, Valneva announced the
initiation of a pivotal Phase 3 clinical trial for VLA15533,
becoming the first company worldwide to advance a chikungunya
vaccine candidate into Phase 3.
About Chikungunya Chikungunya
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 4
to 7 days following the mosquito bite. While mortality with CHIKV
is low, morbidity is high. Clinical symptoms include acute onset of
fever, debilitating joint and muscle pain, headache, nausea and
rash. 4.1%-78.6% of infections develop into chronic arthralgia
(> 3 months). 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 highest risk areas of infection for travelers are
places where chikungunya virus-carrying mosquitos are endemic,
including the Americas, parts of Africa, and Southeast Asia.
As of September 2020, there have been more than 3 million reported
cases in the Americas4 and the economic impact is considered
to be significant (e.g. Colombia outbreak 2014: $73.6 million5).
The medical and economic burden is expected to grow as the CHIKV
primary mosquito vectors continue to further 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 vaccine candidate for protection
against chikungunya disease and currently tested in clinical Phase
3. VLA1553 has been designed by deleting a part of the chikungunya
virus genome. As a live-attenuated vaccine, VLA1553 is particularly
well suited to target long-lasting protection.Valneva is the first
company to advance a chikungunya vaccine candidate into Phase 3.
The sponsor of the first chikungunya vaccine Biologics License
Application (BLA) to be approved in the U.S. will be eligible to
receive a Priority Review Voucher (PRV) 6.VLA1553 would expand
Valneva’s existing travel vaccine portfolio and as such, Valneva
intends to commercialize this vaccine leveraging its existing
manufacturing and commercial operations. The global market for
vaccines against chikungunya is estimated to exceed $500 million
annually by 20327.VLA1553 Phase 1 data in 120 volunteers were
published in The Lancet Infectious Diseases8. The vaccine was well
tolerated at the dose level selected for Phase 3. No
vaccine-related serious adverse events were reported during 12
months of follow-up. Neutralizing antibodies were developed in 100%
of volunteers within 14 days after a single vaccination and were
maintained up to one year. Based on these encouraging results,
pivotal Phase 3 testing was initiated in September 2020 for the
program which was granted Fast Track designation by the U.S. Food
and Drug Administration (FDA). To make VLA1553 also accessible to
Low and Middle Income Countries (LMIC), Valneva and Instituto
Butantan in Brazil signed a binding term sheet in May 2020 for the
development, manufacturing and marketing of VLA1553. The
collaboration will be effective upon the signing of definitive
agreements and will fall within the framework of the $23.4 million
funding which Valneva received from the Coalition for Epidemic
Preparedness Innovations (CEPI) in July 2019.
About Phase 3 study VLA1553-301
VLA1553-301 Phase 3 study was initiated in September 2020. It is a
prospective, double-blinded, multicenter, randomized, pivotal Phase
3 study comprising approximately 4,000 participants aged 18 years
or above. Lyophilized VLA1553 or placebo will be administered as a
single intramuscular immunization. The primary objective of the
study is to evaluate the immunogenicity and safety of the final
dose of VLA1553 28 days following a single immunization. Safety
data collection and immunogenicity will continue to be assessed
until Month 6; further long-term follow up is planned. Additional
information, including a detailed description of the study design,
eligibility criteria and investigator sites, is available at
ClinicalTrials.gov (Identifier: NCT04546724).
About Valneva SEValneva is a
specialty vaccine company focused on prevention against diseases
with major unmet needs. Valneva’s portfolio includes two commercial
vaccines for travelers: IXIARO®/JESPECT® indicated for the
prevention of Japanese encephalitis and DUKORAL® indicated for the
prevention of cholera and, in some countries, prevention of
diarrhea caused by ETEC. The Company has various vaccines in
development including unique vaccines against Lyme disease,
chikungunya and COVID-19. Valneva has operations in Austria,
Sweden, the United Kingdom, France, Canada and the US with over 500
employees. For more information, visit the Company website at
www.valneva.com and follow Valneva on LinkedIn.
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineDirector Investor Relations & Corporate
CommunicationsM +33 (0)6 4516
7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@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 and completion of
research, development and clinical trials for product candidates,
the ability to manufacture, market, commercialize and achieve
market acceptance for product candidates, the ability to protect
intellectual property and operate the business without infringing
on the intellectual property rights of others, estimates for future
performance and estimates regarding anticipated operating losses,
future revenues, capital requirements and needs for additional
financing. 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 their 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
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. 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 Valneva PR: Valneva Awarded FDA Fast Track Designation for
Chikungunya vaccine candidate
2
https://www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines 3
Valneva Initiates Phase 3 Clinical Study for its Chikungunya
Vaccine Candidate VLA1553
4 PAHO/WHO data: Number of reported cases of chikungunya fever
in the Americas.
https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html.
Last accessed 13 Oct 2020.
5 Cardona-Ospina et al. 2015, Trans R Soc Trip Med Hyg
109:793-802.6 https://priorityreviewvoucher.org/
7 VacZine Analytics Chikungunya virus vaccines Global demand
analysis. February 2020
8 Wressnigg et al. 2020, Lancet ID;20(10):1193-1203.
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