- Approximately 6,000 participants 5 years of age and older will
be enrolled in Lyme disease-endemic regions in Europe and the
U.S.
New York &
Saint-Herblain
(France), August
8, 2022 – Pfizer Inc. (NYSE: PFE)
and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced
the initiation of a Phase 3 clinical study, Vaccine Against Lyme
for Outdoor Recreationists (VALOR) (NCT05477524), to investigate
the efficacy, safety and immunogenicity of their investigational
Lyme disease vaccine candidate, VLA15.
“With increasing global rates of Lyme disease,
providing a new option for people to help protect themselves from
the disease is more important than ever,” said Annaliesa Anderson,
Ph.D., Senior Vice President and Head of Vaccine Research &
Development at Pfizer. “We hope that the data generated from the
Phase 3 study will further support the positive evidence for VLA15
to date, and we are looking forward to collaborating with the
research sites across the U.S. and Europe on this important
trial."
Juan Carlos Jaramillo M.D., Chief Medical
Officer of Valneva, said, “We are extremely pleased to reach this
important milestone in the development of VLA15. Lyme disease
continues to spread, representing a high unmet medical need that
impacts the lives of many in the Northern Hemisphere. We look
forward to further investigating the VLA15 candidate in Phase 3,
which will take us a step closer to potentially bringing this
vaccine to both adults and children who would benefit from it.”
The randomized, placebo-controlled, Phase 3
VALOR study is planned to enroll approximately 6,000 participants 5
years of age and older. The study is being conducted at up to 50
sites located in areas where Lyme disease is highly endemic,
including Finland, Germany, the Netherlands, Poland, Sweden and the
United States. Participants will receive three doses of VLA15 180
µg or saline placebo as a primary vaccination series followed by
one booster dose of VLA15 or saline placebo (1:1 ratio).
Data from the Phase 2 studies continue to
demonstrate strong immunogenicity in adults as well as in children,
with acceptable safety and tolerability profiles in both study
populations.1,2 Pending successful completion of the Phase 3 study,
Pfizer could potentially submit a Biologics License Application
(BLA) to the U.S. Food and Drug Administration (FDA) and Marketing
Authorisation Application (MAA) to the European Medicines Agency
(EMA) in 2025.
As per the terms of the collaboration agreement
between Pfizer and Valneva, Pfizer will make a $25 million
milestone payment to Valneva upon initiation of the Phase 3
study.
About VLA15
VLA15 is the only Lyme disease vaccine candidate
currently in clinical development. This investigational multivalent
protein subunit vaccine uses an established mechanism of action for
a Lyme disease vaccine that targets the outer surface protein A
(OspA) of Borrelia burgdorferi, the bacteria that cause Lyme
disease. OspA is a surface protein expressed by the bacteria when
present in a tick. Blocking OspA inhibits the bacterium’s ability
to leave the tick and infect humans. The vaccine covers the six
most common OspA serotypes expressed by the Borrelia burgdorferi
sensu lato species that are prevalent in North America and Europe.
VLA15 has demonstrated a strong immune response and satisfactory
safety profile in pre-clinical and clinical studies so far. Valneva
and Pfizer entered into a collaboration agreement in April 2020 to
co-develop VLA15, with updates to the terms within this agreement
made in June 2022.3,4 The terms of the collaboration agreement
include a $25 million milestone payment made to Valneva upon
Pfizer’s initiation of the Phase 3 study. The program was granted
Fast Track designation by the U.S. FDA in July 2017.5
About Lyme Disease
Lyme disease is a systemic infection caused by
Borrelia burgdorferi bacteria transmitted to humans by infected
Ixodes ticks.6 It is considered the most common vector-borne
illness in the Northern Hemisphere.7 While the true incidence of
Lyme disease is unknown, it is estimated to annually affect
approximately 476,000 people in the United States and 130,000
people in Europe.8,9 Early symptoms of Lyme disease (such as a
gradually expanding erythematous rash called Erythema migrans or
more nonspecific symptoms like fatigue, fever, headache, mild stiff
neck, arthralgia or myalgia) are often overlooked or
misinterpreted. Left untreated, the disease can disseminate and
cause more serious complications affecting the joints (arthritis),
the heart (carditis) or the nervous system.9 The medical need for
vaccination against Lyme disease is steadily increasing as the
geographic footprint of the disease widens.8
About Pfizer: Breakthroughs That Change Patients’
Lives
At Pfizer, we apply science and our global
resources to bring therapies to people that extend and
significantly improve their lives. We strive to set the standard
for quality, safety and value in the discovery, development and
manufacture of health care products, including innovative medicines
and vaccines. Every day, Pfizer colleagues work across developed
and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 170 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.Pfizer.com. In
addition, to learn more, please visit us on www.Pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as
of August 8, 2022. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking
information about a Lyme disease vaccine candidate, VLA15, and a
collaboration between Pfizer and Valneva for VLA15, including their
potential benefits, a Phase 3 clinical trial and the timing of
potential regulatory submissions, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for our clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, including
uncertainties relating to the time needed to accrue cases in the
Phase 3 trial, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when drug
applications may be filed in any jurisdictions for VLA15; whether
and when any such applications may be approved by regulatory
authorities, which will depend on myriad factors, including making
a determination as to whether the product's benefits outweigh its
known risks and determination of the product's efficacy and, if
approved, whether VLA15 will be commercially successful; decisions
by regulatory authorities impacting labeling, manufacturing
processes, safety and/or other matters that could affect the
availability or commercial potential of VLA15; uncertainties
regarding the ability to obtain recommendations from vaccine
advisory or technical committees and other public health
authorities and uncertainties regarding the commercial impact of
any such recommendations; whether our collaboration with Valneva
will be successful; uncertainties regarding the impact of COVID-19
on Pfizer’s business, operations and financial results; and
competitive developments.
A further description of risks and uncertainties
can be found in Pfizer’s Annual Report on Form 10-K for the fiscal
year ended December 31, 2021 and in its subsequent reports on Form
10-Q, including in the sections thereof captioned “Risk Factors”
and “Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
About Valneva SE
Valneva is a specialty vaccine company focused
on the development 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
successfully commercialize two vaccines and to rapidly advance a
broad range of vaccine candidates into and through the clinic,
including candidates against Lyme disease, the chikungunya virus
and COVID-19.
Valneva Forward-Looking
StatementsThis 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 and estimates for future performance. 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 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.
# # #
Media Contacts
PfizerMedia
Relations:PfizerMediaRelations@pfizer.com212-733-1226
Investor Relations:IR@pfizer.com212-733-4848
ValnevaLaëtitia
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
+1 917 815 4520joshua.drumm@valneva.com
References
- Valneva. Valneva Pfizer Report Positive Phase 2 Pediatric Data
for Lyme Vaccine Candidate. April 2022. Available at:
https://valneva.com/press-release/valneva-and-pfizer-report-positive-phase-2-pediatric-data-for-lyme-disease-vaccine-candidate/
Accessed: July 2022.
- Valneva. Valneva Pfizer Report Positive Phase 2 Data for Lyme
Disease Vaccine Candidate. February 2022. Available at:
https://valneva.com/press-release/valneva-and-pfizer-report-further-positive-phase-2-data-for-lyme-disease-vaccine-candidate/
Accessed: July 2022.
- Valneva. Valneva and Pfizer Announce Collaboration to
Co-Develop and Commercialize Lyme Disease Vaccine, VLA15. April
2020. Available at:
https://valneva.com/press-release/valneva-and-pfizer-announce-collaboration-to-co-develop-and-commercialize-lyme-disease-vaccine-vla15/
Accessed: July 2022 .
- Valneva. Valneva and Pfizer Enter into Equity Subscription
Agreement and Update Terms of Collaboration Agreement for Lyme
Disease Vaccine Candidate VLA15. June 2022. Available at:
https://valneva.com/press-release/valneva-and-pfizer-enter-into-an-equity-subscription-agreement-and-update-terms-of-collaboration-agreement-for-lyme-disease-vaccine-candidate-vla15/
Accessed: July 2022.
- Valneva. Valneva Receives FDA Fast track Designation for its
Lyme Disease Vaccine Candidate VLA15. July 2017. Available at:
https://valneva.com/press-release/valneva-receives-fda-fast-track-designation-for-its-lyme-disease-vaccine-candidate-vla15/
Accessed: July 2022.
- Stanek G, Wormser GP, Gray J, et al. Lyme borreliosis. Lancet.
2012; 4;379(9814):461-73
- Gern L, Falco RC.
Lyme disease. Rev Sci Tech. 2000 Apr;19(1):121-35.
- Center for Disease
Control and Prevention. Lyme Disease. Data and Surveillance. April
2021. Available at:
https://www.cdc.gov/lyme/datasurveillance/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Flyme%2Fstats%2Findex.html
Accessed July 2022.
- Sykes RA, et al. An
estimate of Lyme borreliosis incidence in Western Europe. Journal
of Public Health 2017; 39(1): 74-81
- Center for Disease Control and Prevention. Lyme Disease. Signs
and Symptoms of Untreated Lyme disease. January 2021. Available at:
https://www.cdc.gov/lyme/signs_symptoms/index.html Accessed July
2022.
- 22_08_08_VLA15_Phase_3_PR_EN_Final
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