Phase 2 vaccine candidate, VLA15, is
being evaluated for adult and pediatric indications in North
America and Europe.
Saint Herblain (France) and New York, NY, April 30,
2020 – Valneva SE (“Valneva”), a specialty vaccine
company, and Pfizer Inc. (NYSE: PFE) today announced a
collaboration to develop and commercialize Valneva’s Lyme disease
vaccine candidate VLA15, which is currently in Phase 2 clinical
studies.
VLA15 is the only active Lyme disease vaccine program in
clinical development today, and covers six serotypes that are
prevalent in North America and Europe. The investigational
multivalent protein subunit vaccine, VLA15, targets the outer
surface protein A (OspA) of Borrelia, an established mechanism of
action for a Lyme disease vaccine. OspA is one of the most dominant
surface proteins expressed by the bacteria when present in a tick.
VLA15 has demonstrated strong immunogenicity and safety data in
pre-clinical and Phase 1 studies. The program was granted Fast
Track designation by the U.S. Food and Drug Administration (FDA) in
July 20171. Valneva has completed patient enrolment and follow-up
for two Phase 2 studies of its Lyme disease vaccine candidate, in
more than 800 people. Valneva expects to report the first Phase 2
results in mid-2020.
Valneva and Pfizer will work closely together throughout the
development of VLA15. Valneva is eligible to receive a total of
$308 million cash payments consisting of a $130 million upfront
payment, $35 million in development milestones and $143 million in
early commercialization milestones. Under the terms of the
agreement, Valneva will fund 30% of all development costs through
completion of the development program, and in return Pfizer will
pay Valneva tiered royalties starting at 19%. Pfizer will lead
late-stage development and have sole control over
commercialization.
Thomas Lingelbach, Chief Executive Officer,
Valneva, commented “This collaboration is extremely
exciting as it provides the opportunity for the rapid development
and launch of a vaccine that has the potential to address a major
unmet medical need. It validates Valneva’s strong vaccine R&D
capabilities. We believe that Pfizer is the best partner for our
Lyme disease vaccine given their outstanding development and
commercial capabilities. Our team is thrilled about the prospect of
working with such a successful partner.”
“Lyme disease is the most commonly reported tick-borne illness
in the United States and is growing in its prevalence and
geographic reach. We look forward to working closely with Valneva
to continue advancing the VLA15 program and potentially bring a new
solution to patients for this significant unmet need,” said
Nanette Cocero, Global President, Pfizer Vaccines.
“As both a research company, and a manufacturer of pediatric and
adult vaccines including a vaccine for tick-borne encephalitis in
Europe, we believe that Pfizer’s vaccine heritage, scientific
expertise, and global commercial capabilities will help allow the
VLA15 program to reach its maximum potential in helping protect
children and adults from Lyme disease.”
This transaction is subject to customary closing conditions and
clearances under antitrust law, including the Hart-Scott Rodino
Antitrust Improvements Act.
Lazard served as exclusive financial advisor to Valneva and
Dechert LLP served as Valneva’s legal counsel for the
collaboration.
About Lyme Disease Lyme disease is a systemic
infection caused by Borrelia bacteria transmitted to humans by
infected Ixodes ticks2. It is considered the most common vector
borne illness in the Northern Hemisphere. According to the U.S.
Centers for Disease Control and Prevention (CDC), approximately
300,000 Americans3 are diagnosed with Lyme disease each year with
at least a further 200,000 cases in Europe4. Early symptoms of Lyme
disease (such as a gradually expanding erythematous rash called
Erythema migrans or more unspecific 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. The
medical need for vaccination against Lyme disease is steadily
increasing as the disease footprint widens5.
About Pfizer Inc.: 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 150 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.
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. Valneva has various vaccines in development including unique
vaccines against Lyme disease and chikungunya. Valneva has
operations in Austria, Sweden, the United Kingdom, France, Canada
and the US with over 500 employees. More information is available
at www.valneva.com
Valneva
Investor and Media ContactsLaetitia
Bachelot-FontaineDirector of Investor Relations & Corporate
CommunicationsM +33 (0)6 4516 7099investors@valneva.com |
Teresa
PinzolitsCorporate Communications SpecialistT +43 (0)1 20620
1116communications@valneva.com |
|
|
Pfizer Media and Investor Contacts |
|
Europe Media Relations U.S. Media
Relations: Investor Relations: |
Dervila Keane+353 862110834Dervila.M.Keane@pfizer.com Steve
Danehy+1 (978) 273-3946Steven.Danehy@pfizer.com Chuck Triano+1
(212) 733-3901Charles.E.Triano@Pfizer.com |
Forward-Looking
StatementsThis 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.
Pfizer Disclosure NoticeThe information
contained in this release is as of April 30, 2020. 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 an exclusive licensing
agreement between Pfizer and Valneva for VLA15, including their
potential benefits and the expected timing of Phase 2 results, 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, 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; the impact of
COVID-19 on our business, operations and financial results; risks
related to the satisfaction or waiver of the conditions to closing
the transaction in the anticipated timeframe or at all; 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, 2019 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.
1
https://valneva.com/press-release/valneva-receives-fda-fast-track-designation-for-its-lyme-disease-vaccine-candidate-vla15/
2 Stanek et al. 2012, The Lancet 379:461–473
3 As estimated by the CDC,
https://www.cdc.gov/lyme/stats/humancases.html.
4 Estimated from available national data. Number largely
underestimated based on WHO Europe Lyme Report as case reporting
is
highly inconsistent in Europe and many LB infections go
undiagnosed; ECDC tick-borne-diseases-meeting-report
5 New Scientist, Lyme disease is set to explode and we still
don’t have a vaccine; March 29, 2017
https://www.newscientist.com/article/mg23431195-800-lyme-disease-is-set-to-explode-and-you-cant-protect-yourself/
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