- Pfizer will invest €90.5 million in Valneva
- Planned Phase 3 study confirmed to initiate in Q3
2022
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty
vaccine company, and Pfizer Inc. (NYSE: PFE) today announced that
they have entered into an Equity Subscription Agreement and have
updated the terms of their Collaboration and License Agreement for
Lyme disease vaccine candidate VLA15. As previously announced on
April 26, 2022, Pfizer plans to initiate the Phase 3 study of VLA15
in the third quarter of 2022.
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As part of the Equity Subscription Agreement, Pfizer will invest
€90.5 ($95) million in Valneva, representing 8.1% of Valneva’s
share capital at a price of €9.49 per share, through a reserved
capital increase to further support the strategic Lyme partnership
between the two companies. The per share purchase price was
determined based on the average closing price of the Company’s
Shares on Euronext Paris during the 10 trading days preceding the
date of the Equity Subscription Agreement. The equity investment is
due to close on June 22, 2022. Valneva is planning to use the
proceeds from Pfizer’s equity investment to support its Phase 3
development contribution to the Lyme disease program.
In addition, Valneva and Pfizer updated the terms of their
collaboration and license agreement which they announced on April
30, 20201. Valneva will now fund 40% of the remaining shared
development costs compared to 30% in the initial agreement. Pfizer
will pay Valneva tiered royalties ranging from 14% to 22%, compared
to royalties starting at 19% in the initial agreement. In addition,
the royalties will be complemented by up to $100 million in
milestones payable to Valneva based on cumulative sales. Other
development and early commercialization milestones are unchanged,
of which $168 million remain, including a $25 million payment to
Valneva upon Pfizer’s initiation of the Phase 3 study.
Thomas Lingelbach, Chief Executive Officer of Valneva,
commented “Pfizer’s investment in Valneva highlights the quality of
the work that we’ve done together over the past two years and is a
strong recognition of Valneva’s vaccine expertise. This
subscription agreement will contribute to our investment in the
Phase 3 study while limiting the impact on our cash position. Lyme
disease is spreading and represents a high unmet medical need which
impacts the lives of millions of people in the Northern Hemisphere.
We are looking forward to further investigating our VLA15 candidate
in Phase 3, which will take us a step closer to potentially help
protect both adults and children from this devastating
disease.”
“Lyme disease continues to place a heavy burden on countries in
North America and Europe, with an estimated 600,000 cases each year
across both regions,” said Kathrin U. Jansen, Ph.D., Senior Vice
President and Head of Vaccine Research & Development at
Pfizer. “As the geographic footprint of Lyme disease widens,
the medical need for vaccination becomes even more imperative. We
are excited to continue partnering with Valneva on the development
of VLA15 and look forward to working together to progress the
program with the goal of bringing forward a vaccine that could help
prevent this debilitating disease.”
Pending successful initiation and completion of the planned
Phase 3 study for VLA15, Pfizer could potentially submit a
Biologics License Application (BLA) to the U.S. Food and Drug
Administration as early as 2025.
Dilution
The 9,549,761 new ordinary shares to be issued to Pfizer
pursuant to the Equity Subscription Agreement will represent a
dilution of approximately 8.1% of the share capital of the Company.
On an illustrative basis, a shareholder holding 1% of Valneva’s
capital before this capital increase will now hold a stake of
0.919%.
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
one of the most dominant surface proteins 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 Borrelia burgdorferi
sensu lato species that are prevalent in North America and Europe.
VLA15 has demonstrated a strong immunogenicity and safety profile
in pre-clinical and clinical studies so far. The program was
granted Fast Track designation by the U.S. Food and Drug
Administration (FDA) in July 20172. Valneva and Pfizer entered into
a collaboration agreement in April 2020 to co-develop VLA151.
About Lyme Disease
Lyme disease is a systemic infection caused by Borrelia
burgdorferi bacteria transmitted to humans by infected Ixodes (aka
deer or blacklegged) ticks3. It is considered the most common
vector-borne illness in the Northern Hemisphere and according to a
study published on June 13, 2022 in BMJ Global Health, Lyme disease
has likely infected 14.5% of the world’s population4. 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 geographic footprint of the
disease widens5.
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.
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.
Valneva Forward-Looking Statements
This 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.
Pfizer Disclosure Notice
The information contained in this release is as of June 20,
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 an Equity Subscription
Agreement and a Collaboration and License Agreement between Pfizer
and Valneva for VLA15, including their potential benefits and a
planned Phase 3 clinical trial, 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 or enrollment targets 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 planned 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.
1 Valneva and Pfizer Announce Collaboration to Co-Develop and
Commercialize Lyme Disease Vaccine, VLA15 – Valneva 2
https://valneva.com/press-release/valneva-receives-fda-fast-track-designation-for-its-lyme-disease-vaccine-candidate-vla15/
3 Stanek et al. 2012, The Lancet 379:461–473 4
https://gh.bmj.com/content/7/6/e007744?utm_source=STAT%20Newsletters&utm_campaign=c7e76c7c4e
MR_COPY_01&utm_medium=email&utm_term=0_8cab1d7961-c7e76c7c4e-150175797
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/
Category: Vaccines
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version on businesswire.com: https://www.businesswire.com/news/home/20220619005037/en/
Valneva Laëtitia Bachelot-Fontaine VP Global
Communications & European Investor Relations M +33 (0)6 4516
7099 laetitia.bachelot-fontaine@valneva.com
Joshua Drumm, Ph.D. VP Global Investor Relations M +1 917 815
4520 joshua.drumm@valneva.com
Pfizer Media Relations: PfizerMediaRelations@pfizer.com
212-733-1226
Investor Relations: IR@pfizer.com 212-733-4848
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