Pfizer and BioNTech Sign New Global Collaboration Agreement to
Develop First mRNA-based Shingles Vaccine
- Third mRNA vaccine collaboration between the companies aims to
accelerate development of an improved vaccine for shingles, a
debilitating, disfiguring and painful disease that affects people
all over the world
- Product candidates will be based on BioNTech’s proprietary mRNA
technology and on Pfizer’s antigen technology
- Clinical trials are expected to start in the second half of
2022
- BioNTech will receive $225 million upfront, including an
upfront cash payment of $75 million and an equity investment of
$150 million, and will be eligible to receive future approval and
sales milestone payments totaling up to $200 million as well as a
share of gross profits arising from future product sales
- Pfizer will receive an upfront payment of $25 million from
BioNTech for its proprietary antigen sequences identified by
Pfizer
NEW YORK and MAINZ, Germany, January 5,
2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:
BNTX) today announced a new research, development and
commercialization collaboration to develop a potential first
mRNA-based vaccine for the prevention of shingles (herpes zoster
virus, or HZV), a debilitating, disfiguring and painful disease
that impacts about one in three people in the United States during
their lifetime. The collaboration builds on the companies’ success
in developing the first approved and most widely used mRNA vaccine
to help prevent COVID-19. This is the third collaboration between
Pfizer and BioNTech in the infectious diseases field, following the
influenza vaccine collaboration initiated in 2018 and the COVID-19
vaccine collaboration initiated in 2020.
Under the terms of the agreement, the companies
will leverage a proprietary antigen technology identified by
Pfizer’s scientists and BioNTech's proprietary mRNA platform
technology used in the companies’ COVID-19 vaccine. The parties
will share development costs. Clinical trials are planned to start
in the second half of 2022. Pfizer will have rights to
commercialize the potential vaccine on a global basis, with the
exception of Germany, Turkey and certain developing countries where
BioNTech will have commercialization rights. The companies will
share gross profits from commercialization of any product.
“Pfizer and BioNTech co-developed the world’s
first mRNA vaccine, providing a well-tolerated and effective tool
to help address COVID-19 – the most devastating pandemic in a
century – and demonstrating consistent, agile and high-quality
manufacturing on an unprecedented scale,” said Mikael
Dolsten, M.D., Ph.D., Chief Scientific Officer and President,
Worldwide Research, Development & Medical, Pfizer.
“With this agreement, we continue on our journey of discovery
together, by advancing mRNA technology to tackle another health
challenge ripe for scientific innovation, supported by our
world-class manufacturing network.”
“The collaboration aims to develop a new
mRNA-based vaccine against shingles, leveraging the expertise and
resources of both companies,” said Ugur Sahin, M.D., CEO
and Co-Founder of BioNTech. “Adults aged 50 years and
older as well as vulnerable populations like cancer patients are at
an increased risk of shingles. Our goal is to develop an mRNA
vaccine with a favorable safety profile and high efficacy, which is
at the same time more easily scalable to support global
access.”
Under the terms of the agreement, Pfizer will
pay BioNTech $225 million in upfront payments, including a cash
payment of $75 million and an equity investment of $150 million.
BioNTech is eligible to receive future regulatory and sales
milestone payments of up to $200 million. BioNTech will pay Pfizer
$25m for the company’s proprietary antigen technology.
About Shingles (Herpes Zoster
Virus)Shingles (HZV) is a chronic form of the varicella
zoster virus (VZV), which causes an initial chickenpox infection.
After chickenpox disease, the virus remains dormant in human nerve
cells and can re-activate later in life, due to a trigger such as
stress or immunocompromise. This attack can lead to extremely
painful, disfiguring patches, which may continue to be painful
after the episode has resolved, a condition known as postherpetic
neuralgia (PHN). In rare conditions, shingles can also lead to
facial paralysis, deafness and blindness.
According to the U.S. Centers for Disease
Control and Prevention, studies show that more than 99 percent of
Americans 40 years and older have had chickenpox, even if they
don’t remember having the disease.
While there are currently approved vaccines for
shingles, there is an opportunity to develop an improved vaccine
that potentially shows high efficacy and better tolerability, and
is more efficient to produce globally, by utilizing mRNA
technology.
About Pfizer: Breakthroughs That Change
Patients’ LivesAt 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 January 5, 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 potential preventative Herpes Zoster Virus
(HZV) mRNA vaccine candidate and a strategic research, development
and commercialization collaboration between Pfizer and BioNTech for
the development of such HZV mRNA vaccine candidate, including their
potential benefits, 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 a HZV
mRNA vaccine candidate; 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 a HZV mRNA vaccine
candidate 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 a HZV mRNA vaccine candidate; whether the
collaboration between Pfizer and BioNTech will be successful; 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, 2020 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 BioNTechBiopharmaceutical
New Technologies is a next generation immunotherapy company
pioneering novel therapies for cancer and other serious diseases.
The Company exploits a wide array of computational discovery and
therapeutic drug platforms for the rapid development of novel
biopharmaceuticals. Its broad portfolio of oncology product
candidates includes individualized and off-the-shelf mRNA-based
therapies, innovative chimeric antigen receptor T cells,
bi-specific checkpoint immuno-modulators, targeted cancer
antibodies and small molecules. Based on its deep expertise in mRNA
vaccine development and in-house manufacturing capabilities,
BioNTech and its collaborators are developing multiple mRNA vaccine
candidates for a range of infectious diseases alongside its diverse
oncology pipeline. BioNTech has established a broad set of
relationships with multiple global pharmaceutical collaborators,
including Genmab, Sanofi, Bayer Animal Health, Genentech, a member
of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit www.BioNTech.de.
BioNTech Forward-looking
Statements This press release contains “forward-looking
statements” of BioNTech within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements may include, but may not be limited to, the ability of
BioNTech to develop and commercialize a vaccine for the Herpes
Zoster Virus (HZV), the ability of BioNTech to achieve the
collaboration milestone payments and the timing to commence
clinical trials. Any forward-looking statements in this press
release are based on BioNTech’s current expectations and beliefs of
future events, and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. For a discussion of these and other
risks and uncertainties, see the section entitled “Risk Factors” in
BioNTech’s Annual Report on Form 20-F filed with the SEC on March
30, 2021, which is available on the SEC’s website at www.sec.gov.
All information in this press release is as of the date of the
release, and BioNTech undertakes no duty to update this information
unless required by law.
CONTACTS
Pfizer: Media Relations +1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
BioNTech: Media Relations Jasmina Alatovic +49
(0)6131 9084 1513 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
BioNTech (TG:22UA)
Gráfico Histórico do Ativo
De Fev 2024 até Mar 2024
BioNTech (TG:22UA)
Gráfico Histórico do Ativo
De Mar 2023 até Mar 2024