- 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
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.
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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 $25 million 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’
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 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 BioNTech
Biopharmaceutical 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.
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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
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