- Supply of 120 million doses to be provided in the first
half of 2021, subject to regulatory approval
- Agreement is part of Pfizer’s and BioNTech’s global commitment
to help address the pandemic
- Pfizer and BioNTech began a Phase 2b/3 safety and efficacy
trial and remain on track to seek regulatory review as early as
October 2020, and manufacture globally up to 100 million doses by
the end of 2020 and approximately 1.3 billion doses by the end of
2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced an agreement with the Ministry of Health, Labour and
Welfare (MHLW) in Japan to supply 120 million doses of BNT162
mRNA-based vaccine candidate against SARS-CoV2, subject to clinical
success and regulatory approval, beginning in 2021.
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Financial details of the agreement were not disclosed, but the
terms were based on the timing of delivery and the volume of doses.
As requested by the Government of Japan, deliveries of the vaccine
candidate are planned for the first half of 2021.
“We are deeply honored to work with the Japanese government and
to marshal our scientific and manufacturing resources toward our
shared goal of bringing millions of doses of a potential COVID-19
vaccine to the Japanese people as quickly as possible,” said Albert
Bourla, Chairman and CEO, Pfizer. “In the face of this global
health crisis, Pfizer’s purpose – breakthroughs that change
patients’ lives – has taken on an even greater urgency. Under these
difficult circumstances, we are proud to help support Japan in its
steadfast determination to bring the world together at the 2020
Tokyo Olympics, in a celebration of solidarity, friendship and the
power of sport as a global force for good. Our hope is that,
subject to clinical and regulatory success, our potential vaccine
will help make this happen.”
“In bringing the world together at one place, for centuries, the
Olympic Games have been a symbol of a global community. As a
renewed version of that very spirit, the 2020 Tokyo Olympics may
become a symbol for all of us for how all nations around the world
can overcome a global pandemic threat together. We are proud and
honored that our vaccine candidate may contribute to the efforts
undertaken by the government of Japan to turn this vision into
reality,” said Ugur Sahin, M.D., CEO and Co-founder of
BioNTech.
The BNT162 program is based on BioNTech’s proprietary mRNA
technology and supported by Pfizer’s global vaccine development and
manufacturing capabilities. The vaccine development program is
evaluating at least four experimental vaccine candidates, each of
which represents a unique combination of messenger RNA (mRNA)
format and target antigen. The BNT162 vaccine candidates are
undergoing clinical studies and are not currently approved for
distribution anywhere in the world. Both collaborators are
committed to developing these novel vaccines with pre-clinical and
clinical data at the forefront of all their decision-making.
Recently, two of the companies’ four investigational vaccine
candidates – BNT162b1 and BNT162b2 – received Fast Track
designation from the U.S. Food and Drug Administration (FDA). This
designation was granted based on preliminary data from Phase 1/2
studies that are currently ongoing in the United States and Germany
as well as animal immunogenicity studies.
On July 27, Pfizer and BioNTech announced that following
extensive review of preclinical and clinical data from Phase 1/2
clinical trials, and in consultation with the FDA’s Center for
Biologics Evaluation and Research (CBER) and other global
regulators, the companies selected the BNT162b2 vaccine candidate
to move forward into a Phase 2/3 study. BNT162b2 encodes an
optimized SARS-CoV-2 full length spike glycoprotein (S), which is
the target of virus neutralizing antibodies. In the late-stage
trial, the companies will study a 30 µg dose level in a 2 dose
regimen among up to 30,000 participants aged 18 – 85 years. It is
expected to include approximately 120 sites globally including in
regions with significant expected SARS-CoV-2 transmission.
Assuming clinical success, Pfizer and BioNTech are on track to
seek regulatory review for BNT162b2 as early as October 2020 and,
if regulatory authorization or approval is obtained, plan to supply
up to 100 million doses worldwide by the end of 2020 and
approximately 1.3 billion doses by the end of 2021.
In addition to engagements with governments, Pfizer and BioNTech
have provided an expression of interest for possible supply to the
COVAX Facility, a mechanism established by Gavi, the Vaccine
Alliance, the Coalition for Epidemic Preparedness Innovations
(CEPI) and World Health Organization (WHO) that aims to provide
governments, including those in the emerging markets, with early
access to a large portfolio of COVID-19 candidate vaccines using a
range of technology platforms, produced by multiple manufacturers
across the world.
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 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.
Pfizer Disclosure Notice
The information contained in this release is as of July 31,
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 Pfizer’s
efforts to combat COVID-19, the collaboration between BioNTech and
Pfizer to develop a potential COVID-19 vaccine, an agreement with
the government of Japan to supply BNT162 and other potential
agreements, the BNT162 mRNA vaccine program, and modRNA candidates
BNT162b2 and BNT162b1 (including qualitative assessments of
available data, potential benefits, expectations for clinical
trials and timing of regulatory submissions, anticipated
manufacturing, supply and distribution), 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 clinical trials, regulatory submission dates,
regulatory approval dates and/or launch dates, as well as risks
associated with preliminary data, including the possibility of
unfavorable new preclinical or clinical trial data and further
analyses of existing preclinical or clinical trial data that may be
inconsistent with the data used for selection of the BNT162b2
vaccine candidate and dose level for the Phase 2/3 study; the risk
that clinical trial data are subject to differing interpretations
and assessments, including during the peer review/publication
process, in the scientific community generally, and by regulatory
authorities; whether and when data from the BNT162 mRNA vaccine
program will be published in scientific journal publications and,
if so, when and with what modifications; whether regulatory
authorities will be satisfied with the design of and results from
these and future preclinical and clinical studies; whether and when
any biologics license and/or emergency use authorization
applications may be filed in any jurisdictions for BNT162b2 or any
other potential vaccine candidates; 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 vaccine candidate’s benefits outweigh its known risks
and determination of the vaccine candidate’s efficacy and, if
approved, whether it 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 vaccine, including development of
products or therapies by other companies; manufacturing
capabilities or capacity, including whether the estimated numbers
of doses can be manufactured within the projected time periods
indicated; whether and when additional supply agreements will be
reached; uncertainties regarding the ability to obtain
recommendations from vaccine technical committees and other public
health authorities and uncertainties regarding the commercial
impact of any such recommendations; 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.
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, 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, statements concerning: BioNTech’s
efforts to combat COVID-19; the timing to initiate clinical trials
of BNT162 and anticipated publication of data from these clinical
trials; the timing for any potential emergency use authorizations
or approvals; the potential to enter into additional supply
agreements with other jurisdictions or the COVAX Facility; the
potential safety and efficacy of BNT162; the collaboration between
BioNTech and Pfizer to develop a potential COVID-19 vaccine; and
the ability of BioNTech to supply the quantities of BNT162 to
support clinical development and, if approved, market demand,
including our production estimates for 2020 and 2021. Any
forward-looking statements in this press release are based on
BioNTech 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. These risks
and uncertainties include, but are not limited to: competition to
create a vaccine for COVID-19; the ability to produce comparable
clinical results in larger and more diverse clinical trials; the
ability to effectively scale our productions capabilities; and
other potential difficulties. For a discussion of these and other
risks and uncertainties, see BioNTech’s Annual Report on Form 20-F
filed with the SEC on March 31, 2020, 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 Amy Rose +1 (212) 733-7410
Amy.Rose@pfizer.com
Investor Relations Chuck Triano +1 (212) 733-3901
Charles.E.Triano@Pfizer.com
BioNTech: Media Relations Jasmina Alatovic +49 (0)6131
9084 1513 or +49 (0)151 1978 1385 Media@biontech.de
Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074
Investors@biontech.de
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