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 their BNT162
mRNA-based vaccine candidate against SARS-CoV-2, subject to
clinical success and regulatory approval, beginning in 2021.
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 30µg 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’ 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 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 NoticeThe
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 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, Genevant, Fosun Pharma, and Pfizer.
For more information, please visit
www.BioNTech.de
BioNTech Forward-looking
StatementsThis 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.
Pfizer Contacts:
Media RelationsAmy Rose+1 (212)
733-7410Amy.Rose@pfizer.com
Investor RelationsChuck
Triano+1 (212) 733-3901Charles.E.Triano@Pfizer.com
BioNTech Contacts:
Media RelationsJasmina
Alatovic+49 (0)6131 9084 1513 or +49 (0)151 1978
1385Media@biontech.de
Investor RelationsSylke Maas,
Ph.D.+49 (0)6131 9084 1074Investors@biontech.de
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