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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 November 9, 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, the BNT162 mRNA vaccine program, and modRNA
candidate BNT162b2 (including qualitative assessments of available data,
potential benefits, expectations for clinical trials, anticipated timing of
clinical trial readouts and regulatory submissions and anticipated
manufacturing, distribution and supply), 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 and interim data, (including the Phase 3
interim data that is the subject of this release), including the
possibility of unfavorable new preclinical or clinical trial data and
further analyses of existing preclinical or clinical trial data; 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; disruptions in the relationships between us
and our collaboration partners or third-party suppliers; risks related to
the availability of raw materials to manufacture a vaccine; challenges
related to our vaccine candidate’s ultra-low temperature formulation and
attendant storage, distribution and administration requirements, including risks
related to handling after delivery by Pfizer; the risk that we may not be
able to successfully develop non-frozen formulations; the risk that we may
not be able to create or scale up manufacturing capacity on a timely basis
or have access to logistics or supply channels commensurate with global
demand for any potential approved vaccine, which would negatively impact
our ability to supply the estimated numbers of doses of our vaccine
candidate 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 collaboration between BioNTech
and Pfizer to develop a potential COVID-19 vaccine; our expectations
regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial
and/or in commercial use based on data observations to date; the expected
timepoint for additional readouts on efficacy data of BNT162b2 in our Phase
2/3 trial; the nature of the clinical data, which is subject to ongoing
peer review, regulatory review and market interpretation; the timing for
submission of data for, or receipt of, any potential Emergency Use
Authorization; the timing for submission of manufacturing data to the FDA;
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: the ability to
meet the pre-defined endpoints in clinical trials; competition to create a
vaccine for COVID-19; the ability to produce comparable clinical or other
results, including our stated rate of vaccine effectiveness and safety and
tolerability profile observed to date, in the remainder of the trial or in
larger, more diverse populations upon commercialization; 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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