Pfizer (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced
that they had concluded exploratory talks with the European
Commission for a proposed supply of 200 million doses of their
investigational BNT162 mRNA-based vaccine candidate against
SARS-CoV-2 to European Union (EU) Member States, with an option for
further 100 million doses. Deliveries would be starting by the end
of 2020, subject to clinical success and regulatory authorization.
The companies will now enter into contract negotiations with the
European Commission.
The proposed supply agreement with the European
Commission would represent the largest initial order of vaccine
doses for Pfizer and BioNTech to date. Vaccine doses for Europe
would be produced in BioNTech’s German manufacturing sites, as well
as in Pfizer’s manufacturing site in Belgium. If regulatory
approval for the BNT162b2 vaccine candidate is received, the
European Commission would lead the process for allocation of the
vaccine doses among the 27 EU Member States.
“Pfizer and BioNTech’s anticipated agreement
with the European Commission is an important step forward in our
shared goal to have millions of doses of a vaccine against COVID-19
available for vulnerable populations before the end of the year. We
would like to thank the European Commission for its commitment and
confidence in our development efforts,” said Albert Bourla,
Chairman and CEO, Pfizer. “We have activated our supply
chain, most importantly our site in Belgium, and are starting to
manufacture so that our vaccine would be available as soon as
possible, if our clinical trials prove successful and regulatory
approval is granted.”
“As a company founded in the heart of Europe, we
are pleased to have concluded exploratory discussions with the
European Commission, which would be our largest initial order
to date. Our aim is to develop a safe and effective vaccine to
contribute to bringing this pandemic to an end in Europe and across
the world. Today’s decision is a further illustration of how
collaboration and solidarity can help address a global health
crisis as an international community,” said Ugur Sahin,
M.D., CEO and Co-founder of BioNTech.
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, using
a range of technology platforms, aims to provide governments,
including those in the emerging markets, with early access to a
large portfolio of COVID-19 candidate vaccines produced by multiple
manufacturers across the world.
About the BNT162 Vaccine Candidate
ProgramThe BNT162 program is based on BioNTech’s
proprietary mRNA technology and supported by Pfizer’s global
vaccine development and manufacturing capabilities. Two of the
companies’ four investigational vaccine candidates – BNT162b1 and
BNT162b2 – received Fast Track designation from the U.S. Food and
Drug Administration (FDA), based on preliminary data from Phase 1/2
studies that are currently ongoing in the U.S. and Germany as well
as animal immunogenicity studies. During preclinical and clinical
studies, BNT162b1 and BNT162b2 emerged as strong candidates based
on assessments of safety and immune response.
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.
About the Phase 2/3 StudyIn the
late-stage trial, Pfizer and BioNTech are studying a 30µg dose
level in a 2-dose regimen among up to 30,000 participants aged 18
to 85 years. The companies have selected approximately 120 sites
globally, including those in regions with significant expected
SARS-CoV-2 transmission, and are working to reach a diverse
population and enroll those volunteers at increased risk for the
infection with the virus. The Phase 2/3 trial enrollment to date
has exceeded 25,000 participants with a second dose underway.
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, currently 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. To meet those
anticipated quantities and milestones, the companies have produced
sufficient supply for their 30,000 participant Phase 2/3 clinical
trial and have begun to produce and stockpile their pandemic
supply.
The BNT162 vaccine candidate is not currently
approved for distribution anywhere in the world. Both collaborators
are committed to developing these novel vaccines with preclinical
and clinical data at the forefront of all their decision
making.
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 NoticeThe
information contained in this release is as of September 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, a potential agreement with the European
Commission 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 a definitive
supply agreement with the European Commission will be
reached; 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, Regeneron, 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; our expectation to agree
to final terms with and enter into a definitive agreement with the
European Commission; 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 RelationsAndy Widger+44
7970 149098andrew.widger@pfizer.com
Chuck 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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