Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today
announced an agreement with the United Kingdom to supply
30 million doses of their BNT162 mRNA-based vaccine candidate
against SARS-CoV-2, currently in development, subject to clinical
success and regulatory approval. Financial details of the agreement
were not disclosed, but the terms were based on the timing of
delivery and the volume of doses.
“In the face of this global health crisis,
Pfizer’s purpose – breakthroughs that change patients’ lives – has
taken on an even greater urgency. Consequently, we’re harnessing
our scientific expertise, and we’re marshaling our manufacturing
resources to ensure that the vaccine would be available as soon as
possible, if our clinical trials prove successful and regulatory
approval is granted,” said Albert Bourla, Chairman and
Chief Executive Office, Pfizer. “This agreement is a
testament to our shared goal to have millions of doses of a vaccine
against COVID-19 available before the end of the year. We
would like to thank the U.K. government for its commitment and
support in helping to protect the people of the United Kingdom from
this deadly virus.”
“I would like to thank the U.K. government for
its support and putting trust in us. This agreement is part of our
commitment to address the pandemic by creating a global supply. We
are in advanced discussions with multiple other government bodies
and hope to announce additional supply agreements soon. Our goal
remains to bring a safe and effective COVID-19 vaccine to many
people around the world, as quickly as we can,” said Ugur
Sahin, M.D., CEO and Co-founder of BioNTech.
“Finding a vaccine is one way that we will end
the pandemic and return to normal life. That is why we are making
sure people most at risk in the U.K. are vaccinated against
COVID-19 as soon as a safe vaccine becomes available, by partnering
with the world’s foremost pharmaceutical and vaccine companies,”
said Alok Sharma, the U.K.’s Secretary of State for
Business, Energy and Industrial Strategy.
The BNT162 program is based on BioNTech’s
proprietary mRNA technology and supported by Pfizer’s global
vaccine development and manufacturing capabilities. The BNT162
vaccine candidates are undergoing clinical studies and are not
currently approved for distribution anywhere in the world. BioNTech
is the market authorization holder worldwide and will hold all
trademarks for the potential product. Both collaborators are
committed to developing these novel vaccines with pre-clinical and
clinical data at the forefront of all their decision-making.
The Pfizer/BioNTech vaccine development program
is evaluating at least four experimental vaccines, each of which
represents a unique combination of messenger RNA (mRNA) format and
target antigen. On July 1st, Pfizer and BioNTech announced
preliminary data from BNT162b1, the most advanced of the four mRNA
formulations. The early data demonstrates that BNT162b1 is able to
produce neutralizing antibodies in humans at or above the levels
observed in the plasma from patients who have recovered from
COVID-19, and this was shown at relatively low dose levels. Local
reactions and systemic events were dose-dependent, generally mild
to moderate, and transient. No serious adverse events were
reported.
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. Further data
from the ongoing Phase 1/2 clinical trials of the four vaccine
candidates will enable the selection of a lead candidate and dose
level for an anticipated large, global Phase 2b/3 safety and
efficacy study that may begin as early as later this month, pending
regulatory approval.
If the ongoing studies are successful, Pfizer
and BioNTech expect to be ready to seek Conditional Marketing
Authorization or some form of regulatory approval as early as
October 2020. The companies currently expect to manufacture
globally up to 100 million doses by the end of 2020 and
potentially more than 1.3 billion doses by the end of 2021,
subject to final dose selection from the clinical trial.
In addition to the 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 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 20, 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 BNT162
mRNA vaccine program, a collaboration between BioNTech and Pfizer
to develop a potential COVID-19 vaccine, an agreement with the
United Kingdom to supply BNT162 and other potential supply
agreements, including their potential benefits, manufacturing and
distribution and the expected timing of clinical trials and
regulatory submissions, 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 the possibility of
unfavorable new preclinical or clinical trial data and further
analyses of existing preclinical or clinical trial data; risks
associated with preliminary 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
applications may be filed in any jurisdictions for any potential
vaccine candidates under the collaboration; 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
any such vaccine candidates 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 any such vaccine
candidates, 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 United Kingdom will be reached; whether
and when other supply agreements will be reached; uncertainties
regarding the ability to obtain recommendations from vaccine
technical committees and other public health authorities regarding
any such vaccine candidates 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.
Pfizer Contacts:
Media RelationsLisa O’Neill+44
(0)7929 339 560Lisa.O’neill@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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