Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX, “BioNTech”)
today announced that two of the companies’ four investigational
vaccine candidates from their BNT162 mRNA-based vaccine program
(BNT162b1 and BNT162b2) being developed to help protect against
SARS-CoV-2 (the virus that causes COVID-19), received Fast Track
designation from the U.S. Food and Drug Administration (FDA).
BNT162b1 and BNT162b2 are the two most advanced vaccine candidates
in the BNT162 program currently being evaluated in ongoing Phase
1/2 clinical studies in the United States and Germany.
Fast Track is a process designed to facilitate
the development, and expedite the review, of new drugs and vaccines
that are intended to treat or prevent serious conditions that have
the potential to address an unmet medical need.i 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. The companies released early data
from the ongoing U.S. Phase 1/2 study for the product candidate
BNT162b1 on July 1, 2020. The manuscript is available on the online
preprint server medRxiv and is concurrently undergoing scientific
peer-review for potential publication. Early data from the German
trial of BNT162b1 are expected to be released in July.
The BNT162 program is evaluating at least four
experimental vaccines, each of which represent a unique combination
of messenger RNA (mRNA) format and target antigen. BNT162b1 and
BNT162b2 are both nucleoside-modified RNAs, formulated in lipid
nanoparticles. BNT162b1 encodes an optimized SARS-CoV-2
receptor-binding domain (RBD) antigen, while BNT162b2 encodes an
optimized SARS-CoV-2 full-length spike protein antigen.
“The FDA’s decision to grant these two COVID-19
vaccine candidates Fast Track designation signifies an important
milestone in the efforts to develop a safe and effective vaccine
against SARS-CoV-2,” said Peter Honig, Senior Vice
President, Global Regulatory Affairs, Pfizer. “We look
forward to continue working closely with the FDA throughout the
clinical development of this program, Project Lightspeed, to
evaluate the safety and efficacy of these vaccine candidates.”
“We are pleased to have received Fast Track
designation from the FDA for two of our vaccine candidates and look
forward to working closely with the FDA, along with our partner
Pfizer, to expedite the clinical development path forward,” said
Özlem Türeci, Chief Medical Officer at
BioNTech.
The Project Lightspeed vaccine development
program is based on BioNTech’s proprietary mRNA-based technology
platforms and supported by Pfizer’s global vaccine development
capabilities. The BNT162 vaccine candidates are undergoing clinical
studies and are not currently approved for distribution anywhere in
the world. Pfizer and BioNTech are committed to developing these
novel vaccines with pre-clinical and clinical data at the forefront
of all decision-making of both companies. Subject to regulatory
approval, the companies are expecting to start a Phase 2b/3 trial
as soon as later this month and are anticipating enrolling up to
30,000 subjects. If the ongoing studies are successful, and the
vaccine candidate receives regulatory approval, the companies
currently expect to manufacture up to 100 million doses by the end
of 2020 and potentially more than 1.2 billion doses by the end of
2021.
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 13, 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, and a collaboration between BioNTech and
Pfizer to develop a potential COVID-19 vaccine, including their
potential benefits, and anticipated publication of data,
manufacturing and distribution and the expected timing of clinical
trials, 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 the scientific
journal publications referenced above will occur 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; 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 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 any expedited review
resulting from Fast Track designation; collaborations between
BioNTech and Pfizer, and BioNTech and Fosun Pharma, 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. 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 and 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 has been filed
with the SEC and 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 Media RelationsAmy Rose+1 (212)
733-7410Amy.Rose@Pfizer.com
Pfizer Investor RelationsChuck Triano+1 (212)
733-3901Charles.E.Triano@Pfizer.com
BioNTech Media RelationsJasmina Alatovic+49
(0)6131 9084 1513 or +49 (0)151 1978 1385Media@biontech.de
BioNTech Investor RelationsSylke Maas, Ph.D.+49
(0)6131 9084 1074Investors@biontech.de
____________________
i U.S. Food and Drug Administration Fast Track
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
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