Pfizer Inc. (NYSE: PFE) and Beam Therapeutics Inc. (Nasdaq: BEAM),
a biotechnology company developing precision genetic medicines
through base editing, today announced an exclusive four-year
research collaboration focused on in vivo base editing programs for
three targets for rare genetic diseases of the liver, muscle and
central nervous system.
The base editing programs to be evaluated as part of the
collaboration will leverage Beam’s proprietary in vivo delivery
technologies, which use messenger RNA (mRNA) and lipid
nanoparticles (LNP) to deliver base editors to target organs.
Combining these technologies with Pfizer’s proven experience in
developing and manufacturing medicines and vaccines, this
collaboration seeks to advance potentially transformative therapies
for patients living with rare diseases.
Beam’s proprietary base editing technologies are designed to
enable a new class of precision genetic medicines that target a
single base in the genome without making a double-stranded break in
the DNA. This approach aims to create a more precise and efficient
edit compared to traditional gene editing methods, which operate by
creating targeted double-stranded breaks in the DNA, resulting in
potential challenges associated with unwanted DNA
modifications.
“At Pfizer, we believe in the powerful potential of mRNA and LNP
technologies to address the greatest unmet needs for patients, as
evidenced by the beneficial impact our mRNA/LNP-based COVID-19
vaccine is having on the pandemic,” said Mikael Dolsten, M.D.,
Ph.D., Chief Scientific Officer and President, Worldwide Research,
Development and Medical of Pfizer. “We have a strong history in
developing gene replacement therapies for rare diseases, and we see
this collaboration with Beam as an opportunity to advance the next
generation of gene editing therapies – an exciting scientific
frontier – potentially leading to transformation for people living
with rare genetic diseases.”
“We are thrilled to partner with Pfizer, a global leader in the
design, development, and commercialization of novel medicines,”
said John Evans, Chief Executive Officer of Beam. “Our leading
platform for precision genetic medicine has greatly evolved over
the last few years, and we are committed to ensuring the broadest
reach of these potentially life-changing technologies. This
collaboration will provide a unique opportunity to create
potentially transformative base editing programs for indications
with critical unmet needs, leveraging our proprietary base editing
technology and expanding delivery capabilities. We look forward to
working together with Pfizer to advance these technologies and
potentially expand our impact for people suffering from serious
diseases.”
Under the terms of the collaboration agreement, Beam will
conduct all research activities through development candidate
selection for three undisclosed targets, which are not included in
Beam’s existing programs. Pfizer may opt in to exclusive, worldwide
licenses to each development candidate, after which it will be
responsible for all development activities, as well as potential
regulatory approvals and commercialization, for each such
candidate. Beam has a right to opt in, at the end of Phase 1/2
studies, upon the payment of an option exercise fee, to a global
co-development and co-commercialization agreement with respect to
one program licensed under the collaboration pursuant to which
Pfizer and Beam would share net profits as well as development and
commercialization costs in a 65%/35% ratio (Pfizer/Beam).
Beam will receive an upfront payment of $300 million and,
assuming Pfizer exercises its opt-in license rights for all three
targets, is eligible for development, regulatory and commercial
milestone payments for potential total deal consideration of up to
$1.35 billion. Beam is also eligible to receive royalties on global
net sales for each licensed program. The collaboration has an
initial term of four years and may be extended up to one additional
year.
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 January 10, 2022. 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 the
potential of mRNA and LNP technology and a research collaboration
between Pfizer and Beam focused on in vivo base editing programs
for three targets for rare genetic diseases of the liver, muscle,
and central nervous system, including their potential benefits,
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
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when any
applications may be filed for any drug or vaccine candidates in any
jurisdictions; whether and when regulatory authorities may approve
any potential applications that may be filed for any drug or
vaccine candidates in any jurisdictions, 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 drug or
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 drug or vaccine candidates; whether the
collaboration between Pfizer and Beam will be successful;
uncertainties regarding the impact of COVID-19 on Pfizer’s
business, operations and financial results; 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, 2020 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 Beam TherapeuticsBeam Therapeutics
(Nasdaq: BEAM) is a biotechnology company committed to establishing
the leading, fully integrated platform for precision genetic
medicines. To achieve this vision, Beam has assembled a platform
that includes a suite of gene editing and delivery technologies and
is in the process of building internal manufacturing capabilities.
Beam’s suite of gene editing technologies is anchored by base
editing, a proprietary technology that enables precise, predictable
and efficient single base changes, at targeted genomic sequences,
without making double-stranded breaks in the DNA. This enables a
wide range of potential therapeutic editing strategies that Beam is
using to advance a diversified portfolio of base editing programs.
Beam is a values-driven organization committed to its people,
cutting-edge science, and a vision of providing life-long cures to
patients suffering from serious diseases.
Beam Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Investors are cautioned not to place undue
reliance on these forward-looking statements, including, but not
limited to, statements related to the potential benefits of our
collaboration with Pfizer, any future payments we may receive under
our research collaboration agreement with Pfizer, the therapeutic
applications and potential of our technology, including our ability
to deliver base editors to target organs in and beyond the liver
and our ability to develop life-long, curative, precision genetic
medicines for patients through base editing. Each forward-looking
statement is subject to important risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied in such statement, including, without
limitation, risks and uncertainties related to: our ability to
develop, obtain regulatory approval for, and commercialize our
product candidates, which may take longer or cost more than
planned; our ability to raise additional funding, which may not be
available; our ability to obtain, maintain and enforce patent and
other intellectual property protection for our product candidates;
the potential impact of the COVID-19 pandemic; that preclinical
testing of our product candidates and preliminary or interim data
from preclinical studies and clinical trials may not be predictive
of the results or success of ongoing or later clinical trials; that
enrollment of our clinical trials may take longer than expected;
that our product candidates may experience manufacturing or supply
interruptions or failures; risks related to competitive products;
and the other risks and uncertainties identified under the headings
“Risk Factors Summary” and “Risk Factors” in our Annual Report on
Form 10-K for the year ended December 31, 2020, our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2021, our
Quarterly Report on Form 10-Q for the quarter ended June 30, 2021
and our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2021, and in any subsequent filings with the
Securities and Exchange Commission. These forward-looking
statements speak only as of the date of this press release. Factors
or events that could cause our actual results to differ may emerge
from time to time, and it is not possible for us to predict all of
them. We undertake no obligation to update any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as may be required by applicable
law.
Contacts:
Pfizer:
Media Relations
+1 (212) 733-1226PfizerMediaRelations@pfizer.com
Investor Relations
+1 (212) 733-4848IR@pfizer.com
Beam: Investors:Chelcie ListerTHRUST Strategic
Communicationschelcie@thrustsc.com
Media:Dan Budwick1ABdan@1abmedia.com
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