- Four-year research collaboration combines Pfizer’s deep
experience in global drug development, including programs utilizing
messenger RNA (mRNA), lipid nanoparticles (LNP), and gene therapy,
with Beam’s leadership in base editing and mRNA/LNP delivery
technologies
- Beam will receive an upfront payment of $300 million, be
eligible to receive future milestone payments of up to $1.05
billion for a potential total consideration of up to $1.35
billion
- Beam may opt into a global co-development and
co-commercialization agreement for one program
- Research and development activities aim to advance potentially
transformative therapies for patients living with rare genetic
diseases
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.
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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’
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 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 Notice
The 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 Therapeutics
Beam 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
Statements
This 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.
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Pfizer: Media Relations +1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
Beam: Investors: Chelcie Lister THRUST Strategic
Communications chelcie@thrustsc.com
Media: Dan Budwick 1AB dan@1abmedia.com
Beam Therapeutics (NASDAQ:BEAM)
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