Pfizer Inc. (NYSE: PFE) and LianBio (Nasdaq: LIAN), a biotechnology
company dedicated to bringing innovative medicines to patients in
China and other major Asian markets, today announced that Pfizer
opted in to the right to develop and commercialize sisunatovir, a
respiratory syncytial virus (RSV) therapeutic candidate, in
Mainland China, Hong Kong, Macau, and Singapore pursuant to the
companies’ existing strategic collaboration to expand patient
access to novel therapeutics in Greater China.
Sisunatovir is an investigational, orally administered fusion
inhibitor designed to block RSV replication by inhibiting
F-mediated fusion with the host cell. Sisunatovir is being
evaluated for the potential treatment of RSV infection in pediatric
and adult patients.
“Like LianBio, Pfizer recognizes the promise of sisunatovir to
address significant treatment gaps for patient populations
vulnerable to severe complications of RSV,” said Yizhe Wang, Ph.D.,
Chief Executive Officer of LianBio. “During typical RSV seasons,
more than 400,000 pediatric and elderly patients in China are
hospitalized with RSV-associated lower respiratory tract
infections. Pfizer is a leader in advancing research and
development for RSV vaccines and therapeutics, and their expertise
studying different modalities of treatment is expected to be
instrumental in bringing a new therapeutic option to as many
patients in need as possible."
In June 2022, Pfizer acquired ReViral Ltd. and its portfolio of
RSV therapeutic candidates with the exception of development and
commercialization rights for sisunatovir in Mainland China, Hong
Kong, Macau, and Singapore, which LianBio had previously
in-licensed from ReViral in March 2021.
“At Pfizer, we are committed to advancing potentially critical
vaccines and therapies to help address significant unmet need in
infectious diseases around the world, including RSV, and we’re
pleased that this ongoing collaboration with LianBio has the
potential to provide more patients with access to a much-needed
treatment,” said Jean-Christophe Pointeau, China President for
Pfizer Global Biopharma Business. “We believe that, if clinically
successful and approved, sisunatovir may help change the standard
of care for patients with RSV disease, for whom treatment options
are currently limited.”
Under the terms of Pfizer’s opt-in to sisunatovir rights,
LianBio will receive a $20 million upfront payment, to be released
from previously restricted cash paid by Pfizer to LianBio in 2020
under the companies’ existing strategic collaboration.
Additionally, LianBio is eligible to receive up to $135 million in
potential development and commercial milestone payments and tiered
low single digit percent of sisunatovir net sales in the
territories. Pfizer will assume all development and commercial
activities and costs in the region and will release LianBio from
its royalty and milestone obligations for sisunatovir.
About SisunatovirSisunatovir is an
investigational orally administered fusion inhibitor designed to
block RSV replication by inhibiting F-mediated fusion with the host
cell. It has been granted Fast Track designation by the U.S. Food
and Drug Administration (FDA). It significantly reduced viral load
in a phase 2 RSV human challenge study in healthy adults and is
currently being evaluated in a global phase 2 clinical study in
children.
Further clinical studies in adults and children are being
planned and will be initiated following feedback from regulatory
agencies.
About the Pfizer and LianBio Strategic
Collaboration In 2020, LianBio and Pfizer entered into a
collaboration aimed at developing and commercializing
transformative pharmaceutical products in Greater China leveraging
both LianBio’s and Pfizer’s clinical development, regulatory and
commercial expertise. Under the terms of the collaboration, Pfizer
will contribute up to $70M of non-dilutive capital toward
in-licensing, development and commercialization. At LianBio’s
discretion, products are presented to Pfizer, and Pfizer can opt-in
to development and commercial rights. The first program under
development as part of the Pfizer and LianBio strategic
collaboration is sisunatovir, an investigational therapeutic for
the treatment of RSV in pediatric and adult patients.
Pfizer Inc: 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.cn.
Pfizer Disclosure Notice
The information contained in this release is as of December 19,
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 a
strategic collaboration between Pfizer and LianBio to expand
patient access to novel therapeutics in Mainland China, Hong Kong,
Macau and Singapore, including Pfizer’s right to develop and
commercialize sisunatovir, a respiratory syncytial virus (RSV)
therapeutic candidate. Pfizer’s research and development of RSV
vaccines and therapeutics, despite their potential benefits, may
involve substantial risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by any
statements or information contained in this release. Such risks and
uncertainties may 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 preclinical and clinical data (including the data discussed in
this release), including the possibility of unfavorable new
preclinical, clinical or safety data and further analyses of
existing preclinical, clinical or safety data; the risk that
preclinical and clinical trial data are subject to differing
interpretations and assessments; whether regulatory authorities
will be satisfied with the design of and results from these and any
future preclinical and clinical studies; whether and when
applications may be filed in any jurisdiction for any potential
indications for any candidates resulting from this collaboration or
any drug applications for any potential indications for sisunatovir
or any other Pfizer RSV vaccines or therapeutic candidates which
may be filed in particular jurisdictions; whether and when
regulatory authorities in any jurisdictions may approve any such
applications for any candidates resulting from this collaboration
or applications or submissions for sisunatovir or any other Pfizer
RSV vaccines or therapeutic candidates that may be pending or
filed, which will depend on a myriad of 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 candidates resulting from this collaboration
will be commercially successful; decisions by regulatory
authorities impacting labeling or marketing, manufacturing
processes, safety and/or other matters that could affect the
availability or commercial potential of any candidates resulting
from this collaboration or applications or submission for
sisunatovir or any other Pfizer RSV vaccines or therapeutic
candidates, including development of products or therapies by other
companies; whether our collaboration with LianBio will be
successful; uncertainties regarding the impact of COVID-19 on
Pfizer’s business, operations and financial results; and any other
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, 2021 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 LianBio
LianBio is a cross-border biotechnology company on a mission to
bring transformative medicines to patients in China and other Asian
markets. Through partnerships with highly innovative
biopharmaceutical companies around the world, LianBio is advancing
a diversified portfolio of clinically validated product candidates
with the potential to drive new standards of care across
cardiovascular, oncology, ophthalmology, inflammatory disease and
respiratory indications. LianBio is establishing an international
infrastructure to position the company as a partner of choice with
a platform to provide access to China and other Asian markets. For
additional information, please visit the company’s website at
www.lianbio.com.
LianBio’s Cautionary Note Regarding Forward-Looking
Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
forward-looking statements. The words " believe," “expect,”
“potential,” “may” “will” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements in this press release include, but are
not limited to, statements concerning the promise of sisunatovir to
address significant treatment gaps for patient populations
vulnerable to severe complications of RSV, the potential for the
companies’ collaboration to provide more patients with access to a
much-needed therapy, susunatovir’s ability to change the standard
of care for patients with RSV disease and the Company’s timing of
planned clinical trials. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including: the Company’s ability to
successfully initiate and conduct its planned clinical trials and
complete such clinical trials and obtain results on its expected
timelines, or at all; the Company’s plans to leverage data
generated in its partners’ global registrational trials and
clinical development programs to obtain regulatory approval and
maximize patient reach for its product candidates; the Company’s
ability to identify new product candidates and successfully acquire
such product candidates from third parties; competition from other
biotechnology and pharmaceutical companies; general market
conditions; the impact of changing laws and regulations and those
risks and uncertainties described in LianBio’s filings with the
U.S. Securities and Exchange Commission (SEC), including LianBio’s
Annual Report on Form 10-K for the year ended December 31, 2021 and
subsequent filings with the SEC. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and LianBio specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Readers should not rely upon this
information as current or accurate after its publication date.
Pfizer Contacts:
Media RelationsXie Changfeng, External Communications Manager+86
158 0163 2860changfeng.xie@pfizer.com
LianBio Contacts:
Investor RelationsElizabeth Anderson, VP Communications and
Investor Relations+1 (646)
655-8390elizabeth.anderson@lianbio.com
Media RelationsJosh Xu, Director of Communications +86 136 6140
8315 josh.xu@lianbio.com
Katherine Smith, Evoke Canale+1 (619)
849-5378katherine.smith@evokegroup.com
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