- Agreement aims to advance discovery and development of novel
papain-like protease (PLpro) inhibitors and potentially introduce a
new class of oral antivirals in the fight against COVID-19
- Expands Pfizer’s innovative anti-infective pipeline,
complementing the company’s existing portfolio of COVID-19
products
Pfizer Inc. (NYSE: PFE) and Clear Creek Bio, Inc. today
announced a research collaboration and exclusive license agreement
to advance the discovery and development of potential inhibitors of
the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment
of COVID-19. PLpro is an essential enzyme, which, along with the
main protease (Mpro), plays an important role in viral replication.
This program will expand Pfizer’s innovative anti-infective
pipeline and, if successful, will complement Pfizer’s existing
portfolio of COVID-19 products with direct-acting antiviral agents
against different SARS-CoV-2 targets.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20221206005107/en/
“COVID-19 has proven to be a devastating and highly
unpredictable disease, one with the potential to remain a global
health concern for years to come,” said Charlotte Allerton, Chief
Scientific Officer, Anti-Infectives and Head of Medicine Design, of
Pfizer. “It is critical that we try to stay ahead of the virus,
continuing to advance clinical development opportunities for our
current oral therapy as well as innovating through our internal
programs and strategic partnerships to bring forward additional
monotherapy and/or combination treatment candidates that we believe
may play a role in the ongoing fight against COVID-19.”
“As COVID-19 continues to evolve, there is a significant need
for oral antivirals with novel mechanisms of action,” said Vikram
Sheel Kumar, M.D., Chief Executive Officer of Clear Creek Bio. “We
explored the druggable SARS-CoV-2 genome and identified PLpro as a
promising and untapped target. Leveraging our team’s expertise and
success in bringing novel drugs from idea to approval, we
internally developed highly potent PLpro inhibitors. We look
forward to working with Pfizer, a global leader in antiviral
development, to advance a new class of oral antivirals for
COVID-19.”
Under the terms of the agreement, the two companies will work
together to identify a PLpro candidate to progress into the clinic,
at which time Pfizer will be solely responsible for further
development and commercialization activities. Clear Creek Bio will
receive an undisclosed upfront payment and will be eligible to
receive additional potential milestone payments plus royalties on
future product sales.
About SARS-CoV-2 PLpro SARS-CoV-2 has two essential
proteases, the main protease (Mpro) and the papain-like protease
(PLpro), both required to fully process the viral polyprotein and
assemble a functional replicase complex. In addition to its
critical role in viral replication, the PLpro also contributes to
dysregulation of host innate immunity and immune evasion.
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 December 6, 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
research collaboration and exclusive license agreement between
Pfizer and Clear Creek Bio to advance the discovery and development
of potential inhibitors of the SARS-CoV-2 papain-like protease
(PLpro) for the oral treatment of COVID-19, Pfizer’s oral therapy
for COVID-19, and Pfizer’s innovative anti-infective pipeline,
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 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
ability to produce comparable clinical or other results including
efficacy, safety and tolerability profile observed to date, in
additional studies or in larger, more diverse populations following
commercialization; the ability of Pfizer’s current oral therapy for
COVID-19 to maintain efficacy against emerging virus variants; the
risk that serious and unexpected adverse events may occur that have
not been previously reported with use of Pfizer’s current oral
therapy for COVID-19; the risk that preclinical and 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 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
jurisdictions for any potential indications for any candidates
resulting from the collaboration or any drug applications or
submissions to request emergency use or conditional marketing
authorization for any potential indications for Pfizer’s current
oral therapy for COVID-19 may be filed in particular jurisdictions
and if obtained, whether or when such emergency use authorization
or licenses will expire or terminate; whether and when regulatory
authorities in any jurisdictions may approve any such applications
for any candidates resulting from the collaboration or applications
or submissions for Pfizer’s current oral therapy for COVID-19 that
may be pending or filed, 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 candidates
resulting from the 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 the collaboration or Pfizer’s current
oral therapy for COVID-19, including development of products or
therapies by other companies; risks related to the availability of
raw materials for Pfizer’s current oral therapy for COVID-19; the
risk that we may not be able to create or scale up manufacturing
capacity on a timely basis or maintain access to logistics or
supply channels commensurate with global demand, which would
negatively impact our ability to supply the estimated numbers of
courses of Pfizer’s current oral therapy for COVID-19 within the
projected time periods; whether and when additional purchase
agreements will be reached; the risk that demand for any products
may be reduced or no longer exist which may lead to reduced
revenues or excess inventory; whether our collaboration with Clear
Creek Bio 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, 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 Clear Creek Bio
Clear Creek Bio is a private biotechnology company focused on
developing therapeutics for global unmet needs. Activities span
in-house small molecule discovery through early clinical
development. In addition to the PLpro program, Clear Creek Bio is
evaluating brequinar, a potent oral inhibitor of dihydroorotate
dehydrogenase (DHODH), in combinations with other therapeutics
against a wide range of RNA viruses. For additional information,
please visit www.clearcreekbio.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221206005107/en/
Pfizer:
Media Relations +1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations +1 (212) 733-4848 IR@pfizer.com
Clear Creek Bio:
Company Cindy Motaka cmotaka@clearcreekbio.com
Media Relations Jessica Yingling, Ph.D. +1 (858) 344-8091
jessica@litldog.com
Pfizer (NYSE:PFE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2023 to Apr 2024