Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced it has entered into an agreement with the
United States Government to support the development, manufacture
and initial distribution of an investigational biological
therapeutic (CD24Fc, to be named MK-7110) upon approval or
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA). Merck acquired MK-7110 through the
acquisition of OncoImmune, a privately held, clinical-stage
biopharmaceutical company.
“Building upon the promising clinical findings to date for
MK-7110, Merck is pleased to be collaborating with the U.S.
Government to advance the manufacture and distribution of this
candidate for patients with serious COVID-19 disease,” said Dr.
Roger M. Perlmutter, president, Merck Research Laboratories.
Under the agreement, Merck will receive up to approximately $356
million for manufacturing and supply of approximately
60,000-100,000 doses of MK-7110 to the U.S. Government through June
30, 2021 to meet the government’s Operation Warp Speed goals. This
approach is intended to expedite delivery of MK-7110 to the
American people as quickly as possible, following potential EUA or
FDA approval. Merck is also investing to expand its manufacturing
capacity to increase supply of MK-7110.
In September 2020, OncoImmune reported topline findings from an
interim efficacy analysis of a Phase 3 study evaluating MK-7110 for
the treatment of patients with severe and critical COVID-19. An
interim analysis of data from 203 participants (75% of the planned
enrollment) indicated that hospitalized patients with COVID-19
treated with a single dose of MK-7110 showed a 60% higher
probability of improvement in clinical status compared to placebo,
as defined by the protocol. The risk of death or respiratory
failure was reduced by more than 50%. The study is ongoing.
About SAC-COVID Phase 3 Trial
The SAC-COVID Phase 3 clinical trial (NCT04317040) is a
randomized, double blind, placebo-controlled trial designed to
evaluate the safety and efficacy of CD24Fc/MK-7110 in hospitalized
patients with COVID-19 requiring oxygen support, including those
requiring supplemental oxygen, high flow oxygen, and mechanical
ventilation. Participants were randomly assigned into two arms
receiving either standard of care plus a single dose of MK-7110 via
an intravenous infusion on Day 1 or standard of care plus placebo
on Day 1. The multi-center trial was initiated in April 2020 and
had enrolled 243 patients when the trial was closed due to full
enrollment in September 2020.
About Operation Warp Speed
OWS is a partnership among components of the Department of
Health and Human Services and the Department of Defense, engaging
with private firms and other federal agencies, and coordinating
among existing HHS-wide efforts to accelerate the development,
manufacturing, and distribution of COVID-19 vaccines, therapeutics,
and diagnostics.
About MK-7110 (CD24Fc)
MK-7110 is a potentially first-in-class recombinant fusion
protein that targets the innate immune system. In addition to the
Phase 3 clinical trial for COVID-19 patients, MK-7110 has been
studied for safety in healthy volunteers and in Phase 2 clinical
trials for the prevention of graft versus host disease (GVHD)
following hematopoietic stem cell transplantation in patients with
leukemia. A pivotal Phase 3 clinical trial (NCT04095858) for
prophylaxis of GVHD has been initiated nationwide.
About Merck’s Ongoing Commitment to COVID-19
Merck has been committed to developing an effective response to
COVID-19 since the early stage of the pandemic and is exploring
multiple paths to advance the understanding of SARS-CoV-2
infection. In addition to the development of MK-7110, in
collaboration with Ridgeback Biotherapeutics Merck is evaluating
molnupiravir, an investigational orally available anti-viral agent
being evaluated in two Phase 2/3 trials for the treatment of
patients with COVID-19 in both the outpatient and hospital
settings. The company is also conducting clinical trials to
evaluate two SARS-CoV-2/COVID-19 vaccine candidates: V590, being
developed through a collaboration with IAVI, which utilizes a
recombinant vesicular stomatitis vector, and V591 which uses a
measles virus vector-based platform.
About Merck
For more than 125 years, Merck, known as MSD outside of the
United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict
future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign
risk; dependence on the effectiveness of the company’s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2019
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
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