KIRKLAND, QC, Aug. 13, 2021 /CNW/ - Merck (NYSE: MRK),
known as MSD outside the United
States and Canada, today
announced the initiation of a rolling submission to Health Canada
for molnupiravir, an investigational twice daily oral antiviral
agent currently in trials as a potential treatment for COVID-19.
Merck is developing molnupiravir in collaboration with Ridgeback
Biotherapeutics.
The rolling submission process was accepted under the Minister
of Health's Interim Order, which allows for the review of early
safety, quality and efficacy data while later-stage clinical trials
take place. Further findings from the ongoing molnupiravir
development program will be shared with Health Canada as they
become available. Health Canada
will make a decision only when all necessary evidence has been
submitted and reviewed.
Phase 2 interim results from the Phase 2/3 MOVe-OUT clinical
trials were presented at the European Congress of Clinical
Microbiology & Infectious Diseases (ECCMID) in July. Phase 3 of
the trial, evaluating molnupiravir twice daily for five days in
non-hospitalized adults with confirmed SARS-CoV-2, five days or
less following symptom onset and at least one risk factor
associated with poor disease outcomes, is underway and includes
sites in Canada.
About the MOVe-OUT study
MOVe-OUT (MK-4482-002) is a
Phase 2/3, randomized, placebo-controlled, double-blind, multi-site
study evaluating orally administered molnupiravir in
non-hospitalized participants at least 18 years of age with
laboratory confirmed COVID-19 and symptom onset within five days
prior to randomization. The trial plans to enroll a total of 1,850
participants with mild or moderate COVID-19. A total of 1,550
patients in the Phase 3 portion of the trial will be randomized 1:1
to receive either molnupiravir (800 mg) or placebo twice daily for
five days. The primary efficacy objective is to evaluate efficacy
of molnupiravir compared to placebo as assessed by the percentage
of participants who are hospitalized and/or die during the period
from randomization through Day 29. For further information
regarding the trial please visit clinicaltrials.gov
(NCT04575597).
About Molnupiravir
Molnupiravir (EIDD-2801/MK-4482) is
an investigational, orally administered form of a potent
ribonucleoside analog with antiviral activity against SARS-CoV-2,
the causative agent of COVID-19. Molnupiravir has been shown to be
active in several preclinical models of SARS-CoV-2, including for
prophylaxis, treatment, and prevention of transmission, as well as
SARS-CoV-1 and MERS. Molnupiravir was invented at Drug Innovations
at Emory (DRIVE), LLC, a not-for-profit
biotechnology company wholly owned by Emory
University.
About Merck
For more than 130 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.
In Canada, Merck markets a
broad range of vaccines, pharmaceutical and animal health products
and is one of the top R&D investors in Canada, with investments totaling $93.58 million in 2020 and more than $1.3 billion since 2000. Based in Kirkland, Québec, Merck employs approximately
592 people across the country. For more information about our
operations in Canada, visit
www.merck.ca and connect with us on YouTube and Twitter
@MerckCanada.
Forward-Looking Statement of Merck & Co. Inc.,
Kenilworth, NJ, 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 2020
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).
SOURCE Merck Canada Inc.