Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics today announced the New
England Journal of Medicine has published findings from the Phase 3
MOVe-OUT trial evaluating molnupiravir, an investigational oral
antiviral medicine, in non-hospitalized high risk adults with mild
to moderate COVID-19. Data from MOVe-OUT demonstrated that early
treatment with molnupiravir significantly reduced the risk of
hospitalization or death in high risk, unvaccinated adults with
COVID-19. Merck is developing molnupiravir in collaboration with
Ridgeback Biotherapeutics.
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Molnupiravir is authorized in the United Kingdom as the first
oral antiviral for the treatment of mild to moderate COVID-19 in
adults with a positive SARS-CoV-2 diagnostic test and who have at
least one risk factor for developing severe illness. The European
Medicines Agency (EMA) issued a positive scientific opinion for
molnupiravir under Article 5.3 Regulation 726/2004, which is
intended to support national decision-making on the possible use of
molnupiravir prior to marketing authorization. Regulatory
applications are under review or are in the process of being
submitted, including applications for Emergency Use Authorization
(EUA) by the U.S. Food and Drug Administration (FDA) and Japan’s
Ministry of Health, Labor and Welfare.
“In MOVe-OUT, molnupiravir significantly reduced the risk of
hospitalization and death among a diverse population of patients at
risk for more severe COVID-19. The increases in COVID-19 cases,
hospitalizations and deaths being reported globally are a stark
reminder that new tools are urgently needed, which is why we are
moving with speed and rigor to obtain authorizations and to
accelerate broad global access to this investigational medicine for
appropriate patients,” said Dr. Dean Y. Li, president, Merck
Research Laboratories. “Importantly, we observed consistent
efficacy among patients with more common variants at the time, and
more recent preclinical evidence indicates that molnupiravir has
antiviral activity against Omicron, which is encouraging
considering the uncertain future of a rapidly evolving virus such
as SARS-CoV-2.”
“The publication of these positive results in the New England
Journal of Medicine demonstrates that molnupiravir, which was
studied as a single medicine that can be taken at home – regardless
of food intake, with no known drug-drug interactions and without
required dose modifications for those with kidney or liver
impairment – has the potential to be a valuable addition to the
therapeutic options available to fight COVID-19,” said Wendy
Holman, chief executive officer, Ridgeback Biotherapeutics. “We are
grateful for the efforts of the clinical trial participants and
investigators and will continue to study molnupiravir for the
treatment and prevention of COVID-19.”
“One of the hallmarks of the MOVe-OUT study is the diverse
patient population, which included adults from 20 countries, with
one or more risk factors such as obesity, advanced age, diabetes
and serious heart conditions. Based on this study, molnupiravir has
the potential to have a meaningful impact for patients, healthcare
systems and public health,” said Dr. Monica Gomes, Universidade
Federal do Paraná, Brazil.
About the MOVe-OUT Study
The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global
Phase 3, randomized, placebo-controlled, double-blind, multi-site
study of non-hospitalized adult patients with laboratory-confirmed
mild to moderate COVID-19. The primary efficacy objective of
MOVe-OUT is to evaluate the efficacy of molnupiravir 800 mg twice
daily for five days compared to placebo as assessed by the
percentage of patients who are hospitalized and/or die through Day
29.
Patients enrolled in the study had at least one risk factor
associated with poor disease outcomes (age >60 years; active
cancer; chronic kidney disease; chronic obstructive pulmonary
disease; obesity; serious heart conditions; or diabetes mellitus),
and symptom onset within five days prior to study enrollment. Key
exclusion criteria were an anticipated need for hospitalization for
COVID-19 within the next 48 hours, dialysis or estimated glomerular
filtration rate less than 30 ml per minute per 1.73 m2,
unwillingness to use contraception during the intervention period
and for at least 4 days after completion of the regimen, severe
neutropenia (absolute neutrophil count of <500 per milliliter),
platelet count below 100,000 per microliter, any prior SARS-CoV-2
vaccination and pregnancy. The potential impact of molnupiravir on
fetal development if taken during pregnancy is unknown.
Standard-of-care treatment with antipyretic agents,
anti-inflammatory agents, glucocorticoids, or a combination was
permitted; use of therapies intended as COVID-19 treatments
(including any monoclonal antibodies and remdesivir) was prohibited
through Day 29.
In the all randomized analysis, 47.7% of patients had onset of
signs or symptoms three days or less before randomization and 44.5%
had moderate COVID-19. The most common risk factors were obesity
(73.7%), age over 60 years (17.2%) and diabetes mellitus (15.9%).
Presence of baseline SARS-CoV-2 nucleocapsid antibodies was
assessed centrally using the Elecsys® assay. Positive baseline
SARS-CoV-2 antibodies, indicating recent/prior infection (not
vaccination), were reported for 19.8% of patients. Due to the
ongoing nature of testing, the viral variant type at baseline was
not available for 25.9% of randomized patients in the interim
analysis sample and 44.7% of randomized patients in the all
randomized sample at the time of the publication. Among the
all randomized population with sequence data available (55.3%), the
three most common SARS-CoV-2 variants were Delta (58.1%), Mu
(20.5%) and Gamma (10.7%).
Positive top-line results from the interim analysis were
previously announced on Oct. 1, and recruitment into the study was
stopped early at the recommendation of an independent Data
Monitoring Committee and in consultation with the FDA. At the
interim analysis, which was the primary analysis timepoint of the
study, superiority was demonstrated as treatment with molnupiravir
reduced hospitalizations and death: 14.1% (53/377) of patients in
the placebo group were hospitalized or died, compared to 7.3%
(28/385) of patients who received molnupiravir who were
hospitalized; at the interim analysis, no patients who took
molnupiravir died through Day 29, compared to eight patients who
received placebo. The absolute risk reduction was 6.8 percentage
points (95% CI: 2.4, 11.3; p=0.001, one-sided), which is
approximately a 50% relative reduction in the risk of
hospitalization or death through Day 29 for molnupiravir compared
with placebo. In the all randomized analysis (n=1433), molnupiravir
had a lower risk of hospitalization or death through Day 29: 9.7%
(68/699) of patients in the placebo group compared to 6.8% (48/709)
of patients in the molnupiravir group, for an absolute risk
reduction of 3.0% (95% CI: 0.1, 5.9) and a relative risk reduction
of 30%. The efficacy benefit with molnupiravir treatment was
generally consistent across important patient subgroups, including
patients infected with SARS-CoV-2 variants of concern, Delta, Gamma
and Mu. Nine deaths were reported in the placebo group (29-day
all-cause mortality rate of 1.3%) and one in the molnupiravir group
(29-day all-cause mortality rate of 0.1%), representing a relative
reduction in the risk of death of 89% (95% CI: 14, 99).
As in previous trials, no safety concerns with molnupiravir were
identified, and there was no evidence of a pattern of clinically
meaningful abnormalities in laboratory test results. The incidence
of any adverse event (AE) was comparable in the molnupiravir and
placebo groups (30.4% and 33.0%, respectively). The incidence of
drug-related AEs was also comparable (8.0% and 8.4%, respectively),
and a lower percentage of patients in the molnupiravir group
discontinued therapy due to an AE compared to the placebo group
(1.4% and 2.9%, respectively). Serious AEs, none of which were
deemed drug-related by the investigator, were less frequently
reported among patients treated with molnupiravir. Through Day 29,
one death was reported in patients who received molnupiravir, as
compared to nine deaths in the placebo arm. After Day 29, three
additional deaths resulting from adverse events occurred in the
placebo group compared with one additional death reported in the
molnupiravir group.
About Merck’s Global Efforts to Accelerate Access to
Molnupiravir Following Regulatory Authorizations or
Approvals
Global access has been a priority for Merck and Ridgeback since
the inception of their molnupiravir collaboration. The companies
are committed to providing timely access to molnupiravir globally
through our comprehensive supply and access approach, which
includes investing at risk to produce millions of courses of
therapy; tiered pricing based on the ability of governments to
finance health care; entering into supply agreements with
governments; and granting voluntary licenses to generic
manufacturers and to the Medicines Patent Pool to make generic
molnupiravir available in more than 100 low- and middle-income
countries following local regulatory authorizations or
approvals.
Supply: In anticipation of the results from MOVe-OUT and
the potential for regulatory authorization or approval, Merck has
been producing molnupiravir at risk and expects to produce 10
million courses of treatment by the end of 2021, with at least 20
million courses to be produced in 2022.
Supply agreements: Merck entered into a procurement
agreement with the U.S. Government under which the company will
supply approximately 3.1 million courses of molnupiravir to the
U.S. Government, upon Emergency Use Authorization or approval from
the U.S. Food and Drug Administration. Merck has entered into
advance purchase and supply agreements for molnupiravir with
governments and announced agreements for over 20 countries
worldwide, including Australia, Canada, Korea, Japan, Thailand,
United Kingdom and United States, pending regulatory
authorizations, and is currently in discussions with additional
governments. Merck plans to implement a tiered pricing approach
based on World Bank country income criteria to reflect countries’
relative ability to finance their health response to the
pandemic.
Voluntary licenses: As part of its commitment to
widespread global access, Merck previously announced that it has
entered into a licensing agreement with the Medicines Patent Pool
to increase broad access for molnupiravir in low- and middle-income
countries. Additionally, Merck previously announced that the
company has entered into non-exclusive voluntary licensing
agreements for molnupiravir with established generic manufacturers
to accelerate availability of molnupiravir in more than 100 low-
and middle-income countries following approvals or emergency
authorization by local regulatory agencies.
Merck continues to discuss additional measures and
collaborations to accelerate broad, global access to
molnupiravir.
About Molnupiravir
Molnupiravir (MK-4482 and EIDD-2801) is an investigational,
orally administered form of a potent ribonucleoside analog that
inhibits the replication of 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. Pre-clinical data
suggest that molnupiravir has a high barrier to the development of
resistance.
Molnupiravir is being studied as a single medicine (i.e.,
without the need for concomitant antiviral medicines). Based on
available data, no food intake restrictions or dose modifications
based on renal or hepatic impairment are necessary, and no known
drug interactions with molnupiravir have been identified.
Molnupiravir was invented at Emory University. Drug Innovation
Ventures at Emory (DRIVE), LLC, which was formed by Emory to
develop early-stage drug candidates for viral diseases of global
concern, advanced molnupiravir through IND submission. Emory/DRIVE
received some research funding from the U.S. Department of Defense
and the U.S. National Institutes of Health. Molnupiravir is being
developed by Merck in collaboration with Ridgeback Biotherapeutics.
Ridgeback received an upfront payment from Merck and also is
eligible to receive contingent payments dependent upon the
achievement of certain developmental and regulatory approval
milestones. Any profits from the collaboration will be split
between the partners equally. Since licensed by Ridgeback, all
funds used for the development of molnupiravir have been provided
by Merck and Ridgeback.
Molnupiravir was evaluated in MOVe-OUT, a global Phase 3,
randomized, placebo-controlled, double-blind, multi-site study of
non-hospitalized adult patients with symptomatic,
laboratory-confirmed mild to moderate COVID-19 and at least one
risk factor associated with poor disease outcomes. The Phase 3
portion of the MOVe-OUT trial was conducted globally in more than
170 sites in locations including Argentina, Brazil, Canada, Chile,
Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Mexico,
Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan,
Ukraine, the United Kingdom and the United States. For further
information about the MOVe-OUT trial, please visit
clinicaltrials.gov. Molnupiravir is also being evaluated for
post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter,
randomized, double-blind, placebo-controlled Phase 3 study
evaluating the efficacy and safety of molnupiravir in preventing
the spread of COVID-19 within households. For more information,
please visit http://merckcovidresearch.com. Please visit the Merck
media library for molnupiravir images and b-roll.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is
a biotechnology company focused on emerging infectious diseases.
Ridgeback markets EbangaTM for the treatment of Ebola and has a
late-stage development pipeline which includes molnupiravir for the
treatment of COVID-19. The team at Ridgeback is dedicated to
developing life-saving and life-changing solutions for patients and
diseases that need champions as well as providing global access to
these medicines. In line with Ridgeback’s mission for equitable
global access, all Ridgeback services and treatment for Ebola
patients in Africa are delivered free of charge.
About Merck
For over 130 years, Merck, known as MSD outside 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 candidates that
the candidates 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
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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
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Media Contacts: Melissa Moody (215) 407-3536
Courtney Ronaldo (908) 740-6132
Ridgeback Media Contact: Chrissy Carvalho Chrissy@goldin.com
Investor Contacts: Peter Dannenbaum (908) 740-1037
Raychel Kruper (908) 740-2107
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