News Release
____________________________________________________________________________________
FOR IMMEDIATE RELEASE
Media Contacts:
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Investor Contacts:
Peter Dannenbaum
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Patrick Ryan
Raychel Kruper
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Chrissy Carvalho
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MSD and Ridgeback’s Investigational Oral Antiviral Molnupiravir Reduced the
Risk of Hospitalization or Death by Approximately 50 Percent Compared to
Placebo for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis
of Phase 3 Study
At the Interim Analysis, 7.3 Percent of Patients Who Received Molnupiravir
Were Hospitalized Through Day 29, Compared With 14.1 Percent of Placebo-
Treated Patients Who were Hospitalized or Died
MSD Plans to Seek Emergency Use Authorization in the U.S. as Soon as Possible
and to Submit Applications to Regulatory Agencies Worldwide
If Authorized, Molnupiravir Could be the First Oral Antiviral Medicine for COVID-
19
KENILWORTH, N.J., and MIAMI, Oct. 1, 2021 – MSD (NYSE: MRK), known as
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Merck in the United States and Canada, and Ridgeback Biotherapeutics today
announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral
medicine, significantly reduced the risk of hospitalization or death at a planned interim
analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with
mild-to-moderate COVID-19 At the interim analysis, molnupiravir reduced the risk of
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hospitalization or death by approximately 50%; 7.3% of patients who received
molnupiravir were either hospitalized or died through Day 29 following randomization
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(28/385), compared with 14.1% of placebo-treated patients (53/377); p=0 0012
Through Day 29, no deaths were reported in patients who received molnupiravir, as
compared to 8 deaths in patients who received placebo. At the recommendation of an
independent Data Monitoring Committee and in consultation with the U.S. Food and
Drug Administration (FDA), recruitment into the study is being stopped early due to
these positive results. MSD plans to submit an application for Emergency Use
Authorization (EUA) to the U S FDA as soon as possible based on these findings and
plans to submit marketing applications to other regulatory bodies worldwide
“More tools and treatments are urgently needed to fight the COVID-19 pandemic,
which has become a leading cause of death and continues to profoundly affect patients,
families, and societies and strain health care systems all around the world. With these
compelling results, we are optimistic that molnupiravir can become an important
medicine as part of the global efforts to fight the pandemic and will add to MSD’s unique
legacy of bringing forward breakthroughs in infectious diseases when they are needed
most Consistent with MSD’s unwavering commitment to save and improve lives, we will
continue to work with regulatory agencies on our applications and do everything we can
to bring molnupiravir to patients as quickly as possible,” said Robert M. Davis, chief
executive officer and president, MSD. “On behalf of all of us at MSD, I thank our
network of clinical investigators and patients for their essential contributions to the
development of molnupiravir.”
“With the virus continuing to circulate widely, and because therapeutic options
currently available are infused and/or require access to a healthcare facility, antiviral
treatments that can be taken at home to keep people with COVID-19 out of the hospital
are critically needed,” said Wendy Holman, chief executive officer of Ridgeback
Biotherapeutics. “We are very encouraged by the results from the interim analysis and
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hope molnupiravir, if authorized for use, can make a profound impact in controlling the
pandemic. Our partnership with MSD is critical to ensuring rapid global access if this
medicine is approved, and we appreciate the collaborative effort to reach this important
stage of development ”
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About the Results of the Planned Interim Analysis
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The planned interim analysis evaluated data from 775 patients who were initially
enrolled in the Phase 3 MOVe-OUT trial on or prior to Aug 5, 2021 At the time of the
decision to stop recruitment based on the compelling interim efficacy results, the trial
was approaching full recruitment of the Phase 3 sample size of 1,550 patients, with
more than 90% of the intended sample size already enrolled.
Eligibility criteria required that all patients had laboratory-confirmed mild-to-
moderate COVID-19, with symptom onset within 5 days of study randomization All
patients were required to have at least one risk factor associated with poor disease
outcome at study entry Molnupiravir reduced the risk of hospitalization and/or death
across all key subgroups; efficacy was not affected by timing of symptom onset or
underlying risk factor. Additionally, based on the participants with available viral
sequencing data (approximately 40% of participants), molnupiravir demonstrated
consistent efficacy across viral variants Gamma, Delta, and Mu.
The incidence of any adverse event was comparable in the molnupiravir and
placebo groups (35% and 40%, respectively). Similarly, the incidence of drug-related
adverse events was also comparable (12% and 11%, respectively). Fewer subjects
discontinued study therapy due to an adverse event in the molnupiravir group (1.3%)
compared to the placebo group (3.4%).
About MSD Efforts to Enable Access to Molnupiravir, if it is Granted EUA or
Approval
In anticipation of the results from MOVe-OUT, Merck has been producing
molnupiravir at risk MSD expects to produce 10 million courses of treatment by the end
of 2021, with more doses expected to be produced in 2022
MSD has entered into supply and purchase agreements for molnupiravir with
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other governments worldwide, pending regulatory authorization, and is currently in
discussions with other governments.
MSD is committed to providing timely access to molnupiravir globally, if it is
authorized or approved, and plans to implement a tiered pricing approach based on
World Bank country income criteria to reflect countries’ relative ability to finance their
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health response to the pandemic.
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As part of its commitment to widespread global access, MSD 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 (LMICs)
following approvals or emergency authorization by local regulatory agencies.
More 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, at least one risk factor
associated with poor disease outcomes, and symptom onset within five days prior to
randomization The primary efficacy objective of MOVe-OUT is to evaluate the efficacy
of molnupiravir compared to placebo as assessed by the percentage of participants who
are hospitalized and/or die from the time of randomization through Day 29.
The Phase 3 portion of the MOVe-OUT trial was conducted globally, including in
more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile,
Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, 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
The most common risk factors for poor disease outcome included obesity, older
age (>60 years), diabetes mellitus, and heart disease. To date, the Delta, Gamma, and
Mu variants have accounted for nearly 80% of the evaluable cases in the trial.
Recruitment in Latin America, Europe, and Africa accounted for 55%, 23% and 15% of
the study population, respectively.
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About Molnupiravir
Molnupiravir (MK-4482/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
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preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention
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of transmission Additionally, pre-clinical and clinical data have shown molnupiravir to
be active against the most common SARS-CoV-2 variants Molnupiravir was invented at
Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly
owned by Emory University, and is being developed by MSD in collaboration with
Ridgeback Biotherapeutics. Ridgeback received an upfront payment from MSD 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 MSD and by Wayne and
Wendy Holman of Ridgeback
Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-
AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3
study, which is evaluating the efficacy and safety of molnupiravir in preventing the
spread of COVID-19 within households. For more information, please visit
http://merckcovidresearch com
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 Development of molnupiravir is
entirely funded by Ridgeback Biotherapeutics and MSD. All equity capital in Ridgeback
Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to
investing in and supporting medical technologies that will save lives. The team at
Ridgeback is dedicated to working toward finding life-saving and life-changing solutions
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for patients and diseases that need champions
About MSD
For over 130 years, MSD 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
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improve lives. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J.,
U S.A We demonstrate our commitment to patients and population health by increasing access
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to health care through far-reaching policies, programs and partnerships. Today, MSD 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 msd.com and connect with us on Twitter, LinkedIn and
YouTube.
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.
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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 Securities and Exchange Commission (SEC) available at the SEC’s Internet site
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(www sec gov)
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