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
Merck 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
Merck (NYSE: MRK), known as MSD outside 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 hospitalization or death by approximately 50%;
7.3% of patients who received molnupiravir were either hospitalized
or died through Day 29 following randomization (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. Merck 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.
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“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 effort to fight the
pandemic and will add to Merck’s unique legacy of bringing forward
breakthroughs in infectious diseases when they are needed most.
Consistent with Merck’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, Merck. “On behalf of all of us at
Merck, 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 hope molnupiravir, if authorized for
use, can make a profound impact in controlling the pandemic. Our
partnership with Merck 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.”
About the Results of the Planned Interim Analysis
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 Merck’s 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. Merck expects to produce 10 million
courses of treatment by the end of 2021, with more doses expected
to be produced in 2022.
Earlier this year, Merck entered into a procurement agreement
with the U.S. Government under which Merck will supply
approximately 1.7 million courses of molnupiravir to the U.S.
government, upon EUA or approval from the U.S. FDA. Additionally,
Merck has entered into supply and purchase agreements for
molnupiravir with other governments worldwide, pending regulatory
authorization, and is currently in discussions with other
governments.
Merck 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 health
response to the pandemic.
As part of its commitment to widespread global access, 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
(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.
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 preclinical
models of SARS-CoV-2, including for prophylaxis, treatment, and
prevention 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 Merck
& Co., Inc. 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 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 Merck & Co., Inc. 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 for patients and diseases that need
champions.
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 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).
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Media Contacts:
Melissa Moody (215) 407-3536
Patrick Ryan (973) 275-7075
Investor Contacts:
Peter Dannenbaum (908) 740-1037
Raychel Kruper (908) 740-2107
Ridgeback Media Contact:
Chrissy Carvalho (646) 660-8641 Chrissy@goldin.com
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