If Authorized, Molnupiravir Could Be the
First Oral Antiviral Medicine for the Treatment of COVID-19
Submissions to Regulatory Agencies Worldwide
Underway
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics today announced that Merck
has submitted an Emergency Use Authorization (EUA) application to
the U.S. Food and Drug Administration (FDA) for molnupiravir, an
investigational oral antiviral medicine, for the treatment of
mild-to-moderate COVID-19 in adults who are at risk for progressing
to severe COVID-19 and/or hospitalization. The companies are
actively working with regulatory agencies worldwide to submit
applications for emergency use or marketing authorization in the
coming months.
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The submission is based on positive results from a planned
interim analysis from the Phase 3 MOVe-OUT clinical trial, which
evaluated molnupiravir in non-hospitalized adult patients with
mild-to-moderate COVID-19 who were at risk for progressing to
severe COVID-19 and/or hospitalization. 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. The incidence of any adverse event was comparable
in the molnupiravir and placebo groups (35% and 40%, respectively).
The incidence of drug-related adverse events was also comparable
(12% and 11%, respectively), and fewer subjects in the molnupiravir
group discontinued therapy due to an adverse event compared to the
placebo group (1.3% and 3.4%, respectively).
“The extraordinary impact of this pandemic demands that we move
with unprecedented urgency, and that is what our teams have done by
submitting this application for molnupiravir to the FDA within 10
days of receiving the data,” said Robert M. Davis, chief executive
officer and president, Merck. “We are grateful to the patients and
investigators in our study, and of course to our own colleagues who
have exemplified Merck’s high standards of scientific excellence
and our unwavering commitment to patients. I also want to take this
moment to applaud our colleagues in the pharmaceutical industry and
our collaborators in global health for rising to the challenge of
bringing forward medicines and vaccines to fight COVID-19 —
medicines and vaccines are both essential to our collective
efforts. We look forward to working with the FDA on its review of
our application, and to working with other regulatory agencies as
we do everything we can to bring molnupiravir to patients around
the world as quickly as possible.”
“We are grateful to the clinical investigators and patients who
have helped bring us to this important milestone. Without their
significant contributions, today’s achievement would not be
possible. The submission to the FDA is a critical step towards
making molnupiravir available to people who may benefit from an
oral antiviral medicine that can be taken at home shortly after
diagnosis with COVID-19,” said Wendy Holman, chief executive
officer of Ridgeback Biotherapeutics. “We are pleased to partner
with Merck and regulatory authorities to help provide molnupiravir
to the people who need it here in the U.S. and around the
world.”
About Merck’s Efforts to Enable Access to Molnupiravir, if it
is Granted EUA or Approval
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 more courses expected to be
produced in 2022.
Earlier this year, Merck entered into a procurement agreement
with the U.S. Government under which the company 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 advance purchase agreements for
molnupiravir with other governments worldwide, pending regulatory
authorization, and is currently in discussions with additional
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 Indian 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.
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; Emory/DRIVE received some research funding from the
U.S. Department of Defense and the National Institutes of Health.
Molnupiravir 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 the MOVe-OUT Study
The MOVe-OUT trial (MK-4482-002) (NCT04575597) is 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. Patients enrolled in the study were
unvaccinated against SARS-CoV-2, had 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. Delta, Gamma and Mu variants accounted for nearly 80% of
the baseline viral variants that had been sequenced at the time of
the interim analysis. Recruitment in Latin America, Europe, and
Africa accounted for 56%, 23% and 15% of the study population,
respectively.
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
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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 Chrissy@goldin.com
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