Merck Announces Supply Agreement with U.S. Government for Molnupiravir, an Investigational Oral Antiviral Candidate for Treat...
June 09 2021 - 5:45AM
Business Wire
U.S. government commits to purchase
approximately 1.7 million courses of Molnupiravir upon issuance of
Emergency Use Authorization or approval by the U.S. Food and Drug
Administration
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced it has entered into a procurement agreement
with the United States government for molnupiravir (MK-4482).
Molnupiravir is currently being evaluated in a Phase 3 clinical
trial, the MOVe-OUT study, for the treatment of non-hospitalized
patients with laboratory-confirmed COVID-19 and at least one risk
factor associated with poor disease outcomes. Merck is developing
molnupiravir in collaboration with Ridgeback Biotherapeutics.
“Merck is pleased to collaborate with the U.S. government on
this new agreement that will provide Americans with COVID-19 access
to molnupiravir – an investigational oral therapy being studied for
outpatient use early in the course of disease – if it is authorized
or approved,” said Rob Davis, president, Merck. “In addition to
this agreement with the U.S. government, we are actively engaged in
numerous efforts to make molnupiravir available globally to fulfill
Merck’s commitment to widespread access.”
Through the agreement, if molnupiravir receives Emergency Use
Authorization (EUA) or approval by the U.S. Food and Drug
Administration (FDA), Merck will receive approximately $1.2 billion
to supply approximately 1.7 million courses of molnupiravir to the
United States government. Merck has been investing at risk to
support development and scale-up production of molnupiravir and
expects to have more than 10 million courses of therapy available
by the end of 2021.
Merck also plans to submit applications for emergency use or
approval to regulatory bodies outside of the U.S. and is currently
in discussions with other countries interested in advance purchase
agreements for molnupiravir. Merck is committed to providing timely
access to molnupiravir globally and intends to implement a tiered
pricing approach based on World Bank data that recognizes
countries’ relative ability to finance their public health response
to the pandemic.
As part of its access strategy, Merck has also entered into
non-exclusive voluntary licensing agreements for molnupiravir with
established generic manufacturers to accelerate availability of
molnupiravir in 104 low- and middle-income countries (LMICs)
following approvals or emergency authorization by local regulatory
agencies.
In addition to developing molnupiravir, Merck is contributing to
the pandemic response by collaborating with Johnson & Johnson
to support the manufacture of its COVID-19 vaccine.
This procurement of molnupiravir will be supported in whole or
in part with federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and
Response; Biomedical Advanced Research and Development Authority,
in collaboration with the DOD Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND)
under contract number W911QY21C0031.
About Molnupiravir
Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally
bioavailable form of a potent ribonucleoside analog that inhibits
the replication of multiple RNA viruses including SARS-CoV-2, the
causative agent of COVID-19. Molnupiravir has been shown to be
active in several models of SARS-CoV-2, including for prophylaxis,
treatment and prevention of transmission, as well as SARS-CoV-1 and
MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE),
LLC, a not-for-profit biotechnology company wholly owned by Emory
University, and with partial funding support from the U.S.
government. Since licensed by Ridgeback, all funds used for the
development of EIDD-2801 by Ridgeback have been provided by Wayne
and Wendy Holman and Merck.
The Phase 3 portion (Part 2) of the MOVe-OUT study, evaluating
the potential of molnupiravir to reduce the risk of hospitalization
or death, is ongoing. Merck currently anticipates that, pending
favorable results from MOVe-OUT, the earliest possible submission
for an Emergency Use Authorization for molnupiravir will be in the
second half of 2021. Merck and Ridgeback Biotherapeutics plan to
share further findings from the ongoing molnupiravir development
program with regulatory agencies as they become available. For more
information on the molnupiravir clinical trial please visit
https://merckcovidresearch.com/.
In addition, Merck plans to initiate a clinical program to
evaluate molnupiravir for post- exposure prophylaxis in the second
half of 2021.
About Merck
For 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.
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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