Merck, Ridgeback Biotherapeutics and Emory
University Will Not Receive Royalties for Sales of Molnupiravir
Under this Agreement for as Long as COVID-19 Remains Classified as
a Public Health Emergency of International Concern by the World
Health Organization
Collaboration Continues Merck’s Long Track
Record of Making Its Medicines and Vaccines Accessible and
Affordable Globally
This is the First MPP Agreement to Provide
Access for a COVID-19 Medical Technology
The Medicines Patent Pool (MPP) and Merck (NYSE: MRK), known as
MSD outside the United States and Canada, today announced the
signing of a voluntary licensing agreement to facilitate affordable
global access for molnupiravir, an investigational oral COVID-19
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. This agreement will help create broad access for
molnupiravir use in 105 low- and middle-income countries (LMICs)
following appropriate regulatory approvals. Merck and Ridgeback
Biotherapeutics are jointly developing molnupiravir.
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Under the terms of the agreement, MPP, through the license
granted by Merck, will be permitted to further license
non-exclusive sublicenses to manufacturers (“MPP License”) and
diversify the manufacturing base for the supply of quality-assured
or WHO-prequalified molnupiravir to countries covered by the MPP
License, subject to local regulatory authorization. Merck,
Ridgeback Biotherapeutics and Emory University will not receive
royalties for sales of molnupiravir under this agreement for as
long as COVID-19 remains classified as a Public Health Emergency of
International Concern by the World Health Organization.
Charles Gore, MPP, executive director, said, “The interim
results for molnupiravir are compelling and we see this oral
treatment candidate as a potentially important tool to help address
the current health crisis. This transparent, public health-driven
agreement is MPP’s first voluntary license for a COVID-19 medical
technology, and we hope that Merck’s agreement with MPP will be a
strong encouragement to others.”
Frank Clyburn, executive vice president and president of Human
Health, Merck, said, “Merck’s mission to save and improve lives is
a truly global commitment. This agreement with MPP is another
important element in our multi-faceted strategy to accelerate
broad, affordable access to molnupiravir, if approved or
authorized, for patients no matter where they live, including in
countries where governments face greater challenges to finance
healthcare.”
Dr. Philippe Duneton, executive director, Unitaid, co-lead of
the ACT-A Therapeutics Pillar, said, “Effective, easy to
administer, oral treatments that can help to reduce the risk for
progression to severe illness may be an important tool to help get
the pandemic under control. We encourage further efforts in
voluntary licensing to ensure that people in low- and middle-income
countries can access COVID-19 treatments once authorized by WHO or
a stringent regulatory authority.”
Molnupiravir was invented at Emory University and licensed to
Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory
(DRIVE), LLC, which was formed by Emory to advance the development
of early-stage drug candidates for viral diseases of global
concern. Emory received research funding from the U.S. Defense
Threat Reduction Agency and the U.S. National Institute of Allergy
and Infectious Diseases.
Gregory L. Fenves, president, Emory University, said, “The
license for molnupiravir to the Medicines Patent Pool will support
global public health and address unmet medical needs – reflecting
Emory’s mission to serve humanity. Innovative research and
collaboration across organizations have been vital in the fight
against COVID-19.”
Wendy Holman, chief executive officer, Ridgeback
Biotherapeutics, said, “We are pleased to collaborate with MPP to
ensure that quality-assured generic versions of molnupiravir can be
developed and distributed quickly following regulatory
authorization. This agreement is another great example of how
partnerships and collaboration can do more to address global health
challenges than any organization could do on its own.”
Merck and Ridgeback Biotherapeutics recently announced the
submission of an Emergency Use Authorization application for
molnupiravir to the U.S. Food and Drug Administration and are
actively working with additional regulatory agencies worldwide. If
authorized, molnupiravir could be the first oral antiviral medicine
available for COVID-19 therapy. The submission is based on positive
results from a planned interim analysis of the Phase 3 MOVe-OUT
study, 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 and at least
one risk factor for progression to severe disease or death.
Additionally, Merck announced the European Medicines Agency has
initiated a rolling review for molnupiravir for the treatment of
COVID-19 in adults.
Access the license agreement.
MPP invites Expressions of Interest (EoI) from potential
sublicensees based anywhere in the world for sublicenses to
manufacture and sell molnupiravir in the licensed territory:
- Access the EoI portal
- More information about the EoI process
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. Additionally,
pre-clinical and clinical data have shown molnupiravir to be active
against the most common SARS-CoV-2 variants.
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 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.
About the Medicines Patent Pool
The Medicines Patent Pool (MPP) is a United Nations-backed
public health organization working to increase access to, and
facilitate the development of, life-saving medicines for low- and
middle-income countries. Through its innovative business model, MPP
partners with civil society, governments, international
organizations, industry, patient groups, and other stakeholders, to
prioritize and license needed medicines and pool intellectual
property to encourage generic manufacture and the development of
new formulations. To date, MPP has signed agreements with eleven
patent holders for thirteen HIV antiretrovirals, one HIV technology
platform, three hepatitis C direct-acting antivirals, a
tuberculosis treatment, a long-acting technology and an
experimental oral antiviral treatment for COVID-19. MPP was founded
by Unitaid, which continues to be MPP’s main funder. MPP’s work on
access to essential medicines is also funded by the Swiss Agency
for Development and Cooperation (SDC). MPP’s activities in COVID-19
are undertaken with the financial support of the Japanese
Government and SDC. More information at
https://medicinespatentpool.org/ and follow 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.
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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Merck Media:
Melissa Moody (215) 407-3536
Sienna Choi (908) 873-4311
Investor Contacts:
Peter Dannenbaum (908) 740-1037
Raychel Kruper (908) 740-2107
MPP Media:
Gelise McCullough +41 79 685 64 36
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