KIRKLAND, QC, Dec. 3, 2021 /CNW/ - Merck (NYSE: MRK),
known as MSD outside Canada and
the United States, announced today
that it has entered into a Supply Agreement with the Government of
Canada for up to 1 million patient
courses of molnupiravir, its investigational oral antiviral
medicine for the treatment of COVID-19. This investigational
medicine is being developed by Merck in collaboration with
Ridgeback Biotherapeutics.
Through this agreement, the Government of Canada has secured access in 2022 to 500,000
patient courses, with options for up to 500,000 more, pending
Health Canada approval. This new agreement is part of Merck's
commitment to make this investigational medicine widely available
globally, if approved for use by regulatory agencies.
"We applaud the leadership of the federal government who has
worked tirelessly to bolster pandemic preparedness against
COVID-19. While vaccines continue to play a primary role in helping
prevent the spread and seriousness of cases, more treatment options
are urgently needed to help reduce the burden of COVID-19," said
Marwan Akar, President and Managing
Director of Merck Canada.
In November, Merck Canada filed the final wave of the
molnupiravir rolling submission to Health Canada, which will decide
on the therapy's approval only when all necessary evidence has been
reviewed.
About Merck's Global Efforts to Accelerate Access to
Molnupiravir Following Regulatory Authorizations or
Approvals
Merck is committed to providing timely access to molnupiravir
globally through our comprehensive supply and access approach,
which includes investing at risk to produce millions of courses of
therapy; tiered pricing based on the ability of governments to
finance health care; entering into supply agreements with
governments; and granting voluntary licenses to generic
manufacturers and to the Medicines Patent Pool to make generic
molnupiravir available in low- and middle-income countries
following local regulatory authorizations or approvals.
Supply: 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 at least 20
million courses to be produced in 2022.
Supply agreements: Earlier this year, Merck
entered into a procurement agreement with the U.S. Government
under which the company will supply approximately 3.1 million
courses of molnupiravir to the U.S. Government, upon Emergency Use
Authorization (EUA) or approval from the U.S. FDA. Additionally,
Merck has entered into supply and advance purchase agreements for
molnupiravir with governments worldwide and is currently in
discussions with additional governments. Merck 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.
Voluntary licenses: As part of its commitment to
widespread global access, Merck previously announced that
it has entered into a licensing agreement with the Medicines Patent
Pool to increase broad access for molnupiravir in low- and
middle-income countries. Additionally, 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
following approvals or emergency authorization by local regulatory
agencies.
Merck continues to discuss additional measures and
collaborations to accelerate broad, global access to
molnupiravir.
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. The team at Ridgeback is dedicated to developing
life-saving and life-changing solutions for patients and diseases
that need champions as well as providing global access to these
medicines. In line with Ridgeback's mission for equitable global
access, all Ridgeback services and treatment for Ebola patients in
Africa are delivered free of
charge.
About Merck
For over 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 about our operations in
Canada, visit www.merck.ca and
connect with us on YouTube and Twitter @MerckCanada.
Forward-Looking Statement of Merck & Co. Inc.,
Kenilworth, NJ, 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 candidates that the candidates 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).
SOURCE Merck Canada Inc.