GOVERNMENT BUSINESS

Merck and Ridgeback Announce U.K. Government to Purchase Additional 1.75 Million Courses of Molnupiravir

Merck | December 22, 2021

Merck , known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United Kingdom Government will purchase an additional 1.75 million patient courses of molnupiravir (MK-4482), an investigational oral antiviral COVID-19 medicine. In the U.K., LAGEVRIO® is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. With this additional procurement agreement, which follows a previously announced agreement for 480,000 courses of treatment, the U.K. Government has now committed to purchase a total of 2.23 million courses of molnupiravir.

In early November, molnupiravir received conditional marketing authorization in the U.K. for the treatment of mild to moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. Molnupiravir is currently available in the U.K. and patients have started to receive treatment. An application for Emergency Use Authorization for molnupiravir is under review by the U.S. Food and Drug Administration.

Merck has entered into advance purchase and supply agreements for molnupiravir with governments of more than 30 countries worldwide, including 21 agreements with countries in Europe.

About Merck’s Global Efforts to Accelerate Access to Molnupiravir Following Regulatory Authorizations or Approvals

Global access has been a priority for Merck and Ridgeback since the inception of their molnupiravir collaboration. The companies are 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 more than 100 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. To date, Merck has shipped molnupiravir to 12 countries; in countries where it is approved or authorized, patients have begun to receive the drug.

Supply agreements: 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 or approval from the U.S. Food and Drug Administration. Merck has entered into advance purchase and supply agreements for molnupiravir with governments for over 30 countries worldwide, including Australia, Canada, Korea, Japan, Thailand, United Kingdom and United States, pending regulatory authorizations, 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 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 Molnupiravir
Molnupiravir (MK-4482) 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. Pre-clinical data suggest that molnupiravir has a high barrier to the development of resistance.

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