Merck (MRK) and Ridgeback Announce Additional Purchase of 1.4M Courses of Molnupiravir by the US Government
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United States government will exercise two of its options to purchase a total of 1.4 million additional courses of molnupiravir, an investigational oral antiviral medicine, if the medicine is granted Emergency Use Authorization (EUA) or approval by the U.S. Food and Drug Administration (FDA), for approximately $1 billion. With these exercised options, the U.S. government has now committed to purchase a total of approximately 3.1 million courses of molnupiravir, for approximately $2.2 billion, between authorization and early 2022. The U.S. government also has the ability to purchase more than 2 million additional courses through further options that remain in the contract. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.
“We’re honored that the U.S. government has chosen to purchase more than 3 million courses of molnupiravir, our promising oral antiviral, so that molnupiravir, if authorized, will be among the vaccines and medicines available to fight COVID-19 as part of our collective efforts to bring this pandemic to an end. In light of the continued impact of the pandemic on hundreds of thousands of people every day, all of us at Merck are moving with urgency and rigor to bring molnupiravir, with its compelling data showing a significant reduction in death and hospitalizations, to patients as quickly as we can,” said Frank Clyburn, president of Human Health, Merck.
Merck and Ridgeback previously announced the submission of an EUA application to the U.S. FDA for molnupiravir for the treatment of mild-to-moderate COVID-19 in adults at risk for progressing to severe COVID-19 and/or hospitalization. The application will be discussed at the FDA’s Antimicrobial Drugs Advisory Committee meeting on Nov. 30, 2021.
This procurement of molnupiravir will be supported in whole 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 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 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.
Supply agreements: 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 governments worldwide, including the U.K. Government for 480,000 courses of therapy, 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.