Merck (MRK) and Ridgeback Biotherapeutics have announced that the Japanese government will acquire approximately 1.6 million courses of molnupiravir (MK-4482, EIDD-2801), a novel investigational oral antiviral medication, pending authorization or approval.
Molnupiravir is being developed by Merck in partnership with Ridgeback Biotherapeutics. The Japanese Pharmaceuticals and Medical Devices Agency, the US Food and Drug Administration, and the European Medicines Agency are all currently reviewing Merck’s applications for the prospective authorized use of molnupiravir.
In the United Kingdom Molnupiravir is licensed for the treatment of mild-to-moderate COVID-19 in individuals with confirmed positive SARS-CoV-2 laboratory test and at least one risk factor for severe progression of the disease.
Frank Clyburn, president of Human Health, Merck stated:
“We are proud to partner with the Japanese government on this agreement to accelerate access to molnupiravir to patients in Japan if it is authorized or approved. We believe that these government purchase agreements reflect confidence in molnupiravir’s clinical profile and the hope that molnupiravir may have a meaningful impact on efforts to address the pandemic.”
Japanese government to spend approximately $1.2 billion on Merck’s molnupiravir
Merck is set to sell roughly 1.6 million courses of molnupiravir to the Japanese government for approximately $1.2 billion, including relevant taxes, if molnupiravir achieves license or clearance by Japan’s Pharmaceuticals and Medical Devices Agency. Merck has been investing at risk to support the development and scale-up production of molnupiravir in anticipation of the results of the Phase 3 MOVe-OUT clinical trial and the potential for regulatory authorization or approval. Merck expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses produced in 2022.
Merck has also engaged in supply and purchase agreements with the governments of many other nations, and is now in conversations with more governments, as part of its worldwide efforts to speed access.
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.
U.S. Government set to buy approx 3.1 million courses of molnupiravir upon approval
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.
Molnupiravir (MK-4482, 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. If authorized or approved, the recommended dose for molnupiravir based on the Phase 3 MOVe-OUT clinical trial would be 800 mg twice daily for five days.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University; Emory/DRIVE received some research funding from the U.S. Department of Defense and the National Institutes of Health. Molnupiravir is being developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from Merck and also is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Merck and by Wayne and Wendy Holman of Ridgeback.
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.