Business & Finance
Japanese Government to Purchase 1.6m Courses of Molnupiravir, an Investigational Oral COVID-19 Antiviral Medicine, Upon Authorization or Approval
10 November 2021 - - The Japanese government will purchase, upon authorization or approval, approximately 1.6m courses of molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, US-based pharmaceutical company Merck (NYSE: MRK) and US-based biotechnology company Ridgeback Biotherapeutics said.

Merck is developing molnupiravir in collaboration with Ridgeback.

Merck's applications for the potential authorized use of molnupiravir are under review by Japan's Pharmaceuticals and Medical Devices Agency, the US Food and Drug Administration, and the European Medicines Agency. Molnupiravir is authorized in the United Kingdom 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.

Under the agreement, if molnupiravir receives authorization or approval by Japan's Pharmaceuticals and Medical Devices Agency, Merck will supply approximately 1.6m courses of molnupiravir to the Japanese government for approximately USD 1.2bn including applicable taxes.

In anticipation of results from the Phase 3 MOVe-OUT clinical trial, and the potential for regulatory authorization or approval, Merck has been investing at risk to support development and scale-up production of molnupiravir and expects to produce 10m courses of treatment by the end of 2021, with at least 20 m courses to be produced in 2022.

In addition to the Japan agreement, as part of its global efforts to accelerate access, Merck has also entered into supply and purchase agreements with the governments of several other countries and is currently in discussions with additional governments.

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.

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 10m courses of treatment by the end of 2021, with at least 20 m courses to be produced in 2022.

Earlier this year, Merck entered into a procurement agreement with the US government under which the company will supply approximately 3.1m courses of molnupiravir to the US government, upon Emergency Use Authorization or approval from the US 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 said it 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 US Department of Defense and the National Institutes of Health.

Molnupiravir is being developed by Merck and 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.
Login
Username:

Password: