23 December 2021 - - The United Kingdom government will purchase an additional 1.75m patient courses of molnupiravir (MK-4482), an investigational oral antiviral COVID-19 medicine, US-based pharmaceutical company Merck (NYSE: MRK) and US-based Ridgeback Biotherapeutics said.

In the UK, 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 UK government has now committed to purchase a total of 2.23 m courses of molnupiravir.

In early November, molnupiravir received conditional marketing authorization in the UK 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 UK and patients have started to receive treatment. An application for Emergency Use Authorization for molnupiravir is under review by the US 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.

Global access has been a priority for Merck and Ridgeback since the inception of their molnupiravir collaboration.

In anticipation of the results from the phase 3 MOVe-OUT study 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 20m 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.

Merck entered into a procurement agreement with the US government under which the company will supply approximately 3.1 m courses of molnupiravir to the US government, upon Emergency Use Authorization or approval from the US 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 said it 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.

Merck previously 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 said it continues to discuss additional measures and collaborations to accelerate broad, global access to 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.

Molnupiravir was studied as a single medicine (i.e., without the need for co-administered medicines to achieve therapeutic effect). Based on available data, no food intake restrictions or dose modifications based on renal or hepatic impairment are necessary, and no known drug interactions with molnupiravir have been identified.

Results from the Phase 3 MOVe-OUT study demonstrated the efficacy benefit of molnupiravir treatment was generally consistent across patients infected with SARS-CoV-2 variants of concern, Delta, Gamma and Mu.

Preliminary preclinical data has shown that molnupiravir has antiviral activity against the newly identified variant, Omicron (B1.1.529). Molnupiravir has yet to be evaluated against Omicron in clinical studies.

Molnupiravir was invented at Emory University. Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to develop early-stage drug candidates for viral diseases of global concern, advanced molnupiravir through IND submission.

Emory/DRIVE received some research funding from the US Department of Defense and the US National Institutes of Health.

Molnupiravir is being developed by Merck 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 Ridgeback.