Merck (NYSE:MRK) announced today that it entered into an agreement to supply the U.S. government with its molnupiravir (MK-4482) for treating COVID-19.
Molnupiravir, developed through a collaboration between Merck and Ridgeback Biotherapeutics, is currently under evaluation in a Phase 3 clinical trial for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 infection and at least one risk factor associated with poor disease outcomes.
The orally bioavailable form of a potent ribonucleoside analog inhibits the replication of multiple RNA viruses, including SARS-CoV-2, the virus causing COVID-19, the companies say. Molnupiravir has shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission.
Kenilworth, N.J.-based Merck’s agreement with the U.S. government stipulates that, should molnupiravir receive FDA emergency use authorization (EUA), Merck will pick up approximately $1.2 billion to supply approximately 1.7 million courses of molnupiravir to the U.S. government, according to a news release.
The company has also been investing at risk to support the development of the drug and scale up production, with an expectation in place to have more than 10 million courses of the therapeutic available by the end of 2021.
Merck said it plans to submit applications for emergency use or approval to regulatory bodies outside of the U.S. and the company is currently engaging in discussions over advance purchase agreements for molnupiravir. The company also entered into non-exclusive, voluntary licensing agreements with established generic manufacturers to accelerate the availability of the therapeutic in 104 low- and middle-income countries following the necessary approvals or authorizations.
“Merck is pleased to collaborate with the U.S. government on this new agreement that will provide Americans with COVID-19 access to molnupiravir – an investigational oral therapy being studied for outpatient use early in the course of disease – if it is authorized or approved,” Merck president Rob Davis said in the release. “In addition to this agreement with the U.S. government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfill Merck’s commitment to widespread access.”