Merck, called MSD outside the US and Canada, has signed an agreement with the US government to supply about 1.7 million courses of molnupiravir (MK-4482) for the treatment of mild to moderate Covid-19.
Molnupiravir is an investigational, orally bioavailable antiviral candidate that blocks the replication of different RNA viruses, including SARS-CoV-2.
The deal, worth about $1.2bn, is dependent on the receipt of an Emergency Use Authorization (EUA) or approval from the US Food and Drug Administration (FDA for the drug.
Being developed by Merck in alliance with Ridgeback Biotherapeutics, the drug is currently in Phase III clinical trial.
The trial, called MOVe-OUT study, is assessing molnupiravir to treat non-hospitalised Covid-19 patients with at least one risk factor related to poor disease outcomes.
Merck estimates to have approximately ten million courses of molnupiravir available by the end of this year. It is in discussions with other countries for potential advance purchase agreements of the therapy.
Merck president Rob Davis said: “Merck is pleased to collaborate with the US 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.
“In addition to this agreement with the US government, we are actively engaged in numerous efforts to make molnupiravir available globally to fulfil Merck’s commitment to widespread access.”
The company is planning to apply for emergency use or approval in other countries outside the US.
Additionally, it intends to commence a clinical programme to assess the therapy for post-exposure prophylaxis in the second half of this year.
In April this year, Merck signed voluntary licensing agreements with five Indian generic drug manufacturers to expand access to molnupiravir.
The company also signed non-exclusive voluntary licensing agreements with additional generic manufactures to offer the drug in 104 low- and middle-income countries.