The procurement is subject to US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) or approval of molnupiravir
Merck headquarters in Kenilworth, NJ. (Credit: Merck Sharp & Dohme Corp.)
Merck and Ridgeback Biotherapeutics announced that the US government will buy additional 1.4 million courses of their investigational oral antiviral, molnupiravir, for $1bn.
In June this year, the US government has initially signed an agreement to procure 1.7 million courses of the Covid-19 drug.
Last month, Merck has filed an application with the US Food and Drug Administration (FDA) seeking Emergency Use Authorisation (EUA) for the Covid-19 treatment.
The purchase is subject to molnupiravir receiving the US FDA EUA or approval.
Merck human health president Frank Clyburn said: “Molnupiravir, if authorised, will be among the vaccines and medicines available to fight Covid-19 as part of our collective efforts to bring this pandemic to an end.
“In light of the continued impact of the pandemic on hundreds of thousands of people every day, all of us at Merck are moving with urgency and rigour to bring molnupiravir, with its compelling data showing a significant reduction in death and hospitalisations.”
With the latest announcement, the US government is now committed to buying a total of around 3.1 million courses of molnupiravir by early 2022, for around $2.2bn.
The US government is capable of purchasing more than two million additional courses of the Covid-19 treatment, through further options in the contract, said Merck.
Federal funds from the Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response, and Biomedical Advanced Research and Development Authority (BARDA) will support the procurement.
Molnupiravir is an investigational, orally administered ribonucleoside analogue, designed to inhibit the replication of SARS-CoV-2.
It was created at Drug Innovations at Emory (DRIVE), a not-for-profit company of Emory University, and is being developed by Merck together with Ridgeback Biotherapeutics.
Earlier this month, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised molnupiravir to treat adults with mild-to-moderate Covid-19 in the UK.
Last month, Merck has signed a licensing agreement with the UN-backed public health organisation Medicines Patent Pool (MPP) to enhance global access for molnupiravir.