Merck has entered into a voluntary licensing agreement with the Medicines Patent Pool (MPP) to allow the production of Merck’s investigational COVID-19 antiviral molnupiravir by drugmakers in 105 low- and middle-income countries.

Molnupiravir is an investigational oral COVID-19 antiviral medicine being developed by Merck and Ridgeback Biotherapeutics for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. In clinical trials, the drug reduced the risk of hospitalization or death by approximately 50%.

Merck has submitted the drug for emergency use authorization from the US FDA. If authorized, molnupiravir could be the first oral antiviral medicine available for COVID-19 therapy, the company reports.

Under the terms of the agreement, MPP, through the license granted by Merck, will be permitted to further license nonexclusive sublicenses to manufacturers (“MPP License”) and diversify the manufacturing base for the supply of quality-assured or WHO-prequalified molnupiravir to countries covered by the MPP License, subject to local regulatory authorization.

According to the company, Merck, Ridgeback Biotherapeutics and Emory University (which invented the drug) will not receive royalties for sales of molnupiravir under this agreement for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

Charles Gore, MPP, executive director, said, “The interim results for molnupiravir are compelling and we see this oral treatment candidate as a potentially important tool to help address the current health crisis. This transparent, public health-driven agreement is MPP’s first voluntary license for a COVID-19 medical technology, and we hope that Merck’s agreement with MPP will be a strong encouragement to others.”

Frank Clyburn, executive vice president and president of Human Health, Merck, said, “Merck’s mission to save and improve lives is a truly global commitment. This agreement with MPP is another important element in our multi-faceted strategy to accelerate broad, affordable access to molnupiravir, if approved or authorized, for patients no matter where they live, including in countries where governments face greater challenges to finance healthcare.”