Global access to COVID-19 oral antiviral molnupiravir to be licensed through MPP, Merck agreement

This week, an agreement was reached between the Medicines Patent Pool (MPP) and Merck pledges low-cost access to the investigational oral COVID-19 antiviral molnupiravir worldwide, with a particular focus on 105 low and middle-income countries (LMICs).

Jointly developed by Merck and Ridgeback Biotherapeutics — after its invention by Emory University — molnupiravir is currently undergoing global trials that, if followed by authorization, would make it the world’s first oral antiviral medicine for use on COVID-19. The companies have already filed an emergency use authorization application with the U.S. Food and Drug Administration and gained a rolling review for molnupiravir with the European Medicines Agency.

Positive interim results from a Phase 3 MOVe-OUT trial among non-hospitalized adult patients with mild-to-moderate COVID-19 cases showed hospitalizations halved. As of a month post-treatment, no patients given molnupiravir died.

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.”

Supposing molnupiravir is approved, it would be used on adults to treat mild-to-moderate COVID-19 cases with the potential to worsen. Under the terms of their agreement, Merck would grant MPP permission to further license non-exclusive sublicenses of molnupiravir to manufacturers and diversify the global manufacturing base to supply the drug to countries covered by the MPP license, subject to local regulatory authorization.

Additionally, Merck, Ridgeback Biotherapeutics, and Emory University will waive royalties for any sales of molnupiravir made under their agreement with MPP for as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

“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,” Frank Clyburn, executive vice president and president of Human Health at Merck, said.