USA – The Medicines Patent Pool (MPP) and Merck have announced the signing of a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine for the treatment of mild-to-moderate COVID-19 in adults at risk of progressing to severe COVID-19 and/or hospitalization.
Following appropriate regulatory approvals, this agreement will aid in the expansion of molnupiravir use in 105 low- and middle-income countries (LMICs).
Molnupiravir is being developed collaboratively by Merck and Ridgeback Biotherapeutics.
Under the terms of the agreement, MPP will be able to further license non-exclusive 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 approval.
Under this agreement, Merck, Ridgeback Biotherapeutics, and Emory University will not receive royalties from molnupiravir sales as long as COVID-19 is 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.”
Molnupiravir was developed at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory (DRIVE), LLC, which Emory established to advance the development of early-stage drug candidates for viral diseases of global concern.
The US Defense Threat Reduction Agency and the US National Institute of Allergy and Infectious Diseases funded Emory’s research.
Gregory L. Fenves, president, Emory University, said, “The license for molnupiravir to the Medicines Patent Pool will support global public health and address unmet medical needs – reflecting Emory’s mission to serve humanity. Innovative research and collaboration across organizations have been vital in the fight against COVID-19.”
Merck and Ridgeback Biotherapeutics recently announced the submission of an Emergency Use Authorization application for molnupiravir to the US Food and Drug Administration.
They are actively working with other regulatory agencies around the world. Molnupiravir, if approved, could be the first oral antiviral medication available for COVID-19 treatment.
The submission is based on positive interim results from the Phase 3 MOVe-OUT study, a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate COVID-19 and at least one risk factor for progression to severe disease or death.
Merck also announced that the European Medicines Agency has begun a rolling review of molnupiravir for the treatment of COVID-19 in adults.