The Medicines Patent Pool (MPP) and Merck, known as MSD outside the United States and Canada, 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 who are at risk for progressing to severe COVID-19 and/or hospitalization. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) following appropriate regulatory approvals. Merck and Ridgeback Biotherapeutics are jointly developing molnupiravir.
Under the terms of the agreement, MPP, through the license granted by Merck, will be permitted 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 authorization. Merck, Ridgeback Biotherapeutics and Emory University 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.”
Dr. Philippe Duneton, executive director, Unitaid, co-lead of the ACT-A Therapeutics Pillar, said, “Effective, easy to administer, oral treatments that can help to reduce the risk for progression to severe illness may be an important tool to help get the pandemic under control. We encourage further efforts in voluntary licensing to ensure that people in low- and middle-income countries can access COVID-19 treatments once authorized by WHO or a stringent regulatory authority.”
Molnupiravir was invented at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to advance the development of early-stage drug candidates for viral diseases of global concern. Emory received research funding from the U.S. Defense Threat Reduction Agency and the U.S. National Institute of Allergy and Infectious Diseases.
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.”
Wendy Holman, chief executive officer, Ridgeback Biotherapeutics, said, “We are pleased to collaborate with MPP to ensure that quality-assured generic versions of molnupiravir can be developed and distributed quickly following regulatory authorization. This agreement is another great example of how partnerships and collaboration can do more to address global health challenges than any organization could do on its own.”
Merck and Ridgeback Biotherapeutics recently announced the submission of an Emergency Use Authorization application for molnupiravir to the U.S. Food and Drug Administration and are actively working with additional regulatory agencies worldwide. If authorized, molnupiravir could be the first oral antiviral medicine available for COVID-19 therapy. The submission is based on positive results from a planned interim analysis of 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. Additionally, Merck announced the European Medicines Agency has initiated a rolling review for molnupiravir for the treatment of COVID-19 in adults.
MPP invites Expressions of Interest (EoI) from potential sublicensees based anywhere in the world for sublicenses to manufacture and sell molnupiravir in the licensed territory:
- Access the EoI portal
- More information about the EoI process