Merck to share molnupiravir formula with poor countries, enters agreement with MPP
Geneva: To ensure the affordable global access for molnupiravir, pharma giant Merck (MSD) has entered into a voluntary licencing agreement with Medicines Patent Pool (MPP).
Molnupiravir (MK-4482 and EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.
Under the terms of the agreement, MPP, through the license granted by MSD, will be permitted to further license non-exclusive sublicences to manufacturers ("MPP Licence") and diversify the manufacturing base for the supply of quality-assured or WHO-prequalified molnupiravir to countries covered by the MPP Licence, subject to local regulatory authorization. MSD, 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.
This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) following appropriate regulatory approvals. MSD and Ridgeback Biotherapeutics are jointly developing molnupiravir.
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 licence for a COVID-19 medical technology, and we hope that MSD's agreement with MPP will be a strong encouragement to others."
Frank Clyburn, Executive Vice President and President of Human Health, MSD, said, "MSD'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 licencing 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."
MSD and Ridgeback Biotherapeutics recently announced the submission of an Emergency Use Authorization application for molnupiravir to the U.S. Food and Drug Administration. 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, MSD announced the European Medicines Agency has initiated a rolling review for molnupiravir for the treatment of COVID-19 in adults.