MSD, MPP ink voluntary licencing agreement towards access of Covid-19 medicine molnupiravir to LMI countries

As per the agreement, MPP will further license non-exclusive sub-licences to manufacturers and diversify the manufacturing base for the supply of quality-assured or World Health Organization (WHO) -prequalified molnupiravir to countries covered by the MPP Licence.

MSD and Ridgeback Biotherapeutics recently announced the submission of an Emergency Use Authorization (EUA) application for molnupiravir to the US Food and Drug Administration (USFDA).

US drug maker MSD and Medicines Patent Pool (MPP) have entered into voluntary licencing agreement to make investigational oral Covid-19 antiviral medicine molnupiravir accessible to 105 low- and middle-income countries (LMICs) including India.

MPP is a UN-backed organisation that negotiates public-health driven licences with patent holders. It sub-licenses to generic manufacturers to encourage the sale of lower-cost generic versions of medicines.

MSD and Ridgeback Biotherapeutics are jointly developing molnupiravir.

MSD and Ridgeback Biotherapeutics recently announced the submission of an Emergency Use Authorization (EUA) application for molnupiravir to the US Food and Drug Administration (USFDA) 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, MSD announced the European Medicines Agency has initiated a rolling review for molnupiravir for the treatment of COVID-19 in adults.

As per the agreement, MPP will further license non-exclusive sub-licences to manufacturers and diversify the manufacturing base for the supply of quality-assured or World Health Organization (WHO) -prequalified molnupiravir to countries covered by the MPP Licence.

Charles Gore, MPP Executive Director stated in a release, “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 stated in a release, “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 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 stated in a release, “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 stated in a release, “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.”

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