Research & Development
US Merck, Ridgeback Ink Supply Agreement with UNICEF for Investigational Oral Antiviral COVID-19 Medicine Molnupiravir
19 January 2022 - - US-based pharmaceutical company Merck (NYSE: MRK) and US-based biotechnology company Ridgeback Biotherapeutics have signed a long-term supply agreement with the United Nations Children's Fund (UNICEF) to facilitate broad global access for molnupiravir, an investigational oral antiviral COVID-19 medicine, the companies said.

Under the agreement, Merck will allocate up to 3m courses of molnupiravir to UNICEF throughout the first half of 2022 for distribution in more than 100 low- and middle-income countries following regulatory authorizations.

Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics and it has been authorized for use in more than 10 countries, including in the United States, United Kingdom, Japan and Taiwan.

To accelerate broad global access for molnupiravir upon authorization or approval, Merck's comprehensive supply and access approach includes investing at risk to produce millions of courses of therapy, granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to help increase affordable, quality-assured supply in the developing world, and entering into supply agreements with governments and other organizations, including this agreement with UNICEF.

Global access has been a priority for Merck and Ridgeback since the inception of their molnupiravir collaboration.

The companies say they are committed to providing timely access to molnupiravir globally through our comprehensive supply and access approach, which includes investing at risk to produce millions of courses of therapy; tiered pricing based on the ability of governments to finance health care; entering into supply agreements with governments; allocating up to 3m courses of therapy for distribution through UNICEF and the ACT Accelerator Therapeutics Partnership; and granting voluntary licenses to generic manufacturers and to the Medicines Patent Pool to make generic molnupiravir available in more than 100 low- and middle-income countries following local regulatory authorizations or approvals.

In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck produced molnupiravir at risk, manufacturing 10 m courses of treatment by the end of 2021, with at least 20 m courses expected to be produced in 2022.

To date, Merck has shipped molnupiravir to over 20 countries; in countries where it is approved or authorized, patients have begun to receive the drug.

To supplement the supply from licensed generic manufacturers, Merck has entered an agreement with UNICEF to allocate up to 3m courses of therapy to low- and middle-income countries through the first half of 2022.

Merck entered into a procurement agreement with the US government under which the company will supply approximately 3.1m courses of molnupiravir to the US government, upon Emergency Use Authorization or approval from the US Food and Drug Administration.

Merck has entered into advance purchase and supply agreements for molnupiravir with governments for over 30 countries worldwide, including Australia, Canada, Korea, Japan, Thailand, United Kingdom and United States, pending regulatory authorizations, and is currently in discussions with additional governments.

Merck plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries' relative ability to finance their health response to the pandemic.

As part of its commitment to widespread global access, Merck previously announced that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low- and middle-income countries.

Additionally, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.

Merck continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.

The US Food and Drug Administration has issued an EUA for the emergency use of the unapproved molnupiravir, a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis, for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.

Molnupiravir is not FDA-approved for any use including for use for the treatment of COVID-19. Prior to initiating treatment with molnupiravir, carefully consider the known and potential risks and benefits.

Molnupiravir (MK-4482) is an investigational, orally administered nucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.

Merck and Ridgeback's "orange COVID-19 pill" is a Swedish Orange opaque capsule with the Merck corporate logo and "82" printed in white ink, available in certain markets outside of the US as Lagevrio.

Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases.

Ridgeback markets Ebanga for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19.
Login
Username:

Password:


Related Headlines