$120 Million Accelerates Access to Generic COVID-19 Antiviral

The Washington-based Bill & Melinda Gates Foundation announced on October 19, 2021, a commitment of up to $120 million to accelerate access to the investigational antiviral drug molnupiravir as part of its COVID-19 response effort.

The goal is to significantly reduce the time for a new drug to reach low-income countries after it becomes available in high-income markets. The standard gap in rolling out global health products can be 12 months or more.

The new Gates funding will be allocated based on consultations with partners.

It will support the range of activities required to develop and manufacture generic versions of the molnupiravir, which is being developed by Merck & Co and Florida-based Ridgeback Biotherapeutics.

Molnupiravir is an experimental oral antiviral initially developed by Emory University to treat influenza. 

Molnupiravir is an orally bioavailable form of a potent ribonucleoside analog that inhibits replicating multiple RNA viruses, including the SARS-CoV-2 betacoronavirus, the causative agent of COVID-19.

On October 1, 2021, Merck confirmed plans to seek U.S. FDA Emergency Use Authorization.

If Authorized, Molnupiravir could be the first oral antiviral medicine for COVID-19 in the U.S.

"Africa CDC and the Africa Union have been tracking the exciting developments on the antiviral, molnupiravir," said John Nkengasong, director of the Africa Centers for Disease Control and Prevention, stated in a press release. 

"In order to make sure that Africa is not left behind, we have been working with the Bill & Melinda Gates Foundation colleagues on various mechanisms they can facilitate, once all of the regulatory processes are completed, and the drug (Molnupiravir) is officially made available to the world."

The Gates Foundation's previous work to lower costs and increase access to life-saving drugs includes dolutegravir, an HIV drug.

In 2017, the Foundation established a volume guarantee with two generic suppliers that brought therapies containing the drug to more than 18 million people in lower-income countries, in coordination with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis, and Malaria.

The Foundation has already provided expertise and funding to help strengthen generics manufacturers, including $1.3 million to Medicines for All Institute and the University of Manchester to develop low-cost manufacturing processes that dramatically reduce the cost of raw materials and increase product yields.

Additionally, the Foundation has provided $2.4 million in grants to expedite generic company readiness to apply for WHO prequalification and start manufacturing when prequalification is granted.

"Merck has taken important steps to make this drug available as a COVID-19 therapy, including negotiating licenses with generics manufacturers to increase supply. We are pleased to work alongside these efforts to ensure affordability and availability in lower-income countries," commented Bill Gates, co-chair of the Gates Foundation.

"Making life-saving drugs like these available to everyone who needs them is what is necessary to end the acute phase of the pandemic and open pathways to recovery."

Since the start of the COVID-19 pandemic, the Foundation has worked closely with a range of partners on R&D and delivery of COVID-19 tools. The Foundation will continue to work with multilateral organizations, non-governmental organizations, governments, and other partners to ensure that clinical, regulatory, and delivery pathways are ready once molnupiravir and its generic versions become available.

About the Bill & Melinda Gates Foundation: Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives.