Merck to allow other nations to produce new COVID-19 antiviral

Molnupiravir capsules

© 2009-2021 Merck Sharp & Dohme Corp

Merck and the United Nations–based Medicines Patent Pool (MPP) today announced a licensing deal that will allow pharmaceutical companies in other countries to make molnupiravir—an investigational antiviral to treat COVID-19—a step that would ease access in low- and middle-income countries.

First agreement of its kind for the pandemic

Results from promising clinical trials suggest that the drug, the first oral treatment of its kind for COVID-19, could be an important tool for cutting hospitalizations and deaths. Fearing a repeat of the inequitable global rollout of COVID-19 vaccine, global health experts have worried that molnupiravir would be inaccessible and expensive for lower-income countries.

Under the agreement terms, Merck (or MSD, of Kenilworth, New Jersey), Ridgeback Biotherapeutics, and Emory University will not receive sales royalties for molnupiravir as long as COVID-19 is considered a public health emergency of international concern by the World Health Organization (WHO).

In a statement, Charles Gore, MPP's executive director, said "This transparent, public health-driven agreement is MPP's first voluntary license for a COVID-19 medical technology, and we hope that MSD's agreement with MPP will be a strong encouragement to others."

Earlier this month, Merck submitted an application to the US Food and Drug Administration for the drug to be used under emergency use authorization for mild-to-moderate COVID-19, and European regulators this week announced they are speeding its review.

The WHO and the global health group UNITAID issued a statement welcoming the signing of the voluntary licensing agreement, which they called a positive step toward creating broader access by allowing generic makers to prepare supplies and create more affordable versions of the drug.

They said the agreement will speed availability in 105 low- and middle-income countries, but added that they hope other key countries can soon be added to the agreement's scope.

Also, the groups urged Merck to provide clinical trial data to the WHO as soon as possible to allow evaluation and emergency listing to move forward, and they pushed other companies developing vaccines, treatments, and diagnostics to consider similar open and transparent licenses as soon as possible.

MSF says agreement too limiting

Doctors Without Borders (MSF) today said though the agreement is the first of its kind, it doesn't go far enough.

In a statement, Yuanqiong Hu, JD, senior legal and policy advisor for MSF's Access Campaign, said the agreement is a welcome step forward, but it's disappointing that it excludes key upper-income countries such as Brazil and China, both of which have manufacturing capacity and have been hit hard by the pandemic.

Hu also said the license contains an unacceptable clause, put in place by original patent-holder Emory University, that limits the right to challenge molnupiravir patents. She said the clause could stifle production and supply of generics and is problematic, because molnupiravir's development was heavily funded by the US government.

Global cases, deaths tick upward

Global COVID-19 cases and deaths rose slightly last week, partly led by rises in the European region, though some countries in other parts of the world are experiencing new spikes in activity, the WHO said yesterday in its weekly update on the pandemic. Cases and deaths had been on the decline for several weeks but recently showed signs of leveling off.

Regions reporting the highest weekly case incidences were Europe and the Americas, and the five countries reporting the most cases were the United States, the United Kingdom, Russia, Turkey, and Ukraine.

Africa's cases continue to drop steadily, but the WHO said some countries reported sharp rises, including Reunion, Botswana, and Gambia. In another example, some Americas countries also reported sharp spikes, including Dominica, Cayman Islands, and Paraguay.

The global total today reached 244,889,529 cases, along with 4,969,729 deaths, according to the Johns Hopkins online dashboard.

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