Generic versions | Agreement for global access to Merck’s anti-COVID-19 pill

(Geneva) The American laboratory Merck announced on Wednesday an agreement that could allow the widespread distribution in poor countries of generic versions of its anti-COVID-19 drug intended for people infected with the disease.



The Medicines Patent Pool (MPP) said it has signed a voluntary licensing agreement with Merck to facilitate affordable global access to molnupiravir, the experimental oral antiviral drug against COVID-19, developed by Merck.

Subject to regulatory approval, the deal will help broaden access to molnupiravir in 105 low- and middle-income countries.

The drug regulatory authorities in the United States and the European Union have already launched an evaluation of this drug.

Antivirals like molnupiravir work by decreasing the ability of a virus to replicate, thereby slowing down the disease.

Given to patients within days of a positive test, the treatment halves the risk of hospitalization, according to a clinical trial conducted by Merck, also called MSD outside the United States.

The Geneva-based MPP is an international organization supported by the United Nations that works to facilitate development and improve access to medicines in low- and middle-income countries, through an innovative approach to granting voluntary licenses and patent pooling.

As part of the deal, Merck licenses MPP which can then sublicense generic drug manufacturers.

The deal means the drug’s developers will not receive rights to sales as long as COVID-19 remains classified as a public health emergency of international concern by the World Health Organization (WHO).

Last week, its emergency committee reconfirmed the pandemic’s maximum alert status.

“The interim results for molnupiravir are compelling and we see this oral therapy candidate as a potentially important tool to help address the current health crisis,” said MPP Executive Director Charles Gore.

He hopes this first voluntary licensing agreement for a drug linked to COVID-19 will encourage other companies to come forward.

Merck is jointly developing molnupiravir with Ridgeback Biotherapeutics.

Miami-based CEO Wendy Holman said, “We are pleased to work with MPP to ensure that quality generic versions of molnupiravir can be developed and distributed promptly after regulatory clearance.”

“Partnerships and collaboration can do more to meet the challenges of global health than an organization could do on its own,” she added.

Molnupiravir prices have not yet been determined, but its simplicity and competition between generic manufacturers should be able to ensure low prices in the 105 poorest countries, according to Herve Verhoosel, spokesperson for Unitaid (international organization procurement of drugs for poor countries which created the MPP).

Believing that millions of people could need this treatment in countries with low vaccination rates, he called on other laboratories to follow in Merck’s footsteps.

The NGO Médecins sans frontières (MSF) for its part regretted that the agreement did not go further, deploring in a press release that it “excludes almost half of the world population and countries with moderate incomes and with low income. ‘significant drug production capacities like Brazil and China’.


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