Coronavirus – Molnupiravir Pill: Agreement to Extend Generic Manufacturing

The US pharmaceutical company Merck and the United Nations-backed Medicines Patent Pool (MPP) have signed an agreement that will allow more companies to manufacture generic versions of her experimental antiviral drug against him coronavirus, one pill which is taken orally, as the two sides announced today.

Merck said the license, which is not subject to copyright, would apply to 105 low and middle-income countries. Allows manufacturers selected by MPP to make generic versions of it molnupiravir, the antiviral pill developed by Merck in collaboration with Ridgeback Biotherapeutics.

It is recalled that the US Food and Drug Administration (FDA) is considering an application for emergency license of the drug, which has been shown in clinical trials to reduce by 50% the risk of serious illness and death when administered in the early stages of COVID-19.

This is “the first transparent, public health-driven voluntary license for a medical technology against COVID-19,” the MPP and Merck said in a joint statement.

Companies will be able to do Application for licensing by the MPP and the license, which also includes technology transfer, will remain copyright for as long as World Health Organization (WHO) classifies the pandemic as a “Public Health Emergency of International Interest”, is added to the relevant announcement

Doctors Without Borders (MSF), however, expressed frustration with the license restrictions as they exclude almost half of the world’s population and above-middle-income countries with high manufacturing capacity, such as Brazil and China, say .

At least 24 companies have already expressed interest in making the drug

Earlier this year, Merck signed bilateral licensing agreements with eight Indian construction companies generic drugs including Aurobindo Pharma, Cipla Ltd, Dr. Reddy’s Labs, Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceuticals and Torrent Pharmaceuticals.

The agreement with the MPP expands the construction base beyond these companies.

The MPP recently told Reuters that 24 companies expressed interest in the manufacture of the drug.

“We all knew from the beginning that we would like to diversify our partners’ geographical footprint into generics, so that we have not only generic suppliers in India but also in other geographical areas,” said a Merck spokesman.

Finally, it is worth mentioning that Bill & Melinda Gates Foundation said last week it would spend up to $ 120 million to develop generic versions of molnupiravir to ensure low-income countries have equal access to the drug.