Merck, Thermo Fisher in pact to manufacture oral COVID-19 pill in Canada

CANADA – Merck & Co has announced a deal with Thermo Fisher Scientific to manufacture its experimental COVID-19 pill at the medical device maker’s Whitby, Ontario facility, according to Reuters report.

The site will produce molnupiravir pills for distribution in Canada and the United Kingdom, as well as markets in the European Union, Asia Pacific, and Latin America.

“This agreement is part of Merck’s commitment to make this investigational medicine widely available globally, if approved for use by regulatory agencies,” Merck said in a statement.

The Ontario facility is one of three in the world that will manufacture the pill, which is being developed in collaboration with Ridgeback Biotherapeutics.

To this effect, Merck announced that the Canadian government had secured access to 500,000 courses of molnupiravir in 2022, with options for up to 500,000 more pending approval from the country’s health regulator.

Last month, the drugmaker announced that it had submitted the final molnupiravir real-time application for approval in Canada.

Molnupiravir, marketed as Lagevrio, was conditionally approved in the United Kingdom in November for at-risk adults with mild-to-moderate disease.

Merck has three molnupiravir manufacturing sites, but it also has a licensing agreement with the United Nations-backed Medicines Patent Pool (MPP) that will allow select manufacturers in 105 low- and middle-income countries to make generic versions of the pill.

The company had also signed an agreement with the US government to supply up to 5 million courses of the antiviral at a cost of US$700 per course.

The oral treatment has recently encountered some setbacks. According to a recent report by the two companies, the antiviral molnupiravir isn’t as effective as previously thought.

Following interim findings of a 50% reduction in the risk of hospitalization and death, final findings based on all patients enrolled in the trial revealed a 30% relative risk reduction.

Then, in late November, an FDA advisory panel endorsed the oral treatment by a narrow margin of 13-10, despite a number of concerns about efficacy and safety.

Members of the committee stated at the time that they would support withdrawing their support if another oral treatment was approved and demonstrated superior efficacy and safety.

Merck is awaiting a decision from the US Food and Drug Administration after the regulator’s panel of independent advisers voted to recommend that the pill be approved.

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