Why Merck's Covid Pill Is Seen As Such A Breakthrough

As Merck & Co. races ahead with an experimental pill that could play a pivotal role in the fight against Covid-19, efforts are intensifying to bring the drug to developing countries that have struggled to vaccinate their populations.

The global health agency Unitaid and its partners hope to reach an agreement as soon as next week to secure the first supplies of the antiviral treatment for lower- and middle-income nations, Philippe Duneton, its executive director, said in an interview. Unitaid has been in discussions with the company and generic manufacturers, he said.

"This is really what we've waited for all these months," he said. "There is a window of hope with this treatment, and now we need to collectively make it work for people" in less well-to-do countries.

If the new medication hits the market, it could be a turning point in the pandemic, but the global supply picture is uncertain. On the vaccine front, lower-income nations have been left behind. About nine months after the arrival of Covid shots, more than 55 countries have yet to vaccinate 10% of their populations. More than two dozen nations are below 2%.

The drug, known as molnupiravir, reduced the risk of hospitalization or death by 50% in an interim analysis of a late-stage clinical trial, Merck and partner Ridgeback Biotherapeutics LP said Friday.

Seeking Clearance

The results were so positive that Merck and Ridgeback -- in consultation with independent trial monitors and the U.S. Food and Drug Administration -- elected to stop enrolling patients and begin the process of gaining regulatory clearance. Merck plans to submit the data to other regulators worldwide.

The company earlier this year announced that it had signed non-exclusive voluntary licensing agreements for the drug with five generic manufacturers in India in a bid to accelerate availability in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.

Merck said it expects to produce 10 million courses of treatment by year-end, with more expected in 2022. In June, the company agreed to a $1.2 billion supply deal with the U.S. government, under which it would provide 1.7 million courses of the treatment.

Initial production wouldn't go far given the number of worldwide Covid cases. But the drug potentially could be very cheap to manufacture, so it should be available at a low cost in developing nations, Andrew Hill, a senior research fellow at the University of Liverpool, wrote in an email.

"This could be a major advance in the treatment of Covid-19," he said.

Tiered Pricing

Merck said it plans to implement a tiered pricing approach based on World Bank income criteria to reflect countries' ability to finance their health response to the pandemic.

The drug could provide an important tool for the world on top of vaccines, but manufacturing will need to be expanded and more funding is required, according to Unitaid's Duneton said.

"What we need to do is to create an affordable but quality market of generics, exactly what we did for combating AIDS," he said. "It's feasible, it can be done."