Merck marks a first with global health org to license its COVID-19 pill

Merck
Merck has a deal with the Biden administration to supply 1.7 million courses of the oral drug for $1.2 billion, equating to about $700 per course. (Merck)

Merck took another step in the combat against the pandemic, inking a deal of firsts with the Medicines Patent Pool that allows the health organization to sublicense molnupiravir and supply the COVID-19 oral medication to 105 low- and middle-income countries.

The agreement with the MPP—a group backed by the United Nations—expands on a previous deal the pharma giant made with eight generics makers to license the treatment.

The MPP agreement marks the first time the international health organization has moved on a licensing deal related to COVID-19. Previously, the MPP zeroed in on treatments for HIV, hepatitis C and tuberculosis in under-served countries.

“The interim results for molnupiravir are compelling, and we see this oral treatment candidate as a potentially important tool to help address the current health crisis,” Charles Gore, executive director of MPP, said in a statement. “This transparent, public health-driven agreement is MPPs first voluntary license for a COVID-19 medical technology, and we hope that Merck’s agreement with MPP will be a strong encouragement to others.”

In the MOVe-OUT study of high-risk, nonhospitalized adults with mild-to-moderate disease, Merck and Ridgeback Biotherapeutics’ molnupiravir showed a 50% reduction and death risk. The companies submitted an Emergency Use Authorization filing for the oral treatment earlier this month, and the FDA's advisory committee is scheduled to meet and discuss approval Nov. 30. The European Medicines Agency is also reviewing the oral treatment under a rolling review.

Merck said it, Ridgeback Biotherapeutics and Emory University—where the drug was invented—are forgoing royalties under the agreement with MPP until COVID-19 is no longer classified by the World Health Organization as an international public health concern.

Wall Street analysts forecast that even after the pandemic transitions to the endemic stage, the global market for oral antivirals will be $6 billion. 

RELATED: Merck’s molnupiravir will be a blockbuster drug during the pandemic. What about endemic COVID-19?

“This agreement with MPP is another important element in our multifaceted strategy to accelerate broad, affordable access to molnupiravir, if approved or authorized, for patients no matter where they live including countries where governments face greater challenges to finance healthcare,” Frank Clyburn, head of Merck’s human health division, said in a statement.

Merck currently has a deal with President Joe Biden's administration to supply 1.7 million courses of the oral drug to the federal government for $1.2 billion, equating to about $700 per course. The company expects to produce 10 million courses of molnupiravir by the end of the year, which translates to $7 billion in potential revenue.

As vaccinations rates for COVID-19 have begun to steadily climb in richer nations such as the U.S., the European Union and Japan, pharmaceutical companies that make vaccines and treatments have come under growing pressure to supply lower-to-middle income countries with shots and drugs and/or share their recipes. Moderna was recently reported to be in a spat with the White House over not sharing the formula for its successful vaccination.

Merck isn’t alone in developing a COVID-19 oral medication. Pfizer and Roche are running several studies including one by Pfizer that combines its candidate with AbbVie’s HIV antiviral Norvir.