Merck inks license agreement for antiviral COVID-19 pill

At a time in which the U.S. is flush with COVID-19 vaccines, Merck is working to make its antiviral pill available to low- and middle-income countries which have been unable to procure the life-saving shots.

According to a news release, the company has signed a voluntary licensing agreement with the Medical Patent Pool (MPP) in an effort to facilitate affordable access for the proposed antiviral pill, molnupiravir, in 105 low- and middle-income countries following regulatory approvals. This is the first MPP agreement for a COVID-19 medical technology.

Through the agreement, MPP will further license on-exclusive sublicenses to manufacturers and diversify the manufacturing base for the supply of the drug subject to local regulation. Merck will receive no royalties for sales of the pill under the agreement for as long as COVID-19 is classified as public health emergency of international concern by the World Health Organization.

“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, says in the release. “This transparent, public health-driven agreement is MPP’s 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.”

As previously reported, the company has submitted an application for emergency use authorization to the Food and Drug Administration and other global regulatory bodies for the investigational antiviral pill, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults.

A planned interim analysis of a Phase 3 MOVe-OUT trial in 775 at risk, non-hospitalized adult patients with mild to moderate COVID-19 found that the antiviral reduced the risk of hospitalization or death by 50 percent. No patients who received the pill died after 29 days compared to eight who died after receiving a placebo.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Robert M. Davis, CEO and president of Merck, says in the release. “We are grateful to the patients and investigators in our study, and of course to our own colleagues who have exemplified Merck’s high standards of scientific excellence and our unwavering commitment to patients. I also want to take this moment to applaud our colleagues in the pharmaceutical industry and our collaborators in global health for rising to the challenge of bringing forward medicines and vaccines to fight COVID-19 — medicines and vaccines are both essential to our collective efforts. We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

The company plans to produce 10 million courses of treatment by the end of the year and previously entered into an agreement with the federal government to supply about 1.7 million courses of molnupiravir upon receiving an EUA or approval from the FDA. Merck has struck similar deals with other countries.

The agency’s Antimicrobial Drugs Advisory Committee is scheduled to discuss and EUA for the drug Nov. 30.