Merck has signed a landmark voluntary licensing deal with the UN-backed Medicines Patent Pool to expand low-cost access to its Covid-19 antiviral pill throughout the developing world.
It is one of the first royalty-free licensing agreements struck by a pharmaceutical company for a key Covid-19 medical technology and should boost generic manufacturing of Merck’s drug molnupiravir if it is authorised by regulators, according to experts.
Merck has already struck licensing deals with several Indian manufacturers as it races to meet surging global demand for the treatment, which has not yet secured regulatory approval.
The move by Merck stands in stark contrast to the messenger RNA manufacturers Pfizer and Moderna, which have so far balked at sharing their vaccine technology — a policy that has drawn scathing criticism from public health officials who argue that it is contributing to a shortage of jabs in low and middle-income nations.
Charles Gore, executive director of the Medicines Patent Pool, said Merck’s agreement was the first of its kind during the pandemic and would make molnupiravir more widely available in more than 100 nations.
“We hope that Merck’s agreement with MPP will be a strong encouragement to others,” he added.
Health experts say Merck’s antiviral pill could play a key role in battling Covid-19 as trials suggest it can cut the risk of hospitalisation or death in half when taken within five days of infection. US regulators are scheduled to consider authorising molnupiravir at a meeting next month.
The MPP was founded to help provide treatments for HIV/Aids. Last year it expanded its mandate to include Covid-19 treatments and began liaising with companies to try to license medicines and pool intellectual property.
Gore said he had been disappointed by the response of Covid-19 vaccine manufacturers to the initiative so far but acknowledged that vaccines were more complex products to develop and make than antiviral pills.
“I’m disappointed that they [vaccine manufacturers] have not come to us to see whether we can make this work,” he said.
Nancy Jecker, professor at the University of Washington School of Medicine in Seattle, said Merck’s decision to license its antiviral pill was a welcome sign and suggested it was taking steps to meet its human rights responsibilities. But the pill was not a panacea, she added.
“Molnupiravir should not take the pressure off of the pharmaceutical industry to share licences for Covid-19 vaccines and take other steps to improve vaccine access,” Jecker said.
Pfizer and Moderna have both resisted public pressure to share their Covid-19 technology with other manufacturers to boost global supply.
Under the licensing deal struck by Merck, its partner Ridgeback Biotherapeutics and Emory University with MPP, no royalties will be paid while the World Health Organization continues to classify Covid-19 as a public health emergency of international concern.
The WHO welcomed the “voluntary licensing through a public health-oriented lens”, said Dr Mariângela Batista Galvão Simão, the WHO’s assistant director-general for access to medicines.
“Clinical data on molnupiravir is still being provided to WHO and will be assessed by the guidelines development group,” she told the Financial Times. The WHO reviews drugs and gives broad recommendations for use that inform how they can be used globally.