- The U.N.-backed Medicines Patent Pool has signed licenses with 27 generic drugmakers to supply low-cost versions of Merck & Co. and Ridgeback Biotherapeutics' COVID-19 pill molnupiravir to 105 low- and middle-income countries. The licenses, announced Thursday, follow a pact signed in October between Merck and the organization to provide broader access to the antiviral drug.
- In December, molnupiravir became the second oral COVID-19 pill granted emergency authorization in the U.S. to prevent hospitalization and death in people infected with the SARS-CoV-2 virus. The World Health Organization is reviewing molnupiravir and is expected to make a recommendation on its use in February.
- Generic companies that have signed the sublicenses include Aspen Pharmacare in South Africa, Hikma in the Middle East and Beximco in Bangladesh. Under the agreement, Merck, Ridgeback and original inventor Emory University won't receive royalties from the 27 sublicensees as long as the WHO classifies COVID-19 as a public health emergency.
Large drugmakers have faced criticism for introducing COVID-19 treatments and vaccines first in wealthy nations and slowly or not at all in lower-income countries, allowing the pandemic to rebound and metastasize through new virus variants.
Aid and nongovernmental organizations have sought to correct this by securing broad global licenses that can be passed on to generic manufacturers better positioned to supply drugs to low-income nations. (Early in the pandemic, Gilead independently signed voluntary licenses to speed supplies of its drug Veklury to low-income countries.)
When molnupiravir gained FDA authorization, Merck said it planned to produce 10 million courses by the end of 2021 and at least another 20 million by the end of 2022. That will likely fall well short of demand, so the sublicenses announced Thursday could dramatically expand supply.
The agreement was signed with companies that had demonstrated to the Medicines Patent Pool that they could "meet MPP's requirements related to production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines." Of the 27 licensees, five will make raw materials, nine will make finished drugs and 13 will do both.
The Medicines Patents Pool has also signed a license with Pfizer for its COVID-19 antiviral Paxlovid, although the group hasn't announced any sublicensees. Pfizer's global supply is initially much lower, 65,000 in the U.S., although it expects to be able to produce 120 million in 2022.
Initial Paxlovid supply may be low because of shortages of certain chemicals necessary for manufacturing as well as manufacturing complexity, which could be a factor in negotiating sublicences through the Medicines Patent Pool.
While molnupiravir initially appeared highly effective, subsequent data have shown it to be much less so and advisers to the Food and Drug Administration have raised a number of questions about its safety. Paxlovid is viewed more favorably, as it's backed by data showing treatment can cut the risk of hospitalization and death from COVID-19 by nearly 90% when given at the right time to the right patients.