US drugmaker Merck has announced a deal that could see generic versions of its experimental oral COVID-19 treatment for people infected with the disease widely distributed in poorer countries.
The global Medicines Patent Pool (MPP), which is backed by the United Nations, said on Wednesday it had signed a voluntary licensing agreement with Merck to facilitate affordable worldwide access for its antiviral medicine molnupiravir.
Subject to regulatory approval, the deal will help create broad access for use of molnupiravir in 105 low- and middle-income countries.
The US and European Union medicines regulators are already reviewing the drug.
“This is the first transparent, public health-driven voluntary license for a COVID-19 medical technology,” Merck and MPP said in a joint statement. The Geneva-based MPP is a UN-backed international organisation that works to facilitate the development of medicines for low- and middle-income nations.
Companies will be able to apply for a sub-licence from MPP and the licence, which also includes technology transfer, will remain royalty-free so long as the World Health Organization (WHO) classifies the pandemic as a Public Health Emergency of International Concern (PHEIC), the statement said.
A PHEIC is the highest alarm the WHO can sound and its emergency committee last week reconfirmed the pandemic’s top-alert status.
Antivirals like molnupiravir work by decreasing the ability of a virus to replicate, thereby slowing down the disease. Given to patients within days of a positive test, the treatment halves the risk of hospitalisation, according to a clinical trial conducted by Merck, also called MSD, outside the United States.
“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,” said MPP executive director Charles Gore.
Merck is jointly developing molnupiravir with Ridgeback Biotherapeutics.
The Miami-based company’s Chief Executive Wendy Holman said: “We are pleased to collaborate with MPP to ensure that quality-assured generic versions of molnupiravir can be developed and distributed quickly following regulatory authorisation.
“Partnerships and collaboration can do more to address global health challenges than any organisation could do on its own.”
Merck earlier this year signed bilateral licensing deals with eight Indian generic drug-makers, including Aurobindo Pharma , Cipla Ltd, Dr Reddy’s Labs, Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceuticals, and Torrent Pharmaceuticals.
The agreement with MPP broadens the manufacturing base beyond those companies. MPP told the news agency Reuters recently that it had 24 companies that had expressed interest in making the drug.
“We all along knew that we would want to diversify the geographic footprint of our generic partners so that we did not only have generic suppliers in India but in other geographies as well,” Paul Schaper, Merck’s executive director of global public policy, said in an interview.
The Bill & Melinda Gates Foundation said last week it will spend up to $120m to kick-start the development of generic versions of molnupiravir to help ensure lower-income countries have equal access to the drug.