Several companies in China are now allowed to make low-cost versions of Merck's COVID-19 pills to supply low-income countries. This was conveyed by the Medicines Patent Pool (MPP), a United Nations-backed organization.
"Shanghai Fosun Pharmaceutical, BrightGene Bio-Medical Technology, Shanghai Desano Pharmaceuticals and Lonzeal Pharmaceuticals have permits to manufacture the raw material and finished product of the oral antiviral drug molnupiravir," MPP said.
They are among 27 companies from 11 countries, including Beximco Pharmaceuticals Bangladesh, India's Natco Pharma and South Africa's Aspen Pharmacare, which have also been granted non-exclusive licenses to produce molnupiravir raw material, the finished drug, or both.
"We are encouraged by the large number of new and existing partners who are moving quickly to secure sublicense of molnupiravir through MPP," said MPP executive director Charles Gore.
"This is an important step towards ensuring global access to much-needed COVID-19 treatments and we are confident that, as manufacturers work closely with regulatory authorities, the anticipated treatments will become available quickly in low- and middle-income countries."
Molnupiravir is an antiviral drug that decreases the ability of the virus to replicate and slows down the disease. This medication needs to be given twice daily for five days in the early stages of the disease to be effective.
The COVID-19 pill initially indicated a halved risk of hospitalization and death. But the full data released in November showed that the decline was around 30%.
Molnupiravir was originally developed by Emory University and later continued by Merck and Ridgeback Biotherapeutics. This drug has been approved for use in more than 10 countries, including the United States, United Kingdom, and Japan, and is currently under assessment by WHO.
In October, Merck and Ridgeback Biotherapeutics also reached an agreement with MPP to allow the agency to further license non-exclusive sub-licences to manufacturers to supply molnupiravir to 105 low- and middle-income countries.
Requests for sublicense from generic manufacturers are only reviewed by MPP and submitted to Merck. No developer will receive royalties from the sale of Molnupiravir from a sub-licensed MPP manufacturer as long as COVID-19 remains classified as a public health emergency of international concern by WHO.
Previously, Merck had signed a long-term supply agreement with UNICEF to supply up to 3 million Molnupiravir during the first half of 2022 for distribution in more than 100 low- and middle-income countries following regulatory authorization.
Pfizer also signed a voluntary licensing pact with MPP in November that allows the organization to sublicense qualified generic drug manufacturers to make the antiviral pill Nirmatrelvir for 95 low- and middle-income countries, which together account for more than half the world's population.