Nigeria is missing on the list of African countries that have been selected in a landmark deal to produce low-cost versions of molnupiravir, an oral COVID-19 antiviral medicine produced by Merck & Co.
Medicines Patent Pool (MPP) had negotiated a deal with Merck last year to give sublicense to generic drug manufacturers to produce raw ingredients for molnupiravir and the finished drug itself.
On Thursday MPP announced that it has signed agreements with 27 generic manufacturing companies from India, China and other countries in Africa, Asia and the Middle East after they successfully met MPP’s requirements
Kenya, South Africa and Egypt are the lists of countries in Africa that will start producing these COVID-19 pills after demonstrating their capability in terms of production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines.
But, Nigeria’s failure to revamp or scale up the country’s capacity for drug manufacturing at par with global standards is excluding it. Operations of existing drug manufacturing plants hardly conform to global standards for general manufacturing practice (GMP), a deficit analyst say inhibits the potential to attract top manufacturing deals.
Health experts have repeatedly knocked the government for consistently choosing to rely on developed nations rather than build local capacity, even despite the lessons learnt from the devastating COVID-19 pandemic.
This deal backed by the United Nations (UN) five companies will focus on producing the raw ingredients. While 13 companies will produce both raw ingredients, nine will produce the finished drug. The companies span 11 countries, including Bangladesh, China, Egypt, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam.
The deal stipulated the pill would be distributed to 105 low and middle-income countries. An MPP spokesperson said deliveries from some firms covered by the deal could start as early as February.
Merck’s green light to production of its anti-viral pill molnupiravir by other companies during the pandemic has been described as a rare example in the pharmaceutical sector, which usually protects its patented treatments for longer periods.
“We are encouraged by the large number of new and existing partners that have moved quickly to secure a sublicense for molnupiravir through MPP,” Charles Gore, MPP executive director said.
“This is a critical step toward ensuring global access to an urgently needed COVID-19 treatment and we are confident that, as manufacturers are working closely with regulatory authorities, the anticipated treatments will be rapidly available in Low and Middle-Income Countries.”
Paul Schaper, executive director, Global Public Policy, MSD (a trading name of Merck & Co), said, “Accelerating broad, affordable access to molnupiravir has been a priority for MSD from the start, which led us to partner with MPP on a licensing agreement to expand access to quality-assured generic versions of molnupiravir, subject to local regulatory authorisation. We are pleased to see this vision come to life, with strong geographic diversity in MPP’s selected generic manufacturing sublicensees.”
Studies show that molnupiravir reduces the risk of hospitalisation or death from COVID-19. In December 2021, MSD received U.S. FDA Emergency Use Authorization for molnupiravir to treat mild to moderate COVID-19 in adults with positive results of direct COVID-19 viral testing, and who are at high risk for progression to severe COVID-19.
Molnupiravir was invented at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory (DRIVE), LLC, which was formed by Emory to advance the development of early-stage drug candidates for viral diseases of global concern.
Emory received research funding from the U.S. Defense Threat Reduction Agency and the U.S. National Institute of Allergy and Infectious Diseases.