20 January 2022
Geneva – The Medicines Patent Pool (MPP) announced today that it has signed agreements with 27 generic manufacturing companies for the manufacturing of the oral COVID-19 antiviral medication molnupiravir and supply in 105 low- and-middle-income countries (LMICs). The sublicence agreements are the result of the voluntary licensing agreement signed by MPP and MSD, a trade name of Merck & Co., Inc, Kenilworth, NJ, USA, in October 2021 to facilitate affordable global access for molnupiravir, that MSD is developing in partnership with Ridgeback Biotherapeutics.
The non-exclusive sublicences allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself. The companies that were offered the sublicence successfully demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance, and the ability to meet international standards for quality-assured medicines. Five companies will focus on producing the raw ingredients, 13 companies will produce both raw ingredient and the finished drug and 9 companies will produce the finished drug. The companies span 11 countries, Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea, and Vietnam.
While MSD negotiated an agreement with MPP that establishes the terms and conditions, the requests for sublicences from generic producers were reviewed solely by MPP and presented to MSD. Neither MSD, Ridgeback Biotherapeutics nor Emory University, which invented the drug, will receive royalties from sales of molnupiravir from the MPP sublicensees while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization (WHO).
“We are encouraged by the large number of new and existing partners that have moved quickly to secure a sublicence for molnupiravir through MPP,” said Charles Gore, MPP Executive Director. “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 LMICs.”
“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,” said Paul Schaper, Executive Director, Global Public Policy, MSD. “We are pleased to see this vision come to life, with strong geographic diversity in MPP’s selected generic manufacturing sublicensees.”
More on MPP’s licence on molnupiravir and on the sublicence agreements
Press and Media
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.