The Medicines Patent Pool (MPP) announced today that it signed agreements with 27 manufacturers to produce Merck’s COVID-19 pill.
MPP’s agreements with the generic manufacturing companies cover the manufacturing of the oral COVID-19 antiviral medication molnupiravir, with supply set for 105 low- and middle-income countries (LMICs). The agreements come as a result of the voluntary licensing agreement signed by MPP and MSD, a trade name of Merck, to facilitate the affordable global access of the antiviral drug that MSD is developing in partnership with Ridgeback Biotherapeutics.
Companies offered the sublicenses — which allow generic manufacturers to produce the raw ingredients for molnupiravir and/or the finished drug itself — 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.
According to a news release, five companies will focus on producing raw ingredients, 13 will produce both raw ingredients and the finished drug and nine will produce the finished drug. The companies hail from 11 countries: Bangladesh, China, Egypt/Jordan, India, Indonesia, Kenya, Pakistan, South Africa, South Korea and Vietnam.
MSD negotiated an agreement with MPP to establish terms and conditions, but the requests for sublicenses for generic producers were reviewed solely by MPP and presented to MSD. None of MSD, Ridgeback or Emory University (which invented the drug) will receive royalties from the sale 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,” MPP Executive Director Charles Gore said in the release. “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.”