Medicines Patent Pool finalises 27 generic manufacturers to produce molnupiravir
Drug Approval

Medicines Patent Pool finalises 27 generic manufacturers to produce molnupiravir

The drug is to be supplied in 105 low and middle-income countries and 10 Indian firms are on the list

  • By IPP Bureau | January 21, 2022

The Medicines Patent Pool (MPP) announced 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 sub-licence 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.

The Indian companies shortlisted are Arene Lifesciences, BDR Pharma, Biophore, Laurus Labs, Lupin, MSN, Natco, Optimus, Strides Pharma and SMS Pharmaceuticals.

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.”

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