Nineteen drugmakers in India have signed sublicence agreements with the United Nations-backed Medicines Patent Pool (MPP) to manufacture the generic version of Pfizer’s oral COVID-19 antiviral nirmatrelvir, which is to be used in combination with ritonavir.
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They are among the 35 companies across 12 countries to have entered into such agreements with MPP for manufacturing and supplying to 95 low and middle income countries, including India. The non-exclusive sublicences allow the generic manufacturers to produce raw ingredients for nirmatrelvir and/or the finished drug itself co-packaged with ritonavir.
The agreements follow the voluntary licensing agreement MPP and Pfizer signed in November 2021. Pfizer markets its oral COVID-19 treatment under the name of Paxlovid, which has received emergency use/conditional authorisation from USFDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
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Of the 35, six companies will focus on producing the drug substance, nine will produce the drug product and the rest will do both. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP sublicensees so long as COVID-19 remains classified as a Public Health Emergency of International Concern by the WHO.
International standards
MPP said the companies offered the sublicence demonstrated their ability to meet its requirements related to production capacity, regulatory compliance, as well as international standards for quality-assured medicines.
“Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce. We have been very impressed with the quality of manufacturing demonstrated by these companies,” MPP Executive Director Charles Gore said.
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Sun Pharma, Biocon, Aurobindo Pharma, Cadila, Torrent Pharma, Strides, MSN Pharma, Laurus Labs, Granules, Divis Laboratories, Glenmark, Cipla, Emcure, Viatris, Amneal, Arene Lifesciences, Macleods, SMS Pharmaceuticals and Hetero are the 19 drugmakers to receive the sublicence.
Besides from India, the other companies are in Bangladesh, Brazil, China, Dominican Republic, Jordan, Israel, Mexico, Pakistan, Serbia, South Korea and Vietnam. MPP said a licence had also been offered to a company in Ukraine and the offer would remain available as the firm was not able to sign due to the current conflict.
Aurobindo Vice-Chairman and Managing Director K. Nithyananda Reddy said the company had already developed and commercialised ritonavir which is used as a booster along with nirmatrelvir. “We are excited to work on this molecule and will soon make it available commercially at an affordable price for these markets after due process of registration and approval in various countries, including the DCGI in India,” he said.