Pfizer's anti-Covid pill can be made by Indian drug firms without royalties

Pharma major will waive royalties on sales in all countries covered by the MPP agreement apart from poor nations

Generic drug manufacturers in India, among a total of 95 low- and middle- income countries, will be allowed to sell Pfizer’s experimental anti-viral Covid pill, the pharma major said on Tuesday.

“Under the terms of the head license agreement between Pfizer and MPP (medicines patent pool), qualified generic medicine manufacturers worldwide that are granted sub-licenses will be able to supply PF-07321332 in combination with ritonavir to 95 countries, including India,” a Pfizer spokesperson told Business Standard.

The pharma company will not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the MPP agreement while Covid-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.

During its Phase-2 and 3 study, Pfizer found that, when co-administered with a low dose of ritonavir, the scheduled interim analysis showed an 89 per cent reduction in risk of Covid-19-related hospitalization or death as compared to those who were given a placebo.  

“We plan to submit data from the interim analysis of the Phase 2/3 study as part of its ongoing rolling submission to the US FDA for Emergency Use Authorization (EUA) as soon as possible. We have also initiated rolling submissions in several other countries. However we cannot speculate on the regulatory timelines,” the company spokesperson said.

Reuters reported on Monday that Dr Reddy's Laboratories, one of a handful of Indian drug companies licensed to make a new Covid-19 pill developed by Merck, said it was open to making the similar pill from Pfizer, thought to be even more effective.