India's leading drug makers like Sun Pharma, Dr Reddy's and Cipla are likely to benefit from global drug major Pfizer’s decision to license its Covid-19 pill under development to generic drug makers for supply in 95 low and middle income countries covering 53% of the global population.

Pfizer today signed a voluntary licence agreement for its oral antiviral treatment candidate 'Paxlovid' with Medicines Patent Pool (MPP), a United Nations-backed public health organisation. MPP will facilitate additional production and distribution of the investigational antiviral, pending regulatory approval, by granting sub-licences to generic medicine manufacturers. Indian companies are experts in making generic drugs for the world.

Pfizer says the pill will be the first oral antiviral of its kind, designed to treat Covid-19. It could be prescribed more broadly as an at-home treatment to reduce illness severity, hospitalisations and deaths, as well as reduce the probability of infection following exposure, among adults. The drug has to be administered in combination with low-dose HIV drug ritonavir, which many Indians firms are making and supplying to the world. Early this month, Pfizer said PAXLOVID (PF-07321332; ritonavir) was found to reduce the risk of hospitalisation or death by 89% during clinical trials. Pfizer said it was planning to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization as soon as possible.

"We believe oral antiviral treatments can play a vital role in reducing the severity of Covid-19 infections, decreasing the strain on our healthcare systems and saving lives,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “This licence is so important because, if authorised or approved, this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives, contributing to global efforts to fight the current pandemic,” said Charles Gore, Executive Director of MPP. MPP has invited Expressions of Interest from potential sublicensees with a December 6 deadline.

Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while Covid-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization. It will also invest $ 1 billion to support manufacturing and distribution of this investigational treatment candidate, including exploring potential contract manufacturing options.

Covid pill

Sun, Dr Reddy’s in Pfizer Covid-19 drug windfall