INDIA – The Medicines Patent Pool (MPP) has granted licenses to 19 Indian pharmaceutical companies to manufacture and commercialize the generic version of Paxlovid, Pfizer’s oral antiviral Covid-19 pill.

These include Cipla, Sun Pharma, Laurus Labs, Divi’s Laboratories, Glenmark, Emcure, Macleods, SMS Pharmaceuticals, Strides, Torrent, Cadila, Biocon, Aurobindo Pharma, Hetero, Granules, Amneal, and Viatris, among others.

MPP is a United Nations-based public health organization that works to improve access to life-saving medicines in low and middle-income countries (LMICs).

MPP had previously entered into an agreement with PF Prism Holdings BV (Pfizer) under which MPP has the right to sub-license manufacture and commercialization rights to sub-licensees in 95 LMICs, which account for 53% of the world’s population.

Around 100 generic manufacturers from around the world had expressed interest in a sub-license to manufacture the drug with the MPP.

MPP previously announced that it has signed agreements with over a dozen generic drug manufacturers to produce versions of Merck’s COVID-19 pill for distribution to 105 developing countries.

According to the Medicines Patent Pool, the agreements will allow drug companies to manufacture both the raw ingredients and the finished product for molnupiravir.

Torrent Pharma announced that it would manufacture and commercialize the generic version of Pfizer’s oral Covid-19 treatment.

This oral treatment is used to treat and prevent Covid-19.

Paxlovid from Pfizer contains nirmatrelvir, which inhibits a SARS-CoV-2 protein to prevent the virus from replicating, and ritonavir, which slows nirmatrelvir’s breakdown to allow it to stay in the body for a longer period of time at higher concentrations.

Paxlovid’s treatment regimen

Paxlovid is given in the form of three tablets (two nirmatrelvir tablets and one ritonavir tablet) taken orally twice daily for five days, for a total of 30 tablets.

The medication is only available by prescription and should be started as soon as possible after the diagnosis of Covid-19 and within five days of the onset of symptoms.

Torrent Pharma stated that it will launch the product after receiving the necessary regulatory approvals. According to sources, the Indian regulator had requested that companies conduct local clinical trials.

Aman Mehta, Executive Director, Torrent Pharma said: “We are pleased to enter into this agreement with MPP and is part of our continued endeavor to make Covid treatments as accessible as possible to patients.

Cadila Pharma too said that it will cater to the Indian and export markets for this drug. “We are pleased to partner with MPP to make a generic version of the innovative medicine Paxlovid for the global community and contribute towards reducing the health burden due to the pandemic.

“We reiterate our commitment to make affordable innovations available to the last man in society,” said Rajiv Modi, CMD, Cadila Pharmaceuticals.”

The US FDA was the first regulatory agency to approve Paxlovid for adults and pediatric patients over the age of 12 and weighing at least 40 kg.

The drug has been approved by the UK MHRA, as well as regulators in Australia, Japan, China, and several EU countries.

The medication is approved for the treatment of COVID-19 in patients who are at high risk of developing serious illness.

Nirmatrelvir in combination with low-dose ritonavir has shown a significant reduction in hospitalization and deaths in patients with mild-to-moderate Covid-19 who are at high risk of progressing to severe illness.

The FDA approved PAXLOVID for emergency use based on clinical data from the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for Covid-19 in High-Risk Patients) trial, which enrolled non-hospitalized adults aged 18 and older with confirmed Covid-19 who were at high risk of progressing to severe illness.

The data revealed an 89 percent reduction in the risk of Covid-19-related hospitalization or death from any cause in adults treated with PAXLOVID versus placebo within three days of symptom onset when compared to placebo.

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