Pfizer will sub-license the production of its promising paxlovid pill to generic drug companies for delivery in 95 low and middle income countries, covering approximately 53 percent of the world’s population.

As part of the agreement with the global Medicines Patent Pool (MPP), Pfizer – which, together with German laboratory BioNTech, also makes one of the most widely used Covid vaccines – does not receive any license fees from generic drug manufacturers, which makes treatment cheaper.

The agreement is subject to ongoing trials and regulatory approval of the oral antiviral drug.

The Pfizer drug is designed to be taken with the HIV drug ritonavir.

Interim data from ongoing studies showed an 89 percent reduction in the risk of Covid-19-related hospitalization or death compared to a placebo in high-risk adults with Covid-19 not admitted to the hospital within three days of the onset of symptoms, Pfizer said .

Similar results were seen within five days of the onset of symptoms, she added.

The Geneva-based MPP is a United Nations-backed international organization committed to drug development for low- and middle-income countries.

If the pill is approved, the pill could be on the market in “a matter of months,” MPP policy chief Esteban Burrone told AFP.

Pfizer also said Tuesday that it is applying for an Emergency Authorization (EUA) for the Covid pill in the US.

– HIV drug mix –

Pfizer will waive license fees in all countries covered by the agreement, while Covid-19 is classified as a public health emergency of international concern by the World Health Organization.

Last month, the WHO maintained the highest level of alert regarding the spread of the SARS-CoV-2 virus that is causing Covid-19.

Paxlovid, or PF-07321332, is a test antiviral therapy designed to block the activity of the SARS-CoV-2-3CL protease – an enzyme that the coronavirus needs to replicate.

Taking it with a low dose of ritonavir helps slow the breakdown of PF-07321332. It therefore remains active in the body in high concentrations for a longer period of time in order to fight the virus.

The pill could potentially help patients avoid serious illnesses that could lead to hospitalization and death, Pfizer said.

“We believe that oral antiviral treatments can play a critical role in reducing the severity of Covid-19 infections, easing the burden on our health systems and saving lives,” said Albert Bourla, Chairman and CEO of Pfizer.

While a wide variety of vaccines were introduced during the pandemic, the search for treatments for those who are already infected with the disease has not been as successful.

– Agreement follows Merck deal –

The MPP was founded by Unitaid, which works on innovations for the prevention, diagnosis and treatment of serious diseases in poorer countries.

“During a pandemic, saving time means saving lives. This agreement could help us reach more people faster once the drug is approved, ”said Philippe Duneton, Executive Director of Unitaid.

Potential sub-licensees have until December 6th to register an expression of interest.

The announcement came after the MPP signed a similar voluntary license agreement with Pfizer’s US competitor Merck & Co last month for its investigational oral antiviral drug molnupiravir.

Subject to regulatory approval, the transaction will help provide widespread access to molnupiravir in 105 low and middle income countries.

Pills are easier to make than vaccines, do not require a cold chain for delivery, and can be self-administered by the patient.

In terms of relieving the burden on health systems by preventing hospitalizations, “this is a turning point,” said Burrone.

He said prices for the Pfizer pill had not yet been set but said that “in a competitive environment … prices tend to go down” to low levels.

Médecins Sans Frontières (MSF), meanwhile, suggested that consistent with molnupiravir, it could cost around $ 700 per Pfizer course of treatment.

The medical charity said it was discouraged by the deal, saying restrictive voluntary licenses are no substitute for guaranteed global access to Covid tools to help control the pandemic.

rjm-vog / nl / tgb / spm