Pfizer Submits EUA Application for Oral Antiviral Paxlovid and Licenses Generic Production via Medicines Patent Pool

Pfizer Announces New Updates on Oral COVID-19 Treatment Drug.

On November 16 local time, Pfizer Inc. announced on its official website that it had recently reached a voluntary licensing agreement with the public health organization "Medicines Patent Pool" (MPP), which is supported by the United Nations, regarding the company’s investigational oral COVID-19 antiviral candidate drug Paxlovid (PF-07321332; Ritonavir). This agreement will enable MPP to promote additional production and distribution of the investigational antiviral drug by granting licenses to qualified generic drug manufacturers, allowing more people around the world to access this drug.

According to the aforementioned agreement, qualified generic drug manufacturers authorized by MPP will be able to supply the drug to 95 countries, covering approximately 53% of the global population. Additionally, as long as the COVID-19 pandemic remains classified by the World Health Organization as a Public Health Emergency of International Concern, Pfizer will not charge royalties on drug sales in low-income countries and will waive royalties on drug sales in all covered countries under the agreement.

Paxlovid is a treatment method that combines PF-07321332 and ritonavir. PF-07321332 is designed to block the activity of the SARS-CoV-2-3CL protease. Ritonavir, a common HIV drug, helps slow the metabolism or breakdown of PF-07321332 when used together, allowing it to remain active at higher concentrations in the body for a longer period to help combat the virus.

Previously, Pfizer stated that compared with a placebo, the oral COVID-19 trial drug Paxlovid, when taken within three days of symptom onset, reduced the probability of hospitalization or death by 89% in adult patients with mild to moderate illness.

On the same day that Pfizer announced the voluntary licensing agreement, it also announced that it had submitted an application to the U.S. Food and Drug Administration (FDA) for emergency use authorization of its experimental oral antiviral drug PAXLOVID against COVID-19. The FDA's advisory committee is scheduled to meet on November 30 to discuss the application. If approved or authorized, Paxlovid will become the first oral antiviral drug that is a 3CL protease inhibitor.

In terms of promoting the accessibility of drugs, Pfizer stated that if authorized or approved during the pandemic, Pfizer will provide this oral antiviral treatment through a tiered pricing approach based on each country's income level. High-income and upper-middle-income countries will pay more than low-income countries, which will be charged at a non-profit price.

In addition, Pfizer has already started and will continue to invest approximately $1 billion to support the manufacturing and distribution of the investigational treatment candidate, including exploring potential contract manufacturing options. It has signed pre-purchase agreements with multiple countries and has begun bilateral engagements with about 100 countries worldwide.

This is not the first time that pharmaceutical companies have reached a similar licensing agreement for COVID-19 treatment drugs.

Another manufacturer of oral COVID-19 treatment drugs, Merck, also announced at the end of October that it had signed an agreement with the MPP. After obtaining appropriate regulatory approval, this agreement will help to widely distribute its oral COVID-19 treatment drug Molnupiravir in 105 low-income and middle-income countries.

On October 20, the Gates Foundation website also released a statement saying that the foundation has committed to invest up to $120 million to help low-income countries accelerate access to molnupiravir, an investigational oral antiviral drug for COVID-19. The foundation will consult with partners on how to use these funds to support the development and production of generic versions of molnupiravir.

Back in May 2020, Gilead also announced that it had signed non-exclusive voluntary licensing agreements with five generic drug manufacturers based in India and Pakistan to expand the supply of the potential antiviral drug Remdesivir to 127 countries worldwide. By the end of June 2020, the number of authorized manufacturers had increased to nine.