Pfizer Lifts Paxlovid Capacity Before EUA is Granted

01.12.2021 - In response to new data published by rival Merck that downgrade earlier efficacy forecasts for its for Covid-19 oral antiviral treatment, Pfizer has announced will increase production capacity of its own antiviral pill Paxlovid as it waits for an emergency use authorization (EUA) from the FDA.

Specifically, Pfizer is seeking authorization for treatment of mild to moderate disease in patients who are at a higher risk of hospitalization and death. The pill works by stopping the coronavirus from multiplying, using the antiviral PF-07321332 in combination with ritonavir, a drug used to treat HIV.

The New York drugs giant now expects to make 80 million courses of Paxlovid by the end of 2022, up from the previously planned 50 million, Pfizer CEO Albert Bourla said. This includes the 10 million courses it will provide to the US government for $5.29 billion by next year. Pfizer also plans to invest up to $1 billion to support the manufacturing and distribution of the treatment, which has shown an 89% risk reduction. Some of the work may be outsourced to CDMOs, it indicated.

Including intake from the Comirnaty Covid-10 vaccine split with German partner BioNTech and the new oral antiviral, analysts expect Pfizer’s annual sales to top $100 billion in 2022, a level not yet seen in the pharmaceutical industry. This compares with the $82.6 billion reported by Johnson & Johnson in 2020 and is nearly double Pfizer’s own $53.7 billion posted in 2019 before it merged its consumer health arm into a joint venture with GlaxoSmithKline in 2019.

Paxlovid could contribute $24.2 billion to the drugmaker’s annual revenue and Comirnaty $29.7 billion, SVB Leerink analyst Geoffrey Porges estimated in a widely quoted note to shareholders.

Efficacy of Merck’s Covid antiviral less than expected

In contrast to that of the Pfizer pill, the outlook for Merck & Co’s COVID-19 antiviral molnupiravir has now deteriorated. At the end of last week, the New Jersey-based pharma revised the treatment’s relative risk reduction potential downward to a disappointing 30% from 50%, based on the final analysis of its phase 3 data.

In partnership with US biotech Ridgeback Therapeutics, Merck is developing molnupiravir for the treatment of mild to moderate Covid in patients who have tested positive for the disease and are at high risk for progression to severe illness, including hospitalization or death – roughly the same cohort the Pfizer drug targets.

Molnupiravir already has been approved by UK regulator MHRA. The FDA is due to review Merck’s application for an EUA on Nov.30, and the European Medicines Agency (EMA) is also reviewing the drumaker’s application.

Author: Dede Williams, Freelance Journalist