Pfizer Announces Agreement with US Government for COVID-19 Oral Antiviral Treatment

Pfizer announced an agreement with the US government to supply 10 million treatment courses of its investigational COVID-19 oral antiviral candidate of PF-07321332 and ritonavir (Paxlovid), subjected to regulatory authorization from the FDA, according to a recent press release.

“We were thrilled with the recent results of our Phase 2/3 interim analysis, which showed overwhelming efficacy of PAXLOVID in reducing the risk of hospitalization among high-risk patients treated within three days of symptom onset by almost 90% and with no deaths, and are pleased the US government recognizes this potential,” Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement.

Under the agreement, the government would acquire 10 million treatment courses to be delivered by Pfizer beginning later this year and concluding in 2022.

Pfizer will receive $5.29 billion from the government upon regulatory authorization, and the price being paid by the government is reflective of the high committed volume of treatment courses being purchased through 2022.

Pfizer has also entered into advance purchase agreements with several other countries and has initiated bilateral outreach to approximately 100 countries.

If approved or authorized, PF-07321332 would be the first oral antiviral 3CL protease inhibitor specifically designed to combat SARS-CoV-2. It would be administered at a dose of 300 mg (two 150 mg tablets) with one 100 mg tablet of ritonavir, given twice a day for 5 days.

PF-07321332 is intended to block the activity of SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate before viral RNA replication is complete. Additionally, the drug is designed to be administered with a low dose of ritonavir to help low the metabolism.

Pfizer is working to submit applications to regulatory agencies around the world.

Reference

Pfizer to Provide U.S. Government with 10 Million Treatment Courses of Investigational Oral Antiviral Candidate to Help Combat COVID-19. Business Wire. News release. November 18, 2021. Accessed November 22, 2021. https://www.businesswire.com/news/home/20211118005462/en