Benzinga | Jan 4, 2022 11:45AM EST

Pfizer Reports Will Provide US Gov't. With Added 10M Treatment Courses Of Its Oral Antiviral Pill For COVID-19

* PAXLOVID(tm) (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) is authorized by the U.S. FDA for emergency use in both high-risk adults and high-risk pediatric patients 12 years of age and older weighing at least 40 kg

* A total of 20 million treatment courses will be delivered to the U.S. government in 2022, with approximately 10 million treatment courses accelerated for delivery by the end of June

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) announced that the U.S. government has committed to purchasing an additional 10 million treatment courses of its COVID-19 oral therapy, PAXLOVID(tm) (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). This commitment will supplement the 10 million treatment courses previously contracted by the U.S. Government, bringing the total amount of treatment courses to 20 million. Collectively, approximately 10 million PAXLOVID treatment courses have been accelerated for delivery by the end of June, with the remaining 10 million to follow by the end of September.

"With the Omicron variant surging, the availability of and accessibility to treatment options is of utmost importance, as millions of people are being diagnosed with COVID-19 each and every day," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "With data showing significant reductions in hospitalizations and deaths, along with the potential for PAXLOVID to maintain robust antiviral activity against Omicron, we believe this therapy will be an important tool in the fight against COVID-19. We are pleased to be working with the U.S. government to help broaden patient access to this potentially game changing therapy."

PAXLOVID includes nirmatrelvir, a novel main protease (Mpro) inhibitor originating in Pfizer's laboratories, which was specifically designed to block the activity of the SARS-CoV-2 Mpro, an enzyme that the coronavirus needs to replicate. The U.S. Food and Drug Administration (FDA) recently authorized the emergency use of PAXLOVID for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

PAXLOVID is also currently authorized for conditional or emergency use in several countries across the globe. Pfizer has submitted applications for regulatory approval or authorization to multiple regulatory agencies and anticipates further regulatory decisions to follow.

Please see Full Emergency Use Authorization (EUA) Prescribing Information available at www.fda.gov and www.COVID19oralRx.com. Under the EUA, the U.S. Government and State Governments decide how PAXLOVID is distributed among pharmacies, hospitals, urgent cares, and other entities. Healthcare providers and healthcare facilities should contact their state health department to determine how to access product. Additional information about how the U.S. Department of Health and Human Services will supply PAXLOVID can be found at www.PHE.gov and https://www.hhs.gov/coronavirus/covid-19-treatments-therapeutics/index.html. Locations of publicly available COVID-19 Therapeutics can be found at COVID-19 Public Therapeutic Locator | HealthData.gov.

Our Commitment to Equitable Access

Pfizer is committed to working toward equitable access to PAXLOVID for all people, aiming to deliver safe and effective antiviral therapeutics as soon as possible and at an affordable price. During the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach, pending country authorization or approval, based on the income level of each country to promote equity of access across the globe. High and upper-middle income countries will pay more than lower income countries.

Pfizer continues to invest to support the manufacturing and distribution of PAXLOVID, including exploring potential contract manufacturing options. As a result of these efforts, Pfizer is raising its production projections from 80 million to 120 million courses of treatment by the end of 2022.

The company has entered into agreements with multiple countries and has initiated bilateral outreach to approximately 100 countries around the world. Additionally, Pfizer has signed a voluntary license agreement with the Medicines Patent Pool (MPP) for its oral treatment to help expand access, pending country regulatory authorization or approval, in 95 low- and middle-income countries that account for approximately 53% of the world's population.