- The efficacy data for Pfizer’s oral COVID-19 drug now look so appealing that the Big Pharma company is boosting manufacturing capacity even before an expected emergency use authorization from the FDA.
- The company previously said it plans to have the capacity to make 50 million courses.
- It isn’t immediately clear whether the extra courses will come from Pfizer’s own facilities or external help.
- The SARS-CoV-2 coronavirus behind COVID-19 uses the spike protein on its surface to infect healthy cells.
The efficacy statistics for Pfizer’s oral COVID-19 medicine are now so promising that the Big Pharma giant is ramping up production even before the FDA issued an emergency use licence as reported by Fierce Pharma.
Emergency authorization
In a Monday interview with CNBC, Pfizer CEO Albert Bourla, PhD, said the company now intends to create 80 million courses of COVID medicine Paxlovid by the end of 2022. The corporation previously stated that it intends to produce 50 million courses.
Merck announced the reduction in hospitalisation and death risk from its Ridgeback Therapeutics-partnered COVID antiviral, molnupiravir, which was reduced from 50% to 30% in the final analysis. Paxlovid, which has shown an 89% risk reduction in outpatients, is expected to see increasing demand as a result of the new results.
Pfizer has applied to the FDA for an emergency use authorization for Paxlovid and has agreed to give 10 million courses to the US government for $5.29 billion by 2022.
Meanwhile, Pfizer has said that it will invest up to $1 billion in the manufacturing and distribution of the COVID medicine, including the possibility of hiring contract manufacturers.
It’s unclear whether the additional courses will come from Pfizer’s own facilities or from outside help.
Paxlovid
The advent of omicron, a novel coronavirus subtype, has raised questions about the efficacy of existing vaccinations and therapies. Despite these concerns, Bourla believes Paxlovid will continue to be useful.
“The good news is that our treatment was developed with it in mind, with the idea that most mutations happen in the spikes,” Bourla said on CNBC’s “Squawk Box.”
To infect healthy cells, the SARS-CoV-2 coronavirus that causes COVID-19 uses the spike protein on its surface. Paxlovid is a protease inhibitor that prevents the virus from replicating by blocking an enzyme required for replication.
Pfizer currently appears to be the king of oral COVID treatment, with molnupiravir’s efficacy collapse and Roche’s withdrawal from its Atea Pharmaceuticals-partnered COVID pill development.
Before Merck’s data update and Pfizer’s capacity expansion, SVB Leerink analyst Geoffrey Porges estimated Paxlovid could add $24.2 billion to Pfizer’s top line in 2022. Pfizer’s overall revenue next year might top $100 billion, according to Porges, thanks to an expected $29.7 billion from BioNTech-shared COVID vaccination Comirnaty.
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Source: Fierce Pharma
