Pfizer reported $7.514 billion in global revenue for its oral drug Paxlovid in the third quarter.
Full-year sales guidance of $22 billion was unchanged.
Interestingly, Pfizer has started Phase I clinical trials of its second-generation oral drug for COVID-19. Pfizer recently released a ClinicalTrials trial (NCT05580003) to evaluate the safety and serum concentrations of PF-07817883 in healthy individuals.
The second-generation oral drug is similar in that Pfizer still selects the 3CLpro target, but the new drug does not require ritonavir to maintain blood concentrations, thus avoiding many drug interaction problems.
The trial included Chinese participants who were born in mainland China and had two parents of Chinese descent or Japanese who had four Japanese grandparents born in Japan. By adding clinical data to the Asian population, it will help the regulatory progress of drugs in the region.
Gilead raised its full-year guidance for the second time in three months. Most of the increase was attributed to higher Remdesivir sales.
Remdesivir reported sales of $925 million in the third quarter, nearly three times market expectations.
What's interesting is that Gilead Sciences has entered phase 3 clinical trials with the oral version of Remdesivir, GS-5245. And they got fast track from the FDA.
GS-5245 has the same effect as remdesivir on the novel coronavirus. GS-5245 is designed as an oral prodrug to deliver GS-441524, the mother nucleoside of remdesivir, to human cells.
Remdesivir is widely used in Europe and the United States.
In January, Gilead published an article in the New England Journal of Medicine suggesting that remdesivir, administered as an intravenous infusion, reduces the risk of hospitalization by 87 percent in outpatients with COVID-19, about the same as Pfizer P. Thus, remdesivir has expanded its indications to include both severe and mild cases.
In February, the FDA also gave Remdesivir an EUA for children up to age 12.
Remdesivir sold $5.6 billion last year and $1.5 billion in the first quarter of this year. Sales fell sharply in the second quarter due to competition from Pfizer's Paxlovid and Merck's Molnupiravir.
As a result, Gilead accelerated the pace of clinical development of an oral version of Remdesivir. In order to snipe at the other two COVID-19 oral small molecule drugs.
