Pfizer PFE announced that it had submitted a new drug application (“NDA”) to the FDA seeking approval for an oral antiviral pill for COVID-19, Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets).
The NDA seeks approval for Paxlovid for both vaccinated and non-vaccinated patients at the risk of developing further complications from COVID-19.
The NDA filing is based on positive top-line data from the phase II/III EPIC-HR study, which demonstrated that Paxlovid significantly reduced hospitalization and death in high-risk non-hospitalized adult patients with COVID-19. The study showed an 88% reduction in risk compared with placebo in patients treated within five days of symptom onset with Paxlovid.
Even though the EPIC-SR study failed to achieve its primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days, Pfizer submitted the same with the NDA.
The EPIC-SR data will support the EPIC-HR study data, which evaluated Paxlovid in high-risk patients for developing severe COVID-19 infection.
Pfizer shares’ have declined 9.8% compared with the industry’s return of 6.4% in the year-to-date period.
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Paxlovid is FDA authorized for emergency use to treat mild-to-moderate COVID-19 symptoms in adults and pediatric patients (12 years and older and weighing at least 40 kg) at increased risk of hospitalizations or death.
In the first quarter of 2022, Pfizer generated $1.5 billion in global sales from Paxlovid. In full-year 2022, Pfizer expects to generate $22 billion in revenues from Paxlovid.
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However, Pfizer faces stiff competition from other major players in the market, such as Gilead Sciences GILD and Merck MRK.
In 2020, Gilead’s COVID treatment, investigational antiviral Veklury (remdesivir), received FDA authorization for emergency use in adults and pediatric patients with severe-to-moderate COVID-19.
Veklury received a supplemental new drug application (sNDA) approval from the FDA for treating pediatric patients older than 28 days, weighing at least 3 kg and either hospitalized with COVID-19 or have mild-to-moderate COVID-19. and are at high risk for progression to severe COVID-19, including hospitalization or death.
This follows the recent sNDA approval for Veklury to treat non-hospitalized adult and adolescent patients at high risk of progression to severe COVID-19.
In the last reported quarter, Veklury sales reached $1.5 billion, up 5% year over year, driven by higher demand. For full-year 2022, Veklury sales are anticipated at around $2 billion.
Similarly, Merck and partner Ridgeback Biotherapeutics’ oral antiviral pill, Lagevrio (molnupiravir) received Emergency Use Authorization (EUA) for treating high-risk adults with mild-to-moderate COVID-19 from the FDA in December 2021.
In the first quarter of 2022, Lagevrio generated sales of $3.25 billion, primarily from supply to the United States, the United Kingdom, Australia and Japan. Lagevrio is expected to generate $5 billion to $5.5 billion in revenues in 2022.
Zacks Rank & A Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector are Aridis Pharmaceuticals ARDS, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Aridis Pharmaceuticals’ loss per share estimates for 2022 have narrowed from $1.78 to 34 cents in the past 30 days. The same for 2023 has narrowed from 75 cents to 60 cents in the same time frame. Shares of ARDS have plunged 52.7% in the year-to-date period.
Earnings of Aridis missed estimates in two of the trailing four quarters and beat the same on the remaining two occasions, the average negative surprise being 75.16%.
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