We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pfizer (PFE) COVID Pill Maintains Strong Efficacy, Stock Up
Read MoreHide Full Article
Pfizer (PFE - Free Report) announced data from the final analysis of the phase II/III study — EPIC-HR — evaluating its oral antiviral candidate for COVID-19, Paxlovid. The final data demonstrated that Paxlovid reduces the risk of hospitalization or death by 89% compared to placebo in patients treated within three days of symptom onset. The results were consistent with the interim data from the study announced last month.
The study, EPIC-HR, was conducted on non-hospitalized adult patients with COVID-19 who were at high risk of progressing to severe illness. A secondary endpoint data demonstrated that treatment with Paxlovid within five days of symptom onset reduced the risk of hospitalization or death for any cause by 88% versus placebo
The study data showed that 0.7% of the patients treated with Paxlovid within three days of symptom onset were hospitalized and no one died through Day 28, following randomization compared to 6.5% of the patients in the placebo arm who were hospitalized or died. Similarly, in patients treated within five days of symptom onset, 1% of those treated with Paxlovid were hospitalized through Day 28, following randomization compared to 16.3% of the patients in the placebo arm.
We note that Pfizer has already initiated the rolling submission of a regulatory application seeking emergency use authorization (“EUA”) for Paxlovid in the United States. The final data from the EPIC-HR will be shared with the FDA as part of the rolling submission.
Pfizer’s Paxlovid treatment course includes its SARS-CoV-2 3CL protease inhibitor, PF-07321332, co-administered with a low dose of AbbVie’s (ABBV - Free Report) antiviral drug, ritonavir that is available under the trade name of Norvir. While Pfizer’s PF-07321332 helps in inhibiting the replication of coronavirus, AbbVie’s Norvir helps slow the breakdown of PF-07321332. Co-administration of PF-07321332 with Norvir allows the latter to remain active in the body for longer periods of time at higher concentrations.
AbbVie received first approval for Norvir in 1996 for treating HIV-1 infection in combination with other antiretroviral agents. AbbVie’s Norvir is available in two options — oral solution and oral powder.
Shares of Pfizer gained 0.6% on Dec 14, following the final update from the COVID pill study, followed by further gains of 0.7% during after-hours trading. Pfizer’s shares have gained 50.9% so far this year compared with the industry’s increase of 16.4%.
Image Source: Zacks Investment Research
We note that another U.S.-based pharma giant, Merck (MRK - Free Report) is also developing an oral COVID-19 pill, molnupiravir, for high-risk, non-hospitalized patients. Merck also filed an EUA application for a COVID pill in November. Last month, the FDA’s Antimicrobial Drugs Advisory Committee also voted in favor of authorizing Merck’s molnupiravir.
However, Merck’s COVID-19 pill may have lower efficacy compared to Paxlovid. Final data from Merck’s late-stage study showed that molnupiravir reduced the risk of hospitalization or death by approximately 30% in non-hospitalized at-risk adult patients with mild or moderate COVID-19.
In a separate press release, Pfizer announced that the FDA granted approval to its supplemental new drug application (sNDA) for its JAK inhibitor drug, Xeljanz, seeking label expansion to include adults with active ankylosing spondylitis (AS). The drug will be available to treat AS patients who have had an inadequate response or intolerance to one or more tumor necrosis factor ("TNF") blockers. The approval was based on data from a phase III study, which showed that the twice-daily dose of Xeljanz achieved significantly greater improvement in patients compared to placebo at week 16.
The FDA had extended the review period for the sNDA in April this year as the regulatory authority was reviewing the safety profile of JAK inhibitors using data from the post-marketing safety study of Xeljanz as a treatment for rheumatoid arthritis (“RA”) patients. The FDA observed that RA patients treated with both low as well as high doses of Xeljanz experienced a higher rate of serious heart-related events such as heart attack and stroke, cancer, blood clots, and death compared to those treated with TNF inhibitors. In September, the FDA asked to add warnings about an increased risk of these serious side-effects to Xeljanz’s label and a few other JAK inhibitors.
Image: Bigstock
Pfizer (PFE) COVID Pill Maintains Strong Efficacy, Stock Up
Pfizer (PFE - Free Report) announced data from the final analysis of the phase II/III study — EPIC-HR — evaluating its oral antiviral candidate for COVID-19, Paxlovid. The final data demonstrated that Paxlovid reduces the risk of hospitalization or death by 89% compared to placebo in patients treated within three days of symptom onset. The results were consistent with the interim data from the study announced last month.
The study, EPIC-HR, was conducted on non-hospitalized adult patients with COVID-19 who were at high risk of progressing to severe illness. A secondary endpoint data demonstrated that treatment with Paxlovid within five days of symptom onset reduced the risk of hospitalization or death for any cause by 88% versus placebo
The study data showed that 0.7% of the patients treated with Paxlovid within three days of symptom onset were hospitalized and no one died through Day 28, following randomization compared to 6.5% of the patients in the placebo arm who were hospitalized or died. Similarly, in patients treated within five days of symptom onset, 1% of those treated with Paxlovid were hospitalized through Day 28, following randomization compared to 16.3% of the patients in the placebo arm.
We note that Pfizer has already initiated the rolling submission of a regulatory application seeking emergency use authorization (“EUA”) for Paxlovid in the United States. The final data from the EPIC-HR will be shared with the FDA as part of the rolling submission.
Pfizer’s Paxlovid treatment course includes its SARS-CoV-2 3CL protease inhibitor, PF-07321332, co-administered with a low dose of AbbVie’s (ABBV - Free Report) antiviral drug, ritonavir that is available under the trade name of Norvir. While Pfizer’s PF-07321332 helps in inhibiting the replication of coronavirus, AbbVie’s Norvir helps slow the breakdown of PF-07321332. Co-administration of PF-07321332 with Norvir allows the latter to remain active in the body for longer periods of time at higher concentrations.
AbbVie received first approval for Norvir in 1996 for treating HIV-1 infection in combination with other antiretroviral agents. AbbVie’s Norvir is available in two options — oral solution and oral powder.
Shares of Pfizer gained 0.6% on Dec 14, following the final update from the COVID pill study, followed by further gains of 0.7% during after-hours trading. Pfizer’s shares have gained 50.9% so far this year compared with the industry’s increase of 16.4%.
We note that another U.S.-based pharma giant, Merck (MRK - Free Report) is also developing an oral COVID-19 pill, molnupiravir, for high-risk, non-hospitalized patients. Merck also filed an EUA application for a COVID pill in November. Last month, the FDA’s Antimicrobial Drugs Advisory Committee also voted in favor of authorizing Merck’s molnupiravir.
However, Merck’s COVID-19 pill may have lower efficacy compared to Paxlovid. Final data from Merck’s late-stage study showed that molnupiravir reduced the risk of hospitalization or death by approximately 30% in non-hospitalized at-risk adult patients with mild or moderate COVID-19.
In a separate press release, Pfizer announced that the FDA granted approval to its supplemental new drug application (sNDA) for its JAK inhibitor drug, Xeljanz, seeking label expansion to include adults with active ankylosing spondylitis (AS). The drug will be available to treat AS patients who have had an inadequate response or intolerance to one or more tumor necrosis factor ("TNF") blockers. The approval was based on data from a phase III study, which showed that the twice-daily dose of Xeljanz achieved significantly greater improvement in patients compared to placebo at week 16.
The FDA had extended the review period for the sNDA in April this year as the regulatory authority was reviewing the safety profile of JAK inhibitors using data from the post-marketing safety study of Xeljanz as a treatment for rheumatoid arthritis (“RA”) patients. The FDA observed that RA patients treated with both low as well as high doses of Xeljanz experienced a higher rate of serious heart-related events such as heart attack and stroke, cancer, blood clots, and death compared to those treated with TNF inhibitors. In September, the FDA asked to add warnings about an increased risk of these serious side-effects to Xeljanz’s label and a few other JAK inhibitors.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Key Pick
Pfizer currently carries a Zacks Rank #2 (Buy).
Roche (RHHBY - Free Report) is another top-ranked stock from the pharma sector, carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Roche have improved from earnings per share of $2.78 to $2.80 for 2021 and from $2.82 to $2.87 for 2022.
Shares of Roche have gained 12.6% so far this year.