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Pfizer's (PFE) Etrasimod Meets Ulcerative Colitis Study Goals
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Pfizer Inc. (PFE - Free Report) announced topline data from the phase III ELEVATE UC 12 study, which evaluated its immuno-inflammatory pipeline candidate etrasimod for moderately-to-severely active ulcerative colitis (UC).
The ELEVATE UC 12 study evaluated etrasimod versus placebo over a 12-week treatment period in 354 UC patients who already received at least one conventional, biologic or JAK therapy. It achieved both primary and key secondary endpoints with statistically significant improvements. Participants administered with etrasimod achieved the primary endpoint of clinical remission with statistical significance over placebo.
Shares of Pfizer have declined 11.6% this year so far against the industry’s 1.5% rise.
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Pfizer is also evaluating the candidate in another phase III ELEVATE UC 52 study in UC patients for a 52-week treatment period. Results from the same study are awaited by the end of first-quarter 2022. PFE plans to use data from both the ELEVATE UC 12 and ELEVATE UC 52 studies to seek regulatory approvals for etrasimod to address UC indication.
Apart from UC, etrasimod is being studied across multiple gastroenterology and dermatology indications, including atopic dermatitis (AD), eosinophilic esophagitis, Crohn’s disease (CD) and alopecia areata.
We remind investors that etrasimod was added to Pfizer’s pipeline following its acquisition of Arena Pharmaceuticals in an all-cash transaction for a total equity value of approximately $6.7 billion. The transaction closed earlier this month.
Other than etrasimod, the acquisition added two mid-stage candidates, namely APD418 and temanogrel to Pfizer’s pipeline, which are being developed as treatments for cardiovascular disorders.
The targeted UC market is highly competitive with many companies like AbbVie (ABBV - Free Report) and Johnson & Johnson (JNJ - Free Report) marketing their own drugs, which utilize different mechanisms of action to treat the indication.
Earlier this month, AbbVie received an approval for label expansion from the FDA for its JAK inhibitor drug Rinvoq to address UC indication. ABBV’s Rinvoq is already approved for three indications in the United States, such as AD, active psoriatic arthritis and rheumatoid arthritis. In the full year 2021, AbbVie generated $1.6 billion from Rinvoq product sales.
J&J markets its blockbuster drug Stelara, a human IL-12 and IL-23 antagonist, approved by the FDA for treating moderate-to-severely active UC. The drug is also approved for CD indication. Evidently, Stelara is also JNJ’s largest product, accounting for 9.7% of its total 2021 revenues. For the full year, J&J recorded revenues worth $9.1 billion from Stelara sales.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 13% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.
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Pfizer's (PFE) Etrasimod Meets Ulcerative Colitis Study Goals
Pfizer Inc. (PFE - Free Report) announced topline data from the phase III ELEVATE UC 12 study, which evaluated its immuno-inflammatory pipeline candidate etrasimod for moderately-to-severely active ulcerative colitis (UC).
The ELEVATE UC 12 study evaluated etrasimod versus placebo over a 12-week treatment period in 354 UC patients who already received at least one conventional, biologic or JAK therapy. It achieved both primary and key secondary endpoints with statistically significant improvements. Participants administered with etrasimod achieved the primary endpoint of clinical remission with statistical significance over placebo.
Shares of Pfizer have declined 11.6% this year so far against the industry’s 1.5% rise.
Image Source: Zacks Investment Research
Pfizer is also evaluating the candidate in another phase III ELEVATE UC 52 study in UC patients for a 52-week treatment period. Results from the same study are awaited by the end of first-quarter 2022. PFE plans to use data from both the ELEVATE UC 12 and ELEVATE UC 52 studies to seek regulatory approvals for etrasimod to address UC indication.
Apart from UC, etrasimod is being studied across multiple gastroenterology and dermatology indications, including atopic dermatitis (AD), eosinophilic esophagitis, Crohn’s disease (CD) and alopecia areata.
We remind investors that etrasimod was added to Pfizer’s pipeline following its acquisition of Arena Pharmaceuticals in an all-cash transaction for a total equity value of approximately $6.7 billion. The transaction closed earlier this month.
Other than etrasimod, the acquisition added two mid-stage candidates, namely APD418 and temanogrel to Pfizer’s pipeline, which are being developed as treatments for cardiovascular disorders.
The targeted UC market is highly competitive with many companies like AbbVie (ABBV - Free Report) and Johnson & Johnson (JNJ - Free Report) marketing their own drugs, which utilize different mechanisms of action to treat the indication.
Earlier this month, AbbVie received an approval for label expansion from the FDA for its JAK inhibitor drug Rinvoq to address UC indication. ABBV’s Rinvoq is already approved for three indications in the United States, such as AD, active psoriatic arthritis and rheumatoid arthritis. In the full year 2021, AbbVie generated $1.6 billion from Rinvoq product sales.
J&J markets its blockbuster drug Stelara, a human IL-12 and IL-23 antagonist, approved by the FDA for treating moderate-to-severely active UC. The drug is also approved for CD indication. Evidently, Stelara is also JNJ’s largest product, accounting for 9.7% of its total 2021 revenues. For the full year, J&J recorded revenues worth $9.1 billion from Stelara sales.
Pfizer Inc. Price
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Zacks Rank & Stock to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Vertex Pharmaceuticals (VRTX - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Vertex Pharmaceuticals’ earnings per share estimates for 2022 have increased from $14.33 to $14.52 in the past 30 days. Shares of VRTX have risen 13% year to date.
Earnings of Vertex Pharmaceuticals beat estimates in each of the last four quarters, the average being 10%.