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Pfizer Inc.’s
PFE,
promising ulcerative colitis treatment could generate $1.9 billion in sales by 2030 if it’s approved by U.S. regulators next year.
That’s according to SVB Securities analyst David Risinger, who told investors this week that he remains “bullish” on the drug.
Pfizer obtained etrasimod through its $6.7 billion acquisition of Arena Pharmaceuticals Inc., which closed in March. The data that Pfizer shared earlier this week from two pivotal late-stage clinical trials further makes the case for the deal.
One study found patients taking etrasimod reported clinical remission of 32.1% compared with 6.7% taking placebo after 52 weeks. A second study reported clinical remission of 24.8% for patients taking etrasimod compared with 15.2% for placebo after 12 weeks.
“These Phase 3 results support the positioning of etrasimod as the first-in-line oral therapy after conventional treatments fail,” Mike Gladstone, Pfizer’s global president of inflammation and immunology, said Thursday at Digestive Disease Week, according to a FactSet transcript of the presentation.
The experimental therapy is part of a wave of new ulcerative colitis treatments that aim to better treat an inflammatory bowel disease that is estimated to affect about 1 million people in the U.S.
Up to 40% of patients do not respond to biologic treatments (like AbbVie’s
ABBV,
Humira or Johnson & Johnson’s
JNJ,
Simponi, which are both prescribed to people with ulcerative colitis and other immune disorders), according to the Crohn’s & Colitis Foundation. About 30% of ulcerative colitis patients don’t respond to biologics on a long-term basis.
“There is a need for therapies for patients whose disease does not respond to current treatments,” Michael Osso, the foundation’s president and CEO, said in a statement. “Additionally, there is a need for drugs that not only help decrease disease symptoms but also modify the course of [inflammatory bowel disease] in order to induce sustained remission.”
An increasingly crowded market
This new group of treatments includes Bristol Myers Squibb Co.’s
BMY,
Zeposia, which was approved by the Food and Drug Administration as an ulcerative colitis treatment a year ago. The drug was first approved in 2020 for multiple-sclerosis patients.
It’s expected to bring in $619 million in revenue this year and $1.8 billion in 2026, according to a FactSet consensus.
The wholesale acquisition price is about $93,000 per patient a year.
In etrasimod, Zeposia may have a competitor.
“Zeposia’s label requires dose titration and an electrocardiogram when patients initiate therapy due to known concerns with these [adverse events],” Risinger told investors on Wednesday. “If etrasimod is approved without similar safety warnings we believe this would be a benefit over Zeposia and could contribute to etrasimod taking share from BMY’s drug.”
But that’s not the only new ulcerative colitis therapy in development.
Protagonist Therapeutics Inc.
PTGX,
said last month that a larger dose of its ulcerative colitis drug candidate failed a mid-stage study, but smaller doses demonstrated clinical remission. It’s now seeking a “large pharma partner” or a “structured financing arrangement” to help move the therapy into the next phase of clinical studies.
“We believe that PN-943 may represent a substantial commercial opportunity and merits further clinical development,” Protagonist president and CEO Dinesh Patel told investors on May 4.
Then there’s Eli Lilly & Co.
LLY,
experimental ulcerative colitis drug. The company said Tuesday that patients taking mirikizumab had “statistically superior and clinically meaningful improvements at one year compared with placebo.” Though etrasimod and Zeposia are oral S1P receptor modulators, mirikizumab is an anti-IL23p19 monoclonal antibody.
The FDA is expected to make a decision on mirikizumab next year. Pfizer has said it plans to seek regulatory approval later this year.
