A new generation of ulcerative colitis drugs is under development. Will they become blockbusters for Lilly and Pfizer?

PFE by Pfizer Inc.,
The promising ulcerative colitis treatment could generate $1.9 billion in sales by 2030 if approved by US regulators next year.

So says SVB Securities analyst David Risinger, who told investors this week that he remains “optimistic” on the drug.

Pfizer received etrasimod through Arena Pharmaceuticals Inc.’s $6.7 billion acquisition, which closed in March. Data that Pfizer released earlier this week from two late-stage pivotal clinical trials supports the deal.

One study found that patients taking etrasimod reported a 32.1% clinical remission after 52 weeks compared to 6.7% on placebo. A second study reported a clinical remission of 24.8% in patients taking etrasimod compared with 15.2% on placebo after 12 weeks.

“These Phase 3 results support the positioning of etrasimod as a first-in-line oral therapy after conventional treatments have failed,” said Mike Gladstone, Pfizer’s global president of inflammation and immunology, loudly at Digestive Disease Week Thursday a FactSet transcript of the presentation.

The experimental therapy is part of a wave of new treatments for ulcerative colitis aimed at better managing an inflammatory bowel disease that is estimated to affect about 1 million people in the United States

Up to 40% of patients do not respond to biological treatments (such as AbbVie’s ABBV,
Humira or JNJ from Johnson & Johnson,
Simponi, both of which are prescribed for people with ulcerative colitis and other immune disorders), according to the Crohn’s & Colitis Foundation. About 30% of patients with ulcerative colitis do not respond to biologics in the long term.

“There is a need for therapies for patients whose disease is unresponsive to current treatments,” said Michael Osso, the foundation’s president and CEO, in a statement. “In addition, there is a need for drugs that not only help to reduce the symptoms of the disease, but also change the course [inflammatory bowel disease] to induce sustained remission.”

An increasingly crowded market

This new treatment group includes BMY from Bristol Myers Squibb Co.,
Zeposia, which was approved by the Food and Drug Administration a year ago to treat ulcerative colitis. The drug was first approved for multiple sclerosis patients in 2020.

It’s projected to bring in $619 million in revenue this year and $1.8 billion in 2026, according to a FactSet consensus.

The wholesale purchase price is approximately US$93,000 per patient per year.

Zeposia could have a competitor in etrasimod.

“Zeposia’s label requires dose titration and an electrocardiogram when patients initiate therapy with them due to known concerns [adverse events]’ Risinger told investors on Wednesday. “If etrasimod is approved without similar safety considerations, we believe it would be an advantage over Zeposia and could help etrasimod get a stake in the drug from BMY.”

But that’s not the only new therapy for ulcerative colitis in development.

Protagonist Therapeutics Inc. PTGX,
said last month that a larger dose of its drug candidate for ulcerative colitis failed a mid-stage study, but smaller doses showed clinical remission. It’s now looking for a “major pharma partner” or “structured financing arrangement” to take the therapy to the next phase of clinical trials.

“We believe PN-943 may represent a significant commercial opportunity and merits further clinical development,” Dinesh Patel, Protagonist’s President and CEO, told investors May 4.

Then there’s Eli Lilly & Co. LLY,
experimental drug for ulcerative colitis. The company said Tuesday that patients taking mirikizumab had “statistically superior and clinically meaningful improvements compared to placebo at one year.” Although 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 announced that it will apply for regulatory approval later this year.

https://www.marketwatch.com/story/a-new-generation-of-ulcerative-colitis-drugs-is-in-development-will-they-be-the-blockbusters-that-pharma-wants-11653589244?rss=1&siteid=rss A new generation of ulcerative colitis drugs is under development. Will they become blockbusters for Lilly and Pfizer?

Brian Lowry

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