Pfizer Announces FDA and EMA Acceptance of New Drug Applications for Etrasimod in Ulcerative Colitis; Everest Medicines Holds Exclusive Rights for Greater China and South Korea

--Everest Medicines has the rights to develop, manufacture, and commercialize in Greater China and South Korea.etrasimodExclusive Rights—

--The incidence of ulcerative colitis in China continues to rise, and it is expected that by2030The number of patients with ulcerative colitis per year will be compared to2019More than doubled in a year, highlighting a huge unmet need for innovative therapies for the disease.—

ShanghaiDecember 22, 2022PR Newswire -- Everest Medicines' (HKEX 1952.HK) authorized partner, Pfizer Inc. (NYSE: PFE), announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for etrasimod for the treatment of patients with moderately to severely active ulcerative colitis (UC). The FDA is expected to make a decision in the second half of 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod for the same patient population, with a decision anticipated in the first half of 2024. The anticipated approval by the U.S. FDA will mark the first global marketing authorization for etrasimod.

Everest Medicines CEO Jonathan Wang said, "Congratulations to our partner on this important progress, taking a solid step towards bringing etrasimod, a potential best-in-class therapy, to patients with ulcerative colitis. We plan to complete patient enrollment for the Phase 3 study in Asia in the first half of 2023, and hope to bring this innovative therapy to patients in Asia as soon as possible."

Etrasimod was developed by Arena Pharmaceuticals. Pfizer completed the acquisition of Arena Pharmaceuticals earlier this year. In 2017, Everest Medicines obtained exclusive rights from Arena to develop, manufacture, and commercialize etrasimod in Greater China and South Korea. Over recent decades, the incidence of ulcerative colitis in China has continued to rise. By 2030, the number of ulcerative colitis patients in China is expected to more than double from 2019 levels, surpassing 900,000, indicating a significant unmet need for innovative therapies for this disease in the Chinese market. According to a Frost & Sullivan report, the market size for ulcerative colitis in China was RMB 3.4 billion in 2019 and is projected to expand to RMB 8.1 billion by 2024, with a compound annual growth rate (CAGR) of 18.9%.

Pfizer's new drug marketing authorization application is based on the previously announced results of the ELEVATE UC Phase 3 registration program (ELEVATE UC 52 and ELEVATE UC 12). This program aimed to evaluate the safety and efficacy in achieving clinical remission of once-daily 2mg etrasimod in ulcerative colitis patients who had previously failed or were intolerant to at least one conventional therapy, biologic, or Janus kinase (JAK) inhibitor. Both randomized, double-blind, placebo-controlled studies met all primary and key secondary endpoints, with a safety profile consistent with previous studies. In the ELEVATE UC 52 study, the clinical remission rate at week 12 was 27.0% for patients treated with etrasimod compared to 7.4% for those on placebo (a difference of 19.8%, P=˂.001); at week 52, the clinical remission rate was 32.1% for etrasimod-treated patients versus 6.7% for placebo (a difference of 25.4%, P=˂.001). In the ELEVATE UC 12 study, the clinical remission rate was 24.8% for patients treated with etrasimod compared to 15.2% for those on placebo (a difference of 9.7%, P=.0264).

AboutEtrasimod

Etrasimod is a once-daily oral selective sphingosine-1-phosphate (S1P) receptor modulator, designed with optimized pharmacology to bind to S1P receptors 1, 4, and 5, and is under investigation for the treatment of a range of immune-inflammatory diseases.

AboutELEVATE UC 52AndELEVATE UC 12

ELEVATE UC 52 and ELEVATE UC 12 are pivotal trials in the ELEVATE UC Phase 3 registration program.

ELEVATE UC 52 is a randomized, double-blind, placebo-controlled trial with a continuous treatment design, including a 12-week induction period and a 40-week maintenance period. Starting from week 12, all patients could continue receiving their randomized treatment; patients with no improvement or worsening of the disease compared to baseline could discontinue treatment, and eligible patients could enroll in an open-label extension study. The primary objective of this trial was to evaluate the safety and efficacy of once-daily 2mg etrasimod in achieving clinical remission after 12 and 52 weeks of treatment. The primary endpoint was based on the modified Mayo Score (MMS) consisting of three components. In ELEVATE UC 52, at week 12, the clinical remission rates were 27.0% for patients receiving etrasimod and 7.4% for those receiving placebo (19.8% difference, P≤.001), and at week 52, the rates were 32.1% and 6.7%, respectively (25.4% difference, P≤.001). All key secondary endpoints (including endoscopic improvement, symptom relief, and mucosal healing at weeks 12 and 52, as well as corticosteroid-free remission and sustained clinical remission at week 52) achieved statistically significant improvements.

ELEVATE UC 12 is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of once-daily 2mg etrasimod in patients with moderate to severe active ulcerative colitis. The primary objective of the trial is to assess the safety of etrasimod and its efficacy in achieving clinical remission after 12 weeks of treatment, based on the modified Mayo score with three components required by the FDA. In ELEVATE UC 12, 24.8% of patients receiving etrasimod and 15.2% of those receiving placebo achieved clinical remission (9.7% difference, P=.0264). All key secondary endpoints were met at week 12, including endoscopic improvement, symptomatic remission, and mucosal healing.

In ELEVATE UC 12, the proportion of patients experiencing treatment-emergent adverse events (AEs) was similar between the etrasimod 2mg group and the placebo group, while in ELEVATE UC 52, this proportion was higher in the etrasimod 2 mg group compared to the placebo group. The proportion of patients experiencing serious adverse events was similar across treatment groups in both trials. In both trials, up to Week 52, the most common treatment-emergent adverse events occurring at a rate of 3% or higher in the etrasimod group compared to the placebo group were headache, UC exacerbation, COVID-19 infection, dizziness, fever, arthralgia, abdominal pain, and nausea. No serious adverse events of bradycardia or atrioventricular block were reported. Trial data indicate that initiating etrasimod treatment does not require a complex upward titration regimen.

In ELEVATE UC 52 and ELEVATE UC 12, nearly two-thirds of patients had never previously received biologic or JAK inhibitor therapy.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on the development and commercialization of innovative drugs and vaccines, dedicated to addressing unmet medical needs in the Asian market. The management team of Everest Medicines has deep expertise and extensive experience in high-quality clinical development, regulatory affairs, chemistry manufacturing and control (CMC), business development, and operations within China and global leading pharmaceutical enterprises. Everest Medicines has built a portfolio of potential first-in-class or best-in-class drugs globally, most of which are already in the late stages of clinical trials. The company’s therapeutic areas include cardiorenal diseases, autoimmune diseases, infectious and communicable diseases. For more information, please visit the company’s website:www.everestmedicines.com。 

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