b"98 Therst and only sphingosine 1-phosphate (S1P) receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC) in adults 1ANOTHER DAY IS DAWNING IN THE CONTROL OF UCNow many of your patients can choose another path forward before biologics. 1aZEPOSIA delivers: Lasting Remission 1 Demonstrated One Capsule, Signi cantly higher clinicalSafety Pro le 1b Once Daily 1remission rates vs placebo in theStudied in 4 clinical trials Once-daily oral pivotal trial: 18% (79/429) vswith over 1370 ZEPOSIA- administration, with 6% (13/216) at Week 10 (p0.0001)treated patients acrossor without foodand 37% (85/230) vs 19% (42/227)multiple indicationsat Week 52 (p0.0001)ZEPOSIA demonstrated higher rates of clinical remission vs placebo in tumor necrosis factor inhibitor (TNFi)-nave patients at a Week 10 (22% [66/299] vs 7% [10/151]) and at Week 52 (41% [63/154] vs 22% [35/158], respectively) 1 . In UC Study 1 and UC Study 2, of the ZEPOSIA-treated patients who were TNFi-nave, 288 and 145 were also biologic nave, respectively.2 Ef cacy analysis by prior TNFi therapy was prespeci ed, but not powered to detect a difference in the treatment effect in these subgroups.3bZEPOSIA has been studied across multiple indications in 4 clinical trials, including TRUE NORTH (NCT02435992), a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial; TOUCHSTONE (NCT01647516), a randomized, double-blind, placebo-controlled phase 2 clinical trial; and SUNBEAM (NCT02294058) and RADIANCE (NCT02047734), 2 multicenter, randomized, double-blind, double-dummy, active treatment-controlled phase 3 clinical trials. 496 patients receiving the 0.92-mg dose of ZEPOSIA during induction in TRUE NORTH or TOUCHSTONE and 882 patients receiving the 0.92-mg dose of ZEPOSIA in SUNBEAM or RADIANCE were assessed in the safety analysis. 1Visit ZEPOSIAHCP.COM/UC to learn moreClinical Trial: The ef cacy and safety of ZEPOSIA were evaluated in 2 multicenter, randomized, double-blind, placebo-controlled clinical studies (UC Study 1 [induction] and UC Study 2 [maintenance]) in adult patients with moderately to severely active ulcerative colitis, de ned as a Mayo score of 6 to 12 at baseline. 1 IMPORTANT SAFETY INFORMATION (cont'd)Primary Endpoint of Clinical Remission Is De ned as: rectal bleeding subscore (RBS)=0, stool frequency subscore (SFS)Infections: (cont'd)0 or 1 (and a decrease of 1 point from baseline SFS), and endoscopy subscore 0 or 1 without friability.1 Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex UC Study 1 (10-week induction): 645 patients were randomized 2:1 to either ZEPOSIA 0.92 mg given orally once daily orencephalitisandvaricellazostermeningitishavebeenreportedwithsphingosine1-phosphate placebo for 10 weeks, beginning with a dosage titration. The trial included patients who had an inadequate response or(S1P) receptor modulators. Patients without a healthcare professional-con rmed history of varicella were intolerant to any of the following: oral aminosalicylates, corticosteroids, immunomodulators, or a biologic. Patients were required to be on stable doses of oral aminosalicylates and/or corticosteroids 1 (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus .UC Study 2 (42-week maintenance): 457 patients who received ZEPOSIA in either UC Study 1 or in an open-label arm(VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for and achieved clinical response at Week 10 were re-randomized 1:1 and were treated with either ZEPOSIA 0.92 mg (n=230)antibody-negative patients with varicella vaccine is recommended prior to commencing treatment or placebo (n=227) for 42 weeks (UC Study 2), for a total of 52 weeks of treatment. with ZEPOSIA.1INDICATION Casesoffatalcryptococcalmeningitis(CM)werereportedinpatientstreatedwithanotherS1P ZEPOSIA (ozanimod) is indicated for the treatment of moderately to severely active ulcerativereceptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection colitis (UC) in adults. has been excluded. If CM is diagnosed, appropriate treatment should be initiated.IMPORTANT SAFETY INFORMATION In the UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used Contraindications: for treatment of UC. Concomitant use of ZEPOSIA with any of these therapies would be expected Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke,to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/ medications, consider the duration of their effects and their mode of action to avoid unintended IV heart failure or have a presence of Mobitz type II second-degree or third-degree atrioventricularadditive immunosuppressive effects.(AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker Use of live attenuated vaccines should be avoided during and for 3 months after treatment withPatients with severe untreated sleep apnea ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior toPatients taking a monoamine oxidase (MAO) inhibitor initiation of ZEPOSIA.Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatalProgressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months orthe brain that typically occurs in patients who are immunocompromised, and that usually leads after discontinuation of prior UC therapy) complete blood count (CBC) including lymphocyte countto death or severe disability.before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops aPlease see additional safety information and Brief Summary of the Prescribing Information serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA. and Medication Guide on the following pages.2084-US-2200376_ZEP_UC_Branded_JournalAd_Gastro_and_Hepa_P0157262_v01.indd 1-2 3/2/22 11:39 AM"