\nThe MAA submitted to the EMA is based on results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating Zeposia<\/i> as an induction and maintenance therapy in adults with moderately to severely active UC. True North met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at Week 10 and in maintenance at Week 52. The overall safety observed in True North was consistent with the known safety profile for Zeposia<\/i> in approved labeling.\n<\/p>\n
\n\u201cUlcerative colitis is an unpredictable and potentially debilitating disease, and many patients cycle through different therapies as they try to manage their disease,\u201d said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. \u201cThis validation is an important step toward making Zeposia<\/i> available to eligible patients in the European Union, who are in need of new treatment options offering proven efficacy and safety, as well as oral administration.\u201d\n<\/p>\n
About True North <\/b><\/p>\n
\nTrue North is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Zeposia<\/i> 1mg in patients with moderately to severely active ulcerative colitis who did not adequately respond to prior treatment. In the induction phase, a total of 645 patients were randomized to receive Zeposia<\/i> (n=429) or placebo (n=216), of whom 94% and 89%, respectively, completed the induction period. At study entry, mean age was 42 years, 60% were male and mean disease duration was 7 years; patient characteristics were well-balanced across treatment groups. Cohort 1 patients were randomized 2:1 to Zeposia<\/i> or placebo and treated once daily for 10 weeks. Cohort 2 (n=367) was an open-label arm, and included to allow adequate patient numbers for the maintenance phase of the trial. Cohort 2 patients were treated once daily with Zeposia<\/i> for 10 weeks.\n<\/p>\n
\nFor the maintenance phase, 457 patients were re-randomized to maintenance treatment with either Zeposia<\/i> (n=230) or placebo (n=227). Of these, 80% and 54.6% of patients who received Zeposia<\/i> and placebo, respectively, completed the study; disease relapse (13.5% Zeposia<\/i>, 33.9% placebo) was the most common reason for discontinuation. Patients on Zeposia<\/i> from either Cohort 1 or 2 who achieved clinical response in the induction phase at Week 10 were re-randomized 1:1 to Zeposia <\/i>or placebo through Week 52. Patients on placebo who achieved clinical response in the induction phase at Week 10 remained on placebo during this blinded maintenance phase.\n<\/p>\n
\nIn Cohort 1 of the induction phase and in the re-randomized patient group in the maintenance phase, 30% of patients had prior TNF-inhibitor exposure.\n<\/p>\n
\nAll eligible patients were rolled into an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia<\/i> for the treatment of moderately to severely active ulcerative colitis.\n<\/p>\n
\nThe primary endpoints in True North are the proportion of patients in clinical remission based on a composite clinical and endoscopic score (3-component Mayo Score) at Week 10 in the induction phase, and at Week 52 for the maintenance phase. Secondary endpoints include the proportion of patients achieving clinical response at Week 10 and Week 52, the proportion of patients with endoscopic improvement (endoscopy score \u22641) at Week 10 and Week 52, the proportion of patients with mucosal healing at Week 10 and Week 52, and clinical remission at Week 52 in patients that were in remission at Week 10. In this study, mucosal healing is defined as endoscopic improvement with histologic remission. More information can be found on www.clinicaltrials.gov<\/a>, NCT02435992.\n<\/p>\n About Ulcerative Colitis<\/b><\/p>\n \nUlcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon) or rectum. Symptoms, including bloody stools, severe diarrhea and frequent abdominal pain, usually develop over time rather than suddenly. Ulcerative colitis has a major impact on patients’ health-related quality of life, including physical functioning, social and emotional well-being and ability to work. Many patients have an inadequate response or do not respond at all to currently available therapies. It is estimated that approximately 12.6 million people worldwide have IBD.\n<\/p>\n About Zeposia<\/i> (ozanimod)<\/b><\/p>\n Zeposia<\/i> (ozanimod) is an oral, sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia<\/i> reduces the capacity of lymphocytes to exit from lymph nodes, reducing the number of circulating lymphocytes in peripheral blood. The mechanism by which Zeposia<\/i> exerts therapeutic effects in ulcerative colitis is unknown but may involve the reduction of lymphocyte migration into the inflamed intestinal mucosa.\n<\/p>\n \nBristol Myers Squibb is continuing to evaluate Zeposia<\/i> in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia<\/i> for the treatment of moderately to severely active ulcerative colitis. The company is also investigating Zeposia <\/i>forthe treatment of moderately to severely active Crohn\u2019s disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.\n<\/p>\n Zeposia<\/i> was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020.The European Commission approved Zeposia<\/i> for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features in May 2020. Zeposia<\/i> is not approved for the treatment of ulcerative colitis in any country.\n<\/p>\n U.S. FDA-APPROVED INDICATION FOR ZEPOSIA<\/b><\/p>\n \nZEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.\n<\/p>\n IMPORTANT SAFETY INFORMATION<\/b><\/p>\n Contraindications:<\/b><\/p>\n Infections:<\/b> ZEPOSIAmay increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIAin patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIAif a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA\n<\/p>\n Bradyarrhythmia and Atrioventricular Conduction Delays:<\/b> Since initiation of ZEPOSIAmay result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIAwithout dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIAis considered, advice from a cardiologist should be sought for those individuals:\n<\/p>\n Liver Injury:<\/b> Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIAshould be discontinued if significant liver injury is confirmed. Caution should be exercised when using ZEPOSIAin patients with history of significant liver disease\n<\/p>\n Fetal Risk:<\/b> There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA\n<\/p>\n Increased Blood Pressure: <\/b>Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA\n<\/p>\n Respiratory Effects:<\/b> ZEPOSIAmay cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated\n<\/p>\n Macular edema:<\/b> S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIAin patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIAshould be discontinued\n<\/p>\n Posterior Reversible Encephalopathy Syndrome (PRES): <\/b>Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom\/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIAshould be discontinued\n<\/p>\n Unintended Additive Immunosuppressive Effects from Prior Immunosuppressive or Immune-Modulating Drugs:<\/b> When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended\n<\/p>\n Severe Increase in Disability After Stopping ZEPOSIA:<\/b> Severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIAtreatment so patients should be monitored upon discontinuation\n<\/p>\n Immune System Effects After Stopping ZEPOSIA:<\/b> After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA\n<\/p>\n Most common Adverse Reactions (\u2265 4%):<\/b> upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.\n<\/p>\n For additional safety information, please see the full Prescribing Information<\/a> and Medication Guide<\/a>.<\/b><\/p>\n About Bristol Myers Squibb<\/b><\/p>\n \nBristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com<\/a> or follow us on LinkedIn<\/a>, Twitter<\/a>, YouTube<\/a>, Facebook<\/a> and Instagram<\/a>.\n<\/p>\n \nCelgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.\n<\/p>\n Cautionary Statement Regarding Forward-Looking Statements \ncorporatefinancial-news\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20201228005047\/en\/<\/a><\/span><\/p>\n Bristol Myers Squibb <\/b><\/p>\n Media Inquiries: \nKirby Hosea Investors: \nNina Goworek KEYWORDS:<\/b> New Jersey United States North America<\/p>\n INDUSTRY KEYWORDS:<\/b> Health FDA Other Health General Health Clinical Trials Pharmaceutical Biotechnology<\/p>\n\n
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<\/b>This press release contains \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Zeposia (ozanimod) may not receive regulatory approval for the additional indication described in this release and, if approved, whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb\u2019s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb\u2019s Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.<\/i><\/p>\n<\/p>\n
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media@bms.com<\/a><\/p>\n
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Kirby.Hosea@bms.com<\/a><\/p>\n
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Tim Power
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609-252-7509
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Timothy.Power@bms.com<\/a><\/p>\n
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908-673-9711
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Nina.Goworek@bms.com<\/a><\/p>\n
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