Data from Ozanimod Clinical Development Program in Relapsing Forms of Multiple Sclerosis to Be Presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis

Data to be presented include analyses of long-term efficacy and safety of ozanimod in adults with relapsing forms of multiple sclerosis and effects on biomarkers of disease activity


SUMMIT, N.J.-Monday 9 September 2019 [ AETOS Wire ]

(BUSINESS WIRE) -- Celgene Corporation (NASDAQ:CELG) today announced it will present 13 scientific abstracts, including new analyses from the Phase 3 ozanimod clinical development program in adults with relapsing forms of multiple sclerosis (RMS), at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Stockholm, September 11-13, 2019. Ozanimod is an investigational oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).

“Celgene is committed to furthering our understanding of multiple sclerosis (MS) and the full potential of ozanimod,” said Terrie Curran, President, Global Inflammation and Immunology, Celgene. “We look forward to sharing these new analyses with the MS community, including data on the long-term efficacy and safety of ozanimod in adults with relapsing forms of MS.”

Ozanimod is an investigational compound that is not approved for any use in any country.

Abstracts for presentation include:

New Analyses from the Ozanimod Clinical Development Program

Abstract #P615: Ozanimod efficacy in RMS by baseline thalamic volume quartile: a post hoc exploratory analysis of Phase 3 RADIANCE (Poster Session 1; Wednesday, September 11, 5:15-7:15 p.m. CET; lead author: Jeffrey)

Abstract #P980: Effect of ozanimod on the relationship between changes in cognition and grey matter volume in RMS: a post hoc exploratory analysis of the Phase 3 SUNBEAM trial (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Schippling)

Abstract #P993: Absorption, metabolism, and excretion, in vitro pharmacology, and clinical pharmacokinetics of ozanimod, a novel sphingosine 1-phosphate receptor agonist (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Tran)

Abstract #P996: Effect of ozanimod on circulating leukocyte subtypes: data from a randomized, open-label, Phase 1 study in patients with relapsing multiple sclerosis (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Harris)

Abstract #P1031: Long-term safety and efficacy of ozanimod in relapsing multiple sclerosis: results from the DAYBREAK open-label extension study (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Steinman)

Abstract #P1047: Effect of ozanimod on neurofilament light chain level in relapsing multiple sclerosis: pooled results from Phase 2 and Phase 3 trials (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Harris)

Cohort Studies of Patients with Multiple Sclerosis in Sweden

Abstract #148: Cardiovascular disease in patients with multiple sclerosis: a nationwide cohort study in Sweden (Oral: Free Communication 2 – Comorbidities; Thursday, September 12, 9:18-9:30 a.m. CET; lead author: Piehl)

Abstract #P761: Risk of osteoporosis and fractures in patients with multiple sclerosis: a nationwide cohort study in Sweden (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Montgomery)

Abstract #P762: Infections in patients with multiple sclerosis: a nationwide cohort study in Sweden (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Montgomery)

Abstract #272: Risk of comorbidity in patients with multiple sclerosis: a nationwide cohort study in Sweden (Oral: Scientific Session 11 – Registry-based MS Research; Friday, September 13, 9:10-9:22 a.m. CET; lead author: Piehl)

Health Economics and Outcomes Research Data

Abstract #P1065: Treatment patterns among treatment-naive multiple sclerosis patients in a commercially insured US population (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Kantor)

Abstract #P1068: Systematic literature review and network meta-analysis of Ozanimod compared with other treatments in relapsing-remitting multiple sclerosis (Poster Session 2; Thursday, September 12, 5:15-7:15 p.m. CET; lead author: Tencer)

Abstract #EP1590: Number-needed-to-treat analysis and risk-benefit assessment of Ozanimod compared with first-line disease-modifying therapies for relapsing-remitting multiple sclerosis (ePoster; lead author: Kumar)

Abstracts can be found on the ECTRIMS website here.

Celgene will also host a satellite symposium, “The Evolution of MS Study Outcomes: Relevance to Clinical Practice Today,” exploring current trends in MS research and care, including the implementation of novel study endpoints in the clinic, magnetic resonance imaging (MRI) assessment of brain volume change and lesions, the use of patient-reported outcomes and cognition assessment to measure disability progression, and real-world data. The symposium will take place on September 11, 2019 from 12:30-1:30 p.m. CET.

A New Drug Application for ozanimod for the treatment of adults with RMS is currently under review by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act, the FDA has set its action date as March 25, 2020. The European Medicines Agency also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis, with a regulatory decision in the European Union expected in the first half of 2020.

About Ozanimod

Ozanimod is an investigational oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Ozanimod causes lymphocyte retention in lymphoid tissues. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve the reduction of lymphocyte migration into the central nervous system.

Ozanimod is in development for immune-inflammatory indications including RMS, ulcerative colitis and Crohn's disease.

About Multiple Sclerosis

Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate — a process that's currently irreversible. Signs and symptoms vary widely, depending on the amount of damage and the nerves affected. Some people living with MS may lose the ability to walk independently, while others experience long periods of remission during which they develop no new symptoms. MS affects approximately 400,000 people in the U.S. and approximately 2.5 million people worldwide.

RMS is characterized by clearly defined attacks of worsening neurologic function. These attacks — often called relapses, flare-ups or exacerbations — are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely with no apparent progression of disease. RMS is the most common disease course at the time of diagnosis. Approximately 85 percent of patients are initially diagnosed with RMS, compared with 10-15 percent with more progressive forms of the disease.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next‐generation solutions in protein homeostasis, immuno‐oncology, epigenetics, immunology and neuro‐inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: management’s time and attention is diverted on transaction related issues; disruption from the transaction make it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company that could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel.

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