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
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.
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.
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.
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.
Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.
All trademarks are the property of their respective owners.
Executive Director, Investor Relations
Senior Director, Corporate Communications
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
New nCipher HSM as a Service Delivers High-Assurance Security for Organizations Adopting Cloud-First Strategies17.9.2019 10:01:00 EEST | Press release
nCipher Security, an Entrust Datacard company, announces nShield as a Service, a cloud-based hardware security module (HSM) service that allows organizations to protect sensitive data and applications and helps meet compliance mandates – simply and efficiently, using on-demand cryptography. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190917005391/en/ How nCipher Security nShield as a Service works (Graphic: Business Wire) “Organizations embracing cloud-first strategies require cloud-first encryption,” said Peter Galvin, vice president of strategy, nCipher Security. “This means remote, automated management at scale, and flexible access control both in the cloud and onsite. nShield as a Service makes it easy to adopt a secure, multi-cloud encryption strategy using the same nShield HSMs organizations deploy onsite today.” nShield as a Service is ideal for cloud-first strategies, selective cloud migration, or adding HSM capac
Netsam boosts metro network capacity with ADVA technology17.9.2019 10:00:00 EEST | Press release
ADVA (FSE: ADV) today announced that Netsam has deployed its FSP 3000 and FSP 150 to dramatically expand its metro network and answer fierce data demand. Featuring the ADVA FSP 3000 open line system (OLS) with micro-ROADMs and ADVA FSP 150 demarcation technology, the new solution gives the Swedish communication service provider (CSP) the power to quickly and easily turn up new high-value services. The flexible ROADM-based photonic layer ensures Netsam’s fiber resources are used with optimal efficiency. With this and the ADVA FSP 150 deployed at customer premises, Netsam is able to provide SLA-based business services with speeds up to 100Gbit/s. ADVA’s partner NetNordic, a leading solutions integrator in Scandinavia, also played a key role in the project. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190917005130/en/ Netsam has deployed the FSP 3000 and FSP 150 to quickly and easily turn up new high-value services (Photo: Bu
Riversand Technologies Appoints New EVP to Lead Growth in Europe and Middle East17.9.2019 08:00:00 EEST | Press release
Riversand Technologies, a leading software provider of Cloud-native SaaS Master Data Management (MDM) and Product Information Management (PIM), announces the appointment of Mr. Mikkel Jensen as executive vice president for Europe and the Middle East regions. Mikkel will be responsible for overseeing sales and revenue growth in Europe and the Middle East and managing these regions’ operations. He has more than 18 years of experience in Master Data Management. Previously, he held a variety of roles with increasing responsibility at Stibo Systems, including EVP, and VP of Product Strategy. “We are delighted to bring onboard a leader of the caliber of Mikkel with his depth and breadth of knowledge, to head Riversand’s European and Middle East regions,” says Upen Varanasi, founder and CEO at Riversand. Riversand has steadily increased its footprint in Europe over the past few years, successfully establishing itself as a Product Information Management leader serving top European brands acros
Statement From The We Company17.9.2019 05:57:00 EEST | Press release
The We Company (the “Company”) has issued the following statement: “The We Company is looking forward to our upcoming IPO, which we expect to be completed by the end of the year. We want to thank all of our employees, members and partners for their ongoing commitment.” This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations of offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933. A registration statement relating to these securities has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. Copies of the preliminary prospectus relating to the offering, when available, may be obtained from the Company at 115 West 18th Street, New York, New York 10011. View source
PSE plans to become part of Siemens17.9.2019 03:00:00 EEST | Press release
Process Systems Enterprise (PSE), the leading supplier of Advanced Process Modelling (APM) software and services, today announced that it plans to be acquired by Siemens AG in a transaction scheduled to close in Q4 2019. The 160-strong PSE operation will be integrated into the Process Automation Business Unit of Siemens Digital Industries. The current PSE management team will remain in place. PSE’s advanced process models are used within digital R&D, design and operations in the process industries to help make fast, safe and more efficient decisions through rapid and effective exploration of the decision space. The technology is widely used in the chemicals, petrochemicals, pharmaceuticals and food industries to accelerate innovation, improve process design and operation, streamline R&D and manage technology risk. PSE’s model-based solutions span the entire process lifecycle via a unified and integrated set of tools. These strongly complement the Siemens portfolio in the process indust
Velodyne Executive Addresses Why Lidar is Necessary for Safe Vehicle Automation at IAA 2019 Conference17.9.2019 01:19:00 EEST | Press release
Marta Hall, President and Chief Business Development Officer of Velodyne Lidar, Inc. will address the future of vehicle safety at the IAA 2019 Conference in Frankfurt. Hall’s presentation will highlight the development of advanced, cost-effective lidar technology for advanced driver assistance systems (ADAS) and autonomy, particularly to protect pedestrians, assist drivers and save lives. The event will take place at Velodyne’s booth (Hall 8.0, Booth A13) on September 18 at 11:00 a.m. CEST (GMT+2). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190916005913/en/ Marta Hall, President and Chief Business Development Officer of Velodyne Lidar, Inc., will address why lidar is necessary for safe vehicle automation at the IAA 2019 Conference. (Photo: Velodyne Lidar) “There are dozens of companies working on autonomous vehicles. Incredible possibilities have opened as a result of the engineering efforts towards autonomy. In rolling
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom