Business Wire

New Analyses from Pivotal Phase III Trials of Oral Ozanimod in Relapsing Multiple Sclerosis To Be Presented at the 2018 American Academy of Neurology Annual Meeting

Del

Celgene Corporation (NASDAQ:CELG) today announced additional phase III data analyses evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1P1) and 5 (S1P5) receptor modulator, versus interferon beta-1a (IFN β-1a) (Avonex®) in patients with relapsing multiple sclerosis (RMS). These additional data analyses from the SUNBEAM™ and RADIANCE™ Part B trials are being presented at the 2018 American Academy of Neurology (AAN) Annual Meeting in Los Angeles, April 21-27, 2018.

“These new analyses of the pivotal SUNBEAM and RADIANCE Part B trials provide robust evidence that supports ozanimod as a potential new therapeutic option in a broad spectrum of patients with relapsing multiple sclerosis,” said Ludwig Kappos, M.D., Chair of the Department of Neurology at the University of Basel and a presenter of one of the abstracts. “The reduction in annualized relapse rates with ozanimod in these trials was consistent across a range of pre-specified subgroups versus interferon beta-1a.”

The phase III SUNBEAM and RADIANCE Part B studies evaluated two doses of oral ozanimod (1 mg and 0.5 mg ozanimod HCl) compared with IFN β-1a in patients with RMS. In the new analyses, several pre-specified subgroups, including disability severity at baseline (EDSS ≤3.5 vs. EDSS >3.5), presence of gadolinium-enhanced lesions at baseline and prior treatment with disease-modifying therapies, were assessed. Data from these analyses, to be presented in an oral session on April 25, show dose-dependent effects of ozanimod on annualized relapse rates (ARR) versus IFN β-1a across these subgroups that were consistent with the primary endpoint of both SUNBEAM and RADIANCE Part B.

A pair of poster presentations on April 24 examined reductions in brain volume loss, a measure associated with multiple sclerosis (MS) disease progression, for ozanimod compared with IFN β-1a. As previously reported for SUNBEAM at one year and for RADIANCE Part B at two years, whole brain volume loss was reduced relative to IFN β-1a for both the 1 mg dose of ozanimod and the 0.5 mg dose. For both doses, all comparisons were nominally significant.

Additional data in the presentations from exploratory endpoints examined volume loss of specific segments of the brain. Increasing evidence suggests that disease-related damage to grey matter is of major importance in MS. The data analyses to be presented show reductions in cortical grey matter loss and thalamic volume loss are consistent with the reductions in whole brain volume loss seen in SUNBEAM at one year for ozanimod compared with IFN β-1a. Likewise, reductions in cortical grey matter loss and thalamic volume loss are consistent with the reductions in whole brain volume loss seen in RADIANCE Part B at two years.

In the clinical trials, adverse reactions that occurred in at least 5 percent of patients in either ozanimod treatment group, with at least a 1 percent difference greater than the IFN β-1a group, were nasopharyngitis, headache, increased alanine aminotransferase, upper respiratory tract infection, hypertension, increased gamma-glutamyltransferase, pharyngitis and urinary tract infections.

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

About SUNBEAM

SUNBEAM is a pivotal, phase III, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCl, respectively) against weekly intramuscular interferon beta-1a (Avonex®) over a 12-month treatment period. The study included 1,346 people living with RMS across 152 sites in 20 countries.

The primary endpoint of the trial was ARR during the treatment period. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months, number of gadolinium-enhanced brain MRI lesions at month 12 and percent change from baseline in brain volume at month 12.

An analysis of the time to onset of 3-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase III trials.

About RADIANCE

RADIANCE Part B is a pivotal, phase III, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ozanimod (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCl, respectively) against weekly intramuscular interferon beta-1a (Avonex®) over a 24-month treatment period. The study included 1,320 people living with RMS across 147 sites in 21 countries.

The primary endpoint of the trial was ARR over 24 months. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months, number of gadolinium-enhanced brain MRI lesions at month 24 and percent change from baseline in brain volume at month 24.

An analysis of the time to onset of 3-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase III trials.

About Ozanimod

Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1 (S1P1) and 5 (S1P5) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis and Crohn's disease.

Selective binding with S1P1 is believed to inhibit a specific subset of activated lymphocytes from migrating to sites of inflammation. The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity. Importantly, immune surveillance is maintained.

Selective binding with S1P5 is thought to activate specific cells within the central nervous system (CNS). This has the potential to enhance remyelination (when the body is able to repair damaged myelin after inflammation is reduced) and prevent synaptic defects. Ultimately, neurological damage may be prevented.

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. Multiple sclerosis affects approximately 400,000 people in the U.S. and approximately 2.5 million people worldwide.

Relapsing multiple sclerosis (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. Approximately 85 percent of patients with MS have the relapsing form of the disease, compared with 10-15 percent with 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.

Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.

Contact information

For inquiries, please contact:
Celgene Corporation
Investors:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, Investor Relations
or
Media:
Catherine Cantone, 908-897-4256
Senior Director, Corporate Communications

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

IDEMIA Will Present Its 2018 Annual Financial Results to Investors on February 20, 201919.2.2019 16:07:00Pressemelding

IDEMIA, the world leader in Augmented Identity, today announced that it will present its 2018 annual financial results to investors on Wednesday February 20, 2019. Yann Delabrière (CEO), Laurent Lemaire (CFO), and Frédéric Beylier (COO) will be presenting the financial results and taking questions the same day at 4:00 pm CET (3:00 pm London Time / 10:00 am New York Time). For more information, please refer to our website: http://investors.oberthur.com About IDEMIA IDEMIA, the global leader in Augmented Identity, provides a trusted environment enabling citizens and consumers alike to perform their daily critical activities (such as pay, connect, travel and vote), in the physical as well as digital space. Securing our identity has become mission critical in the world we live in today. By standing for Augmented Identity, an identity that ensures privacy and trust and guarantees secure, authenticated and verifiable transactions, we reinvent the way we think, produce, use and protect one of

Zain Group Drives Operational Efficiencies, Financial Compliance with iconectiv’s Comprehensive Fixed Asset Management Solution19.2.2019 15:00:00Pressemelding

Zain Group, a leading mobile telecommunications provider serving more than 47.8 million customers in the Middle East and North Africa, today announced it will incorporate the iconectiv Common Language® solution to enhance capital and operational efficiencies within the company. The solution from iconectiv, an authoritative partner of the global communications industry, will help Zain gain new business insights through the comprehensive and ongoing identification and management of hundreds of thousands of network assets. With $3 billion in annual revenue and operations in more than eight countries, Zain is deploying iconectiv Common Language to ensure the flow of consistent and accurate information throughout its network. “At Zain, we are passionate about customer experience, operational effectiveness and preparing the path for continued business growth,” said Ossama Matta, CFO, Zain Group. “iconectiv Common Language will not only give us real-time status of our network assets but also

Songtradr Acquires Leading Global Music Licensing Agency, Big Sync Music19.2.2019 14:03:00Pressemelding

Songtradr, the largest music licensing platform in the world, today announced it has acquired Big Sync Music Ltd, the world’s leading full service, creative music licensing agency. Headquartered in London, with an APAC-focused team in Singapore and a North/South America-focused team in New York, Big Sync is the largest global music buyer of its kind. Music is sourced for local, regional and worldwide advertising campaigns on behalf of well-known brands, from Dove, Knorr, Magnum and AXE to Johnnie Walker, Samsung, Amazon and Lipton. Songtradr is the only fully-automated, open music licensing marketplace in the world, with over 400,000 artists and catalogs from 190+ countries, developing real-time data intelligence, such as the utilization of streaming and social metadata to guide the licensing experience. “Big Sync’s global footprint working with major international brands combined with Songtradr’s technology and our growing community of artists, creates an unparalleled music licensing

Ahearn & Soper Finds that ExaGrid Stands Behind Its Scalable System19.2.2019 14:00:00Pressemelding

ExaGrid®, a leading provider of intelligent hyperconverged storage for backup, today announced that Ahearn & Soper has optimized and further protected its backup environment by establishing offsite replication using ExaGrid hyperconverged backup with data deduplication, and has been able to match its data growth due to ExaGrid’s scalable architecture. Ahearn & Soper Inc. provides barcode software and hardware solutions that improve accuracy, tracking, and efficiency within distribution, manufacturing, and healthcare operations. The company is headquartered in Toronto, Ontario, and operates across North America from branch sales and service offices. Ahearn & Soper decided to add disaster recovery (DR) to its backup environment and wanted a solution that provided offsite replication. “ExaGrid came to our site and explained how the system worked and the benefits of its architecture. We were quite impressed with the product because of the self-contained nature of the system and how it hand

Head Position During Sleep Has Potential Implications for Neurodegenerative Disease19.2.2019 14:00:00Pressemelding

Could sleeping on your back increase your brain's risk of developing neurodegenerative disease? That possibility is revealed in a new study published in the Journal of Alzheimer's Disease. "We compared the in-home sleep patterns of patients with memory impairment resulting from neurodegenerative diseases to a large group of elderly with normal cognition," stated Daniel J. Levendowski, the study's first author and President of Advanced Brain Monitoring. "Sleeping more than 2 hours with one's head lying face upward (i.e., supine) was a significant nocturnal marker that characterized those with memory impairment, after controlling for factors such as age, sex, snoring, obstructive sleep apnea, and movements during the night." These results corroborate in humans a finding observed in rats by researchers at Stony Brook University and published in the Journal of Neuroscience. Using dynamic contrast MRI, they found that the clearance of neurotoxic proteins from the brain by glymphatic transpo

Huawei Enters into MPEG LA’s AVC Patent Portfolio License19.2.2019 14:00:00Pressemelding

MPEG LA announced today that Huawei Technologies Co., Ltd., Huawei Device Co., Ltd and Huawei Device (Shenzhen) Co., Ltd (“Huawei”) have become Licensees to MPEG LA’s AVC Patent Portfolio License (“AVC License”). As a result of this agreement, all legal disputes related to patent enforcement actions brought by patent holders in MPEG LA’s AVC License against Huawei have been resolved. See https://www.mpegla.com/wp-content/uploads/2018/12/FINAL-Huawei-ZTE-Infringement-PrsRls-2018-11-16.pdf; and https://www.mpegla.com/wp-content/uploads/2019/02/FINAL-PrsRls-2018-12-27.pdf. MPEG LA, LLC MPEG LA is the world’s leading provider of one-stop licenses for standards and other technology platforms. Starting in the 1990s, it pioneered the modern-day patent pool helping to produce the most widely used standards in consumer electronics history. MPEG LA has operated licensing programs for a variety of technologies consisting of nearly 20,000 patents in 90 countries with more than 250 patent holders a