Business Wire

Phase III Efficacy and Safety Data for Oral Ozanimod in Relapsing Multiple Sclerosis to Be Presented at MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting

Del

Celgene Corporation (NASDAQ:CELG) today announced that new data on the efficacy and safety of ozanimod, a novel, oral, selective, sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, in relapsing multiple sclerosis (RMS) were accepted for the MSParis2017 – 7th Joint ECTRIMS – ACTRIMS Meeting, which is being held in Paris, October 25-28, 2017.

“Our strong presence at this year’s meeting and the breadth of data being presented on ozanimod highlight our commitment to bringing forth ozanimod as a potential novel, oral therapeutic option for people with multiple sclerosis,” said Terrie Curran, President, Celgene Inflammation and Immunology.

Full results from the phase III SUNBEAM™ and RADIANCE™ Part B studies evaluating two doses of oral ozanimod compared with Avonex® (interferon beta-1a) (IFN) in people with RMS will be presented as an oral and a late-breaking oral presentation, respectively.

Abstracts at a Glance

Oral Presentations:

Abstract #A-858-0029-00786; Friday, October 27, 2017, 2:52 p.m. – 3:04 p.m. CET / 8:52 a.m. – 9:04 a.m. EDT
Ozanimod demonstrates efficacy and safety in a phase 3 trial of relapsing multiple sclerosis (SUNBEAM); G. Comi
Location: Parallel Session 13: Update on relapsing-remitting MS management, Hall A

Abstract #A-858-0000-02736; Saturday, October 28, 2017, 9:42 a.m. – 9:54 a.m. CET / 3:42 a.m. – 3:54 a.m. EDT
Ozanimod vs interferon β-1a: clinical and MRI results of RADIANCE part B - a 2-year phase 3 trial in relapsing multiple sclerosis; J.A. Cohen
Location: Parallel Session 16: Late Breaking News, Hall A

Poster Presentations:

Abstract #A-858-0032-00784; Thursday, October 26, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Cardiac safety of ozanimod in a QT/QTc trial and a phase 2 trial in RMS; G. Comi
Location: Poster Session 1, Poster Exhibition

Abstract #A-858-0015-00126; Thursday, October 26, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Effect of ozanimod (RPC1063) on action potential parameters in adult human Purkinje fibres; N. Abi-Gerges
Location: Poster Session 1, Poster Exhibition

Abstract #A-858-0027-00623; Thursday, October 26, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Lower baseline levels of vitamin D are associated with a higher risk of new lesion development in patients with relapsing multiple sclerosis; G.J. Opiteck
Location: Poster Session 1, Poster Exhibition

Abstract #A-858-0029-00488; Thursday, October 26, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Ozanimod does not impact cytotoxic T lymphocyte function in vitro demonstrating differentiation from fingolimod’s activity on SET-PP2A; D. Guimond
Location: Poster Session 1, Poster Exhibition

Abstract #A-858-0032-00482; Thursday, October 26, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Ozanimod has an improved nonclinical safety profile relative to fingolimod; S. Meier-Davis
Location: Poster Session 1, Poster Exhibition

Abstract #A-858-0032-00480; Friday, October 27, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Comparison of reproductive and juvenile nonclinical findings between ozanimod and fingolimod; S. Meier-Davis
Location: Poster Session 2, Poster Exhibition

Abstract #A-858-0015-00626; Friday, October 27, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Fingolimod activates the 5-HT1A receptor in S1P3R/5-HT1A heterooligomer complexes in vivo; K. Dines
Location: Poster Session 2, Poster Exhibition

Abstract #A-858-0000-02744; Friday, October 27, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Ozanimod demonstrates preservation of brain volume at 1 and 2 years in two phase 3 trials of relapsing multiple sclerosis (SUNBEAM and RADIANCE); D.L. Arnold
Location: Poster Session 2, Poster Exhibition

Abstract #A-858-0030-00783; Friday, October 27, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Ozanimod (RPC1063) is potentially neuroprotective through direct activity on Th1 and Th17 T cell expansion and migration, monocyte migration and microglia expansion; D. Guimond
Location: Poster Session 2, Poster Exhibition

Abstract #A-858-0030-00485; Friday, October 27, 2017, 3:30 p.m. – 5:00 p.m. CET / 9:30 a.m. – 11:00 a.m. EDT
Ozanimod (RPC1063) is potentially neuroprotective through direct CNS effects; K.R. Taylor Meadows
Location: Poster Session 2, Poster Exhibition

E-posters

Abstract #A-858-0032-00490
Lack of clinically meaningful changes in cardiac effects from co-administration of ozanimod and a beta-blocker or a calcium channel blocker; J.Q. Tran

Abstract #A-858-0027-00781
Ozanimod (RPC1063) reduces the plasma biomarker neurofilament light chain in preclinical rodent models of multiple sclerosis; K.R. Taylor Meadows

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 (1.0 mg and 0.5 mg) 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 were 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 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 (1.0 mg and 0.5 mg) 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 were 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 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 (S1PR1) and 5 (S1PR5) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis and Crohn's disease. Selective binding with S1PR1 is believed to inhibit a specific sub set 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 S1PR5 is thought to activate specific cells within the CNS. This has the potential to enhance remyelination and prevent synaptic defects. Ultimately, neurological damage may be prevented.

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

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. 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 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

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

The 6th Annual World Patient Safety, Science & Technology Summit Kicked off with an Important Announcement about the Progress Being Made to Save Lives in Hospital Settings24.2.2018 10:00Pressemelding

The 6th Annual World Patient Safety, Science & Technology Summit kicked off with an important announcement about the progress being made to save lives in hospital settings. Nearly 4,600 hospitals in 44 countries have committed to adopting patient safety processes that are proven to eliminate preventable deaths in hospitals. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180224005027/en/ England’s Health and Social Care Secretary, Rt. Hon. Jeremy Hunt, launches groundbreaking new measures on Day One of the 6th Annual World Patient Safety, Science & Technology held in London (Photo: Business Wire) The Patient Safety Movement Foundation has taken on an inspiring and ambitious goal of reducing preventable patient deaths in hospitals to ZERO by 2020. The annual Summit in central London plays a major role in taking on that challenge with the participation of 300 global leaders, medical experts, medical technology CEOs, and patient

WuQi Technologies is Latest Licensee of CCww’s NB-IoT UE Protocol-Stack Software24.2.2018 09:06Pressemelding

Communications Consultants Worldwide Ltd. (CCww), global innovator of 3GPP® technologies, has licensed its NB-IoT protocol-stack software to WuQi Technologies Inc., a leading global developer of highly integrated mixed-signal SoC solutions, and the latest licensee of CCww’s NB-IoT Release 13 UE protocol-stack software. Communications Consultants Worldwide (CCww) is working with WuQi Technologies for the integration of its NB-IoT protocol-stack software onto WuQi Technologies’ highly innovative SoC. This relationship, catalyzed by T2M, is enabling the production of a highly integrated, very low power, NB-IoT SoC chipset targeting IoT Smart City, Smart Home, and wearable applications. CCww’s CEO, Richard Carter, said, “NB-IoT is CCww’s latest cellular Protocol-stack SW. We are excited to be working with WuQi to enable a sector-leading NB-IoT SoC, pushing back boundaries of performance and battery life for the next generation of IoT. See our demonstration at the Mobile World Congress (Hal

IDEMIA and Octo Telematics Reinvent Car Sharing Experience by Adding Facial Recognition to EasyOpen Solution23.2.2018 15:57Pressemelding

IDEMIA, the global leader in Augmented Identity for an increasingly digital world, announces today that it has implemented facial recognition technology on EasyOpen, a solution previously developed with its partner Omoove, a wholly-owned Octo Telematics company, Europe’s leading Shared Mobility technology provider. The digital enrolment process combined with facial recognition technology will securely enroll and authenticate the driver before EasyOpen automatically opens the car. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180223005506/en/ (Photo: Idemia) You will never rent a car the same way thanks to EasyOpen solution that combines IDEMIA’s expertise in secure service enablement and Omoove’s experience in Shared Mobility platforms and on-board technology. The first version of the solution was launched last year and allows drivers, who have already registered on the application, to use their smartphones as a key to open

SM-Optics Unveils First FLEXSET Chip, Paving the Way to Optical Micro Nodes23.2.2018 14:00Pressemelding

SM-Optics launches FLEXSET, a single chip embedding multiple processing functionalities raising the bar for performances, density and architectural flexibility. The FLEXSET is the heart of the Lightmode product family. FLEXSET OTN switching matrix scales from 300Gbps to 1Tbps and can be addressed by ports spanning from traditional low-speed services like 2Mbps over micro-OTN, to layer2 and layer3 over ODUFlex, 100G over ODU4 and 200G over FlexO. Thanks to its embedded capabilities including multi-technology OAM, packet processing, synchronization and fast protection functions, FLEXSET operates by design at the lowest latency performances and features an Intel Stratix 10 FPGA. Following the launch of micro-OTN, a revolutionary approach to efficiently extend OTN protocol to low speed services, the launch of FLEXSET advances the vision of a highly interconnected metro network and of micro nodes. Revolving around functional block elements, micro nodes collapse in few rack units OTN and pho

Bitcoin Miner HashGains’ Crowdsale to Build Green Cloud Mining Data Centers Receives Excellent Response23.2.2018 13:56Pressemelding

HashGains.com, a leading cryptocurrency mining platform, has launched its crowdsale program to build mega cryptocurrency cloud mining data centers in India and Canada which uses renewable energy like wind and solar as source of energy. “With the growing worries around bitcoin mining causing environmental damage, difficulty levels of mining increasing and returns heading southwards, there was no better opportunity but to build green energy data centers which run on free sources of energy like wind and solar, ensuring handsome mining rewards while taking care of environment,” said Mr Anuj Bairathi, CEO & Founder, HashGains, who is crypto enthusiast himself. HashGains is a growing cloud mining platform with more than 10,000 active customers enjoying mining returns and is expected to reach the mark of 1 million customers by 2020. To handle such a massive growth and ever growing demand of customers, it becomes even more important that mega mining centers are planned which can serve needs of

Stratecast Recognizes CARDINALITY as a “10 to Watch in 2018”23.2.2018 13:07Pressemelding

In their new report, “Digital Transformation Means New Tools for New Business” —part of the Global Operations, Orchestration, Data Analytics, and Monetisation (ODAM) stream—Stratecast recognises CARDINALITY for their new approach towards processing big data to deliver applications such as Customer Experience, Operational Intelligence, Network Analytics, Churn Management and Marketing Intelligence. Stratecast identified that the CARDINALITY Perception Platform brings large amounts of data from multiple CSP sources together in order to address a growing group of data analysis needs from different operational work teams and the wider business. It also does this at ingestion rates and storage levels previously thought not practical. "Using design principals tied to microservices and containerized solution components, the platform is a major advancement in meeting CSP data analysis needs at a price untouchable by previously-defined platforms," said Karl Whitelock, Stratecast director of glo