Business Wire

Celgene Submits Application to EMA for Ozanimod for the Treatment of Relapsing-Remitting Multiple Sclerosis

Del

Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS). Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).

The pivotal efficacy and safety data provided in the application result from the SUNBEAM™ and RADIANCE™ Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials.

The Company remains on track to submit a New Drug Application to the U.S. Food and Drug Administration for relapsing forms of MS (RMS) by the end of March.

“Celgene believes ozanimod could be a best-in-class, oral option for use early in the treatment of relapsing forms of multiple sclerosis,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We look forward to regulatory review and the potential for ozanimod to improve the lives of people with this disease.”

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

About SUNBEAM™

SUNBEAM is a pivotal, phase 3, 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 HCI respectively) against weekly intramuscular interferon beta-1a (Avonex®) for at least 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 annualized relapse rates (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 whole brain volume at month 12. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator.

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 3 trials.

About RADIANCE™

RADIANCE Part B is a pivotal, phase 3, 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 HCI respectively) against weekly intramuscular interferon beta-1a (Avonex®) over a 24-month treatment period. The study included 1,320 people living with RMS across 150 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 whole brain volume at month 24. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator.

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 3 trials.

About Ozanimod

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which 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 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; pending legal proceedings or any future litigation instituted against Bristol-Myers Squibb, Celgene or the combined company 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.

Contact information

For inquiries, please contact:
Investors:
Nina Goworek
Executive Director, Investor Relations
908-673-9711

Media:
Catherine Cantone
Senior Director, Corporate Communications
908-897-4256

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

Workiva Named Best-In-Class Cloud Service Provider at UK Cloud Awards17.5.2019 12:00:00 CESTPressemelding

Workiva (NYSE:WK), the leading cloud provider of connected data, reporting and compliance solutions, was named the Best-In-Class Cloud Service Provider by the UK Cloud Awards 2019 at a ceremony here last night. Now in its sixth year, the UK Cloud Awards recognise innovation and excellence in the cloud industry by showcasing leading companies, customers and individuals in the United Kingdom. Workiva was recognised for its Wdesk platform that helps organisations consolidate, connect and tag their data in a single, cloud environment so they are able to reduce risk and save time when filing reports with various regulators and other stakeholders. Workiva, the global leader in XBRL and Inline XBRL, is also streamlining how customers comply with the European Securities and Markets Authority's mandate for Inline XBRL for European Single Electronic Format (ESEF) reporting. More than 5,000 EU issuers will be required to use ESEF taxonomy for their annual financial reports, ending on or after Jan

Novaremed Presents Top-Line Results from Phase 2a Diabetic Neuropathic Pain Study of NRD.E1 at NeuPSIG 201917.5.2019 10:13:00 CESTPressemelding

Novaremed AG, a clinical-stage Swiss biopharmaceutical company, today announced a poster presentation highlighting the top-line results from a Phase 2a (Proof of Concept) study of NRD.E1 for the treatment of diabetic neuropathic pain (DNP). The poster presentation took place at the 7th International Congress on Neuropathic Pain Meeting (NeuPSIG) in London, UK on May 9-11, 2019. “This was our first communication at a leading neuropathic pain-focused event. Novaremed’s lead drug, NRD.E1 is a non-opioid small molecule for the treatment of neuropathic pain. The results of our Phase 2a in patients with DNP showed clinically relevant treatment benefit from NRD.E1 across multiple primary and secondary endpoints, providing a strong scientific foundation for advancing the development of NRD.E1 into the upcoming global Phase 2b study in DNP,” said Sara Mangialaio, Head of R&D and Chief Medical Officer of Novaremed AG. “NRD.E1 has the potential to address a major unmet medical need in DNP.” Poste

WIN 2019 Symposium: WINnovation and Global Deployment of Precision Oncology17.5.2019 09:38:00 CESTPressemelding

The 11th WIN Symposium in Precision Oncology will be held in Paris, France on June 23-24, 2019. ASCO® endorsed for the past 11 years, the WIN symposium will deliver an exciting line-up of speakers in Paris (France) on June 23-24, 2019 to discuss Innovation and Global Deployment of Precision Oncology. The current status of Precision Oncology across the globe will be examined with the exceptional participation of the chairmen of the event, Richard L. Schilsky, Chairman WIN Consortium(*), Senior Vice-President and Chief Medical Officer of ASCO, and Josep Tabernero, Vice Chairman WIN Consortium, President of ESMO and Director of Vall d’Hebron Institute of Oncology, Spain. Global experience will be shared: Optimizing Patient Enrollment and Efficacy of Precision Oncology Clinical Trials at UT MD Anderson Cancer Center, USA Decision Support for Precision Oncology: Evolving from Monotherapy to Genomically Informed Combinations, UT MD Anderson Cancer Center, USA The Value of Personalized Medici

Corsearch Acquires Principium Trademark Watch and Domain Services Businesses17.5.2019 08:00:00 CESTPressemelding

Corsearch, the global brand creation, clearance, and protection leader, is pleased to announce the acquisition of the Principium Strategies trademark watch and domain services businesses, the brand protection subsidiary of Ladas and Parry LLP, a leader in global intellectual property law. The acquisition is effective immediately, solidifying and expanding Corsearch’s full-service trademark solutions offering for clients and brands globally. Principium is Corsearch’s third acquisition since becoming a standalone company in January 2018. The acquisition brings Corsearch’s employee count to more than 350 operating in 28 locations worldwide and adds valuable industry expertise and additional capabilities to Corsearch. “This is another really exciting acquisition for our business and a step forward in the evolution of Corsearch,” said Stephen Stolfi, Chief Commercial Officer of Corsearch. “Principium has provided clients with industry-leading trademark watching services for over 80 years an

CNT Among SAP’s "Best of the Best"17.5.2019 08:00:00 CESTPressemelding

Since 2005, SAP is honoring the best of the best SAP projects yearly in Europe, Middle East and Africa. In 2018, 280 customers from 15 markets submitted their regional Gold Award-winning projects. CNT Management Consulting from Vienna won Bronze twice – together with its customers HOERBIGER and TANNPAPIER – a happy day for CNT’s CEO Andreas Doerner. "We are now on the podium for the second time with two projects – thanks to the trust of our customers." The SAP Quality Awards EMEA were presented at an exceptionally festive ceremony in Heidelberg Castle (Baden-Wuerttemberg), and only twelve SAP customers were able to take home the most wanted trophies that were presented by SAP Presidents Brian Duffy (EMEA North) and Hartmut Thomsen (Middle and Eastern Europe). The jury evaluated the projects according to the ten SAP quality principles and the question of whether the respective project could fulfill the expectations of its clients. HOERBIGER - Category Business Transformation Headquarter

EVER Pharma acquires Amneal Deutschland GmbH and extends its commercial presence in Europe17.5.2019 07:25:00 CESTPressemelding

EVER Pharma Holding Ges.m.b.H (Austria) announced today that it has completed the acquisition of Amneal Deutschland GmbH, a subsidiary of Amneal Pharmaceuticals that operates the company's commercial operations in Germany. Amneal Deutschland already distributes several EVER Pharma products in Germany and is a strongly established player in the German hospital market. The acquired entity will be rebranded to EVER Pharma GmbH. “This acquisition represents another milestone in the expansion of EVER Pharma’s commercial footprint in Europe. With this new operation, EVER Pharma extends its portfolio in Germany and establishes a solid platform for the growth of its portfolio and pipeline” commented Georges Kahwati, General Manager of EVER Pharma. “We are pleased to establish another EVER affiliate in one of the key European markets in line with our strategy of establishing our own business presence in core markets.” added Julia Hillebrand, Managing Director and Owner. About EVER Pharma: EVER