Business Wire

Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis

Del

Celgene Corporation (NASDAQ:CELG) today announced that the Company has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS). 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.

“New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “With concurrent applications in the U.S. and EU, we look forward to advancing this promising medicine through the regulatory review process to provide a new option for the treatment of RMS in 2020.”

Earlier this month, the Company also submitted a Marketing Authorization Application to the European Medicines Agency for adults with relapsing-remitting multiple sclerosis.

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

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

Process Systems Enterprise: gPROMS FormulatedProducts 1.4 Includes Enhanced Capabilities Linking Digital Design to Digital Operations19.4.2019 07:58:00 CESTPressemelding

Process Systems Enterprise (PSE), the Advanced Process Modelling company, today released version 1.4 of gPROMS FormulatedProducts, the mechanistic model-based environment for integrated digital design of robust formulated products and their manufacturing processes, and related digital process operation. This release introduces major enhancements to both the gPROMS FormulatedProducts model libraries and the underlying gPROMS platform 6.0, including morphological crystallizer and sensor models to capture particle size and shape evolution, enhanced continuous direct compression models and improved wet granulation models. Platform enhancements include support for cluster computing, to significantly speed up execution of parameter estimation and other complex numerical solutions, and comprehensive global system analysis of dynamic systems for rapid exploration of the time-varying decision space and systematic risk and uncertainty analysis. Version 1.4 also introduces two key usability enhan

LOXAM Contributes to the Reconstruction of Notre Dame De Paris Cathedral19.4.2019 07:44:00 CESTPressemelding

In the wake of the Notre Dame de Paris blaze on Monday 15 April, Loxam the leading equipment rental company in Europe is playing its part in the reconstruction project of the partly destroyed cathedral. A rental operator in the construction equipment, LOXAM pledges to provide, free of charge, machines to the companies and tradesmen who will take part in these restoration works for the scheduled duration of five years. “Notre Dame de Paris Cathedral is the legacy of accomplished builders that we ought to preserve. As a committed rental operator, Loxam wishes to contribute to the rehabilitation of this monument by providing equipment for an overall 10-million € value over the upcoming five years” Gérard DEPREZ, President of LOXAM, indicates. With a fleet of over 200,000 machines, Loxam is meeting the needs of all tradesmen operating on this worksite. View source version on businesswire.com: https://www.businesswire.com/news/home/20190419005025/en/ Contact information PRESS : Virginie Ada

IFF to Release First Quarter 2019 Results May 618.4.2019 20:15:00 CESTPressemelding

Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of scent, taste, and nutrition, announced that it will release its first quarter 2019 earnings results following the market close on Monday, May 6, 2019. The management team will host a live webcast on Tuesday, May 7, 2019 at 10:00 a.m. ET to discuss results and outlook with the investor community. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF) is a leading innovator of scent, taste, and nutrition, with 97 manufacturing facilities, 105 R&D centers, and 39,000 customers globally. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for exploration dri

Gilead Sciences to Release First Quarter 2019 Financial Results on Thursday, May 2, 201918.4.2019 20:05:00 CESTPressemelding

Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its first quarter 2019 financial results will be released on Thursday, May 2, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the first quarter 2019 and provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 5259422 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, May 4, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the conference ID

Andersen Global Expands Africa Presence; Signs Collaboration Agreement in Economic Hub of South Africa18.4.2019 13:30:00 CESTPressemelding

Andersen Global is excited to announce the addition of its first collaborating firm in South Africa. Tabacks Attorneys and Corporate Law Advisors, headquartered in Johannesburg, South Africa, has signed a Collaboration Agreement with Andersen Global, an international association of member and collaborating firms. South Africa marks the tenth country in Africa in which Andersen Global has a presence. Led by Chairman David Woodhouse, Tabacks has a team of 27 lawyers who offer legal assistance and commercial advice to a diverse clientele in construction, manufacturing, energy, mining, explosives, retail, hospitality, logistics, pharmaceutical, property and banking industries. The firm is considered a leading law firm in South Africa, and its practice areas include competition law, commercial law, mining, employment law, environmental health & safety law, tax and litigation. “The global economy is rapidly changing, which brings unique challenges to corporate and commercial law,” said David

Amazon and Google Announce Official YouTube Apps to Launch on Fire TV; Prime Video App Coming to Chromecast and Android TV18.4.2019 13:00:00 CESTPressemelding

Today, Amazon (NASDAQ: AMZN) and Google (NASDAQ: GOOGL) announced that in the coming months, the two companies will launch the official YouTube app on Amazon Fire TV devices and Fire TV Edition smart TVs, as well as the Prime Video app for streaming to Chromecast and Chromecast built-in devices. In addition, Prime Video will be broadly available across Android TV device partners, and the YouTube TV and YouTube Kids apps will also come to Fire TV later this year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190418005212/en/ “We are excited to work with Amazon to launch the official YouTube apps on Fire TV devices worldwide,” said Heather Rivera, Global Head of Product Partnerships at YouTube. “Bringing our flagship YouTube experience to Amazon Fire TV gives our users even more ways to watch the videos and creators they love.” “We’re excited to bring the Prime Video app to Chromecast and Android TV devices, and to give our c