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

 5G Arrives in Asia as Operators Invest Billions Rolling out Next Generation Networks, Finds New GSMA Study26.6.2019 01:00:00 CESTPressemelding

Asia’s mobile operators are set to invest $370 billion building-out new 5G networks between 2018 and 2025, according to the latest Asia Pacific edition of the GSMA’s Mobile Economy series, published at MWC19 Shanghai today. The world’s first nationwide 5G networks went live in South Korea earlier this year, and it is anticipated that 24 Asia Pacific markets will have launched 5G by 2025. It is forecast that 5G will contribute almost $900 billion to the region’s economy over the next 15 years. China is currently testing 5G across all major cities and provinces, including Shanghai, ahead of commercial launches next year. It is forecast that 28 per cent of China’s mobile connections will be running on 5G networks by 2025, accounting for about a third of all 5G connections globally by this point. “Although 4G still has plenty of headroom for growth across Asia, operators in the region are now investing billions in building-out advanced 5G networks that are facilitating an array of new serv

Phunware Offers Phun Utility Token Globally26.6.2019 00:48:00 CESTPressemelding

Phunware, Inc. (NASDAQ: PHUN) (the “Company”), a fully-integrated enterprise cloud platform for mobile that provides products, solutions, data and services for brands worldwide, announced that Phun utility tokens are now available for purchase in international markets. “Phun is a new utility token that enables the international community to participate in our blockchain-enabled data exchange and mobile loyalty ecosystem as we drive towards mainstream global adoption and future exchange listings,” said Randall Crowder, Chief Operating Officer of Phunware. Phunware is an Austin, Texas, headquartered Company with 10 years of success working with the world’s largest organizations. Whether it is enabling immersive gaming and movie experiences for Paramount Pictures International, powering Juniper, Cisco or HP Aruba hardware for app-enabled location services or integrating Electronic Health Records (EHRs) like Epic or Cerner for patient experiences in healthcare, Phunware’s Multiscreen as a

CORRECTING and REPLACING I Squared Capital to Sell Cube Hydro to Ontario Power Generation25.6.2019 23:02:00 CESTPressemelding

Sixth paragraph should read: Centerview Partners acted as financial advisor and Sidley Austin LLP, Troutman Sanders LLP, and Davis Polk & Wardwell LLP served as legal counsel to I Squared Capital on this transaction (instead of Centerview Partners acted as financial advisor and Sidley Austin LLP, Troutman Sanders LLP, and David Polk & Wardwell LLP served as legal counsel to I Squared Capital on this transaction). The corrected release reads: I SQUARED CAPITAL TO SELL CUBE HYDRO TO ONTARIO POWER GENERATION I Squared Capital, through its ISQ Global Infrastructure Fund I, announced today that it has reached an agreement to sell its hydropower platform, Cube Hydro Partners and its affiliate, Helix Partners (taken together, Cube Hydro), to Ontario Power Generation (OPG) through its U.S. hydroelectric platform. Cube Hydro owns 385 megawatts of hydro capacity on ten river systems in five states, with 19 small to mid-sized, run-of-the-river and peaking hydro plants. “This is the third portfoli

Results of the MSCI 2019 Market Classification Review25.6.2019 22:15:00 CESTPressemelding

MSCI Inc. (NYSE:MSCI), a leading provider of critical decision support tools and services for the global investment community, announces today that it will reclassify the MSCI Kuwait Index to Emerging Markets status, subject to omnibus account structures and same National Investor Number (NIN) cross trades being made available for international institutional investors before the end of November 2019. MSCI will communicate its final decision by December 31, 2019. “Kuwait’s Market Development Project has set the path for the seamless implementation of numerous regulatory and operational enhancements in the Kuwaiti equity market. These enhancements have significantly increased the accessibility level of the Kuwaiti equity market for international institutional investors and resulted in broad positive feedback from these investors on our reclassification proposal,” said Sebastien Lieblich, Global Head of Equity Solutions and Chairman of the MSCI Equity Index Committee. Mr. Lieblich added,

I Squared Capital to Sell Cube Hydro to Ontario Power Generation25.6.2019 19:41:00 CESTPressemelding

I Squared Capital, through its ISQ Global Infrastructure Fund I, announced today that it has reached an agreement to sell its hydropower platform, Cube Hydro Partners and its affiliate, Helix Partners (taken together, Cube Hydro), to Ontario Power Generation (OPG) through its U.S. hydroelectric platform. Cube Hydro owns 385 megawatts of hydro capacity on ten river systems in five states, with 19 small to mid-sized, run-of-the-river and peaking hydro plants. “This is the third portfolio company realization in the last twelve months based on the I Squared Capital platform approach, with a total of over $2.8 billion in realized enterprise value,” said Sadek Wahba, Chairman and Managing Partner of I Squared Capital. The other two platforms developed and recently sold by I Squared Capital include Lincoln Clean Energy (a leading onshore wind developer in the U.S. with 800 megawatts) to Ørsted, and Amplus Solar (the preeminent provider of rooftop solar systems for the Indian commercial and in

AerSale Acquires Qwest Air Parts, Inc. to Expand Airframe Parts Sales25.6.2019 19:03:00 CESTPressemelding

AerSale ®, a global supplier of aircraft, engines, used serviceable material (USM), and maintenance, repair, and overhaul (MRO) services, announced today it has acquired aircraft parts distributor Qwest Air Parts, Inc. Based in Memphis, Tennessee, Qwest is a recognized leader in aircraft dismantlement and the refurbishment and resale of USM. Qwest has disassembled over 200 aircraft, offers 24/7 AOG service, and operates a teardown facility in Crestview, Florida. Gary Jones, Qwest’s founder, President and CEO, will continue to lead Qwest, which will operate as a stand-alone independent subsidiary of AerSale. The acquisition of Qwest will add scale and reach to AerSale’s already significant airframe USM offerings. Furthermore, Qwest’s recently certified repair station, Q2 Aviation LLC, will supplement AerSale’s growing MRO platform. “As a proven leader in aircraft parts distribution, Qwest is an optimal partner to help further expand our large inventory of high-demand USM, which we cost-