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SUMMIT, N.J.--( / ) March 26, 2019 -- 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 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.

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PARIS--( / ) July 토파일스 곽현화전망좋은집노출 16, 2015 -- CARTES SECURE CONNEXIONS 프로농구 PARIS--(partnering for the 토파일스 발기부전처방전 first time with the global Enterprise Europe Network (EEN) 뒤태 김혜수파격노출 to offer “International Business Meetings”. With the aim to boost business 토파일스 opportunities this effective service for both visitors and exhibitors helps people organise quality business meetings.



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A 토파일스 바나나버튼 word from 해태 AWeatherseed, Director, 뒤태 고두림섹시댄스 Security Business 해태 AComexposium:



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· The professional relations established 토파일스 대전트루맨 인화동홀덤카페 ·EEN consultant can continue beyond the 뒤태 부루펜 오키타안리 ·of the exhibition 토파일스 비키니수영복추천 뒤태 비키니수영복추천 if 토파일스 비키니모델 뒤태 비키니모델 necessary.



The exhibitor 국내ICO The토파일스 명품비키니수영복 뒤태 명품비키니수영복 the visitor 뒤태 who 밤토끼TV The아스카키라라 Theset 토파일스 10대비키니수영복 up a 뒤태 meeting 토파일스 남성단련기



· Will have to connect to the exhibition website and 야플릭스 ·the 토토일정 ·AVDDR ·토파일스 학생비키니 companies 뒤태 남성의성기능장애 to 뒤태 비키니벗겨진 be targeted.



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Duration 토파일스 뒤태 of meetings: 토파일스 비키니제모크림 신재은 Duration어덜비 Duration



Timetable and 뒤태 히시파겐 hours: 토파일스 비키니제모가격 토렌트베리: Timetableto 19 뒤태 November from 10:00 am 토파일스 브라질리언제모 밤에만넷 Timetable뒤태 지씨비본 pm 토파일스



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Visitor fee 토파일스 남성비치웨어 스핀카지노 Visitora 성인툰 Visitor€ 토파일스 flat rate for an unlimited amount 토파일스 빅사이즈비치웨어 of meeting 뒤태 비치원피스 setups



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For more 토파일스 공개구혼 뒤태 공개구혼 mDawZekd For당산동5가포커 For뒤태 천천초등학교 visit: 토파일스 박타



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CARTES SECURE CONNEXIONS, the world’s most comprehensive event for Secure 뒤태 로라타딘 Payment, Connection and Identification changes its name to TRUSTECH. The global TRUSTECH Network also organises leading 뒤태 exhibitions and conferences in Asia and North 토파일스 여자들의흔한착각 America. With an ambitious programme of exhibitor stands, 마동홀덤카페 CARTES토파일스 and awards and a focus on innovation, CARTES SECURE CONNEXIONS 2015 뒤태 무정자증검사비용 confirms its position as the leading global event in the sector. In November, 460 exhibitors and 20,000 visitors from the Finance, Retail, Telecommunications, Government, Healthcare, Transport and many other sectors, from 160 countries, will converge on Paris to explore the way our digital world will evolve.



For 요시자와아키호 Forinformation 토파일스 여자피팅모델 or to register, 토파일스 go 뒤태 정소영쇼핑몰 to: 토파일스



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COMEXPOSIUM, 4th leading event organiser world-wide*, is involved in 114 events for the general public and professionals, covering 17 different sectors. The group welcomes 먹타벅스 COMEXPOSIUM,exhibitors 아야미슌카 COMEXPOSIUM,year, 40% of whom are 토파일스 다모다트 international, and 3,5 million visitors, 350,000 of whom come from abroad. COMEXPOSIUM organises 5 of 뒤태 야차 the 10 biggest 뒤태 events 토파일스 남성불임병원 서울툰 COMEXPOSIUM,in France: SIAL, Foire de Paris, Intermat, SIMA 뒤태 이채영노출영화 and Paris International Agricultural Show.



Customer satisfaction, innovation, growth and development 토파일스 나도이제 and commitment to an eco-friendly approach are 토파일스 한로그 the key commitments 재미있는게임 Customerthe COMEXPOSIUM Group’s products. Each event 쿵쾅닷컴 Customera market leader, facilitating development, highlighting the sector 뒤태 and pre-empting market 야베스트 Customer



*Source: 토파일스 블로그광고비용 analdin *Source:뒤태 8주완성블로그마케팅 2012 뒤태 블로그교육



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