Business Wire

Oral OTEZLA® (apremilast) Data from Open-Label Phase of ESTEEM and LIBERATE™ Trials to Be Presented at American Academy of Dermatology Congress

Del

Celgene Corporation (NASDAQ:CELG) today announced that findings from ongoing clinical trials of OTEZLA® (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate to severe plaque psoriasis and patients with active psoriatic arthritis will be presented at the 74th Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC. Nine abstracts will be presented, including findings on safety and selected efficacy measures from the open-label phase of these trials. Cost-effectiveness data of OTEZLA in patients with moderate to severe plaque psoriasis will also be shown at the meeting.

The abstracts include an analysis of pooled 182-week (3.5-year) data collected from patients in ESTEEM 1 and 2 who were initially treated with OTEZLA 30 mg twice daily for a duration up to 182 weeks. This study will be summarized in the AAD “Pearls from the Posters” symposium session.

Data from the LIBERATE study will assess the 52-week (one year) effect of either sustained treatment with oral OTEZLA 30 mg twice daily or of switching at week 16 from weekly subcutaneous etanercept 50 mg to OTEZLA 30 mg in patients with moderate to severe plaque psoriasis. Additional one year results from the LIBERATE study will be presented, including effect on difficult-to-treat areas (scalp and nails), pruritus (itching) and Dermatology Quality-of-Life Index scores, as well as a cost-per-responder analysis of 16 weeks of treatment. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.

“Celgene looks forward to sharing additional data with the scientific community that relates to the safety of long-term exposure of OTEZLA in patients with moderate to severe plaque psoriasis or psoriatic arthritis,” said Scott Smith, President, Celgene Inflammation & Immunology. “Celgene’s strong presence at this year’s congress, and the maturation of data from OTEZLA clinical trials presented there, underscore our continued commitment to the dermatology community and to providing these patients with an oral non-biologic treatment option.”

The following abstracts will be presented at American Academy of Dermatology as an exchange of scientific and clinical information (all times, EST):

Abstracts at a Glance

Abstract 2585; Sunday, March 6, 2016, 11:15 - 11:20 AM

Effect of Apremilast and Etanercept on Pruritus and Health-Related Quality of Life in Patients With Moderate to Severe Plaque Psoriasis: Results From the LIBERATE Study; Lawrence Green

Location: E-Poster Presentation Center 3
 
Abstract 2586; Sunday, March 6, 2016, 2:30 - 2:35 PM
Long-term Safety and Tolerability of Apremilast in Patients With Moderate to Severe Psoriasis: Results From the LIBERATE Study; Jeff Crowley
Location: E-Poster Presentation Center 3
 
Abstract 2625; Monday, March 7, 2016, 10:10 - 10:15 AM
Sustained Efficacy of Apremilast in Patients With Moderate to Severe Psoriasis Who Continued on Apremilast or Switched From Etanercept Treatment: 52-Week Results From the LIBERATE Study; Kristian Reich
Location: E-Poster Presentation Center 1
 
Abstract 2626; Monday, March 7, 2016, 10:15 - 10:20 AM
Sustained Efficacy With Apremilast in Patients With Nail and Scalp Psoriasis Who Switched From Etanercept or Continued Apremilast Treatment: 52-Week Results From the LIBERATE Study; Melinda Gooderham
Location: E-Poster Presentation Center 1
 
Abstract 2347; Monday, March 7, 2016, 8:05 - 8:10 AM
Safety and Tolerability of Apremilast Up to 182 Weeks: Pooled Analyses From Phase 3 Clinical Trials; Kim Papp
Location: E-Poster Presentation Center 1
 
Abstract 3043; Sunday, March 6, 2016, 10:25 - 10:30 AM
Cost per Responder of Apremilast and Etanercept in Patients With Moderate to Severe Plaque Psoriasis Using Results From LIBERATE; Tom Tencer
Location: E-Poster Presentation Center 3
 
Abstract 3092; Sunday, March 6, 2016, 10:30 - 10:35 AM
Cost-Effectiveness of Apremilast in Moderate to Severe Psoriasis in the UK; Farhan Mughal
Location: E-Poster Presentation Center 3
 
Abstract 3118; Sunday, March 6, 2016, 11:55 - 12:00 PM
Efficacy of Long-term (104-Week) Treatment With Apremilast in Patients With Psoriatic Arthritis: Results From a Phase III, Randomized, Controlled Trial and Open-Label Extension; Jeffrey Crowley
Location: E-Poster Presentation Center 3
 
Abstract 3447; Sunday, March 6, 2016, 11:30 - 11:35 AM
Efficacy and Safety of Apremilast With or Without Topical or Phototherapy: Sub-analysis of the Population With <PASI-75 in the ESTEEM 1 Phase 3, Randomized, Controlled Trial in Patients With Moderate to Severe Plaque Psoriasis; Kristian Reich
Location: E-Poster Presentation Center 3
 

About ESTEEM

ESTEEM 1 and 2 are two large pivotal phase 3 randomized, placebo-controlled studies evaluating OTEZLA in patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy. Approximately 1,250 patients were randomized 2:1 to receive either OTEZLA 30 mg twice daily or placebo after an initial five-day titration period, for the first 16 weeks, followed by a maintenance phase from weeks 16-32 in which placebo patients were switched to OTEZLA 30 mg twice daily through week 32, and a randomized withdrawal phase for responders from week 32 to week 52 based on their initial OTEZLA randomization and Psoriasis Area and Severity Index (PASI)-75 response (ESTEEM 1) or (PASI)-50 (ESTEEM 2). A 5-year extension study of ESTEEM 1 and 2 is ongoing.

About LIBERATE™

LIBERATE (PSOR-010; EvaLuatIon from a PlaceBo-controllEd Study of ORal ApremilasT and Etanercept in Plaque Psoriasis) is a phase 3b, multicenter, randomized, placebo-controlled, double-blind, double-dummy study of the efficacy and safety of OTEZLA, etanercept and placebo, in subjects with moderate to severe plaque psoriasis. The primary objective of the LIBERATE study was to evaluate the clinical efficacy and safety of oral OTEZLA 30 mg twice daily compared with placebo at week 16. Secondary objectives of the study included: the evaluation of the clinical efficacy and safety of etanercept 50 mg SC once weekly (QW) compared with placebo at week 16, and the evaluation of the relative safety of a crossover from etanercept to OTEZLA 30 mg twice daily after week 16, as compared with OTEZLA dosed since week 0. Subjects were required to have inadequate response, intolerance or contraindication to at least one conventional systemic agent and no prior exposure to biologics. The study enrolled 250 subjects who were randomized 1:1:1 to receive OTEZLA 30 mg twice daily, etanercept 50 mg QW or placebo, for 16 weeks. Following the first 16 weeks, all subjects were switched to (or continued on) OTEZLA 30 mg twice daily through week 104. The primary endpoint was the proportion of subjects with either OTEZLA 30 mg twice daily or placebo who achieved PASI-75 at week 16. Secondary endpoints included other measures of disease activity and quality of life for the comparison of OTEZLA 30 mg twice daily versus placebo and the comparison of etanercept 50 mg SC QW versus placebo.

About OTEZLA

OTEZLA is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients with psoriasis or psoriatic arthritis is not well defined.

OTEZLA is approved:

  • In the U.S.:
    • For the treatment of adults with active psoriatic arthritis
    • For the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
  • In the European Union:
    • For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA)
    • Alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy
  • In Switzerland:
    • For the treatment of adult patients with moderate to severe plaque psoriasis who have not responded to another systemic therapy or do not tolerate such therapy or where such therapy is contraindicated
    • As monotherapy or in combination with disease-modifying anti-rheumatic drugs (DMARDs) for the treatment of active psoriatic arthritis in adults who have not responded to a previous DMARD therapy, who have not tolerated it, or where DMARD therapy is contraindicated
  • In Canada:
    • For the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
    • For the treatment of active psoriatic arthritis, alone or in combination with methotrexate, in adult patients who have had an inadequate response, intolerance or contraindication to a prior disease-modifying anti-rheumatic drug (DMARD)
  • In Australia:
    • For the treatment of signs and symptoms of active psoriatic arthritis in adult patients
    • For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy

Important Safety Information (based on US labeling)

Contraindications

Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.

Warnings and Precautions

Depression: Treatment with OTEZLA is associated with an increase in adverse reactions of depression. During clinical trials, 1.3% (12/920) of patients treated with OTEZLA reported depression compared to 0.4% (2/506) on placebo; 0.1% (1/1308) of OTEZLA patients discontinued treatment due to depression compared with none on placebo (0/506). Depression was reported as serious in 0.1% (1/1308) of patients exposed to OTEZLA, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on OTEZLA, compared to 0.2% (1/506) on placebo. One patient treated with OTEZLA attempted suicide; one patient on placebo committed suicide.

Carefully weigh the risks and benefits of treatment with OTEZLA for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on OTEZLA. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur.

Weight Decrease: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with OTEZLA and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with OTEZLA compared to 1% (3/382) of patients treated with placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of OTEZLA.

Drug Interactions: Apremilast exposure was decreased when OTEZLA was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of OTEZLA efficacy may occur. Concomitant use of OTEZLA with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.

Adverse Reactions

Adverse reactions reported in ≥5% of patients were (OTEZLA%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4).

Use in Specific Populations

Pregnancy and Nursing Mothers: OTEZLA is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when OTEZLA is administered to a nursing woman.

Renal Impairment: OTEZLA dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information.

Please click here for Full Prescribing Information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical 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: @CelgenePinterestLinkedInFaceBook 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. Celgene Corporation undertakes 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 Celgene’s 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 Celgene’s Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission.

Contact information

For inquiries:
Celgene Corporation
Investors:
Patrick E. Flanigan III, 908-673-9969
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

AURAK Enters into a Memorandum of Understanding with Al-Farabi Kazakh National University22.7.2018 09:52Pressemelding

The American University of Ras Al Khaimah (AURAK) President, Professor Hassan Hamdan Al Alkim, and the Al-Farabi Kazakh National University (KazNU) Rector, Professor Galimkair Mutanov, of the Republic of Kazakhstan, signed a Memorandum of Understanding (MoU), agreeing to exchange students, faculty, and research. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180722005025/en/ The Al-Farabi Kazakh National University (KazNU) Rector, Professor Galimkair Mutanov, of the Republic of Kazakhstan and the American University of Ras Al Khaimah (AURAK) President, Professor Hassan Hamdan Al Alkim, exchange a gift to commemorate their universities uniting in an MoU agreement. (Photo: AETOSWire) In the spirit of fostering a close international relationship between the Republic of Kazakhstan and the United Arab Emirates, developing bilateral relations in educational and scientific fields, and wishing to make their own contributions to the

Philip Morris International Announces Non-Executive Board Chairman Louis Camilleri to Assume CEO Role at Ferrari S.p.A.21.7.2018 18:19Pressemelding

The board of directors of Philip Morris International (NYSE:PM) has its board member, Sergio Marchionne, and his family in our thoughts and prayers during this challenging time. We congratulate our board chairman, Louis Camilleri, as he assumes the role of CEO of Ferrari S.p.A. The long term relationship between our two companies is deep and meaningful and we look forward to continued business collaboration. Mr. Camilleri will continue to serve as non-executive chairman of the PMI board. Philip Morris International: Who We Are We are a leading international tobacco company engaged in the manufacture and sale of cigarettes and other nicotine-containing products in markets outside the United States of America. We’re building our future on smoke-free products. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, we aim to ensure that our smoke-free products meet adult consumer preferences and rigorous regulatory requirem

Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 14:51Pressemelding

Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW

Schlumberger Announces Second-Quarter 2018 Results20.7.2018 11:00Pressemelding

Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro

H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 19:50Pressemelding

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&

SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 16:01Pressemelding

We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact investor.relations@sig.biz . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough investor.relations@sig.biz