Business Wire

One Year Data from Phase III Study Evaluating Oral OTEZLA® (apremilast) or Injectable etanercept versus Placebo in Patients with Moderate to Severe Plaque Psoriasis Presented at EADV

Del

Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that results from its ongoing phase III LIBERATEtrial evaluating Otezla® (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate to severe plaque psoriasis were presented as a late-breaker at the 24th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark, October 7-11, 2015.

“Many patients with moderate to severe plaque psoriasis need treatment options that can help in managing multiple facets of the disease, including itching and impact on disease-related quality of life,” said Kristian Reich, M.D., SCIderm Research Institute and Dermatologikum Hamburg, Germany. “The encouraging findings presented at EADV add to the growing body of data which suggest that treatment benefits observed with OTEZLA at week 16 are maintained through week 52 of treatment.”

The LIBERATE study evaluated the clinical efficacy and safety of either oral OTEZLA 30 mg twice daily or weekly subcutaneous (SC) etanercept 50 mg compared with placebo at week 16 in 250 patients who had no prior exposure to a biological therapy. It also examined the relative safety of a switch from etanercept to OTEZLA after week 16 during an open label extension phase. Primary findings were previously presented at the 73rd Annual Meeting of the American Academy of Dermatology (AAD) in San Francisco, California. LIBERATE was not designed or powered to directly compare OTEZLA to etanercept.

As shown at AAD, at week 16, 40 percent (33/83) of patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvements compared with 12 percent (10/84) of patients on placebo in the primary endpoint, Psoriasis Area and Severity Index (PASI)-75 response (P<0.0001). Statistical significance was also achieved for patients receiving weekly injections of etanercept 50 mg compared with placebo [48 percent (n=40/83) vs. 12 percent (n=10/84), respectively, P<0.0001].

New findings presented at EADV showed that 51 percent (42/83) of patients randomized to OTEZLA at baseline and 55 percent of patients who switched from etanercept to OTEZLA at week 15 (46/83) achieved PASI-75 at week 52.

Based on an exploratory analysis, OTEZLA also improved pruritus (itching), one of the most common and bothersome symptoms of psoriasis, as measured by a visual analog scale (0 mm=no itch at all; 100 mm=worst itch imaginable). Significantly greater improvements in itching scores were seen at week 16 for patients treated with OTEZLA 30 mg twice daily (decrease of 38 mm; 95% confidence interval [CI]: -45 to -31 mm) compared with placebo (decrease of 26 mm; CI: -34 to -19 mm). Improvement in pruritus was observed as early as week 2 in patients receiving OTEZLA. Lower itching scores were also observed in patients who received weekly injections of etanercept 50 mg from baseline to week 16.

Improvements in itching were maintained from week 16 to week 52 (decrease of 36 mm) in patients who received OTEZLA from baseline and in patients who switched from etanercept to OTEZLA at week 16 (decrease of 35 mm).

Treatment with OTEZLA 30 mg twice daily also significantly improved disease-related quality of life (a secondary endpoint) at week 16 compared with placebo. OTEZLA showed a mean improvement from baseline in total Dermatology Life Quality Index (DLQI) score (decrease of 8.7; CI: -10.5 to -6.9) vs. placebo (decrease of 4.9; CI: -6.1 to -3.7) at week 16. A decrease in total DLQI scores was also observed for patients who received weekly injections of etanercept 50 mg from baseline to week 16.

Total DLQI scores were maintained from week 16 to week 52 in patients who received OTEZLA from baseline (decrease of 8.9; CI: -10.8 to -7.0) and in patients who switched from etanercept to OTEZLA at week 16 (decrease of 8.0; CI: -9.7 to -6.4).

The safety and tolerability data for OTEZLA observed in the LIBERATE study were generally consistent with previously reported data from six other phase III studies of OTEZLA in psoriasis or psoriatic arthritis; no new safety signals were observed. Adverse events reported in at least five percent of patients taking OTEZLA in the LIBERATE study were diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, headache and tension headache. No new safety or tolerability issues were observed through week 52 in patients who switched from etanercept to OTEZLA at week 16.

The LIBERATE study is ongoing.

The views expressed and the techniques presented by the speakers at the 24 th EADV Congress in Copenhagen, Denmark are not necessarily shared or endorsed by the European Academy of Dermatology and Venereology.

About LIBERATE

LIBERATE (PSOR-010; EvaLuatIon from a PlaceBo-controllEd Study of ORal ApremilasT and Etanercept in Plaque Psoriasis) is a phase IIIb, 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, as compared with OTEZLA dosed since week 0, after week 16. 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 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 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 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, 1.0% (10/998) of patients treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo; 0.3% (4/1441) of patients treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated patients (0/495). Depression was reported as serious in 0.2% (3/1441) of patients exposed to OTEZLA, compared to none in placebo treated patients (0/495). Suicidal ideation and behavior were observed in 0.2% (3/1441) of patients on OTEZLA, compared to none on placebo (0/495). Two patients who received placebo committed suicide compared to none on OTEZLA.

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% was reported in 10% of patients taking OTEZLA and in 3.3% of patients taking 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 (eg, rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended.

Adverse Reactions

Adverse reactions reported in at least 2% of patients taking OTEZLA, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (OTEZLA%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2).

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 Psoriasis

Psoriasis is an immune-mediated, non-contagious chronic inflammatory skin disorder of unknown cause. The disorder is a chronic recurring condition which varies in severity from minor localized patches to complete body coverage. Plaque psoriasis is the most common type of psoriasis. About 80 percent of people who develop psoriasis have plaque psoriasis, which appears as patches of raised, reddish skin covered by silvery-white scales. These patches, or plaques, frequently form on the elbows, knees, lower back, and scalp. Psoriasis occurs nearly equally in males and females. An estimated 125 million people worldwide have psoriasis. To learn more about the role of PDE4 in inflammatory diseases, go to www.discoverpde4.com.

About Celgene

Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. 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 gene and protein regulation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn and YouTube.

OTEZLA® is a registered trademark and LIBERATE™ is a trademark of Celgene Corporation. All other trademarks are the property of their respective owners.

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, please contact:
Celgene Corporation
Investors:
Patrick E. Flanigan III
Vice President, Investor Relations
908-673-9969
or
Media:
Catherine Cantone
Director, Corporate Communications
732-564-3592

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

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

The New Foldable Smartphone ZTE Axon M with Dual Screens Transforms the Mobile Experience for Consumers17.10.2017 14:40Pressemelding

ZTE Mobile Devices today announced the category defining ZTE Axon M, a foldable smartphone with dual screens that delivers a revolutionary smartphone experience to enable consumers to multitask and enjoy content in a better way. The ZTE Axon M provides the multitasking capabilities of two screens and a viewable screen size of a tablet, yet is the size of a traditional smartphone when folded, fitting easily into a pocket. Coming soon to consumers through leading partners in the US, Japan, China and Europe, the ZTE Axon M delivers new experiences never before seen in the smartphone market. “The ZTE Axon M is the beginning of true smartphone innovation, and ZTE is leading the way,” said Lixin Cheng, CEO of ZTE Mobile Devices. “The mobile technology ecosystem and consumer habits have evolved over the past several years, but the smartphone design has only slightly varied throughout that tim

Murex to Offer Cloud-Based Trading and Risk Management Solutions17.10.2017 14:00Pressemelding

Sibos - Murex, an industry leader in trading, risk management and processing solutions for capital markets, announces it has certified its MX.3 technology platform to run on Microsoft Azure. Since early 2016, Murex has collaborated with Microsoft to bring to market solutions enabling clients’ digital transformation. This collaboration has now come to fruition with the availability of support for the Murex MX.3 platform on Azure, as well as the planned integration of Microsoft SQL Server 2016 as a relational database for MX.3. Murex has certified Azure for its most demanding use cases including GPU-powered solutions for computationally intensive workloads. This enables Murex clients to leverage the flexibility and economies of scale of the cloud to meet new requirements. Those opting to adopt cloud as part of their infrastructure will continue to benefit from the full support

euNetworks Partners with Cloudwirx17.10.2017 14:00Pressemelding

euNetworks, a provider of bandwidth services in Europe, today announced it is working with Cloudwirx, enabling their West Coast client base with rapid access to euNetworks high bandwidth services. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171017006083/en/ Brady Rafuse, Chief Executive Officer of euNetworks (Photo: Business Wire) Cloudwirx is a leading procurement and systems integrator for data centre and bandwidth infrastructure services, helping companies source, build and optimise their IT systems and networks. Whether it’s for a start-up or Fortune 100 company, Cloudwirx matches enterprises with the right technologies, services, and suppliers, with the goal of decreasing costs while increasing the value add of their IT systems. They have a growing client base who, while predominantly U

Asseco SEE’s Enterprise Fraud Monitoring & Prevention Solution InACT® is in GarantiBank NV17.10.2017 13:59Pressemelding

Asseco SEE (ASEE), part of Asseco Group, 6th largest software vendor in Europe, announced today, that GarantiBank NV, member of BBVA Group, has deployed InACT® Enterprise Fraud Management to prevent and monitor fraud. Chosen by leading international banks and financial institutions to stop internal and external fraud activities since 2009, an additional tailor-made file management module has been developed for GarantiBank NV to manage SWIFT and SEPA transactions for the project. InACT® File Management Module checks and resolves SWIFT and SEPA message files regularly and filters through InACT® fraud scenarios. Also, InACT® produces alarms for managers to prevent fraudulent activities by identifying related files. With this infrastructure developed by ASEE, GarantiBank NV intends to enhance its fraud monitoring activities on a digital platform rather than manual controls. This change is

Andersen Global Announces Expansion into Ecuador17.10.2017 13:30Pressemelding

Andersen Global is proud to announce a new presence in Ecuador through a Collaboration Agreement with two leading tax advisory firms, FIDESBURó Cia. Ltda. and PROFILE Cia. Ltda. These firms, currently completing a merger to become FidesProfile, are an important addition in expanding Andersen Global’s platform in South America to provide seamless service and solutions of the highest quality to clients around the world. PROFILE is led by Partners Mauricio Durango and Jorge David Uribe. Mauricio and Jorge commented, “Andersen Global’s strategy of focusing on tax and legal services is consistent with the standards of independence and transparency that should govern professional ethics. We are very excited to be part of this process and collaborate in the continuing expansion of Andersen Global.” PROFILE has been a leading firm in Ecuador for twenty years, with headquarters in Qu

CyberOptics Demonstrates New MRS-Enabled AOI, SPI and CMM Solutions at productronica Germany17.10.2017 13:00Pressemelding

CyberOptics® Corporation (NASDAQ:CYBE), a leading global developer and manufacturer of high-precision 3D sensing technology solutions, will demonstrate the SQ3000™-DD 3D Automated Optical Inspection (AOI) system with the new Ultra-High Resolution Multiple-Reflection Suppression (MRS) Sensors in Hall A4, Stand 239 at productronica 2017, scheduled to take place Nov. 14 – 17, 2017 at the Messe München in Germany. The company also will unveil the new SE3000™ 3D SPI and SQ3000™ 3D CMM, both powered by MRS technology. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171017005732/en/ CyberOptics SQ3000-DD AOI System (Photo: Business Wire) The new SQ3000-DD 3D AOI dual lane, dual sensor system maximizes flexibility catering to varying PCB widths. This unique design provides the ability to inspect

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom