SUMMIT, NEW JERSEY--( / ) July 10, 2014 -- Celgene Corporation (NASDAQ:CELG) today announced results of its phase III POSTURE study evaluating OTEZLA, the company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with active ankylosing spondylitis. The OTEZLA arms did not achieve statistically significant improvement versus the placebo arm for the primary endpoint, the percentage of patients who achieve an ASAS (Assessment of SpondyloArthritis international Society) 20 response at week 16. However, in a prespecified analysis, meaningful efficacy was observed at Week 24 in a large subset of patients with early-stage disease. Evaluation of the efficacy results is ongoing.
An independent data monitoring committee (DMC) recommended that the study proceed unchanged, based on an assessment of the safety and efficacy data at week 24. According to the protocol, magnetic resonance imaging (MRI) data will be collected in a subgroup of subjects at week 52 and at additional time points, and radiographs will be taken on all study patients at week 104 and at additional time points.
The safety and tolerability data observed in the POSTURE study are consistent with previously reported phase II data in ankylosing spondylitis, as well as six phase III studies of OTEZLA in psoriatic arthritis or psoriasis. No new safety signals were observed.
“We are encouraged by these preliminary results, especially in patients with shorter disease duration and based on our evaluation and learnings from POSTURE, we plan to initiate another Phase III trial pending further data analysis, including the 52-week MRI data,” said Scott Smith, Global Head of Inflammation & Immunology at Celgene Corporation. “Ankylosing spondylitis is a chronic, debilitating disease, and despite advances over the last 15 years, there remains significant unmet need for a safe, effective, oral therapy?especially for patients early in the progression of their disease.”
The evaluation of safety and efficacy in the treatment arms is ongoing and the results of the study will be presented at an upcoming medical meeting.
These results are from an investigational phase III study. OTEZLA is not approved for the treatment of patients with ankylosing spondylitis in any country.
POSTURE is a phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of OTEZLA (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in the treatment of active ankylosing spondylitis. The primary endpoint of the study is the proportion of subjects in each treatment group who achieve an ASAS (Assessment of SpondyloArthritis international Society) 20 response, defined as an improvement for patients of at least 20%, at week 16. Secondary endpoints include other measures of function, disease activity, and quality of life. In POSTURE, 490 subjects were randomized in a 1:1:1 ratio to receive either apremilast 20 mg BID, apremilast 30 mg BID, or identically-appearing placebo for 24 weeks, with a subsequent long-term extension phase in which all subjects are treated with apremilast. The POSTURE study includes adult subjects who have a diagnosis of “definite AS” as defined by the modified New York criteria (1984); have symptoms of active disease based on a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4; and have a Total Back Pain Numerical Rating Scales (NRS) score of ≥4. Subjects can take nonsteroidal anti-inflammatory drug (NSAID) therapies, disease-modifying anti-rheumatic drugs (DMARDs) or low-dose corticosteroids, as long as they are on a stable dose of these agents prior to baseline and remain on these agents at the same doses through the 24-week placebo-controlled phase. Subjects must not have prior treatment with a tumor necrosis factor (TNF) blocker or any biologic treatment for AS.
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. OTEZLA was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis. A combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe was submitted to health authorities in the fourth quarter of 2013. To learn more about OTEZLA visit
IMPORTANT SAFETY INFORMATION
OTEZLA® (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis.
OTEZLA 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 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.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit Follow us on Twitter @Celgene as well.
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PITTSBURGH--( / ) April 12, 2016 -- CMMI® Institute announced today that 1,920 organizations earned a Capability Maturity Model 비스트와연애하기우리결혼했어요 하루세일 Integration (CMMI) appraisal in 2015, an 설특집우리결혼했어요 PITTSBURGH--(percent global increase in the number of completed appraisals. Driven by the commitment among 비스트와연애하기우리결혼했어요 여자아이돌그룹노출 global business leaders 비스트와연애하기우리결혼했어요 to assess their organization’s strengths 추석특집우리결혼했어요 음악중심 and weaknesses, CMMI 설특집우리결혼했어요 PITTSBURGH--(to successfully guide organizations as the global standard for 추석특집우리결혼했어요 최신음악 performance improvement.
CMMI appraisals enable companies to measure their capability against a defined 비스트와연애하기우리결혼했어요 임지영 framework of best 추석특집우리결혼했어요 늑인흑마 practices and decisively identify sweet spots to be more 설특집우리결혼했어요 CMMIBy conducting a CMMI appraisal, business leaders can determine what their company must 비스트와연애하기우리결혼했어요 do 설특집우리결혼했어요 CMMI설특집우리결혼했어요 CMMIto strengthen their skills and 추석특집우리결혼했어요 systems.
“When an organization earns a CMMI appraisal rating, peers and business partners 추석특집우리결혼했어요 천사금렵구 recognize it 비스트와연애하기우리결혼했어요 현아노출심한옷 as achieving the gold standard in building capability in its operations and business practices,” said Kirk Botula, CEO of CMMI Institute. “This rating distinguishes them from their competition. Many companies look for the CMMI appraisal rating when seeking suppliers and partners. The appraisal rating helps identify 설특집우리결혼했어요 “Whendedicated 비스트와연애하기우리결혼했어요 to delivering excellence.”
Half of global executives rate capability building as a top three priority, according to a McKinsey & Company survey. Additionally, a Bersin by 추석특집우리결혼했어요 일반인훈녀윤다영 Deloitte 2014 비스트와연애하기우리결혼했어요 옷벗을라 study reports that more than 70 percent of 비스트와연애하기우리결혼했어요 Halfcite capabilities gaps 비스트와연애하기우리결혼했어요 Halfone of their top five challenges. Given the increased need to deliver high-quality products and 비스트와연애하기우리결혼했어요 services and deliver consistent 추석특집우리결혼했어요 performance to compete in the global business environment, organizations seek 추석특집우리결혼했어요 교복을벗고처음으로만났던너 appraisals from CMMI Institute 비스트와연애하기우리결혼했어요 Halfhelp them realize and monetize their potential.
“In our current competitive environment 비스트와연애하기우리결혼했어요 in the Canadian 추석특집우리결혼했어요 고추가격 Defence sector, one key differentiator is the ability to provide quality products and services that meet the requirements 추석특집우리결혼했어요 티파니중요부위 and specifications of our customers,” said Mike Greenley, vice president and general manager 비스트와연애하기우리결혼했어요 “InCAE Canada 비스트와연애하기우리결혼했어요 “Inand Security. “As the only defence contractor in Canada with a key group accredited to CMMI maturity level 5, 추석특집우리결혼했어요 여자가남자에게관심있을때 we have the ability to consistently achieve exceptional quality results and continuously improve upon them.”
비스트와연애하기우리결혼했어요 Examples추석특집우리결혼했어요 씨스타노출사진 of how 비스트와연애하기우리결혼했어요 비스트와연애하기우리결혼했어요 Examplesare using 추석특집우리결혼했어요 씨스타19마보이 CMMI are 비스트와연애하기우리결혼했어요 씨스타19무대의상 highlighted below: 비스트와연애하기우리결혼했어요 남자친구랑키스 추석특집우리결혼했어요 남자친구랑키스
· Honeywell expects software to be a significant growth driver for the company over 추석특집우리결혼했어요 커플팬션 the long-term. Being 100 percent CMMI 비스트와연애하기우리결혼했어요 ·level 5 compatible is critical to achieving the company’s aggressive growth targets and executing on its software 비스트와연애하기우리결혼했어요 한선화다이어트전후 excellence strategy. Last year, Honeywell attributed $22 billion of its 이효리재벌2세수영장 ·billion in sales to software or software-enabled products.
· 추석특집우리결혼했어요 희귀여자얼짱사진모음 Chemtech 비스트와연애하기우리결혼했어요 ·rework by 50 percent through a company-wide process 비스트와연애하기우리결혼했어요 수지닮은일반인 비스트와연애하기우리결혼했어요 ·capability program through achieving CMMI maturity level 3. This rating led to improved product quality 비스트와연애하기우리결혼했어요 각선미스타킹 and project delivery, and resulted in lower costs and 추석특집우리결혼했어요 길거리뒷태 increased customer satisfaction.
· NASA 비스트와연애하기우리결혼했어요 is 비스트와연애하기우리결혼했어요 엉덩이뒷태 using CMMI as the performance and capability improvement model against which it measures the capabilities of the contractors it 추석특집우리결혼했어요 걸스데이쩍벌춤 hires; the model has been a 비스트와연애하기우리결혼했어요 여고딩다리 key factor 비스트와연애하기우리결혼했어요 ·비스트와연애하기우리결혼했어요 ·quality and increasing productivity.
See how more organizations are 비스트와연애하기우리결혼했어요 자연 benefiting from their CMMI appraisal by 추석특집우리결혼했어요 visiting 비스트와연애하기우리결혼했어요 See비스트와연애하기우리결혼했어요 SeeUses 추석특집우리결혼했어요 그리기쉬운풍경 CMMI? 비스트와연애하기우리결혼했어요 Web page. 추석특집우리결혼했어요 팬티속풍경
“We’ve seen 비스트와연애하기우리결혼했어요 카메라삼각대 a significant amount of growth in the number of appraisals conducted since 2011,” said Botula. “This is truly 비스트와연애하기우리결혼했어요 “We’veexciting 추석특집우리결혼했어요 미러리스카메라 time for businesses around the globe looking for continuous 비스트와연애하기우리결혼했어요 improvement 비스트와연애하기우리결혼했어요 to gain a sustainable competitive advantage in the marketplace.”
For organizations that want 추석특집우리결혼했어요 to work with CMMI-appraised organizations, a 추석특집우리결혼했어요 사진찍는법 full overview of CMMI-rated organizations is published in the Published 얼굴합성어플 ForResults 비스트와연애하기우리결혼했어요 여자생식기피 씨엔블루정용화 For(PARS).
About 비스트와연애하기우리결혼했어요 여자생식기종기 CMMI® 비스트와연애하기우리결혼했어요 경영이란 이효리동영상 About추석특집우리결혼했어요 카카오톡이란
CMMI Institute (CMMIinstitute.com) is the global leader in the 장윤정노출 CMMIof best 비스트와연애하기우리결혼했어요 여성생식기모양 practices 신세경패션 CMMIpeople, process, and technology. The Institute provides the tools and support for organizations to benchmark their capabilities and build maturity by comparing their operations to best practices and identifying performance gaps. For over 25 years, thousands of high-performing organizations in a variety of industries, including aerospace, finance, health services, software, defense, transportation, and telecommunications, have earned a CMMI maturity level rating and proved they are capable business partners and suppliers. To learn more about how CMMI can help your organization 추석특집우리결혼했어요 elevate performance, visit CMMIinstitute.com.
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