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March 23, 2014
15:44 EDTCELGCelgene releases new research findings on OTEZLA
Celgene Corporation released new research findings on OTEZLA, apremilast, the company’s oral, selective inhibitor of phosphodiesterase 4, PDE4, from the ESTEEM 1 and 2 phase III studies in patients with moderate to severe plaque psoriasis at the 72nd Annual Meeting of the American Academy of Dermatology, AAD, Annual Meeting in Denver, CO. ESTEEM 1 demonstrated a stable mean PASI improvement of 81 to 88% between weeks 32 and 52 for those patients who were treated for 52 weeks with OTEZLA 30 mg BID and who achieved a PASI-75 score at week 32 . These data are consistent with the mean PASI-75 improvement observed between weeks 16 and 32. In the same group of patients, OTEZLA 30 mg BID continued to demonstrate improvements in difficult-to-treat areas affected by plaque psoriasis...In ESTEEM 2, a significantly higher percentage of patients receiving OTEZLA 30 mg BID achieved a PASI-75 response at week 16, primary endpoint, compared with patients who received placebo. Statistical significance at week 16 was also demonstrated for the major secondary endpoint, static Physician Global Assessment, sPGA, score of clear or almost clear. The beneficial effects of OTEZLA on psoriasis in difficult-to-treat areas of scalp, nails, palms and soles were also demonstrated in ESTEEM 2. After 16 weeks of treatment, OTEZLA 30 mg BID demonstrated significantly higher response rates versus placebo for psoriasis affecting the scalp...“Psoriasis of the nails, scalp and palmoplantar regions is very difficult to treat and can be debilitating for individuals dealing with this chronic disease," said Jennifer Cather, MD, Modern Research Associates, Dallas, Texas. “Results from the 52-week analysis of the ESTEEM program suggest that early responses seen with OTEZLA treatment in multiple efficacy endpoints of plaque psoriasis, including difficult to treat areas, are durable over time. Together with the observed long-term consistent safety and tolerability profile, these findings are encouraging.” A separate analysis of long-term safety and tolerability data from ESTEEM 1 identified no new or unexpected adverse events (AEs) for patients treated with OTEZLA compared with results at week 16...No new or unexpected AEs were identified for patients treated with OTEZLA in ESTEEM 2.
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November 21, 2014
06:04 EDTCELGCelgene receives positive CHMP opinion for OTEZLA
Celgene announced that the European Medicines Agency’s, or EMA, Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for OTEZLA, the company’s oral selective inhibitor of phosphodiesterase 4, or PDE4, in two therapeutic indications, 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, or PUVA; alone or in combination with Disease Modifying Antirheumatic Drugs, or DMARD, for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy.
November 19, 2014
09:39 EDTCELGCelgene management to meet with ISI Group
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November 18, 2014
07:34 EDTCELGCelgene presents long-term OTEZLA data at ACR/ARHP meeting
Celgene announced that results from long-term efficacy and safety analyses of OTEZLA from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in Boston. OTEZLA is the Company’s oral, selective inhibitor of phosphodiesterase 4, approved by the U.S. FDA for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. In PALACE 1, 84 percent of patients who completed one year of 30 mg twice daily therapy continued to receive OTEZLA at two years. Improvements in efficacy measures observed at 52 weeks were sustained through 104 weeks of treatment. At week 104, among patients receiving OTEZLA 30 mg twice daily, the ACR20 response rate was 65.3 percent. ACR50 and 70 response rates were 34.0 percent and 19.6 percent, respectively, at week 104. Similar findings were observed in PALACE 4. In this trial, nearly 84 percent of DMARD-naïve patients who completed one year of OTEZLA 30 mg twice daily monotherapy continued to receive OTEZLA at two years. At week 104, among patients treated with OTEZLA 30 mg twice daily monotherapy, an ACR20, 50 and 70 response was reached by 61.4 percent, 40.7 percent and 19.2 percent of patients, respectively. In both PALACE 1 and PALACE 4, changes in other efficacy measures—including the HAQ-DI, which assesses improvements in physical function, and swollen and tender joint counts—were also generally sustained between weeks 52 and 104 with continued OTEZLA treatment. In PALACE 4, treatment with OTEZLA in patients with pre-existing enthesitis or dactylitis, two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.
November 17, 2014
07:16 EDTCELGMilken Institute--Faster Cures to hold a conference
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November 14, 2014
17:07 EDTCELGSoros Fund Management gives quarterly update on stakes
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07:14 EDTCELGAmerican College of Rheumatology is holding a meeting
2014 ACR/ARHP Annual Meeting is being held in Boston on November 14-19.
November 10, 2014
07:19 EDTCELGCredit Suisse to hold a conference
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