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celgene corp (CELG) Details

Celgene Corporation, a biopharmaceutical company, discovers, develops, and commercializes therapies to treat cancer and immune-inflammatory related diseases in the United States and internationally. The company’s commercial stage products include REVLIMID, an oral immunomodulatory drug for the treatment of multiple myeloma, myelodysplastic syndromes (MDS), and mantle cell lymphoma; VIDAZA, a pyrimidine nucleoside analog to treat intermediate-2 and high-risk MDS, and chronic myelomonocytic leukemia, as well as acute myeloid leukemia (AML); ABRAXANE, a solvent-free chemotherapy product for the treatment of breast, non-small cell lung, pancreatic, and gastric cancers; and POMALYST/IMNOVID for the treatment of multiple myeloma. Its commercial stage products also comprise THALOMID for the patients with multiple myeloma and for the acute treatment of the cutaneous manifestations of erythema nodosum leprosum; ISTODAX to treat cutaneous T-cell lymphoma; and FOCALIN, FOCALIN XR, and RITALIN LA products. The company’s pre clinical and clinical stage products consist of OTEZLA for the treatment of psoriatic arthritis, psoriasis, and ankylosing spondylitis; CC-122 and CC-220 to treat hematological and solid tumor cancers; cellular therapies, such as PDA-001 and PDA-002 for Crohn’s and peripheral arterial diseases; CC-486, to treat MDS, AML, and solid tumors; Sotatercept and ACE-536 for the treatment of anemia in patients with rare blood disorders; CC-223 and CC-115 for lymphomas, hepatocellular, and prostate cancers; and CC-292 for the treatment of chronic lymphocytic leukemia and lymphomas. It has strategic drug discovery collaboration with Abide Therapeutics to enhance the treatment paradigm for patients with immune disorders; strategic collaboration with Sutro Biopharma, Inc. to discover and develop antibodies and antibody drug conjugates; and strategic alliance with Forma Therapeutics. Celgene Corporation was founded in 1980 and is headquartered in Summit, New Jersey.

5,100 Employees
Last Reported Date: 02/13/14
Founded in 1980

celgene corp (CELG) Top Compensated Officers

Chairman, Chief Executive Officer and Chairma...
Total Annual Compensation: $1.3M
President and Chief Operating Officer
Total Annual Compensation: $666.7K
Chief Executive Officer of Celgene Cellular T...
Total Annual Compensation: $645.8K
President of Global Hematology and Oncology
Total Annual Compensation: $753.3K
President of Research and Early Development ...
Total Annual Compensation: $645.8K
Compensation as of Fiscal Year 2013.

celgene corp (CELG) Key Developments

Celgene Corporation Announces Data from Two Sub-Group Analyses from AML-001, its Phase III Study of VIDAZA

Celgene Corporation announced that data from two sub-group analyses from AML-001, its phase III study of VIDAZA (azacitidine for injection) compared with conventional care regimens (CCR) in elderly subjects with newly diagnosed acute myeloid leukemia (AML, >30% blasts), were presented at the American Society of Hematology annual meeting. In this global, multi-center, randomized, open-label pivotal study, patients at least 65 years old with newly diagnosed or secondary AML with >30% bone marrow blasts were pre-selected to receive one of three regimens per investigator’s choice: intensive chemotherapy (IC; standard 7+3 regimen), low-dose Ara-C (LDAC; 20 mg SC twice per day for 10 days of each 28-day cycle) or best supportive care (BSC) only. Patients were then randomized to receive either azacitidine (n=241) (75 mg/m2/d SC for 7 days of each 28-day cycle) or their predetermined CCR (n=247). The sub-analyses were not powered to detect statistically significant differences. In the first sub-analysis, Prof. Hervé Dombret reported results from the study focused on patients with AML with morphologic dysplastic changes (AML-MDC). Of 488 patients in the AML-001 study, 158 (32.4%) had AML-MDC. In these patients, the median overall survival (OS) was twice as long in patients who received azacitidine compared with those who received CCR (12.7 months [95% CI, 7.2, 14.1] vs. 6.3 months [95% CI, 4.3, 9.6] [HR 0.69, 0.48, 0.98, p=0.0357]). The one-year survival rate for patients receiving azacitidine was also higher compared with CCR (50.7% vs. 33.8%; 95% CI, 1.5, 32.2). Rates of patients achieving a complete remission plus morphological complete response with incomplete blood count were 26.7% with azacitidine compared with 19.3% with CCR. For patients with AML-MDC who were pre-selected to receive LDAC before randomization to azacitidine or CCR (azacitidine n=49, LDAC n=50), median OS was 13.2 months with azacitidine vs. 6.3 months in the LDAC group (HR=0.76, 95% CI, 0.49, 1.19; p=0.23). The one-year survival rate with azacitidine was 55% vs. 31% with LDAC (95% CI, 5.0, 43.0). Grade 3-4 adverse event rates included: anemia (azacitidine 12%; IC 15%; LDAC 16%; BSC 6%), neutropenia (azacitidine 30%; IC 46%, LDAC 29%; BSC 11%), febrile neutropenia (azacitidine 30%; IC 39%; LDAC 35%; BSC 44%) and thrombocytopenia (azacitidine 28%; IC 31%; LDAC 27%; BSC 11%). In the second sub-analysis, patients were stratified by cytogenetic risk into either poor-risk (n=170) or intermediate-risk (n=315), which includes cytogenetic normal (CN) patients (n=218). Median OS (95% CI) in poor-risk patients was significantly prolonged with azacitidine vs. CCR (6.4 months [4.2, 8.1] vs. 3.2 months [2.2, 4.7], respectively; HR=0.68 [0.50, 0.94], p=0.019). In intermediate-risk patients, median OS was 13.0 months (11.2, 16.3) with azacitidine vs. 10.1 months (7.1, 13.3) with CCR (HR=0.90 [0.70, 1.16], p=0.41). The median OS in the CN subgroup was 14.1 months (12.6, 19.5) vs. 10.0 months (6.4, 13.3), respectively (HR=0.81 [0.59, 1.10], p=0.18). Estimated one-year survival was higher with azacitidine compared with CCR in all cytogenetic risk subgroups.Twice the proportion of azacitidine-treated patients in the poor-risk subgroup were alive at one year compared with CCR patients (30.9% vs 14.0%, respectively; 95% CI, 4.4, 29.5). In the CN subgroup, 60.7% vs. 44.1% of patients were alive at one year in the azacitidine and CCR groups, respectively. The effect on one-year survival in the INT-risk subgroup was also favorable (55.2% for azacitidine vs. 45.5% with CCR). Grade 3-4 events included: anemia (azacitidine 16%; BSC 5%, LDAC 23%, IC 14%), neutropenia (azacitidine 26%; BSC 5%, LDAC 25%, IC 33%), febrile neutropenia (azacitidine 28%; BSC 28%, LDAC 30%, IC 31%), and thrombocytopenia (azacitidine 24%; BSC 5%, LDAC 28%, IC 21%).

Celgene Corporation Announces Results Presented from Multiple Post-Hoc Analyses of its Pivotal Phase III FIRSTTM (MM-020/IFM 07-01) Trial

Celgene Corporation announced that results were presented from multiple post-hoc analyses of its pivotal phase III FIRSTTM (MM-020/IFM 07-01) trial, comparing continuous REVLIMID® (lenalidomide) plus low-dose dexamethasone (continuous Rd) to a fixed duration of 18 cycles of Rd (Rd18) or 12 cycles of melphalan, prednisone and thalidomide (MPT) for the treatment of newly diagnosed, transplant-ineligible multiple myeloma. The studies were presented during the 56th American Society of Hematology (ASH) annual meeting. As previously reported, the study met the primary endpoint of progression-free survival (PFS) in the intent-to-treat analysis of all randomized patients (Median PFS 21.2 months MPT vs 25.5 months Rd, Hazard Ratio (HR) 0.72, p<0.01). In one analysis, the authors examined the impact of age (75 years or younger vs. over 75 years) on PFS and secondary endpoints. Overall, 35% of patients were over 75 years of age. PFS and overall survival (OS) outcomes favored continuous Rd over MPT and over Rd18 in both age groups. In addition, response rates were higher with continuous RD vs MPT and duration of response was longer in the continuous Rd arm compared to MPT in both age groups. Additionally, an analysis of patients with renal impairment (RI) was presented. In the study, 24% had normal renal function (creatinine clearance [CrCl] = 80 mL/min), 44% presented with mild RI (CrCl = 50 and < 80 mL/min), 23% had moderate RI (CrCl = 30 and < 50 mL/min), and 9% had severe RI (CrCl < 30 mL/min). Patients requiring dialysis were excluded. The starting doses of lenalidomide (25 mg for pts with normal renal function or mild RI, 10 mg QD for moderate RI, and 15 mg every other day for severe RI) in the Rd arms and of melphalan (reduced by 50% in patients with moderate or severe RI) in the MPT arm were adjusted for patients with CrCl < 50 mL/min. Continuous Rd demonstrated a longer PFS compared with MPT in all groups of patients with renal impairment, in particular, in patients with normal renal function (HR = 0.71; P = 0.05), in patients with mild RI (HR = 0.74; P = 0.02), patients with moderate RI (HR = 0.66; P < 0.01) and in patients with severe RI (HR 0.76; P=0.31). A slight PFS benefit was also seen with continuous Rd compared to Rd18 (a secondary comparison) in patients with mild or moderate RI (P < 0.01 for both). An analysis of the impact of depth of response on PFS was also presented. In patients who achieved at least a very good partial response (VGPR), median PFS was significantly longer not reached (NR) with continuous Rd compared with Rd18 (31.0 months; HR = 0.46; P < 0.01) or MPT (34.7 months; HR = 0.55; P < 001). A benefit of continuous Rd was observed compared with Rd18 or MPT in patients who achieved a complete response (CR), where the median PFS with continuous Rd was NR vs. 45.2 months with Rd18 (HR = 0.29; P < 0.01) and 44.6 months with MPT (HR = 0.28; P < 0.01). Safety results in the FIRST study (N Engl J Med 2014) showed that grade 3/4 adverse events that occurred in at least 8% of patients in the continuous Rd arm, Rd18 arm or MPT arm included neutropenia (28%, 26% and 45%, respectively), anemia (18%, 16% and 19%, respectively), thrombocytopenia (8%, 8% and 11%, respectively), febrile neutropenia (1%, 3% and 3%, respectively), leukopenia (5%, 6% and 10%, respectively), infection (29%, 22% and 17%, respectively), pneumonia (8%, 8% and 6%, respectively), deep-vein thrombosis and/or pulmonary embolism (8%, 6% and 5%, respectively), asthenia (8%, 6% and 6%, respectively), fatigue (7%, 9% and 6%, respectively), and peripheral sensory neuropathy (1%, < 1% and 9%, respectively). Rates of grade 3/4 cardiac disorders for patients in the continuous Rd, Rd18 and MPT arms were 12%, 7% and 9%, respectively. The incidence of invasive second primary malignancies was 3% in patients taking continuous Rd, 6% in patients taking Rd18 and 5% in patients taking MPT. The overall incidence of solid tumors was identical in the continuous Rd and MPT arms (3%) and 5% in the Rd18 arm. Celgene has submitted applications for approval of REVLIMID in combination with dexamethasone for the treatment of newly diagnosed multiple myeloma patients with the European Medicines Agency (EMA) in February 2014 and with the U.S. Food and Drug Administration (FDA) in April 2014. The U.S. Food and Drug Administration has set a Prescription Drug User Fee Act (PDUFA) date of Feb. 22, 2015.

Celgene Corporation Announces Results from Efficacy and Safety Analyses of OTEZLA(R) (Apremilast) from the Open-Label Phase of Two PALACE Phase III Clinical Trials

Celgene Corporation announced that results from long-term (104-week) efficacy and safety analyses of OTEZLA(R) (apremilast) from the open-label phase of two PALACE phase III clinical trials were presented at the 2014 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) annual meeting in Boston. OTEZLA is the company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), approved by the U.S. Food and Drug Administration (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% (144/171) of patients who completed one year (52 weeks) of 30 mg twice daily therapy continued to receive OTEZLA at two years (104 weeks). 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%. ACR50 and 70 response rates were 34.0% and 19.6%, respectively, at week 104. Similar findings were observed in PALACE 4. In this trial, nearly 84% (168/201) 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%, 40.7% and 19.2% 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 (inflammation at sites where tendons or ligaments insert into bone) or dactylitis (inflammation of an entire digit), two key manifestations of psoriatic arthritis, resulted in improvements in enthesitis and dactylitis that were sustained through 104 weeks of treatment.


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