April 16, 2014 4:24 PM ET

Biotechnology

Company Overview of Celgene International Sarl

Company Overview

Celgene International Sarl operates as a biopharmaceutical company. It discovers, develops, and commercializes therapies to treat cancer and immune-inflammatory related diseases in the United States and internationally. The company was incorporated in 2003 and is based in Boudry, Switzerland. Celgene International Sarl operates as a subsidiary of Celgene Corporation.

Route de Perreux 1

Boudry,  2017

Switzerland

Founded in 2003

Phone:

41 32 729 85 00

Fax:

41 32 729 85 08

Key Executives for Celgene International Sarl

Celgene International Sarl does not have any Key Executives recorded.

Celgene International Sarl Key Developments

Celgene International Sàrl Receives Approval from European Commission for ABRAXANE

Celgene International Sàrl announced that the European Commission has granted approval for ABRAXANE in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer. During the last few decades, little progress has been made in improving outcomes for patients diagnosed with pancreatic cancer. According to the European Cancer Observatory, 78,654 people were diagnosed with pancreatic cancer in the EU in 2012, and 77,940 died that same year. The mortality of pancreatic cancer is high, making it the fourth deadliest cancer for both men and women. Patients diagnosed with metastatic disease have a median life expectancy, after diagnosis, of approximately three to six months. There have been no new medications approved for pancreatic cancer in nearly seven years. The EC decision was based on the results of the MPACT, an open-label, Phase III, randomized, international study published in the New England Journal of Medicine in its October 31, 2013 edition. The MPACT study involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer at 151 community and academic centers from 11 countries, including North America, Eastern and Western Europe, and Australia. In the study, ABRAXANE plus gemcitabine demonstrated a statistically significant improvement in median overall survival compared to gemcitabine alone (8.5 vs. 6.7 months) (HR 0.72, P<0.0001); a 28% overall reduction in risk of death. Grade 3 and higher adverse events that were reported more often with ABRAXANE plus gemcitabine versus gemcitabine alone were neutropenia, fatigue, and peripheral neuropathy. The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use in November 2013. ABRAXANE will be launched in the European Union in the coming months according to local requirements.

Celgene International SARL Announces Results from Two Studies of REVLIMID

Celgene International SARL announced that results from two studies of REVLIMID (lenalidomide) combinations in patients with diffuse large B-cell lymphoma (DLBCL) were presented at the American Society of Hematology annual meeting in New Orleans, La. In the first study, Dr. Nishitha M. Reddy evaluated whether maintenance treatment with lenalidomide plus rituximab would result in a clinically significant reduction in relapse rates when compared with lenalidomide alone. DLBCL patients with an intermediate/high to high-risk international prognostic index (IPI) are at an increased risk of disease relapse rate in the first year after completion of standard therapy with R-CHOP. Forty-four intermediate-high/high risk IPI patients were randomized to receive either lenalidomide at a dose of 25 mg daily for 21 days of 28 days (Arm A n=22) or lenalidomide at a dose of 20mg daily for 21 days of 28 days along with rituximab on day 8 of every other cycle (Arm B n=22). The primary endpoint of the study was to assess the one-year disease-free survival rate (DFS). At a median follow up of 28.3 months, the 2-year disease-free survival (DFS) and overall survival (OS) were 86% and 84%, respectively. For patients in arm A and arm B the 2--year DFS was 90% vs. 82% and the 2--year OS was 96% vs. 72%, respectively (P=NS). Adverse events with patients experiencing grade 3-4 toxicities included neutropenia (23%), fatigue (13%), hypothyroidism (4%), DVT (2%), rash (2%) and febrile neutropenia (3%). Related grade 1-2 toxicities include hypothyroidism (13%) and rash (45%). The results of this study showed that lenalidomide as maintenance therapy demonstrated clinical activity following standard chemotherapy in DLBCL patients with high risk prognostic features.

Celgene International Sàrl Updates Analyses from MM-003

Celgene International Sàrl announced that updated analyses from MM-003, the company's phase III study of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide, administered either alone or in combination were presented at the American Society of Hematology Annual Meeting in New Orleans, La. Pomalidomide is marketed as POMALYST(R) in the United States and IMNOVID(R) in the European Union. It was previously reported that with a median follow-up of 10 months, pomalidomide plus low-dose dexamethasone significantly extended progression-free survival (PFS) (4.0 months vs 1.9 months, HR= 0.48, p<0.001) and overall survival (OS) (12.7 months vs 8.1 months, HR= 0.74, p<0.028) compared with high-dose dexamethasone. The OS benefit was observed despite 50% of the patients in the high-dose dexamethasone arm receiving subsequent pomalidomide. The overall response rate (ORR) for the pomalidomide plus low-dose dexamethasone arm and high-dose dexamethasone arm was 31% vs. 10% (P < 0.001), respectively. The results were published in The Lancet Oncology in September 2013. In a retrospective analysis, the increases in ORR and median PFS were maintained for pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone regardless of modified high-risk cytogenetics (del (17p) or t(4;14)) (ORR: 25% vs. 9%, P=0.071; PFS: 3.8 vs. 1.1 months, HR=0.44, P<0.001) or standard-risk cytogenetics (ORR: 35% vs. 10%, P<0.001; PFS: 4.2 vs. 2.3 months, HR=0.55, P<0.001). Numerical increases in median OS were observed regardless of cytogenetics (modified high risk: 9.9 vs. 4.9 months, HR=0.67, P=0.092; standard risk: 14.1 vs 9 months, HR=0.85, P=0.38). Of note, 46% of patients receiving high-dose dexamethasone with high-risk and 64% of patients receiving high-dose dexamethasone with standard-risk cytogenetics received subsequent pomalidomide. In another retrospective analysis of MM-003 the effect of prior therapies on study outcomes was evaluated. The median number of prior therapies was 5 (range, 2-17). Most patients (75%) were refractory to both bortezomib and lenalidomide. In patients who received pomalidomide plus low-dose dexamethasone, the overall response rate for patients who had at least three prior therapies (n=70) was 26% with 4% of those patients achieving at least a very good partial response. For patients who received pomalidomide plus low-dose dexamethasone and had less than three prior therapies (n=232), the overall response rate was 34% with 8% of patients achieving at least a very good partial response. The hazard ratio for risk of disease progression for pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone was HR=0.63 (0.40-1.00) for patients with up to three prior therapies and HR=0.45 (0.35-0.57) for patients with more than three prior therapies. The hazard ratio for risk of death for pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone was HR=0.56 (0.33-0.96) for patients with at least three prior therapies and HR=0.76 (0.58-1.00) for patients with up to three prior therapies. In the primary analysis, the most frequent grade 3/4 adverse events (AEs) for pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone were neutropenia (48% vs. 16%), anemia (33% vs. 37%), and infections (30% vs. 24%). Grade 3/4 deep-vein thrombosis/pulmonary embolism was infrequent (1% vs. 0%). Only 1% of patients in each arm experienced grade 3/4 peripheral neuropathy. Discontinuation due to AEs was 9% vs 10%.

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