Clinical Data For REVLIMID(R) And VIDAZA(R) In Important Blood Cancers Presented at The 13th European Hematology Association Congress.BOUDRY, Switzerland -- Celgene International Sarl (Nasdaq: CELG): * Study of VIDAZA in Higher-Risk MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there Patients Reports Improved Overall Survival * New Analysis of Phase III Studies Shows REVLIMID Plus Dexamethasone dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the Yielded an Estimated Mean Survival of 5.6 Life Years for Patients with Multiple Myeloma * Health Economic Analysis Reports that REVLIMID is a Cost Effective Treatment for Multiple Myeloma * Preliminary Results from International Study Report that REVLIMID Provides Responses for Patients with Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma * Satellite Symposium Presentation Reports Survival Advantage and Improved Complete Response Rates in Newly Diagnosed Multiple Myeloma Cooperative Group Trials Celgene International Sarl (Nasdaq: CELG) today announced key data was presented over the past weekend highlighting the use of REVLIMID and VIDAZA in several critical blood cancer indications during the 13th European Hematology Association (EHA EHA European Hematology Association EHA Economic History Association EHA Emmanuel Hospital Association EHA Education for All Handicapped Children Act of 1975 EHA Empty Homes Agency EHA English Hockey Association EHA Electrohydrostatic Actuator ) Congress in Copenhagen, Denmark. Additionally, several studies addressed important health economic factors surrounding the use of Celgene therapies. Key presentations at the event were as follows: Abstract #0224 Data from a sub-analysis of a previously reported large, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. phase III study (AZA-001) were reported and showed that treatment with VIDAZA (azacitidine) prolonged overall survival for patients with high-risk myelodysplastic syndromes (MDS) when compared to conventional care regimens (CCR). This analysis evaluated a sub-group of patients (n=94) who were pre-selected to receive low dose Ara-C, a chemotherapy used in the treatment of MDS and acute myeloid leukemia (AML AML - A Manufacturing Language ). The results confirm that the significant survival benefit originally reported with VIDAZA in the overall population was also seen when VIDAZA was directly compared to the active comparator arm of low dose Ara-C. In the sub-analysis, the median overall survival for patients treated with VIDAZA was significantly longer (24.4 months compared to 15.3 months (hazard ratio 0.36) (95% Cl: 0.20-0.65 [p=0.0006]) compared to patients treated with low-dose Ara-C, reducing the risk of death by 64 percent. This improved survival with VIDAZA was supported by significant improvements in hematologic hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. response, and improvement in transfusion independence. A similar rate of thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. was seen in each group. Higher rates of severe anemia were seen in the low-dose Ara-C group. Additionally, low-dose Ara-C provided no survival benefit when compared with best supportive care. In the AZA-001 study, the most commonly occurring major adverse events for patients receiving VIDAZA were thrombocytopenia (69.7%), neutropenia (65.7%) and anemia (51.4%). Abstract #0236 In this study, data showed VIDAZA (azacitidine) provides a significant overall survival benefit for patients with higher-risk myelodysplastic syndromes (MDS) regardless of whether patients were treated with low-dose Ara-C or best supportive care in the control arm. In aggregate, the survival benefit for VIDAZA across all countries was 24.4 months versus 15.3 months (hazard ratio 0.36) (95% Cl: 0.20-0.65) [p=0.0006]) compared to the other treatment arms. VIDAZA was compared with low-dose Ara-C in the UK and France, and compared with best supportive care in Germany, Italy, Sweden, Greece, Spain and the Netherlands. In both groups, VIDAZA consistently showed an overall survival benefit. VIDAZA is a novel epigenetic epigenetic /epi·ge·net·ic/ (-je-net´ik) 1. pertaining to epigenesis. 2. altering the activity of genes without changing their structure. therapy that may restore normal expression to genes critical for cell differentiation and proliferation. The results from this trial are consistent with the data from the large, international, multi-center Phase III trial AZA-001. Abstract #0399 Preliminary data from an international study of single agent REVLIMID([R]) (lenalidomide) in relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ) were also presented. In this study of heavily pretreated patients, 83 were eligible for response evaluation. An objective response was observed in 29 percent of patients, with six percent achieving a complete response (CR/CRu), 23 percent achieving a partial response and 19 percent showing stable disease. According to NHL histology, objective response was 36 percent in mantle cell lymphoma Mantle cell lymphoma (MCL) is one of the rarer of the non-Hodgkin's lymphomas, comprising about 6% of NHL cases.[1] There are only about 15,000 patients presently in the U.S. (The incidence seems to be somewhat higher in Europe. , 22 percent in diffuse large b-cell lymphoma diffuse large B-cell lymphoma Oncology A B-cell lymphoma that is the most common type–accounting for 30-40%–of NHL, which occurs in children and adults. See Lymphoma, Non-Hodgkin's lymphoma, WHO classification. , 33 percent in follicular lymphoma (grade three) and 50 percent in transformed lymphoma. These responses included several patients that had been refractory to their prior therapies, including rituxamab based regimens. In the study, the most common grade 3 or higher adverse events were neutropenia (27%), thrombocytopenia (15%), leucopenia leu·co·pe·ni·a n. Variant of leukopenia. (5%), anemia (8%) and fatigue (5%). Abstract #0441 According to data from a pooled study, multiple myeloma patients taking REVLIMID([R]) (lenalidomide) plus dexamethasone significantly increased their survival rates. A lifetime simulation yielded an estimated mean survival of 5.6 life-years with REVLIMID in combination with dexamethasone (2.2 life-years with dexamethasone alone) for patients with one prior therapy, and 4.2 life-years (1.5 life-years for dexamethasone alone) for patients with multiple prior therapies. This analysis stemmed from the phase III randomized, controlled studies, MM-009 and MM-010 studies, recently published in the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. that demonstrated high response rates and durable remissions resulting in the longest median survival in a phase III trial ever seen in relapsed/refractory multiple myeloma patients. The analysis demonstrated that patients in the two phase III trials showed the greatest improvement to date in TTP TTP (thymidine triphosphate): see thymine. and deepest and greatest duration response rates if used earlier on in the treatment. This study was re-analyzed to validate the long-term survival benefit to patients when appropriate adjustments are made to account for patient's crossing over to the REVLIMID treatment arm of the trial. Patients treated with lenalidomide and dexamethasone had an increase in side effects as compared to patients treated with dexamethasone plus placebo. Grade 3/4 toxicities included neutropenia, thrombocytopenia and anemia. Deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. (DVT See deep vein thrombosis. ) and pulmonary embolism (PE) occurred in 14.1 percent of patients treated with lenalidomide plus dexamethasone, compared to 3.4 percent of patients treated with dexamethasone plus placebo in MM-009, and DVTs and PEs occurred in 9.0 percent of patients treated with lenalidomide plus dexamethasone, compared to 6.0 percent of patients treated with dexamethasone plus placebo in MM-010. Of note, another trial presented at the British Society for Haematology (BSH) Annual Meeting (April 2008) also showed that multiple myeloma patients taking REVLIMID plus dexamethasone experienced a survival gain. On average, patients experienced nearly three extra years of life (4.7 life years) when treated with REVLIMID plus high-dose dexamethasone (1.9 life-years with dexamethasone alone). Additional data from Scotland also presented at the BSH Annual Meeting demonstrated that REVLIMID is a cost-effective treatment. This cost is lower than the threshold of PS30,000 per QALY QALY Quality Adjusted Life Year that is widely considered to be an acceptable value for an additional QALY. Finally, in a presentation at EHA (Abstract #0804), these pooled results were also applied to the management costs reflective of NHS Wales and found to be within the incremental cost-effectiveness threshold range from L20,000 to L30,000 per QALY. Satellite Symposium Data from the ECOG ECOG Eastern Cooperative Oncology Group E4A03 and SWOG SWOG Southwestern Oncology Group 0232 studies were also reported at a Satellite Symposium and showed that newly diagnosed multiple myeloma patients who are eligible for a transplant, obtain better outcomes when treated with REVLIMID (lenalidomide) plus dexamethasone. The data were presented by Dr A. Stewart, from the Mayo Clinic. Updated results from these two large cooperative group trials of REVLIMID in combination with dexamethasone in newly diagnosed patients reported a survival advantage and improved complete response rates for REVLIMID when combined with dexamethasone. In a four-month landmark analysis of ECOG Phase III study E4A03, patients who continued on treatment of REVLIMID plus low-dose dexamethasone (Rd) achieved a two-year overall survival rate of 93 percent. In the same landmark analysis, patients who went on to autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. stem cell transplant achieved the same two-year survival rate of 93 percent. Patients in the landmark analysis who received Rd achieved an overall response rate of 89 percent and CR + VGPR of 56 percent. Patients in the SWOG 0232 Phase III study receiving REVLIMID plus dexamethasone (RD) achieved a progression-free survival rate of 77 percent at one year and CR + VGPR of 62 percent. Results from these studies demonstrate that REVLIMID in combination with dexamethasone is highly active in newly diagnosed multiple myeloma regardless of age or transplant eligibility. Moreover, results from the trials provide the rationale for conducting future prospective trials comparing novel agents to stem cell transplant In the ECOG E4A03 data, recently presented at ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company , Grade 3 or higher non-hematologic toxicities in the RD vs. Rd arms of the study included deep vein thrombosis (DVT)/pulmonary embolism embolism Obstruction of blood flow by an embolus—a substance (e.g., a blood clot, a fat globule from a crush injury, or a gas bubble) not normally present in the bloodstream. Obstruction of an artery to the brain may cause stroke. (PE) (25% vs. 11%) infection/pneumonia (16% vs. 8%) cardiac ischemia (3% vs. 0.5%) and neuropathy (2% in both arms). For SWOG 0232 Grade 3/4 adverse events were more frequent in multiple myeloma patients who received the combination of lenalidomide/dexamethasone compared to dexamethasone alone. Neutropenia (13.8% vs. 2.4%) and infections (18.9% vs. 9.8%) were the most frequently reported adverse events. DVT occurred in 27% of patients receiving REVLIMID and dexamethasone compared to 14.6% with dexamethasone alone. About VIDAZA[R] In May 2004, VIDAZA became the first drug approved in the United States by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the treatment of patients with Myelodysplastic Syndromes (MDS). VIDAZA was approved for IV administration in January 2007. The FDA approved VIDAZA, the first in a new class of drugs called demethylation agents, for treatment of all five MDS subtypes, which include both low-risk and high-risk patients. These subtypes include: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS RARS Refractory anemia with ringed sideroblasts. See Idiopathic sideroblastic anemia. ) if accompanied by neutropenia or thrombocytopenia or requiring transfusions; refractory anemia with excess blasts refractory anemia with excess blasts Hematology A myelodysplastic syndrome of older persons characterized by anemia or pancytopenia and BM hypercellularity Clinical Nonspecific–anemia of gradual onset, fatigue, weakness, exacerbation of underlying heart (RAEB RAEB Refractory Anemia with Excess myeloBlasts, see there ), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). The VIDAZA marketing authorization as a potential treatment for patients with higher -risk MDS is currently under review by the EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. . VIDZA is an epigenetic agent, which may restore normal expression to genes critical for cell differentiation and proliferation. The cytotoxic effects of VIDAZA cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non- proliferating cells are relatively insensitive to VIDAZA. VIDAZA is believed to exert its antineoplastic antineoplastic /an·ti·neo·plas·tic/ (-ne?o-plas´tik) 1. inhibiting or preventing development of neoplasms; checking maturation and proliferation of malignant cells. 2. an agent that so acts. effects by causing hypomethylation of DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of VIDAZA required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. About REVLIMID([R]) REVLIMID is an IMiDs([R]) compound, a member of a proprietary group of novel immunomodulatory agents. REVLIMID and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of oncological conditions, both in blood cancers and solid tumors. The IMiDs pipeline is covered by a comprehensive intellectual property estate of U.S. and foreign issued and pending patent applications including composition-of-matter and use patents. About Multiple Myeloma Multiple myeloma (also known as myeloma or plasma cell myeloma plasma cell myeloma n. A malignant plasmacytoma of bone. ) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein paraprotein /para·pro·tein/ (-pro´ten) a normal or abnormal plasma protein appearing in large quantities as a result of a pathological condition; term now largely replaced by M component. (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown. About quality-adjusted life years Quality-adjusted life years, or QALYs, are a way of measuring both the quality and the quantity of life lived, as a means of quantifying in benefit of a medical intervention. (QALYs) Quality-adjusted life years, or QALYs, is a way of measuring disease burden, including both the quality and the quantity of life lived, as a means of quantifying in benefit of a medical intervention. About Non-Hodgkin's Lymphoma Lymphoma is the name for the group of blood cancers that start in the lymphatic system, which is part of the body's immune system. Lymphomas generally start in the lymph nodes or lymphatic tissue in sites of the body such as the stomach or intestines. They may involve the marrow and the blood in some cases as well. Most people with lymphoma have one of the many different kinds of non-Hodgkin's lymphoma (NHL). About Myelodysplastic Syndromes Myelodysplastic syndromes (MDS) are a group of hematologic malignancies that affect approximately 300,000 people worldwide. Myelodysplastic syndromes occur when blood cells remain in an immature or "blast" stage within the bone marrow and never develop into mature cells capable of performing their necessary functions. Eventually, the bone marrow may be filled with blast cells suppressing normal cell development. According to the American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, , 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with median survival rates ranging from approximately six months to six years for the different classifications of MDS. MDS patients must often rely on blood transfusions to manage symptoms of anemia and fatigue and may develop life-threatening iron overload and/or toxicity from frequent transfusions, thus underscoring the critical need for new therapies targeting the cause of the condition rather than simply managing its symptoms. About Celgene International Sarl Celgene International Sarl, located in Boudry, Switzerland, is a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. 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 the Company's website at www.celgene.com. This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as Form 10-K, 10-Q and 8-K reports. |
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