Presentations at the 14th Congress of the European Hematology Association Demonstrate VIDAZA® Benefits Patients with Myelodysplastic Syndromes

Celgene International Sàrl (NASDAQ: CELG) announced that data presented at the 14^th Congress of the European Society of Hematology demonstrate that treatment with VIDAZA significantly extends overall survival and helps patients with myelodysplastic syndromes (MDS) become or remain red blood cell transfusion independent. Patients who benefited included those with higher-risk MDS or acute myeloid leukaemia (AML) with 20-30% blasts, as defined by the World Health Organization (WHO).

"The presentations at EHA this year continue to support the clinical benefit associated with VIDAZA in MDS, including significantly extended overall survival, and add to the data from the international AZA-001 survival study published in The Lancet Oncology earlier this year,” said Jean-Pierre Bizzari, Senior Vice President and Group Head of Global Oncology/Hematology of Celgene. "Additionally, they reinforce the significant and durable transfusion independence provided by VIDAZA, which is associated with improved overall survival in this difficult to treat group of diseases.”

Azacitidine (AZA) improves overall survival in WHO acute myeloid leukaemia (AML) in elderly patients with low bone marrow blast counts

A sub-analysis of the AZA-001 survival trial sought to confirm and further elucidate a positive overall survival trend shown by a subset of patients in an earlier phase III study (CALGB 9221) comparing VIDAZA against best supportive care in patients with WHO-defined AML with blasts <30%.

Patients with higher-risk MDS classifications (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) were enrolled and randomised either to VIDAZA therapy or conventional care regimens (CCR: best supportive care, low dose ara-C or intensive chemotherapy).

Of 358 patients, 113 (32%) met WHO AML criteria (median 23% marrow blasts). Subsequently, 55 were randomised to VIDAZA and 58 to CCR. Of the 58 CCR patients, 47 percent were treated with best supportive care, 34 percent with low-dose ara-C and 19 percent with intense chemotherapy.

In the study, at two years, 50 percent of patients in the VIDAZA group were alive compared to 16 percent of those in the CCR group (p=0.0007). The median overall survival was 24.5 and 16.0 months in the VIDAZA and CCR groups, respectively, (HR=0.47 [95%CI: 0.28-0.79], p=0.004).

"As shown with higher-risk MDS patients in the AZA-001 study, patients with WHO-defined AML treated with VIDAZA also demonstrate an improved overall survival rate compared to conventional care regimens,” said Prof. Valeria Santini of Policlinico di Careggi, in Florence, Italy. "This also supports the trend shown in the CALGB 9221 study.”

The impact of azacitidine and decitabine (hypomethylating agents) in myelodysplastic syndromes: A systematic review and meta-analysis

In an effort to perform a systematic review of randomised controlled trials of VIDAZA and decitabine versus best supportive care in the absence of a direct comparative trial, a comprehensive literature search was conducted for randomised controlled trials published prior to July 2008 and meeting abstracts from the American Society of Clinical Oncology, American Society of Hematology and European Hematology Association between 2006 and 2008.

Four randomized controlled trials assessing the efficacy of hypomethylating agents for the treatment of MDS were found. Two comparing VIDAZA to supportive care, and two comparing decitabine versus supportive care. Meta-analysis of randomised controlled trials comparing hypomethylating agents versus supportive care showed significantly better overall survival, event-free survival and response rate in favor of the hypomethylating agents without a significant increase in treatment-related mortality. Comparison of VIDAZA versus supportive care also showed a significant advantage in overall survival and event-free survival without significant risk of treatment-related mortality. Comparison of decitabine versus supportive care showed significantly better event-free survival and response rate with decitabine but no difference in overall survival and treatment-related mortality.

Evaluation of VIDAZA versus decitabine showed significantly better overall survival favoring VIDAZA but similar event-free survival, response rate and treatment-related mortality.

"The results of this study demonstrate that patients treated with hypomethylating agents show significant improvement in survival and response. In our indirect comparison, however, VIDAZA had superior overall survival without a significant increase in treatment-related mortality,” said Dr. Ambuj Kumar of the H. Lee Moffitt Cancer Center in Tampa, Florida, USA.

Effect of azacitidine (AZA) on transfusion independence (TI) and overall survival (OS) in patients with higher-risk myelodysplastic syndromes

A second analysis of the AZA-001 survival trial sought to examine overall survival in higher-risk MDS patients relative to their transfusion status – as red blood cell (RBC) transfusion requirements have been shown to correlate with overall survival in these patients.

In the analysis, 179 patients with higher-risk MDS and WHO-defined AML were randomised to VIDAZA^® and evaluated for RBC or platelet transfusion independence, which was defined as a transfusion-free period of =56 consecutive days.

In the VIDAZA group, 50 of 111 RBC transfusion-dependent patients (45%, 95% CI: 35.6, 54.8) achieved RBC-transfusion independence and 16 of 38 patients with platelet transfusion dependence (42%) achieved platelet-transfusion independence.

Additionally, patients who were transfusion independent at some point during treatment regardless of their baseline transfusion status had a longer duration of VIDAZA therapy and longer overall survival. A median overall survival was not reached for patients who were either RBC- or platelet-transfusion dependent at baseline and achieved transfusion independence during VIDAZA treatment.

"Through this study, we were able to confirm that patients who became or remained transfusion independent as a result of VIDAZA therapy had longer treatment duration and a prolonged overall survival compared to transfusion-dependent patients,” said Dr. John Seymour of the Peter MacCallum Cancer Centre in East Melbourne, Australia.

About VIDAZA

In May 2004, VIDAZA became the first drug approved by the FDA for the treatment of patients with MDS. 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 anaemia (RA) or refractory anaemia with ringed sideroblasts (RARS) if accompanied by neutropaenia or thrombocytopaenia or requiring transfusions; refractory anaemia with excess blasts (RAEB), refractory anaemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukaemia (CMMoL). Additionally, in December 2008, VIDAZA was approved by the European Commission for the treatment of treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with: Intermediate-2 and high-risk MDS according to the IPSS, or Chronic myelomonocytic leukaemia (CMML) with 10-29 percent marrow blasts without myeloproliferative disorder, or AML with 20-30 percent blasts and multi-lineage dysplasia, according to WHO classification

VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and cytotoxicity on abnormal haematopoietic 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. 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 effects by causing hypomethylation of DNA and cytotoxicity of abnormal hematopoietic cells in the bone marrow. DNA hypomethylation of aberrantly methylated genes involved in normal cell cycle regulation, differentiation and death pathways may result in gene re-expression and restoration of cancer-suppressing functions to cancer cells. 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 was approved by FDA for IV administration in January 2007.

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a group of haematologic 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, 10,000 to 20,000 new cases of MDS are diagnosed each year in the United States, with mean 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 anaemia 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 Sàrl

Celgene International Sàrl, located in Boudry, Switzerland, is a wholly owned subsidiary 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.

VIDAZA is a registered trademark of Celgene Corporation.

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.