Healthcare Industry News:  myelodysplastic syndromes 

Biopharmaceuticals Oncology

 News Release - June 13, 2008

VIDAZA(R) Continues to Show Significant Overall Survival Benefit When Compared with Conventional Care Regimens Across the EU

Survival analysis pooled results from France, Germany, Italy, Spain, UK, Sweden, Greece and the Netherlands

COPENHAGEN, Denmark--(HSMN NewsFeed)--Celgene International Sŕrl (Nasdaq:CELG ) today announced that 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. The data were presented at the 13th Congress of the European Hematology Association (EHA) in Copenhagen, Denmark.

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 therapy that may restore normal expression to genes critical for cell differentiation and proliferation.

“These data reinforce VIDAZA’s role and the importance of this epigenetic drug in the treatment paradigm for higher-risk MDS patients,” said Professor Valeria Santini, hematologist and lead investigator of the trial, University of Florence. “These results continue to show that VIDAZA can provide a significant overall survival benefit regardless of which regimen is used for comparison.”

The results from this trial are consistent with the data from the large, international, multi-center Phase III trial AZA-001, recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, which demonstrated that VIDAZA was the first drug to significantly prolong overall survival in higher-risk MDS patients.

The most commonly occurring major adverse events for patients receiving VIDAZA are thrombocytopenia (69.7%), neutropenia (65.7%) and anemia (51.4%).

About VIDAZA

In May 2004, VIDAZA became the first drug approved in the United States by the FDA 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) if accompanied by neutropenia or thrombocytopenia or requiring transfusions; refractory anemia with excess blasts (RAEB), 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.

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 effects by causing hypomethylation of DNA 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 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, 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 Sárl

Celgene International Sárl, 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.

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.


Source: Celgene International Sarl

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