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The FDA Grants Fast-Track Status to Revimid in Myelodysplastic Syndromes

WARREN, N.J., April 15 /PRNewswire-FirstCall/ -- Celgene Corporation (Nasdaq: CELG) announced today that REVIMID(TM) (CC-5013) received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of myelodysplastic syndromes (MDS). The FDA grants fast track designation to compounds that may provide a significant improvement in the safety or effectiveness of the treatment for a serious or life-threatening disease. Compounds that receive the designation are also eligible for priority review, which provides for a six-month review of a new drug application by the FDA.

"We are very encouraged by the emerging data on REVIMID as a potential therapy for MDS patients, and based on the data, we are moving REVIMID through the clinical and regulatory development process as quickly as possible to help alleviate the unmet medical needs of MDS patients," said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. "We look forward to presenting updated data from our Phase I/II trial of REVIMID in MDS at the International MDS Symposium that will be held May 15-18, 2003 in Paris, France."

About Myelodysplastic Syndromes
Myelodysplastic syndromes (MDS) are a group of hematologic conditions that affect approximately 50,000 people in the United States. The five types of MDS are refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in formation, and chronic myelomonocytic leukemia. 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 becomes filled with blast cells until there is no room for normal cells to develop. According to the American Cancer Society 14,000 new cases of MDS are diagnosed each year in the United States, with survival rates ranging from six months to five years for the different types of MDS.

REVIMID (CC-5013) is not approved by the FDA and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.

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