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FDA Extends Lenalidomide Review Three Months

SUMMIT, N.J., Oct. 3 /PRNewswire-FirstCall/ -- Celgene Corporation (NASDAQ:CELG) announced today that they received notification late Friday from the United States Food and Drug Administration (FDA) that the action date for FDA's priority review of the New Drug Application (NDA) for REVLIMID (lenalidomide), for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities, has been extended to January 7, 2006. The original action date under the Prescription Drug User Fee Act (PDUFA) for the REVLIMID NDA was October 7, 2005.

The extension is a result of the FDA requiring more time to review additional information on Celgene's RevAssist(R) risk-management program. This additional material has been considered by the FDA to be a major amendment to the REVLIMID NDA allowing the extension of the action date under PDUFA regulations.

"We are working closely with the FDA to enable completion of their review as quickly as possible for REVLIMID approval" said Sol Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation. "We will be ready for immediate commercial launch upon FDA action, and expect a November submission of our REVLIMID application for treatment of previously-treated patients with relapsed or refractory multiple myeloma."

About Revlimid
REVLIMID is a member of a new class of novel IMiDs(R), immunomodulatory drugs. Celgene continues to evaluate treatments with REVLIMID for a broad range of hematology and oncology conditions, including multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS), chronic lymphocytic leukemia, and solid tumor cancers. REVLIMID affects multiple intracellular biological pathways. The IMiD pipeline, including REVLIMID, 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 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 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 anemia and fatigue until they develop life-threatening iron overload and/or toxicity, thus underscoring the critical need for new therapies targeting the cause of the condition as well as therapies that manage symptoms.

About Deletion 5q Chromosomal Abnormality
Chromosomal (cytogenetic) abnormalities are detected in more than half of patients with myelodysplastic syndrome (MDS), and involve a deletion in all or part of one or more specific chromosomes. The most common cytogenetic abnormalities in MDS are deletions in the long arm of chromosomes 5, 7, and 20. Another common abnormality is an extra copy of chromosome 8. A deletion involving the 5q chromosome may be involved in up to 20 to 30% of all MDS patients. The World Health Organization has also recently identified a unique subset of MDS patients with a "5q- Syndrome" where the only chromosomal abnormality is a specific portion of the 5q chromosome.

Source: Celgene Corporation

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