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Lenalidomide Trials Demonstrates Statistically Significant Improvement in Time to Disease Progression

SUMMIT, N.J., March 7 /PRNewswire-FirstCall/ -- Celgene Corporation (NASDAQ:CELG) announced that external Independent Data Monitoring Committee analyses of both Phase III Special Protocol Assessment (SPA) multiple myeloma trials exceeded the pre-specified p "Following preliminary analysis we plan to use this data as the basis of a regulatory submission to the FDA and international regulatory agencies for REVLIMID in previously treated multiple myeloma patients," said Jerome B. Zeldis, M.D., Ph.D., Chief Medical Officer and VP, Medical Affairs of Celgene Corporation.

The REVLIMID Phase III trials included patients with relapsed or refractory multiple myeloma. Patients were randomized to receive REVLIMID plus dexamethasone or dexamethasone alone. The trials enrolled 705 patients and are being conducted in 97 sites internationally, including: U.S., Europe and Australia. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization to the first documentation of progressive disease based on Blade myeloma response criteria.

In addition to the initial positive efficacy profile, the preliminary safety profile was favorable. All data are being analyzed further for the regulatory submissions.

REVLIMID is a member of a new class of novel immunomodulatory drugs, or IMiDs(R). Celgene is evaluating 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) as well as 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 patents and pending patent applications including composition-of-matter and use patents.

REVLIMID (lenalidomide) is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.

About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells 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 (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.

Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a worldwide prevalence of approximately 200,000 cases. In the year 2004, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2005 was about 60,000 worldwide.

Source: Celgene Corporation

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