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DDW Studies Present Evidence That Thalomid (Thalidomide) Is Active In Treating Crohn's Disease

ials using thalidomide to treat Crohn's disease. These groups reported results that are consistent with the Cedars-Sinai, Celgene-supported study during this meeting. There are approximately 200,000 people in the United States who have Crohn's disease, and approximately 5,000-10,000 new cases are diagnosed annually. Researchers have observed that Crohn's disease tends to run in families, and that the disease is most common in North America, Europe and Scandanavia, with a greater incidence of the disease in urban and northern environments.

Celgene Corporation provided the THALOMID (thalidomide) used in the Cedar's-Sinai study. The company received U.S. Food and Drug Administration (FDA) clearance to market and sell THALOMID (thalidomide) for the treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) in leprosy, on July 16, 1998. The drug has been commercially available since October 1, 1998. In December 1998, Celgene licensed from EntreMed, Inc. (NASDAQ: ENMD) the rights to thalidomide as an antiangiogenic agent. Recently, THALOMIDR received orphan drug designation for multiple myeloma and Crohn's disease.

Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. The major adverse drug reactions known to be associated with thalidomide treatment include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with THALOMIDR (thalidomide). Celgene Corporation, headquartered in Warren, N.J., is engaged in the development of pharmaceuticals and agrochemicals.


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Contact: Sandra Van
Sandy@VanCommunications.com
1-800-396-1002
Cedars-Sinai Medical Center
19-May-1999


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