Pharmacology
FDA Approves Budesonide for the Maintenance of Remission in Crohn's disease
By Prometheus Laboratories Inc.
May 11, 2005, 09:58

Prometheus Laboratories Inc., a specialty pharmaceutical company, announced today that the U.S. Food & Drug
Administration (FDA) has approved the supplemental New Drug Application (sNDA)for the additional use of Entocort(R) EC (budesonide) Capsules for the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon for up to three months.

Entocort EC is the only pharmacological product indicated for the treatment of mild to moderate Crohn's disease involving the ileum and/or the ascending colon, which affects nearly 70% of Crohn's patients.

"We are excited to have this additional indication for Entocort EC," said Joseph M. Limber, President and Chief Executive Officer of Prometheus. "Physicians can now provide their patients with an effective long-term therapy
option, in addition to an acute treatment related to mild to moderate active Crohn's disease. Our commitment is to continue to aid physicians in improving the lives of their patients through providing meaningful products and the FDA's additional approval is a significant component in keeping with that commitment."

The additional approval is based on the results of four double-blind, placebo-controlled, 12-month trials in which 380 patients were randomized and treated once daily with either 3 mg or 6 mg Entocort EC, or placebo. The median time to relapse in the pooled population of the 4 studies was 154 days for patients taking placebo, and 268 days for patients taking Entocort EC, at 6 mg/day.

Entocort EC at 6 mg/day significantly reduced the percentage of patients with loss of symptom control (28%) versus placebo (45%) in the pooled population for the 4 studies at three months.

Entocort EC is a topical glucocorticosteriod, working primarily in the intestines. Its specifically designed oral formulation allows local release in the ilium and the ascending colon. The adverse event profile in long-term
treatment was similar to that of short-term treatment with Entocort EC. The most common side effects of Entocort EC observed in clinical trials were headache, respiratory infection, nausea and symptoms of hypercorticism.

About Crohn's Disease

Crohn's disease is a chronic inflammatory bowel disease of unknown origin.An estimated 500,000 Americans have the disorder. Flare-ups of the disease can range from mild to severe and involve symptoms such as diarrhea, abdominal
pain, fever and sometimes rectal bleeding. The condition can be difficult to manage clinically and consumes a substantial amount of healthcare resources in terms of physician time, procedures and medications.

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