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Budesonide Capsules Recommended by American Gastroenterology Association as First-Line Therapy for the Treatment of Mild-to-Moderate Crohn's Disease

SAN DIEGO, C.A. -- June 5, 2006 -- Prometheus Laboratories Inc., a specialty pharmaceutical company, today announced that the latest American Gastroenterological Association position statement recommends Entocort(R) EC (budesonide) Capsules as the first-line therapy for the treatment of mild-to-moderate ileal and right-sided colonic Crohn's disease.(1)

Entocort EC is a non-systemic glucocorticosteroid and is the only pharmacological product indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon for both induction and maintenance therapies.* Because Entocort EC has low systemic bioavailability, it has reduced side effects compared to traditional oral corticosteroids, such as prednisolone.(2)

The position statement was included in an American Gastroenterological Association Institute Technical Review on Corticosteroids, Immunomodulators, and Infliximab in Inflammatory Bowel Disease (IBD) which was published in the March 2006 issue of Gastroenterology. The conclusions in the Technical Review represent the evaluation of treatment options for inflammatory bowel diseases. The Technical Review was authored by Drs. Gary R. Lichtenstein, Maria T. Abreu, Russell Cohen and William Tremaine.

"These evidence-based recommendations can significantly impact the treatment of over 500,000 Crohn's disease patients," said Dr. Gary Lichtenstein. "The recommendations took over a year to develop with numerous health care professionals providing input on the final publication. These recommendations represent the best of current practice for treating inflammatory bowel diseases."

Under the position statement, Entocort EC therapy was recommended as effective for the maintenance of short-term remission. The position statement further states that the use of conventional corticosteroids, such as prednisone, should generally be reserved for patients with moderate to severe disease who failed to respond to first-line therapies for IBD such as mesalamine (for ulcerative colitis) or budesonide (for Crohn's disease).(1)

Entocort EC Background
Entocort EC is a first-line therapy and the only pharmacological product indicated for both induction and maintenance of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon, the sites of disease for approximately 70% of patients.(2,3) Entocort EC is a non-systemic glucocorticosteroid, which means that it works locally or in one area of the body. The most common side effects of Entocort EC observed in clinical trials were headache, respiratory infection, nausea and symptoms of hypercorticism.

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.

AstraZeneca LP launched Entocort EC in November 2001. Prometheus entered into an agreement with AstraZeneca LP for the marketing, sales and distribution of Entocort EC beginning in January 2005.


*For Crohn's disease involving the ileum and/or ascending colon, Entocort EC is indicated for the treatment of mild to moderate active disease (up to 8 weeks with repeated 8-week courses as necessary) and the maintenance of clinical remission of mild to moderate disease for up to an additional 3 months.

Entocort is a registered trademark of the AstraZeneca group of companies. PROMETHEUS is a trademark of Prometheus Laboratories Inc.


REFERENCES:
1. Lichtenstein GR, Abreu MT, Cohen R, Tremaine W. American Gastroenterological Association Institute Technical Review on Corticosteroids, Immunomodulators, and Infliximab in Inflammatory Bowel Disease. Gastroenterology 2006;30:940-987.
2. Entocort EC package insert.
3. Allan RN. Crohn's disease of the small intestine - ileum and right colon. In: Allan RN, Rhodes JM, Hanauer SB, eds. Inflammatory Bowel Diseases. New York, NY: Churchill Livingstone, 1997:589-595.


SOURCE: Prometheus Laboratories Inc.

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