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Salix Pharmaceuticals Reports American College of Gastroenterology COLAZAL(R) Update; COLAZAL(R)-Related Data Presented in Two Poster Presentations.


RALEIGH, N.C. -- Salix Pharmaceuticals, Ltd. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:SLXP) today announced that results of two investigator-initiated trials - one investigating COLAZAL(R) Capsules and one investigating mesalamine delayed-release tablets (ASACOL(R)) - will be presented at the American College of Gastroenterology The American College of Gastroenterology (ACG) is a Bethesda, Maryland-based medical association of gastroenterologists.

The association was founded in 1932 and holds annual meetings and regional postgraduate continuing education courses, establishes research grants,
 2005 Annual Scientific Meeting. Study investigators will present their findings during the ACG ACG American College of Gastroenterology; angiocardiography; apexcardiogram.
AcG accelerator globulin (coagulation factor V).

AcG

accelerator globulin (clotting factor V).
 meeting which is being held October 28 - November 2 in Honolulu, HI.

"The two abstracts presented this week at ACG firstly confirm the utility of COLAZAL as a highly potent anti-inflammatory agent, and secondly underscore the importance of the proper colonic delivery of the active ingredient, 5-ASA, to the colon. COLAZAL's prodrug formulation has demonstrated the ability to deliver 99% of the 5-ASA dose to the colon," stated Bill Forbes, Pharm. D., Vice President, Research and Development, and Chief Development Officer, Salix. "We look forward to ongoing work in order to better understand and more fully realize the potential of this impressive anti-inflammatory agent."

Prevention of Acute Radiation-Induced Proctosigmoiditis

Dr. Christopher Jahraus, University of Alabama The University of Alabama (also known as Alabama, UA or colloquially as 'Bama) is a public coeducational university located in Tuscaloosa, Alabama, USA. Founded in 1831, UA is the flagship campus of the University of Alabama System. , Birmingham, AL, et al. conducted a double-blind, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, placebo-controlled study in 36 patients undergoing pelvic radiotherapy for non-metastatic prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men.  to examine the effectiveness of COLAZAL in preventing acute radiation-induced proctosigmoiditis (RIPS) and other toxicities associated with pelvic radiotherapy. Patients were randomly selected to receive either COLAZAL or placebo. The primary endpoint was development of proctitis Proctitis Definition

Proctitis is an inflammation of the rectum.
Description

Proctitis affects mainly adolescents and adults. It is most common in men around age 30. Proctitis is caused by several different sexually transmitted diseases.
 and secondary endpoints were diarrhea, dysuria dysuria /dys·uria/ (dis-u´re-ah) painful or difficult urination.dysu´ric

dys·u·ri·a
n.
Difficult or painful urination.
, fatigue and weight change. A toxicity index score, based on grade and length of each toxicity, and the total number of days patients experienced each toxicity at a grade equal to or greater than 2 (according to National Cancer Institute Common Toxicity Criteria Common Toxicity Criteria (CTC) is a standardised classification of side effects used in assessing drugs for cancer therapy. Most US drug trials base their observations on this system which has a range of grades from 0-5, 5 usually equating to death. Currently version 3.  v. 2.0) were analyzed for each toxicity. Patients receiving COLAZAL had relative reductions in each of the toxicity indices compared with placebo and fewer days with toxicities at a grade equal to or greater than 2. These reductions were statistically significant for the "average proctitis index score", COLAZAL 25.7 compared to placebo 59.0 (p=0.0096) and "proctitis days of toxicity", COLAZAL 2.5 compared to placebo 18.5 (p=0.007). Weight change and incidence of diarrhea did not differ significantly between the COLAZAL and placebo groups.

Mesalamine Delayed-Release Tablet (ASACOL) Recovery from Fecal Samples

Dr. Alan Safdi, Deaconess Hospital, Cincinnati, OH conducted a study in 30 healthy volunteers to determine the amount of 5-aminosalicylic acid (5-ASA) in whole and partial mesalamine delayed-release tablets (ASACOL) recovered from the fecal samples of healthy volunteers who received mesalamine delayed-release therapy. 30 healthy volunteers received two 400 mg mesalamine tablets twice daily for four days. Whole or partial tablets were recovered from fecal specimens and analyzed to determine the amount of 5-ASA in the tablets. Of the 30 volunteers, 27 (90%) provided fecal samples. Of these, 15 volunteers (55%) presented with at least one mesalamine tablet or fragment in at least one fecal sample. All tablets and fragments had detectable 5-ASA (mean of 97.2 +/- 47.1 mg per tablet/fragment) or approximately 24% of an intact mesalamine tablet.

Salix's first marketed product is COLAZAL(R) (balsalazide disodium balsalazide disodium

Colazide (UK), Colazal

Pharmacologic class: GI agent

Therapeutic class: Anti-inflammatory

Pregnancy risk category B

Action

) Capsules 750 mg, an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis ulcerative colitis

Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus.
. The Company launched the product in the U.S. through its specialty sales force in January 2001. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established. COLAZAL was well tolerated in clinical studies. In clinical trials, patients reported the following adverse events most frequently: headache (8%); abdominal pain (6%); diarrhea (5%); nausea (5%); vomiting (4%); respiratory infection (4%); and arthralgia arthralgia /ar·thral·gia/ (ahr-thral´jah) pain in a joint.

ar·thral·gia
n.
Severe pain in a joint. Also called arthrodynia.
 (4%). Withdrawal from therapy due to adverse events was comparable to placebo.

Salix trades on the NASDAQ National Market under the ticker symbol Ticker Symbol

An arrangement of characters (usually letters) representing a particular security listed on an exchange or otherwise traded publicly. When a company issues securities to the public marketplace, it selects an available ticker symbol for its securities which investors
 "SLXP".

For more information on Salix please call 919-862-1000 or visit www.salix.com. Information on the web site is not incorporated in Salix's SEC filings.

Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks of acquisitions, management of integration of the two companies and rapid growth, risks of regulatory review and clinical trials, intellectual property risks, and the need to acquire additional products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Nov 1, 2005
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