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Salix Pharmaceuticals Announces Positive Top Line Results of,Balsalazide Tablets Registration Study

RALEIGH, N.C.--(BUSINESS WIRE)--Jun 18, 2007 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful completion and outcome of its Phase III registration trial to evaluate the safety and efficacy of a new 1100 mg tablet formulation of balsalazide disodium (balsalazide tablets). Balsalazide disodium is the active ingredient in COLAZAL(R) Capsules 750 mg, an anti-inflammatory drug approved and marketed for the treatment of mildly to moderately active ulcerative colitis.

Commenting on the study, Bill Forbes, Pharm.D., Vice President Research and Development, Salix Pharmaceuticals, stated, "We are very pleased with the results of our placebo-controlled, multi-center study of balsalazide tablets, which was conducted solely in the U.S. When compared to subjects receiving placebo, a statistically significant greater proportion of subjects dosed twice daily with balsalazide tablets for eight weeks achieved clinical improvement. This distinction in response between balsalazide and placebo was observed for both the primary efficacy endpoint (clinical improvement in Disease Activity Index of greater than or equal to 3 points with improvement in rectal bleeding) as well as the following key secondary efficacy endpoints (clinical remission, mucosal healing, improvement of rectal bleeding and improvement in physician global assessment.) These pivotal Phase III trial findings, along with the positive findings of our Phase I trials assessing formulation performance under conditions including fed, fasting and multiple dosing, serve as the basis for our New Drug Application. Additionally, following an April 27, 2007 pre-NDA meeting with the FDA, we currently anticipate an NDA submission by July 31, 2007."

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to i
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