Salix Announces Statistically Significant Top- Line Results for Second Product Registration Study of Granulated Mesalamine in Ulcerative ColitisRALEIGH, N.C.--(BUSINESS WIRE)--Oct 4, 2007 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful completion and outcome of the second of two Phase III registration trials to evaluate the safety and efficacy of the Company's new granulated mesalamine product currently under development for the maintenance of remission in patients with ulcerative colitis. Results from the study indicate that a statistically significantly greater proportion of subjects dosed once-a-day with 1.5 grams of granulated mesalamine remained relapse-free over 6 months of treatment than patients dosed with placebo.
Commenting on the study, Bill Forbes, Pharm.D., Vice President, Research and Development, Salix Pharmaceuticals, stated, "The outcome of this second, 300-subject, multicenter, 6-month, double-blind, randomized, placebo-controlled study confirms the results of the study we reported in September 2007. The results of this second study again demonstrate the utility of our novel delayed and extended release formulation of mesalamine, dosed once a day in this study, to successfully maintain remission in ulcerative colitis patients. We continue to anticipate a December 2007 NDA submission for this product."
Salix acquired rights to market granulated mesalamine in the U.S. from Dr. Falk Pharma GmbH of Freiburg, Germany. Dr. Falk Pharma markets granulated mesalamine in Germany and other European countries, as well as Australia, under the trade name Salofalk Granu-Stix(R). The application to market Salofalk Granu-Stix is currently under regulatory review for additional non-EU countries.
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 in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company's 150-member gastroenterology specialty sales and marketing team.
Salix markets COLAZAL(R) (balsalazide disodium) Capsules 750 mg, XIFAXAN(R) (rifaximin) tablets 200 mg , OSMOPREP(TM) (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP(R) (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL(R) (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, PEPCID(R) (famotidine) for Oral Suspension, Oral Suspension DIURIL(R) (Chlorothiazide), AZASAN(R) Azathioprine Tablets, USP, 75/100 mg , ANUSOL-HC(R) 2.5% (Hydrocortisone Cream, USP), ANUSOL-HC(R) 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT(R) Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT(R) Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. SANVAR(R) IR (vapreotide acetate), balsalazide tablet, encapsulated mesalamine granules and rifaximin for additional indications are under development.
For full prescribing information on Salix products, please visit www.salix.com.
Salix trades on the NASDAQ Global Market under the ticker symbol "SLXP".
For more information please visit our web site at www.salix.com or contact the Company at 919-862-1000. Information on our web site is not incorporated in our 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 regulatory review and clinical trials, potential generic and other competition, market acceptance for approved products, intellectual property risks, the need to acquire additional products and management of rapid growth. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
Salix Pharmaceuticals, Ltd.
Adam C. Derbyshire, 919-862-1000
Senior Vice President and
Chief Financial Officer
Mike Freeman, 919-862-1000
Executive Director, Investor Relations and
Posted: October 2007