POSTER PRESENTATIONS: -0-
TOPIC LEAD AUTHOR DATE ---------------------------------------- -------------------- -------- XIFAXAN An open label series of rifaximin for A. Kornbluth, M.D. May 20 long term maintenance therapy for patients with refractory pouchitis History of hypothyroidism is associated E. Lauritano, M.D. May 20 to small intestinal bacterial overgrowth High dosage rifaximin for the treatment E. Scarpellini, M.D. May 20 of small intestinal overgrowth High recurrence of small intestinal E. Lauritano, M.D. May 20 bacterial overgrowth after antibiotic Rifaximin versus systemic antibiotics M. Gabrelli, M.D. May 20 for the treatment of small bowel bacterial overgrowth Small intestinal bacterial overgrowth in A. Parodi, M.D. May 20 acromegalic patients May breath test be useful in diagnosis A. Parodi, M.D. May 20 of IBS patients? an Italian Study The oral nonsystemic antibiotic H. DuPont, M.D. May 20 rifaximin prevents symptom recurrence in patients with recurrent C. difficile-associated diarrhea Characterization o f C. difficile strain Z. Jiang, M.D. May 20 isolated from patients with hospital- associated diarrhea The effect of selective intestinal A. Saveriadis, M.D. May 20 decontamination on liver hemodynamics in patients with alcohol related decompensated cirrhosis Restless leg syndrome in patients with L. Weinstock, M.D. May 21 irritable bowel disease: response to bacterial overgrowth therapy Small intestinal bacterial overgrowth in L. Weinstock, M.D. May 21 patients with interstitial cystitis and gastrointestinal symptoms Double blind, randomized study to M. Lukas, M.D. May 22 evaluate efficacy and urinary excretional rate of two doses of rifaximin-EIR in mild to moderate active Crohn's disease (GRACE 02 study) Rifaximin as a steroid-sparing T. Shah, M.D. May 23 medication in the management of patients with mild to moderate inflammatory bowel disease Decreasing rates of colectomy despite M. Issa, M.D. May 23 high rates of hospitalization in C. difficile infected IBD patients: a tertiary referral center experience MOVIPREP Better efficacy of a new 2-liter bowel L. Clark May 22 cleansing preparation in the ascending colon Randomised and controlled clinical trial H. Gruss May 23 of polyethylene glycol with electrolytes and ascorbic acid in comparison to sodium phosphate for bowel preparation before colon cancer screening colonoscopy COLAZAL Efficacy and safety of balsalazide for J. Quiros May 22 treatment of pediatric patients with mild to moderate ulcerative colitis: A randomized double-blind study
CONTINUING MEDICAL EDUCATION ACTIVITES
In addition, Salix is supporting, through an unrestricted educational grant, two continuing medical education activities in conjunction with DDW this year: -0-
"Navigating the Clinical Maze of GI Disorders" Faculty Chair Gary Lichtenstein, M.D. Professor of Medicine Director, Center for Inflammatory Bowel Disease University of Pennsylvania School of Medicine
"Maximizing Neoplasia Detection during Colonoscopy: Bowel Preparation Technique and Technology" -0-
Faculty Chair Douglas Rex, M.D. Chancellor's Professor Indiana University - Purdue University Professor of Medicine Indiana University School of Medicine Director of Endoscopy Indiana University Hospital
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 19-24, 2007, at the Washington Convention Center, Washington, DC. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.
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 gastroenterology specialty sales and marketing team.
COLAZAL(R) (balsalazide disodium) Capsules 750 mg, is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL beyond 12 weeks has not been established. COLAZAL was well tolerated in clinical studi es. 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 (4%). Withdrawal from therapy due to adverse events was comparable to placebo.
XIFAXAN(R) (rifaximin) tablets 200 mg are indicated for the treatment of patients (greater than or equal to 12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli. XIFAXAN should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. XIFAXAN should be discontinued if diarrhea symptoms get worse or persist more than 24-48 hours and alternative antibiotic therapy should be considered. In clinical trials, XIFAXAN was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1 %) and rectal tenesmus 7.2% (vs. 8.8%).
MOVIPREP(R) (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities such as diuretics or angiotensin converting enzyme (ACE)-inhibitors or in patients with known or suspected hyponatremia. MOVIPREP should also be used with caution in patients with severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, or toxic megacolon. In clinical trials, abdominal distension, anal discomfort, thirst, nausea and abdominal pain were some of the most common adverse reactions to MOVIPREP administration. Vomiting occurred less frequently.
Salix also markets OSMOPREP(TM) Tablets (sodium phosphate monobas ic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP), VISICOL(R) Tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous), PEPCID(R) (famotidine) Oral Suspension, DIURIL(R) (chlorothiazide) Oral Suspension, AZASAN(R) (Azathioprine Tablets, USP), ANUSOL-HC(R) (Hydrocortisone Cream, USP) and PROCTOCORT(R) (Hydrocortisone Cream, USP). Balsalazide disodium tablets, granulated mesalamine, SANVAR(R) (600 ug vials vapreotide acetate powder) and Xifaxan are under development for additional indications.
Salix trades on the NASDAQ Market under the ticker symbol "SLXP."
For more information please contact the Company at 919-862-1000 or visit our web site at www.salix.com. 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, competition, intellectual property risks, market acceptance for approved products, management of rapid growth 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.
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