Salix Pharmaceuticals Previews American College of Gastroenterology 2011
RALEIGH, NC, October 28, 2011 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that educational activities and numerous presentations describing the investigation of several of the Company's products – including rifaximin, RELISTOR®, APRISO™ and MOVIPREP® –– will occur during the American College of Gastroenterology 2011 Annual Scientific Meeting. ACG 2011 is being held in Washington, DC, October 28 – November 2, 2011.
Continuing Medical Education (CME) Dinner Symposium
(funded by Salix through an unrestricted educational grant)
"Trial by Jury: Clinical Judgments in the Management of HE & HCV"
Gaylord National Hotel & Convention Center
Saturday, October 29, 2011
6:00 – 8:00 p.m.
Rifaximin–Related Presentations
Poster #1171: Pimentel et al. "Evaluation of Rifaximin Efficacy in Non C–IBS Patients by Baseline Disease Severity: Subanalysis of the TARGET 1 and TARGET 2 Studies"
Poster #1172: Pimentel et al. "Understanding Harm in the Pharmacotherapy of Irritable Bowel Syndrome with Diarrhea"
Poster #755: L. Weinstock. "Rifaximin Therapy for Irritable Bowel Syndrome: Efficacy and Durability of Antibiotic Treatment"
Poster #541: Mohammadi et al. "Effectiveness of Antibiotic Therapy on Small Intestinal Bacteria Overgrowth: A Retrospective Study of 401 Patients"
Poster #943: L. Weinstock. "Small Intestinal Bacterial Overgrowth and Rosacea: Prevalence and Response to Rifaximin"
Poster #566: Cheema et al. "Rifaximin Therapy for Small Intestinal Bacterial Overgrowth Associated Arthritis"
Oral Presentation #10: Mellow et al. "Long–term Follow–up of Colonoscopic Fecal Microbiota Transplant (FMT) for Recurrent C. difficile Infection (RCDI)"
Poster #292: Song et al. "Rifaximin Promotes Mucosa Healing via Inhibition of P38 Phosphorylation in CaCo2 Cells"
Poster #1110: Borody et al. "Myoclonus–dystonia Affected by GI Microbiota?"
Poster #675: Brunson et al. "The Colon Had an "Air" About It: A Case of Symptomatic Pneumatosis Intestinalis"
RELISTOR® –Related Presentations
Poster #124: Patel et al. "GI Stasis in Critical Care Patients: Rescue with Methylnaltrexone and Influence on Laxation, Enteral Feeding and Residual Gastric Volume"
Poster #766: Moss et al. "Methylnaltrexone Treats Opioid–Induced Bowel Dysfunction in Three Critically Ill Patients"
APRISO™ –Related Presentations
Poster #298: Bosworth et al. "Optimization of Oral Mesalamine Therapy Leads to Clinical Improvement in Mild to Moderate Ulcerative Pancolitis"
Poster #1149: G. Gordon. "Mesalamine Granules for the Treatment of Clostridium difficile–Associated Pseudomembranous Ulcerative Pancolitis"
Bowel Cleansing–Related Presentations
Oral Presentation #22: Suryakanth et al. "Increased Adenoma Detection Rate with System–
Wide Implementation of a Split–dose Preparation for Colonoscopy"
Poster #412: Gutkin et al. "Full Liquid Diet vs. Clear Liquid Diet for Colonoscopy Preparation:
Preliminary Results"
Poster #785: Godfrey et al. "Low–volume Polyethylene Glycol and Ascorbic Acid for Bowel
Preparation Prior to Colonoscopy: A Meta–Analysis"
Poster #1233: C. Gentry. "Split–Dosing Bowel Preparation in Patients Undergoing Deep
Sedation with Propofol for Colonoscopy"
Additional information for each of the above presentations can be found at the American College
of Gastroenterology website at www.ACG.GI.org .
About XIFAXAN® (rifaximin) 550 mg tablets
Important Safety Information
XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age. In the trials of XIFAXAN for HE, 91 percent of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores greater than 25, and only 8.6 percent of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child–Pugh C).
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema and anaphylaxis.
Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
The most common adverse reactions occurring in greater than eight percent of patients in the clinical study were edema peripheral (15 percent), nausea (14 percent), dizziness (13 percent), fatigue (12 percent), ascites (11 percent), muscle spasms (nine percent), pruritus (nine percent) and abdominal pain (nine percent).
About XIFAXAN® (rifaximin) 200 mg tablets
Rifaximin is a gut–selective antibiotic with negligible systemic absorption and broad–spectrum activity in vitro against both Gram–positive and Gram–negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.
Rifaximin tablets 200 mg, which Salix markets in the U.S. under the trade name XIFAXAN® (rifaximin) tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers' diarrhea (TD) caused by non–invasive 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 (versus placebo) were flatulence 11.3 percent (versus 19.7 percent), headache 9.7 percent (versus 9.2 percent), abdominal pain 7.2 percent (versus 10.1 percent) and rectal tenesmus 7.2 percent (versus 8.8 percent).
Rifaximin has been used in Italy for 24 years and is approved in 33 countries. Salix acquired rights to market rifaximin in North America from Alfa Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets rifaximin in Italy under the trade name Normix®.
About RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection
Important Safety Information
RELISTOR is indicated for the treatment of opioid–induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied.
RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician. Use of RELISTOR has not been studied in patients with peritoneal catheters.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract (e.g., stomach, duodenum, colon).
Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
The most common adverse reactions reported with RELISTOR compared with placebo in clinical trials were abdominal pain (28.5% vs 9.8%), flatulence (13.3% vs 5.7%), nausea (11.5% vs 4.9%), dizziness (7.3% vs 2.4%), diarrhea (5.5% vs 2.4%), and hyperhydrosis (6.7% vs 6.5%).
RELISTOR is under license to Salix Pharmaceuticals and Ono Pharmaceutical from Progenics Pharmaceuticals.
About APRISO™
Important Safety Information
APRISO™ is a locally–acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older. APRISO is contraindicated in patients with hypersensitivity to salicylates, amniosalicylates, or to any of the components of APRISO capsules. The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame, equivalent to 0.56 mg of phenylalanine. In two well–controlled clinical trials, the most common treatment–related adverse events occurring in greater than 3% of adult patients taking 1.5 g/day of APRISO (versus placebo) were headache (11% vs. 8%), diarrhea (8% vs. 7%), upper abdominal pain (5% vs 3%), nausea (4% vs 3%), nasopharyngitis (4% vs 3%), influenza and influenza–like illness (4% vs 4%) and sinusitis (3% vs 3%).
About MOVIPREP® (PEG–3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution)
Important Safety Information
MOVIPREP® (PEG–3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP is contraindicated in patients with gastrointestinal (GI) obstruction, bowel perforation, gastric retention, ileus, toxic colitis or toxic megacolon, and patients who have had a severe hypersensitivity reaction to any of its components. MOVIPREP should be used with caution in patients at risk of or with fluid and electrolyte abnormalities, hyponatremia, arrhythmias, seizures, in patients with impaired renal function or patients taking concomitant medications that affect renal function, patients with known or suspected inflammatory bowel disease, patients with suspected GI obstruction or perforation, patients at risk for aspiration, and patients with glucose–6–phosphate dehydrogenase deficiency. Most common adverse reactions for split dosing (incidence > 5%) are malaise, nausea, abdominal pain, vomiting, and upper abdominal pain. The most common adverse reactions for evening only dosing (incidence > 5%) are abdominal distension, anal discomfort, thirst, nausea, abdominal pain, sleep disorder, rigors, hunger, malaise, vomiting, and dizziness. MOVIPREP contains 233 mg of phenylalanine per treatment. Advise patients to hydrate adequately before, during, and after the use of MOVIPREP.
About Salix
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the prevention and 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.
Salix also markets OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, APRISO™ (mesalamine) extended–release capsules 0.375 g, METOZOLV® ODT (metoclopramide HCl), RELISTOR® (methylnaltrexone bromide) Subcutaneous Injection, PEPCID® (famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® (Azathioprine) Tablets, USP, 75/100 mg, ANUSOL–HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL–HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. Crofelemer, budesonide foam, RELISTOR®, Lumacan® and rifaximin for additional indications are under development.
For full prescribing information and important safety information on Salix products, including BOXED WARNINGS for VISICOL, OSMOPREP and METOZOLV, please visit www.salix.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at 919 862–1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP".
For more information, please visit our Website at www.salix.com or contact the Company at 919–862–1000. Follow us on Twitter (@SalixPharma) and Facebook (www.facebook.com/SalixPharma ). Information on our web site is not incorporated in our SEC filings.
Please Note: The materials provided herein contain projections and other forward–looking statements regarding future events. Such 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, among others: the cost, timing and results of clinical trials and other development activities involving pharmaceutical products; generic and other competition in an increasingly global industry; litigation and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties in an increasingly global industry; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; revenue recognition and other critical accounting policies; and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.