8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) October 6, 2008

SALIX PHARMACEUTICALS, LTD.

(Exact name of registrant as specified in its charter)

Delaware

(State or other jurisdiction of incorporation)

000-23265	94-3267443
(Commission File Number)	(IRS Employer ID Number)

1700 Perimeter Park Drive, Morrisville, North Carolina 27560

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code (919) 862-1000

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01. Other Events.

On October 6, 2008, Salix Pharmaceuticals, Ltd. issued a press release announcing the successful completion and outcome of its pivotal Phase 3 trial to evaluate the efficacy, safety and tolerability of rifaximin in preventing hepatic encephalopathy. A copy of this press release is attached as Exhibit 99.1.

On October 6, 2008, the company also issued a press release announcing that it presented at the annual meeting of the American College of Gastroenterology results from a phase II chemical trial that demonstrate the clinical utility of rifaximin in treating patients with irritable bowel syndrome (IBS). A copy of this press release is attached as Exhibit 99.2.

On October 7, 2008, the company issued a press release announcing data that demonstrates that mesalamine granules maintained remission in ulcerative colitis patients who switched from another 5-ASA product. A copy of this press release is attached as Exhibit 99.3.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press release dated October 6, 2008.
99.2	Press release dated October 6, 2008.
99.3	Press release dated October 7, 2008.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.

	SALIX PHARMACEUTICALS, LTD.
Date: October 7, 2008
	/s/ Adam C. Derbyshire
	Adam C. Derbyshire
	Senior Vice President and Chief Financial Officer

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

Contact:	Adam C. Derbyshire	G. Michael Freeman
	Senior Vice President and	Associate Vice President, Investor Relations
	Chief Financial Officer	and Corporate Communications
	919-862-1000	919-862-1000

RIFAXIMIN DEMONSTRATES HIGHLY STATISTICALLY SIGNIFICANT

RESULTS IN PREVENTION OF HEPATIC ENCEPHALOPATHY IN PIVOTAL

PHASE 3 STUDY

RALEIGH, NC, October 6, 2008 - Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the successful completion and outcome of its pivotal Phase 3 trial to evaluate the efficacy, safety and tolerability of rifaximin in preventing hepatic encephalopathy, or HE. This study demonstrates that the protocol-specified, intent-to-treat, primary endpoint comparison of a 6-month course of rifaximin at 550 mg dosed twice-a-day provides a highly statistically significant result in preventing HE, compared to placebo. The results seen with the primary endpoint are corroborated by the secondary endpoints. Hepatic encephalopathy, which encompasses a spectrum of reversible neuropsychiatric abnormalities that occur in patients with acute or chronic liver disease, is a serious medical condition that has no FDA-approved drug therapies available.

“We are extremely pleased with the outcome of our 299-patient, multicenter, randomized, double-blind, placebo-controlled trial of rifaximin,” stated Bill Forbes, Pharm.D., Vice President, Research and Development, and Chief Development Officer, Salix. “The results of this trial, which to our knowledge is the largest hepatic encephalopathy trial ever conducted, support earlier work that suggests rifaximin may be a suitable and well-tolerated agent for hepatic encephalopathy. We intend to meet with the FDA in the near future to discuss the results of this trial and appropriate next steps for submitting a New Drug Application to the U.S. Food and Drug Administration. Based on the results of this trial, we are excited about the prospects for rifaximin.

“Although the precise pathogenesis of HE is not fully defined, ammonia is the principal gut-derived neurotoxin implicated in the pathogenesis of HE. The use of antibiotics directed at reducing

bacterial production of ammonia is one therapeutic approach that has been utilized in the management of HE. However, the chronic use of antibiotics such as neomycin to prevent HE has been restricted due to side effects including kidney and hearing damage. Because patients with HE often have events that leave them unresponsive and hospitalized, HE has great economic, social, familial and personal implications. The use of a gut-selective antibiotic such as rifaximin that appears effective in treating organisms implicated in producing ammonia may be an important therapeutic advance in this population.”

About Rifaximin

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 is under investigation in the United States as a treatment for hepatic encephalopathy. In the United States, the FDA granted marketing clearance for rifaximin tablets 200 mg (trade name: XIFAXAN^®) indicated for the treatment of patients (>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%).

Rifaximin has been granted orphan drug designation by the U.S. Food and Drug Administration for use in hepatic encephalopathy. Salix believes that this designation will provide the Company with seven years of marketing exclusivity in the U.S. if rifaximin gains approval from the FDA for hepatic encephalopathy.

Rifaximin has been used in Italy for 23 years and is approved in 27 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 Salix

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.

Salix markets XIFAXAN^® (rifaximin) tablets 200 mg , OSMOPREP^® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP^® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL^® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, COLAZAL^® (balsalazide disodium) Capsules 750 mg, 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. METOZOLV™ ODT (metoclopramide), mesalamine granules, balsalazide tablet, vapreotide acetate and rifaximin for additional indications are under development.

For full prescribing information on Salix products, please visit www.salix.com 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 web site at www.salix.com . 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; the high cost and uncertainty of the research; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; our need to return to profitability and our 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.

# # #

EX-99.2

Exhibit 99.2

FOR IMMEDIATE RELEASE

Contact:	Adam C. Derbyshire	G. Michael Freeman
	Senior Vice President and	Associate Vice President, Investor Relations
	Chief Financial Officer	and Corporate Communications
	919-862-1000	919-862-1000

Salix Presents New Phase II Data Evidence Demonstrating the Clinical Utility of Rifaximin in Irritable Bowel Syndrome (IBS)

Results Presented at American College of Gastroenterology Annual Meeting Demonstrate

Quality of Life Benefits and IBS Symptom Severity as Predictor of Clinical Response

ORLANDO, FL, October 6, 2008 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced findings from two analyses of a Phase II clinical trial that demonstrate the utility of rifaximin, a non–absorbed, gut–selective antibiotic, in the treatment of patients with diarrhea–predominant irritable bowel syndrome (IBS). Data presented at the annual meeting of the American College of Gastroenterology (ACG) showed that patients treated with rifaximin demonstrated that the severity of baseline IBS symptoms of abdominal pain and bloating predicted clinical response to rifaximin and demonstrated statistically greater clinical improvement in quality of life compared with placebo.

“The latest findings, along with previously reported data, suggest a potential therapeutic role for rifaximin – a non–absorbed and gut–selective antibiotic – in patients with irritable bowel syndrome,” said William D. Chey, MD, professor of medicine in the Division of Gastroenterology at the University of Michigan, and director of the Gastrointestinal (GI) Physiology Laboratory at the University of Michigan Medical Center. “The evidence in support of rifaximin will be discussed in a forthcoming evidence-based review from the American College of Gastroenterology on the management of IBS.”

Improvements in Quality of Life

In a poster presentation at ACG, Dr. Chey and colleagues reported that a 2-week course of rifaximin (1100 mg/day) significantly improved quality of life (QOL) measures, compared with placebo (Poster #P691, Monday, October 6, 10:30 am – 4:00 pm). In a Phase II multi–center, double–blind, placebo–controlled trial, 191 adult patients diagnosed with diarrhea-predominant IBS (IBS-D) by Rome II criteria were randomized to receive rifaximin 550 mg twice daily (b.i.d.) and 197 patients were randomized to placebo. Following a 2-week initial treatment period, both groups of patients received placebo for an additional 14 days. Quality of life was assessed via the 34-item IBS-QOL questionnaire at baseline and 4 weeks after initiating treatment. Each item was scored on a 5-point scale (1=not at all; 2=slightly; 3=moderately; 4=quite a bit; 5=extremely or a great deal); results for composite and subscale scores were converted to a scale ranging from 0 to 100, with higher scores indicating better QOL.

At Week 4, the mean improvement from baseline in the overall QOL score was significantly greater with rifaximin compared with placebo (20.4 vs. 15.8, respectively; p=0.020). Patients in the rifaximin group also reported significantly greater mean improvement from baseline in QOL subscale scores for dysphoria (restlessness or agitation, 24.8 vs. 19.8; p=0.027), body image (20.1 vs. 14.6; p=0.012), health worry (16.0 vs. 12.2; p=0.047), social reaction (17.3 vs. 13.2; p=0.047), and relationships (14.9 vs. 10.7; p=0.030), compared with placebo. Rifaximin was well tolerated in the study, with a similar incidence of adverse events compared with placebo.

Severity of Baseline Symptoms as Predictor of Clinical Response

In a separate poster presentation from the same study, Mark Pimentel, MD, and colleagues reported that the severity of baseline symptoms of abdominal pain and bloating influenced the response to rifaximin treatment (Poster #P1065, Tuesday, October 7, 10:30am – 4:00pm). The co-primary endpoints in this analysis assessed weekly yes/no responses to questions regarding adequate relief of global IBS symptoms and IBS-associated bloating. Clinical response was defined as adequate relief for at least 2 of the final 3 treatment weeks (Week 2, 3 or 4). Severity of baseline IBS symptoms was evaluated as a potential confounder of clinical response and was categorized as mild/moderate or severe based on a mean score of £4 vs. >4 (on a 7-point scale [0=not bothersome; 6=very bothersome]) for bloating and abdominal pain.

A significantly larger percentage of patients treated with rifaximin reported adequate relief of global IBS symptoms (52% vs. 44% for placebo; p=0.03) and bloating (46% vs. 40%; p=0.04), compared with placebo-treated patients. In patients with mild/moderate abdominal pain, rifaximin produced a greater degree of improvement, compared with placebo, in global symptoms of IBS (50% vs. 39%, respectively; p=0.04) and bloating (44% vs. 35%; p=0.09). Similarly, in patients with mild/moderate bloating, rifaximin treatment was associated with greater improvement, compared with placebo, in global IBS symptoms (56% vs. 41%, respectively; p=0.006) and bloating (47% vs. 36%; p=0.03). However, rifaximin was not significantly superior to placebo in improving global IBS symptoms or bloating in patients who had severe baseline abdominal pain or bloating.

“The symptom-based criteria that are used for enrolling patients with IBS in clinical trials are overly broad and often lead to enrollment of individuals ranging from mild to severe, despite the possibility that patients with severe IBS symptoms may respond differently to treatment compared with individuals with moderate complaints,” commented Dr. Pimentel, who is director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai Medical Center, and associate professor in residence for the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). “Our data demonstrate that patients with mild/moderate IBS symptoms are more likely than those with severe disease to achieve symptomatic relief with rifaximin. Clinical trials evaluating the efficacy of IBS therapies should therefore account for baseline symptom severity because of the potential impact of these symptoms on therapeutic efficacy. Additionally, incorporating severity assessments into clinical practice may improve treatment success in patients with IBS.”

Other Rifaximin-related Presentations at ACG

In addition to the presentations by Drs. Chey and Pimentel, the ACG program includes the following rifaximin-related presentations:

• Poster #P495: Neff, et al. Clostridium difficile infection was not detected in patients who received rifaximin for hepatic encephalopathy in community and university practices. Monday, October 6, 10:30am – 4:00pm.

• Poster #P549: Finkelstein, et al. Efficacy of rifaximin as long-term maintenance therapy for refractory Crohn’s disease. Monday, October 6, 10:30am – 4:00pm.

• Poster #P1046: Bosworth, et al. Long-term follow-up of the use of rifaximin in maintaining clinical remission in moderate and severe Crohn’s disease. Tuesday, October 7, 10:30am – 4:00pm.

• Poster #P670: Shafran, et al. Comparison of computed tomographic enterography with standard diagnostic assessments for detecting active Crohn’s disease. Monday, October 6, 10:30am – 4:00pm.

• Poster #P544: Shafran, et al. Rifaximin monotherapy was effective in patients with newly diagnosed Crohn’s disease. Monday, October 6, 10:30am – 4:00pm.

• Poster #P669: Shafran, et al. Monitoring patients with ulcerative colitis in community-based practice to improve adherence. Monday, October 6, 10:30am – 4:00pm.

• Poster #P700: Jolley. Efficacy of rifaximin for the treatment of symptoms associated with irritable bowel syndrome. Monday, October 6, 10:30am – 4:00pm.

• Poster #P1074: Pimentel, et al. A combination of rifaximin and neomycin is most effective in treating patients with methane on lactulose breath test. Tuesday, October 7, 10:30am – 4:00pm.

• Poster #P448: Weinstock, et al. Rifaximin Improves Restless Legs Syndrome Associated With Bacterial Overgrowth. Monday, October 6, 10:30am – 4:00pm.

• Poster #P447: Weinstock, et al. Celiac disease is associated with restless legs syndrome. Monday, October 6, 10:30am – 4:00pm.

• Poster #P308: Weinstock, et al. Crohn’s Disease is Associated with Restless Legs Syndrome: A New Extraintestinal Manifestation. Sunday, October 5, 3:30pm – 7:00pm.

About IBS

Among one of the most common chronic conditions, irritable bowel syndrome (IBS) affects approximately 14% of adults in the United States. IBS includes altered bowel habits with abdominal

pain and discomfort. Among other contributors, recent science has shown that alterations in gut flora / bacteria have been identified as a potentially important contributor to the pathophysiology of IBS. Small intestinal bacterial overgrowth, a condition associated with excessive numbers of bacteria in the small intestine, may underlie some of the gastrointestinal symptoms associated with IBS.

About XIFAXAN

Rifaximin, which Salix markets in the United States under the trade name XIFAXAN^® (rifaximin), currently is approved for the treatment of patients, 12 years of age or older, with travelers’ diarrhea caused by non–invasive strains of Escherichia coli.

XIFAXAN^® (rifaximin) is a gut–selective antibiotic with negligible systemic absorption (<0.4%) and broad–spectrum activity in vitro against both gram–positive and gram–negative pathogens. Rifaximin has a similar tolerability profile to that of placebo and has activity against the most common TD pathogens.

XIFAXAN is under investigation in the United States as a treatment for irritable bowel syndrome. In the United States, the FDA granted marketing clearance for XIFAXAN tablets 200 mg indicated for the treatment of patients (³12 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% (versus 19.7%), headache 9.7% (versus 9.2%), abdominal pain 7.2% (versus 10.1 %) and rectal tenesmus 7.2% (versus 8.8%).

Rifaximin has been used in Italy for 23 years and is approved in 23 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 Salix

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 also markets OSMOPREP^® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP^® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL^® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, COLAZAL^® (balsalazide disodium) Capsules 750 mg, 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. METOZOLV™ ODT (metoclopramide), mesalamine granules, balsalazide tablet, vapreotide acetate and rifaximin for additional indications are under development.

For full prescribing information on Salix products, please visit www.salix.com 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 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: 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 high cost and uncertainty of the research, clinical trials and other development activities involving pharmaceutical products; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; our need to return to profitability; generic and other competition and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; market acceptance for approved products 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.

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EX-99.3

Exhibit 99.3

FOR IMMEDIATE RELEASE

Contact:	Adam C. Derbyshire	G. Michael Freeman
	Senior Vice President and	Associate Vice President, Investor Relations
	Chief Financial Officer	and Corporate Communications
	919-862-1000	919-862-1000
	Bill Forbes	Media Contact: Alyssa Bleiberg
	Pharm D. and	212-485-6806
	Chief Development Officer
	919-862-100

DATA RELEASED TODAY DEMONSTRATE THAT MESALAMINE GRANULES

MAINTAIN REMISSION IN ULCERATIVE COLITIS PATIENTS WHO SWITCH FROM ANOTHER 5-ASA

More Patients Switched to Mesalamine Granules Maintained Remission

Versus Placebo (78 percent versus 59 percent)

ORLANDO, FL, October 7, 2008 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that 1.5 g mesalamine granules once-daily maintained remission versus placebo in ulcerative colitis (UC) patients who switched from another 5-ASA product (78 percent of relapse-free subjects vs. 59 percent [P<0.001]). These patients also had a greater probability of remaining relapse free after six months compared to placebo (77 percent vs. 50 percent [P<0.001] cumulative relapse-free probability)¹. Mesalamine granules are being studied as a 5-ASA with both a delayed and extended release system that delivers mesalamine directly to the colon with minimal systemic exposure and convenient once-daily dosing. These data were presented today at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting in Orlando, Florida.

“It is crucial for remittent ulcerative colitis patients to stay on treatment to prevent relapse, yet these patients often fail or switch 5-ASA therapy due to non-adherence or lack of efficacy,” said study author Gary R. Lichtenstein, MD, Director, Inflammatory Bowel Disease Program, Gastroenterology Division, Department of Medicine, University of Pennsylvania. “These results coupled with the formulation and convenient once-daily dosing may improve patient compliance, potentially making it an attractive maintenance therapy for remission of ulcerative colitis (subject to the FDA’s pending review).”

About the Study

Patients (n=487) with documented UC remission (as defined by the revised Sutherland Disease Activity Index) received 1.5 g mesalamine granules (four 375-mg capsules once daily) or placebo once daily for six months. Patients taking mesalamine granules achieved the following results:

• Overall, nearly 8 out of 10 patients maintained remission of UC after six months (78 percent vs. 59 percent with placebo [P<0.001])

• In a sub-set analysis, 305 patients who switched from a prior 5-ASA had a higher probability of remaining relapse free after six months (77 percent vs. 50 percent [P<0.001])

Additional Mesalamine Granules Abstracts Presented at ACG

Poster 279

Mesalamine granules 1.5 g once-daily were clinically demonstrated to be more effective than placebo in maintaining long-term remission of UC (79 percent vs. 58 percent of patients were relapse-free at six months [P<0.001]). A larger proportion of mesalamine granules patients showed a clinically favorable change from baseline in physician-rated disease activity at month six compared with placebo (78 percent vs. 64 percent [P=0.005]). Patients taking mesalamine granules also had a higher probability of remaining relapse-free at six months (77 percent vs. 56 percent [P<0.001]). ²

Poster 673

Overall, fewer patients taking mesalamine granules (28 percent) withdrew versus patients who received placebo (43 percent) due to disease relapse (12 percent vs. 20 percent for placebo) or adverse events (11 percent vs. 16 percent for placebo). For mesalamine granules versus placebo, the most common adverse events were UC flare (11 percent vs. 24 percent), headache (11 percent vs. 8 percent), and diarrhea (8 percent vs. 7 percent). Incidence of renal, hepatic, and pancreatic AEs was low and comparable in both the mesalamine granules (6 percent) and placebo (5 percent) groups. The percentage of patients who experienced serious adverse events was small in both the mesalamine granules (1 percent) and placebo (two percent) groups, and no event reported in the mesalamine granules group was considered drug-related.³

Poster 682 & Poster 681

An additional study showed that the pharmacokinetic profile and systemic absorption of mesalamine granules was comparable whether administered once- or twice-daily.⁴ In addition, the overall systemic absorption of mesalamine granules was low and essentially unaltered by a high-fat meal eaten before dosing, as seen in a fifth study⁵. The ability to take mesalamine granules with or without food, along with its once-daily dosing, may improve patient compliance and treatment success.

“The results of these studies, providing evidence of once-daily mesalamine granules in maintaining remission, are good news for remittent ulcerative colitis patients,” said Bill Forbes, Pharm.D., Salix Vice President, Research & Development, and Chief Development Officer. “Salix is committed to continually striving to better serve the needs of patients who suffer from this debilitating condition.”

About Mesalamine Granules

Salix acquired rights to market mesalamine granules in the U.S. from Dr. Falk Pharma GmbH of Freiburg, Germany. Mesalamine granules have been approved in Germany since 2001 for the treatment of symptoms related to inflammatory bowel disease. In addition, the once-daily dosing label is currently approved via mutual recognition procedure in Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Luxemburg, Netherlands, Norway, Portugal, Sweden, UK, and Spain.

Salix is currently seeking regulatory approval of the product in the U.S. Given the product’s unique delivery mechanism, Salix intends to develop it for a variety of treatment options and improved dosing regimens.

About Ulcerative Colitis

Ulcerative colitis is a chronic inflammatory disease of the colon or large intestine. The inflammation usually begins in the rectum and lower colon, but it may also involve the entire colon.

Because the inflammation makes the colon empty frequently, symptoms typically include diarrhea (sometimes accompanied by blood) and often abdominal pain. About five percent of people with ulcerative colitis will develop colorectal cancer.

Patients with ulcerative colitis may experience periods of remission (times when the symptoms go away) that can last for months or years. However, most patients’ symptoms eventually return. Active therapy is treatment given to treat ulcerative colitis symptoms when they are active. Maintenance therapy refers to treatment given to patients to enable them to stay in remission, to maintain their health in a disease-free, or limited-disease, state. Maintenance medications must be taken for a prolonged period of time.

About Salix Pharmaceuticals

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 with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.

Salix markets XIFAXAN^® (rifaximin) tablets 200 mg, OSMOPREP^® (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP^® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL^® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, COLAZAL^® (balsalazide disodium) Capsules 750 mg, 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. METOZOLV™ ODT (metoclopramide), mesalamine granules, balsalazide tablet, vapreotide acetate 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 Select 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 into 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 high cost and uncertainty of the research, clinical trials and other development activities involving pharmaceutical products; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; our need to return to profitability; generic and other competition and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties; market acceptance for approved products 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.

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1. Lichtenstein GR, et al. Once-daily mesalamine granules effectively maintains remission in patients with ulcerative colitis who switch from different 5-ASA formulations

2. Gordon GL, et al. Once-daily mesalamine granules is effective and safe in maintenance of remission in mild-to-moderate ulcerative colitis

3. Zakko, S, et al. Safety profile of once-daily mesalamine granules as maintenance therapy for mild-to-moderate ulcerative colitis

4. Safdi A, et al. Multiple-dose pharmacokinetics of mesalamine granules, a unique formulation providing delayed and extended release of 5-ASA

5. Safdi A, et al. Minimal effect of a high-fat meal on the pharmacokinetics of once-daily mesalamine granules