Salix Pharmaceuticals Previews American College of Gastroenterology 2009 Annual Scientific Meeting

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Mon Oct 26, 2009 11:00am EDT

Data Shows Rifaximin Demonstrated Favorable Long-Term Safety Profile for
Maintenance of Remission of Hepatic Encephalopathy

Data Shows Once-Daily APRISO Maintained Long-Term UC Remission and Reduced Risk
of Adverse Events in Patients Previously Treated with Corticosteroids
SAN DIEGO--(Business Wire)--
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announces that the 2009 American
College of Gastroenterology (ACG) Annual Scientific Meeting will be the venue
for 13 presentations describing the investigation of the Company`s
bacterial-related disease, inflammatory bowel disease and bowel cleansing
product lines. ACG is being held in San Diego, CA October 23-28. 

Rifaximin Has a Favorable Long-Term Safety Profile for Maintenance of Remission
from Overt Hepatic Encephalopathy

Oral 54, Wed., Oct. 28, 8:30 - 10:15 a.m., Room: Ballroom 20 AB 

In an oral presentation, Dr. Muhammad Y. Sheikh and colleagues will present the
results of an open-label maintenance extension study from the pivotal Phase 3,
multinational, randomized, double-blind, placebo-controlled study of 299
patients with a history of hepatic encephalopathy (HE). The results demonstrate
the rates and spectrum of adverse events (AEs) were similar in rifaximin-treated
patients compared with patients receiving placebo. Most patients in both
treatment arms - rifaximin and placebo - received concomitant lactulose therapy.
A total of 336 patients, comprised of the 299 patients who completed the
six-month randomized, double-blind, placebo-controlled trial plus 37 new
patients, were treated with rifaximin for up to 840 days. Of these, 257 patients
were on rifaximin for equal to or greater than six months and 114 patients were
on rifaximin for equal to or greater than one year. In the six-month randomized
trial, the pattern of adverse events was similar between rifaximin and placebo
groups, with adverse events experienced by 80 percent of patients in each group.
Fewer patients in the rifaximin group than the placebo group experienced severe
AEs (26% vs 31%), drug-related AEs (19% vs 21%), serious AEs (36% vs 40%) and
AEs leading to discontinuation (21% vs 28%). The safety profile of rifaximin
during long-term treatment was similar to that in the six-month randomized
trial. 

"The robust data emerging from these studies clearly demonstrate that rifaximin
has a very promising long-term safety profile for maintenance of remission from
overt hepatic encephalopathy," said Muhammad Y. Sheikh M.D., Associate Professor
of Clinical Medicine, University of California San Francisco (UCSF) and Chief of
Gastroenterology at UCSF Fresno. "With the previous data demonstrating
rifaximin`s durable efficacy in the maintenance of remission of HE, these
results continue to support rifaximin`s potential role in the long term
management of this disabling complication of cirrhosis. We believe the
availability of rifaximin has the potential to bring a paradigm shift in the
management of HE. We have waited for such a pharmacologic change for more than
30 years. Today`s news marks another positive milestone for rifaximin and
patients suffering from this serious condition." 

Long-Term Maintenance with Mesalamine Granules (1.5 g) in Patients Previously
Treated with Corticosteroids is Associated with a Low Incidence of Ulcerative
Colitis-Related Adverse Events

Poster 718 Mon, Oct. 26, 12:15 - 2:00 p.m. 

Dr. Gary Lichtenstein and colleagues will present results describing the
long-term (over 30 months) impact of once-daily mesalamine granules (MG) (1.5 g)
on patients in remission from ulcerative colitis (UC) who were treated with
steroids prior to enrollment. Patients were enrolled in two Phase 3, randomized,
double-blind, placebo-controlled trials (RCT) and treated for six months with
once-daily dosing of 1.5 g granulated mesalamine and then rolled over into a
24-month open label extension trial (OLT). The results of this long-term trial
demonstrate that the reduced risk of treatment emergent adverse events and
UC-related symptoms demonstrated during the two RCT trials (six months) was
sustained over the subsequent OLT (24 months). In the two RCT trials, more
MG-treated patients than placebo-treated patients remained relapse-free for six
months (79.4 % vs. 63.0%; p<0.001). This highly significant effect also was
noted in a subpopulation of 158 patients treated with steroids prior to
enrollment (77% vs. 55%; p<0.004). Seventy four MG-treated patients from the two
RCT trials continued MG treatment into the 24-month open label extension trial.
The low probability of recurrence of events and symptoms was sustained during
the 24-month open label extension trial. 

"Ulcerative colitis is a chronic disease that requires continuous management and
it is critically important to provide patients with a treatment option that will
offer long-term symptom relief," said study author Gary R. Lichtenstein, M.D.,
Director, Inflammatory Bowel Disease Program, Gastroenterology Division,
Department of Medicine, University of Pennsylvania. "This data further
demonstrates that APRISO is a safe and effective option to maintain remission,
even for UC patients who have previously received steroid therapy." 

Additional Presentations

RIFAXIMIN

* Poster 747 - Basu, et al. Prevalence of Restless Leg Syndrome in Patients with
Functional Bowel Disease in the Community. Mon, Oct. 26, 12:15 - 2:00 p.m. 
* Poster 534 - Randall, et al. Rifaximin is Efficacious in the Treatment of
Small Intestinal Bacterial Overgrowth. Mon, Oct. 26, 12:15 - 2:00 p.m. 
* Oral 17 - Chang, et al. Double-Blind Randomized Controlled Trial of Rifaximin
for Small Intestinal Bacterial Overgrowth (SIBO) in Celiac Disease. Mon, Oct.
26, 2:00 - 2:40 p.m., Room: Ballroom 20 CD 
* Poster 998 - Neff, et al. Efficacy of Rifaximin in Maintenance of Remission in
Patients with Hepatic Encephalopathy. Tues, Oct. 27, 12:15 - 2:00 p.m. 
* Poster 1139 - Shafran, et al. Rifaximin Maintenance Therapy for Crohn`s
Disease. Tues, Oct. 27, 12:15 - 2:00 p.m. 
* Poster 1155 - Infantolino, et al. Small Intestinal Bacterial Overgrowth (SIBO)
in Patients with Irritable Bowel Syndrome (IBS); A Retrospective Review of
Symptoms Following Treatment. Tues, Oct. 27, 12:15 - 2:00 p.m. 
* Poster 1093 - Basu, et al. Rifaximin Salvage Therapy for
Metronidazole-Resistant Clostridium difficile Infection - A Prospective Pilot
Trial. Tues, Oct. 27, 12:15 - 2:00 p.m. 
* Poster 1074 - Lillo, et al. Rifaximin: A Predisposing Agent to Clostridium
difficile? Tues, Oct. 27, 12:15 - 2:00 p.m.

APRISO

* Poster 717 - Lichtenstein, et al. Effect of Prognostic Factors on Maintenance
of Remission from Ulcerative Colitis in Patients Treated with Once-Daily
Mesalamine Granules (1.5 g). Mon, Oct. 26, 12:15 - 2:00 p.m.

MOVIPREP®

* Poster 412 - Cohen, et al. Is a "Good" Colonoscopy Bowel Prep Good Enough?
Adenoma Detection Rates from a Randomized Study of Two Colon Cleansing
Formulations. Mon, Oct. 26, 3:30 - 7:00 p.m. 
* Poster 759 - Matro, et al. Efficacy and Tolerance of 2L Polyethylene
Glycol-electrolyte Solution with Sodium Ascorbate and Ascorbic Acid (PEG)
Administered Entirely in the Morning (AM-only) Compared to Split Dose (PM/AM)
Administration Prior to Afternoon Colonoscopy. Mon, Oct. 26, 12:15 - 2:00 p.m.

About Hepatic Encephalopathy

Hepatic encephalopathy (HE) is a neurological disorder caused by chronic liver
failure resulting in cognitive, psychiatric, and motor impairments.1 The
condition encompasses a wide spectrum of often reversible neuropsychiatric
abnormalities caused by the inability of the liver to remove toxic products in
the gut, most notably ammonia- producing bacteria.2 When toxins reach the
central nervous system, this condition can result in symptoms ranging in
severity from mild cerebral function deficits to coma and characterized by
disruption in sleep patterns, changes in personality and intellectual capacity,
high blood ammonia levels, altered neuromuscular activity and
electroencephalogram (EEG) abnormalities.3,4

About XIFAXAN® (rifaximin) 

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. 

Rifaximin tablets 200 mg, which Salix markets in the United States 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 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 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%). 

About APRISO

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®

MOVIPREP® (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. 

About Salix Pharmaceuticals

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, 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 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, METOZOLVTM ODT (metoclopramide HCl), 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 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 unpredictable nature of the duration and results of
clinical trials and regulatory review of new drug applications; market
acceptance for approved products; generic and other competition; 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 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.

1 National Institute on Alcoholism and Alcohol Abuse of the National Institutes
of Health. Hepatic Encephalopathy. September 29, 2004. Available at:
http://pubs.niaaa.nih.gov/publications/arh27-3/240-246.htm. 

2 Blei AT, Co'rdoba J and The Practice Parameters Committee of the American
College of Gastroenterology. Hepatic Encephalopathy. Practice Guidelines. Vol.
96, No. 7, 2001. 

3 IBID 

4 Abou-Assi S. Vlahcevic ZR. Hepatic encephalopathy. Metabolic consequence of
cirrhosis often is reversible. Postgraduate Medicine. 109(2):52-4, 57-60, 63-5
passim, 2001 Feb.

Salix Pharmaceuticals, Ltd.
Adam C. Derbyshire
Executive Vice President and Chief Financial Officer
919-862-1000
or
G. Michael Freeman
Associate Vice President, Investor Relations and Corporate Communications
919-862-1000 



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