Balsalazide 3.3 Grams Twice-Daily Shows Significant Improvement in Bowel Function...

Balsalazide 3.3 Grams Twice-Daily Shows Significant Improvement in Bowel Function and Some Quality of Life Measures as Early as Week Two

Ulcerative Colitis Patients Reported Improvement in Rectal
Bleeding, Bowel Frequency and Bowel Healing, as Well as Emotional and
Social Functions
SAN DIEGO--(Business Wire)--
Salix Pharmaceuticals, Ltd. (NASDAQ: SLXP) today announced that as
early as two weeks into treatment, patients with mild-to-moderate
active ulcerative colitis taking 3.3 g balsalazide disodium tablets
twice-daily versus placebo for active disease management experienced
significantly greater quality of life (QoL) improvements in bowel
function, as well as improvement in their emotional state as measured
by a variety of factors including feelings of frustration, anger,
impatience and anxiety. Balsalazide 1.1 g tablets will be the first
5-ASA agent for active disease that patients will only need to take
twice a day. These data were presented today at the Digestive Disease
Week 2008 annual meeting in San Diego, California.

"The quality of life benefits seen with balsalazide's twice-daily
dosing regimen enhance the utility of this proven anti-inflammatory
agent and make the 1.1 g tablet an important new treatment option for
patients suffering with this debilitating disease," said study author
Ellen Scherl, MD, Director, Jill Roberts Center for Inflammatory Bowel
Disease, The New York Presbyterian Hospital, Weill Medical College of
Cornell University.

Results

After two weeks, patients taking balsalazide 3.3 g twice-daily
reported significantly greater improvement versus placebo across a
broad range of measures including bowel symptoms, systemic symptoms,
emotional function and social function. Additionally, significantly
more patients who received balsalazide 3.3 g twice-daily reported they
were satisfied or very satisfied with treatment versus those taking
placebo (73 percent vs. 56 percent (P=0.0230)) at the end of the eight
week trial.

-0-
*T
At Two Weeks
----------------------------------------------------------------------
Balsalazide Placebo Statistical
3.3 g Significance
twice-daily
----------------------------------------------------------------------
Mean Bowel Symptom Score 9.7 points 6.3 points P=0.0043
----------------------------------------------------------------------
Mean Emotional Function Score 11.1 points 8.2 points P=0.0105
----------------------------------------------------------------------
Mean Social Function Score 3.5 points 2.4 points P=0.0043
----------------------------------------------------------------------
Mean Total QoL Score 27.9 points 20.1 points P=0.0064
----------------------------------------------------------------------
At Eight Weeks
----------------------------------------------------------------------
Mean Emotional Function Score 12 points 10.5 points P=0.0192
----------------------------------------------------------------------
Mean Social Function Score 4.7 points 4.1 points P=0.0055
----------------------------------------------------------------------
Total QoL Score 32.7 points 29.7 points P=0.0302
----------------------------------------------------------------------

*T

Balsalazide 3.3 g Tablets Twice-Daily Effective in Improving Signs
and Symptoms of Mild-to-Moderate Disease

Another abstract from the study presented today showed that
patients taking three 1.1 g balsalazide tablets twice-daily versus
placebo experienced improvement in their symptoms at week eight,
including rectal bleeding (59 percent vs. 42 percent (P=0.01)); bowel
frequency (49 percent vs. 37 percent (P=0.08)); and mucosal appearance
(53 percent vs. 37 percent (P=0.02)), significant indicators of bowel
healing. Importantly, this improvement was measured by both patient
and physician assessment.

-- A significantly larger proportion of patients in the
balsalazide 1.1 g twice-daily group vs. placebo
experienced improvement in the total Modified Mayo Disease
Activity Index (MMDAI) score at week eight (67 percent vs.
47 percent (P=0.004)).

-- A significantly larger proportion of patients in the
balsalazide 1.1 g twice-daily group vs. placebo
experienced improvement in the physician's assessment of
disease (60 percent vs. 36 percent (P=0.0004)).

A third abstract reported that balsalazide 3.3 g tablets
twice-daily were well tolerated with a side effect profile equal to or
better than placebo. The percentage of patients who experienced any
adverse events (AEs) was 55 percent for balsalazide 3.3 g tablets
twice-daily versus 68 percent for placebo. The majority of AEs
experienced by either group were mild or moderate in intensity. The
most common AEs were exacerbation of ulcerative colitis, headache,
diarrhea and abdominal pain.

Twice-Daily Dosing Stands to Improve Patient Compliance

Balsalazide 1.1 g tablets will be the first 5-ASA agent that
patients with mild-to-moderate active ulcerative colitis will only
need to take twice a day -- standing to improve their adherence to
therapy. Despite the effectiveness of oral 5-ASA agents (like
balsalazide 1.1 g tablets), a majority of patients do not take their
medications as prescribed because of the frequency and number of pills
required to control their symptoms. A study conducted by the Crohn's
and Colitis Foundation of America (CCFA) found that 65 percent of
patients with ulcerative colitis are poorly compliant with their
medication, citing pill burden and inconvenience associated with the
medication as key reasons.

About the Study

Adults (n=250) with mild-to-moderate active ulcerative colitis
were randomized to receive either balsalazide 3.3 g twice-daily or
placebo for eight weeks. Patient quality of life was assessed at
baseline, week two and week eight (or last treatment) by the
inflammatory bowel disease questionnaire (IBDQ), a 32-item patient
questionnaire grouped into four components: bowel symptoms, systemic
symptoms, emotional function and social function. At the end of the
study, patients were interviewed to assess satisfaction with
treatment.

A colonoscopy or sigmoidoscopy was performed at screening and at
week eight or end of treatment. Secondary efficacy endpoints were
assessed using the MMDAI at screening, baseline and at week eight.
Safety evaluations involved clinical lab assessments (e.g., hematology
and blood chemistry) at baseline and weeks two and eight, with vital
sign measurements and AE and concomitant medication documentation at
baseline and weeks one, two, four and eight.

About Ulcerative Colitis

Ulcerative colitis is a chronic disease of the colon or large
intestine. The disease is marked by inflammation and ulceration of the
colon mucosa or innermost lining. Tiny open sores, or ulcers, form on
the surface of the lining, where they bleed and produce pus and mucus.
Because the inflammation makes the colon empty frequently, symptoms
typically include diarrhea (sometimes accompanied by blood) and often
abdominal pain. The inflammation usually begins in the rectum and
lower colon, but it may also involve the entire colon.

Some people with ulcerative colitis have remissions--periods when
the symptoms go away--that last for months or years. However, most
patients' symptoms eventually return. Active therapy is treatment
given to treat UC 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.

People with ulcerative colitis have abnormalities of the immune
system, but it is not known whether these abnormalities are a cause or
a result of the disease. The body's immune system is believed to react
abnormally to the bacteria in the digestive tract. Ulcerative colitis
is not caused by emotional distress or sensitivity to certain foods or
food products, but these factors may trigger symptoms in some people.
About 5 percent of people with ulcerative colitis develop colorectal
cancer. The risk of cancer increases with the duration of the disease
and how much the colon has been damaged. For example, if only the
lower colon and rectum are involved, the risk of cancer is no higher
than normal. However, if the entire colon is involved, the risk of
cancer may be as much as 32 times the normal rate.

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.

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 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; market acceptance for approved products; the need to
acquire new 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. 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 Derbyshire, Chief Financial Officer
Bill Forbes, Pharm D., Chief Development Officer
G. Michael Freeman, Investor Relations &
Corporate Communications
919-862-1000
or
Media:
Alyssa Bleiberg, 212-485-6806

Copyright Business Wire 2008