Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact:
Adam C. Derbyshire Mike Freeman Mark R. Vincent
Vice President and Director, Investor Relations and Euro RSCG Life NRP
Chief Financial Officer Corporate Communications
919-862-1000 919-862-1000 212-845-4239
SALIX Presents Results from COLAZAL(R) Ulcerative Colitis
Studies at Digestive Disease Week 2003
RALEIGH, NC, May 21, 2003 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP), today
announced that results from two COLAZAL(R) (balsalazide disodium) studies were
presented at Digestive Disease Week 2003 (DDW) in Orlando, Florida.
Results from the first study, titled, "An Open Label Comparison of Asacol(R) and
COLAZAL(R) in a Selected Group of Patients with Ulcerative Colitis", show that
57% of the 28 patients in this study who were switched from Asacol to COLAZAL
due to intolerability or suboptimal therapeutic response to Asacol experienced
at least a 50% decrease in the number of bowel movements by week 4 of the study.
The authors concluded that this effect may be attributed to higher delivery of
5-ASA to the colon by COLAZAL compared to Asacol.
Results from a three-year study, titled, "Long-Term Patient-Led Maintenance of
Remission in Ulcerative Colitis with Balsalazide: Is it Effective and Safe?",
show that long-term, patient-led maintenance therapy with balsalazide appears to
be well tolerated and effective for ulcerative colitis patients.
"DDW provides a scientific forum for Salix to discuss its ongoing efforts to
develop significant products for the treatment of gastrointestinal diseases with
gastroenterologists and other health care providers," commented Carolyn J.
Logan, President and Chief Executive Officer, Salix
Pharmaceuticals. "This year at DDW 2003 in Orlando, approximately 35 members of
the Salix Product Development and Sales and Marketing teams interacted with
numerous attendees to discuss product innovations and to gain valuable insight
into their specific needs. By maintaining close relationships with the
gastroenterology community, Salix has been able to identify and advance products
that provide specialists with effective treatments for debilitating illnesses,
including our marketed product, COLAZAL, and Rifaximin, our
gastrointestinal-specific, broad-spectrum oral antibiotic that we expect to
launch next year."
COLAZAL(R) Study Summaries and Results:
"An Open Label Comparison of Asacol(R) and COLAZAL(R) in a Selected Group of
Patients with Ulcerative Colitis"
Devang G. Patel and Kiron M. Das, Crohn's and Colitis Center of New Jersey
This open-label study was conducted in 28 patients to assess the efficacy and
tolerability of COLAZAL in patients with active ulcerative colitis (UC) who
either could not tolerate Asacol(R) (mesalamine) or had suboptimal therapeutic
response to Asacol. Symptomatic UC patients were changed from Asacol (1.6 to 4.8
g/day) to COLAZAL (4.5 to 6.75 g/day). Fifty-seven percent of patients
experienced at least a 50% decrease in the number of bowel movements by week 4
of the study. The authors concluded that this effect may be attributed to higher
delivery of 5-ASA to the colon by COLAZAL compared to Asacol. Additionally,
COLAZAL was well tolerated by all patients, including the five patients who
switched from Asacol due to side effects.
"Long-Term Patient-Led Maintenance of Remission in Ulcerative Colitis with
Balsalazide: Is it Effective and Safe?"
Jonathan R. Green, City General Hospital, Stoke-on-Trent, UK
This prospective study assessed the efficacy and tolerability of patient-led
balsalazide dosing over a period of three years in 52 patients in long-term
(stable) remission and 76 patients in recent remission. Patients were allowed to
decide their appropriate doses of therapy. The daily dose of balsalazide, in
both groups over the three year period, ranged from 1.5 g/day to 6.0 g/day and
the average daily dose was 3.0 grams. Assessments of symptoms, muscosal
inflammation,
general well-being and adverse events were made every three months and
laboratory assessments were made every six months. Analyses of laboratory
findings revealed no adverse medication-related hematological or biochemical
changes and no mortality or significant morbidity in either group. The authors
concluded that this long-term, patient-led, maintenance therapy with balsalazide
appears to be well-tolerated and effective for UC patients.
Additional Salix Updates at Digestive Disease Week 2003
Rifaximin
As announced last week, patient enrollment in the Company's Crohn's disease
study was completed in January 2003 and the study should be concluded this
month. Results of a preliminary analysis of interim data for the study are being
presented to the Salix Rifaximin Advisory Board during a meeting of the Advisory
Board at DDW. The results indicate that a positive trend was noted throughout
the course of treatment with Rifaximin. Furthermore, based upon the analysis of
the data, the Advisory Board concluded that further research and study of the
use of Rifaximin in the treatment of Crohn's disease is warranted.
Continuing Medical Education Symposium
For the third consecutive year Salix is supporting a Continuing Medical
Education symposium at DDW. The event this year is entitled "Managing the Most
Difficult Therapeutic Problems in IBD Patients." "The goal of this CME symposium
is to discuss the most current clinical data specific to the management of
inflammatory bowel disease," stated Ellen Marth McKim, Executive Director,
Marketing, Salix Pharmaceuticals. "We are honored to have a distinguished
faculty of gastroenterology thought leaders present this valuable educational
experience that should equip health care professionals with information that
will be useful in their clinical practices."
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
84-member gastroenterology specialty sales and marketing team. Salix's first
marketed product is COLAZAL(R) (balsalazide disodium) Capsules 750mg, 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. The Company launched the product in the U.S. through its
specialty sales force in January 2001. COLAZAL was well tolerated in clinical
studies. 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. Salix's next product
candidate is Rifaximin, currently in development for the potential treatment of
infections of the gastrointestinal tract. The Company submitted an NDA for
Rifaximin for the treatment of travelers' diarrhea to the FDA on December 26,
2001. The Company received an approvable letter from the FDA on October 25, 2002
and is currently working with the FDA to complete the approval process. In July
2002, Salix acquired exclusive U.S. development and marketing rights to a pellet
formulation of mesalamine. The Company intends to complete the development work
required to secure regulatory approval for the product in the U.S. Salix trades
on the Nasdaq National 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.
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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 market acceptance for approved
products, risks of regulatory review and clinical trials, intellectual property
risks, 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.