Exhibit 99.2
FOR IMMEDIATE RELEASE
Contact: Adam C. Derbyshire Mike Freeman
Vice President and Director, Investor Relations and
Chief Financial Officer Corporate Communications
919 862-1000 919 862-1000
SALIX PHARMACEUTICALS REPORTS
RESULTS OF SECOND PHASE III TRIAL OF
RIFAXIMIN
RALEIGH, NC, May 29, 2001 - Salix Pharmaceuticals, Ltd. (Nasdaq: SLXP) today
announced results from its latest Phase III clinical trial of rifaximin, a
minimally absorbed, rifamycin-class antibiotic. The results of this trial, "A
Randomized Double-Blind, Parallel, Placebo-Controlled Study of Rifaximin at 600
mg and 1200 mg/day in the Treatment of Bacterial Infectious Diarrhea in
Travelers" were presented yesterday at the 7/th/ Conference of the International
Society for Travel Medicine in Innsbruck, Austria.
The evaluation of the effectiveness of a 3-day regimen of rifaximin or placebo
was based upon the rapidity of resolution of the diarrhea attack and the
modification of stools. The trial's primary efficacy endpoint was Time to Last
Unformed Stool (TLUS). The median TLUS, in hours, was: placebo = 60.0,
rifaximin 600 mg = 32.5 (p < 0.001), and rifaximin 1200 mg = 32.9 (p < 0.001.)
Secondary efficacy endpoints included the number of unformed stools per 24-hour
time interval, rates of wellness and rates of treatment failure. Both rifaximin
groups were superior to placebo with respect to the secondary endpoints listed
above. Evaluation of safety was based upon the incidence of adverse events
(AEs), physical examination, and laboratory investigations. There were no
between-group differences in the incidence of the safety measures.
This multi-center trial was conducted in 380 subjects affected by acute
diarrhea. Study centers were located in Mexico, Guatemala and Kenya. Principal
investigators of the study included
Herbert DuPont, M.D., Professor of Medicine, University of Texas - Houston;
David Sack, M.D., Professor, Department of International Health, for Johns
Hopkins University School of Hygiene and Public Health; and Robert Steffen,
M.D., Professor, Institute for Social and Preventive Medicine, University of
Zurich. Dr. DuPont also serves as a member of the Food and Drug Administration
Advisory Committee on Vaccines and Biologics, and he is the author of the
guidelines to evaluate new anti-infective therapies for the treatment of acute
infectious diarrhea.
The findings of this trial, reported yesterday, and the findings of a previously
completed head-to-head trial designed to compare the clinical outcomes of
rifaximin and ciprofloxacin for the treatment of infectious diarrhea will serve
as the basis for Salix's New Drug Application (NDA) for the use of rifaximin in
the treatment of infectious diarrhea. In the comparative trial of rifaximin and
ciprofloxacin, the primary efficacy endpoint, TLUS, in hours, for rifaximin
(median = 25.7) was statistically equivalent to TLUS for ciproflaxacin (median =
25.0) (p = 0.006). Secondary efficacy endpoints included the number of unformed
stools per 24-hour time interval, rates of wellness and rates of treatment
failures. There was no statistically significant difference between treatment
groups with respect to the secondary endpoints listed above. Evaluation of
safety was based upon the incidence of AEs, physical examination, and laboratory
investigations. There was no statistically significant difference between
treatment groups for any of the safety analyses. This randomized, comparative,
double-blind study was conducted in 187 subjects affected by acute diarrhea.
Study centers were located in Mexico and Jamaica.
"The results of this study are very exciting and, in conjunction with the
results of the earlier study, show that rifaximin, if approved by the FDA,
could offer an alternative to ciprofloxacin and other fluoroquinolones in the
treatment of bacterial infectious diarrhea," said Dr. Herbert DuPont, Professor
of Medicine, University of Texas - Houston. "This is an important finding in
view of the emergence of fluoroquinolone or quinolone resistance in many parts
of the world."
"We are keenly interested in the therapeutic potential of this next generation
antibiotic," commented Dr. Lorin Johnson, Senior Vice President, Development and
Chief Scientific Officer, Salix Pharmaceuticals. "If approved, a safe and
effective agent specifically targeted for
infections of the gastrointestinal tract would be a very useful addition to the
physician's armamentarium. We are encouraged by the results of this latest trial
of rifaximin. Based upon the results of our two Phase III trials, we are
currently assembling the New Drug Application for the use of rifaximin in the
treatment of infectious diarrhea."
Rifaximin is a new, broad-spectrum antibiotic that belongs to the rifamycin
class of antibiotics. The drug is chemically structured to deliver high
concentrations of antibiotic to the gastrointestinal tract while remaining
minimally absorbed outside the gastrointestinal tract. Salix licensed U.S. and
Canadian rights to rifaximin from Alfa Wassermann. The Company's current
development plan for rifaximin includes:
. 2Q2001
initiation of the U.S. arm of the Phase III trial for hepatic encephalopathy
(Salix has received Orphan Drug Designation for this indication) which has
already been started in Europe by Alfa Wassermann
. 4Q2001
submission of a New Drug Application for treatment of infectious diarrhea
. Ongoing
assessment of additional potential uses including antibiotic-associated
colitis, diverticulitis, bacterial overgrowth of the small intestine and
irritable bowel syndrome
Rifaximin is marketed in Italy and other countries by Alfa-Wassermann under the
trade names Normix(R) and Rifacol(R). In Italy, rifaximin 2000 annual sales
totaled approximately US$24 million.
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 proprietary
therapeutic drugs that have an existing database of positive, late-stage
clinical data; complete the development and regulatory submission of these
products; and market them through the Company's gastroenterology specialty sales
force. Salix's lead product is COLAZAL(TM), an anti-inflammatory drug approved
for the treatment of mildly to moderately active ulcerative colitis. The Company
launched the product in the U.S. through its
specialty sales force in January 2001. Salix's follow-on product candidate is
rifaximin, currently in development for the potential treatment of infections of
the lower gastrointestinal tract. The Company currently intends to submit an NDA
for rifaximin for the treatment of infectious diarrhea to the U.S. FDA in late
2001. 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.salixpharm.com.
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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 the
uncertainty of market acceptance of COLAZAL and rifaximin, our limited
sales and marketing experience, our ability to manage growth, risks of
clinical trials and regulatory review, 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.