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 Announces Positive Results from Rifaximin Antibiotic Study
-Study Analysis Suggests Rifaximin Does Not Promote Antibacterial Resistance-
RALEIGH, NC, May 12, 2003 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP), a
developer and marketer of prescription pharmaceutical products for the treatment
of gastrointestinal diseases, today announced positive results from a study
analysis which concluded that rifaximin does not promote the resistance of
gram-negative or gram-positive intestinal flora. Rifaximin is a rifamycin
derivative that is being investigated as a potential treatment of infectious
conditions of the gastrointestinal tract. Salix submitted a New Drug Application
(NDA) for rifaximin for the treatment of travelers' diarrhea to the U.S. Food
and Drug Administration (FDA) in December 2001, and received an approvable
letter from the FDA on October 25, 2002.
The results of this recently completed analysis assessing the potential of
rifaximin for the production of antibacterial resistance were recently presented
at the 8th Annual International Society of Travel Medicine convention in New
York, NY.
"Bacterial pathogens play a significant role in many diarrheal illnesses,
including travelers' and bacterial diarrhea, for which antibiotics are a
mainstay of treatment," said Herbert L. DuPont, M.D., Chief, Internal Medicine
and Medical Director, Travel Medicine, St. Luke's Episcopal Hospital, and
Director, Center for Infectious Diseases, University of Texas-Houston School of
Public Health. "Unfortunately, the emergence of widespread bacterial resistance
now threatens to limit the utility of many of these agents. We have previously
shown that rifaximin fails to induce resistance in the causative agents in
bacterial diarrhea, and the data presented at this meeting show that rifaximin,
a virtually non-absorbed
gastrointestinal tract-specific antibiotic, does not produce resistance of
intestinal bacterial flora, offering further evidence that the drug is not
associated with clinically relevant resistance."
Dr. DuPont conducted the analysis to assess the influence of rifaximin on the
development of resistant intestinal bacteria, specifically gram-negative flora
and gram-positive Enterococci. The analysis was conducted using stool samples
collected from a Salix-sponsored Phase III trial. In this trial, U.S. college
students, over the age of 18, traveling to Guadalajara, Mexico who developed
acute diarrhea received rifaximin 1,200 mg/day, rifaximin 600 mg/day, or
placebo. Stool samples were collected prior to treatment (Day 0), at the end of
therapy (Day 3), and 2 days after cessation of therapy (Day 5) and studied for
resistant intestinal flora (n=27) and resistant Enterococci (n=71).
One of the most commonly used measures to assess the susceptibility of bacteria
to antibiotics is MIC \\90\\. Analysis of MIC \\90\\ data suggest that, after
three days of therapy, gram-negative intestinal flora developed no clinically
relevant resistance to rifaximin. Additionally, Enterococci were isolated from
post-treatment samples with equal frequency between rifaximin and placebo
groups. This finding suggests that rifaximin is not associated with clinically
relevant resistance.
"We are excited by these results, as they further demonstrate the potential for
rifaximin to treat infectious conditions of the gastrointestinal tract. Salix
remains focused on advancing treatments for gastrointestinal diseases, and we
are confident that our emerging product line will provide the fuel to drive
future corporate revenues as we leverage our existing sales and marketing
infrastructure," stated Carolyn Logan, President and Chief Executive Officer of
Salix Pharmaceuticals. "We are proceeding as planned with the development of
rifaximin and anticipate launching immediately upon final FDA approval."
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 the required development and
regulatory submission of these products, and market them through the Company's
78-member gastroenterology specialty sales team. Rifaximin currently is 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. 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.
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 risks of regulatory review and
clinical trials, intellectual property risks, the need to acquire additional
products and management of rapid growth. 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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