Exhibit 99.1
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' NEW DRUG
APPLICATION FOR LUMENAX(TM)(RIFAXIMIN)
FOR THE TREATMENT OF TRAVELERS'
DIARRHEA ACCEPTED FOR FILING BY FDA
RALEIGH, NC, February 25, 2002 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today
announced that its New Drug Application (NDA) for LUMENAX(TM) (rifaximin) has
been accepted for filing by the U.S. Food and Drug Administration. Salix
submitted its NDA on December 26, 2001 seeking approval to market rifaximin for
the treatment of travelers' diarrhea. Acceptance for filing occurs automatically
60 days after submission of an NDA, unless the FDA raises issues during the
60-day period.
Rifaximin is a non-systemic antibiotic characterized by activity against a broad
spectrum of enteric bacterial pathogens and the delivery of high concentrations
of antibiotic to the gastrointestinal tract. Salix licensed U.S. and Canadian
rights to rifaximin from Alfa Wassermann S.p.A. Currently, the product is
marketed in Italy by Alfa Wassermann under the trade name Normix(R) and is
licensed by Alfa Wassermann in Mexico to GlaxoSmithKline and Schering-Plough
under the respective trade names RedActiv(R) and Flonorm(R). If approval to
market is received from the FDA, Salix intends to market rifaximin under the
trade name LUMENAX.
Commenting on the Company's development program for LUMENAX, Allen Mangel, M.D.,
Ph. D., Vice President Research, and Development, stated, "We believe that our
work to date on LUMENAX, and the submission of this NDA seeking marketing
approval for the treatment of
travelers' diarrhea is only the first step in the development of this antibiotic
as a treatment for a host of diseases treated by gastroenterologists. We believe
that during 2001 between 4 and 5 million people sought treatment for infectious
diarrhea in the U.S. Clinical investigation is underway to assess the utility of
LUMENAX for the treatment of hepatic encephalopathy, a severe condition caused
by compromised liver function that affects 60,000 patients in the U.S. The
Company intends to initiate clinical studies for additional potential
indications. These indications, and an estimate of the number of patients in the
U.S. with each indication include: diverticular disease (2.3 million), bacterial
overgrowth of the small intestine (500,000), C. difficile-associated diarrhea
(450,000), and pouchitis (45,000.) We are committed to developing the product to
its fullest potential."
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
60-member 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. 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 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 risks
of regulatory review and clinical trials, 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.