PALO ALTO, CA, Dec. 21 /CNW-PRN/ - Salix Pharmaceuticals, Ltd. (TSE: SLX)
today announced that it had received confirmation from the United States Food
and Drug Administration (FDA) that Salix's submission of responses to an FDA
``approvable'' letter for its drug product, balsalazide disodium, for the
treatment of acute ulcerative colitis in adults has been accepted for review
by the FDA. The FDA indicated that the submission by Salix was considered a
complete response to the ``approvable'' letter for balsalazide disodium.
However, the FDA's acceptance for review is not an indication of the adequacy
of Salix's responses to the issues in the ``approvable letter.'' The FDA's
target date for completing its review of Salix's response is March 24, 2000.
``We are very pleased that FDA considers our submission to be a complete
response to the approvable letter and we look forward to working closely with
FDA should any further questions be raised during their review process,'' said
Lorin Johnson, Ph.D., Senior Vice President, Research & Development, of Salix.
Salix develops and markets prescription pharmaceutical products for the
treatment of gastrointestinal diseases. The Company's strategy is to
in-license proprietary therapeutic drugs with an existing database of
positive, late-stage clinical data in humans, complete the development, and
market these products. Salix's lead product is balsalazide disodium. The
product was first approved by the United Kingdom Medicines Control Agency in
July 1997 as a treatment for acute ulcerative colitis and has since also been
approved for use in the maintenance of remission of ulcerative colitis.
Colazide has also been approved in Argentina, Austria, Belgium, Czech
Republic, Denmark, Italy, Luxembourg, Norway, Sweden and Switzerland. If
approved in the United States, balsalazide disodium will be marketed under the
tradename BalAsa(R).
In addition to balsalazide, Salix is in Phase III clinical development of
rifaximin, a broad-spectrum gastrointestinal specific antibiotic, licensed
from Alfa Wassermann, S.p.A., an Italian company. Rifaximin has been marketed
in Italy by Alfa Wassermann for several years and is used for several
gastrointestinal conditions including hepatic encephalopathy, infectious
diarrhea, and prophylaxis prior to bowel surgery.
The statements in this press release that are not purely statements of
historical fact are forward-looking statements, and actual results may differ
materially from those anticipated. With respect to Salix, important factors
that could cause results to differ include risks associated with regulatory
decisions, product development and commercialization activities, and funding
of operations, which are described in Salix's reports on Form 10-K, Form 10-Q
and Form 8-K filed with the Securities and Exchange Commission. Readers are
cautioned not to place undue reliance on these forward-looking statements,
which speak only as of the date hereof. Salix assumes no obligation to update
the information in this release.
Please Note: This press release contains 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. The reader is referred to the
documents that the Company files from time to time with applicable Canadian
securities, Regulatory authorities and with the Securities and Exchange
Commission, in particular the Company's Registration Statement on Form S-1 in
connection with the Company's most recent public offering and the section
entitled ``Risk Factors'' and its quarterly reports on Form 10-Q and 10-K.
For further information: Robert P. Ruscher (650) 849-5900
SOURCE Salix Pharmaceuticals, Ltd.
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CONTACT: Robert P. Ruscher (650) 849-5900
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