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 IN-LICENSES
ULCERATIVE COLITIS PRODUCT FROM
DR. FALK PHARMA
Salix Pharmaceuticals/Dr. Falk Pharma Establish
Collaboration
RALEIGH, NC, July 15, 2002 - Salix Pharmaceuticals, Ltd. (Nasdaq:SLXP) today
announced that it has in-licensed rights to a pellet formulation of mesalamine
under an agreement with Dr. Falk Pharma GmbH (Freiburg, Germany). The agreement
gives Salix the exclusive rights to develop and market the product in the United
States. In return Salix will make upfront, milestone and royalty payments to
Falk. The agreement also provides Salix the right of first negotiation with
respect to rights to develop and market certain additional Falk products in the
United States.
The new mesalamine product is marketed in Germany by Falk under the trade name
Salofalk(R) Granu-Stix(R) for the treatment of acute episodes and the
maintenance of remission of ulcerative colitis. Salofalk Granu-Stix delivers the
therapeutically active anti-inflammatory agent mesalamine (5-aminosalicylic acid
or 5-ASA) to the distal ileum and colon by means of dual-release granules.
Salix intends to complete the development work required to secure regulatory
approval for the product in the U.S., which is patent protected until 2018.
"Salofalk Granu-Stix represents a unique release mechanism and formulation for
the delivery of mesalamine to the distal ileum and colon," commented Dr. Allen
Mangel, Vice President,
Research and Development, Salix. "The addition of this product to our portfolio
will allow the Company to expand its range of treatment options for ulcerative
colitis. The product's prolonged release system is designed to consistently
release mesalamine in the distal ileum and throughout the entire colon.
Furthermore, the release characteristics of the product may present the
possibility of less frequent dosing; therefore, we intend to explore the
development of improved dosing regimens."
Carolyn Logan, President and CEO of Salix, stated, "We are extremely pleased to
announce the initiation of a collaboration between Dr. Falk Pharma and Salix
Pharmaceuticals, as well as the in-licensing of a late-stage product for the
treatment of ulcerative colitis. Dr. Falk Pharma is one of the most recognized
companies worldwide in gastroenterology. Since 1967, the Falk Foundation has
sponsored over 150 international symposia in which thought leaders from over 100
countries have come together to advance knowledge in the treatment of
gastroenterology and hepatology. We are honored to be allied with Dr. Falk
Pharma and look forward to bringing innovations from their research efforts to
gastroenterologists and their patients in the U.S."
The Company will host a conference call at 10:00 a.m. EDT, on July 16, 2002 to
discuss the subjects of this press release. Interested parties may access the
conference call by way of web cast or telephone. The live web cast will be
available at http://www.salix.com. The web cast will be archived on the
Company's web site through July 22. The telephone numbers to access the
conference call are (800) 500-0177 (U.S. and Canada) or (719) 457-2679
(international). A replay of the call will be available from 1:00 p.m. EDT, July
16 through July 22. The telephone numbers to access the replay of the call are
(888) 203-1112 (U.S. and Canada) or (719) 457-0820 (international). The access
code for the replay is 140756.
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 first marketed product
is COLAZAL(R) (balsalazide disodium) Capsules 750 mg, 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's next product candidate is rifaximin,
currently in development for the potential treatment of infections of the lower
gastrointestinal tract. The Company submitted an NDA for rifaximin for the
treatment of travelers' diarrhea to the FDA on December 26, 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.salix.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.