Salix Pharmaceuticals Licenses OSMOPREP™
To Mayoly–Spindler in France
Tablet Bowel Cleanser Patented In Europe to 2016
RALEIGH, NC, October 4, 2007 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that it has licensed exclusive rights to market OSMOPREP
™
(sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets in France to Mayoly–Spindler
S.A.S of Chatou, France. Under the terms of the agreement, Salix may receive up to $1 million in milestone payments, as well as royalty payments
based on product sales. Mayoly–Spindler will join the current mutual recognition process being conducted by Dr. Falk Pharma to obtain Marketing
Authorization in Europe.
Commenting on the agreement, Carolyn Logan, President and Chief Executive Officer, Salix, stated, "We are pleased to initiate a relationship with the highly–regarded
company, Mayoly–Spindler. In keeping with our strategy, this agreement allows Salix to focus its commercial efforts on the
U.S. market and our partner, Mayoly–Spindler, to focus on developing the commercial potential of OSMOPREP in France, its core market." Speaking
on behalf of Mayoly–Spindler, President Jean–Gilles Vernin stated, "We are pleased with the opportunity to work with Salix, a leading
U.S. gastroenterology company. The acquisition of this product reinforces our portfolio and confirms our effort to better support the French gastroenterology
community. We anticipate marketing approval for the product in the first half of 2009."
OSMOPREP™ Tablets were granted Marketing Authorization in the United Kingdom in December 2006, where it is indicated for cleansing of the bowel when required as a preparation for certain diagnostic procedures such as colonoscopy. OSMOPREP has patent protection in Europe to May 2016.
Laboratories Mayoly–Spindler is a privately–owned pharmaceutical company that develops and markets products in the therapeutic areas of gastroenterology,
rheumatology and dermatology.
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 any required
development and regulatory submission of these products, and market them in the United States through the Company's 150–member gastroenterology
specialty sales and marketing team.
Salix markets COLAZAL® (balsalazide disodium) Capsules 750 mg, XIFAXAN® (rifaximin) tablets 200 mg , OSMOPREP™
(sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP® (PEG 3350, Sodium
Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid for Oral Solution), VISICOL® (sodium phosphate monobasic
monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, PEPCID® (famotidine) for Oral Suspension, Oral Suspension
DIURIL® (Chlorothiazide), AZASAN® Azathioprine Tablets, USP, 75/100 mg , ANUSOL–HC® 2.5% (Hydrocortisone
Cream, USP), ANUSOL–HC® 25 mg Suppository (Hydrocortisone Acetate), PROCTOCORT® Cream (Hydrocortisone
Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate Rectal Suppositories) 30 mg. SANVAR® IR (vapreotide
acetate), balsalazide tablet, encapsulated mesalamine granules and rifaximin for additional indications are under development.
In the U.S., OsmoPrep Tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable
caution should be advised before OsmoPrep Tablets are used in patients with severe renal insufficiency, congestive heart failure, ascites, unstable
angina, gastric retention, ileus, acute obstruction or pseudo–obstruction of the bowel, severe chronic constipation, bowel perforation, acute
colitis, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal function,
patients with a history of acute phosphate nephropathy, patients with a history of seizures or at higher risk of seizure, patients with higher risk
of cardiac arrhythmias, known or suspected electrolyte disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients
with electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected
before treatment with OsmoPrep Tablets. OsmoPrep is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts
or any of its ingredients. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were transient and self–limited
abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving OsmoPrep Tablets be advised to adequately
hydrate before, during, and after the use of OsmoPrep.
For full prescribing information on Salix products, please visit www.salix.com or
contact the Company at 919–862–1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP".
For more information please visit our web site at www.salix.com or contact the Company at 919–862–1000. Information on our web site is not incorporated
in our SEC filings.
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COLAZAL® (balsalazide disodium) Capsules 750 mg are indicated for the treatment of mildly to moderately active Ulcerative Colitis in patients 5 years of age and older.
COLAZAL does not relieve symptoms in all patients; your patients' results may vary. In four well-controlled clinical trials, patients receiving a COLAZAL dose of 6.75g/day most frequently reported the following events
(reporting frequency > 3%): 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. In the pediatric trial, patients most frequently reported the following adverse events: headache (15%), abdominal pain upper (13%), abdominal pain (12%), vomiting (10%), diarrhea (9%), colitis ulcerative (6%),
nasopharyngitis (6%) and, pyrexia (6%). COLAZAL is contraindicated in patients with a hypersensitivity to salicylates or the components of COLAZAL capsules or balsalazide metabolites. The safety and effectiveness of
COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults have not been established.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.