04.10.2007 11:00:00
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Salix Pharmaceuticals Licenses OSMOPREP(TM) To Mayoly-Spindler in France
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.
Salix trades on the Nasdaq Global 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: reliance on third parties for international
sales; risks of regulatory review and clinical trials; intellectual
property risks; market acceptance for approved products; competition,
including from potential generic or over-the-counter products;
management of rapid growth; and the need to acquire additional products. 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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