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Salix Pharmaceuticals Licenses DIACOL(TM) to Dr. Falk Pharma in Europe.


RALEIGH, N.C. -- Salix Pharmaceuticals, Ltd. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:SLXP) today announced that it has licensed exclusive rights to market DIACOL[TM] 1500 mg Tablets in 28 territories in Europe to Dr. Falk Pharma GmbH of Freiberg, Germany. DIACOL, or, sodium phosphate monobasic monobasic /mono·ba·sic/ (-ba´sik) having but one atom of replaceable hydrogen.

mon·o·ba·sic
adj.
1. Having only one hydrogen ion to donate to a base in an acid-base reaction.
 monohydrate mon·o·hy·drate
n.
A compound, such as calcium chloride monohydrate, that contains one molecule of water.
, USP, and sodium phosphate dibasic dibasic /di·ba·sic/ (di-ba´sik) containing two replaceable hydrogen atoms, or furnishing two hydrogen ions.

di·ba·sic
adj.
1. Containing two replaceable hydrogen atoms.

2.
 anhydrous, tablets, USP, are marketed in the United States under the trade name OSMOPREP[TM] Tablets. As part of the agreement, Falk also has a non-exclusive option to market DIACOL in Italy and France. Under the terms of the agreement, Salix may receive up to $4 million in milestone payments, as well as royalty payments based on product sales. Falk made the first milestone payment of $1.5 million upon execution of the agreement. Falk is obligated to use all reasonable efforts to obtain Marketing Authorization by means of the Mutual Recognition Procedure in the territories and option countries.

DIACOL[TM] 1500 mg Tablets are indicated for cleansing of the bowel when required as a preparation for certain diagnostic procedures such as colonoscopy. DIACOL was granted Marketing Authorization in the United Kingdom in December 2006. DIACOL has patent protection in Europe to May 2016.

Dr. Falk Pharma GmbH, based in Freiburg, Germany, specializes in the development and marketing of products used in hepatology and gastroenterology. Falk currently markets its products by means of subsidiary companies in selected European countries and a network of sales partners within Europe and other geographic areas. The Falk Foundation, an independent organization associated with Dr. Falk, is well-known internationally for its symposia, forums, postgraduate courses and educational literature in hepatology and gastroenterology.

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina For other uses of this name, see Raleigh.
Raleigh (IPA: /ˈrɑli/, ral-ee) is the capital of the State of North Carolina and the county seat of Wake County.
, 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([R])(balsalazide) Capsules, XIFAXAN([R])(rifaximin) Tablets, OSMOPREP[TM] (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets, MOVIPREP([R])(PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate a·scor·bate
n.
A salt of ascorbic acid.



ascorbate

a compound or derivative of ascorbic acid. See also sodium ascorbate.
 and ascorbic acid for Oral Solution), VISICOL([R])Tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous), PEPCID([R]) (famotidine) for Oral Suspension, DIURIL([R])(chlorothiazide chlorothiazide /chlo·ro·thi·a·zide/ (klor?o-thi´ah-zid) a thiazide diuretic used in the form of the base or the sodium salt to treat hypertension and edema. ) Suspension, AZASAN([R])(Azathioprine azathioprine: see metabolite.  Tablets, USP), ANUSOL-HC([R]) (Hydrocortisone hydrocortisone (hī'drəkôr`tĭzōn'), another name for the steroid hormone cortisol, more especially used to refer to preparations of this hormone used medicinally.  Cream, USP) and PROCTOCORT([R])(Hydrocortisone Cream, USP). Balsalazide disodium tablets, Granulated Mesalamine, SANVAR([R]) (600 ug vials vapreotide acetate powder) and Xifaxan are under development for additional indications.

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 congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , ascites, unstable angina, gastric retention, ileus Ileus Definition

Ileus is a partial or complete non-mechanical blockage of the small and/or large intestine. The term "ileus" comes from the Latin word for colic.
, 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 Hypernatremia Definition

The normal concentration of sodium in the blood plasma is 136-145 mM. Hypernatremia is defined as a serum sodium level over 145 mM. Severe hypernatremia, with serum sodium above 152 mM, can result in seizures and death.
, hyperphosphatemia, hypokalemia Hypokalemia Definition

Hypokalemia is a condition of below normal levels of potassium in the blood serum. Potassium, a necessary electrolyte, facilitates nerve impulse conduction and the contraction of skeletal and smooth muscles, including the heart.
, or hypocalcemia Hypocalcemia Definition

Hypocalcemia, a low bood calcium level, occurs when the concentration of free calcium ions in the blood falls below 4.0 mg/dL (dL = one tenth of a liter). The normal concentration of free calcium ions in the blood serum is 4.0-6.
 should have their electrolytes corArected 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 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. 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 17, 2007
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