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MoviPrep(R) Granted FDA Marketing Approval; New Two-Liter Liquid Bowel Cleansing Prep for Colonoscopy.


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 the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted marketing approval for prescription 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). MoviPrep is indicated for bowel cleansing prior to colonoscopy. Salix licensed exclusive rights to MoviPrep in the United States from Norgine B.V., which has filed a patent application for the drug that, if granted, will provide protection until 2023. The Company's 2006 total product revenue guidance of $205 million remains unchanged at this time. We expect to launch MoviPrep during mid-fourth quarter 2006. The Company will consider changing 2006 total product revenue guidance upon the launch of MoviPrep.

"MoviPrep is unique among the available purgatives in that it is the only liquid PEG bowel cleansing agent that incorporates ascorbic acid in its formulation, which contributes to MoviPrep's efficacy and taste. The addition of ascorbic acid provides a novel osmotic cleansing action that enables two-liter MoviPrep to provide the level of bowel cleansing previously only associated with four-liter bowel cleansing agents," stated Bill Forbes, Pharm. D., Vice President, Research and Development, and Chief Development Officer. "MoviPrep's approval reflects data from patients that were allowed to eat a regular breakfast, a light lunch and a snack the day of administering the purgative purgative /pur·ga·tive/ (purg´it-iv) cathartic (1, 2).

pur·ga·tive
n.
An agent used for purging the bowels.

adj.
Tending to cause evacuation of the bowels.
. We believe MoviPrep provides an excellent alternative for physicians and patients who would prefer a two-liter liquid PEG cleansing agent over the currently available four-liter PEG products. MoviPrep, unlike the current market-leading bowel prep, is the only two-liter purgative that eliminates the concomitant need for the laxative bisacodyl. We believe this important differentiation should give MoviPrep a distinct advantage in the marketplace."

"We are very pleased to announce the approval of MoviPrep, our two-liter liquid bowel cleansing agent," stated Carolyn Logan, President and Chief Executive Officer. "We believe that physicians who prefer PEG-based bowel preps will find MoviPrep to be an excellent alternative to the currently-marketed two-liter and four-liter PEG products. We are pleased with the opportunity to work with Norgine to bring this state-of-the-art bowel cleansing agent to market in the United States. MoviPrep and OsmoPrep(TM), our recently approved tablet bowel cleansing agent, create an unmatched purgative product portfolio that should meet the needs and preferences of most patients and physicians. Salix looks forward to becoming a single-source provider of liquid and tablet bowel cleansing agents that physicians can prescribe for their patients with confidence in terms of effectiveness and assurance in terms of patient acceptability."

Colorectal Cancer Screening

The majority of colonoscopies performed in the United States are indicated for colorectal cancer screening, and more than 10 million uses of bowel cleansing agents were prescribed during 2005. Today less than half of adults age 50 and older in the U.S. undergo recommended colorectal cancer screening. Colonoscopy is very effective in the early detection of colorectal cancer, and about 90% of colorectal cancers and deaths are preventable if detected early. The American Cancer Society American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
 estimates that more than 30,000 lives could be saved annually by widespread screening. Results of a study conducted by the Mayo Clinic demonstrated that patient unwillingness to take a bowel preparation is the single largest barrier to colorectal cancer screening.

Norgine B.V. is a privately-owned, European specialty pharmaceutical company, developing and marketing pharmaceutical products in the therapeutic areas of gastroenterology, hepatology and pain management. Norgine is a leader in this sector in Europe and is unique in having a balanced sales presence across all the major markets.

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 through the Company's 150-member gastroenterology specialty sales and marketing team.

MoviPrep(R) (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. MoviPrep(R) should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities (such as diuretics or angiotensin converting enzyme Noun 1. angiotensin converting enzyme - proteolytic enzyme that converts angiotensin I into angiotensin II
angiotensin-converting enzyme, ACE

peptidase, protease, proteinase, proteolytic enzyme - any enzyme that catalyzes the splitting of proteins into
 (ACE)-inhibitors) or in patients with known or suspected hyponatremia Hyponatremia Definition

The normal concentration of sodium in the blood plasma is 136-145 mM. Hyponatremia occurs when sodium falls below 130 mM. Plasma sodium levels of 125 mM or less are dangerous and can result in seizures and coma.
. MoviPrep(R) should also be used with caution in patients with severe ulcerative colitis, 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.
, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, or toxic megacolon. In clinical trials, abdominal distension, anal discomfort, thirst, nausea and abdominal pain were some of the most common adverse reactions to MoviPrep(R) administration. Vomiting occurred less frequently.

Salix also markets Colazal(R) (balsalazide disodium) Capsules 750 mg, Xifaxan(R) (rifaximin) tablets 200 mg, Visicol(R) Tablets (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 USP - unique sales point , 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, USP), OsmoPrep(TM) Tablets (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP), Azasan(R) (azathioprine azathioprine: see metabolite.  75mg and 100mg tablets, USP), Anusol-HC(R) 2.5% (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), Anusol-HC(R) 25 mg Suppository suppository /sup·pos·i·to·ry/ (su-poz´i-tor?e) an easily fusible medicated mass to be introduced into a body orifice, as the rectum, urethra, or vagina.

sup·pos·i·to·ry
n.
 (Hydrocortisone Acetate), Proctocort(R) Cream (Hydrocortisone Cream USP) 1% and Proctocort(R) Suppositories suppositories,
n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum.
 (Hydrocortisone Acetate Rectal Suppositories, 30 mg). Granulated mesalamine is under development.

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.

AZASAN(R) is a registered trademark of AAI Properties Inc.

MOVIPREP(R) is a registered trademark of Velinor A.G.

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 market acceptance for approved products, management of rapid growth, risks of regulatory review and clinical trials, intellectual property risks, 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 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Aug 2, 2006
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