Salix's MoviPrep gets FDA marketing approval

By Elaine Rigoli

Tampa, Fla., Aug. 2 - Salix Pharmaceuticals, Ltd. announced that the Food and Drug Administration has granted marketing approval for prescription MoviPrep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, 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 BV, 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.

Salix said it expects to launch MoviPrep during mid-fourth-quarter 2006.

The company also said it will consider changing 2006 total product revenue guidance upon the launch of MoviPrep.

"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, 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," president and chief executive officer Carolyn Logan said in a news release.

"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."

Norgine is a pharmaceutical company located in Middlesex, England.

Salix, based in Raleigh, N.C., develops prescription pharmaceutical products.

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