Salix acquires Norgine's liquid bowel cleansing product to market in United States

By E. Janene Geiss

Philadelphia, Dec. 7 - Salix Pharmaceuticals, Ltd. announced Wednesday that Norgine BV has granted Salix the exclusive rights to sell a patent-protected, liquid PEG bowel cleansing product, NRL944, in the United States.

The product is under review at the U.S. Food and Drug Administration to obtain marketing approval for bowel cleansing prior to colonoscopy, intestinal surgery and barium enema X-ray examinations, according to a company news release.

The product has patent protection until 2013 and additional patent protection pending that, if issued, will provide patent protection until 2023, officials said.

Salix is required to make an up-front payment and regulatory and sales performance milestone payments to Norgine that could total as much as $37 million, with the majority contingent upon achievement of regulatory and sales performance milestones, officials said.

The agreement also calls for Norgine to supply Salix with the product and Salix to pay Norgine royalties on net sales.

The product is a state-of-the-art bowel cleansing agent that is differentiated from currently marketed, liquid PEG bowel cleansing agents. Norgine submitted a New Drug Application to the FDA during the second quarter of 2005. As required by the Prescription Drug User Fee Act, results of the FDA review are scheduled for release in April 2006.

"The acquisition of this product advances our effort to build a bowel cleansing franchise consisting of both a tablet formulation and a liquid formulation. We believe that the availability of this differentiated, liquid bowel cleansing preparation and our unique tablet formulation of Visicol or INKP-102, which offers an alternative to liquid preparations, should provide the necessary options leading to enhanced bowel cleansing coupled with improved patient compliance, patient satisfaction and a greater patient willingness to return for follow-up procedures as required or recommended," said Carolyn Logan, Salix president and chief executive officer, in the release.

Norgine is Middlesex, England, specialty pharmaceutical company focused on gastroenterology, hepatology and pain management therapeutics.

Salix, based in Raleigh, N.C., develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.