Norgine B.V. has granted Salix Pharmaceuticals the exclusive rights to sell a patent-protected, liquid PEG bowel cleansing product, NRL944, in the United States.
The product is currently under review at the US Food and Drug Administration to obtain marketing approval for bowel cleansing prior to colonoscopy, intestinal surgery and barium enema X-ray examinations. The product has patent protection until 2013, and additional patent protection pending that, if issued, will provide patent protection until 2023, informs a company release.
Salix is required to make an up-front payment and regulatory and sales performance milestone payments to Norgine. Over the life of the agreement, these payments by Salix could total as much as $37 million, with the majority contingent upon achievement of regulatory and sales performance milestones. In addition, the agreement 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 (PDUFA), results of the FDA review are scheduled for release in April 2006.
Carolyn Logan, president and CEO, Salix, stated, "We are pleased about the opportunity of working with Norgine to maximise the potential the bowel cleansing market offers. 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.”
Peter Stein, CEO, Norgine, said, "We are delighted to be teaming up with Salix on what will be our first product entry into the US market. As a leader in the gastroenterology market, we believe Salix is well-positioned to develop the potential for NRL944 in the United States and we look forward to doing what we can to help them achieve this."
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.
Salix Pharmaceuticals Ltd develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases.