RALEIGH, N.C.--(BUSINESS WIRE)--Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that Wilmington Pharmaceuticals has granted Salix the exclusive, worldwide right to metoclopramide-Zydis®. Metoclopramide is indicated for short-term (4-12 weeks) therapy for adults with symptomatic documented gastroesphageal reflux who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. Wilmington Pharmaceuticals plans to file a New Drug Application for their Zydis formulation of metoclopramide with the U.S. Food and Drug Administration during the fourth quarter of 2007. The product has patent protection until 2022, and additional patent protection pending that, if issued, will provide patent protection until 2025. Salix is required to make a small up-front payment to Wilmington, a regulatory milestone payment to Wilmington upon NDA approval and to pay royalties to Wilmington on net sales. Additionally, Salix has entered into a separate agreement with Catalent Pharma Solutions to supply the product. Catalent’s Zydis® technology is a unique, freeze-dried oral solid dosage form that disintegrates rapidly on the tongue and can be taken without water.
