Salix Pharmaceuticals, Ltd 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 US 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.
"Salix is expanding its product portfolio with the acquisition of a fast-dissolving formulation of metoclopramide," stated Carolyn Logan, president and chief executive officer, Salix. "Market research indicates a high level of demand for a patient-friendly formulation of this widely-prescribed agent. We believe the availability of metoclopromide-Zydis should serve to increase patient compliance and, in many instances, provide an economical alternative to emergency room visits and/or intravenous infusion by patients suffering from nausea and gastric distress."
Commenting on the agreement, Eugene Haley, chief executive officer, Wilmington Pharmaceuticals, stated, "We are very pleased with the opportunity to have Salix commercialize metoclopramide-Zydis. Much like Salix, we pride ourselves in our specialized strategy to create value while avoiding the cost and risk associated with much larger and less focused pharmaceutical product development. We are confident that Salix will dedicate the marketing and sales expertise necessary to optimize the commercial potential of metoclopramide-Zydis."
Wilmington Pharmaceuticals, LLC creates valuable new medicines while avoiding the large development and support staff of traditional pharmaceutical companies. Their efforts bring patient-friendly drug delivery technologies to well-established drug products that are only available in less than optimal dosage forms.
Catalent Pharma Solutions, headquartered in Somerset, NJ, is the world leader in providing advanced dosage form delivery technologies. Catalent's Zydis is the fastest dissolving oral tablet in the world. Zydis is a unique, freeze-dried oral solid dosage form that can be swallowed without water, because it dissolves rapidly on the tongue in less than three seconds. Zydis offers the potential for added patient and consumer convenience, enhanced drug performance and improved patient compliance.