SkyePharma PLC notes that its partner for Zileuton CR, Critical Therapeutics (CTI), has entered into a co-promotion agreement with DEY, LP, an affiliate of Merck KGaA.
The agreement means that a combined sales force of 240 representatives will be available to promote Zileuton CR, once it receives approval from the Food and Drug Administration ('FDA'). The FDA is reviewing the New Drug Application for Zileuton CR, which has a Prescription Drug User Fee Act (PDUFA) date of May 31, 2007. Product launch is scheduled for the second half of 2007, pending regulatory approval. Zileuton CR uses SkyePharma's proprietary Geomatrix oral drug controlled release technology.
SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The company has nine approved products in the areas of oral, inhalation and topical delivery that are marketed throughout the world by leading pharmaceutical companies.