LONDON, UK and ATLANTA, US, 5 September 2007 - SkyePharma PLC (LSE:SKP.L - News) and Sciele Pharma. Inc. (NasdaqGS:SCRX - News) today announce that the U.S. Food & Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Sciele’s new Sular formulation, with a Pharmacy Drug User Fee Act (PDUFA) date of 2 November 2007. Sular(R) is a calcium channel blocking agent for the treatment of high blood pressure. The new Sular formulation utilizes SkyePharma’s patented Geomatrix(TM) technology, which is designed to provide a lower dose of Sular for each of its current doses.
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Company has eleven approved products in the areas of oral, inhalation and topical delivery. The Group’s products are marketed throughout the world by leading pharmaceutical companies.
For more information, visit http://www.skyepharma.com
