5th Sep 2007 07:02
Skyepharma PLC05 September 2007 SKYEPHARMA AND SCIELE PHARMA ANNOUNCE ACCEPTANCE BY FDA OF SNDA FOR NEW SULAR FORMULATION PDUFA DATE OF 2 NOVEMBER 2007 LONDON, UK and ATLANTA, US, 5 September 2007 - SkyePharma PLC (LSE:SKP) andSciele Pharma. Inc. (NASDAQ:SCRX) today announce that the U.S. Food & DrugAdministration (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 thetreatment of high blood pressure. The new Sular formulation utilizesSkyePharma's patented Geomatrix(TM) technology, which is designed to provide alower dose of Sular for each of its current doses. For further information please contact: SkyePharma PLC Frank Condella +44 20 7491 1777 Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113 Deborah Scott Trout Group (US Enquiries) Christine Labaree +1 617 583 1308 Seth Lewis About SkyePharma PLC Using its proprietary drug delivery technologies, SkyePharma develops newformulations of known molecules to provide a clinical advantage and life-cycleextension. The Company has eleven approved products in the areas of oral,inhalation and topical delivery. The Group's products are marketed throughoutthe world by leading pharmaceutical companies. For more information, visit www.skyepharma.com This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
SKP.L