SKP.L Regulatory News (SKP)

10 Dec 2007 13:46

Skyepharma PLC10 December 2007 U.S. FDA ISSUES APPROVABLE LETTER FOR REQUIP(R) XL(TM) EXTENDED RELEASE TABLETS LONDON, UK, 10 December 2007-- SkyePharma PLC (LSE: SKP) today announces thatthe United States Food and Drug Administration (FDA) has issued an approvableletter for GlaxoSmithKline's (NYSE:GSK) Requip(R) XL(TM) Extended Releasetablets. An approvable letter is an official notification from the FDA thatcontains conditions that must be satisfied prior to obtaining final U.S.marketing approval. Requip(R) XL(TM) is a once-daily oral dopamine agonist developed for thetreatment of the signs and symptoms of idiopathic Parkinson's disease. The newRequip(R) XL(TM) formulation uses SkyePharma's patented GEOMATRIX(TM) technologyand is designed to provide a steady rate of absorption in the body to helpreduce daily blood plasma fluctuations. GSK is committed to working with the FDAto address any questions they have and evaluate the best way forward. Requip(R) XL(TM) is approved in eight countries in Europe and a mutualrecognition procedure was successfully completed on 27 November 2007, in 17additional European countries. This step should result in approval of Requip(R)XL(TM) and launches in these countries from the first quarter of 2008 onwards. 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, visitwww.skyepharma.com About GlaxoSmithKline Requip(R) XL(TM) was developed and is marketed by GlaxoSmithKline, one of theworld's leading research-based pharmaceutical and healthcare companies. Moreinformation on GlaxoSmithKline is available at the company's website at www.gsk.com. This information is provided by RNS The company news service from the London Stock Exchange