SKP.L Regulatory News (SKP)

5 Feb 2008 07:01

Skyepharma PLC05 February 2008 SkyePharma PLC U.S. FDA EXTENDS REVIEW PERIOD FOR REQUIP(R) (ropinirole) XLTM EXTENDED RELEASE TABLETS LONDON, UK, 5 February 2008-- SkyePharma PLC (LSE: SKP) has been informed thatthe United States Food and Drug Administration (FDA) has extended thePrescription Drug User Fee Act (PDUFA) action date for GlaxoSmithKline's (NYSE:GSK) Requip(R) XLTM Extended Release tablets. The PDUFA action date is the dateby which the FDA is expected to issue a response on a pending new drugapplication. Following the approvable letter for Requip XL issued in December2007, GlaxoSmithKline submitted a response to the FDA. A final decision fromthe FDA had been expected in Q1 2008. However, GSK has recently submittedadditional information on food effect to the FDA. The Agency has determined thatthey would not have sufficient time to review this information prior to the Q1action date and the final decision is now expected to be received in Q2 2008. Requip(R) XLTM is the first and only once-daily oral non-ergot dopamine agonistindicated to treat the signs and symptoms of idiopathic Parkinson's disease. Ituses SkyePharma's patented GEOMATRIXTM technology and has been designed toprovide a steady rate of absorption in the body to help reduce daily bloodplasma fluctuations. The product is expected to be available in pharmaciesshortly after the anticipated approval. SkyePharma PLC is pleased to note the launch in France last week of Requip(R) LPExtended Release tablets (as Requip(R) XLTM Extended Release tablets are knownin France). 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 twelve 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 About GlaxoSmithKline Ropinirole Extended-Release Tablets have been approved in 13 European countriesand are marketed by GlaxoSmithKline under the brand names Requip XL, RequipModutab, Requip LP and Requip Depot. GlaxoSmithKline is one of the world'sleading research-based pharmaceutical and healthcare companies. More informationon 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