18th Dec 2007 07:01
Skyepharma PLC18 December 2007 SkyePharma PLC FlutiformTM - Enrolment into Efficacy Trials Completed LONDON, UK, 18 December 2007-- SkyePharma PLC (LSE: SKP) today announces that ithas completed enrolment of patients into the three double-blind efficacy trialscurrently underway for FlutiformTM, its lead development product for thetreatment of asthma. The three efficacy trials, involving nearly 1,400 patients, will provide coreclinical data for the New Drug Application (NDA) to be filed with the U.S. Foodand Drug Administration (FDA) and will also support the European MarketingAuthorisation Application (MAA). It is anticipated that the trials will befully completed in April 2008. The trials are designed to demonstrate thesuperiority of FlutiformTM over the individual components and, in two of thestudies, also over placebo. In November, the Company announced the successful completion of the Phase III,long-term, open label, safety study for FlutiformTM, involving 472 patients andfurther to our announcement of 11 September 2007, the additional clinicalefficacy study, agreed with the FDA will commence in early 2008. This study willinvolve approximately 375 patients. Dr Ken Cunningham, COO of SkyePharma said: "We have completed another importantmilestone in the development of FlutiformTM and remain focussed on meeting allnecessary requirements for the NDA filing." 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 This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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