2nd Nov 2007 07:00
Skyepharma PLC02 November 2007 SkyePharma PLC FlutiformTM - Results of Safety Study LONDON, UK - 2 November 2007 -- SkyePharma PLC (LSE: SKP) today announces thatthe Phase III, long-term, open label, safety study for FlutiformTM, theCompany's lead development product for the treatment of asthma, has beencompleted and the results are consistent with the large safety database alreadyaccumulated on the individual constituents fluticasone and formoterol. Thestudy involved 472 patients who were treated with FlutiformTM for 6 or 12 monthsand will form part of the US New Drug Application ("NDA") for FlutiformTM.Three double-blind efficacy trials are currently ongoing, of which one is fullyenrolled and the other two are nearing full enrolment. Submission of the NDA isexpected in the second half of 2008. Frank Condella, CEO of SkyePharma said, "The results of this study are as weexpected and represent a significant milestone achieved in the FlutiformTMdevelopment programme. We continue to make good progress towards the approvalof this exciting product." For further information please contact: SkyePharma PLC Frank Condella, Chief Executive OfficerKen Cunningham, Chief Operating Officer +44 207 491 1777Peter Grant, Finance Director Financial Dynamics (London enquiries)David Yates / Deborah Scott +44 207 831 3113 Trout Group (US enquiries)Christine Labaree / Seth Lewis +1 617 583 1308 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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