11th Sep 2007 07:03
Skyepharma PLC11 September 2007 SkyePharma PLC Further Update on Flutiform(TM) LONDON, UK, 11 September 2007 - Further to its announcement of 6 August 2007,SkyePharma PLC (LSE: SKP) today confirms that the Company met with the FDA andagreed on an approach for the additional clinical work required forFlutiform(TM), which will include a further study to provide more efficacy data.Discussions with the FDA are ongoing in relation to the design of this studyand will be finalised after submission of supporting Chemistry, Manufacturingand Controls (CMC) data. The anticipated date for filing of the Flutiform(TM) NDA remains the second halfof 2008. The anticipated net cash cost to the Company for the additional workremains in the order of £3m to £5m. 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 John Gilbert 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 Certain statements in this news release are forward-looking statements. inparticular in relation to the timing of regulatory filings and estimated costs.Although SkyePharma believes that the expectations reflected in theseforward-looking statements are reasonable, it can give no assurance that theseexpectations will materialize. Because the expectations are subject to risks anduncertainties, actual results may vary significantly from those expressed orimplied by the forward-looking statements based upon a number of factors, whichare described in SkyePharma's Annual Report. Factors that could causedifferences between actual results and those implied by the forward-lookingstatements contained in this news release include, without limitation, risksrelated to the timing and scope of any additional clinical work. SkyePharmaundertakes no obligation to revise or update any such forward-looking statementto reflect events or circumstances after the date of this release. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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