SOURCE: SkyePharma PLC

September 11, 2007 02:04 ET

SkyePharma PLC Announces Further Update on Flutiform™

London, UK--(Marketwire - September 11, 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 and agreed on an approach for the additional clinical work required for Flutiform™, which will include a further study to provide more efficacy data. Discussions with the FDA are ongoing in relation to the design of this study and will be finalised after submission of supporting Chemistry, Manufacturing and Controls (CMC) data.

The anticipated date for filing of the Flutiform™ NDA remains the second half of 2008. The anticipated net cash cost to the Company for the additional work remains in the order of GBP3m to GBP5m.

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 new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Company has eleven approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies.

For more information, visit www.skyepharma.com

Certain statements in this news release are forward-looking statements. in particular in relation to the timing of regulatory filings and estimated costs. Although SkyePharma believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will materialize. Because the expectations are subject to risks and uncertainties, actual results may vary significantly from those expressed or implied by the forward-looking statements based upon a number of factors, which are described in SkyePharma's Annual Report. Factors that could cause differences between actual results and those implied by the forward-looking statements contained in this news release include, without limitation, risks related to the timing and scope of any additional clinical work. SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.



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