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 £3m to £5m.
For further information please contact: SkyePharma PLC
