SOURCE: SkyePharma PLC

December 18, 2007 07:20 ET

SkyePharma PLC - Research Update

London, UK--(Marketwire - December 18, 2007) -

                            SkyePharma PLC

       FlutiformTM - Enrolment into Efficacy Trials Completed
LONDON, UK, 18 December 2007-- SkyePharma PLC (LSE: SKP) today announces that it has completed enrolment of patients into the three double-blind efficacy trials currently underway for FlutiformTM, its lead development product for the treatment of asthma.

The three efficacy trials, involving nearly 1,400 patients, will provide core clinical data for the New Drug Application (NDA) to be filed with the U.S. Food and Drug Administration (FDA) and will also support the European Marketing Authorisation Application (MAA). It is anticipated that the trials will be fully completed in April 2008. The trials are designed to demonstrate the superiority of FlutiformTM over the individual components and, in two of the studies, 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 and further to our announcement of 11 September 2007, the additional clinical efficacy study, agreed with the FDA will commence in early 2008. This study will involve approximately 375 patients.

Dr Ken Cunningham, COO of SkyePharma said: "We have completed another important milestone in the development of FlutiformTM and remain focussed on meeting all necessary 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 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

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