SOURCE: SkyePharma PLC

September 05, 2007 02:02 ET

SkyePharma PLC announces Regulatory Approval

London, UK--(Marketwire - September 5, 2007) -


           SKYEPHARMA AND SCIELE PHARMA ANNOUNCE ACCEPTANCE BY FDA OF SNDA
                            FOR NEW SULAR FORMULATION 

                          PDUFA DATE OF 2 NOVEMBER 2007

LONDON, UK and ATLANTA, US, 5 September 2007 - SkyePharma PLC (LSE:SKP) and
Sciele Pharma. Inc. (NASDAQ: SCRX) today announce that the U.S. Food & Drug
Administration (FDA) has accepted the supplemental New Drug Application (sNDA)
for Sciele's new Sular formulation, with a Pharmacy Drug User Fee Act (PDUFA)
date of 2 November 2007.  Sular(R) is a calcium channel blocking agent for the
treatment of high blood pressure.  The new Sular formulation utilizes
SkyePharma's patented Geomatrix(TM) technology, which is designed to provide a
lower dose of Sular for each of its current doses.

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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