SkyePharma PLC announces that it has successfully completed the review of the Phase II trial results of Propofol IDD-D with the US Food & Drug Administration (FDA). Propofol IDD-D is licensed in North America to Endo Pharmaceuticals and, under the terms of the December 2002 agreement as amended between SkyePharma and Endo, a US$5 million milestone payment to SkyePharma is now due.

SkyePharma and Endo have agreed upon the Phase III trial programme and expect Propofol IDD-D to commence Phase III trials around the middle of this year.

Propofol IDD-D is a 2 per cent intravenous formulation of propofol as the sole active ingredient and employs SkyePharma's patented Insoluble Drug Delivery (IDD-D technology. In contrast with currently marketed versions of propofol, SkyePharma believes that Propofol IDD-D will not support significant microbial growth and therefore will not require incorporation of a preservative. Propofol IDD-D is intended for the maintenance of anaesthesia in adults during surgery and for sedation of adults hospitalized in an intensive-care setting.

Propofol IDD-D has been studied in a Phase II clinical trial. The study, involving 79 female patients undergoing laparoscopic gynaecological surgery, was designed to show clinical effect of Propofol IDD-D versus AstraZeneca's Diprivan, a currently marketed version of 1 per cent propofol. The study results provided evidence of comparable pharmacokinetics, efficacy and safety of the two formulations which will need to be confirmed in phase III trials.