SkyePharma to Receive Milestone Payment from Endo for Propofol IDD-D(TM)

Phase III Trials to Start by Mid-Year

08-Apr-2004

London. SkyePharma PLC announces today that it has successfully completed the review of the Phase II trial results of Propofol IDD-D(TM) with the US food & Drug Administration ("FDA"). Propofol IDD-D(TM) is licensed in North America to Endo Pharmaceuticals (NASDAQ:ENDP) ("Endo") 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(TM) to commence Phase III trials around the middle of this year.

Propofol IDD-D(TM) is a 2% intravenous formulation of propofol as the sole active ingredient and employs SkyePharma's patented Insoluble Drug Delivery (IDD-D(TM)) technology. In contrast with currently marketed versions of propofol, SkyePharma believes that Propofol IDD-D(TM) will not support significant microbial growth and therefore will not require incorporation of a preservative. Propofol IDD-D(TM) 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(TM) 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(TM) versus AstraZeneca's Diprivan, a currently marketed version of 1% 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.

https://www.bionity.com/en/news/36631/skyepharma-to-receive-milestone-payment-from-endo-for-propofol-idd-d-tm.html