SkyePharma PLC announces today that it has agreed with its North American partner Endo Pharmaceuticals to terminate the joint development of Propofol IDD-D, an injectable anaesthetic and sedative that was licensed to Endo in December 2002. SkyePharma is evaluating its options worldwide for this product, which remains under strategic review.
Propofol is a widely-used intravenous anaesthetic and sedative, supplied as a 1% injectable emulsion. It is used for induction of short-term anaesthesia (typically 30-60 minutes) or as an infusion for sedation. Propofol IDD-D is a 2% intravenous formulation of propofol as the sole active ingredient and employs SkyePharma's patented Insoluble Drug Delivery (IDD-D) technology. Propofol IDD-D was designed to avoid the need for incorporation of a preservative to prevent microbial contamination. The product successfully completed Phase II trials in 2004.
Under the terms of the December 2002 agreement with Endo, SkyePharma would have been responsible for the cost of Phase III development for Propofol IDD-D (estimated to be up to $30 million) but could have received up to $45 million in additional milestone payments from Endo if the product had been approved by the US Food & Drug Administration with a label meeting certain predetermined criteria and also a share of Endo's sales of Propofol IDD-D that could have varied between 30% and 60% (out of which SkyePharma would have paid for manufacturing costs).
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