LONDON, April 21 /PRNewswire-FirstCall/ -- SkyePharma PLC announces today that it has agreed with its North American partner Endo Pharmaceuticals to terminate the joint development of Propofol IDD-D(TM), 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(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. Propofol IDD-D(TM) 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(TM) (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(TM) that could have varied between 30% and 60% (out of which SkyePharma would have paid for manufacturing costs).
SkyePharma’s agreement with Endo over DepoDur(TM), the sustained release injectable version of morphine for control of post-operative pain, is unaffected by the termination of the joint development of Propofol IDD-D(TM).
For further information please contact:
SkyePharma PLC +44 207 491 1777
Frank Condella, Chief Executive Officer
Peter Laing, Director of Corporate Communications +44 207 491 5124
Sandra Haughton, US Investor Relations +1 212 753 5780
Buchanan Communications +44 207 466 5000
Tim Anderson / Mark Court / Rebecca Skye Dietrich
About SkyePharma
SkyePharma PLC develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now twelve approved products incorporating SkyePharma’s technologies in the areas of oral, injectable, inhaled and topical delivery, supported by advanced solubilisation capabilities. For more information, visit http://www.skyepharma.com.
Certain statements in this news release are forward-looking statements and are made in reliance on the safe harbour provisions of the U.S. Private Securities Litigation Act of 1995. Although SkyePharma believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurance that these expectations will materialize. Because the expectations are subject to risks and uncertainties, actual results may vary significantly from those expressed or implied by the forward-looking statements based upon a number of factors, which are described in SkyePharma’s 20-F and other documents on file with the SEC. Factors that could cause differences between actual results and those implied by the forward-looking statements contained in this news release include, without limitation, risks related to the development of new products, risks related to obtaining and maintaining regulatory approval for existing, new or expanded indications of existing and new products, risks related to SkyePharma’s ability to manufacture products on a large scale or at all, risks related to SkyePharma’s and its marketing partners’ ability to market products on a large scale to maintain or expand market share in the face of changes in customer requirements, competition and technological change, risks related to regulatory compliance, the risk of product liability claims, risks related to the ownership and use of intellectual property, and risks related to SkyePharma’s ability to manage growth. SkyePharma undertakes no obligation to revise or update any such forward-looking statement to reflect events or circumstances after the date of this release.
SkyePharma PLC
CONTACT: SkyePharma PLC, +44-207-491-1777, Frank Condella, Chief Executive Officer; or Peter Laing, Director of Corporate Communications, +44-207-491-5124; Sandra Haughton, US Investor Relations, +1-212-753-5780, all of SkyePharma PLC; or Tim Anderson, Mark Court, or Rebecca Skye Dietrich, all of Buchanan Communications, +44-207-466-5000
Web site: http://www.skyepharma.com/
