21st Apr 2006 11:16
Skyepharma PLC21 April 2006 For Immediate Release 21 April, 2006 SkyePharma PLC SkyePharma and Endo Agree to Terminate Joint Development of Propofol IDD-DTM for North America LONDON, ENGLAND, 21 April, 2006 -- SkyePharma PLC (LSE: SKP; Nasdaq: SKYE)announces today that it has agreed with its North American partner EndoPharmaceuticals ("Endo", Nasdaq: ENDP) to terminate the joint development ofPropofol IDD-DTM , an injectable anaesthetic and sedative that was licensed toEndo in December 2002. SkyePharma is evaluating its options worldwide for thisproduct, 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-DTM is a2% intravenous formulation of propofol as the sole active ingredient and employsSkyePharma's patented Insoluble Drug Delivery (IDD-DTM) technology. PropofolIDD-DTM was designed to avoid the need for incorporation of a preservative toprevent microbial contamination. The product successfully completed Phase IItrials in 2004. Under the terms of the December 2002 agreement with Endo, SkyePharma would havebeen responsible for the cost of Phase III development for Propofol IDD-DTM (estimated to be up to $30 million) but could have received up to $45 million inadditional milestone payments from Endo if the product had been approved by theUS Food & Drug Administration with a label meeting certain predeterminedcriteria and also a share of Endo's sales of Propofol IDD-DTM that could havevaried between 30% and 60% (out of which SkyePharma would have paid formanufacturing costs). SkyePharma's agreement with Endo over DepoDurTM, the sustained releaseinjectable version of morphine for control of post-operative pain, is unaffectedby the termination of the joint development of Propofol IDD-DTM. For further information please contact: SkyePharma PLC +44 207 491 1777Frank Condella, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 207 491 5124 Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court Notes for editors About SkyePharma SkyePharma PLC develops pharmaceutical products benefiting from world-leadingdrug delivery technologies that provide easier-to-use and more effective drugformulations. There are now twelve approved products incorporating SkyePharma'stechnologies in the areas of oral, injectable, inhaled and topical delivery,supported by advanced solubilisation capabilities. For more information, visitwww.skyepharma.com. Certain statements in this news release are forward-looking statements and aremade in reliance on the safe harbour provisions of the U.S. Private SecuritiesLitigation Act of 1995. Although SkyePharma believes that the expectationsreflected in these forward-looking statements are reasonable, it can give noassurance that these expectations will materialize. Because the expectations aresubject to risks and uncertainties, actual results may vary significantly fromthose expressed or implied by the forward-looking statements based upon a numberof factors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. Factors that could cause differences between actual results andthose implied by the forward-looking statements contained in this news releaseinclude, without limitation, risks related to the development of new products,risks related to obtaining and maintaining regulatory approval for existing, newor expanded indications of existing and new products, risks related toSkyePharma's ability to manufacture products on a large scale or at all, risksrelated to SkyePharma's and its marketing partners' ability to market productson a large scale to maintain or expand market share in the face of changes incustomer requirements, competition and technological change, risks related toregulatory compliance, the risk of product liability claims, risks related tothe ownership and use of intellectual property, and risks related toSkyePharma's ability to manage growth. SkyePharma undertakes no obligation torevise or update any such forward-looking statement to reflect events orcircumstances after the date of this release. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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