28th Jun 2005 07:00
Skyepharma PLC28 June 2005 FOR IMMEDIATE RELEASE 28 June, 2005 SkyePharma Welcomes Return of Paxil CR(TM) to US Market LONDON, ENGLAND, 28 June, 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP)welcomes the announcement by its partner GlaxoSmithKline ("GSK") that PaxilCR(TM) is now available at pharmacies throughout the United States. Michael Ashton, SkyePharma's Chief Executive, said: "Paxil CR(TM) was designed to address the side-effect of early nausea that affects many patients being treated with SSRI antidepressants so its return to the US market fills an obvious therapeutic gap. Paxil CR(TM) was our most important source of royalty income in 2004. We are confident that a rebuild in US revenues, and the new higher royalty rate, will mean that it will also be the major source of royalty income in 2005." On 4 March 2005, the US Food & Drug Administration ("FDA") halted distributionof supplies of Paxil CR(TM), and another unrelated product, from GSK'smanufacturing plant at Cidra, in Puerto Rico, and from distribution depots,thereby halting US distribution of Paxil CR(TM). Both GSK and the FDA agreed atthe time that manufacturing issues cited by the FDA posed no significant safetyissue for patients. On 28 April 2005, SkyePharma announced that it had enteredinto an amendment agreement with GSK whereby the royalty rate payable on GSK'ssales of Paxil CR(TM) was increased from 3% to 4%. GSK also agreed to maintainroyalty payments while the product was off the market. For further information please contact: SkyePharma PLC +44 207 491 1777Michael Ashton, Chief Executive OfficerPeter Laing, Director of Corporate Communications +44 205 491 5124 Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court Notes to 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 eleven 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. About Paxil CR(TM) In March 1996, SkyePharma entered into a License Agreement with SmithKlineBeecham (now part of GlaxoSmithKline) for the development, manufacture andmarketing of a modified release version of Paxil(R)/Seroxat(R) (paroxetinehydrochloride) using a combination of SkyePharma's Geomatrix(TM) PositionedRelease and Zero Order systems. Paxil(R) is an FDA-approved antidepressant drugthat is currently marketed primarily in the United States and Europe (where itis known as Seroxat(R)) and is an immediate release formulation prescribed forcentral nervous system disorders. Paxil CR(TM) was approved by the FDA inFebruary 1999 for the treatment of depression. Subsequently Paxil CR(TM) has been approved by the FDA for four additional indications: panic disorder, thecontinuous treatment of Pre-Menstrual Dysphoric Disorder (PMDD), social anxietydisorder and the intermittent treatment of PMDD. 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:
SKP.LGlaxosmithkline