SKP.L Regulatory News (SKP)

1 Feb 2005 07:01

Skyepharma PLC01 February 2005 For immediate release 1 February 2005 SKYEPHARMA AND FIRST HORIZON EXTEND AGREEMENT FOR NOVEL FORMULATION OF FENOFIBRATE LONDON, UK, 1 February 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announcestoday that it has extended an agreement with First Horizon PharmaceuticalCorporation ("First Horizon", Nasdaq: FHRX) originally signed in May 2004 inconnection with SkyePharma's novel formulation of fenofibrate, currently underreview by the US Food and Drug Administration ("FDA"). Subject to FDA approval,the amended agreement would now permit First Horizon to launch the novelfenofibrate product in the first half of 2005. Michael Ashton, SkyePharma's Chief Executive Officer, said: "We are delighted bythis demonstration of First Horizon's continuing commitment." SkyePharma PLC develops pharmaceutical products benefiting from world-leadingdrug delivery technologies that provide easier-to-use and more effective drugformulations. There are now nine approved products incorporating three fromSkyePharma's five technologies in the areas of oral, injectable, inhaled andtopical delivery, supported by advanced solubilisation capabilities. For moreinformation, visit www.skyepharma.com. For further information please contact: SkyePharma PLCMichael Ashton, Chief Executive Officer +44 207 491 1777Peter Laing, Director of Corporate Communications +44 205-491 5124Sandra Haughton, US Investor Relations +1 212 753 5780 Buchanan Communications +44 207 466 5000Tim Anderson / Mark Court Except for the historical information herein, the matters discussed in this newsrelease include forward-looking statements that may involve a number of risksand uncertainties. Actual results may vary significantly based upon a number offactors, which are described in SkyePharma's 20-F and other documents on filewith the SEC. These include without limitation risks in obtaining andmaintaining regulatory approval for existing, new or expanded indications forits products, other regulatory risks, risks relating to SkyePharma's ability tomanufacture pharmaceutical products on a large scale, risks that customerinventory will be greater than previously thought, risks concerning SkyePharma'sability to manage growth, SkyePharma's marketing partners' ability to market apharmaceutical product on a large scale and manage their sales and marketingorganisation and maintain or expand sales and market share for its products,risks relating to the ability to ensure regulatory compliance, risks related tothe research, development and regulatory approval of new pharmaceuticalproducts, risks related to research and development costs and capabilities,market acceptance of and continuing demand for SkyePharma's products and theimpact of increased competition, risks associated with anticipated top andbottom line growth and the possibility that upside potential will not beachieved, competitive products and pricing, and risks associated with theownership and use of intellectual property rights. SkyePharma undertakes noobligation to revise or update any such forward-looking statement to reflectevents or circumstances after the date of this release. This information is provided by RNS The company news service from the London Stock Exchange