SKP.L Regulatory News (SKP)

9 May 2005 07:01

Skyepharma PLC09 May 2005 For immediate release 9 May 2005 SKYEPHARMA RECEIVES FDA APPROVAL FOR TRIGLIDE(TM) A NOVEL FORMULATION OF FENOFIBRATE LONDON, UK, 9 May 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) announcestoday that the US Food and Drug Administration ("FDA") has approvedTriglide(TM), its novel formulation of fenofibrate. This approval will trigger a$15 million milestone payment from our partner First Horizon PharmaceuticalCorporation ("First Horizon", Nasdaq: FHRX). In May 2004, SkyePharma announced that it had granted First Horizon exclusiveU.S. marketing and distribution rights for a cardiovascular product (nowidentified as fenofibrate IDD(R)-P). Under this agreement, SkyePharma willreceive up to $50 million in milestone payments, $30 million of which aresales-based milestone payments. In addition SkyePharma will receive 25% of FirstHorizon's net sales of the product. $5 million was paid to SkyePharma uponsignature of the agreement. SkyePharma will manufacture and supply the productfrom its Lyon manufacturing facility. SkyePharma will also make a contributionof up to $5 million to First Horizon's initial marketing expenses to establishthe product. Michael Ashton, SkyePharma's Chief Executive Officer, said: 'We are delightedwith the approval of Triglide(TM). This approval further reinforces our strategyto improve quality of earnings via increased royalties. We are confident thatFirst Horizon's 400-strong representative force with their focus oncardiovascular physicians and high-prescribing primary care practitioners willbe able to successfully create a substantial franchise in this therapeutic area." Fenofibrate is an oral treatment for lipid disorders such as elevatedcholesterol and triglycerides. The main drawback of fenofibrate is insolubilityin water, resulting in variable uptake from the stomach and requiring thepatient to take the tablets with food. Triglide(TM) the new formulationdeveloped by SkyePharma, has a comparable absorption under fed and fastingconditions and therefore allows patients to take the drug at any time, improvingcompliance and simplicity for both patients and prescribers. This represents thefirst approval for a product utilizing SkyePharma's solubilization IDD(R)-Ptechnology. SkyePharma PLC develops pharmaceutical products benefiting from world-leadingdrug delivery technologies that provide easier-to-use and more effective drugformulations. There are now ten 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. For further information please contact: SkyePharma PLC +44 207 491 1777Michael Ashton, Chief Executive OfficerPeter 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