SKP.L Regulatory News (SKP)

29 Jun 2007 07:03

Skyepharma PLC29 June 2007 FOR IMMEDIATE RELEASE SkyePharma PLC - AGM Statement LONDON, UK, Friday, June 29, 2007 - SkyePharma PLC (LSE: SKP) Chairman, Dr JerryKarabelas, will make the following statement at today's Annual General Meeting: Progress continues to be made with the Flutiform(TM) clinical developmentprogramme and we continue to expect a launch in mid-2009. The phase IIIclinical trials are now over 80% recruited, the long-term safety study remainson track to complete in July 2007 and CMC development continues to go well.Although the pace of recruitment reduced during the Spring, due to competitionfor patients during the allergic rhinitis season, we have taken a number ofactions to boost enrollment and we expect to complete recruitment in the autumn.We have a pre-NDA (New Drug Application) meeting scheduled with the Food andDrug Administration ("FDA") in July 2007 and are now targeting to file the NDAfor the US around the end of Q1 2008. Additionally, we continue to beencouraged by the support from our marketing and distribution partners, Abbottand Mundipharma. The latter commenced paediatric trials for European approvalin May 2007. At our Lyon manufacturing facility, we are making progress with ramping up forthe launches later this year of ZYFLO CR(TM) (which was approved by the FDA on 31 May 2007) and in early 2008 of Lodotra(TM). We are also installing themanufacturing line for Sular(R) CR (which completed clinical trials in May)prior to its planned launch in 2008. We expect that these products will make asignificant contribution to capacity utilisation in our factory in 2008 andbeyond. On 26 June we were pleased to announce the licensing deal with SomnusTherapeutics for SKP-1041, a product to treat sleep disorders. We arecontinuing to work on a number of new development and licensing deals. There has been no material change in the Directors' expectations for theoperating result for 2007 although sales and cost levels may be somewhat reduceddue to exchange translation effects. The interim results for the 6 months ending 30 June 2007 will be announced on 20September 2007. For further information please contact: SkyePharma PLC Frank Condella +44 20 7491 1777 Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113 Deborah Scott Trout Group (US Enquiries) Christine Labaree +1 617 583 1308 Seth Lewis About SkyePharma PLC Using its proprietary drug delivery technologies, SkyePharma develops newformulations of known molecules to provide a clinical advantage and life-cycleextension. The Company has eleven approved products in the areas of oral,inhalation and topical delivery. The Group's products are marketed throughoutthe world by leading pharmaceutical companies. For more information, visitwww.skyepharma.com This information is provided by RNS The company news service from the London Stock Exchange