30th Apr 2008 07:00
Skyepharma PLC30 April 2008 SkyePharma Announces Flutiform(TM) Phase III Efficacy Study Meets Primary Endpoints LONDON, UK, 30 April, 2008 - SkyePharma PLC (LSE: SKP) today announces that itsPhase III efficacy study evaluating Flutiform(TM) for the treatment of asthma inadolescent and adult patients, met its primary endpoints. This is the first ofseveral clinical efficacy studies being carried out in preparation forregulatory filing. The study (SKY2028-3-002) was conducted in centres across Canada and the UnitedStates and the full analysis set includes a total of 357 patients. The studywas a randomised, double-blind, active-controlled, parallel group, stratified,12-week study comparing the safety and efficacy of fluticasone and formoterolcombination (Flutiform(TM) 100/10ug twice daily) in a single inhaler(SkyePharma HFA pMDI) versus the administration of fluticasone (100ugtwice daily) and formoterol (10ug twice daily) alone in adolescent andadult patients with mild to moderate asthma. In a top line analysis of key results, the levels of improvement in FEV1 (forcedexpiratory volume in the 1st second), the primary endpoints measured, showedstatistically significant differences in favour of Flutiform(TM) compared withboth fluticasone and formoterol taken alone. Frank Condella, CEO of SkyePharma, said: "The preliminary results in this PhaseIII efficacy study represent a key step forward in the development of Flutiform(TM). We are looking forward to the top line results from the remaining Phase III efficacy trials being announced in the coming months." The results of this trial, together with the long-term Phase III safety trialreported last year, will form part of the New Drug Application (NDA) for USapproval for Flutiform(TM). The last patient visits for two additional Phase IIIefficacy studies, SKY2028-3-004 and SKY2028-3-001, have taken place in the lastfew days. The additional efficacy study, SKY2028-3-005, required for the NDA,has commenced recruitment and the overall development program remains onschedule for the NDA to be filed in Q1, 2009. On 15th April 2008, SkyePharma announced that its partner for the developmentand marketing of Flutiform(TM) in Europe, Mundipharma, had successfully completedan efficacy study of Flutiform(TM) in 211 paediatric patients, with preliminaryanalysis showing that it had met its primary end point of statisticalnon-inferiority to the combination product Seretide. -- ends -- For further information please contact:SkyePharma PLC Frank Condella +44 20 7491 1777During office hours Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113Outside office hours 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 twelve 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 About Flutiform(TM) Flutiform(TM) HFA-MDI is a fixed-dose combination of formoterol and fluticasone ina metered dose inhaler ('MDI'). The product incorporates a fast onsetlong-acting beta-agonist (formoterol fumarate) with the most commonly prescribedinhaled anti-inflammatory corticosteroid (fluticasone propionate) in combinationwith an environmentally-friendly aerosol propellant hydrofluoroalkane ("HFA")and is being developed for asthma. Flutiform(TM) is aimed at the market forcombination steroid and long-acting beta-agonist inhalers which is forecast tobe approximately US$10 billion worldwide by 2010. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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