SKP.L Regulatory News (SKP)

15 Apr 2008 07:01

Skyepharma PLC15 April 2008 SkyePharma Announces Positive Results of FlutiformTM Paediatric Study -- The first of a number of important announcements regarding FlutiformTM in the coming months -- LONDON, UK 15 April 2008 - SkyePharma PLC (LSE: SKP) today announces that itsdevelopment and marketing partner Mundipharma has successfully completed aFlutiformTM paediatric study with positive results. As part of the European development programme for FlutiformTM, Mundipharma hasconducted a study for the treatment of asthma in children aged four to twelve.211 paediatric patients suffering from mild to moderate persistent andreversible asthma were recruited in the trial. This randomised, open label, parallel group study compared FlutiformTM at itslowest dose (100 mcg fluticasone & 10mcg formoterol) to Seretide (100 mcgfluticasone & 50 mcg salmeterol), with the aim of demonstrating comparableefficacy between treatment arms. Enrolled patients had to have a diseasehistory of six months and more, and received treatment for 12 weeks, with anongoing six month extension for follow up of safety and growth. Improvement in FEV1 (Forced Expiratory Volume in the 1st second) was the primaryparameter measured and the preliminary analysis shows that this end point wassuccessfully met. The statistical analysis shows that, in both treatmentgroups, there was an improvement in lung function from the baseline measurement(using FEV1) whilst the performance of FlutiformTM was not statisticallyinferior to that of Seretide. The results of this trial will be taken into account in designing any paediatricinvestigation plan required in accordance with EU Regulations. SkyePharma's Chief Executive Officer, Frank Condella, said: "The successfulconclusion of this paediatric trial comparing FlutiformTM with Seretide is afurther important step in the development of the product and follows thesuccessful completion of the long-term safety study in 2007. The release ofthis data is the first of a number of important announcements that we shall bemaking regarding FlutiformTM over the coming months as the results come throughfrom the various pivotal Phase III trials that are now nearing completion. Welook forward to announcing the first of three pivotal clinical efficacy trialresults in the coming weeks and to progressing the path of this importantpipeline product through to market." 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 FlutiformTM FlutiformTM 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) with the most commonly prescribed inhaledsteroid (fluticasone) in combination with an environmentally-friendly aerosolpropellant hydrofluoroalkane ("HFA") and is being developed for asthma.FlutiformTM is aimed at the market for combination steroid and long-actingbeta-agonist inhalers which is forecast to be approximately US$10 billionworldwide by 2010, which is when the Board expects FlutiformTM to be in themarket in both the USA and Europe. This information is provided by RNS The company news service from the London Stock Exchange