Skyepharma PLC Announces Flutiform(TM) Phase III Efficacy Study Meets Primary Endpoints
The study (SKY2028-3-002) was conducted in centres across Canada and the United States and the full analysis set includes a total of 357 patients. The study was a randomised, double-blind, active-controlled, parallel group, stratified, 12-week study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform(TM) 100/10ug twice daily) in a single inhaler (SkyePharma HFA pMDI) versus the administration of fluticasone (100ug twice daily) and formoterol (10ug twice daily) alone in adolescent and adult patients with mild to moderate asthma.
In a top line analysis of key results, the levels of improvement in FEV1 (forced expiratory volume in the 1st second), the primary endpoints measured, showed statistically significant differences in favour of Flutiform(TM) compared with both fluticasone and formoterol taken alone.
Frank Condella, CEO of SkyePharma, said: "The preliminary results in this Phase III 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 trial reported last year, will form part of the New Drug Application (NDA) for US approval for Flutiform(TM). The last patient visits for two additional Phase III efficacy studies, SKY2028-3-004 and SKY2028-3-001, have taken place in the last few days. The additional efficacy study, SKY2028-3-005, required for the NDA, has commenced recruitment and the overall development program remains on schedule for the NDA to be filed in Q1, 2009.
On 15th April 2008, SkyePharma announced that its partner for the development and marketing of Flutiform(TM) in Europe, Mundipharma, had successfully completed an efficacy study of Flutiform(TM) in 211 paediatric patients, with preliminary analysis showing that it had met its primary end point of statistical non-inferiority to the combination product Seretide.
For further information please contact: SkyePharma PLC Frank Condella +44 20 7491 1777 During office hours Ken Cunningham Peter Grant Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113 Outside 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 new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Company has twelve approved products in the areas of oral, inhalation and topical delivery. The Group's products are marketed throughout the world by leading pharmaceutical companies. For more information, visit www.skyepharma.com
About Flutiform(TM)
Flutiform(TM) HFA-MDI is a fixed-dose combination of formoterol and fluticasone in a metered dose inhaler ('MDI'). The product incorporates a fast onset long-acting beta-agonist (formoterol fumarate) with the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane ("HFA") and is being developed for asthma. Flutiform(TM) is aimed at the market for combination steroid and long-acting beta-agonist inhalers which is forecast to be approximately US$10 billion worldwide by 2010.