SkyePharma Announces Phase III Efficacy Study Meets Primary Endpoints
LONDON, UK, 17 June, 2008 - SkyePharma PLC (LSE:SKP.L - News) today announces that its second Phase III efficacy study evaluating FlutiformTM for the treatment of moderate to severe asthma in adolescent and adult patients has met its primary endpoints. This is the second of several clinical efficacy studies being carried out in preparation for regulatory filing.
The study (SKY2028-3-004) was conducted in centres across the United States and Europe. The full analysis set includes a total of 557 patients. The study was a randomised, double-blind, placebo-controlled, parallel group, stratified, multi-centre study comparing the safety and efficacy of fluticasone and formoterol combination (FlutiformTM 100/10 micrograms or 250/10 micrograms twice daily) in a single inhaler (SkyePharma HFA pMDI) versus the administration of either placebo or fluticasone (250 micrograms twice daily) or formoterol (10 micrograms twice daily) alone in adolescent and adult patients with moderate to severe asthma. Patients were treated for 12 weeks after initial screening and a 14 day run-in period.
In a top line analysis of key results, the levels of improvement in FEV1 (forced expiratory volume in the first second), the primary endpoint in the active treatment arms, showed statistically significant differences in favour of FlutiformTM compared with both fluticasone and formoterol taken alone. In addition, the results demonstrated a significantly lower number of discontinuations due to lack of efficacy for FlutiformTM as compared with placebo.
Frank Condella, CEO of SkyePharma, said: "The preliminary results from this second double-blind, Phase III study provide evidence of efficacy in moderate to severe asthma and represent another major step forward in the development of FlutiformTM. The last patient visits for the third Phase III efficacy study, SKY2028-3-001, took place in April 2008 and we expect to announce results shortly."
The results of Study 004, together with the long-term Phase III safety trial reported last year and the first efficacy trial (key results published 30 April 2008), will form part of the New Drug Application ("NDA") for US approval for FlutiformTM. As announced on 30 April 2008, the first efficacy study (SKY2028-3-002) included 357 patients in a randomised, double-blind, active-controlled, parallel group, stratified, 12-week design, comparing the safety and efficacy of FlutiformTM 100/10(micrograms) twice daily in a single inhaler (SkyePharma HFA pMDI) versus the administration of fluticasone (100(micrograms) twice daily)and formoterol (10(micrograms) twice daily) alone in adolescent and adult patien ts with mild to moderate asthma. In a top line analysis of these key results, the levels of improvement in FEV1, the primary endpoint measured, showed statistically significant differences in favour of FlutiformTM compared with both fluticasone and formoterol taken alone.
Recruitment is ongoing for the additional efficacy study (SKY2028-3-005) required for the NDA and the overall development program remains on schedule for the NDA to be filed in Q1, 2009.
For further information please contact:
SkyePharma PLC Frank Condella +44 20 7491 1777
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products 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 http://www.skyepharma.com.
FlutiformTM 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. FlutiformTM is aimed at the market for combination steroid and long-acting beta-agonist inhalers which isforecast to be approximately USUSD10 billion worldwide by 2010. FlutiformTM is licensed in the U.S. to Kos Life Sciences, a wholly owned subsidiary of Abbott.