SkyePharma : Second Flutiform Phase III Efficacy Study Meets Primary Endpoints

17 June, 2008 - SkyePharma PLC (LSE: SKP) announces that its second Phase III efficacy study evaluating Flutiform™ 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 (Flutiform™ 100/10μg or 250/10μg twice daily) in a single inhaler (SkyePharma HFA pMDI) versus the administration of either placebo or fluticasone (250μg twice daily) or formoterol (10μg 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... SkyePharma's Press Release -

SkyePharma : exclusive License Agreement with Kyorin for Development and Distribution of Flutiform in Japan

22 April, 2008 - SkyePharma PLC (LSE: SKP) announces that it has entered into an exclusive Development, Distribution and License Agreement for Flutiform(TM), its lead development product for the treatment of asthma, with Kyorin Pharmaceutical Co., Ltd., a subsidiary of Kyorin Co., Ltd. for Japan. SkyePharma will receive signing, development and approval milestones worth several millions of pounds plus a high mid-single digit royalty on sales.The development costs associated with obtaining approval for the Japanese market will largely be met by Kyorin, which is responsible for clinical trials and regulatory submissions. Development is expected to take several years... SkyePharma's Press Release -