Flutiform - Results of Safety StudyLONDON, - 2 November 2007 -- SkyePharma PLC (LSE: SKP) today announces that the Phase III, long-term, open label, safety study for FlutiformTM, the Company's lead development product for the treatment of asthma, has been completed and the results are consistent with the large safety database already accumulated on the individual constituents fluticasone and formoterol. The study involved 472 patients who were treated with FlutiformTM for 6 or 12 months and will form part of the US New Drug Application ('NDA') for FlutiformTM. Three double-blind efficacy trials are currently ongoing, of which one is fully enrolled and the other two are nearing full enrolment. Submission of the NDA is expected in the second half of 2008.
Frank Condella, CEO of SkyePharma said, 'The results of this study are as we expected and represent a significant milestone achieved in the FlutiformTM development programme. We continue to make good progress towards the approval of this exciting product.'
For further information please contact:
Frank Condella, Chief Executive Officer
Ken Cunningham, Chief Operating Officer +44 207 491 1777
Peter Grant, Finance Director
Financial Dynamics (London enquiries) David Yates / Deborah Scott +44 207 831 3113
Trout Group (US enquiries) Christine Labaree / Seth Lewis +1 617 583 1308
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 eleven 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.
Posted: November 2007