LONDON, UK - 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.
