SOURCE: SkyePharma PLC

July 03, 2008 02:00 ET

Skyepharma PLC Announces Research Update

LONDON--(Marketwire - July 3, 2008) -



SkyePharma Announces Third FlutiformTM


Phase III Efficacy Study Meets Primary
Endpoints and Completes Original Core Clinical Trial Programme


LONDON, UK, 3 July, 2008 - SkyePharma PLC (LSE: SKP) today announces
that its third Phase III efficacy study evaluating FlutiformTM for the
treatment of mild to moderate asthma in adolescent and adult patients
has met its primary endpoints. This is the third of several clinical
efficacy studies being carried out in preparation for regulatory
filing and completes the original core clinical trial programme.


The study (SKY2028-3-001) was conducted in centres across North
America and Europe.  The full analysis set includes a total
of 475 patients. The study was a randomised, double-blind, placebo-
controlled, parallel group, stratified, multi-centre, 12-week study
comparing the safety and efficacy of fluticasone and formoterol
combination (FlutiformTM 100/10 micrograms twice daily) in a single
inhaler (SkyePharma HFA pMDI) with the administration of placebo or
fluticasone (100 micrograms twice daily) or formoterol (10 micrograms
twice daily) alone in adolescent and adult patients with mild
to moderate asthma.  Patients were treated for 12 weeks after initial
screening and a two to four week 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 compared with placebo.


Ken Cunningham, COO and CEO-designate of SkyePharma, said: "This is the
third of the core clinical efficacy trials to meet its primary
endpoints. These studies together with the Phase III safety study have
included a total of 1,861 patients.  We are very pleased with the
progress being made with the development of FlutiformTM and now look
forward to the results of the one remaining clinical efficacy
trial required for the US filing. This is being conducted by Kos Life
Sciences (a wholly owned subsidiary of Abbott), and is on track
to be fully recruited in July and completed in the second half of this
year."


The results of Study 001, together with the long-term Phase III safety
trial reported last year and the two efficacy trials already
reported on 30 April and 17 June 2008, respectively, and
summarised again below, will form part of the New Drug Application
("NDA") for U.S. regulatory approval for FlutiformTM.


The first efficacy study, SKY2028-3-002, included 357 patients in North
America. It was a randomised, double-blind, active-controlled, parallel
group, stratified, 12-week design. It compared the safety and efficacy
of FlutiformTM 100/10 micrograms versus the administration of
fluticasone (100 micrograms twice daily) and formoterol (10 micrograms
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 showed statistically significant differences in
favour of FlutiformTM compared with both fluticasone and formoterol
taken alone.


Study SKY2028-3-004 was conducted in 557 patients across the United
States and Europe. It 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) 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.  In a
top line analysis of key results, the levels of improvement in FEV1
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
compared with placebo.


Recruitment is on track to be completed in July for the additional
efficacy study (SKY2028-3-005) required for the US NDA and the overall
development program remains on schedule for the NDA to be filed in Q1,
2009.


We are continuing to explore options for refinancing or renegotiating
the convertible bonds and will make an update announcement in due
course.


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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 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 www.skyepharma.com.


About FlutiformTM

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 is
forecast 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.


                    This information is provided by RNS
          The company news service from the London Stock Exchange

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