SOURCE: SkyePharma PLC

June 17, 2008 02:00 ET

Skyepharma PLC - Research Update

London, UK--(Marketwire - June 17, 2008) -

SkyePharma Announces Second FlutiformTM 

Phase III Efficacy Study Meets Primary Endpoints 


LONDON, UK, 17 June, 2008 - SkyePharma PLC (LSE: SKP) 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.  


-- ends --


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 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.


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

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