SOURCE: SkyePharma PLC

May 20, 2008 02:22 ET

Skyepharma PLC announces Research Update

LONDON--(Marketwire - May 20, 2008) -


SkyePharma Announces Presentation of FlutiformTM 

Phase III Safety Study at ATS in Toronto 


LONDON, UK, 20 May, 2008 - SkyePharma PLC (LSE: SKP) today announces
the presentation of its Phase III, long-term, open label safety study
evaluating FlutiformTM for the treatment of asthma in adolescent and
adult patients.  The scientific poster will be shown today, during the
American Thoracic Society ("ATS") Meeting in Toronto, Canada.


The ATS meeting is one of the largest gatherings of Pulmonary and
Critical Care clinicians and researchers in the world.  Last year's
conference in San Francisco was attended by over 16,000 people from 90
countries.  The conference provides information on the latest and most
significant developments in clinical practice, research (clinical,
basic and translational), health advocacy and education. 


As announced in November 2007, the study (SKY2028-3-003) involved 472
patients, who were assigned to treatment with FlutiformTM, either 100/
10?g or 250/10?g twice daily, for 6 or 12 months. The author of the
poster, Dr. Ekkehard Beck, stated "Study results suggest that long
term treatment with FlutiformTM 100/10?g and FlutiformTM 250/10?g will
be a safe therapy for patients with persistent asthma."


The results of this trial will form part of the US New Drug Application
("NDA") for FlutiformTM. As announced on 30 April 2008, a top line
analysis of key results of the first Phase III efficacy study
(SKY2028-3-002) demonstrated statistically significant differences in
favour of FlutiformTM compared with both fluticasone and formoterol
taken alone at the level of improvement in FEV1 (forced expiratory
volume in the first second), the primary endpoints measured.
It has also been announced that: the last patient visits for the two
remaining core Phase III efficacy studies, SKY2028-3-004 and
SKY2028-3-001, have taken place and results are expected in the summer;
the additional efficacy study, SKY2028-3-005, required for the
NDA, has commenced recruitment; and the overall development
programme remains on schedule for the NDA to be filed with the FDA in
the USA in Q1, 2009.  


Frank Condella, CEO of SkyePharma, said: "We are pleased that this
poster will be presented today at the ATS, which includes additional
data from the Phase III, long-term, open label safety study evaluating
FlutiformTM for the treatment of asthma in adolescent and adult
patients.  The results from our Phase III work continue to be
encouraging."


Background information on study SKY2028-3-003

(presented at ATS 2008 on poster board A40, on 20 May, from 10.45am -
12.15 pm Toronto time)


SkyePharma performed a long term, open-label safety study with
FlutiformTM in 472 adult and adolescent patients with asthma. Eligible
patients had FEV1 of ?40 ?85% of predicted normal values. 


This long-term safety study demonstrated that the drug was effective
and well tolerated in these study patients. 


87.5% of the patients completed the study. Seven patients withdrew due
to an adverse event, 8 patients withdrew due to an asthma exacerbation
and 6 patients withdrew due to lack of efficacy.
The study population had a mean FEV1 predicted of 73% and a mean
bronchodilator reversibility response of 28%. The overall mean change
in FEV1 from baseline to the final visit was +389 +/- 466 mL, pless than0.001
in both groups. 


37% of patients had treatment emergent adverse events ("TEAEs"), of
which 19.9% of were mild and 13.3% were moderate in severity. The most
common adverse events were nasopharyngitis, pharyngitis and respiratory
tract infection. Ten patients had serious TEAEs, which included 12
events, 4 of which were related to the respiratory system.




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 being developed as a fixed-dose combination of
formoterol and fluticasone in a metered dose inhaler ('MDI') for the
treatment of asthma. The product incorporates a long-acting
beta-agonist (formoterol fumarate) with 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.

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

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