SkyePharma Announces Positive Results
for Two European Studies for Flutiform™
LONDON, UK 22 July 2008 - SkyePharma PLC (LSE : SKP ) today announces
that its development and marketing partner Mundipharma has
successfully completed two Phase III clinical studies for the European
development programme for Flutiform™, both of which show positive
results.
Study FLT-3501 assessed 182 patients, suffering from mild to
moderate-severe persistent and reversible asthma, who were treated in
accordance with the protocol. This randomised, open label, parallel
group study compared Flutiform™ pMDI (100 mcg fluticasone & 10mcg
formoterol bid, or 250/10 mcg bid, respectively) to Seretide® pMDI
(100 mcg fluticasone & 50 mcg salmeterol bid, or 250/50 mcg bid,
respectively), with the goal to demonstrate comparable efficacy between
treatment arms. Enrolled patients had to have a disease history of at
least six months and were treated for 12 weeks.
Mean pre-dose FEV1 (Forced Expiratory Volume in the first second) was
the primary parameter measured and the top line analysis shows that
this end point was successfully met. The statistical analysis shows
that, in both treatment groups, there was an improvement in lung
function from the baseline measurement (using FEV1) whilst the
performance of Flutiform™ was not statistically inferior to that of
Seretide®.
Study FLT-3505 analysed 196 adult and adolescent patients, suffering
from mild to moderate-severe persistent and reversible asthma, who were
treated in accordance with the protocol. This randomised, open label,
parallel group study compared Flutiform™ pMDI (100 mcg fluticasone &
10mcg formoterol bid, or 250/ 10 mcg bid, respectively) to its
individual components, fluticasone and formoterol, administered
concurrently with the goal to demonstrate non-inferiority of Flutiform
™ to the other treatment arm based on FEV1. Enrolled patients were
again treated for 12 weeks. The top line statistical analysis of the
primary parameter confirms that Flutiform™ is not inferior compared
with the concurrent administration of fluticasone and formoterol.
SkyePharma's Chief Operating Officer, Dr Ken Cunningham, said: "We are
delighted that along with the three Phase III pivotal efficacy studies
conducted for NDA submission, we now have two further Phase III studies
for European regulatory submission that have met their primary
endpoints."
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 Flutiform™
Flutiform™ 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) with the
most commonly prescribed inhaled steroid (fluticasone) 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. Flutiform™ is licensed in the U.S. to Kos Life Sciences, a
wholly owned subsidiary of Abbott; in Europe to Mundipharma and
in Japan to Kyorin Pharmaceutical Co. Ltd.
This information is provided by RNS
The company news service from the London Stock Exchange
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