London, UK--(Marketwire - April 15, 2008) -
SkyePharma Announces Positive Results
of FlutiformTM Paediatric Study
-- The first of a number of important announcements regarding
FlutiformTM in the coming months --
LONDON, UK 15 April 2008 - SkyePharma PLC (LSE: SKP) today announces that its
development and marketing partner Mundipharma has successfully completed a
FlutiformTM paediatric study with positive results.
As part of the European development programme for FlutiformTM, Mundipharma has
conducted a study for the treatment of asthma in children aged four to twelve.
211 paediatric patients suffering from mild to moderate persistent and
reversible asthma were recruited in the trial.
This randomised, open label, parallel group study compared FlutiformTM at its
lowest dose (100 mcg fluticasone & 10mcg formoterol) to Seretide (100 mcg
fluticasone & 50 mcg salmeterol), with the aim of demonstrating comparable
efficacy between treatment arms. Enrolled patients had to have a disease
history of six months and more, and received treatment for 12 weeks, with an
ongoing six month extension for follow up of safety and growth.
Improvement in FEV1 (Forced Expiratory Volume in the 1st second) was the primary
parameter measured and the preliminary 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 FlutiformTM was not statistically
inferior to that of Seretide.
The results of this trial will be taken into account in designing any paediatric
investigation plan required in accordance with EU Regulations.
SkyePharma's Chief Executive Officer, Frank Condella, said: "The successful
conclusion of this paediatric trial comparing FlutiformTM with Seretide is a
further important step in the development of the product and follows the
successful completion of the long-term safety study in 2007. The release of
this data is the first of a number of important announcements that we shall be
making regarding FlutiformTM over the coming months as the results come through
from the various pivotal Phase III trials that are now nearing completion. We
look forward to announcing the first of three pivotal clinical efficacy trial
results in the coming weeks and to progressing the path of this important
pipeline product through to market."
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 known molecules 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) 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 USD10 billion
worldwide by 2010, which is when the Board expects FlutiformTM to be in the
market in both the USA and Europe.
This information is provided by RNS
The company news service from the London Stock Exchange