SkyePharma Announces Positive Results of Flutiform Paediatric Study
The first of a number of important announcements regarding Flutiform(tm) in the coming months
LONDON, April 15, 2008 - SkyePharma PLC (LSE: SKP) today announces that its development and marketing partner Mundipharma has successfully completed a Flutiform(tm) paediatric study with positive results.
As part of the European development programme for Flutiform(tm), 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 Flutiform(tm) 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 Flutiform(tm) 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 Flutiform(tm) 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 Flutiform(tm) 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."
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 www.skyepharma.com>
About Flutiform(tm)
Flutiform(tm) 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. Flutiform(tm) is aimed at the market for combination steroid and long-acting beta-agonist inhalers which is forecast to be approximately US$10 billion worldwide by 2010, which is when the Board expects Flutiform(tm) to be in the market in both the USA and Europe.
Mo Noonan Manager Financial Communications
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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
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Christine Labaree
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Seth Lewis
Posted: April 2008
