Claire SkyePharma Announces Positive Results for Two European Studies for Flutiform
LONDON, UK, July 22, 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."
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.comwww.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. Flutiform™ 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. 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.
Claire Rowell Manager Financial Communications
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Posted: July 2008