23rd Oct 2008 07:00
SkyePharma Announces Successful Completion of Flutiform™ U.S. Clinical Trial Programme
LONDON, UK, 23 October, 2008 - SkyePharma PLC (LSE: SKP) today announces that the final U.S. Phase III efficacy study evaluating Flutiform™ for the treatment of moderate to severe asthma in adolescent and adult patients has met its primary endpoint. The study is the last Phase III clinical efficacy study to be carried out in preparation for regulatory filing.
In a top line analysis of key results, the levels of improvement in FEV1 (forced expiratory volume in the first second), the primary endpoint in the active treatment arms, showed statistically significant differences in favour of Flutiform™ compared with two different formulations of fluticasone taken alone.
The study (SKY2028-3-005) was conducted in centres across the United States, Latin America and Europe; and the full data set includes a total of 438 patients. The study was a randomised, double-blind, active-controlled, parallel group, stratified, multi-centre, 12-week study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform™ 250/10μg twice daily) in a single inhaler (SkyePharma HFA pMDI) with the administration of fluticasone (250μg twice daily) alone in two different formulations in adolescent and adult patients with moderate to severe asthma. Patients were treated for 12 weeks after initial screening and a two week run-in period.
Dr Ken Cunningham, CEO of SkyePharma, said: "This final successful Phase III efficacy study is the last trial to be completed prior to the submission of the NDA which is on track for filing with the FDA in Q1 2009."
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For further information please contact:
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SkyePharma PLC |
Ken Cunningham |
+44 20 7491 1777 |
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During office hours |
Peter Grant |
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Financial Dynamics (UK Enquiries) |
David Yates |
+44 20 7831 3113 |
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Outside office hours |
Jonathan Birt |
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Trout Group (US Enquiries) |
Seth Lewis |
+1 617 583 1308 |
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Brandon 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 fumarate) with the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) 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 Abbott Respiratory LLC (formerly known as Kos Life Sciences, Inc.), a wholly owned subsidiary of Abbott.
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