2nd Nov 2009 10:07
FOR IMMEDIATE RELEASE
SkyePharma Announces Successful Completion of
Flutiform™ EU Clinical Trial Programme
LONDON, UK, 2 November, 2009 - SkyePharma PLC (LSE: SKP) today announces that its development and marketing partner Mundipharma International Corporation Limited ("Mundipharma") has successfully completed the final Phase III clinical study for the European development programme for Flutiform™, with the higher dose strength study (FLT 3503) meeting its primary endpoints. This will enable the regulatory filing with the European authorities to take place in Q1 2010 as planned.
Study FLT-3503 included 529 patients, who met the requirements for the "per protocol" analysis, and were suffering from severe, persistent and reversible asthma. They were treated in an eight week double-blind, double dummy, randomised multiple centre four arm parallel group study to assess the efficacy and safety of Flutiform™. The four treatment arms were: (1) Flutiform™ (fluticasone 500 μg/formoterol 20 μg); (2) Flixotide (fluticasone 500 μg) and Foradil (formoterol 24 μg) administered concurrently; (3) Flutiform™ (fluticasone 100 μg /formoterol 10 μg); and (4) Flixotide (fluticasone 500 μg). Enrolled patients had to have a disease history of at least six months.
The changes in the mean pre-dose FEV1 (Forced Expiratory Volume in the first second) at baseline to the pre-dose FEV1 and the two hour post-dose FEV1 at eight weeks, were the primary endpoints measured and the top line analysis confirms that Flutiform™ produces similar results (statistically not inferior) when compared with the concurrent administration of Flixotide and Foradil. The results demonstrated that Flutiform™ was well tolerated in the study patients. The analysis of multiple secondary endpoints is ongoing.
Dr Ken Cunningham, CEO of SkyePharma, said: "We are very pleased that study FLT-3503 has met its primary endpoints. Results from the study confirm the efficacy of the high dose strength of Flutiform™ (fluticasone 500 μg and formoterol 20 μg). The successful completion of this study will enable the European Marketing Authorisation Application to be filed as planned in Q1 2010."
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SkyePharma PLC |
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Ken Cunningham, Chief Executive Officer |
+44 (0) 207 491 1777 |
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Peter Grant, Chief Financial Officer |
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Financial Dynamics |
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Jonathan Birt |
+44 (0) 207 831 3113 |
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Susan Quigley |
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 Group 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 fluticasone and formoterol in a metered dose inhaler (MDI). The product incorporates the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) and a long-acting beta-agonist (formoterol fumarate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane (HFA) and is being developed for asthma. The rights for commercialisation of Flutiform™ outside the Americas and Japan are licensed to Mundipharma International Corporation Limited.
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