SOURCE: SkyePharma PLC

November 02, 2009 05:24 ET

Flutiform EU Clinical Trial Successfully Completed

LONDON--(Marketwire - November 2, 2009) -


FOR IMMEDIATE RELEASE


SkyePharma Announces Successful Completion of

FlutiformTM 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 FlutiformTM, 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 FlutiformTM. The four treatment
arms were: (1) FlutiformTM (fluticasone 500 microgram/formoterol
20 microgram); (2)Flixotide (fluticasone 500 microgram) and Foradil
(formoterol 24 microgram)administered concurrently; (3) FlutiformTM
(fluticasone 100 microgram /formoterol 10 microgram); and (4)
Flixotide (fluticasone 500  microgram ). 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 FlutiformTM produces similar results
(statistically not inferior) when compared with the concurrent
administration of Flixotide and Foradil. The results demonstrated that
FlutiformTM 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 FlutiformTM
(fluticasone 500  microgram and formoterol 20  microgram).
The successful completion of this study will enable the European
Marketing Authorisation Application to be filed as planned in Q1 2010."



SkyePharma PLC

Ken Cunningham, Chief Executive Officer  +44 (0) 207 491 1777
Peter Grant,    Chief Financial Officer


Financial Dynamics
Jonathan Birt                            +44 (0) 207 831 3113
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 FlutiformTM

FlutiformTM 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 FlutiformTM outside
the Americas and Japan are licensed to Mundipharma International
Corporation Limited.



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