LONDON -- 10/23/08 --
SkyePharma Announces Successful Completion of FlutiformTM 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
FlutiformTM 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 FlutiformTM compared with two
differentformulations 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 (FlutiformTM 250/10microgram twice daily)
in a
single inhaler (SkyePharma HFA pMDI) with the administration of
fluticasone (250microgram 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."
-- ends --
For further information please contact:
SkyePharma PLC Ken Cunningham +44 20 7491 1777
During office hours Peter Grant
Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113
Outside office hours Jonathan Birt
Trout Group (US Enquiries) Seth Lewis +1 617 583 1308
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 FlutiformTM
FlutiformTM 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. FlutiformTM is aimed at the
market
for combination steroid and long-acting beta-agonist inhalers
which is
forecast to be approximately USUSD10 billion worldwide by 2010.
FlutiformTM is licensed in the U.S. to Abbott Respiratory LLC
(formerly
known as Kos Life Sciences, Inc.), a wholly owned subsidiary of
Abbott.
This information is provided by RNS
The company news service from the London Stock Exchange
END
Contacts:
RNS
Customer
Services
0044-207797-4400
Email Contact
http://www.rns.com
