London, UK--(Marketwire - December 18, 2007) -
SkyePharma PLC
FlutiformTM - Enrolment into Efficacy Trials Completed
LONDON, UK, 18 December 2007-- SkyePharma PLC (LSE: SKP) today announces that it
has completed enrolment of patients into the three double-blind efficacy trials
currently underway for FlutiformTM, its lead development product for the
treatment of asthma.
The three efficacy trials, involving nearly 1,400 patients, will provide core
clinical data for the New Drug Application (NDA) to be filed with the U.S. Food
and Drug Administration (FDA) and will also support the European Marketing
Authorisation Application (MAA). It is anticipated that the trials will be
fully completed in April 2008. The trials are designed to demonstrate the
superiority of FlutiformTM over the individual components and, in two of the
studies, also over placebo.
In November, the Company announced the successful completion of the Phase III,
long-term, open label, safety study for FlutiformTM, involving 472 patients and
further to our announcement of 11 September 2007, the additional clinical
efficacy study, agreed with the FDA will commence in early 2008. This study will
involve approximately 375 patients.
Dr Ken Cunningham, COO of SkyePharma said: "We have completed another important
milestone in the development of FlutiformTM and remain focussed on meeting all
necessary requirements for the NDA filing."
For further information please contact:
SkyePharma PLC Frank Condella +44 20 7491 1777
Ken Cunningham
Peter Grant
Financial Dynamics
(UK Enquiries) David Yates +44 20 7831 3113
Deborah Scott
Trout Group
(US Enquiries) Christine Labaree +1 617 583 1308
Seth Lewis
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 Company has eleven 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
This information is provided by RNS
The company news service from the London Stock Exchange