London, UK--(Marketwire - September 11, 2007) -
SkyePharma PLC
Further Update on Flutiform(TM)
LONDON, UK, 11 September 2007 - Further to its announcement of 6 August 2007,
SkyePharma PLC (LSE: SKP) today confirms that the Company met with the FDA and
agreed on an approach for the additional clinical work required for
Flutiform™, which will include a further study to provide more efficacy data.
Discussions with the FDA are ongoing in relation to the design of this study
and will be finalised after submission of supporting Chemistry, Manufacturing
and Controls (CMC) data.
The anticipated date for filing of the Flutiform™ NDA remains the second half
of 2008. The anticipated net cash cost to the Company for the additional work
remains in the order of GBP3m to GBP5m.
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
John Gilbert
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
Certain statements in this news release are forward-looking statements. in
particular in relation to the timing of regulatory filings and estimated costs.
Although SkyePharma believes that the expectations reflected in these
forward-looking statements are reasonable, it can give no assurance that these
expectations will materialize. Because the expectations are subject to risks and
uncertainties, actual results may vary significantly from those expressed or
implied by the forward-looking statements based upon a number of factors, which
are described in SkyePharma's Annual Report. Factors that could cause
differences between actual results and those implied by the forward-looking
statements contained in this news release include, without limitation, risks
related to the timing and scope of any additional clinical work. SkyePharma
undertakes no obligation to revise or update any such forward-looking statement
to reflect events or circumstances after the date of this release.
This information is provided by RNS
The company news service from the London Stock Exchange