FOR IMMEDIATE RELEASE
SkyePharma PLC - AGM Statement
LONDON, UK, Friday, June 29, 2007 - SkyePharma PLC (LSE: SKP) Chairman, Dr Jerry
Karabelas, will make the following statement at today's Annual General Meeting:
Progress continues to be made with the Flutiform(TM) clinical development
programme and we continue to expect a launch in mid-2009. The phase III
clinical trials are now over 80% recruited, the long-term safety study remains
on track to complete in July 2007 and CMC development continues to go well.
Although the pace of recruitment reduced during the Spring, due to competition
for patients during the allergic rhinitis season, we have taken a number of
actions to boost enrollment and we expect to complete recruitment in the autumn.
We have a pre-NDA (New Drug Application) meeting scheduled with the Food and
Drug Administration ("FDA") in July 2007 and are now targeting to file the NDA
for the US around the end of Q1 2008. Additionally, we continue to be
encouraged by the support from our marketing and distribution partners, Abbott
and Mundipharma. The latter commenced paediatric trials for European approval
in May 2007.
At our Lyon manufacturing facility, we are making progress with ramping up for
the launches later this year of ZYFLO CR(TM) (which was approved by the FDA on
31 May 2007) and in early 2008 of Lodotra(TM). We are also installing the
manufacturing line for Sular(R) CR (which completed clinical trials in May)
prior to its planned launch in 2008. We expect that these products will make a
significant contribution to capacity utilisation in our factory in 2008 and
beyond.
On 26 June we were pleased to announce the licensing deal with Somnus
Therapeutics for SKP-1041, a product to treat sleep disorders. We are
continuing to work on a number of new development and licensing deals.
There has been no material change in the Directors' expectations for the
operating result for 2007 although sales and cost levels may be somewhat reduced
due to exchange translation effects.
The interim results for the 6 months ending 30 June 2007 will be announced on 20
September 2007.
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
SkyePharma PLC announces AGM Statement
| Source: SkyePharma PLC
London, UK--(Marketwire - June 29, 2007) -