SkyePharma PLC
FDA Extends PDUFA Date on New Sular Formulation to 2 January 2008
LONDON, UK - 5 November 2007 -- SkyePharma PLC (LSE: SKP) today announces that
Sciele Pharma Inc.'s (NASDAQ: SCRX ) new Sular formulation, which was filed as a
supplemental New Drug Application (sNDA) on 30 June 2007 with the U.S. Food &
Drug Administration (FDA), has had its Pharmacy Drug User Fee Act (PDUFA) date
extended to 2 January 2008 (from 2 November 2007). Sular(R) is a calcium
channel blocking agent for the treatment of high blood pressure. The new Sular
formulation utilizes SkyePharma's patented GeomatrixTM technology, which is
designed to provide a lower dose of Sular for each of its current doses.
For further information please contact:
SkyePharma PLC
Frank Condella, Chief Executive Officer
Ken Cunningham, Chief Operating Officer +44 207 491 1777
Peter Grant, Finance Director
Financial Dynamics (London enquiries)
David Yates / Deborah Scott +44 207 831 3113
Trout Group (US enquiries)
Christine Labaree / Seth Lewis +1 617 583 1308
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
END
SkyePharma PLC announces Product Update
| Source: SkyePharma PLC
London, UK--(Marketwire - November 5, 2007) -