21st Jan 2009 07:00
Flutiform™ Update
LONDON, UK, 21 January 2009 -- SkyePharma PLC (LSE: SKP) today announces that it has been notified by its partner Mundipharma that there may be a few months' delay in the filing of the European Marketing Authorisation Application for Flutiform™. This is due to the need to recruit additional patients into the on-going high dose strength study, after some patients were assigned to the wrong study arm in this four-armed study due to a randomisation issue. There is no cost implication for the additional work to SkyePharma as a result of this.
Flutiform™ remains on track for a U.S. New Drug Application filing in the first quarter of 2009.
For further information please contact:
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SkyePharma PLC |
Ken Cunningham |
+44 20 7491 1777 |
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During office hours |
Peter Grant |
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Financial Dynamics |
David Yates |
+44 20 7831 3113 |
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Outside office hours |
Jonathan Birt |
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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.
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