SKYEPHARMA PLC - Flutiform U.S. NDA Update
LONDON, UK, 21 January 2010 - SkyePharma PLC (LSE: SKP) today announces the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) in respect of the New Drug Application (NDA) for FlutiformTM (fluticasone propionate/formoterol fumarate), an investigational treatment for persistent asthma in patients 12 years of age and older.
The FDA stated that it could not approve the NDA in its present form and raised a number of substantive issues to be addressed, which, if undertaken, would involve significant additional clinical work including work to provide the additional data on dosing as previously disclosed.
Discussions will be sought with the FDA as soon as possible to determine what steps would need to be taken before the application can be approved. Further information on the impact of the additional work on timing and costs will be announced once clarification has been obtained.
The review issues are not expected to have an impact upon the development of FlutiformTM in Europe, (where the European Marketing Authorisation Application remains on track to be filed in Q1, 2010) or in Japan (where Phase 2 studies are expected to be completed this year).
As at 31 December 2009 the Group had net cash and cash equivalents of £27 million (compared with £22.1 million as at 30 June 2009). The results for the year ended 31 December 2009 are scheduled to be announced on 25 March 2010.
For further information please contact:
Ken Cunningham, Chief Executive Officer
+44 207 491 1777
Peter Grant, Chief Financial Officer
Debbie Scott/Stephanie Cuthbert
+44 207 831 3113
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 Group 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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