5th Feb 2010 14:34
SKYEPHARMA PLC - Flutiform™ U.S. NDA Update
LONDON, UK, 5 February 2010 - SkyePharma PLC (LSE: SKP) today announces that the New Drug Application (NDA) for Flutiform™ (fluticasone propionate/formoterol fumarate) in the U.S. is being transferred to SkyePharma.
As previously announced, following receipt of the Complete Response Letter in January, discussions are being sought with the U.S. Food and Drug Administration (FDA) as soon as possible to determine what steps would need to be taken before the application for Flutiform™ can be approved. The transfer of the NDA will enable SkyePharma to deal directly with the FDA in these discussions.
SkyePharma and its U.S. licensing partner, Abbott Respiratory LLC, are working together on the transfer of the NDA and will consider implications for Flutiform™ in the U.S. in due course.
As previously advised, the issues raised in the Complete Response Letter are not expected to have an impact upon the development of Flutiform™ in Europe or Japan.
For further information please contact:
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SkyePharma PLC |
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Ken Cunningham, Chief Executive Officer |
+44 207 491 1777 |
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Peter Grant, Chief Financial Officer |
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Financial Dynamics |
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Jonathan Birt/Susan Quigley |
+44 207 831 3113 |
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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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