SKYEPHARMA PLC - Flutiform U.S. Filing Update
LONDON, UK, 1 September 2009 - SkyePharma PLC (LSE: SKP) today provides an update following a meeting held with the US Food and Drug Administration (FDA) to discuss the previously announced potential review issues in respect of the New Drug Application (NDA) for its lead development product, FlutiformTM (fluticasone propionate/formoterol fumarate), an investigational treatment for persistent asthma in patients 12 years of age and older.
As previously announced, in June 2009 the FDA gave preliminary notice of some potential review issues which it had identified in its preliminary evaluation of the NDA, which had been accepted for substantive review. As a result, the Company announced that it appeared likely that some additional clinical work may be required to provide more data on dosing and that a meeting was being sought with the FDA with a view to agreeing how the potential review issues may be addressed.
A meeting has now been held with the FDA and it has been confirmed that additional clinical work will be required to provide more data on dosing. The Board believes that it is unlikely that FlutiformTM will, therefore, be approved in the US before the second half of 2011. In the meantime the review of the NDA is continuing.
Under the current license agreement Abbott is responsible for paying for additional clinical or other trials required by the FDA, and is entitled to recoup such costs out of up to 25 per cent. of any approval or post-approval milestones and royalties.
The potential review issues are not expected to have an impact upon the development of FlutiformTM for Europe or Japan, which remain on track.
Dr Ken Cunningham, Chief Executive Officer, said:
"We now have greater clarity from the FDA on its approach to our filing and we are working to address these issues as soon as possible. FlutiformTM remains on track in Europe and Japan, and we remain confident that, once approved and launched in its various markets, FlutiformTM will be a successful product for SkyePharma in terms of both revenues and cash flows."
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 |
+44 207 831 3113 |
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Susan Quigley |
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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.
About FlutiformTM
FlutiformTM HFA-MDI is a fixed-dose combination of fluticasone and formoterol in a metered dose inhaler (MDI). The product incorporates the most commonly prescribed inhaled anti-inflammatory corticosteroid (fluticasone propionate) and a long-acting beta-agonist (formoterol fumarate) in combination with an environmentally-friendly aerosol propellant hydrofluoroalkane (HFA) and is being developed for asthma. The rights for commercialisation of FlutiformTM in the U.S. are licensed to Abbott Respiratory LLC, a wholly-owned subsidiary of Abbott.