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SkyePharma Inc. (SKYE) Says FDA May Need More Flutiform Data


6/9/2009 10:03:02 AM

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SkyePharma PLC (LSE: SKP) today announces that the US Food and Drug Administration (FDA) has issued a communication 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.

The communication, known as a 74-day letter, confirms, as previously announced, that the NDA is sufficiently complete to permit a substantive review and, in line with standard review practice, the FDA has given preliminary notice of some potential review issues. The FDA states that its filing review is only a preliminary evaluation of the application and is not indicative of deficiencies that may be identified during its review and that issues may be added, deleted, expanded upon, or modified as it reviews the application.

Further clarification is required of some of these potential review issues and steps are being taken to seek discussions with the FDA with a view to agreeing how they may be addressed. Although the requirements cannot be precisely assessed prior to discussion with the FDA, based on a preliminary assessment, it appears likely that some additional clinical work may be required to provide more data on dosing.

As previously announced, the regulatory review timeline for asthma treatments is typically longer than the standard 10-month Prescription Drug User Fee Act timeline. Should additional clinical work be required this is likely to impact on the timeline for the review and any potential approval.

The potential review issues are not expected to have an impact upon the development of FlutiformTM for Europe or Japan.

For further information please contact:

SkyePharma PLC Ken Cunningham, Chief Executive Officer Peter Grant, Chief Financial Officer +44 207 491 1777

Financial Dynamics Jonathan Birt Susan Quigley +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.

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.


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