SKYEPHARMA PLC - FlutiformTM U.S. NDA Update
LONDON, UK, 24 June 2010 - SkyePharma PLC (LSE: SKP) announces the outcome of a meeting with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter received in January 2010 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.
As previously disclosed, in the Complete Response Letter the FDA stated that it could not approve the NDA in its present form and raised a number of new substantive issues to be addressed, which, if undertaken, would involve significant additional clinical work including generating additional data on dose ranging.
From the discussions held at the meeting it is apparent that the FDA's requirements for approving FlutiformTM have changed materially during the course of the development program, and meeting these requirements would involve significant additional work, including a large post-approval safety study.
The Company is working with its advisers to review all of the options available to it with a view to determining whether there is a viable way forward for FlutiformTM in the United States.
In the meantime the European Marketing Authorisation Application for FlutiformTM, filed in March 2010, remains under regulatory review in Europe, where the regulatory approach is different from the United States, and progress continues to be made with the development in Japan.
For further information please contact:
Ken Cunningham, Chief Executive Officer
+44 207 491 1777
Peter Grant, Chief Financial Officer
Jonathan Birt /Sue 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.