LONDON, UK, 18 October 2011 - SkyePharma PLC (LSE: SKP) today announces that the review of the European Marketing Authorisation Application ("MAA") for FlutiformTM will take longer than originally anticipated due to lack of complete consensus by the Concerned Member States ("CMSs") within the timescale laid down by the decentralised review procedure.
Mundipharma International Limited ("Mundipharma") has been informed that the decentralised procedure for the review of FlutiformTM was unable to be completed at Day 210 with a consensus of the Reference Member State and the 21 CMSs. The UK (the Reference Member State for the review of FlutiformTM) and almost all of the CMSs were in agreement that the product was approvable but a complete consensus was not achieved by Day 210, which was 17 October 2011.
The procedure has now moved into a referral process during which the Member States involved will use their best endeavours to achieve a consensus on the final regulatory position of FlutiformTM within 60 days of the process commencing. The process should normally commence within 30 days.
The MAA for FlutiformTM was filed by Mundipharma, SkyePharma's authorised distributor, in March 2010 and accepted for review in May 2010.
SkyePharma and Mundipharma are confident in the efficacy and safety profile of FlutiformTM, which is supported by the clinical evidence. The MAA consisted of a substantial package of data including the results of eight phase I/II studies and nine Phase III studies conducted in a population of over 1,900 patients.
For further information please contact:
Axel Müller, Chief Executive Officer
+44 207 881 0524
Peter Grant, Chief Financial Officer
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. 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.