Flutiform (Skye/Mundipharma) European application referred to arbitration

SkyePharma PLC announced that the decentralised procedure ("DCP") for the regulatory review of Flutiform (fluticasone plus formoterol),which was submitted by its partner MundiPharma International, has been referred to the European Medicines Agency ("EMA") and its Committee for Medicinal Products for Human Use ("CHMP") for arbitration. The arbitration procedure is part of the DCP and is initiated when a unanimous decision of the Reference Member State ("RMS") and Concerned Member States ("CMSs") cannot be reached in relation to granting a marketing authorisation for a medicine in Europe. As announced on 18 October 2011, although the UK, the RMS and almost all CMSs were in agreement that the product was approvable, a complete consensus had not been achieved.