Business
Marketing approval of nicotine gum in Europe
Marketing approval of nicotine gum in Europe.
About this update from Itaconix Plc
[{"type":"text","content":"\n \nRNS Number : 4427T Revolymer PLC 20 November 2013 \n \n\n20th November, 2013 \nRevolymer plc\nRevolymer files for marketing approval of its nicotine gum in Europe\nRevolymer plc (\"Revolymer\" or the \"Company\"), the British polymer technology company, is pleased to announce that, on the 19th November 2013, its wholly-owned UK operating subsidiary Revolymer (U.K.) Limited filed for marketing authorisation in Europe of its proprietary nicotine gum products by submitting an application under Directive 2001/83/EC to the Medicines and Healthcare products Regulatory Agency (MHRA).\nIf approved, such authorisation will permit the marketing of Revolymer's 2mg and 4mg strength nicotine gum in the UK, Ireland, Poland and Spain. These countries are expected to be the first in Europe where Revolymer's nicotine gum products will be sold. Revolymer has already established a supply and distribution agreement for its nicotine gum in Poland, and aims to conclude commercialisation deals in the UK, Ireland and Spain in due course. The Company also plans to apply for marketing authorisations for additional countries in Europe as it establishes appropriate commercial pathways.\nRoger Pettman, Chief Executive of Revolymer said: \"I am pleased that our strategy to commercialise our nicotine gum products in Europe is progressing, as demonstrated by the achievement of this latest milestone. We believe that not only is our product bioequivalent to the existing reference product in Europe, but that it has additional benefits that consumers will value, namely a more confectionery-like chew.\"\nThe establishment of further nicotine gum commercialisation deals in Europe and the filing for regulatory approval of its nicotine gum in the US are expected to be the sub...