Business
Regulatory Update
Regulatory Update.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 0389I Allergy Therapeutics PLC 08 June 2011 \n \n\n8 June 2011\nAllergy Therapeutics plc\n(\"Allergy Therapeutics\" or \"the Company\")\n \nRegulatory Update \n \nAllergy Therapeutics plc (AIM: \"AGY\" or the \"Company\"), the fully integrated specialty pharmaceutical company specializing in allergy vaccines, has, as expected, received from the Paul Ehrlich Institute (\"PEI\"), the complete report on its Marketing Authorization Application (\"MAA\") for Grass MATA MPL (marketed as Pollinex® Quattro/ Complete). The Company submitted its MAA to PEI, the Regulatory Authority for biological products in Germany, on 3rd March 2009. \n \nIn line with the normal review process, PEI has raised a number of questions on the Company's MAA submission; the report has not requested any additional clinical studies. The Company believes that all the questions can be addressed and will be working closely with the PEI to provide a complete response later this year. Pollinex® Quattro will continue to be sold as a named patient product in Germany until the MAA is approved.\n \nUnlike the European Medicines Agency (\"EMA\") and the Food and Drug Administration (\"FDA\"), national authorities such us the PEI are not obliged to follow a particular timetable for review if the MAA's are submitted using the individual country route. Since the introduction of the Therapeutic Allergen Regulation in 2008, the PEI has been inundated with a large number of submissions resulting in longer than usual review time.\n \nFollowing the German national approval, Europe-wide registration under the European Union Mutual Recognition Procedure (\"MRP\") will commence. In the initial phase of MRP, the Company has elected to apply for authorisation in the markets with the greatest revenue potential for Grass MATA MPL.\n \nAs announced on 26 April 2011, the FDA has confirmed that the clinical hold on the Investigational New Drug applications (INDs) for the three MATA-MPL products will be lifted once the protocols have been agreed. The Company is now in the process of submitting protocols to the FDA. \n \n-Ends-\n \nFor further information\n \n\n\n\n\nAllergy Therapeutics\n\n\n+44 (0) 1903 845 820\n\n\n\n\nManuel Llobet, Chief Executive Officer\n\n\n\n\n\n\n\nIan Postlethwaite, Financ...