Business
Grass EU Submission
Grass EU Submission.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n RNS Number : 2707O Allergy Therapeutics PLC 04 March 2009 \n \nWednesday 4 March 2009\n\nAllergy Therapeutics plc\n(\"Allergy Therapeutics\" or \"the Company\")\n\nPollinex® Quattro Grass Dossier Submitted for European Union ('EU') Regulatory Review\n\nAllergy Therapeutics (AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that it has submitted its Pollinex Quattro Grass dossier for regulatory approval in the EU.\n\nThe dossier has been submitted to the German Regulatory authority, the Paul Ehrlich Insitut (\"PEI\"), recognised to be the European authority most expert in the allergy vaccine field. The PEI has agreed to act as 'Reference Member State' for Europe-wide registration under the European Union Mutual Recognition Procedure ('MRP'). Following the German national phase, which is expected to take approximately one year, the MRP will commence. \n\nIn the initial phase of MRP, the Company has elected to apply for authorisation in the markets with the greatest revenue potential for Pollinex Quattro and, if the submission to the PEI is successful, approvals could be expected from 2010 with launches taking place in these countries across the following two years. \n\nThis is the first submission for an injected therapeutic allergy vaccine aimed at EU-wide approval and marks the culmination of a development programme in which the Company has invested more than £20 million over several years. The submission follows the positive outcome, announced last year, of Allergy Therapeutics' Pollinex Quattro Grass Phase III study, G301, the largest controlled allergy vaccine study ever conducted. The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro has significant clinical benefits over placebo. \n\n\nKeith Carter, Chief Executive of Allergy Therapeutics, said:\n\n\"Injected vaccines are the preferred immunotherapy option for allergy specialists because of the excellent compliance levels. As the injections are controlled by the physicians, they can ensure that the patients receive a full course of therapy. This is especia...