Business
Clinical update
Clinical update.
About this update from Allergy Therapeutics Plc
[{"type":"text","content":"\n Allergy Therapeutics PLC\n19 July 2006\n\n\n\n Allergy Therapeutics plc, \"Allergy Therapeutics\" or \"the Company\"\n \nSuccessful review meeting with Japan's Pharmaceutical and Medical Devices Agency\n \n Japan development of Pollinex(R) Quattro progressed\n\n\n\nAllergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company\nfocused on allergy vaccination, announces today that it has concluded a\nsuccessful meeting with the Pharmaceutical and Medical Devices Agency (\"PDMA\")\nin Japan at which the development of its ultra short course vaccine Pollinex(R)\nQuattro Grass was discussed.\n\n\nFollowing a broad ranging review of preclinical, manufacturing and clinical\ndata, the PMDA has accepted the Company's plans to conduct further trials for\nthe eventual registration of Pollinex Quattro in Japan. The substantial data\nalready available for the grass pollen product forms the basis of a \"bridging\nprogramme\" to enable use of the same product in the Japanese population.\n\n\nAllergy Therapeutics has agreement to submission of a Clinical Trial\nNotification in Japan and a clear understanding of the path to achieve this\nregulatory goal. It is the Company's strategy to proceed with clinical trials\nwhen a suitable partner is found. Together with the compelling evidence of the\nsafety and efficacy of Pollinex Quattro, the Company believes it is a very\nstrong position to attract potential partners in Japan for its Grass and\nJapanese Cedar development projects.\n\n\nKeith Carter, Chief Executive Officer of Allergy Therapeutics, said:\n\n\n\"Japanese healthcare standards are among the highest in the world and as the\nsecond largest pharmaceutical market it is not one we intend to ignore. This\nannouncement provides further reassurance that Allergy Therapeutics' developments are\nconceived as global and conducted to the very highest standards.\n\n\n\"29 million people in Japan suffer from allergic rhinitis, a significant portion\nbecause of pollinosis. There are currently no equivalent products available to\ntreat the cause of this allergy. These facts, combined with aggressive public\nhealth awareness campaigns, contrive to provide a sizeable and readily accessible\nmarketplace.\"\n\n\n\n -ends-\n\n\nFor further information\n\nAllergy Therapeutics plc +44 (0)1903 845 820\n\nKeith Carter, Chief Executive Officer\n\n...