Clinical update

Allergy Therapeutics PLC 19 July 2006 Allergy Therapeutics plc, "Allergy Therapeutics" or "the Company" Successful review meeting with Japan's Pharmaceutical and Medical Devices Agency Japan development of Pollinex(R) Quattro progressed Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, announces today that it has concluded a successful meeting with the Pharmaceutical and Medical Devices Agency ("PDMA") in Japan at which the development of its ultra short course vaccine Pollinex(R) Quattro Grass was discussed. Following a broad ranging review of preclinical, manufacturing and clinical data, the PMDA has accepted the Company's plans to conduct further trials for the eventual registration of Pollinex Quattro in Japan. The substantial data already available for the grass pollen product forms the basis of a "bridging programme" to enable use of the same product in the Japanese population. Allergy Therapeutics has agreement to submission of a Clinical Trial Notification in Japan and a clear understanding of the path to achieve this regulatory goal. It is the Company's strategy to proceed with clinical trials when a suitable partner is found. Together with the compelling evidence of the safety and efficacy of Pollinex Quattro, the Company believes it is a very strong position to attract potential partners in Japan for its Grass and Japanese Cedar development projects. Keith Carter, Chief Executive Officer of Allergy Therapeutics, said: "Japanese healthcare standards are among the highest in the world and as the second largest pharmaceutical market it is not one we intend to ignore. This announcement provides further reassurance that Allergy Therapeutics' developments are conceived as global and conducted to the very highest standards. "29 million people in Japan suffer from allergic rhinitis, a significant portion because of pollinosis. There are currently no equivalent products available to treat the cause of this allergy. These facts, combined with aggressive public health awareness campaigns, contrive to provide a sizeable and readily accessible marketplace." -ends- For further information Allergy Therapeutics plc +44 (0)1903 845 820 Keith Carter, Chief Executive Officer Bell Pottinger +44 (0)20 7861 3232 Dan de Belder / Emma Charlton About Pollinex Quattro There are three programmes of subcutaneous immunotherapy in clinical development. The three programmes are Pollinex Quattro Grass, Pollinex Quattro Tree & Pollinex Quattro Ragweed, all of which are based on proprietary technologies. Preparations for initiating all three Phase III developments later this year are well underway and collectively these form the "Caution: Allergen" programme. In addition there is an oral vaccine development currently in phase II development. A new product designed to treat allergies due to Japanese Cedar pollens is being readied for its First in Man study. Pollinex Quattro vaccines contain three distinct technologies which act synergistically. Natural allergens are chemically modified to improve safety and allow for delivery of higher doses. These are combined with a depot technology to provide prolonged desensitization and further improved tolerability. Finally, the immune response is specifically enhanced and directed by an adjuvant, monophosphoryl lipid A (MPL) (R). MPL is a Toll-Like 4 Receptor (TLR4) agonist and has been extensively tested in Pollinex Quattro and other late stage and registered vaccines including GlaxoSmithKline's Fendrix(R) and Cervarix(R) This information is provided by RNS The company news service from the London Stock Exchange
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