Clinical update

Allergy Therapeutics PLC 04 July 2006 Allergy Therapeutics plc, "Allergy Therapeutics" or "the Company" Successful end of Phase II meeting with FDA - Allergy Therapeutics to proceed with Phase III development of Pollinex Quattro Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, announced today that the Company has concluded a successful end of Phase II meeting with the Food and Drug Administration (FDA) in the United States for its ultra short course grass pollen allergy vaccine Pollinex(R) Quattro ('Grass MATAMPL'). Following a broad ranging review of Pollinex Quattro's preclinical, manufacturing and clinical data, and, subject to minor clarifications, the FDA has accepted the Company's plans to conduct a single pivotal Phase III trial for registration of Pollinex Quattro Grass. With a clear understanding of the path to achieve the regulatory submission, the Company will now finalise preparations for a randomized, placebo-controlled, double-blind study to confirm the efficacy of Pollinex Quattro in patients with seasonal allergic rhinitis due to grass pollen exposure. Dosing of patients is expected to commence in Q4 2006. Evidence of the safety and efficacy of Pollinex Quattro has been established through earlier clinical trials in Europe and is further supported in clinical practice via the named patient use of the vaccine in over 74,000 patients. Keith Carter, Chief Executive Officer of Allergy Therapeutics, said: "We have been working with the Agency for nearly two years and share the aim of making a standardized and rigorously tested allergy vaccine available for health care professionals in the US." "The market opportunity is vast, with the American Academy of Allergy Asthma and Immunology estimating that 33 million allergy shots a year are given in the United States alone." Tom Holdich, Director of R&D said: "This is an important milestone for the Company and follows two years of United States focused development. The FDA's rigour and expertise are renowned and we are pleased that their independent review of the technology and the development programme has been achieved. A successful outcome of this Phase III trial will open the door for Pollinex Quattro to become the first registered, next generation allergy vaccine in the US. "Pollinex Quattro has been designed to address the major unmet needs in allergic rhinitis and , if confirmed, its therapeutic profile is truly transformational compared with current treatments." -ends- For further information, please contact: Allergy Therapeutics plc Keith Carter, Chief Executive Officer +44 (0)1903 845 820 Bell Pottinger Dan de Belder / Emma Charlton +44 (0)20 7861 3232 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. 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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