Research Update

Allergy Therapeutics PLC 31 January 2007 31 January 2007 Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company") Successful end of Phase II meeting with FDA on Pollinex(R) Quattro Ragweed Second Phase III allergy vaccine programme expected to commence in March FDA agrees to single pivotal Phase III trial for registration Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical company focused on allergy vaccination, announces that it has concluded a successful end of Phase II meeting with the US Food and Drug Administration ("FDA") for its ultra short course allergy vaccine Pollinex Quattro Ragweed. 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. With a clear understanding of the path to achieve the regulatory submission, the Company is finalising preparations for a randomised, placebo-controlled, double-blind study to confirm the efficacy and safety of Pollinex Quattro in patients with seasonal allergic rhinitis due to ragweed pollen exposure. The investigators study kick off meeting is planned for beginning of February with first dosing expected in March. The company announced on 23 January 2007 that it had begun dosing patients in its Phase III trial for Pollinex Quattro Grass - the first ever global allergy vaccine trial. Pollinex Quattro is an ultra-short course vaccine requiring only four shots over three weeks and incorporates the TLR4 agonist adjuvant MPL(R). In contrast, for example in the United States, existing vaccine treatments typically require between 16 and 50 injections taken under specialist supervision prior to the start of the hayfever season. Pollinex Quattro therefore has the potential to transform allergy treatment by providing a safe, effective and highly convenient method of vaccination. The Company has three programmes of Pollinex Quattro allergy vaccines in clinical development: Grass, Tree and Ragweed. Evidence of the safety and efficacy of Pollinex Quattro has been established through earlier clinical trials in Europe. Furthermore, substantial exposure data in more than 87,000 patients is available from the named patient programme in Europe. The market opportunity is considerable with the American College of Allergy, Asthma & Immunology identifying ragweed pollen as the number one cause of seasonal allergies. Allergic rhinitis (hay fever) is a large and growing problem. Prevalence estimates vary on a country by country basis but range from 14-29% of the total population*. Worldwide over 150m people are estimated to suffer from allergic rhinitis and the prevalence is increasing*. There is a substantial unmet medical need in a market currently worth an estimated US$12 billion per annum. * Decision Resources Allergic Rhinitis June 2005 Keith Carter, Chief Executive of Allergy Therapeutics, said: "We recently announced the first patient dosed in our pivotal Phase III Pollinex Quattro Grass trial. Today's announcement confirms that we are in the enviable position of having two allergy vaccines in late stage of clinical development. We have just opened a new manufacturing facility in the UK, part of a significant investment programme to ramp up production capacity ahead of the expected registration of these products next year. "We believe these products are best in class, and will provide an important new treatment option for the millions of moderate to sever allergy sufferers." For further information Allergy Therapeutics +44 (0) 1903 844 722 Keith Carter, Chief Executive Financial Dynamics +44 (0) 207 831 3113 David Yates Ben Brewerton About Pollinex Quattro There are three programmes of subcutaneous immunotherapy in clinical development; Pollinex Quattro Grass, Pollinex Quattro Ragweed & Pollinex Quattro Tree, all of which are based on proprietary technologies. Collectively these form the "Caution: Allergen" programme. Pollinex Quattro Ragweed is currently under review by Health Canada. In addition, an oral vaccine development is completing its first phase II 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). 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) About Allergy Therapeutics plc Allergy Therapeutics plc is a UK AIM-listed specialty pharmaceutical company focused on allergy vaccination. It has a profitable core business achieving sales of allergy vaccines of over £24m in Germany, Italy, Spain and other EU markets through its own sales and marketing infrastructure. This information is provided by RNS The company news service from the London Stock Exchange This information is provided by RNS The company news service from the London Stock Exchange
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