Allergy Thera. Regulatory News (AGY)

14 Jun 2007 07:01

Allergy Therapeutics PLC14 June 2007 14 June 2007 Allergy Therapeutics plc ("Allergy Therapeutics" or "the Company") Pollinex(R) Quattro Grass Phase III Study Fully Recruited On track to launch the first approved ultra-short course allergy vaccine in 2009 Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical companyfocused on allergy vaccination, today announces that its Pollinex Quattro GrassPhase III trial begun in January, the first ever global allergy vaccineprogramme, has been fully recruited and that the path to marketing approvalduring 2009 is now clear. Following discussion with the FDA, the Company confirms that the trial has beenfully recruited with a total of 1,028 patients from 94 centres in 4 countries.The majority of the patients, 620, have been recruited in the United States,with 291 in Canada and a further 117 from European centres. Data collection isongoing and to date the early discontinuation rate has been extremely low. The primary objective of this double blind, randomised trial is to compare theefficacy of Pollinex Quattro Grass versus placebo. Evidence of the safety andefficacy of Pollinex Quattro has been established through earlier clinicaltrials in Europe. Furthermore, substantial exposure data in more than 90,000patients is available from the sale of 'named patient' products in Europe. In addition, the Company has agreed the safety study protocol for PollinexQuattro Grass with the FDA; the set-up for this study has already begun. Initial results are expected around the end of Q1 2008 with full data expectedin mid-year. These trials, if successful, are suitable for registration in boththe United States and Europe. For the US a Biologics License Application ("BLA") submission is planned for early in the second half of 2008 and AllergyTherapeutics remains on track to launch Pollinex Quattro as the first approvedallergy vaccine in the United States in 2009. The market opportunity is considerable with the American Academy of Allergy,Asthma and Immunology estimating that 33 million allergy injections a year aregiven in the United States. Allergic rhinitis (hay fever) is a large andgrowing problem. Prevalence estimates vary on a country by country basis butrange from 14-29% of the total population*. Worldwide over 150m people areestimated to suffer from allergic rhinitis and the prevalence is increasing*.There is a substantial unmet medical need in a market currently worth anestimated US$12 billion per annum. * Decision Resources Allergic Rhinitis June 2005 Keith Carter, Chief Executive of Allergy Therapeutics, said: "The path to registration of Pollinex Quattro Grass is now clear. The speed withwhich we were able to recruit speaks very favourably for the product's profile,with no other allergy vaccine promising such rapid administration and efficacy.This is very attractive to patients suffering from both moderate and severehayfever, offering a highly effective, 4-shot vaccine over just a three weekperiod. "This is the first full Phase III registration trial for an allergy vaccineundertaken in the United States and a successful outcome has the potential totransform allergy treatment by providing a safe, effective and highly convenientmethod of vaccination for the first time." For further information Allergy Therapeutics +44 (0) 1903 845 820Keith Carter, Chief ExecutiveTom Holdich, R&D DirectorFinancial Dynamics +44 (0) 207 831 3113David YatesBen Brewerton About Pollinex Quattro There are three programmes of subcutaneous immunotherapy in clinicaldevelopment; Pollinex Quattro Grass, Pollinex Quattro Ragweed & Pollinex QuattroTree, all of which are based on proprietary technologies. A submission forlicensure for Pollinex Quattro Ragweed is currently under review by HealthCanada. In addition, an oral MPL vaccine development recently completed itsfirst phase II study, with some exciting results. Pollinex Quattro vaccines contain three distinct technologies which actsynergistically. Natural allergens are chemically modified to improve safety andallow for delivery of higher doses. These are combined with a depot technologyto provide prolonged activity and further improved tolerability. Finally, theimmune response is specifically enhanced and directed by an adjuvant,monophosphoryl lipid A (MPL). MPL is a Toll-Like 4 Receptor (TLR4) agonist andhas been extensively tested in Pollinex Quattro and other late stage andregistered vaccines including GlaxoSmithKline's Fendrix(R) and Cervarix(R) About Allergy Therapeutics plc Allergy Therapeutics plc is a UK AIM-listed specialty pharmaceutical companyfocused on allergy vaccination. It has a profitable core business achievingsales of allergy vaccines of over £24m in Germany, Italy, Spain and other EUmarkets through its own sales and marketing infrastructure. Allergy Therapeutics is now running the two largest international allergyvaccine trials ever conducted with pivotal Phase III studies well underway forPollinex Quattro Grass and Pollinex Quattro Ragweed. The Company is well placedto launch in 2009 the first approved allergy vaccines in the United States. This information is provided by RNS The company news service from the London Stock Exchange