Allergy Thera. Regulatory News (AGY)

31 Jan 2007 07:01

Allergy Therapeutics PLC31 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 companyfocused on allergy vaccination, announces that it has concluded a successful endof Phase II meeting with the US Food and Drug Administration ("FDA") for itsultra 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 FDAhas accepted the Company's plans to conduct a single pivotal Phase III trial forregistration. With a clear understanding of the path to achieve the regulatory submission, theCompany is finalising preparations for a randomised, placebo-controlled,double-blind study to confirm the efficacy and safety of Pollinex Quattro inpatients with seasonal allergic rhinitis due to ragweed pollen exposure. Theinvestigators study kick off meeting is planned for beginning of February withfirst dosing expected in March. The company announced on 23 January 2007 that it had begun dosing patients inits Phase III trial for Pollinex Quattro Grass - the first ever global allergyvaccine trial. Pollinex Quattro is an ultra-short course vaccine requiring only four shots overthree weeks and incorporates the TLR4 agonist adjuvant MPL(R). In contrast, forexample in the United States, existing vaccine treatments typically requirebetween 16 and 50 injections taken under specialist supervision prior to thestart of the hayfever season. Pollinex Quattro therefore has the potential totransform allergy treatment by providing a safe, effective and highly convenientmethod of vaccination. The Company has three programmes of Pollinex Quattroallergy vaccines in clinical development: Grass, Tree and Ragweed. Evidence of the safety and efficacy of Pollinex Quattro has been establishedthrough earlier clinical trials in Europe. Furthermore, substantial exposuredata in more than 87,000 patients is available from the named patient programmein Europe. The market opportunity is considerable with the American College of Allergy,Asthma & Immunology identifying ragweed pollen as the number one cause ofseasonal allergies. Allergic rhinitis (hay fever) is a large and growingproblem. Prevalence estimates vary on a country by country basis but range from14-29% of the total population*. Worldwide over 150m people are estimated tosuffer from allergic rhinitis and the prevalence is increasing*. There is asubstantial unmet medical need in a market currently worth an estimated US$12billion 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 PollinexQuattro Grass trial. Today's announcement confirms that we are in the enviableposition of having two allergy vaccines in late stage of clinical development.We have just opened a new manufacturing facility in the UK, part of asignificant investment programme to ramp up production capacity ahead of theexpected registration of these products next year. "We believe these products are best in class, and will provide an important newtreatment option for the millions of moderate to sever allergy sufferers." For further information Allergy Therapeutics +44 (0) 1903 844 722Keith Carter, Chief Executive Financial 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. Collectively theseform the "Caution: Allergen" programme. Pollinex Quattro Ragweed is currentlyunder review by Health Canada. In addition, an oral vaccine development iscompleting its first phase II study. 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 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 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. 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