Allergy Thera. Regulatory News (AGY)

4 Jul 2006 07:00

Allergy Therapeutics PLC04 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 FDAhas accepted the Company's plans to conduct a single pivotal Phase III trial forregistration of Pollinex Quattro Grass. With a clear understanding of the path to achieve the regulatory submission, theCompany will now finalise preparations for a randomized, placebo-controlled,double-blind study to confirm the efficacy of Pollinex Quattro in patients withseasonal allergic rhinitis due to grass pollen exposure. Dosing of patients isexpected to commence in Q4 2006. Evidence of the safety and efficacy of Pollinex Quattro has been establishedthrough earlier clinical trials in Europe and is further supported in clinicalpractice 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 ofmaking a standardized and rigorously tested allergy vaccine available for healthcare professionals in the US." "The market opportunity is vast, with the American Academy of Allergy Asthma andImmunology estimating that 33 million allergy shots a year are given in theUnited States alone." Tom Holdich, Director of R&D said: "This is an important milestone for the Company and follows two years of UnitedStates focused development. The FDA's rigour and expertise are renowned and weare pleased that their independent review of the technology and the developmentprogramme has been achieved. A successful outcome of this Phase III trial willopen the door for Pollinex Quattro to become the first registered, nextgeneration allergy vaccine in the US. "Pollinex Quattro has been designed to address the major unmet needs in allergicrhinitis and , if confirmed, its therapeutic profile is truly transformationalcompared 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 clinicaldevelopment. The three programmes are Pollinex Quattro Grass, Pollinex QuattroTree & Pollinex Quattro Ragweed, all of which are based on proprietarytechnologies. Preparations for initiating all three Phase III developmentslater this year are well underway and collectively these form the "Caution:Allergen" programme. In addition there is an oral vaccine development currentlyin phase II development. Pollinex Quattro vaccines contain three distinct technologies which actsynergistically. Natural allergens are chemically modified to improve safetyand allow for delivery of higher doses. These are combined with a depot technology to provide prolonged desensitization and further improvedtolerability. Finally, the immune response is specifically enhanced anddirected by an adjuvant, monophosphoryl lipid A (MPL) (R). MPL is a Toll-Like 4Receptor (TLR4) agonist and has been extensively tested in Pollinex Quattro andother 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