Allergy Thera. Regulatory News (AGY)

19 Jul 2006 07:01

Allergy Therapeutics PLC19 July 2006 Allergy Therapeutics plc, "Allergy Therapeutics" or "the Company" Successful review meeting with Japan's Pharmaceutical and Medical Devices Agency Japan development of Pollinex(R) Quattro progressed Allergy Therapeutics plc (AIM: AGY), the specialist pharmaceutical companyfocused on allergy vaccination, announces today that it has concluded asuccessful meeting with the Pharmaceutical and Medical Devices Agency ("PDMA")in Japan at which the development of its ultra short course vaccine Pollinex(R)Quattro Grass was discussed. Following a broad ranging review of preclinical, manufacturing and clinicaldata, the PMDA has accepted the Company's plans to conduct further trials forthe eventual registration of Pollinex Quattro in Japan. The substantial dataalready available for the grass pollen product forms the basis of a "bridgingprogramme" to enable use of the same product in the Japanese population. Allergy Therapeutics has agreement to submission of a Clinical TrialNotification in Japan and a clear understanding of the path to achieve thisregulatory goal. It is the Company's strategy to proceed with clinical trialswhen a suitable partner is found. Together with the compelling evidence of thesafety and efficacy of Pollinex Quattro, the Company believes it is a verystrong position to attract potential partners in Japan for its Grass andJapanese Cedar development projects. Keith Carter, Chief Executive Officer of Allergy Therapeutics, said: "Japanese healthcare standards are among the highest in the world and as thesecond largest pharmaceutical market it is not one we intend to ignore. Thisannouncement provides further reassurance that Allergy Therapeutics' developments areconceived as global and conducted to the very highest standards. "29 million people in Japan suffer from allergic rhinitis, a significant portionbecause of pollinosis. There are currently no equivalent products available totreat the cause of this allergy. These facts, combined with aggressive publichealth awareness campaigns, contrive to provide a sizeable and readily accessiblemarketplace." -ends- For further information Allergy Therapeutics plc +44 (0)1903 845 820 Keith Carter, Chief Executive Officer Bell Pottinger +44 (0)20 7861 3232 Dan de Belder / Emma Charlton 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. A new product designed to treat allergies due toJapanese Cedar pollens is being readied for its First in Man study. 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