Allergy Thera. Regulatory News (AGY)

10 May 2005 07:01

Allergy Therapeutics PLC10 May 2005 Allergy Therapeutics announces clearance from Health Canada for vaccine studies Allergy Therapeutics plc, the specialty pharmaceuticals company focused onallergy vaccines, announces today that it has received clearance from HealthCanada, the country's federal department for health, to commence its studiesinto Ragweed vaccines. Ragweed pollen is the principal airborne allergen in North America where itaffects approximately 55% of all allergic rhino-conjunctivitis sufferers. The studies are particularly important as, on the basis of a positive outcome,Allergy Therapeutics will be able to submit a dossier for registration for anMPL(R)-based vaccine for allergy to Ragweed pollen in Canada. If successful, the study will allow submission for registration in H1 2006,offering the possibility of a first marketing authorisation for a PollinexQuattro product in time for the 2007 season. Should such a registration beachieved, Allergy Therapeutics intends to conduct post-marketing studies tocollect further safety and efficacy data which will be supportive to theregistration applications made in other territories, in particular the USA. This announcement follows the opening of an Investigational New Drug (IND)application with the Federal Drug Administration (FDA) to conduct pre-pivotalstudies in humans with Allergy Therapeutics' Grass pollen product. Keith Carter, CEO of Allergy Therapeutics, commented: "This is a particularly pleasing development, being the first pivotal PollinexQuattro study and especially given the efficiency of Health Canada's process. Wehave continued to make strong progress since the flotation in October 2004 inline with our stated strategy. The Company has strengthened its focus on productdevelopment and we have continued to build on our international sales andmarketing efforts." - ends - For further information: Allergy Therapeutics 01903 844720Keith Carter, Chief Executive Bell Pottinger 020 7861 3232Dan de Belder / Emma Charlton This information is provided by RNS The company news service from the London Stock Exchange