Allergy Thera's ragweed vacc OKed for Ph III

UK-based specialist pharmaceutical company Allergy Therapeutics says that the US Food and Drug Administration has accepted plans for a pivotal Phase III trial of its Pollinex Quattro ragweed vaccine. The study will assess the product as an ultra-short course treatment for the prevention of seasonal hay fever and, if successful, will serve as the basis for registration with the agency.

Allergy said that, having met with the FDA, it is in the process of finalizing plans for the randomized, placebo-controlled, double-blind assessment, which is scheduled to start in March. The primary aim of the program is to demonstrate the product's safety and efficacy when used in the treatment of allergic rhinitis caused by ragweed pollen exposure. The firm added that data from European studies, which enrolled more than 87,000 patients, indicates that the drug is both safe and effective for this indication.

Early last year, the company reported that it was moving its Pollinex Quattro grass allergy vaccine into Phase III assessment (Marketletter March 13, 2006). The firm added that the market opportunity for such products is considerable, citing data from health care analysts Decision Resources which estimates that over 150 million people worldwide suffer from seasonal allergies, with the prevalence, on a country by country basis, thought to be in the 14% to 29% range.