Stallergènes: the positive results of the grass pollen tablet study allow the active continuation of its development program.

The VO 34 study of rhino-conjunctivitis allergies to grass pollen (« hay fever») enables to conclude that the allergen tablet ORALAIR^® Grasses induces, right from the first season of treatment, a 37% reduction(*) of symptoms and a 46% reduction of allergy symptomatic  drugs consumption(**) vs. placebo. These results are statistically highly significant (respectively p<0,0001 and p<0,02).

The VO 34 study is a phase IIb/III randomized double blinded study, versus placebo trial on 630 patients. It was conducted in 42 centers throughout 10 European countries. The patients were all allergic to grass pollen and were showing moderate to severe symptoms of allergic rhinoconjunctivitis. They were randomly included either in a non treated group (placebo group) or in one of the three treated groups with tablets dosed at 100 IR, 300 IR or 500IR.

Tolerance has been good in all groups.

On the basis of the convincing results of this study, an international committee of independent experts recently met and recommended the daily dose of 300 IR to confirm these data for children in a new study of phase III which Stallergènes should set up during next pollen season (study VO 42).

Furthermore, Stallergènes selected this dose of 300 IR/day to prolong the observation of this

same cohort of patients during 3 years, among which two years are under treatment, in order to demonstrate the long term desensitization effect by ORALAIR^® Grasses (study VO 40).

Stallergènes will file the registration request of ORALAIR^® Grasses through a Mutual Recognition Procedure as early as Q1/2006 and expects to launch this product on the market in the first semester of 2007.

* These reductions are based on median scores calculations.

** The consumption is measured in number of treatment days.