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STALLERGENES is Granted a Marketing Authorization for Oralair(R) in Europe
Date:11/27/2009

al protocol (the treatment is taken for four months prior to the pollen season and then throughout it, for three consecutive seasons) rather than a perennial protocol (when the treatment is taken all year round). A pharmacodynamic study has demonstrated that Oralair(R) is effective from the first month of treatment.

The clinical development program for Oralair(R) is continuing. The results of three phase III clinical studies are expected by the end the year: the US study in adults, the third year of a long-term study, and the protocol optimization study. The long-term results will be available in a year.

About The Stalair(R) Program

Stalair(R) is the pharmaceutical and clinical development program for immunotherapy tablets being implemented by Stallergenes with a view to obtaining marketing registrations for pharmaceutical products in Europe and in other strategic markets.

Oralair(R) is the first project resulting from this program. A Mutual Recognition Procedure has been completed.

A positive phase IIb/III study was completed for the dust mite immunotherapy tablet, Actair(R) in allergic rhinitis in adults during the first half of 2009. A pediatric phase III study has been launched.

The Bet v 1 tablet (birch pollen recombinant) has been the subject of a positive phase IIb/III clinical trial conducted in allergic rhinitis caused by birch pollen. A confirmatory phase III study is currently being prepared with a view to EMEA registration.

The other allergens concerned by the program are ragweed for the North American market and Japanese cedar pollen for the Japanese market. Altogether, the program covers 80% of the epidemiology for all markets.

About Stallergenes

Stallergenes is a European biopharmaceutical company dedicated to immunotherapy treatments for the prevention and treatment of allergy-related respiratory diseases, su
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