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Stallergenes: Oralair: Very Positive 3-Year Results of the Long-Term Study
Date:12/7/2009

d a reduction of 30% in the 1st year (relative median differences versus placebo). These results not only demonstrate the sustained clinical effect of Oralair(R) administered using a pre- and coseasonal treatment regimen but also suggest an increase in efficacy over the seasons.

In addition, each of the six individual symptom scores has demonstrated a statistically significant improvement. All the outcomes obtained in the secondary endpoints were statistically significant and consistent with those of the primary endpoint.

Patient compliance was very satisfactory over the three seasons and the overall tolerance was excellent.

In accordance with the recommendation of a board of independent experts (Data and Safety Monitoring Board), the study will be continued over the next 2 years in order to assess the disease modifier effect (maintenance of therapeutic benefit after treatment discontinuation).

In addition to this long-term study, in 2009 Stallergenes conducted a phase III one-season optimization study (VO60.08) with Oralair(R) 300 IR. This randomized, double-blind, placebo-controlled study was performed without dose escalation and used a 2-month pre-seasonal treatment regimen. In this trial, 180 patients were enrolled in each of the two arms. The analysis on the primary endpoint did not reach a statistically significant difference, although positive trends were demonstrated. Further in-depth analyses will be performed, to identify likely methodological bias.

"We are very enthusiastic about the results of the VO53.06 study which far exceed our expectations. We will file for an extension of the product's current labeling, as defined in the marketing authorization recently obtained via a Mutual Recognition Procedure (MRP) in 23 European countries. Such setbacks due to the VO60.08 study outcome can occur in any large development program, and in no way call into doubt the overall findings of
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