STALLERGENES: Persistent Efficacy Demonstrated After a Year on Actair(R) Followed by a Second Treatment-Free Year

June 28, 2010

ANTONY, France, June 28, 2010 /PRNewswire-FirstCall/ — After having
announced positive results for the first year of its phase IIb/III clinical
trial (VO 57.07) conducted on Actair(R) sublingual allergen immunotherapy
tablets in allergic rhinitis triggered by house dust mites in April 2009,
Stallergenes S.A. today announces the results of the second year of this

Following this first year which demonstrated positive results for both
the dosages tested (300 IR[1] and 500 IR) and which is key for the marketing
authorization application, the second year of the study involved an
exploratory evaluation of the persistence of the therapeutic effect of
Actair(R) in the following year. Out of the 509 patients originally included
in the study, 397 participated until the end of the second year. The primary
endpoint for this second year was the Average Adjusted Symptom Score
(AAdSS)[2] measured one year after the end of treatment.

The results of this second year demonstrate not only that the efficacy of
Actair(R) persists well beyond the first six months after treatment is
stopped but also that the size effect is globally equivalent to that observed
in the first year. Thus in the main assessment period for the efficacy
endpoint (between 10 and 12 months after the discontinuation of treatment),
both active groups demonstrated a persistent effect of the treatment, with a
statistically significant difference for the AAdSS versus placebo [(p=0.0342)
for the 300 IR dosage; (p=0.0229) for the 500 IR dosage], still with no
difference between the two treated groups.

This study is a world first in that, for the first time, it indisputably
demonstrates the persistence of the effect of sublingual allergen
immunotherapy in perennial allergic rhinitis triggered by house dust mites,
as well as the early onset of this effect, from the end of the first year.
The duration and the dynamics of this effect will have to be explored.

“We’re clearly delighted with these results. For the first time ever, the
persistence of the therapeutic effect of allergen immunotherapy has been
demonstrated after only a year. This is yet another illustration of the
contribution that the large-scale studies conducted as part of the Stalair(R)
clinical development program can make to our understanding of allergen
immunotherapy”, says Albert Saporta, Chairman and CEO of Stallergenes. “Like
the trial conducted in asthma triggered by house dust mites with Staloral(R)
300 in China, this study will help us construct a development plan for
Actair(R) that is ambitious in terms of the indications envisaged and
realistic, proposing discontinuous protocols that meet the expectations of
both patients and health system paying authorities.”


In Europe, almost 40% of allergic respiratory diseases, on average, are
triggered by house dust mites, making this the leading cause of respiratory
allergy, ahead of grass pollens. Dust mites are responsible for allergic
rhinitis that begins in early childhood, gradually worsens over time and
naturally progresses to asthma. These conditions have marked symptoms that
significantly impair patients’ quality of life.


Stalair(R) is the name of the pharmaceutical and clinical development
program for immunotherapy tablets being implemented by Stallergenes with a
view to obtaining market authorizations 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 in Europe. Having recently
demonstrated its efficacy after 3 years of treatment (study VO53.06 conducted
in Europe), Oralair(R) has been the subject of a positive phase III trial in
adults in the United States (VO61.08).

The second project in the program is Actair(R), dust mite immunotherapy
tablet. Following the results of the first year of the phase IIb/III study in
allergic rhinitis in adults, a phase III pediatric study has been launched.

The Stalair(R) r Bet v 1 tablet (birch pollen recombinant allergen) 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 EMA registration.

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


Staloral(R) 300 is a sublingual solution of allergen extracts for
allergen immunotherapy. It is indicated in the treatment of allergic
rhinitis, rhinoconjunctivitis and seasonal or perennial mild to moderate
allergic asthma in adults and children over the age of 5 years. Prescribed by
allergy specialists, Staloral(R) 300 is particularly aimed at patients
suffering from severe allergic diseases inadequately controlled by the use of
symptomatic treatments.

In the context of a phase III clinical trial (VO55.06) conducted in
China, Staloral(R) 300 has demonstrated its efficacy in the control of asthma
triggered by house dust mites on the basis of “well-controlled asthma” and
“total asthma control” criteria in adult GINA 3 patients (moderate asthma
stabilized by inhaled corticosteroids).


Stallergenes is a European biopharmaceutical company dedicated to
immunotherapy treatments for the prevention and treatment of allergy-related
respiratory diseases, such as allergic rhinoconjunctivitis, rhinitis and
asthma. Stallergenes is the seventh-ranked French pharmaceutical company. A
pioneer and leader in sublingual immunotherapy treatments, Stallergenes
devotes more than 20% of its turnover, in gross terms, to Research and
Development and is actively involved in the development of a new therapeutic
class: sublingual immunotherapy tablets. In 2009, Stallergenes had a turnover
of 193 million euros and more than 500,000 patients were treated with
Stallergenes immunotherapy products.

[1] Reactivity index for standardized extracts

[2] AAdSS: Average Adjusted Symptom Score taking into account the total
daily rhinoconjunctivitis symptom score and recourse to authorized rescue

    Euronext Paris (Compartment B)
    SBF 120.

    ISIN code: FR0000065674
    Reuters code: GEN.PA
    Bloomberg code: GEN.FP

    Additional information is available at: http://www.stallergenes.com

SOURCE Stallergenes

Source: newswire

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