Stallergenes: Positive Results for Oralair(R) Phase III ...

Stallergenes: Positive Results for Oralair(R) Phase III Trial in the
USA

Antony, France, April 19, 2010 (ots/PRNewswire) - Stallergenes S.A.
today announced the first results of a phase III clinical trial
(VO61.08) conducted in the USA on its sublingual grass pollen
immunotherapy tablet, Oralair(R).

This phase III study is the first clinical study in the USA to be
conducted by Stallergenes as part of the Oralair(R) clinical
development which already encompassed 4 phase III clinical trials
conducted in Europe.
This development program has so far included
over 2,300 patients. This study is pivotal in the perspective of a
market authorization application for Oralair(R) in the USA with an
adult indication (BLA[1]).

The VO61.08 study is a randomized, double-blind,
placebo-controlled, phase III trial. It included 473 adult patients,
aged 18 to 65 years, suffering from grass pollen-induced
rhinoconjunctivitis, in 51 centers in the United States. The patients
were divided into two arms: one group was treated with Oralair(R) and
the other with a placebo. The primary endpoint was the reduction of
the "combined score", taking into account symptoms and rescue drugs.

The study achieved its objective on the primary endpoint: the
reduction of the combined score obtained by Oralair(R) compared to
the placebo is statistically very significant and of a similar
magnitude to the results of European studies. The product was very
well tolerated.

"We are proud to have conducted this study in the USA and very
satisfied with the results obtained which confirm the high level of
evidence in support of Oralair(R)" commented Albert Saporta, Chairman
and CEO of Stallergenes. "We have passed an important milestone in
our strategy for the US market and are actively preparing the
registration file with a view to filing a Market Authorization
application in early 2011."

About Oralair(R)

The Oralair(R) active substance consists of five purified and
calibrated pollen extracts corresponding to the epidemiological
characteristics of patient exposure in Europe: perennial rye grass
(Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum
pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass
(Anthoxanthum odoratum).

From the outset, its clinical development has taken into account
the benefit to patients: proven efficacy, safety, ease of use,
compliance, and cost-containment through a pre- and coseasonal
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.

The clinical development program for Oralair(R) is continuing.
Stallergenes has recently announced the positive 3-year results of a
phase III clinical trial (VO53.06) intended to assess the long-term
or sustained effect of Oralair(R) along with maintenance of the
therapeutic benefit after treatment discontinuation (disease-modifier
effect). This study is the first ever pivotal study designed to
measure this dual effect from the outset. It will continue for 2
years without treatment so that the disease-modifier effect can be
fully assessed.

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 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.

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 EMA 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, 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 over 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, the company had a turnover
of 193 million euros and more than 500,000 patients were treated with
Stallergenes products.

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

---------------------------------

[1] BLA: Biologics License Application

ots Originaltext: Stallergenes
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: Contacts: Albert Saporta - Chairman and CEO,
Tel:+33-1-55-59-20-04, Christian Thiry - Financial Director,
Tel:+33-1-55-59-20-95, e-mail: investorrelations@stallergenes.fr;
Pressrelations, Lise Lemonnier - Communication Manager, Tel:
+33-1-55-59-20-96,e-mail: llemonnier@stallergenes.fr, Investor and
Analyst relations: Lucilede Fraguier - Pavie Finance, Tel:
+33-1-42-15-04-39, e-mail:contact@pavie-finance.com


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