Stallergenes: Positive Results for Oralair Phase III Trial in the USA
ANTONY, France, April 19, 2010/PRNewswire-FirstCall/ --
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).
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
"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."
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
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
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
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
 BLA: Biologics License Application
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: firstname.lastname@example.org; Press
relations, Lise Lemonnier - Communication Manager, Tel:
+33-1-55-59-20-96, e-mail: email@example.com, Investor and
analyst relations: Lucile de Fraguier - Pavie Finance, Tel:
+33-1-42-15-04-39, e-mail: firstname.lastname@example.org
Posted: April 2010