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Last updated on April 20, 2014 at 8:07 EDT

STALLERGENES is Granted a Marketing Authorization for Oralair(R) in Europe

November 27, 2009

PARIS, November 27 /PRNewswire-FirstCall/ — Stallergenes has been
granted European approval to market Oralair(R) in both adults and children
through a Mutual Recognition Procedure. Germany, the first country where
Oralair(R) has been marketed, was the reference Member state.

Oralair(R) is now registered in Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Estonia, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, and Spain. All the countries in which
Stallergenes filed its application have approved it.

Oralair(R) is an immunotherapy tablet aimed at patients suffering from
severe rhinoconjunctivitis caused by grass pollens, inadequately controlled
using symptomatic treatments (antihistamines, corticosteroids).

“The European registration of Oralair(R) is a major milestone for
Stallergenes. It confirms the evolution of immunotherapy towards
EBM-documented, well-tolerated treatments, effective from the very first
season. Immunotherapy tablets now share the same level of recognition as
conventional pharmaceuticals and form a new therapeutic class: allergens. The
next step is to implement the price and reimbursement assessment procedures
prior to the launch country by country,” says Albert Saporta, Chairman and
CEO of Stallergenes.

About Oralair(R)

The Oralair(R) active substance consists of a set of pollens
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 (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, such as allergic rhinoconjunctivitis, rhinitis and
asthma. As of today, Stallergenes is the seventh-ranked French pharmaceutical
company. A pioneer and leader in sublingual immunotherapy treatments,
Stallergenes devotes 21% 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 2008, Stallergenes had a turnover of 171 million euros and more than
500,000 patients were treated with Stallergenes immunotherapy 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

SOURCE Stallergenes


Source: newswire