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STALLERGENES: Oralair(R) Grasses Obtains a Pediatric MA(1) in Germany
Date:1/19/2009

ANTONY, France, January 19 /PRNewswire-FirstCall/ -- Stallergenes S.A. today announced that the Paul Ehrlich Institute, the German agency in charge of regulating biological products, has approved its application for a pediatric extension (5-17 years) of the indications for Oralair(R) Grasses, sublingual tablets for desensitization to grass pollens.

The marketing authorization for adults was granted on June 24, 2008. Oralair(R) Grasses will therefore be marketed for both indications in Germany for the 2009 pollen season.

Stallergenes will now begin a mutual recognition procedure for registration of the product in Europe for both the adult and pediatric indications, with Germany as the reference member state. The pivotal phase III pediatric trial, VO 52.06(2), conducted in 278 allergic rhinoconjunctivitis-sufferers aged between 5 and 17 years in 5 European countries (Denmark, France, Germany, Poland, Spain), confirmed the results of the adult trial: an excellent tolerance profile and a statistically and clinically significant reduction in symptoms. The pediatric and adult dosages are identical.

"This new MA(1) for Oralair(R) Grasses represents an important milestone in the field of pediatric desensitization therapy. Thanks to the quality of the clinical trials conducted during the development of the tablet, grass pollen desensitization therapy has now achieved a level of evidence so far unprecedented in children and in line with the requirements of evidence-based-medecine(3). Children are a core target for desensitization therapy, accounting for around 40% of patients."

"Oralair(R) Grasses has already been well received in adults: both its price and its pre- and coseasonal position fit squarely with the expectations of German allergy specialists. This EBM-documented, well-tolerated and easy-to-take treatment, which is effective from the very first season, is set to quickly becom
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SOURCE Stallergenes
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