ANTONY, France, June 24 /PRNewswire-FirstCall/ -- Today, Stallergenes has been granted with the marketing authorisation for its sublingual desensitisation tablet, Oralair(R) Grasses in adults, by PEI (Paul Ehrlich Institute), the biological branch of the German health agency.
Based on the positive results of the paediatric pivotal study (VO52), Stallergenes will immediately apply for a paediatric extension of the product's indications.
Stallergenes will launch Oralair(R) Grasses in the adult indication on the German market in the coming weeks. The company expects to extend this launch to the paediatric population this year so as to capture the forthcoming prescription period for grass pollen desensitisation in both indications.
Subsequent market authorization in Europe will be applied afterwards through a Mutual Recognition Procedure (MRP) for both indications, Germany being the reference member state.
"The registration of Oralair(R) Grasses in Germany is a significant breakthrough that gives desensitisation treatments the same level of recognition as mainstream pharmaceuticals and creates a new therapeutic class: "the allergens". I am particularly proud of the fact that Stallergenes has succeeded in turning itself into a genuine biopharmaceutical company, capable of developing and registering pharmaceuticals that meet the highest regulatory standards. We expect the Oralair programme to bring in a steady flow of product licenses in the next few years," says Albert Saporta, Chairman and CEO of Stallergenes.
About The Oralair development programme
According to World Health Organisation (WHO) estimates, 20 to 25% of
the world's population suffer from respiratory allergic symptoms, rhinitis
and/or asthma. By 2020, 50 % of the world's population will be concerned by
allergy according to ISAAC study. According to WHO, desensitisation is the
only treatment that addresses the immunological cause of allergy and
modifies the na
Copyright©2008 PR Newswire.
All rights reserved