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 natural course of the disease. Nearly 15 to 20% of these patients suffer from moderate to severe allergic rhinitis and rhino-conjunctivitis, not controlled by their usual medical treatment.
Since 2003, Stallergenes has been carrying out the Oralair programme which addresses these unmet medical needs with EBM-documented, registered allergen tablets that are safe and easy-to-use.
This programme consists in the development of the four main allergens accounting for more than 80% of the epidemiology of these allergies: grass pollens, house dust mites, birch pollen and ragweed pollen.
The entire programme is in the clinical development stage and is proceeding according to schedule.
About Oralair(R) Grasses
With a safe and easy-to-use daily dose of Oralair(R) Grasses, patients enjoy a very significant alleviation of all their rhino-conjunctivitis symptoms, a marked reduction in their symptomatic medication use and a noticeable improvement in their quality of life.
Oralair(R) Grasses is a fast-dissolving tablet that has demonstrated
high efficacy in allergic rhino-conjunctivitis to grass pollen in the first
season, throughout the pollen season and at the pollen peak on:
- poly- and mono-sensitised patients, as well as asthmatic patients,
- every individual symptom, and in peculiar in nasal congestion and
Oralair(R) Grasses is a pre-coseasonal treatment: it has to be started four months before the pollen season, maintained throughout the season, then stopped and restarted the following season.
Oralair(R) Grasses contains a mix of 5 standardised grass allergens: perennial rye grass (Lolium perenne), meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum), as a daily dose of 300 IR, so as to mimic patients' natural exposure.
The clinical development programme has already enrolled around 1600 patients to date.
A long term pivotal study is proceeding according to schedule, and is currently in its second year.
The company plans to file two INDs for adult and paediatric trials with the FDA this year.
Stallergenes is a European biopharmaceutical company dedicated to desensitisation therapies for the prevention and treatment of allergy-related respiratory diseases, e.g. rhino-conjunctivitis and allergic asthma. A pioneer and leader in sublingual desensitisation treatments, Stallergenes devotes 18% of its turnover to Research and Development and is actively involved in the development of a new therapeutic class: sublingual desensitisation tablets.
In 2007, Stallergenes had a turnover of 147 million euros and provided desensitisation treatments to more than 500,000 patients.
Stallergenes is listed in Euronext Paris (Compartment B) and is part of
the sample composing the SBF 120 index.
ISIN Code: FR0000065674
Reuters Code: GEN.PA
Bloomberg Code: GEN.FP
Additional information is available on http://www.stallergenes.com
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