ANTONY, France, June 24 Today, Stallergenes hasbeen granted with the marketing authorisation for its sublingualdesensitisation tablet, Oralair(R) Grasses in adults, by PEI (Paul EhrlichInstitute), 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 theproduct's indications.
Stallergenes will launch Oralair(R) Grasses in the adult indication onthe German market in the coming weeks. The company expects to extend thislaunch to the paediatric population this year so as to capture theforthcoming prescription period for grass pollen desensitisation in bothindications.
Subsequent market authorization in Europe will be applied afterwardsthrough a Mutual Recognition Procedure (MRP) for both indications, Germanybeing the reference member state.
"The registration of Oralair(R) Grasses in Germany is a significantbreakthrough that gives desensitisation treatments the same level ofrecognition as mainstream pharmaceuticals and creates a new therapeuticclass: "the allergens". I am particularly proud of the fact that Stallergeneshas succeeded in turning itself into a genuine biopharmaceutical company,capable of developing and registering pharmaceuticals that meet the highestregulatory standards. We expect the Oralair programme to bring in a steadyflow 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 theworld's population suffer from respiratory allergic symptoms, rhinitis and/orasthma. By 2020, 50 % of the world's population will be concerned by allergyaccording to ISAAC study. According to WHO, desensitisation is the onlytreatment that addresses the immunological cause of allergy and modifies thenatural course of the disease. Nearly 15 to 20% of these patients suffer frommoderate to severe allergic rhinitis and rhino-conjunctivitis, not controlledby their usual medical treatment.
Since 2003, Stallergenes has been carrying out the Oralair programmewhich addresses these unmet medical needs with EBM-documented, registeredallergen tablets that are safe and easy-to-use.
This programme consists in the development of the four main allergensaccounting for more than 80% of the epidemiology of these allergies: grasspollens, house dust mites, birch pollen and ragweed pollen.
The entire programme is in the clinical development stage and isproceeding according to schedule.
About Oralair(R) Grasses
With a safe and easy-to-use daily dose of Oralair(R) Grasses, patientsenjoy a very significant alleviation of all their rhino-conjunctivitissymptoms, a marked reduction in their symptomatic medication use and anoticeable improvement in their quality of life.
Oralair(R) Grasses is a fast-dissolving tablet that has demonstrated highefficacy in allergic rhino-conjunctivitis to grass pollen in the firstseason, throughout the pollen season and at the pollen peak on:
Oralair(R) Grasses is a pre-coseasonal treatment: it has to be startedfour months before the pollen season, maintained throughout the season, thenstopped 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), timothygrass (Phleum pratense), cocksfoot (Dactylis glomerata) and sweet vernalgrass (Anthoxanthum odoratum), as a daily dose of 300 IR, so as to mimicpatients' natural exposure.
The clinical development programme has already enrolled around 1600patients to date.
A long term pivotal study is proceeding according to schedule, and iscurrently in its second year.
The company plans to file tw