ANTONY, France, January 19 Stallergenes S.A.today announced that the Paul Ehrlich Institute, the German agency in chargeof regulating biological products, has approved its application for apediatric 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 Germanyfor the 2009 pollen season.
Stallergenes will now begin a mutual recognition procedure forregistration of the product in Europe for both the adult and pediatricindications, with Germany as the reference member state. The pivotal phaseIII pediatric trial, VO 52.06(2), conducted in 278 allergicrhinoconjunctivitis-sufferers aged between 5 and 17 years in 5 Europeancountries (Denmark, France, Germany, Poland, Spain), confirmed the results ofthe adult trial: an excellent tolerance profile and a statistically andclinically significant reduction in symptoms. The pediatric and adult dosagesare identical.
"This new MA(1) for Oralair(R) Grasses represents an important milestonein the field of pediatric desensitization therapy. Thanks to the quality ofthe clinical trials conducted during the development of the tablet, grasspollen desensitization therapy has now achieved a level of evidence so farunprecedented in children and in line with the requirements ofevidence-based-medecine(3). Children are a core target for desensitizationtherapy, accounting for around 40% of patients."
"Oralair(R) Grasses has already been well received in adults: both itsprice and its pre- and coseasonal position fit squarely with the expectationsof German allergy specialists. This EBM-documented, well-tolerated andeasy-to-take treatment, which is effective from the very first season, is setto quickly become firmly established for pediatric use", states AlbertSaporta, Chairman and CEO of Stallergenes.
About Oralair(R) Grasses
Oralair(R) Grasses is a tablet for desensitization to grass pollens, theallergen that causes rhinoconjunctivitis and allergic rhinitis in more than50% of patients in Europe.
With a safe and easy-to-use daily tablet of Oralair(R) Grasses, patientsenjoy a very significant alleviation of all their rhinoconjunctivitissymptoms, a marked reduction in their symptomatic medication use and anoticeable improvement in their quality of life.
Oralair(R) Grasses has been shown to be effective in rhinoconjunctivitiscaused by allergy to grass pollens from the first season, throughout theentire pollen season and during pollen peaks:
Oralair(R) Grasses is indicated as a pre- and coseasonal treatment:treatment should be started four months before the pollen season starts andthen be maintained throughout the season. Treatment should be repeated,following the same protocol, for 3 consecutive pollen seasons.
Oralair(R) Grasses contains a mix of five standardized grass pollens,mimicking patients' natural exposure: perennial rye grass (Lolium perenne),meadow grass (Poa pratensis), timothy grass (Phleum pratense), cocksfoot(Dactylis glomerata) and sweet vernal grass (Anthoxanthum odoratum).
The clinical development program has already enrolled around 1,600patients to date, including 278 children. A pivotal trial aimed at confirmingthe long-term efficacy of the treatment is currently under way. In line withthe program schedule, the results will be communicated at the end of 2009.Finally, the company is presently carrying out a trial in adults, with a viewto registration in the USA.
About The Oralair Development Program
According to World Health Organization (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 affected by allergyaccording to the ISAAC study. According to WHO, desensitization 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 rhinoconjunctivitis, not controlledby their usual medical treatment.
Since 2003, Stallergenes has been running the Oralair program, whichaddresses these unmet medical needs with EBM-documented, registered allergentablets that are safe and easy-to-use.
This program consists in the development of tablets for four of the mainallergens triggering more than 80% of these allergies: grass pollens, housedust mites, birch pollen and ragweed pollen.
The entire program is in the clinical development stage and is proceedingaccording to schedule.
Stallergenes is a European biopharmaceutical company dedicated todesensitization therapies for the prevention and treatment of allergy-relatedrespiratory diseases, such as rhinoconjunctivitis and allergic asthma. Apioneer and leader in sublingual desensitization treatments, Stallergenesdevotes 20% of its turnover, in gross terms, to Research and Development andis actively involved in the development of a new therapeutic class:sublingual desensitization tablets.
In 2008, Stallergenes had a turnover of 170,9 million euros and provideddesensitization treatments to more than 500,000 patients.
Stallergenes is listed on Euronext Paris (Compartment B and is part ofthe sample composing the SBF 120 index.
(2) Wahn U, et al. Efficacy and safety of 5-grass-pollen sublingualimmunotherapy tablets in pediatric allergic rhinoconjunctivitis. The Journalof Allergy and Clinical Immunology. January 2009 (Vol. 123, Issue 1, Pages160-166.e3).
(3) Evidence-Based Medicine (EBM) is defined as "the conscientious,explicit, and judicious use of current best evidence in making decisionsabout the care of individual patients" (Sackett, 1996).- in poly- and mono-sensitized patients and asthmatic patients, - on every individual symptom, and, in particular, on nasal congestion and watery eyes.