ANTONY, France, June 21, 2010 Stallergenes S.A.announces the results of a phase III clinical trial (VO55.06) conducted inChina aimed at assessing the efficacy and safety of sublingual immunotherapy(Staloral(R) mites 300) in adult patients suffering from asthma triggered byhouse dust mites.
Study VO55.06 is a phase III randomized, double-blind, placebo-controlledstudy conducted over a period of 15 months in 14 centers located in China'smain cities. After an observation period of 3 months, 484 adult patients withmild to moderate asthma well controlled under inhaled corticosteroid therapywere divided into two groups, one treated with Staloral(R) 300 and one givena placebo for a period of 12 months. Throughout the duration of the study,the patients received inhaled corticosteroid therapy at gradually reduceddosages. The patients were assessed on the basis of the level of asthmacontrol as defined by GINA(1).
Staloral(R) 300 demonstrated statistically significant efficacy versusplacebo for the control of asthma, on the basis of the following criteria:"well-controlled asthma" and "totally controlled asthma" in GINA 3 patients(moderate asthma stabilized with corticosteroids by bronchial route). In thispopulation, the probability of a patient having his/her asthma well ortotally controlled is more than twice as high with Staloral(R) 300 as it isin the placebo group (odds ratios and 95% confidence intervals of 2.10 [1.01;4.36] and 2.43 [1.28; 4.61] respectively).
The treatment was well tolerated. There were no pulmonary side effectsrelated to worsening of asthma or deterioration in lung function.
"We are very pleased with the outstanding outcomes of this large-scalestudy, conducted in China with a solid methodology. They pave the way forbetter asthma management and improved quality of life for patients",emphasizes Prof. YIN Jia, Principal Coordinator and Head of the AllergyDepartment at the Peking Union Medical College Hospital and President of theChinese Allergology Society.
"For the first time, the efficacy of sublingual allergen immunotherapyhas been demonstrated in the stabilization of allergic asthma due to mites inadults through a large-scale clinical trial. This very good outcome willenable us to apply for registration of Staloral(R) mites 300 in China in thenear future. Obviously, these results will lead the clinical developmentprogram for Actair(R), our sublingual immunotherapy tablet for the treatmentof allergic rhinitis triggered by dust mites, to also focus on the treatmentof asthma in patients allergic to mites", adds Albert Saporta, Chairman andCEO of Stallergenes.
ABOUT ALLERGIC ASTHMA
Asthma is a chronic inflammatory disease of the airways, very oftenlinked to allergic rhinitis: 80% of allergic asthma sufferers also haveallergic rhinitis and 40% of patients with untreated rhinitis go on todevelop asthma.
Particularly common in children, asthma is a major public health problem.The frequency of the condition varies from one country to another; in thegreat majority of developed countries, between 5 and 15% of the adultpopulation and 3 to 7% of the pediatric population are affected. Theprevalence of asthma has been gradually increasing over the last 20 years inindustrialized countries, at a rate of around 5% per year.
ABOUT RESPIRATORY ALLERGY IN CHINA
The prevalence of respiratory allergy in China ranges from 10 to morethan 20% of the population. The most commonly reported related conditions areasthma (9.2%), rhinosinusitis (13.3%) and atopic dermatitis (16.4%). In urbanpopulations, 2 out of 3 allergic rhinitis sufferers are consulting aphysician, and 40% of these will have allergen tests.
China is one of the countries offering the greatest potential foreconomic growth globally in the medium term. It is among the top tenpharmaceutical markets in the world and is well on the way to entering thetop 5 by 2011(1).
ABOUT STALORAL(R) 300
Staloral(R) 300 is a sublingual solution of allergen extracts forallergen immunotherapy. It is indicated in the treatment of seasonal orperennial allergic rhinitis, rhinoconjunctivitis and allergic mild tomoderate asthma in adults and children over the age of 5 years. Prescribed byallergy specialists, Staloral(R) 300 is particularly aimed at patientssuffering from severe allergic diseases inadequately controlled despite theuse of symptomatic treatments.
The Actair(R) mites immunotherapy tablet is part of the Stalair(R)sublingual immunotherapy tablet pharmaceutical and clinical developmentprogram being implemented by Stallergenes with a view to obtaining marketingauthorizations for pharmaceutical products in Europe and in other strategicmarkets.
ActairÃ¢ was the subject of a positive IIb/III trial in allergic rhinitisin adults in the first half of 2009. A phase III pediatric trial has beenlaunched.
Stallergenes is a European biopharmaceutical company dedicated toimmunotherapy treatments for the prevention and treatment of allergy-relatedrespiratory diseases, such as allergic rhinoconjunctivitis, rhinitis andasthma. Stallergenes is the seventh-ranked French pharmaceutical company. Apioneer and leader in sublingual immunotherapy treatments, Stallergenesdevotes more than 20% of its turnover, in gross terms, to Research andDevelopment and is actively involved in the development of a new therapeuticclass: sublingual immunotherapy tablets.
In 2009, Stallergenes had a turnover of 193 million euros and more than500,000 patients were treated with Stallergenes immunotherapy products.
Additional information is available at http://www.stallergenes.com
(1)GINA : Global Initiative on Asthma. GINA, in collaboration with theNational Heart, Lung, and Blood Institute, National Institute of Health, USA,and the World Health Organization, is elaborating and updating the worldwideconsensus on asthma management. GINA has defined 4 levels of asthma from mild(1) up to severe (4).
(2)IMS Health, Market Prognosis, March 2009 classification in constant US$Euronext Paris (Compartment B) SBF 120. ISIN code: FR0000065674 Reuters code: GEN.PA Bloomberg code: GEN.FP