DBV Technologies

Regulatory Filings • Jun 28, 2013

DBV Technologies announces breakthrough Data Presentations at EAACI-WAO Congress

BAGNEUX, France, June 28, 2013 - DBV Technologies (Euronext: DBV – ISIN: FR0010417345), creator of Viaskin®, a new standard in the treatment of allergy, presented six clinical and preclinical presentations on Epicutaneaous Immunotherapy (EPIT®) at the European Academy of Allergy & Clinical Immunology & World Allergy Organization & World Allergy & Asthma Congress (EAACI-WAO) in Milan, Italy. DBV's Viaskin technology was highlighted in six presentations, which included one oral presentation on DBV's currently ongoing phase IIb (VIPES) food challenge methodology, as well as multiple poster presentations on EPIT's immunological impact.

Data demonstrating that there is a weak correlation between the severity of subjective symptoms and the severity of objective symptoms in patient responses during double-blind placebo-controlled food challenges was presented during an oral presentation. In DBV's Phase IIb VIPES study, the Company has performed real time analysis of the occurrence of symptoms, both subjective and objective. The data reinforced the need to clearly distinguish both types of symptoms in order to eliminate bias from patient responses.

DBV also presented five posters, which were related to Viaskin EPIT technology in several indications, including a model evaluating EPIT's efficacy in eosinophil gastro-intestinal disorders (EGIDs), a disease mainly triggered by food allergies.

• 1. "Epicutaneous Immunotherapy (EPIT®) acts on allergic eosinophilic gastritis in piglets sensitized to peanut" (poster 1943) analyses for the first time a model of peanut-sensitized piglets with eosinophilic eosophagitis (EoE)/ -gastritis (EoG) in order to evaluate the efficacy of DBV's Epicutaneous Immunotherapy ('EPIT') using Viaskin®. Peanut-sensitized piglet is a model allowing for demonstration of EPIT's efficacy in eosinophilic gastritis associated with peanut allergy.
• 1. "Epicutaneous immunotherapy but not sublingual immunotherapy ('SLIT') protects against eosinophilic infiltration in a mouse model of eosinophilic esophagitis" (poster 223) shows that eosinophilic esophagitis following a sustained peanut challenge in mice sensitized to peanut is suppressed when animal has been previously treated by EPIT but not by SLIT.
• 1. "Long-term maintenance of regulatory T-cells induced by specific Epicutaneous vs Sublingual Immunotherapy in mice sensitized to Peanut"" (poster 1295), shows that EPIT and SLIT have a similar efficacy in decreasing allergen-specific Th2 responses. However, this study also shows that only EPIT decreased eosinophils infiltration in esophagus after peanut oral exposure.
• 1. "Epicutaneous and sublingual immunotherapy induce different phenotypes of regulatory T-Cells in mice sensitized to peanut" (poster 1297) shows that only EPIT-induced naïve Tregs may have important consequences on long-term tolerance and on further sensitization to other allergens.
• 1. "Milk-Epicutaneous Immunotherapy in milk-sensitized mice inhibits their sensitization to peanut"(poster 224) that a successful early milk-Epicutaneous Immunotherapy might reduce the risk for further sensitization, thus may influence the allergy's natural history, via a Treg mechanism. These data may have important clinical benefits in the future.

Dr Lucie Moudoulet PhD, DBV's Head of Research, who presented poster 224 received the poster discussion award for the session of Sunday 23.

All abstracts are available on the EAACI website as well as on the DBV website.

About peanut allergy: a life-threatening risk for millions of people

In the US, about 1.1% of the general population, or over 3 million people, is allergic to peanuts, which results in about 100 to 150 deaths per year. This allergy affects both adults and children, and in the United Kingdom, it has been estimated that peanut allergy affects 1.8% of young children. The prevalence of peanut allergy in other Western countries (e.g., Canada, France and Spain) has been studied by many researchers, and the prevalence ranges from 0.9% to 1.5%. Peanut allergy is generally considered to be persistent; many studies indicate that fewer than 20% of children will outgrow their allergy. Peanut allergy is more severe than other common food allergies, including milk and egg allergies.

About DBV Technologies:

DBV Technologies is developing Viaskin®, an innovative new approach to the treatment of allergies – a major public health issue that is constantly increasing in prevalence. Food allergies represent a true handicap in everyday life for millions of people, constituting a major unmet medical need. DBV Technologies, incorporated in France in 2002, has developed a proprietary, worldwide-patented technology for administering an allergen to intact skin while avoiding transfer to the blood. The Viaskin® technology combines efficacy and safety as part of a treatment that seeks to improve the patient's tolerability of peanuts, and thus considerably lowers the risk of a systemic, allergic reaction in the event of accidental exposure The product's clinically proven safety profile enables the application of effective desensitization techniques in the most severe forms of the allergy. DBV Technologies is focusing on food allergies, including milk and peanut, for which there are currently no effective treatments. DBV Technologies has designed two products: Viaskin® Peanut and Viaskin® Milk. The clinical development program for Viaskin® Peanut has received Fast Track designation from the US Food and Drug Administration and is currently being studies in Phase II program. The company will subsequently develop a Viaskin® patch for young children with house dust mite allergy – a true public health issue because this pathology is a primary risk factors for childhood asthma.

DBV Technologies shares are traded on segment C of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345).

For more information on DBV Technologies, please visit our website: www.dbv-technologies.com

Contacts

DBV Technologies David Schilansky Chief Financial Officer Tél. : +33(0)1 55 42 78 75 david.schilansky@dbv-technologies.com

US & UK investors The Trout Group Investor Relations Alan S. Roemer Tél. : +1 (212) 531-3315 aroemer@troutgroup.com

French investors

NewCap. Financial Communication and investor relations Emmanuel Huynh / Valentine Brouchot Tél. : +33(0)1 44 71 94 94 dbv@newcap.fr

US press & media Ronald Trahan, APR Press relations Ronald Trahan Tél. : +1 508 359 4005 rctrahan@ronaldtrahan.com