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DBV Technologies launches its third Viaskin® program, a first for the treatment of House Dust Mites (HDM) allergy in young children

Regulatory News:

DBV Technologies, (Euronext: DBV – ISIN: FR0010417345), creator of Viaskin®, a new standard in the treatment of allergies, announced today the launch of its third Viaskin programme in the treatment of House Dust Mites (HDM) allergy. Viaskin® HDM’s development aims to demonstrate - for the first time ever - safe desensitization in young children allergic to house dust mites. This programme will be carried out in the framework of ImmunAVia, a €16.4 million project supported and partly financed by the public funds provided by the Industrial Strategic Innovation program (ISI) of Oseo. ImmunAvia is a multidimensional project in the field of diagnostics and treatment of House Dust Mites allergy led by DBV and regrouping Genclis, a French biotech company specialized in recombinant proteins and CHU of Lyon (Hospices civils and university Claude Bernard Lyon1) in the field of paediatric clinical development.

DBV Technologies will receive from OSEO-ISI up to €5.1 million in milestones (composed of subsidies and advance payments) for the development of Viaskin HDM up to proof of concept (end of phase II) out of a total grant of €7.6 million for the full ImmunAvia project. Approximately 30% DBV’s milestones will be paid upfront early 2013. The development of Viaskin HDM will therefore be positive to DBV in terms of cash burn in 2013 and 2014. Viaskin HDM preclinical studies will start in the first half of 2013.

Dr. Pierre-Henri Benhamou, Chairman & CEO of DBV Technologies, said: “The launch of DBV’s third Viaskin programme in the treatment of HDM represents a cornerstone in our development. With this first project in the area of respiratory allergies, Viaskin represents a real hope for millions of patients suffering from an allergy recognized as the first cause of asthma in children. We strongly believe Viaskin is best placed – thanks to its safety profile - to address this vulnerable patient population that would benefit the most from early desensitization.” Dr. Pierre-Henri Benhamou concluded: “We are very thankful to OSEO-ISI for having selected ImmunAvia as a project eligible to public financing and are delighted to have the HCL and Genclis on board. Today, DBV is entering the development of its third product in better conditions than anticipated thanks to the strong partnership with HCL and Genclis and the support of OSEO.”

House dust mites allergy is major public concern. It is estimated that 9.5 million children under 6 in developed countries are allergic to HDM. This allergy is the first cause of asthma in children: scientific publications indicate that 82% of patient with a severe asthma are allergic to HDM, and that 64% of children allergic to HDM will develop asthma before the age of 7. Early treatment for HDM allergy is therefore a major public concern, and Viaskin HDM could be instrumental in the prevention of asthma. A recent study has shown that children at the age of 2, HDM allergy will multiply by 6.6 the rik of developing asthma.

The costs associated with house dust mites’ allergy and asthma amount to several billion dollars worldwide, representing a significant burden to social security systems worldwide. In France alone, asthma linked to allergy represents €1.5 billion per year.

About DBV Technologies

DBV Technologies is opening up a decisive new approach to the treatment of allergy – a major public health issue that is constantly increasing in prevalence. Food allergies represent a true handicap in everyday life for millions of people and thus constitute a major unmet medical need. DBV Technologies has developed a unique, proprietary, worldwide-patented technology for administering an allergen to intact skin and avoiding massive 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 peanut and thus considerably lower the risk of a systemic, allergic reaction in the event of accidental exposure to the allergen. The company's significant development program has taken this revolutionary method through to the industrial stage in Europe, initially. The product's clinically proven safety of use enables the application of effective desensitization techniques (the efficacy of which is acknowledged worldwide) in the most severe forms of the allergy. DBV Technologies is focusing on food allergies (milk and peanut) for which there are currently no effective treatments. It has developed 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. 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 one of the main 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.

CAUTION: Viaskin® is not approved for sale in the USA.

DBV Technologies - Forward Looking Statement

The forward-looking statements, objectives and targets contained herein are based on the Company’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Furthermore, the Research and Development process involves several stages each of which involve the substantial risk that the Company may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Company cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. DBV technologies’ business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers.

Contacts:

DBV Technologies
David Schilansky, +33(0)1 55 42 78 75
Chief Financial Officer
david.schilansky@dbv-technologies.com
or
NewCap.
Financial Communication and investor relations
Emmanuel Huynh / Alexandra Schiltz, +33(0)1 44 71 94 94
dbv@newcap.fr
or
Ronald Trahan, APR
Press relations
Ronald Trahan, +1 508 359 4005
rctrahan@ronaldtrahan.com

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