SOURCE: DBV Technologies

April 25, 2013 03:31 ET

DBV Technologies Publishes Its 2012 Registration Document and Its 2012 Annual Financial Report

DBV Technologies Publishes Its 2012 Registration Document and Its 2012 Annual Financial Report

BAGNEUX, FRANCE--(Marketwired - Apr 25, 2013) - DBV Technologies (EURONEXT PARIS: DBV) (ISIN: FR0010417345), creator of Viaskin®, a new reference in the treatment of allergy, announced today that its 2012 Registration Document ('Document de Reference') has been filed with the French « Autorité des Marchés » (AMF), and registered under number R.13-015.

The document is available on the Company's website: and on the AMF's website: Copies are also available at DBV technologies' headquarter - 80/84 rue des Meuniers, 92220 Bagneux - France.

The following documents are incorporated into the 2012 Registration Document ('Document de Reference'):

  • The Annual Financial Report ;
  • The Chairman's report on the preparation and organisation of the works of the Board of Directors and internal control procedures and risk management procedures and the corresponding Statutoty Auditor's report ;
  • The information relating to the fees paid to the Statutory Auditors ;
  • The Annual Information report.

In addition, DBV will a rich newsflow in the course of 2013:

  • In June 2013, DBV Technologies will present at the European Allergy And Clinical Immunology congress (EAACI;
  • During the first half of 2013, DBV will collaborate with the Consortium for Food Allergy Research ('CoFAR') for the launch of an important NIH-sponsored efficacy study, CoFAR6, in peanut allergic patients
  • DBV is still awaiting 18 months-results for the "ARACHILD" pilot study sponsored by AP-HP (Assistance Publique - Hôpitaux de Paris) and understands from its partner that it could receive safety and efficacy data before summer.
  • DBV will also continue throughout the year its partnership with the University of Geneva in the field of vaccination, and expects to make good progress in a very promising joint development programme.

The table below summarizes the development plan set up by the Company:

    Pre-clinical   Phase I   Phase II   Phase III   Filing
Viaskin Peanut           2012   2014   2016
Viaskin Milk           2013   2015   2017
Viaskin HDM*   2014   2015   2016   2017   2019

NOTE : years indicate starting dates
* House Dust Mites

Since its IPO, the most upstream development program in DBV's pipeline, Viaskin house dust mites (HDM ') has been slightly delayed. The Company has indeed chosen to wait in order to apply for a grant with OSEO-ISI in order to support part of this development, that it obtained late 2012. Moreover, initially scheduled for late 2012, the beginning of the clinical development program of Viaskin ® Milk was also delayed by a few months due to the numerous scientific consultations needed to develop an optimal clinical protocol.

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:

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.

2012 Registration Document and its 2012 Annual Financial Report :

Contact Information

  • Contacts

    DBV Technologies
    David Schilansky
    Chief Financial Officer
    Tél. : +33(0)1 55 42 78 75

    US investors
    The Trout Group
    Investor Relations
    Alan S. Roemer
    Tél. : +1 (212) 531-3315

    French investors
    Financial Communication and investor relations
    Emmanuel Huynh / Valentine Brouchot
    Tél. : +33(0)1 44 71 94 94

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