Report Publication Announcement • Apr 25, 2013
Report Publication Announcement
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Bagneux, France 25 April 2013 - DBV Technologies (Euronext: 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: www.dbv-technologies.com and on the AMF's website: www.amffrance.org. 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'):
In addition, DBV will a rich newsflow in the course of 2013:
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.
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
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.
DBV Technologies David Schilansky Chief Financial Officer Tél. : +33(0)1 55 42 78 75 [email protected]
US investors The Trout Group Investor Relations Alan S. Roemer Tél. : +1 (212) 531-3315 [email protected]
NewCap. Financial Communication and investor relations Emmanuel Huynh / Valentine Brouchot Tél. : +33(0)1 44 71 94 94 [email protected]
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