Regulatory Filings • May 16, 2013
Regulatory Filings
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ANTONY and BAGNEUX, France, 16 May 2013 ‐ DBV Technologies (Euronext: DBV – ISIN: FR0010417345), creator of Viaskin®, a new standard in the treatment of allergies, and Stallergenes S.A. (Euronext Paris CAC small), worldwide leader in allergen immunotherapy, announced today that they have entered into a strategic research partnership.
This partnership combines Stallergenes' world class know‐how in respiratory allergies with DBV's Viaskin, a unique platform allowing for epicutaneous desensitization. DBV will conduct all preclinical work, up to proof‐of‐concept studies using Viaskin® and Stallergenes' aeroallergens. Stallergenes will finance all of DBV's research on these aeroallergens and will have development and commercialization rights. In the coming months, the parties will enter into license agreements for each aeroallergen, defining the opt‐in terms for development and commercialization.
Dr. Pierre‐Henri Benhamou, Chairman and CEO of DBV Technologies, said: "The agreement with Stallergenes is very much in line with our strategy to expand our Viaskin® proprietary platform beyond food allergies. Stallergenes is an ideal partner and has the expertise in respiratory allergies, a major health issue affecting approximately 20% of the general population. Both companies share a passion for innovation, and I strongly believe that the combination of our respective strengths will lead to best‐in‐class treatments for the benefit of patients."
Dr. Roberto Gradnik, CEO of Stallergenes, said: "We are very pleased to team up with DBV Technologies, a company that is developing innovative products designed to deliver allergens with epicutaneous immunotherapy. This collaboration will reinforce our deep expertise in allergen immunotherapy, well‐established for more than 50 years, and demonstrates our continuous focus on innovation. Our expertise combined with DBV's new route of administration will give the opportunity to patients, especially young children, to benefit from a new innovative solution in allergen immunotherapy."
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.
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.
Stallergenes is an international biopharmaceutical company dedicated to the treatment of allergy‐related respiratory diseases, such as severe rhinoconjunctivitis and rhinitis, as well as allergic asthma, using allergen immunotherapy. The leader in sublingual immunotherapy treatments, Stallergenes devotes around 20% of its annual gross sales to Research & Development and is actively involved in the development of a new therapeutic class: sublingual immunotherapy tablets.
In 2012, the Company generated sales of € 240 million, and more than 500,000 patients were treated with Stallergenes products.
Euronext Paris (Compartment B) CAC small ISIN: FR0000065674 Reuters: GEN.PA Bloomberg: GEN.FP
Additional information is available at http://www.stallergenes.com
This press release may contain forward‐looking statements, including forecasts of future revenue and operating profit as well as expected business‐related events. Such statements are based upon the current beliefs and expectations of Stallergenes' management and are subject to risks and uncertainties. Actual results may differ from those set forth in the forward‐looking statements, due to various factors. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, changes in competitive factors and reliance on suppliers. The Company disclaims any intention or obligation to update or revise any forward‐looking statements whether as a result of new information or future events and except as required by law.
| Stallergenes Roberto Gradnik, Chief Executive Officer Tel. +33 1 55 59 20 04 |
Investor and analyst relations: Peter Buhler Chief Financial Officer Tel. +33 1 55 59 20 95 e‐mail: [email protected] |
Press Relations: Lise Lemonnier Senior Communication & Public Affairs Director Tel. + 33 1 55 59 20 96 e‐mail: [email protected] |
|---|---|---|
| Investor and press relations agency: FTI Consulting |
Analyst and investor contact Stéphanie Bia Tel. +33 1 47 03 68 16 [email protected] |
Press contact Emmanuelle Flobert Tel. +33 1 47 03 68 56 [email protected] |
| 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 (646) 378‐2945 [email protected] French investors NewCap. Financial Communication and investor relations Emmanuel Huynh / Valentine Brouchot Tél. : +33(0)1 44 71 94 94 [email protected]
US press & media Ronald Trahan, APR Press relations Ronald Trahan Tél. : +1 508 359 4005 [email protected]
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