• Meaningful clinical development progress and key corporate partnerships established in 2013
• Significant scientific and clinical news flow expected in 2014
BAGNEUX, France, Dec. 17, 2013 — DBV Technologies (Euronext: DBV – ISIN: FR0010417345), creator of Viaskin®, a new paradigm for the treatment of allergies, announced today a summary of corporate activities in 2013 and provided news flow guidance for 2014.
Dr. Pierre-Henri Benhamou, Chairman & CEO of DBV Technologies, said: “It has been an extremely successful year for the evolution of DBV. We have strengthened our team with several new talented individuals, and we completed a €29.9m private placement that provides us with the necessary cash to file for Viaskin Peanut’s marketing approval with the FDA. We have also rebalanced our shareholder base with top-tier US healthcare investors, which allows for further valuation potential.” Dr. Benhamou concluded: “We look forward to 2014 with great confidence, as this will be a pivotal year and should reveal the potential value that lies in the Viaskin platform.”
Summary of 2013: strong progress in clinical development and corporate partnerships
In 2013, Viaskin® solidified its position as the world’s first and only EPIT-based therapy developed for peanut allergy, a tremendous unmet medical need.
• Viaskin® Peanut’s safety was confirmed in DBV’s 12-month phase IIb clinical study (VIPES), which is currently ongoing in North America and Europe;
• Viaskin® Peanut’s initial efficacy results showed a strong response in children aged 5-11 in a phase II academic study (ARACHILD);
• OLFUS-VIPES is evaluating the long-term efficacy and safety of Viaskin® Peanut;
• NIH-sponsored Consortium of Food Allergy Research (CoFAR) started enrolling a Phase II clinical study with Viaskin® Peanut for the treatment of peanut allergy in leading US centers for food allergy.
Throughout 2013, DBV has continued to diversify its Viaskin® platform beyond the field of food allergies by establishing partnerships with leading industrial partners or leading academic centers worldwide.
• DBV partnered with Stallergenes for the development of respiratory allergy treatments using the Viaskin® platform. The first collaborative product, now at pre-clinical stage, is in Birch pollen allergy;
• DBV announced collaborations with the University of Geneva and BioNet-Asia for whooping cough boost vaccine;
• DBV and INRA (Institut National de la Recherche Agronomique) are exploring a Viaskin®-based product in respiratory syncytial virus (RSV).
During 2013, DBV also expanded it capabilities for phase III and commercialization through the following activities:
• In-house industrial scale up to manufacture 30 million Viaskin® patches per year;
• Strategic manufacturing agreement with Sanofi for Active Pharmaceutical Ingredients (API) based on whole natural allergens;
• Creation of a market access function with the appointment of Véronique Foutel as Chief Strategic Marketing Officer.
Scientific and clinical news flow guidance for 2014
• Medical meeting presentations
a. In February 2014, DBV will present 3 abstracts and 1 oral presentation at AAAAI (American Academy of Allergy Asthma and Immunology) (http://annualmeeting.aaaai.org/);
b. In April and June 2014, respectively, DBV will present at EAACI (European Academy of Allergology and Clinical Immunology) (http://www.eaaci2014.com) and at CFA (Congrès Francophone d’Allergie) (http://www.congres-allergologie.com/) during a dedicated session on Specific Immunotherapy.
• In terms of clinical development during 2014, DBV anticipates the following news flow for 5 clinical studies using Viaskin® :
a. Release Viaskin® Peanut’s phase IIb (VIPES) topline safety and efficacy results in early Q4 2014;
b. Launch a phase II clinical trial in mid-2014 with Viaskin® Milk for the treatment of severe cow’s milk allergy in children;
c. Fund a pilot study for the treatment of eosinophilic eosophagitis (‘EoE’), which will be conducted at the Children Hospital of Philadelphia (USA) in mid-2014;
d. In H2 2014, launch a clinical proof–of-concept study using Viaskin® PT, which is Viaskin® with a recombinant non-toxic Pertussis Toxin (rPT). This will be conducted in partnership with the University of Geneva and BioNet-Asia;
e. Liaise with its academic partner, Assistance Publique – Hôpitaux de Paris (AP-HP), a network of French Hospitals, to publish Viaskin® Peanut’s Arachild 36-month data in H2 2014.
Financial news flow in 2014
DBV Technologies will announce the company’s financial and operating results as follows:
• Full Year 2013 topline financial results and cash position on January 30, 2014
• Full Year 2013 audited financial results on March 17, 2014
• First Half 2014 financial results on July 28, 2014
• First nine months topline financial results and cash position on October 14, 2014.
• DBV Technologies’ Annual General Meeting will be held on June 3, 2014 in Paris, France.
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.
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.
DBV Technologies Contacts
Chief Financial Officer
Tél. : +33(0)1 55 42 78 75
US & UK investors
The Trout Group
Alan S. Roemer
Tél. : +1 646 378-2945
Financial Communication and investor relations
Emmanuel Huynh / Valentine Brouchot
Tél. : +33(0)1 44 71 94 94
US press & media
Ronald Trahan, APR
Tél. : +1 508 359 4005