- 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 (GLOBE NEWSWIRE) -- 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 partnershipsIn 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.
- 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).
- 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.
- Medical meeting presentations
- 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/);
- 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® :
- Release Viaskin® Peanut's phase IIb (VIPES) topline safety and efficacy results in early Q4 2014;
- Launch a phase II clinical trial in mid-2014 with Viaskin® Milk for the treatment of severe cow's milk allergy in children;
- 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;
- 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;
- 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.
- 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.
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