DBV Technologies Announces Completion of Recruitment in Global Phase III Study of Viaskin Peanut for the Treatment of Peanut Allergic Children

Press Release Montrouge, France, June 27, 2016

DBV Technologies Announces Completion of Recruitment in Global Phase III Study of Viaskin Peanut for the Treatment of Peanut Allergic Children

Company Expects to Report Topline Results for PEPITES in 2H 2017

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, today announced that it has reached its patient recruitment objective for PEPITES (PEanut EPIT® Efficacy and Safety), the company's pivotal Phase III trial of Viaskin® Peanut for the treatment of peanut allergic children. Recruitment in PEPITES exceeded initial expectations, with a total of 500 patients screened. As a result, the company increased its initial randomization target of 330 patients to at least 350 patients. Viaskin Peanut is the company's lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through the skin. Topline results from PEPITES are expected in the second half of 2017.

"Today marks an important milestone for peanut allergic patients worldwide, as PEPITES is the first Phase III clinical trial in this disease to successfully finalize recruitment," said Dr. David Fleischer, Principal Investigator for the PEPITES trial and Associate Professor of Pediatrics, Children's Hospital Colorado. "We hope that the results in PEPITES will reflect the positive data that we have observed in other Viaskin Peanut trials."

"We are extremely proud to see that due to the enthusiasm from our trial's investigators and strong patient demand we were able to complete the recruitment milestone earlier than anticipated and well ahead of our expectations, taking us one step closer to the approval phase for Viaskin Peanut," said Dr. Pierre-Henri Benhamou, Chairman and Chief Executive Officer DBV Technologies. "This excitement for PEPITES captures the real need for a safe and effective treatment for peanut allergy, and we are deeply thankful for our patients, caretakers and clinicians' support during this short recruitment process."