DBV Technologies Announces Publication of Positive Viaskin Peanut Data From NIAID-Sponsored Phase II Academic Study in the Journal of Allergy and Clinical Immunology

The study, CoFAR6, evaluated peanut-allergic patients 4 to 25 years of
age

Primary endpoint of the study was met; greatest benefit observed in
children

MONTROUGE, France–(BUSINESS WIRE)–$DBVT–DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock
Market: DBVT) today announced the publication of 12-month results from
CoFAR6, a Consortium of Food Allergy Research (CoFAR) study sponsored by
the National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health (NIH), investigating the use of
Viaskin Peanut for the treatment of peanut-allergic patients 4 to 25
years of age. The primary endpoint of the study, which measured a
statistically significant desensitization to peanut, was met, with a
greater clinical benefit reported in younger participants. The authors
of the publication concluded that Viaskin Peanut was safe and could
potentially be a convenient mode of treatment for peanut allergy.

Results from the CoFAR6 study were previously announced and presented at
the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual
Meeting in March 2016 in Los Angeles, CA.

No FDA-approved treatment for peanut allergy exists today. Risks of
severe reactions from accidental exposure are a constant threat for
these patients, even when following a peanut-free diet,
” said Dr.
Stacie Jones
, Professor of Pediatrics, University of Arkansas for
Medical Sciences, Arkansas Children’s Hospital, Little Rock, AR, and
lead author of the publication. “A novel treatment that can provide
an essential balance between safety and efficacy will be of key
importance in the treatment of these patients. The results from CoFAR6
with Viaskin Peanut are promising, and we are looking forward to
learning more about this new treatment modality.

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.

The CoFAR6 study publication, titled Epicutaneous Immunotherapy for
the Treatment of Peanut Allergy in Children and Young Adults,
was
published online ahead of print in the Journal of Allergy and
Clinical Immunology
(JACI): www.jacionline.org/inpress
(DOI: 10.1016/j.jaci.2016.08.017).

About the CoFAR6 Study

In October 2013, CoFAR launched a multi-center, randomized,
double-blind, placebo-controlled trial to evaluate Viaskin Peanut in
children, adolescents and young adults allergic to peanuts. This trial
is sponsored and funded by the NIAID and led by Dr. Stacie Jones. The
CoFAR6 trial is being conducted in five hospitals in the United States,
and 75 patients were enrolled; 54 children four to 11 years of age and
21 adolescents and adults 12 to 25 years of age. In CoFAR6, subjects
were randomized 1:1:1 to two doses of Viaskin Peanut (100 µg and 250 µg)
or placebo. The primary outcome measure was percent of patients
desensitized to peanut protein during peanut protein oral food challenge
(OFC) at week 52. Responders were characterized as patients who
successfully passed a 5044 mg OFC or who successfully consumed a dose
ten times greater as compared to baseline.

About DBV Technologies

DBV Technologies is developing Viaskin®, a proprietary technology
platform with broad potential applications in immunotherapy. Viaskin is
based on epicutaneous immunotherapy, or EPIT®, DBV’s method of
delivering biologically active compounds to the immune system through
intact skin. With this new class of self-administered and non-invasive
product candidates, the company is dedicated to safely transforming the
care of food allergic patients, for whom there are no approved
treatments. DBV’s food allergies programs include ongoing clinical
trials of Viaskin Peanut and Viaskin Milk, and preclinical development
of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical
study of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and
exploring potential applications of its platform in vaccines and other
immune diseases.

DBV Technologies has global headquarters in Montrouge, France and New
York, NY. Company shares are traded on segment B of Euronext Paris
(Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and
traded on the Nasdaq Global Select Market in the form of American
Depositary Shares (each representing one-half of one ordinary share)
(Ticker: DBVT). For more information on DBV Technologies, please visit
our website: www.dbv-technologies.com

Forward Looking Statements

This press release contains forward-looking statements, including
statements regarding the potential safety and efficacy of Viaskin Peanut
and statements reflecting management’s expectations for clinical
development of our product candidates and the commercial potential of
our product candidates. These forward-looking statements are not
promises or guarantees and involve substantial risks and uncertainties.
Among the factors that could cause actual results to differ materially
from those described or projected herein include uncertainties
associated generally with research and development, clinical trials and
related regulatory reviews and approvals, the risk that historical
preclinical results may not be predictive of future clinical trial
results, and the risk that historical clinical trial results may not be
predictive of future trial results. A further list and description of
these risks, uncertainties and other risks can be found in the Company’s
regulatory filings with the French Autorité des Marchés Financiers, the
Company’s Securities and Exchange Commission filings and reports,
including in the Company’s Annual Report on Form 20-F for the year ended
December 31, 2015 and future filings and reports by the Company.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date hereof. DBV Technologies undertakes no obligation to update or
revise the information contained in this Press Release, whether as a
result of new information, future events or circumstances or otherwise.

Contacts

DBV Technologies
Susanna Mesa, +1 212-271-0861
Senior
Vice President, Strategy
susanna.mesa@dbv-technologies.com
or
Media
Centron
PR

Erinn White, +1-646-722-8822
ewhite@centronpr.com
or
Media
Europe

Alize RP
Relations Presse
Caroline
Carmagnol,
+33 (0)6 64 18 99 59
caroline@alizerp.com

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