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2016-11-12

DBV Technologies: DBV Technologies Announces Poster Presentations at the 2016 American College of Allergy, Asthma, and Immunology Meeting

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| Press Release |
| |
|Montrouge, France, November 11, 2016 |
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DBV Technologies Announces Poster Presentations at the 2016 American College of Allergy, Asthma, and Immunology MeetingDBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market:
DBVT), today announced the presentation of two posters on its Viaskin Peanut
development program at the American College of Allergy, Asthma, and
Immunology (ACAAI) 2016 meeting in San Francisco, CA, November 10 to 14,
2016.

Viaskin Peanut is currently being investigated for the treatment of peanut
allergy in a Phase III program. The Viaskin technology is based on
epicutaneous immunotherapy (EPIT), a proprietary technology platform that can
deliver biologically active compounds to the immune system through the skin.

"Monitoring Viaskin Peanut Treatment Progression with a Biomarker-Based Model
" (P269) highlighted additional data from DBV's proprietary biomarker model,
which aims to predict patients' cumulative reactive dose (CRD) during an oral
food challenge to peanut. Based on clinical data from the VIPES and
OLFUS-VIPES trials, results show that predicted tolerance levels correlate
with the outcome of oral food challenges to peanut during the studies. Poster
#269 was presented by Dr. Luis Salmun, Vice President, Medical Affairs, DBV
Technologies, on Friday, November 11, at 3:40 PM PST. DBV's biomarker-based
model program is being developed to provide physicians with an additional
tool to monitor treatment progression with Viaskin Peanut.

"
What happens when epicutaneous immunotherapy ends"
(P273) was presented by Megan Ott Lewis, MSN, RN, CPNP, Children's Hospital of
Philadelphia, on Friday, November 11, at 4:20 PM PST. In this single-center
assessment, 15 peanut-allergic patients under investigation of treatment with
Viaskin Peanut reported satisfaction from participating in the OLFUS-VIPES
study, as well as no or low interference with daily activities. A majority of
patients reported a statistically significant improvement in quality of life
as measured by the Food Allergy Quality of Life Questionnaire (FAQLQ). The
poster also highlighted that 80% of patients have reintroduced peanut into
their diets without any severe reactions or persistent symptoms.

Both abstracts have been published online in a supplement to the November
issue ofAnnals of Allergy, Asthma&Immunology
, ACAAI's scientific journalhttp://www.annallergy.org/.

About the VIPES Phase IIb Study

The VIPES (Vi
askinP
eanut'sE
fficacy andS
afety) trial was a double-blind, placebo-controlled, multi-center clinical
trial conducted at 22 sites in North America and Europe. 221 peanut-allergic
subjects were randomized 1:1:1:1 into four treatment arms to evaluate three
doses of Viaskin Peanut, 50 µg, 100 µg and 250 µg, compared to placebo. Each
patient underwent two DBPCFCs: one at screening and one after 12 months of
treatment. The challenge was halted once the subject exhibited an objective
allergic symptom. Patients in VIPES received a daily application of the
Viaskin Peanut patch over 12 months. Each patch was applied for 24 hours on
the upper arm for adults (age 18-55) and adolescents (age 12-17) or on the
back of children (age 6-11). The primary efficacy endpoint was the percentage
of treatment responders for each active treatment group compared to placebo.
With Viaskin Peanut 250 µg, 53.6% of children were observed to respond to
treatment compared to a 19.4% response rate in the placebo group (p=0.008).
The compliance rate was more than 97% across all cohorts, the dropout for
related adverse events was less than 1%, and there were no reported serious
adverse events or epinephrine injection related to treatment.

About the OLFUS-VIPES Study

OLFUS-VIPES (O
pen-L
abelF
ollow-U
pS
tudy-Vi
askinP
eanut'sE
fficacy andS
afety), or OLFUS, enrolled 171 subjects who had previously received either
placebo or one of three 12-month dose regimens administered during VIPES.
During the first year of OLFUS, patients were to receive a daily application
of Viaskin Peanut 50 µg or Viaskin Peanut 100 µg or Viaskin Peanut 250 µg for
12 months. According to a study protocol change implemented in March 2014,
all patients were switched to receive Viaskin Peanut 250 mcg during OLFUS.
All patients in OLFUS maintained a peanut-free diet during the study.
Baseline response levels in OLFUS were based on the results of the last
double-blind, placebo controlled food challenge (DBPCFC) in VIPES, and
adjusted by the number of patients enrolling in OLFUS. Responders in the
OLFUS trial were defined as subjects with a peanut protein eliciting dose
equal to or greater than 1,000 mg peanut protein or with a greater than
10-fold increase of the eliciting dose compared to their baseline eliciting
dose observed in the VIPES study. Patients enrolled in OLFUS who received
placebo in VIPES were analyzed separately from subjects who initially
received Viaskin Peanut. At month-24 in OLFUS, patients who were unresponsive
to a cumulative dose above 1,440 mg were eligible to discontinue study drug
for two months while maintaining a peanut-free diet. Patients who opted to
enter into this additional period performed a DBPCFC at month-26 to assess
durability of response.

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.

DBV Technologies Contact

Susanna Mesa

Senior Vice President, Strategy
+1 212-271-0861
susanna.mesa@dbv-technologies.com

Media Contact

Erinn White, Centron PR

+1-646-722-8822
ewhite@centronpr.com

Media Contact Europe

Caroline Carmagnol, Alize RP, Relations Presse

+33 (0)6 64 18 99 59
caroline@alizerp.com

PDF Version
http://hugin.info/156437/R/2056492/770271.pdf

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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: DBV Technologies via Globenewswire

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