DBV Technologies Completes Enrollment of Phase IIb VIPES Study, the First-Ever Global Trial in Desensitization to Peanut Allergy

BAGNEUX, FRANCE–(Marketwired – Jul 8, 2013) – DBV Technologies
(
EURONEXT PARIS:
DBV) (ISIN: FR0010417345) –

• VIPES’ results expected in 2H 2014
• First global desensitization trial in peanut-allergic
  children, adolescents and adults

DBV Technologies (
EURONEXT PARIS:
DBV) (ISIN: FR0010417345), creator of
Viaskin®, a new standard in the treatment of allergy,
announced today the completion of enrollment in its global phase
IIb clinical trial, VIPES (
Viaskin
Peanut’s
Efficacy and
Safety), a 12-month treatment study with
Viaskin® Peanut. VIPES started in August 2012 and is being
conducted in Europe (France, The Netherlands and Poland) and in
North America (Canada and USA) with a total of 22 investigators,
who collectively screened and randomized 315 and 221
peanut-allergic subjects respectively. VIPES’ patient population
includes 113 chidren (6-11 years), 73 adolescents (12-17 years) and
35 adults (18-55 years). DBV anticipates reporting 12-month topline
data during the second half of 2014. Viaskin® Peanut was
granted Fast Track designation by the U.S. Food and Drug
Administration.

Three doses of Viaskin
®Peanut, i.e. 50 µg, 100 µg and 250 µg
peanut protein compared to placebo are being evaluated in VIPES. A
total of 221 peanut-allergic subjects (55 subjects per treatment
group) were randomized following a double-blind, placebo-controlled
food challenge (‘food challenge’) that established the baseline
threshold of peanut reaction. Patients receive a daily application
of the Viaskin
®Peanut patch over a 12-month treatment period. Each
patch will be applied for 24 hours, either on the upper arm for
adults (18-55 years) and adolescents (12-17 years) or on the back
of children (6-11 years).

The principal coordinating investigator for North America is Pr.
Hugh Sampson, M.D., Chief of the Division of Allergy &
Immunology in the Department of Pediatrics, Director of the Jaffe
Food Allergy Institute, and Dean of Translational Biomedical
Science at The Mount Sinai Medical Center in New York, USA. Pr.
Sampson is also a member of DBV’s Scientific Advisory Board as well
as Principal Investigator of the National Institutes of
Health-sponsored Consortium of Food Allergy Research clinical study
with Viaskin® Peanut (CoFAR6). The principal coordinating
investigator for Europe is Christophe Dupont, M.D, Ph.D., Head of
the Pediatric-Gastroenterology Ambulatory Department at the Necker
Hospital (AP-HP). He is a member of the European Society for
Pediatric Gastroenterology, Hepatology and Nutrition and of the
Committee of Nutrition of the French Pediatric Society. Pr. Dupont
is also Chairman of DBV’s Scientific Advisory Board.

Charles Ruban,MBA, DBV’s Chief Development Officer
said:
“VIPES is designed to confirm the optimal treatment dose of
Viaskin® Peanut in each of the relevant patient
populations.The study protocol will benefit from an improved,
standardized methodology for the food challenge, as well as
cutting-edge monitoring tools. Most importantly, tVIPES’ results
will guide the design of the subsequent Phase III clinical
trial.”Charles Ruban concluded:
“VIPES is the largest trial ever conducted in desensitization
to peanut allergy, and we take great pride in paving the
way.”

Viaskin
®Peanut demonstrated positive efficacy trends in
severely peanut-allergic children after 18-months at a 100 µg
dose. These findings were recently reported in the ARACHILD pilot
study, a multicenter double-blind, placebo-controlled Phase II
clinical trial in 54 randomized subjects aged 5 to 17 that was
sponsored by AP-HP (Assistance Publique – Hôpitaux de Paris).
Overall, the data showed that two-thirds of children under 12 years
old met the primary efficacy endpoint over 18 months of treatment.
The serological response observed during the treatment period also
suggested efficacy of the ongoing desensitization process.

About peanut allergy: a life-threatening allergy for
millions of people

In the United States, about 1.1% of the general population, or
over 3 million people, is allergic to peanuts. Peanut allergy
causes about 100 to 150 deaths per year. This allergy affects both
adults and children, and it has been estimated that peanut allergy
affects 1.8% of young children in the United Kingdom. The
prevalence of peanut allergy in other Western countries (e.g.,
Canada, France and Spain) has been studied by many researchers and
ranges from 0.9% to 1.5%. This allergy is generally considered to
be persistent; many studies indicate that fewer than 20% of
children will outgrow their peanut allergy. Peanut allergy is more
severe than other common food allergies (e.g. milk and egg
allergies).

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 completes enrollment of Phase IIb VIPES study:

http://hugin.info/156437/R/1714701/569488.pdf