DBV Technologies Receives FDA Fast Track Designation for Viaskin Milk for the Treatment of Cow’s Milk Protein Allergy

Guía de Regalos

DBV first to announce Fast Track designation for IgE-mediated CMPA;
Viaskin Milk is currently being investigated in a Phase IIb study

Second Fast Track designation for the Viaskin platform in food allergies
reinforces DBV’s commitment to improve the lives of food allergic
patients

MONTROUGE, France–(BUSINESS WIRE)–$DBVT–DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock
Market: DBVT), today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for Viaskin
Milk, the Company’s investigational treatment for pediatric patients two
years of age and older with Immunoglobulin E (IgE)-mediated cow’s milk
protein allergy (CMPA), currently under clinical investigation in a
Phase IIb trial. There are currently no approved treatments for CMPA,
the most common food allergy in infants and young children. Fast Track
is a process designed by the FDA to facilitate the development, expedite
the review of drugs to treat serious conditions and fill an unmet
medical need.1

Chief Development Officer of DBV Technologies, Laurent Martin,
said, “This achievement reinforces our commitment to bringing novel
therapies to food allergic patients. We are the first to announce Fast
Track designation in this indication, and Viaskin Milk is DBV’s second
product candidate to secure an expedited review designation by the FDA.” 
Mr.
Martin
 continued, “CMPA is one of the most common food
allergies in children, and a life-threatening disease for which there
currently is no approved treatment, representing a major public health
challenge. We look forward to working closely with the FDA throughout
the development process of Viaskin Milk.”

Results from the ongoing Phase IIb portion of the Viaskin MILk Efficacy
and Safety (MILES) Phase I/IIb study of Viaskin Milk in
IgE-mediated CMPA children and adolescents ages two to 17 are expected
in the second half of 2017. A Phase II clinical trial assessing Viaskin
Milk for the treatment of milk allergy-induced Eosinophilic Esophagitis
(EoE) in children ages four to 17 is also ongoing in collaboration with
the Children’s Hospital of Philadelphia.

This milestone underscores the high unmet need for patients
suffering from CMPA. Viaskin Milk could potentially bring the first
approved treatment to patients suffering from the debilitating burden of
CMPA, and we welcome this FDA decision.
” said Alan Kerr,
Senior Vice President, Global Regulatory Affairs of DBV Technologies.

About Viaskin Milk

Viaskin Milk is an investigational therapy in development for the
treatment of pediatric cow’s milk protein allergy (CMPA) and
Eosinophilic Esophagitis (EoE). The Viaskin Milk patch is based on
epicutaneous immunotherapy (EPIT), a proprietary technology platform
that can deliver biologically active compounds to the immune system
through intact skin without allowing compound passage into the blood.

About Cow’s Milk Protein Allergy

Cow’s milk protein allergy (CMPA) is the most common food allergy in
infants and young children, affecting 2% to 3% of the general
population. Symptoms can include gastrointestinal problems such as
vomiting and diarrhea, skin rash, angioedema or rapid swelling of the
skin, and anaphylaxis. The only option available for CMPA management is
the avoidance of cow’s milk, which can lead to issues of dietary
imbalance, failure to thrive and poor quality of life.

About Eosinophilic Esophagitis

Eosinophilic Esophagitis (EoE) is an allergic inflammatory disease
characterized by the swelling of the esophagus. Typical symptoms include
vomiting, abdominal pain, regurgitation, dysphagia, and in young
children and infants, feeding difficulties and failure to thrive.
Because the diverse and non-specific symptoms, EoE can be diagnosed only
by esophageal biopsy. In addition to presenting symptoms, acute and
chronic complications that may arise if EoE remains untreated include
food impaction, esophageal stricture, narrow-caliber esophagus, and
esophageal perforation. It is estimated that EoE impacts one in every
2,000 children. EoE is considered to be a chronic condition with no
currently approved treatments. Cow’s Milk Protein Allergy (CMPA) is
believed to be involved in a majority of cases of EoE in children, and
therefore a cow’s milk-free diet is often able to reduce EoE symptoms.

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 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 reflecting management’s expectations for clinical development
of our product candidates and the commercial potential of our product
candidates generally. 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.

References

1. Food and Drug Administration. For Patients: Fast Track, Breakthrough
Therapy, Accelerated Approval, and Priority Review. Available at: http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.
Accessed September 2016.

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

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