DBV Technologies Receives FDA Fast Track Designation for Viaskin Milk for the Treatment of Cow's Milk Protein Allergy
(Thomson Reuters ONE) -
Press Release
Montrouge, France, September 21, 2016
DBV Technologies Receives FDA Fast Track Designation for Viaskin Milk for the
Treatment of Cow's Milk Protein Allergy
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
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.
DBV Technologies Contact
Susanna Mesa
Senior Vice President, Strategy
+1 212-271-0861
susanna.mesa(at)dbv-technologies.com
Media Contact
Erinn White, Centron PR
+1-646-722-8822
ewhite(at)centronpr.com
Media Contact Europe
Caroline Carmagnol, Alize RP, Relations Presse
+33 (0)6 64 18 99 59
caroline(at)alizerp.com
PDF Version:
http://hugin.info/156437/R/2043501/762931.pdf
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
Unternehmensinformation / Kurzprofil:
Datum: 21.09.2016 - 07:30 Uhr
Sprache: Deutsch
News-ID 496045
Anzahl Zeichen: 9478
contact information:
Town:
Bagneux
Kategorie:
Business News
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