DBV Technologies Announces Filing and Validation of Marketing Authorization Application for Viaskin™ Peanut by European Med...
November 02 2020 - 1:30AM
Montrouge, France, November 2, 2020
DBV Technologies Announces Filing and
Validation of Marketing Authorization Application for
Viaskin™ Peanut by European Medicines
Agency
DBV Technologies (Euronext: DBV – ISIN:
FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage
biopharmaceutical company, today announced that its Marketing
Authorization Application (MAA) for its investigational product
Viaskin™ Peanut (DBV712) has been validated by the European
Medicines Agency (EMA). The validation of the MAA confirms that the
submission is sufficiently complete to begin the formal review
process for the investigational non-invasive, once-daily
epicutaneous patch to treat peanut allergies in children ages 4 to
11 years.
Following the MAA validation, the EMA’s
Committee for Medicinal Products for Human Use (CHMP) will review
the application and provide a recommendation to the European
Commission (EC) on whether to grant a marketing authorization. DBV
expects to receive the first set of questions from the EMA
approximately 120 days post-validation.
In August 2020, the Company announced that it
had received a Complete Response Letter (CRL) from the U.S Food and
Drug Administration (FDA) for its Biologics License Application
(BLA) for investigational Viaskin™ Peanut. The Company is in
the process of engaging FDA to discuss the regulatory path
forward.
About DBV Technologies
DBV Technologies is developing Viaskin™, an
investigational 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 non-invasive product candidates, the
Company is dedicated to safely transforming the care of food
allergic patients. DBV’s food allergies programs include ongoing
clinical trials of Viaskin™ Peanut. DBV Technologies has global
headquarters in Montrouge, France and offices in Bagneux, France,
and North American operations in Summit, NJ and New York, NY. The
Company’s ordinary shares are traded on segment B of Euronext Paris
(Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each
representing one-half of one ordinary share) are traded on the
Nasdaq Global Select Market (Ticker: DBVT).
Forward Looking Statements
This press release may contain forward-looking
statements and estimates, including statements regarding the
therapeutic potential of Viaskin™ Peanut as a treatment for
peanut-allergic children; anticipated regulatory interactions and
procedures, including the expected timing of receipt of initial
questions from EMA and the Company’s planned interactions with the
FDA regarding investigational Viaskin™ Peanut; the implementation
and impact of cost-reduction measures to be undertaken by the
Company; and the advancement of the Company’s clinical development
and regulatory review of investigational Viaskin™ Peanut. These
forward-looking statements and estimates are not promises or
guarantees and involve substantial risks and uncertainties. At this
stage, the products of the Company have not been authorized for
sale in any country. 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, including the impact of the COVID-19 pandemic, and the
Company’s ability to successfully execute on its restructuring
plans. Furthermore, the timing of any action by any regulatory
entity and possible regulatory paths forward with FDA cannot be
guaranteed, particularly in light of the COVID-19 pandemic. 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, 2019, and future filings and reports by the Company.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements and estimates, which
speak only as of the date hereof. Other than as required by
applicable law, DBV Technologies undertakes no obligation to update
or revise the information contained in this Press Release.
Investor Relations ContactAnne
Pollak+ 1 (857) 529-2363anne.pollak@dbv-technologies.com
Media ContactAngela Marcucci+ 1
(646) 842-2393angela.marcucci@dbv-technologies.com
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