Nicox holds successful pre-NDA meeting with FDA on AC-170 clinical package
26 Janeiro 2015 - 4:35AM
Nicox S.A. (NYSE Euronext Paris: COX), the international
ophthalmic company, today announced that it has held a positive
pre-New Drug Application (NDA) meeting with the United States Food
and Drug Administration (FDA) regarding AC-170, a topical ocular
formulation of cetirizine developed for the treatment of ocular
itching associated with allergic conjunctivitis. The purpose of the
meeting was to discuss the clinical package for AC-170, and based
on the available efficacy and safety data, the Agency recommended
submission of the NDA. Nicox will hold an additional pre-NDA
meeting regarding the Chemistry, Manufacturing and Controls (CMC)
data package, which is expected to take place in the first quarter
of 2015. Nicox will update the market in due course on the expected
NDA submission date.
AC-170 is a novel formulation of cetirizine being developed for
the first time for topical application in the eye. Cetirizine is a
second-generation histamine H1-receptor antagonist and a leading
antihistamine which has been marketed for more than 25 years.
AC-170 has been developed for the treatment of ocular itching
associated with allergic conjunctivitis by Aciex Therapeutics,
Inc., which became a wholly-owned subsidiary of Nicox in October
2014.
About Nicox
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is an emerging
international company focused on the ophthalmic market. With a
heritage of innovative R&D, business development and commercial
expertise, the Nicox team is building a diversified portfolio of
ophthalmic products that can help people to enhance their sight.
The Company has established direct commercial operations in the
main European markets as well as an expanding international network
of distributors.
Nicox's R&D pipeline features several near-term
therapeutics, including VESNEO (latanoprostene bunod), a novel
compound based on Nicox's proprietary nitric oxide (NO)-donating
research platform currently in phase 3 with Bausch + Lomb for
glaucoma and ocular hypertension, and AC-170 (cetirizine eye drop),
which has completed phase 3 for allergic conjunctivitis. The
Company is also conducting other research programs based on its
NO-donating platform.
Nicox is headquartered in France and is listed on Euronext Paris
(Compartment B: Mid Caps). For more information on Nicox or its
products please visit www.nicox.com.
This press release contains certain forward-looking
statements. Although the Company believes its expectations are
based on reasonable assumptions, these forward-looking statements
are subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated in the
forward-looking statements.
Risks factors which are likely to have a material effect on
Nicox's business are presented in: the 4th chapter of the "Document
de référence, rapport financier annuel et rapport de gestion 2013"
filed with the French Autorité des Marchés Financiers (AMF) on
April 2nd, 2014; the "Rapport semestriel financier et d'activité au
30 juin 2014"; the 5th chapter of the "Actualisation du Document de
Référence 2013" filed with the AMF on September 30, 2014 (D.
14-0271-A01); and the section B of the 'Document E' registered with
the AMF on September 30, 2014 (E.14-060). All these documents are
available on Nicox's website ( www.nicox.com
).
Contacts |
|
Nicox |
Gavin Spencer |
Executive Vice President Corporate Development |
|
Tel +33 (0)4 97 24 53 00 |
communications@nicox.com |
Media
Relations |
|
United Kingdom |
Jonathan Birt |
|
M +44 7860 361 746 |
jonathan.birt@ymail.com |
France |
Caroline Cour me |
Communication Manager |
|
Tel +33 (0)4 97 24 53 43 |
courme@nicox.com |
Press release http://hugin.info/143509/R/1889287/668708.pdf
HUG#1889287
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