SOURCE: NICOX
SOPHIA ANTIPOLIS, FRANCE–(Marketwire – June 28, 2010) – www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) today announced that new preclinical
results for NCX 434 were presented at the Retina International World
Congress in Stresa, Italy. NCX 434 is a nitric oxide (NO)-donating new
molecular entity (NME) and a potential preclinical candidate in Diabetic
Macular Edema (DME). It was shown to reduce retinal damage due to ischemia
(restriction of blood flow) and reperfusion (return of blood supply
following ischemia) in a preclinical model without inducing a significant
increase of intraocular pressure (IOP), in contrast to a reference steroid.
DME is a form of diabetic retinopathy, which results from high blood sugar
causing progressive damage to retinal cells and can lead to blindness. In
addition to laser surgery, DME is often treated with injections of steroids
inside the eye (intravitreal injections), which tend to increase IOP,
presenting a significant safety concern. Additionally, local ischemia
resulting from an imbalance between NO, known for its vasodilation
properties, and a vasoconstrictor substance called endothelin-1 (ET-1)
appears to play a pivotal role in DME progression.
This presentation showed that NCX 434 was efficient in reducing several
biochemical and functional aspects of retinal damage in a preclinical model
of ischemia/reperfusion induced by the injection of ET-1. NCX 434 did not
significantly change IOP in this model, while triamcinolone acetonide, a
reference steroid, resulted in significant increase in IOP.
Previous preclinical results showing that NCX 434 enhanced oxygen
saturation in various optic nerve head structures in contrast to a
reference steroid were presented recently at the Ocular Diseases & Drug
Discovery conference in Boston (NicOx press release dated June 1, 2010).
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 2009 ”
filed with the French Autorité des Marchés Financiers (AMF) on
March 5, 2010 and available on NicOx’s website (www.nicox.com) and on the
AMF’s website (www.amf-france.org).
The Company notably draws the investors’ attention to the following risk
factors:
– Risques liés à la dépendance de la Société
à l’égard du naproxcinod (Risks related to the Company’s
dependence on the success of its lead product naproxcinod)
– Risques commerciaux et développements cliniques (Clinical
developments and commercial risk)
– Risques liés aux contraintes réglementaires et à la
lenteur des procédures d’approbation (Risks linked to regulatory
constraints and slow approval procedures)
– Manque de capacités dans les domaines de la vente et du marketing
(Lack of sales and marketing capabilities)
– Incertitude relative aux prix des médicaments et aux régimes de
remboursement, ainsi qu’en matière de réforme des régimes
d’assurance maladie (Uncertainty on drug pricing and reimbursement policies
and on the reforms of the health insurance systems)
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a pharmaceutical company
focused on the research, development and future commercialization of drug
candidates. NicOx is applying its proprietary nitric oxide-donating R&D
platform to develop an internal portfolio of New Molecular Entities (NME)
for the potential treatment of inflammatory, cardio-metabolic and
ophthalmological diseases.
NicOx’s lead investigational compound is naproxcinod, an NME and a first-
in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-
inflammatory drug candidate developed for the relief of the signs and
symptoms of osteoarthritis (OA), which is currently under review by
regulatory authorities, following the submission and filing of a New Drug
Application (NDA) to the US Food and Drug Administration (FDA) and a
Marketing Authorization Application (MAA) to the European Medicines Agency
(EMA). The FDA and the EMA are evaluating the data submitted. The FDA has
set an action date of July 24, 2010, under the Prescription Drug User Fee
Act (PDUFA).
In addition to naproxcinod, NicOx’s pipeline includes several nitric oxide-
donating NMEs, which are in development internally and with partners,
including Merck & Co., Inc. and Bausch + Lomb, for the treatment of
hypertension, cardiometabolic diseases, eye diseases and dermatological
diseases.
NicOx S.A. is headquartered in France and is listed on Euronext Paris
(Compartment B: Mid Caps).
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.
For a discussion of risks and uncertainties which could cause actual
results, financial condition, performance or achievements of NicOx S.A. to
differ from those contained in the forward-looking statements, please refer
to the Risk Factors (“Facteurs de Risque”) section of the Document de
Reference filed with the AMF, which is available on the AMF website
(http://www.amf-france.org) or on NicOx S.A.’s website
(http://www.nicox.com).
CONTACTS
NicOx
Gavin Spencer – Vice President Business Development
Tel +33 (0)4 97 24 53 00 – [email protected]
Media Relations
Financial Dynamics
Europe
Guillaume Granier (France) – Tel: +33 (0)1 47 03 68 10 –
[email protected]
Stéphanie Bia (France) – Tel: +33 (0)1 47 03 68 10 –
[email protected]
Jonathan Birt (UK) – Tel +44 (0)20 7269 7205 – [email protected]
United States
Robert Stanislaro – Tel +1 212 850 5657 – [email protected]
Irma Gomez-Dib – Tel +1 212 850 5761 – [email protected]
NicOx S.A.,
Les Taissounières – Bât HB4 – 1681 route des Dolines – BP313,
06906 Sophia Antipolis cedex, France. Tel. +33 (0)4 97 24 53 00 – Fax +33
(0)4 97 24 53 99
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