SOPHIA ANTIPOLIS, FRANCE -- (MARKET WIRE) -- 05/11/10 --
www.nicox.com
NicOx S.A. (NYSE Euronext Paris: COX) announces today that the U.S. Food
and Drug Administration (FDA) has published on its website both the FDA's
briefing book and NicOx's briefing book ahead of the May 12 meeting of the
Arthritis Advisory Committee and the Drug Safety and Risk Management
Advisory Committee to discuss the New Drug Application (NDA) for
naproxcinod. The briefing documents can be found at:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/ucm203434.htm.
Naproxcinod is currently under review by the US Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) and NicOx is
seeking approval for the indication of the relief of the signs and symptoms
of osteoarthritis.
The FDA Advisory Committee meeting is scheduled on Wednesday May 12 at 8:00
am EST (2:00 pm CET - 1:00 pm UK) in Washington.
The FDA Advisory Committee is a joint meeting with the Arthritis Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee, two independent panels of experts which provide advice and
recommendations to the FDA. The FDA uses committees and panels to obtain
independent expert advice on scientific, technical, and policy matters to
assist in its mission to protect and promote public health. FDA regulations
indicate that, although the FDA will consider the recommendation of the
panel, the final decision regarding the approval of an investigational drug
product is made by the FDA.
The meeting will be webcast live by commercial organizations. It will be
webcast neither on the FDA's website nor on NicOx's website.
NicOx will request the Company's stock trading to be halted during the FDA
Advisory Committee meeting
Considering that the FDA Advisory Committee is a public meeting, NicOx
intends to request NYSE Euronext to suspend trading of the Company's common
stock from Wednesday May 12 at 2:00 pm CET (8:00 am EST - 1:00 pm UK) until
the conclusion of the meeting and to resume normal trading on Thursday May
13 at 9:00 am CET.
NicOx will issue a press release on the outcome of the FDA Advisory
Committee meeting on Thursday May 13 before the opening of the market
trading in France.
Conference calls on Thursday May 13
NicOx will hold a conference call in French on Thursday May 13 at 3:00 pm
CET (9:00 am EST - 2:00 pm UK) and another one in English at 4:00 pm CET
(10:00 am EST - 3:00 pm UK) to discuss the outcome of the Advisory
Committee meeting. Details of these conference calls will be available on
the Company's website www.nicox.com on May 11, by 10:00 am CET.
About naproxcinod
Naproxcinod is NicOx's lead investigational compound and the first in a new
class of anti-inflammatory agents known as CINODs (Cyclooxygenase-
Inhibiting Nitric Oxide Donators). The NDA file is supported by data from a
large program of 35 clinical trials that involved more than 6,500 subjects.
The program evaluated the efficacy of naproxcinod in relieving signs and
symptoms of osteoarthritis, as well as its safety, with particular care
given to its effect on blood pressure.

In September 2009, NicOx submitted an NDA for naproxcinod, seeking approval
for the relief of the signs and symptoms of osteoarthritis, which was
accepted for filing by the FDA in November 2009. Based on the Prescription
Drug User Fee Act (PDUFA), the FDA has set an action date of July 24, 2010.
In December 2009, NicOx submitted a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA), which was validated in
January 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 has set an action date of July 24, 2010, under the
Prescription Drug User Fee Act (PDUFA). The FDA and the EMA are evaluating
the data submitted. NicOx does not wish to make any claims in regard to
naproxcinod's safety or efficacy prior to its potential approvals.
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, widespread 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: www.nicox.com
NicOx:
Gavin Spencer Vice President Business Development
Tel +33 (0)4 97 24 53 00 - communications@nicox.com
Media Relations
Financial Dynamics
Europe
Guillaume Granier (France) - Tel: +33 (0)1 47 03 68 10 -
guillaume.granier@fd.com
Stéphanie Bia (France) - Tel: +33 (0)1 47 03 68 10 -
stephanie.bia@fd.com
Jonathan Birt (UK) - Tel +44 (0)20 7269 7205 - jonathan.birt@fd.com
United States
Robert Stanislaro - Tel +1 212 850 5657 - robert.stanislaro@fd.com
Irma Gomez-Dib - Tel +1 212 850 5761 - irma.gomez-dib@fd.com
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
This information is provided by HUGIN