NicOx Receives FDA Feedback That No Cardiovascular Outcomes Study Required For Naproxcinod NDA

NicOx S.A.
(Eurolist: NICOX) today announced that the United States Food and Drug
Administration (FDA) has provided feedback on the requirements for
long-term safety data needed for the submission of a New Drug Application
(NDA) for naproxcinod (HCT 3012). The FDA correspondence stated that based
on the information available at this time, a large clinical cardiovascular
outcomes study would not be required at the time of NDA submission for
naproxcinod. Naproxcinod is in phase 3 clinical development for the
treatment of the signs and symptoms of osteoarthritis.



Based on this current feedback and previous discussions held with the
FDA, NicOx believes that its global registration plan for naproxcinod (see
NOTE 1) will be adequate to satisfy current requirements in the US with
regards to demonstrating the efficacy and safety of naproxcinod for
treating the signs and symptoms of osteoarthritis.



Philippe Serrano, Senior Director of Regulatory Affairs at NicOx,
commented: "This response from the FDA confirms that our previously
announced clinical plan for naproxcinod will provide an adequate safety
database for NDA submission and is consistent with recent advice received
from the EMEA. We will continue with our existing clinical plan, with the
goal of submitting an NDA and MAA for naproxcinod in the US and Europe in
the first quarter of 2009."



Naproxcinod is a unique anti-inflammatory agent and the first compound
in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class. Following its
review of the non-clinical, pharmacokinetic and clinical data supplied by
NicOx regarding naproxcinod and COX inhibition, the FDA has concluded that
a large clinical cardiovascular outcomes study would not be required for
naproxcinod at the time of NDA submission. As with the development of any
new molecular entity, additional safety studies could be required if any
safety signals were to be observed in the development program.



NOTE 1: NicOx's global registration plan for naproxcinod consists of
three phase 3 efficacy trials, the first of which reported top-line data on
October 27, 2006 (the 301 study). This trial is expected to be followed by
the initiation of two additional studies in knee and hip osteoarthritis
during 2007 (the 302 and 303 studies).



NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development of nitric oxide-
donating drugs to meet unmet medical needs. NicOx is targeting the
therapeutic areas of pain and inflammation and cardio-metabolic disease.
Resources are focused on two lead compounds, naproxcinod (formerly HCT
3012), in phase 3 development for the treatment of osteoarthritis, and NCX
4016, in phase 2 for type 2 diabetes. NicOx has strategic partnerships with
some of the world's leading pharmaceutical companies, including Pfizer Inc.
and Merck and Co., Inc.



NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a
public company listed on the Eurolist of Euronext Paris (segment: Next
Economy).



The elements included in this communication may contain forward-looking
statements subject to certain risks and uncertainties. Actual results of
the company may differ materially from those indicated in the
forward-looking statements because of different risks factors described in
the company's document de reference.


NicOx S.A.

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