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NicOx Reports Results for the First Three Quarters of 2008

SOPHIA ANTIPOLIS, France, October 22 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today reported financial results for the nine months ended September 30, 2008.

Key highlights of the third quarter of 2008:

- Positive top-line results from the 302 study for naproxcinod. The study

met all three co-primary efficacy endpoints at week-13 (p<0.001) and

naproxcinod 750 mg bid comfortably met the main secondary endpoint of

non-inferiority to naproxen 500 mg bid at week-13 and 26. Blood

pressure data from the 302 study also supported naproxcinod's non-

detrimental effect on blood pressure.

- Good overall long term safety demonstrated for both doses of

naproxcinod in the 301 extension study, with no unexpected safety

findings. In addition, the patients' mean blood pressure remained

stable for the 52 weeks following the completion of the 301 study,

suggesting that naproxcinod does not increase blood pressure over time.

- Exclusive agreement signed with Capsugel, the leading

producer of two-piece capsules, for the commercial manufacture of

naproxcinod capsules. Capsugel will be responsible for the formulation

and encapsulation of naproxcinod API.

- Enrollment of 417 osteoarthritis patients with controlled

hypertension successfully completed in two Ambulatory Blood Pressure

Monitoring (ABPM) trials, the 111 and 112 studies. These trials are

designed to assess the 24-hour blood pressure profile of naproxcinod,

in comparison to ibuprofen and naproxen.

- PF-03187207 demonstrated an improvement over Xalatan(R) 0.005% in a

Japanese phase 2 study in glaucoma, although the primary endpoint

at day 28 was not met. NicOx is currently discussing the rights to

PF-03187207 with Pfizer to allow its potential continued development

and commercialization, following Pfi

Copyright©2008 PR Newswire.
All rights reserved

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