NicOx announces EMEA approval of Naproxcinod study plan

NicOx S.A today announced that it has received scientific advice on its proposed phase 3 clinical plan for naproxcinod (HCT 3012) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

The CHMP stated that it agrees with NicOx' pre-approval safety database proposal for naproxcinod, which does not include a long-term cardiovascular safety study. NicOx expects to file a Marketing Authorization Application (MAA) for naproxcinod in Europe during the first quarter of 2009.

Philippe Serrano, Senior Director of Regulatory Affairs at NicOx, commented: "We are very pleased that the European Medicines Agency agrees with our proposed pre-approval safety database for naproxcinod, which conforms with ICH guidelines. We view this as a significant step toward the commercialization of this potentially important treatment option for patients suffering from osteoarthritis."

Naproxcinod, NicOx' most advanced product, is in phase 3 development for treating the signs and symptoms of osteoarthritis. Naproxcinod is a unique anti-inflammatory agent and the first compound in the CINOD (COX-inhibiting nitric oxide-donating) class. The development program for naproxcinod is designed to demonstrate that the compound has no detrimental effect on blood pressure and good gastroint estinal safety and tolerability. NicOx aims to establish naproxcinod as the drug-of-choice for osteoarthritis patients.

In the scientific advice provided to NicOx, the CHMP stated that it agrees with the Company's safety database proposal for naproxcinod. NicOx will collect safety data during the phase 3 trials for naproxcinod (see NOTE 1), providing a preapproval safety database that satisfies the International Conference on Harmonization (ICH) E1A recommendations.

NicOx' current plans do not include a separate long-term cardiovascular safety study.

The CHMP commented on a number of specific points regarding the assessment of naproxcinod's efficacy in the phase 3 trials. NicOx is considering these comments and whether any modifications to the currently proposed design of the remaining phase 3 program should be implemented. The Company believes that if any changes are made they will not affect the filing of an MAA for naproxcinod during the first quarter of 2009.

The CHMP feedback highlighted the importa nce of the blood pressure monitoring program that NicOx is implementing in the phase 3 program (see NOTE 2) and stressed the importance of assessing the incidence of new hypertension and hypotension, in addition to platelet function. The CHMP also confirmed that NicOx' plan to conduct a predefined pooled analysis on the blood pressure data from the phase 3 trials is appropriate. The non-steroidal anti-inflammatory drugs (NSAIDs) that are currently used to treat the signs and symptoms of osteoarthritis have the propensity to increase blood pressure and interfere with antihypertensive medication. The sustained release of nitric oxide from naproxcinod is expected to endow it with an improved blood pressure profile, compared to NSAIDs, due to the well establishe d role of endothelial nitric oxide in controlling blood pressure.

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