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

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics;  Clinical Trials / Drug Trials
Article Date: 11 Nov 2006 - 0:00 PDT


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.
http://www.nicox.com

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