NicOx SA Completes Enrolment Of Phase 3 Trial For HCT 3012 In Osteoarthritis Ahead Of Schedule

SOPHIA ANTIPOLIS, France, May 24 /PRNewswire-FirstCall/ -- NicOx S.A. (Eurolist: NICOX) today announced that it has successfully completed patient enrolment in the first phase 3 trial for HCT 3012. The randomization of 820 patients with osteoarthritis (OA) of the knee at 120 clinical sites in the United States was initiated in late December 2005 and has been completed ahead of the projected timelines. Results are anticipated in the fourth quarter of 2006. HCT 3012 is a novel, proprietary, nitric oxide-donating derivative of naproxen, which NicOx aims to develop as the drug-of-choice for osteoarthritis patients, particularly those with coexisting hypertension (high blood pressure), a key cardiovascular risk in up to 40% of the OA population.

The phase 3 trial is designed to demonstrate that HCT 3012 is superior to placebo and as effective as naproxen in relieving the signs and symptoms of osteoarthritis, in addition to showing that HCT 3012 has no detrimental effect on blood pressure, unlike all other non-steroidal anti-inflammatory drugs (NSAIDs). An additional trial was recently initiated, using ambulatory blood pressure monitoring (ABPM) to compare the 24-hour blood pressure profile of HCT 3012 and naproxen in hypertensive subjects (see press release of May 4, 2006).

"We have made great efforts to recruit high quality clinical sites for this trial and have encountered a very strong interest among investigators towards HCT 3012 and our goal of establishing this product as the reference drug for millions of osteoarthritis patients, including those with coexisting hypertension," said Dr. Maarten Beekman, Vice President of Clinical Development at NicOx. "The completion of enrolment in this phase 3 study in under five months represents a very significant achievement. We believe this performance reflects the strength of the clinical team we have assembled at NicOx and the excellent collaboration with PRA International, a leading contract research organization. We eagerly await the results of this phase 3 trial before year end, along with the results from the recently initiated ambulatory blood pressure monitoring study."

Summary of the design and endpoints of the phase 3 trial

The phase 3 study is a 13-week, double-blind, placebo and naproxen- controlled trial, in patients with osteoarthritis of the knee. Eligible patients were randomized to one of four treatment groups: HCT 3012 375 mg bid, HCT 3012 750 mg bid, naproxen 500 mg bid or placebo bid, with approximately 205 patients enrolled per treatment group. HCT 3012 and placebo will be compared on three co-primary endpoints, based on the mean change between baseline and week-13 in the following scores: the WOMAC(TM) pain subscale, the WOMAC function subscale and patients' overall rating of disease status, which are the standard end-points used to demonstrate the efficacy of a drug for treating the signs and symptoms of osteoarthritis. A non-inferiority comparison of HCT 3012 and naproxen will be a secondary endpoint of the study.

Office blood pressure measurements (OBPM) will be performed at each visit.

The key blood pressure endpoint will be based on the difference between the systolic blood pressure measurements at baseline and the mean of the measurements at week 2, 6 and 13 in the overall patient population. A number of additional endpoints will compare the blood pressure effect of HCT 3012 to naproxen and placebo, in the overall population and the subpopulation of patients with hypertension, in addition to the number of patients who need to initiate, switch or increase the dose of their antihypertensive medication.

An estimated 43 million people suffer from arthritis in the United States, and the number is expected to rise to 59 million by 2020. Arthritic conditions account for the majority of the prescriptions for NSAIDs and COX-2 inhibitors. These agents have recently been linked to an increased risk of cardiovascular adverse events, which may be partially due to their propensity to increase blood pressure and interfere with antihypertensive medication. Therefore, a true medical need exists for a product with a neutral blood pressure-effect, or even a small blood pressure decrease, especially among the 40% of osteoarthritis patients who are estimated to be hypertensive.

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 HCT 3012, in phase 3 development for the treatment of osteoarthritis, and NCX 4016, in phase 2 for Peripheral Arterial Obstructive Disease (PAOD). 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.

CONTACTS: NicOx: Karl Hanks Manager of Corporate Relations and Market Analysis Tel +33 (0) 497 15 22 03 hanks@nicox.comwww.nicox.com Investors in the United States - Burns McClellan Lisa Burns - lburns@burnsmc.com Laura Siino - lsiino@burnsmc.com +1 212 213 0006 Financial Dynamics: Jonathan Birt Tel +1 212 850 5634 jbirt@fd-us.com Julia Phillips Tel +44 (0) 20 7831 3113 julia.phillips@fd.com

CONTACT: NicOx: Karl Hanks, Manager of Corporate Relations and MarketAnalysis, +33-0-497-15-22-03, or hanks@nicox.com ; Investors in the UnitedStates - Lisa Burns, lburns@burnsmc.com , or Laura Siino,lsiino@burnsmc.com , both for - Burns McClellan, +1-212-213-0006 ; orFinancial Dynamics: Jonathan Birt, +1-212-850-5634, or jbirt@fd-us.com , orJulia Phillips, +44-0-20-7831-3113, or julia.phillips@fd.com , all forNicOx S.A.

Web site: http://www.nicox.com/