Financial Results for Full Year 2008: NicOx in a Unique Position to Deliver Significant Shareholder Value
 
SOPHIA ANTIPOLIS, France, February 26 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced its financial results for full year 2008 and provided an overview of the development and pre-commercialization activities for naproxcinod, its lead investigational drug for the treatment of the signs and symptoms of osteoarthritis (OA).

Michele Garufi, Chief Executive Officer of NicOx, commented: "We believe NicOx has entered 2009 in its strongest strategic position to date. We intend to use the excellent platform that we have developed over the last several years to transform NicOx into a self-sustainable biopharmaceutical company. Central to our ambition is to maximize the strategic and economic value of naproxcinod by signing the most appropriate commercial deal for this unique new product. Our intention is to retain select commercialization rights to naproxcinod to enable the creation of our own sales and marketing operations. Therefore, in parallel with our on-going discussions with potential naproxcinod partners, we are accelerating our search for marketed or late-stage clinical products for in-licensing or acquisition to leverage our future commercial infrastructure. We are confident we will achieve these key near term milestones, which should position NicOx to deliver sustainable profitability in the mid-term."

    Key highlights 2008:     
    - Successful completion of the phase 3 clinical program for naproxcinod in OA patients, with all three studies (301, 302 and 303) achieving highly statistically significant results on all three co-primary efficacy endpoints (the WOMAC(TM) pain and function subscales and patients' overall rating of disease status).

- Positive results on naproxcinod's blood pressure profile from a prospectively designed statistical analysis of the pooled Office Blood Pressure Measurement (OBPM) data from the phase 3 program (304) and two Ambulatory Blood Pressure Monitoring (ABPM) studies (111 and 112), which showed naproxcinod's favorable 24-hour blood pressure profile.

- Signature of two commercial supply agreements for naproxcinod with world leading manufacturing companies: DSM for the production of active pharmaceutical ingredient (API) and Capsugel for the production of naproxcinod capsules.

- Further progress in the collaboration with Merck & Co., Inc., following the initiation of a series of phase 1b studies in mild to moderate hypertensive volunteers, which have the aim of selecting the most appropriate compound to advance into phase 2.