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. - Two phase 2 studies for PF-03187207 in glaucoma patients conducted by Pfizer Inc demonstrated an improvement over Xalatan(R) 0.005%, in terms of intraocular pressure lowering, but did not reach statistical significance on the primary endpoint. Eric Castaldi, Chief Financial Officer of NicOx, commented: "As planned, we successfully completed the phase 3 clinical program for naproxcinod in 2008. We believe that the attractive profile of naproxcinod achieved in the phase 3 program should ensure our compound's future commercial success. Our balance sheet has enabled us to continue to expand the pre-commercialization activities for naproxcinod in parallel with the ongoing partnering discussions. We project cash burn will substantially decline throughout 2009, following the completion of the phase 3 program, and we currently believe we have sufficient cash to finance the activities of the Company until the end of 2010. This projection does not include the possible upfront and milestone payments we expect from a potential commercialization agreement for naproxcinod." Financial summary of 2008 Revenues for the full year 2008 were EUR3.4 million, compared to EUR20.6 million in 2007. These revenues were due to payments received in previous years from NicOx' partnered programs with Merck & Co., Inc. in the antihypertensive field and Pfizer Inc in ophthalmology. Operating expenses totaled EUR86.4 million in 2008, compared to EUR61.8 million in 2007. The majority of these expenses were associated with the phase 3 clinical program for naproxcinod in osteoarthritis (OA) patients, which was successfully completed in the second half of 2008. Naproxcinod is the first Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) and a New Drug Application (NDA) submission to the US Food and Drug Administration (FDA) is projected for mid-2009. NicOx' net loss was EUR73.9 million for the full year 2008, compared to EUR32.1 million in 2007. On December 31, 2008, NicOx had cash, cash equivalents and financial instruments of EUR104.7 million, compared to EUR172.8 million on December 31, 2007. Considerable progress made in naproxcinod pre-commercialization activities In 2008, NicOx signed two major manufacturing agreements to prepare the commercial launch of naproxcinod. In September, an agreement was signed with Capsugel, for the commercial manufacture and supply of naproxcinod capsules and in December, an agreement was signed with DSM for the commercial manufacturing and supply of naproxcinod drug substance (Active Pharmaceutical Ingredient, API). The aim of these agreements is to ensure sufficient commercial supplies of naproxcinod to underpin its successful market launch. NicOx is currently in discussions with a number of companies regarding a potential commercialization agreement for naproxcinod. NicOx aims to retain certain commercialization rights for naproxcinod, in order to fully exploit the drug's commercial and strategic value and aid the Company's planned transition to a self-sustainable pharmaceutical business. Completed phase 3 program confirms naproxcinod's efficacy and achieves target product profile In 2008, NicOx successfully completed the phase 3 clinical program for naproxcinod in patients with OA of the knee (the 301 and 302 studies) and hip (the 303 study), with all three studies achieving highly statistically significant results on all three co-primary efficacy endpoints (the WOMAC(TM) pain subscale, WOMAC(TM) function subscale and subject's overall rating of disease status), as well as good overall safety and tolerability. - In July, the top-line results of the 52-week safety extension of the 301 study were reported, which revealed no unexpected safety findings and showed a good overall long term safety for both doses of naproxcinod. - The 302 study reported top-line results in 1020 knee-OA patients in September 2008. In addition to meeting the three co-primary endpoints at 13 weeks (p