SOPHIA ANTIPOLIS, France, July 28 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today reported its financial results for the six months ended June 30, 2008. Key highlights for the first six months of 2008: - Completion of patient enrollment in the third naproxcinod pivotal phase 3 study (303) - Post hoc analysis of Office Blood Pressure Measurements (OBPM) from the naproxcinod 301 phase 3 study presented at EULAR, showing a statistically significant difference between naproxcinod and naproxen in 3 out of 4 comparisons - Initiation of two large Ambulatory Blood Pressure Monitoring (ABPM) studies for naproxcinod in hypertensive patients with osteoarthritis, which aim to provide complimentary data on naproxcinod's blood pressure profile. These studies have subsequently completed patient enrollment in July - Agreement signed with Archimica Inc. for commercial manufacture of naproxcinod drug substance - Initiation of first clinical trial by Merck & Co., Inc. for an investigational nitric oxide-donating agent in hypertensive volunteers - Extension of the research agreement with Pfizer Inc, which covers NicOx' proprietary technology in ophthalmology - Announcement of the results of a U.S. phase 2 study for the nitric oxide-donating prostaglandin analog PF-03187207 and the decision by Pfizer not to launch a global phase 3 development program for this compound Michele Garufi, Chairman and CEO of NicOx, commented: "We remain focused on finalizing our planned NDA submission for naproxcinod with the US FDA in mid 2009. We are on track to achieve this important milestone with our two ongoing phase 3 studies nearing completion. Our confidence in our lead product has led us to sign an agreement with Archimica for the supply of naproxcinod drug substance for our future commercial needs. Additionally, we are proud of the relationships we have built with our pharmaceutical partners, with Pfizer extending our ophthalmology research collaboration and Merck initiating the first clinical trial in hypertensive volunteers in the first half of this year. We believe NicOx is in a strong position to face the future and we look forward to confirming the efficacy and blood pressure profile of naproxcinod during the second half of 2008." Revenues for the first half of 2008 were EUR2.2 million, compared to EUR11.2 million during the same period in 2007. These revenues were due to payments received from NicOx' partnered programs with Merck & Co., Inc. in the antihypertensive field and Pfizer Inc in ophthalmology. For the first six months of 2008, operating expenses were EUR40.6 million, compared to EUR23.7 million for the same period in 2007. The majority of these expenses relate to the phase 3 and the overall clinical development of naproxcinod, NicOx' lead drug candidate, which is a unique, first in class, Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) in development for the treatment of the signs and symptoms of osteoarthritis. The Company recorded a net loss of EUR33.1 million for the first six months of 2008, compared to a net loss of EUR6.6 million for the same period in 2007. On June 30, 2008, NicOx had cash, cash equivalents and current and non-current financial instruments of EUR141.6 million, compared to EUR195.2 million on June 30, 2007. Review of the first six months of 2008: Naproxcinod phase 3 studies near completion ahead of projected New Drug Application (NDA) filing in mid 2009 NicOx' plan for the regulatory filing of naproxcinod consists of three pivotal phase 3 trials (the 301, 302 and 303 studies). Each of these studies has been designed to compare the efficacy of naproxcinod to placebo on three standard co-primary endpoints after 13 weeks. Positive efficacy and blood pressure results from the 301 study, which was conducted in patients with osteoarthritis of the knee, were presented at the American College of Rheumatology (ACR) in November 2007. An additional analysis of the Office Blood Pressure Measurements (OBPMs) from the 301 study was presented in June 2008 at the European League Against Rheumatism (EULAR) and showed a statistically significant difference (p