NicOx: Presentations at EULAR congress
Sophia Antipolis, France, June 21, 2010 -- NicOx S.A. (NYSE Euronext Paris: COX) today announced that additional naproxcinod clinical data were presented at the Annual European Congress of Rheumatology, the annual conference of the European League Against Rheumatism (EULAR), which took place from June 16 to June 19 in Rome, Italy. Two posters on clinical results for naproxcinod were presented. The abstracts are available on the congress website (www.eular.org/congress_home.cfm).
Naproxcinod is the first-in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drugcandidate developed for the relief of the signs and symptoms of osteoarthritis. It is currently under review by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Risks factors which are likely to have a material effect on NicOx’s business are presented in the 4th chapter of the « Document de référence, rapport financier annuel et rapport de gestion 2009 » filed with the French Autorité des Marchés Financiers (AMF) on March 5, 2010 and available on NicOx’s website ( www.nicox.com) and on the AMF’s website (www.amf-france.org).
The Company notably draws the investors’ attention to the following risk factors: • Risques liés à la dépendance de la Société à l’égard du naproxcinod (Risks related to the Company’s dependence on the success of its lead product naproxcinod) • Risques commerciaux et développements cliniques (Clinical developments and commercial risk) • Risques liés aux contraintes réglementaires et à la lenteur des procédures d'approbation (Risks linked to regulatory constraints and slow approval procedures) • Manque de capacités dans les domaines de la vente et du marketing (Lack of sales and marketing capabilities) • Incertitude relative aux prix des médicaments et aux régimes de remboursement, ainsi qu’en matiè re de réforme des régimes d’assurance maladie (Uncertainty on drug pricing and reimbursement policies and on the reforms of the health insurance systems) NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a pharmaceutical company focused on the research, development and future commercialization of drug candidates. NicOx is applying its proprietary nitric oxide-donating R&D platform to develop an internal portfolio of New Molecular Entities (NME) for the potential treatment of inflammatory, cardiometabolic and ophthalmological diseases.
NicOx's lead investigational compound is naproxcinod, an NME and a first-in-class CINOD (Cyclooxygenase-Inhibiting Nitric Oxide-Donating) anti-inflammatory drug candidate developed for the relief of the signs and symptoms of osteoarthritis (OA), which is currently under review by regulatory authorities, following the submission and filing of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). The FDA and the EMA are evaluating the data submitted. The FDA has set an action date of July 24, 2010, under the Prescription Drug User Fee Act (PDUFA).
In addition to naproxcinod, NicOx’s pipeline includes several nitric oxide-donating NMEs, which are in development internally and with partners, including Merck & Co., Inc. and Bausch + Lomb, for the treatment of hypertension, cardiometabolic diseases, eye diseases and dermatological diseases.
NicOx S.A. is headquartered in France and is listed on Euronext Paris (Compartment B: Mid Caps).
For a discussion of risks and uncertainties which could cause actual results, financial condition, performance or achievements of NicOx S.A. to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Document de Reference filed with the AMF, which is available on the AMF website (http://www.amf-france.org) or on NicOx S.A.'s website (http://www.nicox.com).
CONTACTS www.nicox.com NicOx Gavin Spencer • Vice President Business Development Tel +33 (0)4 97 24 53 00 • email@example.com Media Relations Financial Dynamics Europe Guillaume Granier (France) • Tel: +33 (0)1 47 03 68 10 • firstname.lastname@example.org Stéphanie Bia (France) • Tel: +33 (0)1 47 03 68 10 • email@example.com Jonathan Birt (UK) • Tel +44 (0)20 7269 7205 • firstname.lastname@example.org United States Robert Stanislaro • Tel +1 212 850 5657 • email@example.com Irma Gomez-Dib • Tel +1 212 850 5761 • firstname.lastname@example.org
Posted: June 2010