{"id":7463,"date":"2017-04-27T05:32:49","date_gmt":"2017-04-27T05:32:49","guid":{"rendered":"https:\/\/www.nicox.com\/nicox-point-dactivite-du-premier-trimestre-2017-et-position-de-tresorerie\/"},"modified":"2017-04-27T05:32:49","modified_gmt":"2017-04-27T05:32:49","slug":"nicox-point-dactivite-du-premier-trimestre-2017-et-position-de-tresorerie","status":"publish","type":"post","link":"https:\/\/www.nicox.com\/fr\/nicox-point-dactivite-du-premier-trimestre-2017-et-position-de-tresorerie\/","title":{"rendered":"Nicox : Point d\u2019activit\u00e9 du premier trimestre 2017 et position de tr\u00e9sorerie"},"content":{"rendered":"<ul>\n<li>\n<h2>Vyzulta<sup>TM1<\/sup> : date PDUFA fix\u00e9e au 24 ao\u00fbt 2017<\/h2>\n<\/li>\n<li>\n<h2>ZERVIATE<sup>2<\/sup> : date PDUFA fix\u00e9e au 8 septembre 2017<\/h2>\n<\/li>\n<li>\n<h2>NCX 4251 et NCX 470 pr\u00eats \u00e0 entrer en \u00e9tude clinique de Phase 2<\/h2>\n<\/li>\n<li>\n<h2>Position de tr\u00e9sorerie de 25 millions d\u2019euros<sup>3<\/sup> au 31 mars 2017<\/h2>\n<\/li>\n<\/ul>\n<p>Sophia Antipolis, France<\/p>\n<p><strong>Nicox S.A.<\/strong> (Euronext Paris : FR0013018124, COX, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, fait le point sur ses activit\u00e9s et sa position de tr\u00e9sorerie au 31 mars 2017.<\/p>\n<p>\u00ab\u00a0<em>Les dates PDUFA \u00e9tant d\u00e9sormais fix\u00e9es pour Vyzulta<sup>TM<\/sup> et ZERVIATE, nous nous focalisons actuellement sur la recherche d&rsquo;un partenariat pour ZERVIATE aux \u00c9tats-Unis et sur la pr\u00e9paration de l&rsquo;initiation d&rsquo;\u00e9tudes cliniques de Phase 2 pour NCX 4251 et NCX 470, candidats m\u00e9dicaments prometteurs de notre portefeuille de produits, pr\u00e9vues respectivement au quatri\u00e8me trimestre 2017 et au premier trimestre 2018,<\/em>\u00a0\u00bb d<strong>\u00e9clare Michele Garufi, Pr\u00e9sident Directeur G\u00e9n\u00e9ral de Nicox<\/strong>. \u00ab\u00a0<em>Au cours des 12 prochains mois et sous r\u00e9serve des approbations de la FDA, nous serions ainsi susceptibles de disposer de deux produits \u00e0 m\u00eame de g\u00e9n\u00e9rer des revenus et de deux candidats m\u00e9dicaments en d\u00e9veloppement clinique, pla\u00e7ant ainsi la Soci\u00e9t\u00e9 dans une position favorable pour devenir un acteur majeur de Recherche et D\u00e9veloppement dans le domaine de l&rsquo;ophtalmologie gr\u00e2ce \u00e0 son large portefeuille clinique et pr\u00e9clinique.<\/em>\u00ab\u00a0<\/p>\n<h3>Principaux \u00e9l\u00e9ments financiers du premier trimestre 2017<\/h3>\n<p>Au 31 mars 2017, la tr\u00e9sorerie, les \u00e9quivalents de tr\u00e9sorerie et les instruments financiers du Groupe s\u2019\u00e9levaient \u00e0 25.0 millions d\u2019euros<sup>3<\/sup> compar\u00e9s \u00e0 28,9 millions d\u2019euros au 31 d\u00e9cembre 2016. Le Groupe n\u2019a pas enregistr\u00e9 de chiffre d\u2019affaires pour le premier trimestre 2017.<\/p>\n<h3>Principaux \u00e9v\u00e8nements du premier trimestre 2017 et post-cl\u00f4ture<\/h3>\n<ul>\n<li>Nouveau d\u00e9p\u00f4t d&rsquo;un dossier de demande d\u2019autorisation de mise sur le march\u00e9 (<em>New Drug Application<\/em>, NDA) aupr\u00e8s de la FDA am\u00e9ricaine (<em>U.S. Food and Drug Administration<\/em>) le 24 f\u00e9vrier 2017 pour Vyzulta<sup>TM<\/sup> (solution ophtalmique de latanoprost\u00e8ne bunod) 0,024% par Bausch + Lomb (filiale de Valeant Pharmaceuticals International, Inc.), partenaire licenci\u00e9 de Nicox. Le latanoprost\u00e8ne bunod est un collyre administr\u00e9 une fois par jour en monoth\u00e9rapie pour r\u00e9duire la pression intraoculaire chez les patients atteints de glaucome \u00e0 angle ouvert ou d\u2019hypertension oculaire. La FDA s\u2019est fix\u00e9e la date butoir du 24 ao\u00fbt 2017 (date PDUFA) pour finaliser son \u00e9valuation du dossier de demande d\u2019autorisation de mise sur le march\u00e9 (cf. communiqu\u00e9 de presse du 20 mars 2017).<\/li>\n<li>Nouveau d\u00e9p\u00f4t par Nicox d&rsquo;un dossier de demande d&rsquo;autorisation de mise sur le march\u00e9 (NDA) aupr\u00e8s de la FDA am\u00e9ricaine le 8 mars 2017 pour ZERVIATE (solution ophtalmique de c\u00e9tirizine) 0,24%, son collyre innovant et de formulation brevet\u00e9e \u00e0 base de c\u00e9tirizine, d\u00e9velopp\u00e9 dans le traitement du prurit oculaire (d\u00e9mangeaisons) associ\u00e9 aux conjonctivites allergiques. La FDA s&rsquo;est fix\u00e9e la date butoir du 8 septembre 2017 (date PDUFA) pour finaliser son \u00e9valuation du dossier de demande d\u2019autorisation de mise sur le march\u00e9 (cf. communiqu\u00e9 de presse du 11 avril 2017).<\/li>\n<\/ul>\n<h3>Prochaines \u00e9tapes cl\u00e9<\/h3>\n<ul>\n<li>24 ao\u00fbt 2017 : Approbation potentielle de la demande d&rsquo;autorisation de mise sur le march\u00e9 am\u00e9ricain de Vyzulta<sup>TM<\/sup> par la FDA<\/li>\n<li>8 septembre 2017 : Approbation potentielle de la demande d&rsquo;autorisation de mise sur le march\u00e9 am\u00e9ricain de ZERVIATE par la FDA<\/li>\n<li>2\u00e8me semestre 2017 : Commercialisation sur le march\u00e9 am\u00e9ricain de VyzultaTM pr\u00e9vue par Bausch + Lomb, sous r\u00e9serve de l&rsquo;approbation de la FDA<\/li>\n<li>4\u00e8me trimestre 2017 : Initiation pr\u00e9vue de l&rsquo;\u00e9tude clinique de Phase 2 pour NCX 4251<\/li>\n<li>1er trimestre 2018 : Initiation pr\u00e9vue de l&rsquo;\u00e9tude clinique de Phase 2 pour NCX 470<\/li>\n<\/ul>\n<p><strong>Notes:<\/strong><br \/>\n 1. Vyzulta est le nom commercial provisoirement approuv\u00e9 pour la solution ophtalmique de latanoprost\u00e8ne bunod, 0,024%.<br \/>\n 2. ZERVIATE est le nom commercial provisoirement approuv\u00e9 par la FDA pour l\u2019AC-170, solution ophtalmique de c\u00e9tirizine, 0,24%.<br \/>\n 3. Chiffres non audit\u00e9s.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>VyzultaTM1 : date PDUFA fix\u00e9e au 24 ao\u00fbt 2017 ZERVIATE2 : date PDUFA fix\u00e9e au 8 septembre 2017 NCX 4251 et NCX 470 pr\u00eats \u00e0 entrer en \u00e9tude clinique de Phase 2 Position de tr\u00e9sorerie de 25 millions d\u2019euros3 au 31 mars 2017 Sophia Antipolis, France Nicox S.A. (Euronext Paris : FR0013018124, COX, \u00e9ligible PEA-PME), [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[32,16],"tags":[],"class_list":["post-7463","post","type-post","status-publish","format-standard","hentry","category-actualites","category-actualites-et-media"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nicox : Point d\u2019activit\u00e9 du premier trimestre 2017 et position de tr\u00e9sorerie - Nicox<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.nicox.com\/fr\/nicox-point-dactivite-du-premier-trimestre-2017-et-position-de-tresorerie\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nicox : Point d\u2019activit\u00e9 du premier trimestre 2017 et position de tr\u00e9sorerie - Nicox\" \/>\n<meta property=\"og:description\" content=\"VyzultaTM1 : date PDUFA fix\u00e9e au 24 ao\u00fbt 2017 ZERVIATE2 : date PDUFA fix\u00e9e au 8 septembre 2017 NCX 4251 et NCX 470 pr\u00eats \u00e0 entrer en \u00e9tude clinique de Phase 2 Position de tr\u00e9sorerie de 25 millions d\u2019euros3 au 31 mars 2017 Sophia Antipolis, France Nicox S.A. 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