{"id":7683,"date":"2020-04-02T05:36:35","date_gmt":"2020-04-02T05:36:35","guid":{"rendered":"https:\/\/www.nicox.com\/nicox-depot-dun-dossier-de-designation-de-medicament-orphelin-pour-le-naproxcinod-dans-la-drepanocytose-par-son-partenaire-fera-pharmaceuticals\/"},"modified":"2020-04-02T05:36:35","modified_gmt":"2020-04-02T05:36:35","slug":"nicox-depot-dun-dossier-de-designation-de-medicament-orphelin-pour-le-naproxcinod-dans-la-drepanocytose-par-son-partenaire-fera-pharmaceuticals","status":"publish","type":"post","link":"https:\/\/www.nicox.com\/fr\/nicox-depot-dun-dossier-de-designation-de-medicament-orphelin-pour-le-naproxcinod-dans-la-drepanocytose-par-son-partenaire-fera-pharmaceuticals\/","title":{"rendered":"Nicox : D\u00e9p\u00f4t d\u2019un dossier de d\u00e9signation de m\u00e9dicament orphelin pour le naproxcinod dans la dr\u00e9panocytose par son partenaire Fera Pharmaceuticals"},"content":{"rendered":"<p>Sophia Antipolis, France<\/p>\n<p><strong>Nicox SA<\/strong> (Euronext Paris: FR0013018124, COX, \u00e9ligible au PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, et Fera Pharmaceuticals, soci\u00e9t\u00e9 pharmaceutique sp\u00e9cialis\u00e9e am\u00e9ricaine \u00e0 capitaux priv\u00e9s, annoncent aujourd&rsquo;hui que Fera a d\u00e9pos\u00e9 un dossier de d\u00e9signation de m\u00e9dicament orphelin (<em>Orphan Drug Designation,<\/em> ODD) pour le naproxcinod dans la dr\u00e9panocytose aupr\u00e8s de la <em>Food and Drug Administration<\/em> (FDA) am\u00e9ricaine.<\/p>\n<p>A la suite des r\u00e9sultats des premi\u00e8res \u00e9tudes non cliniques sur le naproxcinod dans des mod\u00e8les de dr\u00e9panocytose, Fera a d\u00e9cid\u00e9 de concentrer son d\u00e9veloppement dans le traitement des crises vaso-occlusives douloureuses de la dr\u00e9panocytose. Fera pr\u00e9voit de r\u00e9aliser des \u00e9tudes suppl\u00e9mentaires ainsi que d\u2019autres activit\u00e9s de d\u00e9veloppement en pr\u00e9vision de l\u2019entr\u00e9e directe dans une \u00e9tude clinique d\u2019efficacit\u00e9 pour le naproxcinod chez des patients atteints de dr\u00e9panocytose, sous r\u00e9serve d\u2019avoir obtenu une d\u00e9signation de m\u00e9dicament orphelin.<\/p>\n<p>Le naproxcinod, un inhibiteur de cyclooxyg\u00e9nase donneur d&rsquo;oxyde nitrique (CINOD), bas\u00e9 sur le naprox\u00e8ne, est un candidat m\u00e9dicament anti-inflammatoire non-st\u00e9ro\u00efdien, d\u00e9couvert et d\u00e9velopp\u00e9 par Nicox, con\u00e7u pour lib\u00e9rer de l\u2019oxyde nitrique (NO). Nicox et Fera ont conclu un accord en d\u00e9cembre 2015, amend\u00e9 en septembre 2018, allouant \u00e0 Fera les droits exclusifs pour le d\u00e9veloppement et la commercialisation du naproxcinod sur le march\u00e9 am\u00e9ricain. Nicox pourrait potentiellement recevoir un unique paiement d\u2019\u00e9tape li\u00e9 aux ventes d\u2019un montant de 40 millions de dollars si les ventes annuelles du naproxcinod atteignent 1 milliard de dollars (quelle que soit l\u2019indication) aux Etats-Unis ainsi que des redevances de 7% sur les futures ventes de naproxcinod aux Etats-Unis. Fera est responsable de l\u2019ensemble des activit\u00e9s de d\u00e9veloppement clinique, de fabrication, r\u00e8glementaires et de commercialisation.<\/p>\n<h4>R\u00f4le de l\u2019oxyde nitrique dans la dr\u00e9panocytose<\/h4>\n<p>La dr\u00e9panocytose est une maladie du sang h\u00e9r\u00e9ditaire rare o\u00f9 les globules rouges sont falciformes (sous forme de faucille) du fait d\u2019un d\u00e9faut de l&rsquo;h\u00e9moglobine. La rupture de ces cellules dans la circulation sanguine peut entra\u00eener une inflammation, une r\u00e9duction d\u2019oxyde nitrique (NO), et ult\u00e9rieurement un \u00e9paississement de la paroi des cellules endoth\u00e9liales ainsi qu\u2019une activation plaquettaire. Dans cet environnement de microvascularisation inflammatoire, les globules rouges falciformes, les leucocytes (globules blancs) et les plaquettes activ\u00e9es s\u2019aggr\u00e8gent pour cr\u00e9er une occlusion conduisant \u00e0 une crise vaso-occlusive douloureuse.<\/p>\n<h4>A propos du naproxcinod<\/h4>\n<p>Le naproxcinod, est un donneur d&rsquo;oxyde nitrique (NO), bas\u00e9 sur le naprox\u00e8ne, combinant l\u2019activit\u00e9 d\u2019un anti-inflammatoire non st\u00e9ro\u00efdien (AINS) et celle du NO. Les m\u00e9canismes d\u2019action concomitants de l\u2019inhibition de la cyclooxyg\u00e9nase (COX) et du donneur de NO font du naproxcinod un inhibiteur de cyclooxyg\u00e9nase donneur d&rsquo;oxyde nitrique (<em>COX-Inhibiting NO-donor<\/em>, CINOD). Alors que le composant AINS fournit l&rsquo;efficacit\u00e9 analg\u00e9sique et anti-inflammatoire attribu\u00e9e aux AINS traditionnels, la partie NO peut jouer un r\u00f4le significatif en maintenant la fonction et l&rsquo;int\u00e9grit\u00e9 des cellules endoth\u00e9liales vasculaires, l&rsquo;hom\u00e9ostasie de la pression art\u00e9rielle et la circulation microvasculaire. Une importante base de donn\u00e9es cliniques existe d\u00e9j\u00e0 pour le naproxcinod dans l\u2019arthrose, comprenant trois \u00e9tudes de phase 3 conduites chez plus de 2700 patients.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX, \u00e9ligible au PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, et Fera Pharmaceuticals, soci\u00e9t\u00e9 pharmaceutique sp\u00e9cialis\u00e9e am\u00e9ricaine \u00e0 capitaux priv\u00e9s, annoncent aujourd&rsquo;hui que Fera a d\u00e9pos\u00e9 un dossier de d\u00e9signation de m\u00e9dicament orphelin (Orphan Drug Designation, ODD) pour le naproxcinod dans la dr\u00e9panocytose aupr\u00e8s de la Food and [&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-7683","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 - 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