{"id":26644,"date":"2023-11-19T10:55:35","date_gmt":"2023-11-19T09:55:35","guid":{"rendered":"https:\/\/www.unither-pharma.com\/fabrication-des-lots-denregistrement-de-pxt3003-en-unidose\/"},"modified":"2026-03-30T17:54:42","modified_gmt":"2026-03-30T15:54:42","slug":"fabrication-des-lots-denregistrement-de-pxt3003-en-unidose","status":"publish","type":"post","link":"https:\/\/www.unither-pharma.com\/fr\/fabrication-des-lots-denregistrement-de-pxt3003-en-unidose\/","title":{"rendered":"Fabrication des lots d&rsquo;enregistrement de PXT3003 en unidose"},"content":{"rendered":"<p class=\"article-title\"><span style=\"font-size: 16px;\">Communiqu\u00e9 de presse, <\/span>Source : Pharnext &#8211; Pharnext annonce avoir r\u00e9ussi la fabrication des lots d&rsquo;enregistrement de PXT3003 aux \u00c9tats-Unis<b><\/b><\/p>\n<p>&nbsp;<\/p>\n<h2>Pharnext annonce avoir r\u00e9ussi la fabrication des lots d&rsquo;enregistrement de PXT3003 aux \u00c9tats-Unis<\/h2>\n<p>&nbsp;<\/p>\n<p><strong>PARIS, France, le 20 novembre \u00e0 8h30 (CET) \u2013 Pharnext SCA (FR001400JXB0 &#8211; ALPHA)<\/strong>\u00a0(la \u00ab\u00a0Soci\u00e9t\u00e9\u00a0\u00bb), soci\u00e9t\u00e9 biopharmaceutique \u00e0 un stade clinique avanc\u00e9 d\u00e9veloppant de nouvelles th\u00e9rapies pour des maladies neurod\u00e9g\u00e9n\u00e9ratives sans solution th\u00e9rapeutique satisfaisante, annonce avoir r\u00e9alis\u00e9 avec succ\u00e8s la production des trois lots d&rsquo;enregistrement de PXT3003 sous forme de solution buvable en sachets unidoses aux \u00c9tats-Unis, en utilisant une technologie innovante de pointe \u00ab\u00a0<em>form-fill-seal liquid sachets<\/em>\u00a0\u00bb (proc\u00e9d\u00e9 d&#8217;emballage int\u00e9grant les op\u00e9rations de thermoformage-remplissage-scellage) \u00e0 l&rsquo;usine am\u00e9ricaine d&rsquo;Unither de Rochester, dans l&rsquo;\u00c9tat de New York, et initier l\u2019\u00e9tude de stabilit\u00e9 d\u2019enregistrement requise pour le dossier de demande de nouveau m\u00e9dicament (NDA).<\/p>\n<p>Cette \u00e9tape est importante pour pr\u00e9parer le d\u00e9p\u00f4t de la demande de NDA<em>\u00a0<\/em>(\u00ab\u00a0<em>New Drug Application<\/em>\u00a0\u00bb) aupr\u00e8s de la FDA am\u00e9ricaine (\u00ab\u00a0<em>Food and Drug Administration<\/em>\u00a0\u00bb) en 2024 puis la commercialisation potentielle de PXT3003 chez les patients atteints de la maladie de Charcot-Marie-Tooth de type 1A (CMT1A) aux \u00c9tats Unis, si l&rsquo;\u00e9tude clinique pivot de Phase III de PXT3003 (l&rsquo;\u00e9tude PREMIER) est positive (les donn\u00e9es de base devraient \u00eatre annonc\u00e9es en d\u00e9cembre 2023).<\/p>\n<p>Sous r\u00e9serve de l&rsquo;approbation de la FDA, ce produit sera commercialis\u00e9 sous forme de sachets unidoses de 5mL.<br \/>\nPour rappel, le transfert du proc\u00e9d\u00e9 de fabrication et l\u2019augmentation de la capacit\u00e9 de production de PXT3003 avaient \u00e9t\u00e9 r\u00e9alis\u00e9s aux \u00c9tats-Unis en janvier 2023.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Raj Thota, Directeur du Manufacturing et de la CMC, a d\u00e9clar\u00e9<\/strong>\u00a0: \u00ab\u00a0<em>C\u2019est un immense plaisir d\u2019annoncer l\u2019atteinte d\u2019\u00e9tapes majeures telles que l&rsquo;ach\u00e8vement de la production des lots d&rsquo;enregistrement de PXT3003 et l&rsquo;initiation de la stabilit\u00e9 pour l&rsquo;enregistrement du produit. Ces jalons nous rapprochent de notre objectif de d\u00e9p\u00f4t du dossier de NDA en 2024 et d&rsquo;un potentiel lancement commercial, si le dossier est approuv\u00e9 en 2025<\/em>\u00a0\u00bb.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>Hugo Brugi\u00e8re, Repr\u00e9sentant de la G\u00e9rance, a conclu<\/strong>\u00a0: \u00ab\u00a0<em>Nous avons franchi l\u00e0 une nouvelle \u00e9tape majeure vers la commercialisation du PXT3003. Nous attendons maintenant avec beaucoup d\u2019impatience les donn\u00e9es pr\u00e9liminaires de notre \u00e9tude clinique pivot de Phase III qui sont d\u00e9sormais attendues avant mi-d\u00e9cembre. Nous pr\u00e9ciserons le calendrier dans les prochains jours<\/em>\u00a0\u00bb.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Avertissement<\/strong><\/h3>\n<p><em>La soci\u00e9t\u00e9 Pharnext a mis en place un financement sous forme d\u2019OCEANE-BSA avec la soci\u00e9t\u00e9 Global Tech Opportunities 13, qui, apr\u00e8s avoir re\u00e7u les actions issues de la conversion ou de l\u2019exercice de ces instruments, n\u2019a pas vocation \u00e0 rester actionnaire de la soci\u00e9t\u00e9.<br \/>\nLes actions, r\u00e9sultant de la conversion ou de l\u2019exercice des titres susvis\u00e9s, seront, en g\u00e9n\u00e9ral, c\u00e9d\u00e9es dans le march\u00e9 \u00e0 tr\u00e8s brefs d\u00e9lais, ce qui peut cr\u00e9er une forte pression baissi\u00e8re sur le cours de l\u2019action.<br \/>\nLes actionnaires peuvent subir une perte de leur capital investi en raison d\u2019une diminution significative de la valeur de l\u2019action de la soci\u00e9t\u00e9, ainsi qu\u2019une forte dilution en raison du grand nombre de titres \u00e9mis au profit de la soci\u00e9t\u00e9 Global Tech Opportunities 13.<br \/>\nLes investisseurs sont invit\u00e9s \u00e0 \u00eatre tr\u00e8s vigilants avant de prendre la d\u00e9cision d\u2019investir dans les titres de la soci\u00e9t\u00e9 admise \u00e0 la n\u00e9gociation qui r\u00e9alise de telles op\u00e9rations de financement dilutives particuli\u00e8rement lorsqu\u2019elles sont r\u00e9alis\u00e9es de fa\u00e7on successive. La soci\u00e9t\u00e9 rappelle que la pr\u00e9sente op\u00e9ration de financement dilutif n\u2019est pas la premi\u00e8re qu\u2019elle a mise en place.<br \/>\nLes investisseurs sont notamment invit\u00e9s \u00e0 prendre connaissance des risques aff\u00e9rents \u00e0 ces op\u00e9rations, mentionn\u00e9s dans le communiqu\u00e9 ci-dessous.<\/em><\/p>\n<p>&nbsp;<\/p>\n<h3><strong>\u00c0 propos de Pharnext<br \/>\n<\/strong><\/h3>\n<p>Pharnext est une soci\u00e9t\u00e9 biopharmaceutique \u00e0 un stade clinique avanc\u00e9, qui d\u00e9veloppe de nouvelles th\u00e9rapies pour les maladies neurod\u00e9g\u00e9n\u00e9ratives actuellement sans solution th\u00e9rapeutique satisfaisante. Pharnext poss\u00e8de un nouveau candidat m\u00e9dicament, PXT3003, en d\u00e9veloppement dans la maladie de Charcot-Marie-Tooth de type 1A (CMT1A), une neuropathie p\u00e9riph\u00e9rique h\u00e9r\u00e9ditaire, rare et invalidante. PXT3003 b\u00e9n\u00e9ficie du statut de m\u00e9dicament orphelin en Europe et aux Etats-Unis. En 2018, PXT3003 a termin\u00e9 une \u00e9tude clinique de Phase III, l\u2019essai PLEO-CMT, avec des r\u00e9sultats pr\u00e9liminaires encourageants. Cet essai a \u00e9t\u00e9 suivi d\u2019une \u00e9tude d\u2019extension en ouvert, l\u2019essai PLEO-CMT-FU, dans laquelle 120 patients poursuivent encore actuellement le traitement avec PXT3003. Les r\u00e9sultats \u00e0 long terme sugg\u00e8rent un b\u00e9n\u00e9fice maintenu en termes de tol\u00e9rance et d\u2019efficacit\u00e9, apr\u00e8s une dur\u00e9e totale d\u2019\u00e9tude clinique de 6 ans. Une \u00e9tude clinique pivot de Phase III internationale, l\u2019essai PREMIER, incluant 387 patients atteints de CMT1A s\u2019est termin\u00e9 en ao\u00fbt 2023. Les premiers r\u00e9sultats de l\u2019essai PREMIER sont attendus au quatri\u00e8me trimestre 2023. PXT3003 a \u00e9t\u00e9 d\u00e9couvert avec l\u2019approche R&amp;D de Pleotherapy\u2122. Pharnext attire l\u2019attention des investisseurs sur les facteurs de risques, notamment financiers, d\u00e9taill\u00e9s dans ses rapports financiers. Plus d\u2019information sur\u00a0<a href=\"file:\/\/\/C:\/Users\/cmertens\/AppData\/Local\/Microsoft\/Windows\/INetCache\/Content.Outlook\/YT8LIPA0\/www.pharnext.com\">www.pharnext.com<\/a>.<br \/>\nPharnext est cot\u00e9e sur le march\u00e9 Euronext Growth \u00e0 Paris (code ISIN : FR001400JXB0).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Communiqu\u00e9 de presse, Source : Pharnext &#8211; Pharnext annonce avoir r\u00e9ussi la fabrication des lots d&rsquo;enregistrement de PXT3003 aux \u00c9tats-Unis &nbsp; Pharnext annonce avoir r\u00e9ussi la fabrication des lots d&rsquo;enregistrement de PXT3003 aux \u00c9tats-Unis &nbsp; PARIS, France, le 20 novembre \u00e0 8h30 (CET) \u2013 Pharnext SCA (FR001400JXB0 &#8211; ALPHA)\u00a0(la \u00ab\u00a0Soci\u00e9t\u00e9\u00a0\u00bb), soci\u00e9t\u00e9 biopharmaceutique \u00e0 un stade [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16314,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-26644","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-actualites"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Fabrication des lots d&rsquo;enregistrement de PXT3003 en unidose | Unither<\/title>\n<meta name=\"description\" content=\"Fabrication des lots d&rsquo;enregistrement de PXT3003 en unidose | Unither\" \/>\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.unither-pharma.com\/fr\/fabrication-des-lots-denregistrement-de-pxt3003-en-unidose\/\" \/>\n<meta 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