{"id":1972,"date":"2019-11-09T11:40:53","date_gmt":"2019-11-09T11:40:53","guid":{"rendered":"https:\/\/xspraypharma.com\/affarsmodell-copy\/"},"modified":"2025-09-09T12:16:35","modified_gmt":"2025-09-09T12:16:35","slug":"var-historia-tidslinje","status":"publish","type":"page","link":"https:\/\/xspraypharma.com\/sv\/om-oss\/var-historia-tidslinje\/","title":{"rendered":"V\u00e5r historia \u2013 en tidslinje"},"content":{"rendered":"\n\n<section class=\"block content-block\">\n\t\t\t\t\t\t<div class=\"container-fluid container-small editor_content\">\n\t\t\t\t<h2>V\u00e5r historia p\u00e5 en tidslinje<\/h2>\n<p>Xspray Pharma har under l\u00e5ng tid utvecklat de metoder som anv\u00e4nds idag, och f\u00f6rfinat aff\u00e4rsmodellen.<\/p>\n<p><strong>2025<br \/>\n<\/strong>Bioekvivalens bekr\u00e4ftades mellan XS003 (nilotinib) och Tasigna\u00ae vad g\u00e4ller systemisk exponering (AUC och Cmax), trots att dosen av XS003 var mindre \u00e4n h\u00e4lften s\u00e5 stor som referensl\u00e4kemedlet. Ut\u00f6ver detta visade XS003 en tydligt f\u00f6rb\u00e4ttrad f\u00f6dointeraktion och en mer f\u00f6ruts\u00e4gbar dosrespons, vilket underl\u00e4ttar precisa dosjusteringar i klinisk praxis. Xspray Pharma l\u00e4mnade in ans\u00f6kan om marknadsgodk\u00e4nnande f\u00f6r XS003 f\u00f6r behandling av kronisk myeloisk leukemi (KML) till den amerikanska l\u00e4kemedelsmyndigheten FDA. Xspray Pharma ingick ett licensavtal med Handa Therapeutics (\u201cHanda\u201d) som ger Handa en icke-exklusiv licens till vissa av Xsprays patent. Licensen avser kommersialisering av en dasatinib-produkt p\u00e5 den amerikanska marknaden och i ett senare skede p\u00e5 utvalda asiatiska marknader.<\/p>\n<p><strong>2024<\/strong><br \/>\nXspray Pharma fokuserade p\u00e5 att etablera den kommersiella infrastrukturen och att f\u00f6rankra behovet av Dasynoc\u00ae i det amerikanska sjukv\u00e5rdssystemet. Bolaget deltog vid konferenser som ASH (American Society of Hematology), ASCO (American Society of Clinical Oncology), NCODA (National Community Oncology Dispensing Association) och SOHO (The Society of Hematologic Oncology). F\u00f6r att minska risken f\u00f6r feldosering justerades vissa av Dasynocs tablettstyrkor. Registreringsgrundande studier genomf\u00f6rdes med XS003 nilotinib. En ytterligare produktkandidat offentliggjordes, XS025 cabozantinib.<\/p>\n<p><strong>2023<\/strong><br \/>\nXspray Pharma f\u00f6rst\u00e4rkte den kommersiella organisationen inf\u00f6r lansering och kommersialisering av Dasynoc\u00ae i USA och ingick ett avtal med EVERSANA Life Science Services, LLC (EVERSANA). Bolaget ingick en uppg\u00f6relse med Bristol-Myers Squibb Company (BMS) som undanr\u00f6jer alla patentanspr\u00e5k p\u00e5 Dasynoc\u00ae och g\u00f6r det m\u00f6jligt f\u00f6r Xspray Pharma att lansera Dasynoc\u00ae efter ett FDA-godk\u00e4nnande. Studieresultat som publicerades i European Journal of Haematology bekr\u00e4ftar att Dasynoc\u00ae har en viktig funktion att fylla genom att f\u00f6r cancerpatienter m\u00f6jligg\u00f6ra samtidig behandling av till exempel mags\u00e5r. XS003 nilotinib uppn\u00e5dde j\u00e4mf\u00f6rbar biotillg\u00e4nglighet med Tasigna\u00ae.<\/p>\n<p><strong>2022<\/strong><br \/>\nFDA inledde en fullst\u00e4ndig granskning av ans\u00f6kan om marknadsgodk\u00e4nnande f\u00f6r Dasynoc\u00ae. BMS l\u00e4mnade in en st\u00e4mningsans\u00f6kan mot Xspray Pharma f\u00f6r patentintr\u00e5ng i februari 2022. FDA beviljade Dasynoc\u00ae s\u00e4rl\u00e4kemedelsstatus f\u00f6r b\u00e5de behandling av kronisk myeloisk leukemi och behandling av akut lymfatisk leukemi.<\/p>\n<p><strong>2021<\/strong><br \/>\nEn studie visade att Xspray Pharmas Dasynoc\u00ae n\u00e5r samma biotillg\u00e4nglighet som referensprodukten Sprycel\u00ae, men med en 30% l\u00e4gre dos. Xspray Pharma l\u00e4mnade in ans\u00f6kan till FDA f\u00f6r marknadsgodk\u00e4nnande av Dasynoc\u00ae enligt 505(b)(2) NDA-f\u00f6rfarandet. Bolaget beslutade att enbart fokusera sin forskning och utveckling p\u00e5 f\u00f6rb\u00e4ttrade PKI:er ist\u00e4llet f\u00f6r b\u00e5de f\u00f6rb\u00e4ttrade och generiska PKI:er.<\/p>\n<p><strong>2020<\/strong><br \/>\nXspray Pharma s\u00e4kerst\u00e4llde produktionsfl\u00f6det f\u00f6r Dasynoc\u00ae, fr\u00e5n tillverkning av aktiv substans till tillverkning av f\u00e4rdig tablett. En klinisk studie bekr\u00e4ftade att kroppens absorption av Dasynoc\u00ae inte p\u00e5verkas av mags\u00e4ckens surhetsgrad eller av samtidig behandling med protonpumpsh\u00e4mmare som omeprazol. Utvecklingsarbete utf\u00f6rdes f\u00f6r bolagets produktkandidat XS003-nilotinib. FDA beviljade s\u00e4rl\u00e4kemedelsstatus f\u00f6r XS003 nilotinib f\u00f6r behandling av kronisk myeloisk leukemi.<\/p>\n<p><strong>2003-2019<\/strong><br \/>\nXspray Pharma grundades 2003. Bolagets HyNap-teknologi utvecklades med fokus p\u00e5 PKI:er f\u00f6r behandling av cancer. Positiva resultat visades fr\u00e5n kliniska studier av en f\u00f6rb\u00e4ttrad respektive generisk version av dasatinib f\u00f6r behandling av kronisk myeloisk leukemi. Xspray Pharma inledde samarbete med italienska NerPharMa S.r.l. som skulle ansvara f\u00f6r produktion av Dasynoc\u00ae p\u00e5 en ny Good Manufacturing Practice-klassad produktionsanl\u00e4ggning. Bolaget lyckades framg\u00e5ngsrikt tillverka det amorfa materialet f\u00f6r Dasynoc\u00ae i kommersiell skala.<\/p>\n\t\t\t<\/div>\n\t\t\t<\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":1707,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1972","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>V\u00e5r historia \u2013 en tidslinje - Xspray<\/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:\/\/xspraypharma.com\/sv\/om-oss\/var-historia-tidslinje\/\" \/>\n<meta property=\"og:locale\" content=\"sv_SE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"V\u00e5r historia \u2013 en tidslinje - 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