{"id":5931,"date":"2019-09-10T17:18:52","date_gmt":"2019-09-10T11:48:52","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=5931"},"modified":"2021-07-24T12:57:32","modified_gmt":"2021-07-24T07:27:32","slug":"recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo","title":{"rendered":"Daiichi Sankyo fuels commercialization of DS-8201 in Japan; Roivant Sciences transfers its biotech stake for USD 3 Billion; FDA, EMA accepts marketing of Allergan\u2019s abicipar"},"content":{"rendered":"\n

Daiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan’s Ministry of Health, Labour and Welfare (MHLW). <\/strong><\/h4>\n\n\n\n

DS-8201 [fam-] trastuzumab deruxtecan), is an investigational antibody-drug conjugate (ADC) designed to deliver cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker.<\/p>\n\n\n\n

Japan\u2019s NDA is based on the results of DESTINY-Breast01, a global pivotal phase II study. <\/p>\n\n\n\n

Daiichi Sankyo, a pharmaceutical company developing novel treatment regimens for cancer, entered into a collaboration with Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize [fam-] trastuzumab deruxtecan as a medicine worldwide<\/p>\n\n\n\n

Metastatic HER2-Positive Breast Cancer <\/a><\/strong>is a type of breast cancer in which breast cancer cells test shows positive status for a protein receptor called human epidermal growth factor receptor 2. According to DelveInsight\u2019s estimates, the total incident population of breast cancer <\/a>in the 7MM was found to be 626,867 in 2017, which is expected to grow during the study period [2017\u20132028].<\/p>\n\n\n\n

According to the American Cancer Society, about 17% of breast cancers overproduce the growth-promoting protein HER2.<\/p>\n\n\n\n

Key players such as MacroGenics, Puma Biotechnology, Seattle Genetics, Jiangsu HengRui Medicine, Prestige Biopharma Pte Ltd, EirGenix, Inc., and others are involved in developing therapies for Metastatic HER-2 Positive Breast Cancer<\/a><\/strong>.<\/p>\n\n\n\n

Allergan\u2019s DARPin- a drug discovery platform- has received the recommendations of US FDA and EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration. <\/strong><\/h4>\n\n\n\n

Abicipar pegol is a novel,\ninvestigational DARPin therapy used to treat patients with neovascular (wet) age-related\nmacular degeneration (nAMD). The FDA is expected to take action on the BLA\nmid-2020. A decision from the European Commission is expected in the second\nhalf of 2020.<\/p>\n\n\n\n

The Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings depend on the results of Phase III clinical trials, CEDAR and SEQUOIA. The trials supported the non-inferior efficacy of the Abicipar quarterly dosing regimen to maintain vision gains with more than 50 per cent fewer injections versus ranibizumab (13 vs. 6) dosed monthly in the first year.<\/p>\n\n\n\n

Abicipar, is the most advanced DARPin therapeutic\ncandidate, as claimed by Molecular partners. It is designed to inhibit VEGF and\nis currently under investigation for the treatment of wet age-related macular\ndegeneration, or wet AMD, and diabetic macular edema, or DME. <\/p>\n\n\n\n

Designed offers the potential for less frequent dosing as it is designed to remain in the eye for a longer period of time, it was licensed to Allergan in May 2011. <\/p>\n\n\n\n

Sumitomo Dainippon Pharma has entered into a strategic partnership with Roivant Sciences to obtain the stake in the Roivant\u2019s subsidiaries for USD 3 Billion.<\/strong><\/h4>\n\n\n\n

The collaboration will give the Sumitomo\nDainippon ownership of Roivant\u2019s companies, technology platforms and an equity\nstake of over 10% of Roivant\u2019s shares. The companies set to be overtaken\ninclude\nMyovant, Urovant, Enzyvant, Altavant and another undisclosed spinout company.<\/p>\n\n\n\n

The companies acquired are focused on advancing the therapy areas significantly in women\u2019s health, urinary diseases and paediatric rare diseases. With the acquisition, Sumitomo will also have dominance over 25 clinical programmes, with potential product launches expected from 2020 to 2022.<\/p>\n\n\n\n

Sumitomo Dainippon is planning to prepare beforehand for the loss it may incur after the patent of its major selling schizophrenia <\/a><\/strong>drug Latuda antipsychotic expires in the US in the year 2023. <\/p>\n","protected":false},"excerpt":{"rendered":"

Daiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan’s Ministry of Health, Labour and Welfare (MHLW). DS-8201 [fam-] trastuzumab deruxtecan), is an investigational antibody-drug conjugate (ADC) designed to deliver cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor […]<\/p>\n","protected":false},"author":1,"featured_media":5932,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[70,1635,1271,704,639,5789],"industry":[17225],"therapeutic_areas":[17228,17244],"class_list":["post-5931","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-allergan","tag-daiichi-sankyo","tag-delveinsight-pharma-news","tag-fda","tag-pharma-news","tag-recent-pharma-news","industry-pharmaceutical","therapeutic_areas-oncology","therapeutic_areas-ophthalmology"],"acf":[],"yoast_head":"\nDaiichi Sankyo fuels DS-8201; Roivant Sciences transfers biotech stake<\/title>\n<meta name=\"description\" content=\"\ufeffDaiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan's Ministry of Health, Labour and Welfare (MHLW).\" \/>\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.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Daiichi Sankyo fuels DS-8201; Roivant Sciences transfers biotech stake\" \/>\n<meta property=\"og:description\" content=\"\ufeffDaiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan's Ministry of Health, Labour and Welfare (MHLW).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2019-09-10T11:48:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-07-24T07:27:32+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2019\/09\/17140409\/News-10.09.2019.png\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"DelveInsight\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"DelveInsight\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Daiichi Sankyo fuels DS-8201; Roivant Sciences transfers biotech stake","description":"\ufeffDaiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan's Ministry of Health, Labour and Welfare (MHLW).","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo","og_locale":"en_US","og_type":"article","og_title":"Daiichi Sankyo fuels DS-8201; Roivant Sciences transfers biotech stake","og_description":"\ufeffDaiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan's Ministry of Health, Labour and Welfare (MHLW).","og_url":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo","og_site_name":"DelveInsight Business Research","article_publisher":"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/","article_published_time":"2019-09-10T11:48:52+00:00","article_modified_time":"2021-07-24T07:27:32+00:00","og_image":[{"width":772,"height":482,"url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2019\/09\/17140409\/News-10.09.2019.png","type":"image\/png"}],"author":"DelveInsight","twitter_card":"summary_large_image","twitter_creator":"@DelveInsight","twitter_site":"@DelveInsight","twitter_misc":{"Written by":"DelveInsight","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo","url":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo","name":"Daiichi Sankyo fuels DS-8201; Roivant Sciences transfers biotech stake","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo#primaryimage"},"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo#primaryimage"},"thumbnailUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2019\/09\/17140409\/News-10.09.2019.png","datePublished":"2019-09-10T11:48:52+00:00","dateModified":"2021-07-24T07:27:32+00:00","author":{"@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/5fbf6ca478835d03fdb5e17d905b520a"},"description":"\ufeffDaiichi Sankyo announced the submission of a New Drug Application (NDA) of DS-8201 to Japan's Ministry of Health, Labour and Welfare (MHLW).","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/recent-pharma-happenings-for-daiichi-roivant-allergan-sumitomo#primaryimage","url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2019\/09\/17140409\/News-10.09.2019.png","contentUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2019\/09\/17140409\/News-10.09.2019.png","width":772,"height":482,"caption":"Pharma News"},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/5fbf6ca478835d03fdb5e17d905b520a","name":"DelveInsight","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/afdd550c64e18f6ad8957080b017c6ae55f4916951d641d3cd40264176aa0e86?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/afdd550c64e18f6ad8957080b017c6ae55f4916951d641d3cd40264176aa0e86?s=96&d=mm&r=g","caption":"DelveInsight"}}]}},"author_meta":{"display_name":"DelveInsight","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/gtadmin"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2019\/09\/17140409\/News-10.09.2019-300x187.png","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Allergan<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Daiichi Sankyo<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">delveinsight pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">FDA<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">recent pharma news<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Allergan<\/span>","<span class=\"advgb-post-tax-term\">Daiichi Sankyo<\/span>","<span class=\"advgb-post-tax-term\">delveinsight pharma news<\/span>","<span class=\"advgb-post-tax-term\">FDA<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">recent pharma news<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 7 years ago","modified":"Updated 5 years ago"},"absolute_dates":{"created":"Posted on Sep 10, 2019","modified":"Updated on Jul 24, 2021"},"absolute_dates_time":{"created":"Posted on Sep 10, 2019 5:18 pm","modified":"Updated on Jul 24, 2021 12:57 pm"},"featured_img_caption":"Pharma News","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/5931","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=5931"}],"version-history":[{"count":0,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/5931\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/5932"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=5931"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=5931"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=5931"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=5931"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=5931"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}