{"id":51651,"date":"2022-12-07T08:02:18","date_gmt":"2022-12-07T07:02:18","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/delta-fly-pharma-inc-is-granted-orphan-drug-designation-by-us-food-and-drug-administration-for-dfp-10917\/"},"modified":"2022-12-07T08:02:18","modified_gmt":"2022-12-07T07:02:18","slug":"delta-fly-pharma-inc-is-granted-orphan-drug-designation-by-us-food-and-drug-administration-for-dfp-10917","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/delta-fly-pharma-inc-is-granted-orphan-drug-designation-by-us-food-and-drug-administration-for-dfp-10917\/","title":{"rendered":"Delta-Fly Pharma, Inc. is granted Orphan Drug Designation by US Food and Drug Administration for DFP-10917"},"content":{"rendered":"<div>\n<p>TOKUSHIMA, Japan&#8211;(BUSINESS WIRE)&#8211;Delta-Fly Pharma, Inc. announces that DFP-10917, a leading pipeline of the company, is granted Orphan Drug Designation (ODD) by US Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML).\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20221206006153\/en\/1657667\/5\/Delta-Fly_Pharma_logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20221206006153\/en\/1657667\/21\/Delta-Fly_Pharma_logo.jpg\"><\/a><\/p>\n<p>\nBe given to ODD, Delta-Fly Pharma, Inc. can be entitled to seven extra years of marketing exclusivity and receive some benefits such as R&amp;D rebate by getting approval.\n<\/p>\n<p>\nDFP-10917 is an anti-cancer agent in development for the treatment of patients with Refractory\/Relapsed AML. A Phase 3 clinical study has been underway at MD Anderson Cancer Center in Texas and other major sites of Hematologic Cancer Treatment in USA. The company expects to complete the patients\u2019 enrollment plan soon.\n<\/p>\n<p>\nDelta-Fly Pharma, Inc. focuses not only on cancer itself but on the whole conditions of cancer patients, and aims to deliver medicines that are recommendable for cancer patients and their families.\n<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl\">\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"2\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n<b><span class=\"bwuline\">Company profile<\/span><\/b>\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nCompany name\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDelta-Fly Pharma, Inc. [Tokyo:4598]\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nCapital\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n3352 million Japanese Yen\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nName and Title of Representative\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nKiyoshi Eshima, PhD, President\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDate of Incorporation\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDecember 6, 2010\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nDescription of Business\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nResearch and development, manufacturing and marketing of pharmaceuticals\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nHead Office\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\n37-5, Nishikino, Miyajima, Kawauchi-cho, Tokushima 771-0116, Japan\n<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nBranch Office\n<\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0\" colspan=\"1\" rowspan=\"1\">\n<p class=\"bwcellpmargin\">\nTokyo, Beijing, Vancouver\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n\u00a0\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nDelta-Fly Pharma, Inc.<br \/>\n<br \/>Inquiries: Yasuo Matsueda<br \/>\n<br \/>TEL: +81-(0)3-6231-1278<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#x69;&#108;&#116;o:&#x79;&#x6d;&#x61;&#x74;&#115;&#117;ed&#x61;&#x31;&#x32;&#48;&#54;&#64;de&#x6c;&#x74;&#x61;&#45;&#102;ly&#x70;&#x68;&#x61;&#x72;&#109;&#97;&#46;c&#x6f;&#x2e;&#x6a;&#112;\" rel=\"nofollow noopener\" shape=\"rect\">&#x79;&#x6d;&#x61;&#x74;&#x73;&#x75;&#x65;&#100;&#97;&#49;&#50;&#48;6&#64;de&#x6c;&#x74;&#x61;&#x2d;&#x66;&#x6c;&#x79;&#x70;&#104;&#97;&#114;&#109;&#97;&#46;co&#46;&#x6a;&#x70;<\/a><br \/><a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.delta-flypharma.co.jp%2Fen%2F&amp;esheet=53015578&amp;newsitemid=20221206006153&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.delta-flypharma.co.jp%2Fen%2F&amp;index=1&amp;md5=72ab372f1549409cd11abd83d5fabb8b\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.delta-flypharma.co.jp\/en\/<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>TOKUSHIMA, Japan&#8211;(BUSINESS WIRE)&#8211;Delta-Fly Pharma, Inc. announces that DFP-10917, a leading pipeline of the company, is granted Orphan Drug Designation (ODD) by US Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML). Be given to ODD, Delta-Fly Pharma, Inc. can be entitled to seven extra years of marketing exclusivity and receive some &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/delta-fly-pharma-inc-is-granted-orphan-drug-designation-by-us-food-and-drug-administration-for-dfp-10917\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-51651","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Delta-Fly Pharma, Inc. is granted Orphan Drug Designation by US Food and Drug Administration for DFP-10917 - Pharma Trend<\/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:\/\/pharma-trend.com\/en\/delta-fly-pharma-inc-is-granted-orphan-drug-designation-by-us-food-and-drug-administration-for-dfp-10917\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Delta-Fly Pharma, Inc. is granted Orphan Drug Designation by US Food and Drug Administration for DFP-10917 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"TOKUSHIMA, Japan&#8211;(BUSINESS WIRE)&#8211;Delta-Fly Pharma, Inc. announces that DFP-10917, a leading pipeline of the company, is granted Orphan Drug Designation (ODD) by US Food and Drug Administration (FDA) for the treatment of Acute Myeloid Leukemia (AML). Be given to ODD, Delta-Fly Pharma, Inc. can be entitled to seven extra years of marketing exclusivity and receive some ... 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