*DJ Elbit Imaging Announces That Gamida Cell Receives Orphan Drug Designation From the Fda for Nicord(R) as a Treatment for Hematopoietic Stem Cell Transplantation
*DJ Elbit Imaging Announces That Gamida Cell Receives Orphan Drug Designation From the Fda for Nicord(R) as a Treatment for Hematopoietic Stem Cell Transplantation
Press Release: Elbit Imaging Announces That Gamida Cell Receives Orphan Drug Designation From the Fda for Nicord(R) as a Treatment for Hematopoietic Stem Cell Transplantation
新聞稿：埃爾比特成像公司宣佈Gamida細胞公司獲得FDA的孤兒藥物稱號，用於治療造血幹細胞移植的NiCord(R)
Elbit Imaging Announces That Gamida Cell Receives Orphan Drug Designation From the Fda for Nicord(R) as a Treatment for Hematopoietic Stem Cell Transplantation
埃爾比特成像公司宣佈，Gamida Cell公司獲得美國食品和藥物管理局指定的用於治療造血幹細胞移植的孤兒藥物NiCord(R)
Tel Aviv, Israel, July 17, 2018 (GLOBE NEWSWIRE) -- Elbit Imaging Ltd. ("EI" or the "Company") (TASE, NASDAQ: EMITF) announced today that Gamida Cell Ltd. ("Gamida"), an indirect shareholding of the Company, informed that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for NiCord as a treatment for hematopoietic stem cell transplantation (HSCT). Gamida was previously granted orphan drug designation for NiCord by the FDA as a treatment for several hematologic malignancies.
以色列特拉維夫，2018年7月17日(Global Newswire)--Elbit Image Ltd.(以下簡稱“EI”或“公司”)(TASE，NASDAQ：EMITF)今天宣佈，該公司的間接持股公司Gamida Cell Ltd.(簡稱“Gamida”)通知稱，美國食品和藥物管理局(FDA)已批准NiCord作為造血幹細胞移植(HSCT)的孤兒藥物。Gamida之前被FDA批准為NiCord的孤兒藥物，用於治療幾種血液惡性腫瘤。
Orphan drug status is granted to a drug that has an advantage over existing treatments of rare diseases, in order to facilitate drug development. Orphan drug status grants up to seven years of market exclusivity upon regulatory product approval and may provide benefits in obtaining grants and financial exemptions during the development and registration of the drug for marketing.
孤兒藥物地位被授予比現有治療罕見疾病的藥物更具優勢的藥物，以促進藥物開發。孤兒藥物地位在獲得監管產品批准後，可獲得長達七年的市場獨佔權，並可在藥物開發和註冊上市期間獲得贈款和財務豁免方面的好處。
It should be noted that as of this date, Gamida's products development stage has not been completed yet and there is no certainty that they will be marketed on a commercial basis.
應該指出的是，到目前為止，Gamida的產品開發階段還沒有完成，還不能確定它們是否會在商業基礎上上市。
The Company holds approximately 89% of the share capital of Elbit Medical Technologies Ltd. (TASE: EMTC-M) (approximately 58% on a fully diluted basis) which, in turn, holds approximately 18% of the share capital in Gamida (approximately 13% on a fully diluted basis).
該公司持有Elbit Medical Technologies Ltd.(多倫多證券交易所市場代碼：EMTC-M)約89%的股本(在完全稀釋基礎上約為58%)，而後者又持有Gamida公司約18%的股本(在完全稀釋基礎上約為13%)。
For Further Information:
欲瞭解更多信息，請訪問：
Company Contact
公司聯繫
Ron Hadassi
羅恩·哈達西
Chief Executive Officer and Chairman of the Board of Directors
首席執行官兼董事會主席
Tel: +972-3-608-6048
電話：+972-3-608-6048
Fax: +972-3-608-6050
傳真：+972-3-608-6050
ron@elbitimaging.com
郵箱：ron@elbitimaging.com
(END) Dow Jones Newswires
(完)道瓊通訊社
July 17, 2018 08:42 ET (12:42 GMT)
2018年7月17日東部時間08：42(格林尼治標準時間12：42)
*DJ Elbit Imaging Announces That Gamida Cell Receives Orphan Drug Designation From the Fda for Nicord(R) as a Treatment for Hematopoietic Stem Cell Transplantation
*DJ Elbit成像公司宣佈，Gamida Cell獲得FDA的孤兒藥物稱號，用於NiCord(R)作為造血幹細胞移植的治療
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July 17, 2018 08:42 ET (12:42 GMT)
2018年7月17日東部時間08：42(格林尼治標準時間12：42)
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