RedHill Biopharma Ltd. (納斯達克： RDHL) (特拉維夫股票交易所：RDHL) (“RedHill” 或“公司”), 是一家專業生物製藥公司，主要專注于開發幷銷售胃腸疾病和炎症性疾病及癌症治療方面的處于後期臨床試驗階段的專有口服小分子藥物。本公司今天宣布美國食品藥品監督管理局已經授予YELIVA® (ABC294640)治療膽管癌的孤兒藥認證。
孤兒藥認證使得RedHill開發膽管癌藥物YELIVA® (ABC294640)的多項激勵措施，幷且産品獲批上市之後，將享有七年的市場獨占權。
YELIVA®治療晚期不可切除肝內和肝外膽管癌患者的二a期試驗計劃在2017年第三季度啓動。
膽管癌是一種高度致命性的惡性腫瘤，强烈需要更加高效的系統性治療。患者五年相對存活率在2%到30%之間，取决于腫瘤類型和診斷時的階段。
YELIVA®治療晚期實體瘤的一期試驗成功達到了主要和次要終點。參與一期試驗的三名膽管癌患者，其中一名獲得了持續部分應答，其他兩位病情穩定時間延長。
RedHill正在推進YELIVA®的多個一/二期臨床試驗，靶向爲多種腫瘤和炎症適應症，其中一些項目得到美國國家癌症研究所對Apogee Biotechnology和美國大學的撥款支持。
YELIVA®爲專有的首創口服鞘氨醇激酶-2（SK2）選擇性抑制劑，具有抗癌和抗炎症活性。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家總部位于以色列的專業生物醫藥公司，主要專注于開發幷銷售治療腸胃疾病和炎症性疾病以及癌症方面的處于後期臨床試驗階段的專有口服小分子藥。RedHill已與Concordia就Donnatal®簽署美國地區的聯合推廣協議，Donnatal®是一種用于治療腸易激綜合征和急性小腸結腸炎的處方口服輔助藥物。RedHill目前處于臨床階段的産品管綫包括：(i) RHB-105 -治療幽門螺杆菌感染的口服混合藥，首個三期試驗獲得成功；(ii) RHB-104 -治療克羅恩病的口服混合藥，正在進行首項三期試驗以及治療多發性硬化症的IIa期概念驗證試驗；(iii)BEKINDA™ (RHB-102) -日服一次的昂丹司瓊口服藥片製劑，正在美國進行治療急性腸胃炎和慢性胃炎的三期試驗，以及治療腹瀉型腸易激綜合征的二期試驗；(iv) RHB-106 -腸道準備藥物膠囊，已經授權給Salix Pharmaceuticals Ltd.；(v) YELIVA™ (ABC294640) -二期階段的口服SK2選擇性抑制劑，是首創新藥，靶向爲多種腫瘤、炎症性和胃腸道適應症；(vi) MESUPRON® -處于二期試驗階段的口服蛋白酶抑制劑，是首創新藥，靶向爲胃腸和其他實體瘤；(vii) RIZAPORT™ (RHB-103) -利扎曲坦口服薄膜製劑，用于治療急性偏頭痛，正在與美國食品藥品監督管理局討論新藥申請，2015年10月獲准在德國上市。欲瞭解與本公司有關的更多資訊，請訪問：www.redhillbio.com。
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
注：該新聞稿的唯一官方版本是本公司發布的英文原版稿件。本摘要和翻譯版本僅爲方便閱讀之目的。
公司聯絡人：
Adi Frish
業務發展和許可高級副總裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投資者關係聯絡人（美國）：
Marcy Nanus
高級副總裁
The Trout Group
+1-646-378-2927
[email protected]
