以色列特拉維夫/ 北卡羅來納州羅利，2017年11月9日 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，主要致力於專有胃腸疾病、炎症性疾病和癌症藥物的後期臨床開發和商業化。本公司今天宣布RHB-104治療克羅恩病的三期試驗（MAP美國試驗）最後一名患者已入組。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd (納斯達克：RDHL)(特拉維夫股票交易所：RDHL)是一家專業生物醫藥公司，主要專注於腸胃疾病和炎症性疾病以及癌症方面後期臨床試驗階段的專有口服小分子藥的開發和商業化。 RedHill在美國推廣三款胃腸產品，其臨床階段的產品管線包括胃腸適應症、胰腺癌和急性偏頭痛藥物：Donnatal®—腸易激綜合徵和急性小腸結腸炎口服處方輔助藥物；49.3毫克埃索美拉唑鍶遲釋膠囊—成人胃食管反流疾病和其他胃腸疾病的質子泵抑製劑；以及EnteraGam®—醫生監督下慢性腹瀉和稀便飲食管理的醫療食品。 RedHill目前處於臨床階段的產品管線包括：(i)TALICIA™(RHB—105)—幽門螺桿菌感染口服混合藥，首項三期試驗獲得成功，正在進行驗證性三期試驗；(ii)RHB— 104—克羅恩病口服混合藥，正在進行首項三期試驗，已經完成治療多發性硬化症的概念驗證IIa期試驗幷計劃進行治療非結核性分枝桿菌感染的關鍵性三期試驗；( iii)BEKINDA®(RHB—102)—日服一次的昂丹司瓊口服片劑，急性腸胃炎和慢性胃炎三期試驗取得成功結果，腹瀉型腸易激綜合徵二期試驗取得成功結果；( 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選擇性抑製劑，是首創新藥，靶向為多種腫瘤、炎症性和胃腸道適應症；(vi)MESUPRON—處於二期試驗階段的口服蛋白酶抑製劑，是首創新藥，靶向為胰腺癌和炎症性胃腸疾病；(vii)RIZAPORT® (RHB —103)—利扎曲坦口服薄膜製劑，治療急性偏頭痛，已經向美國食品藥品監督管理局重新提交新藥申請，並已通過歐洲分散審批程序在兩個歐盟國家獲得上市許可。
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® and EnteraGam®; (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 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; (xii) estimates of the Company’s expenses, future revenues capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other 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. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise, 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供方便閱讀之目的。
| 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 |
投資者關係聯絡人（美國）：
Marcy Nanus 高級副總裁
The Trout Group +1-646-378-2927 |
