RedHill Biopharma Ltd. (纳斯达克:RDHL) (特拉维夫股票交易所:RDHL) (“RedHill”或“公司”) 是一家专业生物制药公司，主要专注于开发并销售胃肠疾病和炎症性疾病及癌症治疗方面的处于后期临床试验阶段的专有口服小分子药物。本公司今天宣布RHB-105（新商标名称TALICIA™）启动治疗幽门螺杆菌感染的炎症性三期试验（根除幽门螺杆菌试验2）。
TALICIA™ (RHB-105)是由两种抗生素和一种质子泵抑制剂混合而成的专有固定剂量口服一体化胶囊，用于根除幽门螺杆菌感染。
验证性三期试验预计将完成RHB-105（新商标名称TALICIA™）在美国提交新药申请所需的条件，但仍取决于取得成功结果以及监管机构进一步的反馈。
本次双臂随机双盲活性药物对照组验证性三期试验将在美国65个临床基地展开，计划招募444名未接受研究、确诊幽门螺杆菌的消化不良患者，主要终点是在发起治疗后42天到70天期间根除幽门螺杆菌感染。
TALICIA™ (RHB-105)首个三期试验（根除幽门螺杆菌试验）显示幽门螺杆菌感染根治率达到89.4%（p<0.001），证明相比目前的标准治疗药物TALICIA™ (RHB-105)在疗效上具有潜在优势。
TALICIA™ (RHB-105)获得了美国食品药品监督管理局根据抗生素研发激励法案授予的合格感染疾病产品资格，享受开速通道开发，新药申请优先审核，以及美国市场独占权延长至8年等优惠。
幽门螺杆菌感染是慢性胃炎、消化性溃疡、胃癌和黏膜相关的淋巴组织淋巴瘤的主要原因。据估测，全球一半以上的成人都伴有幽门螺杆菌感染。
世界卫生组织近期发布了全球12种威胁生命的抗多种药物高优先级细菌列表，其中幽门螺杆菌感染被列入第二组高优先级细菌，亟需新的治疗药物。
按照目前的原研药价格水平，2015年全球和美国幽门螺杆菌根治药物潜在市场规模分别约48.3亿美元和14.5亿美元。
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd (纳斯达克：RDHL) (特拉维夫股票交易所：RDHL)是一家总部位于以色列的专业生物医药公司，主要专注于开发并销售治疗肠胃疾病和炎症性疾病以及癌症方面的处于后期临床试验阶段的专有口服小分子药。RedHill在美国推广两款胃肠产品——治疗肠易激综合征和急性小肠结肠炎的口服处方辅助药物Donnatal®，以及用于医生监督下慢性腹泻和稀便饮食管理的医疗食品EnteraGam®。RedHill目前处于临床阶段的产品管线包括： (i) TALICIATM (RHB-105) -治疗幽门螺杆菌感染的口服混合药，首个三期试验获得成功，正在进行验证性三期试验；(ii) RHB-104 -治疗克罗恩病的口服混合药，正在进行首项三期试验，已经完成治疗多发性硬化症的IIa期试验并获得非结核性分枝杆菌感染的合格感染疾病产品资格；(iii)BEKINDA@ (RHB-102) -日服一次的昂丹司琼口服药片制剂，急性肠胃炎和胃炎三期试验取得成功结果，正在进行治疗腹泻型肠易激综合征的二期试验；(iv) RHB-106 -肠道准备药物胶囊，已经授权给Salix Pharmaceuticals Ltd.；(v) YELIVA@ (ABC294640) -二期阶段的口服SK2选择性抑制剂，是首创新药，靶向为多种肿瘤、炎症性和胃肠道适应症； (vi) MESUPRON -处于二期试验阶段的口服蛋白酶抑制剂，是首创新药，靶向为胃肠和其他实体瘤；(vii) RIZAPORT@ (RHB-103) -利扎曲坦口服薄膜制剂，治疗急性偏头痛，正在与美国食品药品监督管理局讨论新药申请，通过欧洲分散审批程序在两个欧盟国家获得上市许可。欲了解与本公司有关的更多资讯，请访问：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® 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 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：该新闻稿的唯一官方版本是本公司发布的英文原版稿件。本摘要和翻译版本仅为方便阅读之目的。
公司联络人
Adi Frish
业务发展和许可高级副总裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投资者关系联络人 （美国）
Marcy Nanus
高级副总裁
The Trout Group
+1-646-378-2927
[email protected]
