RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”) 是一家生物制药公司，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。该公司今日宣布已经与美国食品药品管理局（FDA）举行了积极的B类会议，进而就RHB-105三期开发计划的化学、制造和控制（CMC）方面展开了讨论。RHB-105是一种用于消灭幽门螺旋杆菌感染的专有、固定计量口服药物。
RHB-105用于幽门螺旋杆菌感染的验证性三期研究预计将在2017年上半年启动，此前公司将完成正在进行的支持性PK研究。在取决于成功结果情况下，验证性三期研究和支持性PK研究预计将构成RHB-105美国新药申请所需的组合包，包括临床数据和CMC。
在最近的B型CMC会议之后且在取决于会议最终结果情况下，FDA已接受了RedHill提交CMC组合包的制造计划，此举是公司未来提交RHB-105美国新药申请的一部分。
RHB-105的首项三期试验成功的证实其在幽门螺旋杆菌感染方面的治疗率高达89.4%，进而为RHB-105相对于当前标准护理（SoC）疗法的潜在优异疗效提供了支持。
根据GAIN法，RHB-105已获得了FDA的QIDP认证，包括快速通道开发、新药申请优先审查及美国市场排他性的扩大，这一授权的期限为8年。
随着抗生素耐药性和SoC疗法的随之而来失败率，幽门螺旋杆菌已变成一种越来越重要的人类病原体。它是慢性胃炎、消化性溃疡病、胃癌和粘膜相关淋巴组织淋巴瘤的主要发病因。
幽门螺旋杆菌感染预计会对全球超过一半的成年人产生影响。2015年全球和美国幽门螺旋杆菌根除治疗方面的市场潜力估计分别约为48.3亿美元和14.5亿美元。
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家总部位于以色列的新兴生物医药公司，主要专注于开发幷销售治疗炎症性疾病和肠胃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。 公司目前的专有产品管线包括：(i) 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；(ii) RHB-104 -治疗克罗恩病的口服混合药，正在进行首个三期试验以及治疗多发性硬化症的二a期概念验证试验；(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司琼口服药片制剂，正在美国进行治疗急性肠胃炎和慢性胃炎的三期试验，以及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uPA抑制剂口服胶囊，是首创新药，靶向为胃肠和其他实体瘤；(vii) RP101 – Hsp27抑制剂口服药片，是处于二期试验阶段的首创新药，靶向为胰腺癌和其他胃肠癌，RedHill拥有该药物的收购选择权；(viii) RIZAPORT™ (RHB-103) -利紮曲坦口服薄膜制剂，用于治疗急性偏头痛，正在与美国食品药品监督管理局讨论新药申请，2015年10月获准在德国上市；以及(ix) RHB-101 -心血管药物卡维地洛日服一次的口服药片制剂。
前瞻性陈述
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 establish and maintain corporate collaborations; (vi) 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; (vii) 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; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. 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 25, 2016. 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.
公司联络人：
Adi Frish
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
业务发展和许可高级副总裁
The Trout Group
+1-646-378-2927
[email protected]
