以色列特拉维夫/北卡罗来纳州罗利，2017年9月13日 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，主要专注于开发幷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。本公司今天公布已经启动49.3毫克埃索美拉唑锶迟释胶囊在美国市场的推广活动。
49.3毫克埃索美拉唑锶迟释胶囊是获得美国食品药品监督管理局批准的专有处方质子泵抑制剂，适应症为成人胃食管反流疾病和其他胃肠疾病。
质子泵抑制剂是美国最常用的处方药之一，2016年估测市场价值超过200亿美元。
RedHill专注于胃肠的销售团队总部设在北卡罗来纳州罗利，正在美国推广三款胃肠特色产品：Donnatal®、EnteraGam®和49.3毫克埃索美拉唑锶迟释胶囊。
RedHill美国市场销售和营销副总裁Valerie Graceffa称：“我们很兴奋启动第三款胃肠特色产品的推广活动。所选择的49.3毫克埃索美拉唑锶迟释胶囊完美契合RedHill不断壮大胃肠特色产品组合的战略，自2017年6月以来我们的销售团队一直在美国积极推广这些胃肠特色药。我们的销售团队已经经过良好训练，期待与胃肠病学家讨论这些新产品并为患者提供更多治疗选择。”
RedHill Biopharma Ltd.简介：
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，主要专注于开发幷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在美国推广三款胃肠产品——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®，用于医生监督下慢性腹泻和稀便饮食管理的医疗食品EnteraGam®，以及适应症为成人胃食管反流病和其他胃肠疾病的处方质子泵抑制剂——49.3毫克埃索美拉唑锶迟释胶囊。RedHill目前处于临床阶段的产品管线包括： (i) TALICIA™ (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概念验证IIa期试验幷计划进行治疗非结核性分枝杆菌感染的三期试验；(iii)BEKINDA® (RHB-102) -日服一次的昂丹司琼口服片剂，急性肠胃炎和慢性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) the Company’s Expanded Access Program, which allows patients with life-threatening diseases potential access, subject to regulatory and other approvals, to RedHill’s investigational new drugs that have not yet received regulatory marketing approval, if a patient suffers an adverse experience using such investigative drug, potentially adversely affecting the clinical development program of that investigational product or the Company generally; (xiv) 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 |
