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和印度专业制药公司ParaPRO LLC (“ParaPRO”)达成了商业化协议，授予RedHill在美国部分地区向肠胃科医师推广埃索美拉唑锶缓释胶囊的独家权力。
49.3毫克埃索美拉唑锶缓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，适应症包括成人胃食管反流疾病以及其他胃肠疾病。
RedHill预计将在未来几周启动 49.3毫克埃索美拉唑锶缓释胶囊在美国的推广工作。
49.3毫克埃索美拉唑锶缓释胶囊将是RedHill在美国推广的第三款商业胃肠产品。
RedHill肠胃产品销售团队目前正在美国推广两款专业产品：Donnatal®和EnteraGam®，为RedHill后期临床阶段的胃肠产品上市（如果获得批准）打下基础。
质子泵抑制剂是美国最常用的处方药之一，据估测2016年这类药物的市场价值超过了200亿美元。
RedHill业务运营和市场准入副总裁Craig Miller称：“RedHill在美国的商业运营总部设在北卡罗来纳州罗利，由40名销售代表组成的胃肠产品销售团队正在美国部分地区推广Donnatal®[1]和EnteraGam®[2]。我们很高兴将推广第三款胃肠产品，以及为患者带来新的治疗选择。49.3毫克埃索美拉唑锶缓释胶囊将对RedHill迅速增长的美国专业胃肠产品商业组合起到补充作用。RedHill正在专业胃肠产品领域追求更多商业机会，以进一步扩大在美国的商业业务。我们很感谢新合作伙伴ParaPRO的信任与合作，幷期待本次合作将结出丰硕成果。”
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®，并且与ParaPRO签署了49.3毫克埃索美拉唑锶缓释胶囊在美国商业化的协议。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) 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。
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公司联络人： |
投资者关系联络人（美国）： +1-646-378-2927 |
[1] Donnatal® （苯巴比妥、硫酸莨菪碱、硫酸阿托品、氢溴酸东莨菪碱）是一种处方药，归类为肠易激综合征（激惹性结肠、痉挛性结肠、粘液性结肠炎）和急性小肠结肠炎潜在有效联合治疗药物。欲了解更多信息，请查看开药信息： http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.
[2] EnteraGam®（血清源性牛免疫球蛋白/ 蛋白分离物）是一款已经上市的医疗食品，用于在医生监督下进行肠道失调引起的慢性腹泻和稀便饮食管理。
