Redhill Biopharma Ltd (NASDAQ:RDHL) 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。本公司宣布通过胃肠方面销售团队开始在美国推广两款胃肠类专业产品——Donnatal® (苯巴比妥、 硫酸莨菪碱、硫酸阿托品、氢溴酸东莨菪碱)[1] 和EnteraGam® (从血清中提取的牛免疫球蛋白/血清蛋白)[2]。
RedHill在美国的商业运营总部设在北卡罗来纳州罗利，包括由30多名销售代表组成的胃肠方面销售团队。
RedHill首席商务官Guy Goldberg称：“我们很激动启动Donnatal®和EnteraGam®在美国的推广工作。这一战略步骤标志着RedHill转型成为美国市场上一家产生营收的专注于胃肠药的专业医药公司。RedHill已经组建经验丰富的销售力量，幷在商业总部办公室配备胃肠领域有着成功经验的人员。我们期待服务患者需求，幷以Donnatal®和EnteraGam®的更大市场潜力为目标。我们在美国的商业运营是RedHill专有后期阶段胃肠产品——肠胃炎和腹泻型肠易激综合征药物BEKINDA® (RHB-102)[3]、幽门螺杆菌感染药物RHB-105以及克罗恩病药物RHB-104在美国商业化战略计划中不可或缺的一部分，前提是这些药物获得美国食品药品监督管理局批准。”
Donnatal®是口服处方药，用于与其他药物联合治疗肠易激综合征（大肠敏感、结肠痉挛、粘液性结肠炎）和急性小肠结肠炎。RedHill与Concordia International Corp. (NASDAQ: CXRX) (TSX: CXR) 子公司Concordia Pharmaceuticals Inc签订了独家联合推广协议，将Donnatal®在美国市场的部分推广权授权给RedHill。根据协议，RedHill推广Donnatal®所带来的收入将由RedHill和Concordia将按照约定比例分享。
EnteraGam®是一款医疗食品，用于慢性腹泻和稀便的饮食管理，必须在医生监督下服用。RedHill与 Entera Health Inc. (“Entera Health”)签订了授权许可协议，幷取得了EnteraGam®在美国市场的独家授权。根据协议，RedHill将依据销售EnteraGam®所得净销售额向Entera Health 支付特许权使用费。
RedHill Biopharma Ltd介绍：
RedHill Biopharma Ltd. (NASDAQ/TASE: 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®。RedHill目前处于临床阶段的产品管线包括：(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，正在进行首项三期试验以及治疗多发性硬化症的IIa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，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。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。
Company contact:
Adi Frish
Senior VP Business Development & Licensing
RedHill Biopharma
+972-54-6543-112
[email protected]
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
[email protected]
