RedHill Biopharma公布2017年年中业务最新进展
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。本公司今天公布了核心项目、潜在里程碑和预期大事件时间表方面的最新信息。
RedHill美国胃肠产品销售团队正在推广两款特色产品,为RedHill后期临床阶段的胃肠产品上市(如果获得批准)以及收购更多商业胃肠产品打下基础。
TALICIA™ (RHB-105) 幽门螺杆菌感染根除抗精核蛋白的验证性三期试验正在进行中。TALICIA™ 获得了美国食品药品监督管理局授予的合格感染疾病产品资格,可享受快速通道和优先审核待遇,有望使美国食品药品监督管理局的新药申请审核时间缩短。如果获得批准上市,所享受的市场独占权将在标准基础之上再延长五年。
获得数据安全监测委员会一致性积极建议之后,RHB-104治疗克罗恩病的MAP美国三期试验正在继续照计划进行。非盲三期延伸试验(MAP美国2试验)正在同步进行中。
继24毫克BEKINDA®治疗急性胃肠炎的三期试验取得积极结果之后,计划中的讨论上市许可潜在路径的美国食品药品监督管理局B类会议结果预计将在2017年10月公布。
12毫克BEKINDA®腹泻型肠易激综合征二期试验结果预计将在2017年9月发布。
根据美国食品药品监督管理局近期对RHB-104作为非结核性分枝杆菌感染一线疗法上市许可潜在路径给出的指导意见,RedHill计划在获得监管批准的条件下于2018年第一季度在美国启动RHB-104非结核分枝杆菌感染关键性三期试验。RHB-104已经获得美国食品药品监督管理局授予的治疗非结核分枝杆菌感染的合格感染疾病产品资格。
鉴于之前非临床试验所取得的令人鼓舞的结果,美国国立变态反应与传染病研究所安全委员会近期批准了评估RedHill 专有埃博拉病毒实验治疗药物的概念验证试验,预计将在2017年第四季度开始试验。
急性偏头痛药物RIZAPORT®预计将在2017年10月重新提交新药申请。
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®。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 46 32970 46 15231 0 0 1628 0 0:00:20 0:00:09 0:00:11 3253may 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.
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
adi@redhillbio.com
投资者关系联络人(美国):
Marcy Nanus
高级副总裁
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com
近期Redhill Biopharma 新闻稿
[2017-07-18] RedHill Biopharma宣布BEKINDA ® 腹泻型肠易激综合征二期 试验完成最后一名患者随访
[2017-07-13]RedHill Biopharma宣布数据安全监测委员会会议时间及RHB-104克罗恩病三期试验受试者招募最新信息
[2017-06-15] RedHill Biopharma宣布启动RHB-105 (TALICIA™)幽门螺杆菌感染验证性三期试验
[2017-06-14] RedHill Biopharma宣布BEKINDA® 急性胃肠炎三期试验取得成功[2017-06-13] RedHill Biopharma开始在美国推广Donnatal®和EnteraGam®
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