RedHill Biopharma Ltd. (納斯達克：RDHL) (特拉維夫股票交易所：RDHL) (“RedHill”或“公司”) 是一家專業生物製藥公司，主要專注于開發幷銷售胃腸疾病和炎症性疾病及癌症治療方面的處于後期臨床試驗階段的專有口服小分子藥物。本公司今天公布了核心項目、潜在里程碑和預期大事件時間表方面的最新信息。
RedHill美國胃腸産品銷售團隊正在推廣兩款特色産品，爲RedHill後期臨床階段的胃腸産品上市（如果獲得批准）以及收購更多商業胃腸産品打下基礎。
TALICIA™ (RHB-105) 幽門螺杆菌感染根除抗精核蛋白的驗證性三期試驗正在進行中。TALICIA™ 獲得了美國食品藥品監督管理局授予的合格感染疾病産品資格，可享受快速通道和優先審核待遇，有望使美國食品藥品監督管理局的新藥申請審核時間縮短。如果獲得批准上市，所享受的市場獨占權將在標準基礎之上再延長五年。
獲得數據安全監測委員會一致性積極建議之後，RHB-104治療克羅恩病的MAP美國三期試驗正在繼續照計劃進行。非盲三期延伸試驗（MAP美國2試驗）正在同步進行中。
繼24毫克BEKINDA®治療急性胃腸炎的三期試驗取得積極結果之後，計劃中的討論上市許可潜在路徑的美國食品藥品監督管理局B類會議結果預計將在2017年10月公布。
12毫克BEKINDA®腹瀉型腸易激綜合征二期試驗結果預計將在2017年9月發布。
根據美國食品藥品監督管理局近期對RHB-104作爲非結核性分枝杆菌感染一綫療法上市許可潜在路徑給出的指導意見，RedHill計劃在獲得監管批准的條件下于2018年第一季度在美國啓動RHB-104非結核分枝杆菌感染關鍵性三期試驗。RHB-104已經獲得美國食品藥品監督管理局授予的治療非結核分枝杆菌感染的合格感染疾病産品資格。
鑒于之前非臨床試驗所取得的令人鼓舞的結果，美國國立變態反應與傳染病研究所安全委員會近期批准了評估RedHill 專有埃博拉病毒實驗治療藥物的概念驗證試驗，預計將在2017年第四季度開始試驗。
急性偏頭痛藥物RIZAPORT®預計將在2017年10月重新提交新藥申請。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd (納斯達克：RDHL) (特拉維夫股票交易所：RDHL)是一家總部位于以色列的專業生物醫藥公司，主要專注于開發幷銷售治療腸胃疾病和炎症性疾病以及癌症方面的處于後期臨床試驗階段的專有口服小分子藥。RedHill在美國推廣兩款胃腸産品——治療腸易激綜合征和急性小腸結腸炎的口服處方輔助藥物Donnatal®，以及用于醫生監督下慢性腹瀉和稀便飲食管理的醫療食品EnteraGam®。RedHill目前處于臨床階段的産品管綫包括： (i) TALICIATM (RHB-105) -治療幽門螺杆菌感染的口服混合藥，首個三期試驗獲得成功，正在進行驗證性三期試驗；(ii) RHB-104 -治療克羅恩病的口服混合藥，正在進行首項三期試驗，已經完成治療多發性硬化症的IIa期試驗幷計劃進行治療非結核性分枝杆菌感染的三期試驗；(iii)BEKINDA@ (RHB-102) -日服一次的昂丹司瓊口服藥片製劑，急性腸胃炎和胃炎三期試驗取得成功結果，正在進行治療腹瀉型腸易激綜合征的二期試驗；(iv) RHB-106 -腸道準備藥物膠囊，已經授權給Salix Pharmaceuticals Ltd.；(v) YELIVA@ (ABC294640) -二期階段的口服SK2選擇性抑制劑，是首創新藥，靶向爲多種腫瘤、炎症性和胃腸道適應症； (vi) MESUPRON -處于二期試驗階段的口服蛋白酶抑制劑，是首創新藥，靶向爲胃腸和其他實體瘤；(vii) RIZAPORT@ (RHB-103) -利扎曲坦口服薄膜製劑，治療急性偏頭痛，正在與美國食品藥品監督管理局討論新藥申請，通過歐洲分散審批程序在兩個歐盟國家獲得上市許可。欲瞭解與本公司有關的更多資訊，請訪問：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.
公司聯絡人：
Adi Frish
業務發展和許可高級副總裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投資者關係聯絡人（美國）：
Marcy Nanus
高級副總裁
The Trout Group
+1-646-378-2927
[email protected]
