RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”) 是一家生物製藥公司，主要專注於開發並銷售胃腸疾病和炎症性疾病及癌症治療方面的處於後期臨床試驗階段的專有口服小分子藥物。該公司今日宣佈已經與美國食品藥品管理局（FDA）舉行了積極的B類會議，進而就RHB-105三期開發計劃的化學、製造和控制（CMC）方面展開了討論。RHB-105是一種用於消滅幽門螺旋桿菌感染的專有、固定計量口服藥物。
RHB-105用於幽門螺旋桿菌感染的驗證性三期研究預計將在2017年上半年啟動，此前公司將完成正在進行的支持性PK研究。在取決於成功結果情況下，驗證性三期研究和支持性PK研究預計將構成RHB-105美國新藥申請所需的組合包，包括臨床數據和CMC。
在最近的B型CMC會議之後且在取決於會議最終結果情況下，FDA已接受了RedHill提交CMC組合包的製造計劃，此舉是公司未來提交RHB-105美國新藥申請的一部分。
RHB-105的首項三期試驗成功的證實其在幽門螺旋桿菌感染方面的治療率高達89.4%，進而為RHB-105相對於當前標準護理（SoC）療法的潛在優異療效提供了支持。
根據GAIN法，RHB-105已獲得了FDA的QIDP認證，包括快速通道開發、新藥申請優先審查及美國市場排他性的擴大，這一授權的期限為8年。
隨著抗生素耐藥性和SoC療法的隨之而來失敗率，幽門螺旋桿菌已變成一種越來越重要的人類病原體。它是慢性胃炎、消化性潰瘍病、胃癌和粘膜相關淋巴組織淋巴瘤的主要發病因。
幽門螺旋桿菌感染預計會對全球超過一半的成年人產生影響。2015年全球和美國幽門螺旋桿菌根除治療方面的市場潛力估計分別約為48.3億美元和14.5億美元。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家總部位於以色列的新興生物醫藥公司，主要專注於開發幷銷售治療炎症性疾病和腸胃疾病以及癌症方面的處於後期臨床試驗階段的專有口服小分子藥。 公司目前的專有產品管線包括：(i) RHB-105 -治療幽門螺桿菌感染的口服混合藥，首個三期試驗獲得成功；(ii) RHB-104 -治療克羅恩病的口服混合藥，正在進行首個三期試驗以及治療多發性硬化症的二a期概念驗證試驗；(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司瓊口服藥片製劑，正在美國進行治療急性腸胃炎和慢性胃炎的三期試驗，以及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，靶向為多種腫瘤、炎症性和胃腸道適應症；(vi) MESUPRON® – 處於二期試驗階段的uPA抑制劑口服膠囊，是首創新藥，靶向為胃腸和其他實體瘤；(vii) RP101 – Hsp27抑制劑口服藥片，是處於二期試驗階段的首創新藥，靶向為胰腺癌和其他胃腸癌，RedHill擁有該藥物的收購選擇權；(viii) RIZAPORT™ (RHB-103) -利紮曲坦口服薄膜製劑，用於治療急性偏頭痛，正在與美國食品藥品監督管理局討論新藥申請，2015年10月獲准在德國上市；以及(ix) RHB-101 -心血管藥物卡維地洛日服一次的口服藥片製劑。
前瞻性陳述
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 establish and maintain corporate collaborations; (vi) 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; (vii) 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; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. 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 25, 2016. 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
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
業務發展和許可高級副總裁
The Trout Group
+1-646-378-2927
[email protected]
