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。本公司宣布與Entera Health Inc 簽訂獨家授權協議，根據協議，RedHill將取得EnteraGam®[1]在美國市場的獨家授權。Entera Health 是一家私人持有的美國企業，專注于增值蛋白質和蛋白質副產品的研究、製造和商業化。
RedHill預計將在2017年年中在美國啟動兩款已經上市的胃腸特殊產品——Donnatal®和EnteraGam®的推廣工作。
根據協議，RedHill將依據銷售EnteraGam®所得凈銷售額向Entera Health支付權利金。
EnteraGam®是一款用於慢性腹瀉和稀便飲食管理的醫療食品，必須在醫生監督下服用。2016年EnteraGam®在美國的凈銷售額為500萬美元。
RedHill 首席商務官Guy Goldberg表示：“我們期待在2017年年中啟動Donnatal®[2]和EnteraGam®的推廣工作。RedHill目前正處在建立美國商業運營的後期階段，我們期待通過第二款瞄準腸胃病的上市產品來完善公司產品組合。我們要感謝新的合作夥伴Entera Health，並期待未來的長期合作。”
RedHill業務發展和許可高級副總裁Adi Frish稱：“我們的目標是在美國市場上成為一家專注于胃腸病的產生營收的特種藥公司，現在我們在實現這一戰略計劃上又邁出了重要一步。我們繼續尋求在特種腸胃藥領域的更多商業產品機會，從而進一步擴大商業運營。同時，我們繼續推進開發三個三期階段的腸胃藥，如果獲得美國FDA批准，我們計劃產品在美國上市。”
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd. (NASDAQ/TASE: 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已與Concordia就Donnatal®簽署美國地區的聯合推廣協議，Donnatal®是一種用于治療腸易激綜合征和急性小腸結腸炎的處方口服輔助藥物。RedHill目前處于臨床階段的産品管綫包括：(i) 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；(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以及治療多發性硬化症的IIa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，用于治療急性偏頭痛，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。欲了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®, (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：該新聞稿的唯一官方版本是本公司發布的英文原版稿件。本摘要和翻譯版本僅爲方便閱讀之目的。
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]
