Redhill Biopharma Ltd (NASDAQ:RDHL) 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。本公司宣布通過胃腸方面銷售團隊開始在美國推廣兩款胃腸類專業産品——Donnatal® (苯巴比妥、 硫酸莨菪碱、硫酸阿托品、氫溴酸東莨菪碱)[1] 和EnteraGam® (從血清中提取的牛免疫球蛋白/血清蛋白)[2]。
RedHill在美國的商業運營總部設在北卡羅來納州羅利，包括由30多名銷售代表組成的胃腸方面銷售團隊。
RedHill首席商務官Guy Goldberg稱：“我們很激動啓動Donnatal®和EnteraGam®在美國的推廣工作。這一戰略步驟標志著RedHill轉型成爲美國市場上一家産生營收的專注于胃腸藥的專業醫藥公司。RedHill已經組建經驗豐富的銷售力量，幷在商業總部辦公室配備胃腸領域有著成功經驗的人員。我們期待服務患者需求，幷以Donnatal®和EnteraGam®的更大市場潜力爲目標。我們在美國的商業運營是RedHill專有後期階段胃腸産品——腸胃炎和腹瀉型腸易激綜合征藥物BEKINDA® (RHB-102)[3]、幽門螺杆菌感染藥物RHB-105以及克羅恩病藥物RHB-104在美國商業化戰略計劃中不可或缺的一部分，前提是這些藥物獲得美國食品藥品監督管理局批准。”
Donnatal®是口服處方藥，用于與其他藥物聯合治療腸易激綜合征（大腸敏感、結腸痙攣、粘液性結腸炎）和急性小腸結腸炎。RedHill與Concordia International Corp. (NASDAQ: CXRX) (TSX: CXR) 子公司Concordia Pharmaceuticals Inc簽訂了獨家聯合推廣協議，將Donnatal®在美國市場的部分推廣權授權給RedHill。根據協議，RedHill推廣Donnatal®所帶來的收入將由RedHill和Concordia將按照約定比例分享。
EnteraGam®是一款醫療食品，用于慢性腹瀉和稀便的飲食管理，必須在醫生監督下服用。RedHill與 Entera Health Inc. (“Entera Health”)簽訂了授權許可協議，幷取得了EnteraGam®在美國市場的獨家授權。根據協議，RedHill將依據銷售EnteraGam®所得淨銷售額向Entera Health 支付特許權使用費。
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) 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) 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]
