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。本公司今天公布已經和印度專業製藥公司ParaPRO LLC (“ParaPRO”)達成了商業化協議，授予RedHill在美國部分地區向腸胃科醫師推廣埃索美拉唑鍶緩釋膠囊的獨家權力。
49.3毫克埃索美拉唑鍶緩釋膠囊是獲得美國食品藥品監督管理局批准的專有處方質子泵抑制劑，適應症包括成人胃食管反流疾病以及其他胃腸疾病。
RedHill預計將在未來幾周啓動 49.3毫克埃索美拉唑鍶緩釋膠囊在美國的推廣工作。
49.3毫克埃索美拉唑鍶緩釋膠囊將是RedHill在美國推廣的第三款商業胃腸産品。
RedHill腸胃産品銷售團隊目前正在美國推廣兩款專業産品：Donnatal®和EnteraGam®，爲RedHill後期臨床階段的胃腸産品上市（如果獲得批准）打下基礎。
質子泵抑制劑是美國最常用的處方藥之一，據估測2016年這類藥物的市場價值超過了200億美元。
RedHill業務運營和市場准入副總裁Craig Miller稱：“RedHill在美國的商業運營總部設在北卡羅來納州羅利，由40名銷售代表組成的胃腸産品銷售團隊正在美國部分地區推廣Donnatal®[1]和EnteraGam®[2]。我們很高興將推廣第三款胃腸産品，以及爲患者帶來新的治療選擇。49.3毫克埃索美拉唑鍶緩釋膠囊將對RedHill迅速增長的美國專業胃腸産品商業組合起到補充作用。RedHill正在專業胃腸産品領域追求更多商業機會，以進一步擴大在美國的商業業務。我們很感謝新合作夥伴ParaPRO的信任與合作，幷期待本次合作將結出豐碩成果。”
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產品——治療腸易激綜合徵和急性小腸結腸炎的口服處方輔助藥物Donnatal®，以及用於醫生監督下慢性腹瀉和稀便飲食管理的醫療食品EnteraGam®，並且與ParaPRO簽署了49.3毫克埃索美拉唑鍶緩釋膠囊在美國商業化的協議。RedHill目前處于臨床階段的産品管綫包括： (i) TALICIA™ (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.
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。
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