以色列特拉維夫/北卡羅來納州羅利，2017年9月13日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，主要專注於開發幷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。本公司今天公佈已經啟動49.3毫克埃索美拉唑鍶遲釋膠囊在美國市場的推廣活動。
49.3毫克埃索美拉唑鍶遲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製劑，適應症為成人胃食管反流疾病和其他胃腸疾病。
質子泵抑製劑是美國最常用的處方藥之一，2016年估測市場價值超過200億美元。
紅山專注於胃腸的銷售團隊總部設在北卡羅來納州羅利，正在美國推廣三款胃腸特色產品：Donnatal®，EnteraGam®和49.3毫克埃索美拉唑鍶遲釋膠囊。
RedHill美國市場銷售和營銷副總裁Valerie Graceffa稱：“我們很興奮啟動第三款胃腸特色產品的推廣活動。所選擇的49.3毫克埃索美拉唑鍶緩釋膠囊完美契合RedHill不斷壯大胃腸特色產品組合的戰略，自2017年6月以來我們的銷售團隊一直在美國積極推廣這些胃腸特色藥。我們的銷售團隊已經經過良好訓練，期待與胃腸病學家討論這些新產品並為患者提供更多治療選擇。“
RedHill Biopharma Ltd.簡介：
RedHill Biopharma Ltd（納斯達克：RDHL）（特拉維夫股票交易所：RDHL）是一家總部位於以色列的專業生物醫藥公司，主要專注於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理後期臨床試驗階段的專有口服小分子藥.RedHill在美國推廣三款胃腸產品 – 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®，用於醫生監督下慢性腹瀉和稀便飲食管理的醫療食品EnteraGam®，以及適應症為成人胃食管反流病和其他胃腸疾病的處方質子泵抑製劑–49.3毫克埃索美拉唑鍶遲釋膠囊。RedHill目前處於臨床階段的產品管線包括：（i）TALICIA™（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，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概念驗證IIA期試驗幷計進行治療非結核性分枝桿菌感染的三期試驗;（iii）BEKINDA®（RHB-102） – 日服一次的昂丹司瓊口服片劑，急性腸胃炎和慢性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徵的二期試驗;（iv）RHB-106 – 腸道準備藥物膠囊，已經授權給Salix Pharmaceuticals有限公司;（v）YELIVA®（ABC294640） – 二期階段的口服SK2選擇性抑製劑，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口服蛋白酶抑製劑，是首創新藥，靶向為腸和其他實體瘤;（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® 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為方便閱讀之目的。
| 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 |
投資者關係聯絡人(美國):
Marcy Nanus 高級副總裁 The Trout Group +1-646-378-2927 |
