以色列特拉維夫 / 北卡羅來納州羅利，2017年11月1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，主要專注於胃腸疾病和炎症性疾病及癌症治療方面、處於後期臨床試驗階段的專有口服小分子藥物的開發和商業化。本公司與領先的口服藥控釋公司IntelGenx Corp. (TSXV: IGX; OTCQX: IGXT)（“IntelGenx”）今天聯合宣布，已經向美國食品藥品監督管理局（FDA）重新提交10毫克RIZAPORT®的505 (b)(2)新藥申請。 IntelGenx主要專注於通過VersaFilm™專有技術平台來開發和製造創新藥物口服衣膜。
RIZAPORT®是專有的利扎曲坦口服薄膜製劑，用於治療急性偏頭痛。
如果提交的申請材料被認為完整并將接受全面審核，那麼預計美國FDA將確定2018年上半年的處方藥使用者費用法日期。
RIZAPORT®（5毫克和10毫克）已經通過歐洲分散審批程序在德國和盧森堡獲得上市許可，並已在西班牙提交全國上市許可申請。
RIZAPORT®已經在西班牙市場上與Grupo JUSTE S.A.Q.F.簽訂商業化協議，並在韓國市場與Pharmatronic Co. 簽訂了協議。
RedHill和IntelGenx繼續在與美國、歐洲和其他市場的潛在商業化合作夥伴進行討論。
RedHill高級研發副總裁Reza Fathi博士稱：“我們十分欣喜RIZAPORT®在美國重新提交新藥申請，在此之前RIZAPORT®已經通過歐洲分散審批程序在德國和盧森堡獲得上市許可。我們專注於通過合作夥伴實現近期RIZAPORT®在美國、歐洲和其他市場的商業化，並繼續在與潛在合作夥伴進行討論。”
“RIZAPORT®重新提交505(b)(2)新藥申請，對於IntelGenx來說是一個重要里程碑，” IntelGenx 總裁兼首席執行官Horst G. Zerbe 博士說道，“我們期待繼續與FDA合作，尋求推動這一治療偏頭痛患者的新藥物上市。”
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd(納斯達克：RDHL)(特拉維夫股票交易所：RDHL)是一家總部位於以色列的專業生物醫藥公司，主要專注於腸胃疾病和炎症性疾病以及癌症方面後期臨床試驗階段的專有口服小分子藥的開發和商業化。 RedHill在美國推廣三款胃腸產品——腸易激綜合徵和急性小腸結腸炎口服處方輔助藥物Donnatal®，成人胃食管反流疾病和其他胃腸疾病的質子泵抑製劑—49.3毫克埃索美拉唑鍶遲釋膠囊，以及醫生監督下慢性腹瀉和稀便飲食管理的醫療食品EnteraGam®。 RedHill目前處於臨床階段的產品管線包括：(i)TALICIA™(RHB—105)—幽門螺桿菌感染口服混合藥，首項三期試驗獲得成功，正在進行驗證性三期試驗；(ii)RHB— 104—克羅恩病口服混合藥，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期試驗並計劃進行治療非結核性分枝桿菌感染的關鍵性三期試驗；( 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，腹瀉型腸易激綜合徵二期試驗取得成功結果；( 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，靶向為胰腺癌和炎症性胃腸疾病；(vii)RIZAPORT® (RHB —103)-利扎曲坦口服薄膜製劑，治療急性偏頭痛，已經向美國食品藥品監督管理局重新提交新藥申請，並已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 |
