以色列特拉維夫/北卡羅來納州羅利 – 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，主要專注於開發並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。本公司今天披露了截至2017 年6月30日的第二季度財務結果。
截至2017年第二季度末，RedHill資產負債表上現金[1]達到$5100萬，零債務。
[1] 包括現金及短期投資部分近期里程碑包括：
• RedHill專注於胃腸的兩款特殊產品Donnatal®和EnteraGam®在美國開始推廣活動之後，6月12日至30日期間實現初步淨收入約$50萬元
• 24毫克BEKINDA® (RHB-102)急性胃腸炎和慢性胃炎三期GUARD試驗取得積極結果
• 啟動TALICIA™ (RHB-105) 幽門螺桿菌感染驗證性三期試驗
• 12毫克BEKINDA®腹瀉型腸易激綜合徵二期試驗最後一名患者出組
• 膽管癌藥物YELIVA® (ABC294640)獲得孤兒藥認證
2017年下半年預計將實現的潛在里程碑：
• RHB-104克羅恩病首個三期試驗第二次獨立數據安全監測委員會會議，包括中期療效分析，以及評估因為成功的驚人效果提前結束試驗的方案。數據安全監測委員會建議預計將在2017年8月初發布
• 12毫克BEKINDA®腹瀉型腸易激綜合徵結果預計將在2017年9月發布
• 預計將在2017年10月舉行有關成功的24毫克BEKINDA 三期GUARD試驗的B類美國食品藥品監督管理局會議
• 啟動YELIVA®膽管癌、頭頸癌黏膜炎和潰瘍性結腸炎多個一B和二期試驗，以及MESUPRON胰腺癌試驗
• 預計將在2017年10月重新向美國食品藥品監督管理局提交RIZAPORT®的新藥申請
RedHill首席執行官Micha Ben Chorin說道：“我們對第二季度期間實現的重要里程碑感到滿意，包括24毫克BEKINDA®急性胃腸炎三期GUARD試驗取得積極結果，啟動TALICIA™幽門螺桿菌感染驗證性三期試驗，專注於胃腸道的銷售團隊啟動Donnatal®和EnteraGam®在美國的推廣活動並單單在6月下半月便取得了令人鼓舞的約$50萬初步淨收入。截至第二季度末現金頭寸$5100萬，使我們能夠繼續執行戰略計劃，積極推進後期臨床項目，以及進一步收購在美國的商業胃腸產品。”
電話會議和網絡播放信息：
公司週二（2017年7月25日）召開電話會議來查看財務結果和業務亮點。可以在公司網站http://ir.redhillbio.com/events.cfm重聽電話會議，重聽有效期30天。
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，主要專注於開發並銷售治療腸胃疾病和炎症性疾病以及癌症方面的處於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®。 RedHill目前處於臨床階段的產品管線包括： (i) TALICIATM (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IIa期試驗並獲得非結核性分枝桿菌感染的合格感染疾病產品資格；(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徵的二期試驗；(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，靶向為胃腸和其他實體瘤；(vii) RIZAPORT@ (RHB-103) -利扎曲坦口薄膜製劑，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]
