RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) 是一家生物製藥公司，主要專注於開發並銷售炎症性疾病和胃腸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，該公司連同加拿大專注於口服給藥的藥物遞送公司IntelGenx Corp.今日宣佈與Grupo JUSTE S.A.Q.F （Grupo JUSTE）簽署獨家許可協議，該協議涉及RIZAPORT在西班牙地區的商業化以及在其他地區的優先購買權。RIZAPORT是一種用於治療急性偏頭痛的專有利紮曲普坦口服薄膜配方。
Grupo JUSTE是西班牙一家有名的私營企業，擁有超過90年的專有醫藥產品研發和商業化經驗，包括在歐洲、拉丁美洲和其他地區銷售的用於治療偏頭痛和其他中樞神經系統疾病的藥物。
按照協議條款，RedHill向Grupo JUSTE授予了可在西班牙地區登記並商業化RIZAPORT的獨家權益以及預定期限內該產品在伯利茲、加勒比海、智利、哥倫比亞、哥斯達黎加、多明尼加共和國、薩爾瓦多、危地馬拉、洪都拉斯、墨西哥、尼加拉瓜、巴拿馬、中東和摩洛哥地區的優先購買權。
RedHill和IntelGenx有權收取一定的預付款和額外的里程碑付款（取決於某些預定監管和商業目標的實現）以及分級權利金。該協議的財務條款尚未披露。該協議的初始期限為從首次商業銷售之日開始算起的10年時間，且將自動續約另外兩年時間。該藥在西班牙地區的商業化推出預計將在2017年下半年發生。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家總部位於以色列的新興生物醫藥公司，主要專注於開發幷銷售治療炎症性疾病和腸胃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。 公司目前的產品管線包括：(i) 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；(ii) RHB-104 -治療克羅恩病的口服混合藥，正在進行首個三期試驗以及治療多發性硬化症的二a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uPA抑制劑口服膠囊，是首創新藥，靶向為胃腸和其他實體瘤；(vii) RP101 – Hsp27抑制劑口服藥片，是處於二期試驗階段的首創新藥，靶向為胰腺癌和其他胃腸癌，RedHill擁有該藥物的收購選擇權；(viii) RIZAPORT™ (RHB-103) -利紮曲坦口服薄膜製劑，用於治療急性偏頭痛，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；以及(ix) RHB-101 -心血管藥物卡維地洛日服一次的口服藥片製劑。
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 establish and maintain corporate collaborations; (vi) 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; (vii) 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; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. 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 25, 2016. 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.
公司連絡人：
Adi Frish
業務發展和許可高級副總裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投資者關係連絡人（美國）：
Marcy Nanus
高級副總裁
The Trout Group
+1-646-378-2927
[email protected]
