RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) 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，該公司宣佈RHB-104已從美國食品藥品管理局（FDA）獲得用於治療非結核分歧桿菌（NTM）感染的合格感染病產品（QIDP）認證。QIDP認證是根據FDA的生成抗生素激勵法案（GAIN）授權的，其目的旨在鼓勵治療嚴重或危及生命感染方面新抗生素藥物的開發。
根據FDA的生成抗生素激勵法案，QIDP認證會確保藥物處於快速開發狀態及優先審查階段，進而可能會縮短FDA的新藥申請審查時間，且如果獲得批准的話，該藥物還可在標準排他期基礎上獲得額外5年的美國市場專賣權。
NTM感染可發生在身體的任何一個部位，但肺部感染、淋巴結炎、皮膚和軟組織感染則最為常見。在過去20年當中，全球範圍內的NTM感染已與日俱增。受抗性開發風險影響，NTM的治療時間通常比較長，且需要多藥方案。
RHB-104針對克羅恩病的首項三期臨床試驗（MAP US研究）目前正在美國和另外的國家進行。越來越多的證據為克羅恩病和其他自身免疫疾病與易感患者的鳥分枝桿菌亞種副結合感染有關的假說提供了支援。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家總部位於以色列的專業生物醫藥公司，主要專注于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已與Concordia就Donnatal®簽署美國地區的聯合促銷協定，Donnatal®是一種用於治療IBS和急性小腸結腸炎的處方口服輔助藥物。RedHill目前處於臨床階段的產品管線包括：(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，正在進行首項三期試驗以及治療多發性硬化症的IIa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口服蛋白酶抑制劑，是首創新藥，靶向為胃腸和其他實體瘤；(vii) 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。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 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.
注：該新聞稿的唯一官方版本是本公司以英文出版的。本摘要和意譯版本僅為方便起見。
| 公司聯絡人： | 投資者關係聯絡人（美國） | |
| Adi Frish | Marcy Nanus | |
| 業務發展和許可高級副總裁 | 高級副總裁 | |
| RedHill Biopharma | The Trout Group | |
| +972-54-6543-112 | +1-646-378-2927 | |
| [email protected] | [email protected] |
