share_log

Redhill Biopharma | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Redhill Biopharma | 6-K:外國發行人報告

SEC announcement ·  03/11 19:06
牛牛AI助理已提取核心訊息
RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced on March 11, 2024, that the U.S. Patent and Trademark Office (USPTO) has issued a new patent for Talicia, their all-in-one treatment for Helicobacter pylori (H. pylori) infection. The patent, which extends protection for Talicia until February 12, 2034, supports the company's existing intellectual property portfolio, including composition of matter patents and FDA-granted data exclusivities under the GAIN QIDP designation and section 505(b)(2). Talicia is the only FDA-approved therapy containing rifabutin for H. pylori eradication and is the leading branded first-line therapy prescribed by U.S. gastroenterologists. The infection affects approximately 35% of the U.S. adult population. The new patent is expected to bolster Talicia's market exclusivity and strengthen RedHill's commercial position. The announcement also highlighted Talicia's optimized antibiotic resistance profile and its pivotal Phase 3 study results, which showed an 84% eradication rate of H. pylori. RedHill Biopharma focuses on gastrointestinal and infectious diseases and promotes other gastrointestinal drugs alongside Talicia.
RedHill Biopharma Ltd., a specialty biopharmaceutical company, announced on March 11, 2024, that the U.S. Patent and Trademark Office (USPTO) has issued a new patent for Talicia, their all-in-one treatment for Helicobacter pylori (H. pylori) infection. The patent, which extends protection for Talicia until February 12, 2034, supports the company's existing intellectual property portfolio, including composition of matter patents and FDA-granted data exclusivities under the GAIN QIDP designation and section 505(b)(2). Talicia is the only FDA-approved therapy containing rifabutin for H. pylori eradication and is the leading branded first-line therapy prescribed by U.S. gastroenterologists. The infection affects approximately 35% of the U.S. adult population. The new patent is expected to bolster Talicia's market exclusivity and strengthen RedHill's commercial position. The announcement also highlighted Talicia's optimized antibiotic resistance profile and its pivotal Phase 3 study results, which showed an 84% eradication rate of H. pylori. RedHill Biopharma focuses on gastrointestinal and infectious diseases and promotes other gastrointestinal drugs alongside Talicia.
專業生物製藥公司RedHill Biopharma Ltd. 於2024年3月11日宣佈,美國專利商標局(USPTO)已爲其治療幽門螺桿菌(H. pylori)感染的多合一療法塔利西亞頒發了一項新專利。該專利將對塔利西亞的保護延長至2034年2月12日,支持該公司現有的知識產權組合,包括在GAIN QIDP名稱和第505(b)(2)條下授予的物質專利和美國食品藥品管理局授予的數據專有權。塔利西亞是唯一一種經美國食品藥品管理局批准的含有利福布汀的用於根除幽門螺桿菌的療法,也是美國胃腸病學家開出的領先品牌一線療法。該感染影響了大約35%的美國成年人口。預計這項新專利將增強塔利西亞的市場排他性並鞏固RedHill的商業地位。該公告還強調了塔利西亞優化的抗生素耐藥特徵及其關鍵的3期研究結果,該結果顯示幽門螺桿菌的根除率爲84%。RedHill Biopharma專注於胃腸道和傳染病,除塔利西亞外,還推廣其他胃腸道藥物。
專業生物製藥公司RedHill Biopharma Ltd. 於2024年3月11日宣佈,美國專利商標局(USPTO)已爲其治療幽門螺桿菌(H. pylori)感染的多合一療法塔利西亞頒發了一項新專利。該專利將對塔利西亞的保護延長至2034年2月12日,支持該公司現有的知識產權組合,包括在GAIN QIDP名稱和第505(b)(2)條下授予的物質專利和美國食品藥品管理局授予的數據專有權。塔利西亞是唯一一種經美國食品藥品管理局批准的含有利福布汀的用於根除幽門螺桿菌的療法,也是美國胃腸病學家開出的領先品牌一線療法。該感染影響了大約35%的美國成年人口。預計這項新專利將增強塔利西亞的市場排他性並鞏固RedHill的商業地位。該公告還強調了塔利西亞優化的抗生素耐藥特徵及其關鍵的3期研究結果,該結果顯示幽門螺桿菌的根除率爲84%。RedHill Biopharma專注於胃腸道和傳染病,除塔利西亞外,還推廣其他胃腸道藥物。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生,只对除中国内地以外的地区提供。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。