RedHill Biopharma Gets New USPTO Patent for COVID-19 Drug

TL;DR

RedHill just got a new US patent for their COVID drug opaganib (RHB-107) - big win for exclusivity!

AI Summary

RedHill Biopharma Ltd. filed a Form 6-K on March 11, 2024, to report a press release regarding a new USPTO patent. The press release details the allowance of a patent for RedHill's RHB-107 (opaganib) drug, which is intended for the treatment of COVID-19 and other viral infections. This patent is expected to provide market exclusivity in the United States.

Why It Matters

The allowance of this new USPTO patent for RHB-107 strengthens RedHill's intellectual property position and could provide significant market exclusivity for its COVID-19 treatment in the United States.

Risk Assessment

Risk Level: medium — While a new patent is positive, the actual market impact and commercial success of the drug remain subject to clinical trial results, regulatory approvals, and market adoption.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• RHB-107 (drug) — Drug name
• opaganib (drug) — Drug name
• COVID-19 (disease) — Indication
• USPTO (organization) — Patent office

FAQ

Filing Documents

• zk2431122.htm (6-K) — 50KB
• image00001.jpg (GRAPHIC) — 308KB
• 0001178913-24-000888.txt ( ) — 476KB

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. REDHILL BIOPHARMA LTD. (the "Registrant") Date: March 11, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer 2 Press Release RedHill Announces New USPTO Patent Covering Talicia Through 2034 U.S. Patent and Trademark Office (USPTO) issues new patent covering Talicia 1 as an all-in-one treatment of Helicobacter pylori (H. pylori), supporting Talicia protection until February 12, 2034 -- This new patent adds to the existing strong intellectual property portfolio protecting Talicia, including composition of matter and other patents and FDA-granted data exclusivities granted under the GAIN QIDP designation and section 505(b)(2) -- Talicia is the only FDA-approved rifabutin-containing all-in-one therapy for the eradication of H. pylori, providing an optimized antibiotic resistance profile and the leading branded first-line therapy prescribed by U.S. gastroenterologists 2 for H. pylori infection, which affects approximately 35% of the U.S. adult population 3 TEL-AVIV, Israel / RALEIGH, NC, March 11, 2024 /PRNewswire/, -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new U.S. patent covering Talicia 1 as an all-in-one fixed-dose combination of amoxicillin, omeprazole and rifabutin and its use for the treatment of helicobacter pylori ( H. pylori ) infection (Patent No. 11,931,463 to be issued March 19, 2024 4 ). Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection, which affects approximately 35% of the U.S. adult population and this patent is expected to provide protection for Talicia until February 12, 2034. "Talicia is the only FDA-approved rifabutin-containing all-in

Forward Looking Statements

Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. 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, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-stu

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View this 6-K filing on SEC EDGAR