RedHill Biopharma Secures New US Patent for Talicia

TL;DR

RHBP just got a new US patent for Talicia, extending exclusivity until 2036. Big win for their H. pylori drug.

AI Summary

RedHill Biopharma Ltd. announced on June 3, 2024, that it has been granted a new U.S. patent for its Talicia drug, which is used to treat Helicobacter pylori infections. This patent, expected to expire in 2036, provides market exclusivity for Talicia in the United States.

Why It Matters

The new patent extends market exclusivity for Talicia, a key revenue driver for RedHill, potentially impacting its competitive position and future sales.

Risk Assessment

Risk Level: medium — While a new patent is positive, the company's overall financial health and the competitive landscape for H. pylori treatments remain significant factors.

Key Numbers

• 2036 — Patent Expiration (Provides market exclusivity for Talicia in the US.)

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• Talicia (drug) — Drug for H. pylori treatment
• 2036 (date) — Expiration of new patent
• June 3, 2024 (date) — Filing date of the 6-K

FAQ

Key Financial Figures

• $100 billion — he global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (

Filing Documents

• zk2431551.htm (6-K) — 35KB
• image00001.jpg (GRAPHIC) — 308KB
• 0001178913-24-001919.txt ( ) — 461KB

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: June 3, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release RedHill Announces a New Patent Covering Opaganib in Combination with Immune Checkpoint Inhibitors, Valid Through 2040 New Chinese patent notice of allowance issued covering opaganib in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response 1 . Provides protection for opaganib's potential use in combination with a range of approved and in- development (ICIs) across a growing range of indications 2 through 2040 -- ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 billion by 2028, including Merck's Keytruda (pembrolizumab) and BMS' Yervoy (ipilimumab) 3 -- Opaganib, a host-directed and potentially broad acting twice-daily oral, small molecule with a demonstrated safety & efficacy profile, is in development for multiple oncology, viral and inflammatory indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and two U.S. government-sponsored countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure TEL-AVIV, Israel / RALEIGH, NC, June 3, 2024 /PRNewswire/, -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new Chinese patent notice of allowance for opaganib 4 in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response, providing protection for opaganib's potential use with a range of approved and in-development immune checkpoint inhib

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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