RedHill's Talicia Gains Humana Coverage, Expands Reach

TL;DR

Humana added RedHill's Talicia to its Part D plan, covering 8M lives. Big win for access.

AI Summary

RedHill Biopharma Ltd. announced on January 21, 2025, that its drug Talicia® now has coverage for 8 million lives through Humana®'s Part D plan. Additionally, new data supporting a simplified three-times daily dosing regimen for Talicia has been published.

Why It Matters

This expansion of coverage by a major insurer like Humana significantly increases patient access to Talicia, potentially boosting sales and market penetration for RedHill Biopharma.

Risk Assessment

Risk Level: medium — While positive news, the filing doesn't detail financial impact or specific prescription volume changes, leaving the immediate market reaction uncertain.

Key Numbers

• 8 Million — Lives Covered (Coverage by Humana's Part D plan for Talicia)

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• Talicia® (drug) — Product
• Humana® (company) — Insurer
• 8 Million (dollar_amount) — Lives covered

FAQ

Filing Documents

• zk2532592.htm (6-K) — 52KB
• image00001.jpg (GRAPHIC) — 491KB
• 0001178913-25-000175.txt ( ) — 729KB

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: January 21, 2025 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release RedHill's Talicia Adds 8 Million Lives With Coverage by Humana 's Part D Plan. Also, New Data Supporting Simplified Three-Times Daily Talicia Dosing Published Talicia is now covered by Humana's Part D Plan, providing access to Talicia for H. pylori therapy to more than eight million additional Medicare lives, without requiring prior therapeutic steps or authorization -- The recently updated American College of Gastroenterology (ACG) Clinical Guideline lists Talicia as a first-line option for treatment of H. pylori infection. Talicia continues to be the most prescribed branded H. pylori therapy by U.S. gastroenterologists -- Additionally, new data describing the foundations for Talicia's recent FDA-approved label change to a more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine, supporting patient adherence, has been published in the Journal of Clinical Pharmacology -- The published data describe the use of physiologically-based pharmacokinetic (PBPK) modeling and simulation to demonstrate pharmacokinetic equivalence of the TID regimen to the previous every 8-hour (Q8H) dosing regimen -- H. pylori infection affects approximately 35% of the U.S. adult population and is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease RALEIGH, N.C. and TEL-AVIV, Israel, January 21, 2025, RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the coverage of Talicia b

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 may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential effects of Talicia in the treatment of Helicobacter pylori infection. 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 Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; 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-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-10

View Full Filing

View this 6-K filing on SEC EDGAR