RedHill Biopharma Launches Talicia in UAE

TL;DR

RHBP launches Talicia in UAE, expanding global reach for H. pylori treatment.

AI Summary

RedHill Biopharma Ltd. announced on August 21, 2024, the launch of Talicia® in the United Arab Emirates. This marks a significant step in expanding the availability of their antibiotic for the treatment of Helicobacter pylori infection.

Why It Matters

The launch of Talicia in the UAE expands RedHill's global reach for its H. pylori treatment, potentially increasing revenue and market share in a new region.

Risk Assessment

Risk Level: medium — The company is in the pharmaceutical sector, which is inherently risky due to regulatory hurdles, clinical trial outcomes, and market competition.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• Talicia® (product) — Antibiotic for H. pylori infection
• United Arab Emirates (location) — Market for launch
• August 21, 2024 (date) — Date of announcement

FAQ

Filing Documents

• zk2431897.htm (6-K) — 48KB
• image00001.jpg (GRAPHIC) — 308KB
• 0001178913-24-002719.txt ( ) — 473KB

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: August 21, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release Talicia Launched in the United Arab Emirates RedHill's Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori, is now available on prescription to treat adults with H. pylori infection in the United Arab Emirates (UAE) -- The commercial launch of Talicia triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales -- Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists 1 for the treatment of H. pylori, a bacterial infection that affects 41% of the UAE population 2 and over 50% of the world's adult population 3 RALEIGH, N.C., August 21, 2024, RedHill Biopharma Ltd. (Nasdaq: RDHL ) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the launch of Talicia (omeprazole magnesium, amoxicillin and rifabutin) 4 in the United Arab Emirates (UAE) – making it available by prescription to treat adults with Helicobacter pylori ( H. pylori ) infection. The commercial launch of Talicia in the UAE triggers RedHill's eligibility for additional potential milestone payments, minimum sales payments and tiered royalties up to mid-teens on net sales. Talicia is the first approved low-dose rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori . "We are delighted with the commercial launch of Talicia in the UAE, bringing this important medicine to patients in the region," said Rick Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer . "As one of t

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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