RedHill Secures Talicia® Patent Extension to 2042 for H. pylori Treatment

TL;DR

**RedHill just locked in Talicia® patent protection until 2042, boosting its long-term drug value.**

AI Summary

RedHill Biopharma Ltd. announced on January 25, 2024, that the U.S. Patent and Trademark Office (USPTO) granted a new patent for its drug Talicia®, extending its protection for treating H. pylori infections through 2042. This patent grant is significant because it provides RedHill with a longer period of market exclusivity for Talicia, potentially increasing future revenue streams and protecting its investment in the drug, which is crucial for investors considering the stock's long-term value.

Why It Matters

This patent extension through 2042 for Talicia® provides RedHill Biopharma with a significantly longer period of market exclusivity, protecting its revenue stream from generic competition and enhancing the drug's long-term value.

Risk Assessment

Risk Level: low — This filing reports a positive development (patent grant) that reduces future competitive risk for a key product, making it a low-risk event.

Analyst Insight

A smart investor would view this patent extension as a positive long-term catalyst for RedHill Biopharma, potentially increasing the intrinsic value of Talicia® and reducing future competitive risks, warranting a deeper look into the company's growth prospects.

Key Numbers

• 2042 — patent expiration year (extends market exclusivity for Talicia®)
• January 2024 — month of report (when the 6-K was filed)
• 001-35773 — Commission File No. (RedHill Biopharma Ltd.'s SEC file number)

Key Players & Entities

• RedHill Biopharma Ltd. (company) — the registrant filing the 6-K
• Talicia® (company) — RedHill's drug for H. pylori treatment
• U.S. Patent and Trademark Office (company) — the office that granted the patent
• H. pylori (company) — the infection Talicia® treats

Forward-Looking Statements

• RedHill Biopharma's revenue from Talicia® will be more secure due to extended patent protection. (RedHill Biopharma Ltd.) — high confidence, target: 2042
• The market valuation of Talicia® as an asset will increase due to its longer exclusivity period. (Talicia®) — medium confidence, target: 2025

FAQ

Filing Documents

• zk2430817.htm (6-K) — 49KB
• image00001.jpg (GRAPHIC) — 81KB
• 0001178913-24-000241.txt ( ) — 161KB

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 25, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release RedHill Announces New USPTO Patent Grant for Talicia for H. pylori Treatment Through 2042 USPTO issues new patent covering Talicia 1 as a method for eradicating H. pylori regardless of patient Body Mass Index (BMI) 2 , supporting Talicia protection until May 2042 -- The patent is supported by previously published pooled data from two Phase 3 studies showing Talicia's efficacy was unaffected by presence of elevated BMI 3 -- The U.S. FDA recently granted five years' market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, additional to the three years' exclusivity granted for the approval of Talicia under section 505(b)(2) -- Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists 4 for eradication of H. pylori - a bacterial infection that affects approximately 35% of the U.S. adult population 5 TEL-AVIV, Israel / RALEIGH, NC, January 25, 2024 /PRNewswire/, -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Patent and Trademark Office (USPTO) issued a new patent, U.S. Patent No. 11,878,011, covering Talicia as a method for eradicating Helicobacter pylori ( H. pylori ) regardless of patient Body Mass Index (BMI). This new patent is expected to provide protection for Talicia until May 2042. "Rates of obesity continue to rise in the U.S., with over 70% of the population being overweight or obese 6 , and published data have shown that obesity has been associated with failure of cla

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. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. 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, including without limitation, 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 risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not succeed to expand Talicia's reach to additional ex-U.S. territories; as well as other risk and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's th

View Full Filing

View this 6-K filing on SEC EDGAR