Talicia

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RedHill Biopharma Signs New $1.8 Million Plus Sales Royalties Middle East Deal For Talicia®
Prnewswire· 2025-10-06 12:00
The deal aims to accelerate Talicia's entry into new Middle East markets Under the terms of the agreement RedHill will receive $500,000 in guaranteed payments, including a $250,000 upfront payment and $250,000 in fixed payments due within 18 months, plus a minimum of $1.3 million in near- term potential milestone payments, as well as tiered royalties up to mid-teens percent on Talicia net sales Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based therapy to address H. pylori antibiotic re ...
RedHill Wins New York Supreme Court Appeal, Upholding $10 Million Summary Judgment Against Kukbo
Prnewswire· 2025-09-29 11:00
Accessibility StatementSkip Navigation The New York Supreme Court has, on appeal, upheld its original summary judgment ruling in favor of RedHill The New York Supreme Court unequivocally dismissed Kukbo Co. Ltd's ("Kukbo") defense again, further ruling that RedHill had fulfilled its agreement obligations even after Kukbo's breach RedHill has been granted approximately $10 million in total awards comprised of the $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses ( ...
RedHill Biopharma Announces First Half 2025 Financial Results and Operational Highlights
Prnewswire· 2025-09-05 11:00
Extensive strategic, financial and operational overhaul has reshaped and refocused our business; Strong progress on multiple fronts Commercial and R&D Highlights: Corporate and financial highlights: TEL AVIV, Israel and RALEIGH, N.C., Sept. 5, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its first half of 2025 financial results and operational highlights for the six months ended June 30, 2025. Dror Ben-Asher, R ...
RedHill Received Talicia® Licensing Payments Totaling $1.1 Million
Prnewswire· 2025-08-18 13:00
Core Insights - RedHill Biopharma has received its first sales milestone payment and royalties totaling approximately $1.1 million for Talicia following its first ex-U.S. commercial launch in 2024 [1] - Talicia is the first FDA-approved rifabutin-based product specifically designed to treat Helicobacter pylori (H. pylori), which affects over 50% of the global adult population and is a significant risk factor for gastric cancer and peptic ulcer disease [1][2] - Talicia is recognized as the leading first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection and has been granted a Qualified Infectious Disease Product (QIDP) designation, providing eight years of U.S. market exclusivity [1][7] Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [16] - The company promotes Talicia for the treatment of H. pylori infection in adults and is engaged in discussions with potential partners to secure additional non-dilutive ex-U.S. licensing revenue streams [2][16] Product Details - Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) [6] - In clinical studies, Talicia demonstrated up to 90% eradication of H. pylori infection in adherent patients, significantly outperforming traditional clarithromycin-based therapies [3][6] - Talicia is patent protected until 2042, with additional patents pending in various territories worldwide [7][8] Market Context - H. pylori infection is classified by the WHO as a Group 1 carcinogen, with over 27,000 Americans diagnosed with gastric cancer annually [4][12] - Current clarithromycin-based therapies show declining effectiveness, with eradication rates dropping to 32% in patients with resistant H. pylori strains [3][4] - The increasing resistance of H. pylori to antibiotics, particularly clarithromycin, highlights the urgent need for effective first-line therapies like Talicia [5][16]
RedHill Receives Positive FDA Feedback on Pathway to Approval of Groundbreaking RHB-204 for Crohn's Disease
Prnewswire· 2025-07-21 13:00
Core Viewpoint - RedHill Biopharma received positive FDA feedback for its RHB-204 Crohn's disease development program, indicating a promising pathway to approval for a potentially groundbreaking therapy targeting the root cause of the disease [1][2]. Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology [15]. - The company is actively pursuing non-dilutive funding options for its RHB-204 program, including grant applications and discussions with external funding sources [1][10]. Product Development - RHB-204 is a next-generation formulation of RHB-104, designed to enhance tolerability, safety, and patient adherence, with a 40% reduction in pill burden [5][13]. - The drug is patent protected until 2041 and is expected to receive pediatric orphan drug designation, along with potential breakthrough therapy and fast track designations [1][10][14]. - The Phase 2 study of RHB-204 will be the first clinical trial targeting a specific population of Mycobacterium avium subspecies paratuberculosis infected Crohn's disease patients, aiming to address both the cause and symptoms of the disease [2][6]. Clinical Study Insights - The primary endpoints of the Phase 2 study will focus on mucosal remission, which is considered a new gold standard in efficacy evaluation for Crohn's disease, correlated with MAP status and clinical remission [4]. - The study design allows for a smaller sample size, which could lead to lower costs and faster completion times [4][6]. Market Potential - The Crohn's disease market is projected to grow significantly, with sales expected to increase from $13.6 billion in 2024 to over $19 billion by 2033, representing a compound annual growth rate (CAGR) of 3.87% [9]. - Up to 40% of Crohn's disease patients do not respond to existing anti-TNF treatments, highlighting the need for new, effective therapies like RHB-204 [8]. Competitive Landscape - Current FDA-approved therapies for Crohn's disease include Abbvie's Humira, Janssen's Remicade, and others, which are often expensive and have known safety issues [11][8]. - RHB-204 aims to provide a safe and effective oral therapy alternative, potentially transforming treatment options for Crohn's disease patients [7][8].
RedHill-Supported Medscape H. Pylori Educational Program to Launch at Major Gastroenterology Congress
Prnewswire· 2025-05-02 11:00
Core Insights - RedHill Biopharma Ltd. supports an independent medical education grant for a new two-part H. Pylori Continuing Medical Education (CME) program aimed at enhancing clinical knowledge and improving patient outcomes [1][3] - H. pylori is a significant health concern, classified as a Group 1 carcinogen by WHO, affecting nearly 50% of the global population and representing a billion-dollar market opportunity [1][5] - Talicia® is highlighted as the leading branded therapy for H. pylori, being the only FDA-approved all-in-one, low-dose rifabutin-based treatment [1][6] Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [18] - The company promotes Talicia for the treatment of H. pylori infection in adults and plans to submit a Marketing Authorisation Application (MAA) for Talicia in the UK [6][18] H. Pylori Infection Insights - H. pylori infection affects approximately 50% of the global adult population and is the strongest known risk factor for gastric cancer, causing 70% to 90% of cases [5][7] - The infection is also a major risk factor for peptic ulcer disease, with eradication becoming increasingly difficult due to high antibiotic resistance [7][8] CME Program Details - The CME program consists of two parts: - Part 1: A livestreamed expert panel on May 6, 2025, focusing on antibiotic resistance and guideline-directed therapies [3][4] - Part 2: An interactive online discussion scheduled for June 2025, addressing challenges in H. pylori diagnosis and treatment [4][5] Talicia Overview - Talicia is a fixed-dose, all-in-one oral capsule combining amoxicillin, rifabutin, and omeprazole, approved by the FDA in November 2019 [8][9] - The drug has received eight years of U.S. market exclusivity and is protected by patents extending until 2034 [8][18]
RedHill Biopharma Secures Allowance of Key Chinese Patent Application for Proprietary COVID-19 Treatment, RHB-107
Prnewswire· 2025-04-28 11:03
Core Insights - RedHill Biopharma has received a critical composition-of-matter patent for RHB-107, enhancing its market exclusivity in the COVID-19 therapeutic space, which is projected to exceed $3 billion by 2025 [1][2] - RHB-107 has shown promising results in a U.S. Phase 2 study, achieving a 100% reduction in hospitalization rates among treated patients compared to a 15% hospitalization rate in the placebo group [2] - The drug is designed to be a broad-acting antiviral that targets human serine proteases, potentially effective against various SARS-CoV-2 variants [3][4] Company Overview - RedHill Biopharma focuses on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology, with a notable product being Talicia for H. pylori infection [5] - The company has a diverse pipeline, including RHB-204 for Crohn's disease and opaganib for cancer and COVID-19, indicating a strong commitment to addressing multiple health challenges [5] Clinical Data - In the Phase 2 study, RHB-107 demonstrated a 100% reduction in hospitalization (0/41) versus 15% (3/20) in the placebo group, with a nominal p-value of 0.0317, and an 88% reduction in new severe COVID-19 symptoms [2] - The study also indicated faster recovery times, with a median recovery of 3 days for RHB-107 compared to 8 days for placebo [2] Patent and Market Position - The newly allowed patent in China strengthens RedHill's intellectual property portfolio and expands its presence in Asia, a significant pharmaceutical market [2] - RHB-107's unique mechanism of action, targeting host cells rather than the virus directly, positions it as a potential alternative to existing treatments like Pfizer's Paxlovid [2][3]
RedHill Biopharma Receives Nasdaq Notification Regarding Minimum Stockholders' Equity Deficiency
Prnewswire· 2025-04-17 20:01
Core Viewpoint - RedHill Biopharma Ltd. has received a Notification Letter from Nasdaq indicating non-compliance with listing requirements due to a stockholders' deficit of $4,683,000, but this does not immediately affect its listing or operations [1][2][3]. Group 1: Compliance Status - The company is required to maintain a minimum of $2,500,000 in stockholders' equity for continued listing on the Nasdaq Capital Market [2]. - As of the fiscal year ended December 31, 2024, the company reported a stockholders' deficit of $4,683,000, leading to non-compliance with Nasdaq Listing Rule 5550(b)(1) [2]. - The company has 45 days to submit a plan to regain compliance, with a deadline of May 30, 2025, and if accepted, Nasdaq may grant an extension of up to 180 days [3][4]. Group 2: Company Operations and Plans - The company is exploring various options to regain compliance and intends to submit its compliance plan as soon as possible [4]. - There is no assurance that the company's compliance plan will be accepted or that it will successfully regain compliance with the Nasdaq listing requirements [4]. Group 3: Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [5]. - The company promotes the FDA-approved drug Talicia for treating H. pylori infection and has several late-stage clinical development programs, including opaganib, RHB-204, RHB-104, RHB-107, and RHB-102 [5].
RedHill Biopharma Receives Nasdaq Notification Regarding Minimum Stockholders' Equity Deficiency
Prnewswire· 2025-04-17 20:01
The Notification Letter has no immediate effect on the Company's listing on the Nasdaq Capital Market at this time, nor are the Company's business operations affected by receipt of the Notification LetterTEL AVIV, Israel and RALEIGH, N.C., April 17, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company received a written notification (the "Notification Letter") from the Listing Qualifications Departmen ...