RedHill Biopharma Ltd (RDHL)

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RedHill-Supported Medscape H. Pylori Educational Program to Launch at Major Gastroenterology Congress

https://finance.yahoo.com/news/redhill-supported-medscape-h-pylori-110000775.html

RedHill supports an independent medical education grant that includes a new two-part H. Pylori Continuing Medical Education (CME) program, developed by Medscape aimed at advancing clinical knowledge and improving patient outcomes
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The first part of the program, led by a faculty of William Chey, MD, Vivian Asamoah, MD and Shailja Shah, MD, MPH, will take place May 6 during a major U.S. gastroenterology meeting
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H. pylori is classified by the World Health Organization (WHO) as a Group 1 carcinogen, being the strongest known risk factor for gastric cancer[1] and a major risk factor for peptic ulcer disease[2]. With almost half the global population infected by H. pylori[3], its treatment represents a billion-dollar market opportunity[4]
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Listed by the American College of Gastroenterology (ACG) Clinical Guideline[5] as a first-line option, Talicia® is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists, and the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics

RALEIGH, N.C., May 2, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its support of an independent medical education grant that includes a new two-part H. Pylori CME program, developed by Medscape and designed to advance clinical knowledge and improve patient outcomes. The first part of the program, a livestreamed event entitled "Let's Get Social About H. pylori Management" led by William Chey, MD, Vivian Asamoah, MD and Shailja Shah, MD, MPH, will take place on May 6 during a major gastroenterology meeting.

RedHill also announces that it will be attending Digestive Diseases Week (DDW) in San Diego and will be available at booth 5312.

Kel Sheldon, PhD, BCMAS, RedHill's Director, Medical Affairs, said: "We are proud to announce that RedHill is supporting a Medscape CME educational program to help meet the need for healthcare professional education on H. pylori infection and treatment options. RedHill believes in the critical need to effectively treat H. pylori at the first attempt amid increasing global concern of rising antibiotic resistance, particularly within the macrolide class of anti-infectives. H. pylori is estimated to be carried by around 50% of the global population and it is the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease. This CME program is targeted to help thousands of specialists, primary care providers, nurses, and advanced practice providers, by providing education on guideline-driven H. pylori management, designed to advance clinical knowledge and improve patient outcomes in H. pylori diagnosis and treatment."

The 2-part Medscape CME program consists of:

Part 1: Let's Get Social About H. pylori Management
Faculty: William Chey, MD; Vivian Asamoah, MD; Shailja Shah, MD, MPH
Date/Time: May 6, 2025, at 12 PM ET / 9 AM PT
Link to Event: Youtube -

LinkedIn - https://www.linkedin.com/events/7320172841423761409/
Facebook - https://www.facebook.com/events/1396855524656365

Overview: A 30-minute expert panel livestream (0.5 CME Credits) on Medscape's social media channels (YouTube, LinkedIn, Facebook, X), focusing on antibiotic resistance, guideline-directed therapies, and patient adherence in H. pylori management. The event will remain available on-demand post-livestream to support those gastroenterology professionals unable to attend the live event.

Part 2: Expert Roundtable: Overcoming Challenges in H. pylori Diagnosis and Treatment
Faculty: Colin Howden, MD; William Chey, MD; Shailja Shah, MD, MPH
Date/Time: June 2025 (TBD)
Overview: A 30-minute interactive, case-based online discussion (0.5 CME Credits), with Q&A, focusing on antibiotic resistance, adherence to new guidelines, and optimizing patient care pathways, in order to help clinicians translate key guideline updates into clinical practice.

H. pylori infection affects around 50% of the global adult population and is classified, by the World Health Organization (WHO), as a Group 1 carcinogen and the strongest known risk factor for gastric cancer (causing between 70% to 90% of cases)[6] and a major risk factor for peptic ulcer disease (causing 90% of cases)[7].

Talicia, the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics, is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and is listed by ACG Clinical Guideline as an empiric first-line option. Talicia is also launched in the United Arab Emirates (UAE) and the Company recently announced its plan to submit a Marketing Authorisation Application (MAA) for Talicia in the UK, which if approved may be accepted by some additional countries as a reference for their own approval processes, which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia.

About H. pylori
H. pylori is a bacterial infection that affects approximately 35% of the U.S. population[8], with an estimated two million patients treated annually. Worldwide, around 50% of the population has H. pylori infection, which is classified by the World Health Organization (WHO) as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[9]. More than 27,000 Americans are diagnosed with gastric cancer annually[10]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[11].

About Talicia
Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia has received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health and was launched there by Ghassan Aboud Group (GAG) in August 2024.

TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION
Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial­­, indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

IMPORTANT SAFETY INFORMATION
Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.
Talicia is contraindicated in patients receiving rilpivirine-containing products.
Talicia is contraindicated in patients receiving delavirdine or voriconazole.
Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.
Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia.
Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin.
Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.
Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.
Talicia should not be used in patients with hepatic impairment or severe renal impairment.
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.
The most common adverse reactions (=1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at
1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full prescribing information for Talicia is available at www.Talicia.com.