RedHill's Talicia® Listed as First-Line Choice for H. pylori in New American College of Gastroenterology Guidelines
RedHill Biopharma (Nasdaq: RDHL) announced that its product Talicia® has been listed as a first-line choice for treating H. pylori infection in the new American College of Gastroenterology (ACG) Clinical Guideline. This is significant as it's the first update since Talicia's approval. Talicia offers a convenient all-in-one formulation taken three times daily, supporting high eradication rates without prior resistance testing.
Talicia is currently the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori, which affects about 35% of U.S. adults. Globally, H. pylori infects around 66% of the population and is classified as a Group 1 carcinogen by the WHO, being the strongest known risk factor for gastric cancer.
RedHill Biopharma (Nasdaq: RDHL) ha annunciato che il suo prodotto Talicia® è stato elencato come una scelta di prima linea per il trattamento dell'infezione da H. pylori nelle nuove Linee Guida Cliniche dell'American College of Gastroenterology (ACG). Questo è significativo poiché si tratta del primo aggiornamento dalla approvazione di Talicia. Talicia offre una formulazione comoda e completa assunta tre volte al giorno, supportando elevate percentuali di eradicazione senza necessità di test di resistenza preliminari.
Talicia è attualmente la principale terapia di prima linea a marchio prescritta dai gastroenterologi statunitensi per H. pylori, che colpisce circa il 35% degli adulti negli Stati Uniti. A livello globale, H. pylori infetta circa il 66% della popolazione ed è classificato come un cancerogeno di Gruppo 1 dall'OMS, essendo il più forte fattore di rischio noto per il cancro gastrico.
RedHill Biopharma (Nasdaq: RDHL) anunció que su producto Talicia® ha sido listado como una opción de primera línea para el tratamiento de la infección por H. pylori en las nuevas Guías Clínicas del Colegio Americano de Gastroenterología (ACG). Esto es significativo ya que es la primera actualización desde la aprobación de Talicia. Talicia ofrece una formulación conveniente y todo en uno que se toma tres veces al día, apoyando altas tasas de erradicación sin necesidad de pruebas de resistencia previas.
Talicia es actualmente la terapia de primera línea de marca más prescrita por los gastroenterólogos de EE. UU. para H. pylori, que afecta aproximadamente al 35% de los adultos en EE. UU.. A nivel mundial, H. pylori infecta alrededor del 66% de la población y es clasificado como un carcinógeno del Grupo 1 por la OMS, siendo el factor de riesgo más fuerte conocido para el cáncer gástrico.
RedHill Biopharma (Nasdaq: RDHL)은 자사의 제품 Talicia®가 미국 위장병학회(ACG)의 새로운 임상 지침에서 H. pylori 감염 치료를 위한 1차 선택으로 목록에 올라갔다고 발표했습니다. 이는 Talicia의 승인 이후 첫 업데이트인 만큼 중요합니다. Talicia는 하루에 세 번 복용하는 편리한 올인원 제형을 제공하며, 사전 내성 검사 없이도 높은 박멸율을 지원합니다.
Talicia는 현재 H. pylori에 대해 미국 위장병 전문의가 처방하는 주요 브랜드 1차 치료제로, 이는 약 35%의 미국 성인에게 영향을 미칩니다. 전 세계적으로 H. pylori는 약 66%의 인구를 감염시키며 WHO에 의해 1군 발암물질로 분류되어 있으며, 위암의 가장 강력한 위험 요소로 알려져 있습니다.
RedHill Biopharma (Nasdaq: RDHL) a annoncé que son produit Talicia® a été inscrit comme un choix de première ligne pour le traitement de l'infection à H. pylori dans les nouvelles lignes directrices cliniques de l'American College of Gastroenterology (ACG). Cela est significatif car c'est la première mise à jour depuis l'approbation de Talicia. Talicia offre une formulation pratique tout-en-un à prendre trois fois par jour, soutenant des taux d'éradication élevés sans test de résistance préalable.
Talicia est actuellement la thérapie de première ligne de marque la plus prescrite par les gastro-entérologues américains pour H. pylori, qui affecte environ 35% des adultes aux États-Unis. À l'échelle mondiale, H. pylori infecte environ 66% de la population et est classé comme un cancérogène de groupe 1 par l'OMS, représentant le facteur de risque le plus fort connu pour le cancer gastrique.
RedHill Biopharma (Nasdaq: RDHL) gab bekannt, dass sein Produkt Talicia® in den neuen klinischen Leitlinien des American College of Gastroenterology (ACG) als erstlinige Wahl zur Behandlung der H. pylori-Infektion aufgeführt ist. Dies ist bedeutsam, da es das erste Update seit der Zulassung von Talicia ist. Talicia bietet eine praktische All-in-One-Formulierung, die dreimal täglich eingenommen wird und eine hohe Eradikationsrate ohne vorherige Resistenztests unterstützt.
Talicia ist derzeit die führende markenmäßige Erstlinien-Therapie, die von US-Gastroenterologen für H. pylori verschrieben wird, was etwa 35% der US-Erwachsenen betrifft. Weltweit infiziert H. pylori etwa 66% der Bevölkerung und wird von der WHO als Gruppe-1-Karzinogen klassifiziert, da es der bekannteste Risikofaktor für Magenkrebs ist.
- Talicia listed as first-line choice in new ACG Clinical Guideline
- Leading branded first-line therapy prescribed by U.S. gastroenterologists
- All-in-one formulation supports high eradication rates without prior resistance testing
- Minimal resistance rates to Talicia's antibiotics (amoxicillin <3.0%, rifabutin <1.0%)
- None.
The inclusion of Talicia as a first-line treatment option in the new ACG guidelines is a significant development for RedHill Biopharma. This recognition underscores Talicia's effectiveness against H. pylori, particularly in the face of growing antibiotic resistance. The guideline's emphasis on Talicia's ability to be prescribed without prior resistance testing is a key advantage, potentially streamlining the treatment process.
From a clinical perspective, Talicia's low resistance rates to its component antibiotics (
This guideline update is likely to have a positive impact on RedHill's market position. As Talicia is already the leading branded first-line therapy prescribed by U.S. gastroenterologists, its inclusion in the ACG guidelines could further solidify its market share. The potential for increased prescriptions without the need for resistance testing could accelerate revenue growth.
Investors should note the large market opportunity: with
The updated ACG guideline presents a strategic advantage for RedHill in the competitive landscape of H. pylori treatments. By positioning Talicia as a first-line empirical treatment option, it differentiates the product from clarithromycin-based therapies, which now require prior resistance testing. This could lead to a shift in prescribing habits among gastroenterologists and primary care physicians.
The guideline's timing, coming almost eight years after the previous update, suggests that Talicia could benefit from a prolonged period of favorable positioning. However, it's important to monitor the response of competitors and potential new entrants in the market. The global prevalence of H. pylori and its classification as a carcinogen by WHO underscore the long-term market potential for effective treatments like Talicia.
First new American College of Gastroenterology (ACG) Clinical Guideline[1] for H. pylori infection since Talicia's approval lists Talicia as an empirically prescribed first-line option
Talicia's convenient all-in-one three times daily (TID) formulation offers a simplified patient experience, supporting high rates of eradication without needing prior resistance testing
Talicia is the leading branded first-line therapy prescribed by
Worldwide, around
"The ACG Clinical Guideline is clear that clarithromycin-based triple therapy is no longer a reliable first-line option for the treatment of H. pylori infection, unless prior resistance testing has shown clarithromycin susceptibility. Resistance rates to both of the antibiotics contained in Talicia, amoxicillin and rifabutin, are minimal - <
It has been almost eight years since the ACG Clinical Guideline's last update, which was prior to the launch of Talicia. "The newly updated ACG Clinical Guideline confirms the use of Talicia as a first-line option," said Rick D. Scruggs, President and Chief Commercial Officer of RedHill Biopharma, Inc. "Healthcare providers can be confident in their choice of Talicia without the requirement of prior resistance testing, and we trust that this newly updated ACG Clinical Guideline will continue to change the status quo of H. pylori treatment to further improve patient outcomes."
About H. pylori
H. pylori is a bacterial infection that affects approximately
About Talicia®
Talicia® is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the WHO in recent years.
Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the
Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by
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 (≥
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.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[16], and Aemcolo®, for the treatment of travelers' diarrhea in adults[17]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a
More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.
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-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks 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 or the development of a commercial companion diagnostic for the detection of MAP; (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 therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 |
Category: Commercial
[1] Chey, William D. MD, FACG1; Howden, Colin W. MD, FACG2; Moss, Steven F. MD, FACG3; Morgan, Douglas R. MD, MPH, FACG4; Greer, Katarina B. MD, MSEpi5; Grover, Shilpa MD, MPH6; Shah, Shailja C. MD, MPH7. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. The American Journal of Gastroenterology 119(9):p 1730-1753, September 2024. | DOI: 10.14309/ajg.0000000000002968
[2] IQVIA XPO Data on file
[3] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
[4] https://wwwnc.cdc.gov/travel/yellowbook/2024/infections-diseases/helicobacter-pylori
[5] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
[6] NIH – Helicobacter pylori and Cancer, September 2013.
[7] Ho JJC, Navarro M, Sawyer K, Elfanagely Y, Moss SF. Helicobacter pylori Antibiotic Resistance in
[8] Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
[9] Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.
[10] NIH – Helicobacter pylori and Cancer, September 2013.
[11] Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.
[12] National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).
[13] Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.
[14] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.
[15] The pivotal Phase 3 study with Talicia® demonstrated
[16] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
[17] Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.Aemcolo.com.
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FAQ
What is the significance of Talicia being listed in the new ACG Clinical Guideline for H. pylori treatment?
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