RedHill Biopharma Launches H. pylori Disease State Awareness Field Campaign Ahead of Talicia® Launch
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H. pylori infection is a highly prevalent and increasingly resistant Group 1 carcinogen. RedHill’s disease state educational field campaign is intended to provide healthcare professionals with a greater awareness of the risks related to H. pylori infection and the high and growing resistance of the H. pylori bacterium to standard-of-care antibiotics, which has led to a 25-40% failure rate of current therapies2. The campaign is primarily being carried out by RedHill’s field sales force, which has grown over the past several months and is expected to include 140 representatives within the coming weeks. It is estimated that H. pylori resistance to clarithromycin more than doubled between 2009-20133. The campaign aims to raise awareness among the main physicians who treat the disease, which include gastroenterologists, primary care and other healthcare providers. This educational effort is further supported by RedHill’s medical affairs, thought leader liaisons and marketing teams.
“Ahead of the planned U.S. commercial launch of Talicia later this quarter, we are excited to offer an educational resource to healthcare professionals to gain a greater understanding of the risks and causes of treatment failure and the importance of diagnosis and eradication of H. pylori,” said
“H. pylori infection is a highly prevalent Group 1 carcinogen and the strongest risk factor for peptic ulcer disease and non-cardia gastric cancer. More than 27,500 Americans are diagnosed with gastric cancer each year, and more than 11,000 die from the disease annually4. As a recent publication5 has shown, eradication of H. pylori reduces the risk of gastric cancer. Despite the risks associated with H. pylori infection, there has been a lack of advances in treatment options over the past decade and treatment has become increasingly difficult due to growing bacterial resistance to antibiotics used in current therapies,” said
About H. Pylori
H. pylori bacterial infection affects approximately 35% of the U.S. population6, with an estimated two million patients treated annually7. H. pylori infection, which is classified by the
About Talicia® (omeprazole magnesium, amoxicillin and rifabutin)
INDICATION AND USAGE
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 CONTRAINDICATIONS
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.
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.
Acute Interstitial Nephritis has been observed in patients taking PPIs and penicillins.
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
Full prescribing information for Talicia® is available at http://bit.ly/2CozHNH.
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 include, without limitation, risks related to the timing for the launch of Talicia® as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its therapeutic candidates and its
1 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: http://bit.ly/2CozHNH.
2 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.
3 Shiota S, Reddy R, Alsarraj A, et al. Antibiotic resistance of Helicobacter pylori among male
5 Kumar S et al. Risk Factors and Incidence of Gastric Cancer After Detection of Helicobacter pylori Infection: A Large Cohort Study. Gastroenterology 2019; doi: 10.1053/j.gastro.2019.10.019.
6 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.
7 IQVIA Custom Study for
8 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.
9 NIH – Helicobacter pylori and Cancer,
10 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.
Adi FrishSenior VP of Business Development & Licensing RedHill Biopharma+972-54-6543-112 email@example.com IR contact (U.S.): Timothy McCarthy, CFA, MBA Managing Director, Relationship Manager LifeSci Advisors, LLC+1-212-915-2564 firstname.lastname@example.org
Source: RedHill Biopharma Ltd.