RedHill Biopharma Ltd (RDHL)

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RedHill Initiates First Community-Setting Warranty Program to Refund Talicia Non-Responders

https://finance.yahoo.com/news/redhill-initiates-first-community-setting-110000513.html

RedHill commits to reimburse out-of-pocket costs for Talicia patients that complete the full 14-day treatment course and whose infection is not eradicated based on post-treatment confirmation testing - warranty commitment extends to all commercially insured or non-insured Talicia patients[1]

Talicia warranty program believed to be the first of its kind offered for a widespread community (non-hospital) treated condition, lowering the bar for patient access to an H. pylori therapy with a demonstrated more than 90% cure rate in the confirmed adherent population

Talicia, the leading prescribed branded H. pylori therapy by U.S. gastroenterologists[2], is an empiric first-line therapy for eradication of H. pylori, a bacterial infection that affects approximately 35% of the U.S. adult population[3]

RALEIGH, N.C. and TEL AVIV, Israel, March 21, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced the availability of a warranty program for its Helicobacter pylori (H. pylori) eradication therapy, Talicia®[4], in which RedHill commits to reimburse patient out of pocket costs should Talicia not work. Talicia is the most prescribed branded agent by gastroenterologists[2] and this warranty commitment extends to all commercially insured and non-insured Talicia patients who complete the full 14-day treatment course and whose infection is not eradicated based on post-treatment confirmation testing.

Dr. June Almenoff, MD, Ph.D., RedHill's Chief Medical Officer said: "H. pylori is the number one risk factor for gastric cancer and a major risk factor for development of peptic ulcers, including bleeding ulcers which could require hospitalization[5], [6]. In a pivotal clinical trial, Talicia demonstrated a more than 90% cure rate in patients in the confirmed adherent population and 84% in the intent-to-treat population, with a less than 1% discontinuation rate. Our clinical trial data support a high degree of confidence in both the efficacy and tolerability of Talicia[4], [7]. We are committed to working towards all appropriate patients having access to this important medication and, to our knowledge, this is the first time a warranty program has been offered for a widespread community (non-hospital) treated condition and should serve to lower the bar for patient access."

Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms[8]. Other studies have also shown that for clarithromycin-resistant strains of H. pylori the risk of eradication failure increases 3-7–fold when treated with clarithromycin-containing regimens[9],[10]. Clarithromycin-based treatment efficacy can also be negatively impacted by patient BMI or diabetic status, neither of which impact Talicia's eradication rates[11],[12].

In 2017 the American College of Gastroenterology guidelines were changed to recommend against using clarithromycin in the majority of situations[5], in particular where there is known resistance or increased risk for resistance, including any previous H. pylori treatment or treatment for any reason with a macrolide antibiotic (e.g. erythromycin, clarithromycin, azithromycin), which accounts for approximately 100 million Americans every four years[13].

About H. pylori infection
H. pylori is a bacterial infection that affects approximately 35%[2] of the U.S. population, with an estimated two million patients treated annually[14]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[15] and a major risk factor for peptic ulcer disease[16] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[17]. More than 27,000 Americans are diagnosed with gastric cancer annually[18]. 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[2].

About Talicia
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), approved by the U.S. FDA for the treatment of H. pylori infection in adults.

Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address H. pylori's high resistance to 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 World Health Organization (WHO) in recent years.

In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[19] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[20]. 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.

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 U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.

TALICIA: IMPORTANT SAFETY INFORMATION

Tell your healthcare provider about all of the medicines you take, including prescription or non-prescription medications or herbal supplements before starting Talicia. Talicia may affect the way other medicines work, and other medicines may affect the way Talicia works. Do not start any new medications while taking Talicia without first speaking with your healthcare provider.

You should not take Talicia if you are known to be sensitive to any of the components of Talicia (omeprazole, amoxicillin, rifabutin), penicillins, proton pump inhibitors or rifamycins.

You should not take Talicia if you are taking rilpivirine-containing products, delavirdine or voriconazole.

Before you take Talicia, tell your healthcare provider about all of your medical conditions, including if you:

Are pregnant or plan to become pregnant. Talicia may harm your unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during your treatment with Talicia.

Have severe kidney disease or liver disease.

When taking Talicia, do not crush or chew capsules. Do not take Talicia with alcohol.

Call your healthcare provider immediately if while taking Talicia you develop:

New rash or other skin changes, muscle or joint pains, swelling of any area of the body, severe flu-like symptoms, difficulty breathing, fever, blood in your urine, increased or decreased urination, drowsiness, confusion, nausea, vomiting, ongoing stomach pain, bloody diarrhea, or if diarrhea continues after therapy is completed, weight gain or changes in your eyesight.

What are the common side effects of Talicia?

The most common side effects of Talicia are diarrhea, headache, nausea, stomach pain, rash, indigestion, mouth or throat pain, vomiting, and vaginal yeast infection. Call your healthcare professional for medical advice about side effects.

Tell your healthcare provider if you experience tiredness, weakness, achiness, headaches, dizziness, depression, increased sensitivity to light, or pain when taking a deep breath.

Talicia may reduce the effectiveness of oral or other forms of hormonal birth-control. You should use an additional non-hormonal highly effective method of birth control while taking Talicia.

You may experience a brown-orange discoloration of your urine or tears while taking Talicia.

The information here is not comprehensive. Talk to your healthcare provider to learn more.

APPROVED USE FOR TALICIA

TALICIA is a prescription medicine for the treatment of a bacteria, Helicobacter pylori (H. pylori), in the stomach of adults.

Click here for the full Prescribing Information for TALICIA.

You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.