RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma Announces Talicia Approved in the United Arab Emirates and First Commercial Order Outside the U.S.

https://finance.yahoo.com/news/redhill-biopharma-announces-talicia-approved-110000468.html

RedHill's partner, Gaelan Medical, part of the Ghassan Aboud Group (GAG), receives marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia

Gaelen placed a meaningful initial Talicia order and commences commercialization activities

Talicia, a novel rifabutin-containing all-in-one oral capsule specifically designed to treat H. pylori, is the leading branded first-line therapy prescribed by U.S. gastroenterologists[1] for eradication of H. pylori - a bacterial infection that affects 41% of the UAE adult population[2]

RALEIGH, N.C. and TEL-AVIV, Israel, Aug. 1, 2023 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, announced that its partner, Gaelan Medical LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), has received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin)[3]. The approval makes Talicia the first approved rifabutin-containing all-in-one combination product in the UAE specifically designed to treat H. pylori.

"We are delighted with the rapid progress our partner, Gaelen Medical, has made in achieving marketing approval for Talicia in the UAE, and we are pleased to have received the first commercial order for Talicia from Gaelen," said Adi Frish, RedHill's Chief Corporate & Business Development Officer. "H. pylori is a major public health concern in the region, impacting up to 84% of the population[4], and is one of the strongest risk factors for gastric cancer. Considering the alarming failure rates of clarithromycin-based therapies and the need for highly effective first-line H. pylori therapy, we continue our efforts to help bring Talicia to H. pylori patients in additional countries as we continue to explore, with GAG and other potential partners, the expansion of Talicia's reach into new territories."

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[5]. 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[6],[7]. Clarithromycin-based treatment efficacy can also be negatively impacted by patient BMI or diabetic status, neither of which impact Talicia's eradication rates, according to data from post-approval post-hoc analysis[8],[9].

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[10]. 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[11] and a major risk factor for peptic ulcer disease[12] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[13]. More than 27,000 Americans are diagnosed with gastric cancer annually[14]. 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[15] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[16]. 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 indicated for the treatment of Helicobacter pylori infection in 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.

About Gaelan Medical

Gaelan Medical is a part of Ghassan Aboud Group, an international conglomerate that has been engaged in several key business sectors including health care, automotive, hospitality, real estate, retail, catering, logistics, pastoral, trade and distribution and media for more than two decades. Headquartered in the United Arab Emirates, GAG's business operations are complemented by offices in Australia, Belgium, Jordan and Turkey.

Ghassan Aboud Group believes that productivity, innovation and transformation require community engagement and ensures that its exclusive portfolio operates in a corporate conscious and a responsible manner making people the number one priority behind its vision "Being at the forefront of excellence".

Gaelan Medical, the UAE based healthcare and beauty distribution business follows a mission of care and cure and is dedicated to support healthcare providers with world-class solutions to better serve communities across the GCC region. Gaelan Medical, with its experienced management team, caters to diverse healthcare needs including, pharmaceuticals, medical consumables, medical equipment, and beauty products. The company's flexibility and strong financial capabilities of its parent company GAG makes it the preferred partner-of-choice and one stop solution for the region.