Talicia® is indicated for the treatment of Helicobacter pylori infection in adults

Patients can now access RedHill’s Talicia® via the PhilRx Platform

Phil Inc., a patient access platform company that revolutionizes life science product commercialization, today announced an agreement with RedHill Biopharma (Nasdaq: RDHL) (‘RedHill’) to make its medication Talicia® (omeprazole magnesium, amoxicillin, and rifabutin) available via the PhilRx Patient Access Platform.

The PhilRx Patient Access Platform provides end-to-end visibility into the entire prescription life cycle, starting the moment the physician writes a prescription. HCPs can send an electronic prescription (eRx) for Talicia® to PhilRx directly from their electronic health record (EHR). The PhilRx Patient Access Platform simplifies the prior authorization process (PA) for physicians by allowing them to submit PAs for the medication with just one-click, streamlining the insurance coverage process for patients and increasing the chances of insurance reimbursement.

The partnership between Phil and RedHill enables patients to receive Talicia® prescriptions quickly, easily, and affordably. Using the PhilRx Patient Access Platform, patients can fill their prescription, review prescription records, and obtain assistance navigating insurance benefits.

“RedHill is focused on advancing gastrointestinal and infectious diseases management through innovation, dedication, and a collective mindset of delivering on our promises. Our partnership with Phil will elevate our ability to eliminate access barriers to Talicia®,” said Ben Sloan, VP of Market Access at RedHill. “We are continually seeking ways to streamline prior authorizations and help patients navigate their insurance coverage, and the PhilRx platform will address and simplify these complex processes.”

Talicia® is approved for the treatment of H. pylori, a common gastrointestinal (GI) bacterial infection that damages tissue in the stomach. While most people have H. pylori bacteria for years, many do not experience symptoms. In some cases, though, the infection can cause redness and swelling of the stomach lining. H. pylori is the main cause of peptic ulcers, and it can also cause gastritis and stomach cancer.

“H. pylori affects approximately 35% of adult Americans, and these conditions often go undiagnosed or untreated,” said Patrick Leary, Chief Commercial Officer, Phil. “Phil’s modern technology platform aims to improve the prescription process for life science companies, physicians, and patients – and working alongside RedHill to improve access to medication has the potential to transform their brand and positively impact patients.”

Learn more about the PhilRx Patient Access Platform.

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 the key components 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 to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm. 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 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 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, and Aemcolo^® for the treatment of travelers' diarrhea in adults. 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 U.S. Government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease. More information about the Company is available at www.redhillbio.com/ twitter.com/RedHillBio.

About Phil, Inc.

Phil, Inc. revolutionizes life science product commercialization with technology to improve prescription access. Our patient access platform removes barriers to medication access and ensures patients can seamlessly start and adhere to therapy. Providing end-to-end visibility into the prescription life cycle, we unlock coverage and maximize reimbursement for brands while integrating into the lives and workflows of patients and providers. We combine a Silicon Valley mindset and deep pharma expertise with data insights and software-driven platform customization to improve provider experience and elevate brand value.

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