RedHill Biopharma Announces FDA Grant of 5-Year US Market Exclusivity for Talicia® with IP Protection Running to 2034

The U.S. FDA has granted five years' market exclusivity for Talicia under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, as recommended by the FDA Exclusivity Board

This grant is on top of three years' exclusivity granted for the approval of Talicia under section 505(b)(2). Talicia is protected by its broad intellectual property suite to 2034

Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists¹ for eradication of H. pylori - a bacterial infection that affects approximately 35% of the U.S. adult population²

 RedHill Biopharma Ltd. a specialty biopharmaceutical company, announced that the U.S. FDA (U.S. Food and Drug Administration) has granted five years' market exclusivity for Talicia³ under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, as recommended by the FDA Exclusivity Board. This grant is on top of three years' exclusivity granted for the approval of Talicia under section 505(b)(2). Talicia is protected by its broad intellectual property suite to 2034.

Talicia is the only FDA-approved rifabutin-based therapy for the eradication of H. pylori. Its components and formulation are optimized to provide patients with the necessary medications for successful H. pylori eradication, an innovation rewarded by this market exclusivity and other IP, providing protection to 2034," said Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs. "With significant concerns around maintaining effective therapeutic options for infectious diseases in the face of growing microbial resistance, it is vital that the most effective options are utilized first line. Talicia's favorable efficacy, tolerability, and resistance profile, in the only all-in-one formulation available, provides potential advantages over clarithromycin-based regimens for most patients."

The FDA recently approved a supplemental new drug application (sNDA) for Talicia, allowing a change to a more flexible three times daily (TID), taken at least 4 hours apart with food, dosing regimen for H. pylori eradication enabling patients to follow a convenient "breakfast, lunch and dinner" dosing routine, which may support increased patient adherence and optimize the potential for successful H. pylori eradication.

About H. pylori infection     

H. pylori is a bacterial infection that affects approximately 35% of the U.S. population, with an estimated two million patients treated annually⁴. 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 cancer⁵ and a major risk factor for peptic ulcer disease⁶ and gastric mucosa-associated lymphoid tissue (MALT) lymphoma⁷. More than 27,000 Americans are diagnosed with gastric cancer annually⁸. 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 therapies2.

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 adherent⁹ to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm¹⁰. 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.

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 adults3, and Aemcolo^®, for the treatment of travelers' diarrhea in adults¹¹. 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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!