RedHill Biopharma Submits New Drug Application for Talicia for H. pylori Infection

RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on gastrointestinal diseases, today announced that, following a positive pre-NDA meeting held recently with the U.S. Food and Drug Administration (FDA), it has submitted a New Drug Application (NDA) to the FDA for Talicia (RHB-105)1 for the treatment of H. pylori infection.

The NDA was submitted under the 505(b)(2) regulatory pathway. Talicia was granted Qualified Infectious Disease Product (QIDP) designation by the FDA and is eligible for six-month priority review of the NDA. If approved, Talicia will receive an additional five years of U.S. market exclusivity on top of the standard exclusivity period, for a total of eight years of market exclusivity. Talicia is also covered by U.S. patents which extend patent protection until at least 2034, with additional patents and applications pending in various territories worldwide.

Gilead Raday, RedHill’s chief operating officer, stated: "The NDA submission for Talicia is a transformative milestone for RedHill and a critical step in our efforts to bring this much needed potential new therapy for H. pylori infection to the market. Assuming FDA approval, commercial launch is planned for the fourth quarter of 2019 with our established U.S. sales force, led by a highly experienced commercial management team."

The NDA for Talicia is supported by a clinical package including two positive Phase 3 studies in the U.S., along with two pharmacokinetic studies evaluating food effects and the comparative bioavailability of Talicia. The first Phase 3 study with Talicia (ERADICATE Hp) successfully met its primary endpoint of superiority over historical standard-of-care eradication rate of 70%, demonstrating 89.4% efficacy in eradicating H. pylori infection with Talicia (p<0.001). The confirmatory Phase 3 study (ERADICATE Hp2) also met its primary endpoint, demonstrating 84% eradication of H. pylori infection with Talicia vs. 58% in the active comparator arm (p<0.0001). Moreover, 90% of subjects with confirmed blood levels of Talicia’s actives on day 13 of treatment (an indicator of compliance) achieved confirmed eradication of H. pylori. Importantly, low rates of eradication were obtained in patients treated with physician-directed standard-of-care therapies in the open-label parts of these studies (63% and 53%, respectively). These results are consistent with the literature describing the diminished efficacy of standard-of-care therapies. RedHill plans to share the ERADICATE Hp2 data in greater detail at upcoming scientific conferences and publications.

Ira Kalfus, M.D., RedHill’s medical director, said: "Talicia demonstrated robust results in its clinical studies for H. pylori infection, a common and increasingly resistant and difficult to treat pathogen. Importantly, in our clinical study, no H. pylori resistance to rifabutin, one of the key ingredients in Talicia, was identified pre and post treatment. We believe Talicia has the potential to become the new first-line, standard-of-care therapy for H. pylori infection and would like to thank the patients, investigators and clinical support staff who were involved in the clinical studies of this important potential new therapy."

RedHill continues to implement its U.S. commercialization strategy in anticipation of the potential launch of Talicia with its dedicated sales force. As part of the ongoing preparations for the potential launch, RedHill continues to strengthen its commercial management team with additional senior industry executives. The Company’s sales and marketing teams currently promote several commercial GI products to gastroenterologists, other high-prescribing specialists and primary care physicians across select U.S. territories.

Talicia is a novel, patent-protected and proprietary fixed-dose, all-in-one oral capsule for the treatment of H. pylori infection. Talicia is addressing the increasing resistance of H. pylori bacteria to the antibiotics commonly used in current standard-of-care therapies and the imperative need for new treatments, as defined by the World Health Organization (WHO)2.

It is estimated that H. pylori infection affects over 50% of the population worldwide3 and approximately 35% of the U.S. population4, with an estimated 2.5 million patients treated annually in the U.S.5 H. pylori, classified as a group I carcinogen, is the strongest risk factor for the development of gastric cancer3 and a major risk factor for development of peptic ulcer disease6. The 2018 potential market for H. pylori eradication therapies was estimated at approximately $4.8 billion worldwide and $1.4 billion in the U.S.7

About Talicia (RHB-105)

Talicia (RHB-105) is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole. Talicia is pursuing an indication of treatment of H. pylori infection, regardless of ulcer status, a significantly broader indication than current standard treatments for H. pylori infection. Talicia has been investigated in two positive Phase 3 studies in the U.S. for the treatment of H. pylori: the ERADICATE Hp2 confirmatory Phase 3 study met its primary endpoint, with results demonstrating 84% eradication of H. pylori infection with Talicia (p<0.0001). The ERADICATE Hp first Phase 3 study met its primary endpoint, demonstrating 89.4% efficacy in eradicating H. pylori infection with Talicia (p<0.001). Eradication of H. pylori is becoming increasingly difficult; current standard-of-care therapies fail in approximately 30-40% of patients who remain H. pylori positive due to increasing resistance of H. pylori to antibiotics commonly used in standard combination therapies8. No resistance to rifabutin, a key component of Talicia, was detected in culture results taken throughout the ERADICATE Hp2 study from patients across 20 U.S. states. Talicia was granted Qualified Infectious Disease Product (QIDP) designation and Fast-Track development designation by the FDA, including eligibility for six-month priority review and a total of eight years of U.S. market exclusivity. Talicia is also covered by U.S. patents, which extend patent protection until at least 2034, with additional patents and applications pending in various territories worldwide.

About H. pylori

H. pylori bacterial infection affects over 50% of the population worldwide3 and approximately 35%, or over 100 million people, in the U.S.4, with an estimated 2.5 million patients treated annually in the U.S.8 H. pylori is classified as a group I carcinogen by the International Agency for Research on Cancer. It is the strongest risk factor for the development of gastric cancer3, a major risk factor for peptic ulcer disease7 and gastric mucosa-associated lymphoid tissues (MALT) lymphoma9. Eradication of H. pylori is becoming increasingly difficult; current standard-of-care therapies fail in approximately 30-40% of patients who remain H. pylori positive due to growing resistance of H. pylori to clarithromycin and metronidazole, antibiotics commonly used in standard combination therapies9. Clarithromycin-resistant H. pylori was formally categorized by the World Health Organization (WHO) as a pathogen for which there is a high priority need to develop new treatments2. The 2018 potential market for H. pylori eradication therapies was estimated at approximately $4.8 billion worldwide and $1.4 billion is from the U.S.8

The ERADICATE Hp2 and ERADICATE Hp Phase 3 studies with Talicia (RHB-105) are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health (NIH), which provides access to information on publicly and privately supported clinical studies.

About RedHill Biopharma Ltd.

    RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) is a specialty biopharmaceutical company, primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases. RedHill commercializes and promotes several gastrointestinal products in the U.S.: Donnatal® - a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis; EnteraGam® - a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools and Mytesi® - an anti-diarrheal drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. RedHill’s key clinical-stage development programs include: (i) Talicia® (RHB-105) for the treatment of Helicobacter pylori infection with a U.S. NDA submitted; (ii) RHB-104, with positive top-line results from a first Phase 3 study for Crohn's disease; (iii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iv) BEKINDA® (RHB-102), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) YELIVA® (ABC294640), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 2a study for cholangiocarcinoma; (vi) RHB-106, an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd. and (vii) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases.

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