RedHill Biopharma Ltd (RDHL)

[noretreat]

Attached please find RedHill Biopharma’s press release announcing that it has submitted a New Drug Application (NDA) to the U.S. FDA for Talicia (RHB-105) for the treatment of H. pylori infection.
The NDA follows a recent positive pre-NDA meeting with the FDA.
The NDA for Talicia is eligible for six-month priority review.
Talicia is eligible for a total of eight years of U.S. market exclusivity, in addition to patent protection until at least 2034.
RedHill continues to strengthen its U.S. commercial operations with senior industry executives ahead of the planned commercial launch of Talicia, as early as Q4/2019.
H. pylori bacterial infection is the strongest risk factor for developing gastric cancer and affects over 50% of the population worldwide and approximately 35% of the U.S. population.

Current standard-of-care therapies fail in approximately 30-40% of patients due to increasing resistance to antibiotics commonly used in standard combination therapies; notably, no resistance to rifabutin, a key component of Talicia, was detected throughout the Phase 3 ERADICATE Hp2 study.

Talicia has the potential to become the new first-line standard-of-care therapy for H. pylori infection, targeting an estimated 2.5 million U.S. patients treated annually.

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.”
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.”