Israeli biopharmaceutical firm RedHill Biopharma Ltd. said on Tuesday it has submitted a new drug application (NDA) request to the US Food and Drug Administration for its drug to treat a bacterial infection that can cause ulcers and gastric cancer.
The firm, whose shares are traded on the Nasdaq and the Tel Aviv Stock Exchange, said that if its request is approved, its Talicia (or RHB-105 as it is also known) fixed-dose oral capsule for the treatment of H. pylori infection will get an exclusivity period of eight years for the production and the sale of the drug in the US, in addition to patent protection until at least 2034, according to a statement.
The drug is a combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI) called omeprazole.
H. pylori is a bacterial infection proven to be a major cause of ulcers and a major contributor to gastroenteritis, gastric cancer, and other stomach-related maladies.
“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,” said Gilead Raday, RedHill’s chief operating officer, in the statement. “Assuming FDA approval, commercial launch is planned for the fourth quarter of 2019.”
The firm has a sales force ready to go on the ground in the US, he said.
Redhill said its two Phase 3 studies in the US, along with two additional pharmacokinetic studies, have shown the efficacy of Talicia in eradicating the H. pylori infection, with results of 84% and 89.4% compared with 70% for historical standard-of-care antibiotics used to treat the condition.
Talicia also addresses the increasing resistance of the H. pylori bacteria to the antibiotics commonly used in current standard-of-care therapies, triggering the necessity to develop new treatments, the statement said. Current standard-of-care antibiotic therapies fail in approximately 30-40% of patients who remain H. pylori positive, due to increasing resistance of the bacteria to the antibiotics commonly used to combat it.
“Talicia demonstrated robust results in its clinical studies for H. pylori infection, a common and increasingly resistant and difficult to treat pathogen,” said Ira Kalfus, M.D., RedHill’s medical director, in the statement. “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.”
It is estimated that H. pylori infection affects over 50 percent of the population worldwide and some 35% in the US, where some 2.5 million patients are treated annually, the statement said. H. pylori is a strong risk factor for the development of gastric cancer and a major risk factor for the development of peptic ulcers, studies cited by Redhill have shown.
The 2018 potential market for H. pylori eradication therapies was estimated at approximately $4.8 billion worldwide and $1.4 billion in the US, the statement said.
RedHill was founded by Dror Ben-Asher and Ori Shilo, two kibbutz dwellers turned investment bankers and now entrepreneurs.
RedHill shares were trading 6.7% higher in afternoon trading in Tel Aviv, bringing its rise in the past 12 months to 62%.
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