NEWS: Talicia NDA filed!
7 May, 2019
TEL-AVIV, Israel and RALEIGH, N.C., May 7, 2019 -- 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
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