RedHill jumps on FDA H. pylori drug approval

Dror Ben-Asher

H. pylori is classified as a Group I carcinogen and is the strongest risk factor for the development of peptic ulcer disease, gastritis and non-cardia gastric cancer.

Israeli drug development company RedHill Biopharma Ltd. (Nasdaq: RDHL); TASE: RDHL) announced today that it has received US Food and Drug Administration (FDA) approval for marketing Talicia, an antibiotic cocktail for the treatment of the H. pylori infection. H. pylori is classified as a Group I carcinogen and is the strongest risk factor for the development of peptic ulcer disease, gastritis and non-cardia gastric cancer.

Redhill plans launching the drug in the US from the first quarter of 2020, having already built a marketing and distribution network for gastrointestinal drugs based on products whose marketing rights it has purchased from other companies.

RedHill Biopharma CEO Dror Ben-Asher said, "The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases. We thank the patients, researchers and clinical staff who participated in the studies of Talicia and the RedHill team and vendors for this important milestone achieved by their commitment and hard work. We are working to expand our sales force to approximately 140 representatives who will promote Talicia, Aemcolo and other gastrointestinal-focused products in our basket."

Antibiotic treatments for H. pylori exist but in many cases the bacteria have developed immunity to these existing treatments and alternatives are therefore required.

In premarket trading on Nasdaq, RedHill's share price is up 32.08% at $9.12, having risen 2.67% yesterday to $6.92, giving a market cap of $248 million.

Published by Globes, Israel business news - en.globes.co.il - on November 4, 2019

© Copyright of Globes Publisher Itonut (1983) Ltd. 2019

Dror Ben-Asher
Dror Ben-Asher
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