BRIEF—Israel's RedHill Biopharma files NDA for Talicia

Israel’s RedHill Biopharma today announced that, following a positive pre-NDA meeting held recently with the US Food and Drug Administration, it has submitted a New Drug Application (NDA) to the FDA for Talicia (RHB-105) for the treatment of H. pylori infection.

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 US market exclusivity on top of the standard exclusivity period, for a total of eight years of market exclusivity.

Talicia is also covered by US patents which extend patent protection until at least 2034, with additional patents and applications pending in various territories worldwide.

RedHill continues to implement its US 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 US territories.