RedHill Biopharma is a specialty pharma company with a broad R&D pipeline focusing on gastrointestinal and inflammatory diseases and also promotes several GI products in the US. The most advanced programs are TALICIA for H. pylori infection, RHB-104 for Crohn’s disease, BEKINDA for gastroenteritis and IBS-D, and RHB-204 for NTM.
RedHill Biopharma announced yesterday that the FDA has approved Talicia for the treatment of H. pylori infection in adults. The label is broad and potentially positions Talicia to compete as a front-line treatment. Talicia now is the only rifabutin-based combination antibiotic treatment approved by the FDA. In two Phase III clinical trials conducted by RedHill, no resistance to rifabutin was observed, which will be the key competitive advantage compared to standard-of-care clarithromycin-based H. pylori treatment. We previously assigned a high likelihood (90%) of successful approval given the good efficacy data and clean safety profile. Our last published RedHill valuation was $556m or $15.8 per ADS, which we increase to $571m or $16.2 per ADS following the removal of the remaining probability of success from our model.
RedHill’s main focus on GI and inflammation include a range of conditions, which although can be treated with a variety of innovative and established products, there is still an unmet need in each of the diseases. In our view, carefully positioned, innovative solutions for the patients will attract attention.