Memorandum
In a surprise Tuesday morning announcement, Allergan announced that it will acquire Tobira Therapeutics in a $1.7 billion deal. Tobira is known for its focus on liver diseases, and accordingly, Allergan will now make nonalcoholic steatohepatitis (NASH) a pipeline priority. Specifically, Allergan will develop cenicriviroc (CVC), a CCR2/CCR5 inhibitor in phase 2, and evogliptin, a DPP-4 inhibitor in phase 1 as an add-on to CVC. The FDA previously granted Fast Track status to CVC for the treatment of liver fibrosis and NASH, a common co-morbidity of type 2 diabetes and obesity, and an area of high unmet need. Notably, one-year interim topline results from the two-year trial showed that CVC failed to meet its primary endpoint of improved NAFLD Activity score, which may hinder the candidate’s development. That said, CVC demonstrated significant improvements in the secondary endpoint of fibrosis, and there’s a chance that with a Special Protocol Assessment the FDA could approve the candidate on the fibrosis data alone. Evogliptin is the first DPP-4 inhibitor being investigated for NASH. Elevated serum DPP-4 levels and increased hepatic DPP-4 expression have been correlated with NASH severity and we’re intrigued by the potency of a CVC/evogliptin combination. Very notably, Allergan is buying Tobira for 19 times its previous market value, a strong vote of confidence in the market potential for NASH therapies, and we certainly hope to see clinical advancements now that Allergan houses some of the strongest contenders for this indication. Allergan’s acquisition marks the latest major pharmaceutical player to enter the NASH field – see our updated competitive landscape for more. Okay, back to the drawing board for Allergan on diabetes/obesity – we covered Lap-Band for many years as a reminder to longtime readers – we look forward to watching the company’s work in NASH.
-- by Payal Marathe, Helen Gao, and Kelly Close