Allergan has entered into a definitive agreement to acquire Tobira Pharmaceuticals, a clinical-stage biopharma company developing therapies for non-alcoholic steatohepatitis (NASH) and other liver disease, for a total potential consideration of $1.7 billion in cash and certain development, regulatory and commercial milestones. The boards of directors of both companies have approved the transaction and Allergan anticipates closing by the end of 2016.
 
NASH is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver, accompanied by inflammation and cellular damage leading to cirrhosis, portal hypertension, liver cancer and eventual liver failure.
 
The acquisition adds Cenicriviroc (CVC) and Evogliptin, two differentiated, complementary development programs for the treatment of the multi-factorial elements of NASH, including inflammation, metabolic syndromes and fibrosis, to Allergan’s gastroenterology R&D pipeline.

Cenicriviroc  is a first-in-class, once-daily, oral Phase III ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in the inflammatory and fibrogenic pathways in NASH. Phase II studies have demonstrated a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH. Evogliptin is an oral DPP-4 (Dipeptidyl peptidase-4) inhibitor for the potential treatment of NASH which is being studied in a Phase I trial assessing the safety, tolerability and steady-state pharmacokinetic parameters of the compound.
 
“The acquisition of Tobira is a strategic R&D investment within a white space area of our global Gastroenterology franchise and an opportunity to advance the development of novel treatments for NASH,” said Brent Saunders, CEO and President of Allergan. “With the increasing rates of diabetes, obesity and other metabolic conditions in the U.S. and in developed nations globally, NASH is set to become one of the next epidemic-level chronic diseases we face as a society. It is important that we invest in new treatments today so that healthcare systems, providers and patients have treatment options to face this challenge in the coming years.”

“I am extremely excited to see Tobira and Allergan come together,” said Laurent Fischer, M.D., Chief Executive Officer, Tobira Therapeutics. “The combination of our team’s innovation in the NASH space and the infrastructure, development expertise and world-class ability of Allergan to market medicines will enable us to more rapidly develop and commercialize needed medications for patients suffering from NASH and other serious fibrotic diseases around the world.”