Allergan has gone on the acquisition trail once again, stumping up more than $1.7bn for non-alcoholic steatohepatitis (NASH) drug developers Tobira Therapeutics and Akarna Therapeutics.
The headline deal is the $1.69bn offered for Tobira Therapeutics and lead NASH candidates cenicriviroc and evogliptin, which was swiftly followed by an agreement to buy preclinical-stage Akarna for $50m upfront and undisclosed milestones.
Investors were wide-eyed about the size of the Tobira deal – which comes in at a six-fold premium to the small company’s closing share price ahead of the announcement – particularly as cenicriviroc failed to meet its objectives in a phase IIb trial reported in July. Tobira insisted at the time there were sufficient signs of efficacy to push the drug into phase III trials, due to start next year.
The draw for Allergan is the sheer scale of NASH, which currently has no approved therapies. It is a form of liver disease characterised by the accumulation of fat and affects up to 15 million people in the US – often being seen in people with obesity, type 2 diabetes, and insulin resistance – and is becoming increasingly common worldwide.
NASH is predicted to become the leading cause of liver transplantation by 2020, and some analysts have predicted that the market for treatments could reach an eye-watering $35-40bn by 2025. “NASH is set to become one of the next epidemic-level chronic diseases we face as a society,” said Allergan CEO Brent Saunders.
Turning to the second deal, UK-based Arkana’s lead candidate is a non-bile farnesoid X receptor (FXR) agonist – AKN-083 – with a number of other follow-ups in the pipeline.
The acquisition puts Allergan in a race to market with other FXR-targeting drugs for NASH, including Intercept Pharma which has a drug with mechanism already on the market for another indication, as well as Gilead Sciences and Phenex. Allergan maintains AKN-083 is potentially best-in-class.
Intercept is testing its Ocaliva (obeticholic acid) drug in phase III trials for NASH, having picked up an FDA approval for the drug in May for another liver disease called primary biliary cholangitis.
The size of the market opportunity in NASH means that pharma pipelines are packed pretty full, with dozens of drugs already in the clinic, so Allergan could find its drugs have to jostle for position if they make it through to registration.
Other candidates in clinical development include Bristol-Myers Squibb/Ambrx’ BMS 986036, Horizon/Raptor Therapeutics’ RP103, Zydus Cadila’s saroglitazar (in phase III) and Gilead Sciences’ simtuzumab (phase II).
The two deals take Allergan’s acquisitions this month to four – coming after it bought dermatology company Vitae Pharmaceuticals for $640m and gene therapy start-up RetroSense Therapeutics for $60m.