Allergan swoops for NASH biotechs

Allergan has raised eyebrows with its acquisition of two companies working to find treatments for liver disease non-acoholic steatohepatitis (NASH) – an area of research that has also attracted attention from Gilead and Shire.

Allergan aims to combine the lead drugs from Tobira and Akarna to produce a treatment for NASH, for which there is no approved treatment.

In patients with NASH, a build-up of fat in the liver can lead to cirrhosis, leaving it scarred and unable to work properly.

Allergan is to buy Tobira for up to $1.7 billion if its late stage NASH drug is successful – buying the company for $29.35 a share up front, followed by a contingent value right of $49.84 per share based on completion of development, regulatory and commercial milestones.

The deal is surprising given that phase 2b study results released in July show that Tobira’s lead product, cenicriviroc, failed to meet its primary endpoint of a two-point reduction in a fibrosis score.

However the drug did meet a secondary endpoint of improvement in at least one stage without worsening of the disease.

The company plans to use this an endpoint for phase 3 studies to support a filing, which could begin next year.

The trial failure had sent Tobira’s share price down, but it yesterday it surged by 720% to $38.91 on the NASDAQ stock exchange following the news, although Allergan’s value ticked down because of the risky nature of the deal.

Cenicriviroc (CVC) is a first-in-class, once-daily, oral immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure.

Tobira also has evogliptin, an oral dipeptidyl peptidase-4 (DPP-4) inhibitor for NASH in phase 1 development.

Allergan followed the Tobira announcement with the news it had acquired privately held biotech, Akarna, for an upfront payment of $50 million plus other milestones related to its lead compound, AKN-083.

AKN-083 is a potentially best-in-class preclinical farnesoid X receptor (FXR) agonist in development for the treatment of NASH, which Allergan said is “highly complementary” to Tobira’s cenicriviroc and evogliptin.

Several other companies are competing to develop treatments for NASH – in April Gilead paid $1.2 billion for Nimbus Therapeutics’ liver drug subsidiary, which is also developing a NASH treatment.

The US Food and Drug Administration has fast-tracked Shire’s early stage NASH drug, volixibat, and Intercept has obeticholic acid, already approved in another liver disease, in phase 3b development.

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