Calliditas gets controlling stake, option to buy out Genkyotex and its failed PBC drug

Calliditas gets controlling stake, option to buy out Genkyotex and its failed PBC drug

Calliditas is spending a little over €20 million for a controlling stake in Genkyotex in the hope it can help revive its faltering attempts in primary biliary cholangitis (PBC).

First up, the nuts and bolts of the deal are this: Calliditas snaps up 62.7% of Genkyotex for €20.3 million in cash at €2.80 per share, with total consideration for 100% of Genkyotex coming to around €32 million. On top of this are milestones of up to €55 million.

The biobucks payments are wedded to NOX inhibitor setanaxib (GKT831), Genkyotex’ lead drug which is focused on PBC.

PBC, previously known as primary biliary cirrhosis, is an autoimmune disease of the liver and causes bile ducts to be damaged. Intercept Pharmaceuticals has an approved drug for the condition, Ocaliva, though it’s usually seen as lower in importance when compared to NASH, or fatty liver disease, in terms of sales potential.

Last May, it revealed data from a placebo-controlled trial, missing its primary endpoint, percentage change in serum gamma-glutamyl transferase (GGT) at 24 weeks. They had seen better luck in a smaller trial over a shorter period of time six months before this.

The company still decided to push on with more trials, and now has a little more capital and the backing of Calliditas to help.

“We believe this transaction represents an exciting expansion of our pipeline in orphan diseases related to inflammation and fibrosis”, said Calliditas’ CEO Renée Aguiar-Lucander.

“We believe Genkyotex’s novel NOX inhibition technology may have broad clinical utility not just in PBC, but as a platform therapy with the potential to target other fibrotic indications, including Primary Sclerosing Cholangitis (PSC), selected kidney diseases and Idiopathic Pulmonary Fibrosis (IPF), in which an investigator led phase 2 trial is expected to start recruitment later this year.”

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