Please login to the form below

Not currently logged in

Calliditas bets on PBC drug in Genkyotex buyout

Calliditas will acquire 62.7% of company for an initial €20.3m

Calliditas is set to acquire a controlling interest in French biotech Genkyotex, gaining access to its lead primary biliary cholangitis (PBC) asset in the process.

Calliditas will acquire 62.7% of Genkyotex in an initial payment of €20.3m, expected to close in early October. The company will then seek to acquire all outstanding Genkyotex shares, with a total acquisition cost of approximately €32.2m as well as up to €55m in contingent rights.

The additional payments are dependent on the success of setanaxib (GKT831), Genkyotex’s lead clinical candidate which is currently in development for PBC, a chronic liver disease caused by progressive destruction of the bile ducts in the liver.

In a phase 2 clinical trial, setanaxib demonstrated evidence of anti-fibrotic activity and also possessed a favourable tolerability level, as well as a statistically significant effect on fatigue. The drug is also being evaluated in a phase 2 clinical trial in type 1 diabetes and kidney disease, and a further phase 2 trial of the drug in IPF is scheduled to recruit patients over the course of 2020.

Genkyotex will be eligible to receive €30m on approval of setanaxib for a first indication by the US Food and Drug Administration, as well as another €15m dependent on the drug's first approval by  the European Commission. A further €10m will be payed following the approval by the FDA or EC in either idiopathic pulmonary fibrosis (IPF) or type 1 diabetes.

Genkyotex’s platform identifies small molecules which can selectively inhibit specific NOX enzymes that amplify multiple disease processes including fibrosis, inflammation, pain processing, cancer development and neurodegeneration. Setanaxib, a NOX1 and NOX4 inhibitor, has potential in a range of fibrotic indications, according to Genkyotex.

"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,” said Renée Aguiar-Lucander, chief executive officer at Calliditas.

Article by
Lucy Parsons

14th August 2020

From: Sales



Subscribe to our email news alerts

Featured jobs


Add my company
Hanover Communications

Healthcare is evolving rapidly. To stand out from the crowd requires a potent combination of rich insight, innovative ideas and...

Latest intelligence

Environment: where does the pharmaceutical industry stand?
The communication challenge of helping he next generation to be healthier
As the pressure on the health service increases the health of the next generation is vital for everyone. How do we show positive attitudes and change behaviour while future proofing...
Are we losing sight of what the democratisation of healthcare really looks like?
We have a core responsibility as healthcare communicators to consistently drive for better inclusion, engagement and compliance. What does the ‘democratisation of healthcare’ really look like?...