The German Federal Cartel Office (Bundeskartellamt) has approved Novo Nordisk A/S’s planned acquisition of all shares in Akero Therapeutics, Inc., concluding that the merger does not raise concerns regarding innovation competition in the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
Novo Nordisk, headquartered in Denmark, is a leading global pharmaceutical company specializing in therapies for diabetes and obesity. Its best-known products include the semaglutide-based treatments Wegovy and Ozempic. In addition to their established uses, semaglutide is currently being investigated for the treatment of MASH, a chronic liver disease which, in advanced stages, can progress to life-threatening cirrhosis.
Akero Therapeutics, based in South San Francisco, focuses exclusively on MASH research. Unlike Novo Nordisk, the company has no approved products on the market. Its sole drug candidate, efruxifermin (EFX), is being developed for both pre-cirrhotic MASH and MASH-related cirrhosis. Clinical trials for EFX are underway globally.
According to the Bundeskartellamt, the companies’ research pipelines overlap only in the early stages of MASH. Importantly, both firms face significant competition from other global pharmaceutical and biotechnology companies developing treatments for fatty liver disease. For advanced cirrhosis, a competing research project is already at a more advanced stage than either Novo Nordisk’s or Akero’s work.
Andreas Mundt, President of the Bundeskartellamt, stated:
“There is a significant unmet need for the treatment of advanced fatty liver disease, which affects an estimated 250 million people worldwide. The research efforts of Novo Nordisk and Akero overlap only at an early disease stage. Given the presence of an approved product and several advanced research projects from other companies, as well as a further-developed competing project for cirrhosis, a restriction of innovation competition is not expected.”
The merger review was conducted under the transaction value threshold provision of German competition law, which allows the authority to scrutinize transactions exceeding €400 million even when the target company generates little or no revenue.
With the clearance granted, Novo Nordisk may proceed with the acquisition of Akero Therapeutics.