The biggest biopharma acquisition of a drug company in 2021 has been delayed as antitrust reviews drag on.
Wednesday, Australian biotech CSL said (PDF) the regulatory review of its $11.7 billion acquisition of Switzerland’s Vifor Pharma will take “a few more months,” suggesting it won’t be able to close the transaction by June 2022 as previously expected.
In its own statement, Vifor on Thursday said some antitrust authorities haven’t delivered a verdict. A Vifor spokesperson declined to specify which regulators remain undecided or whether any specific concerns have been raised. Rulings from the U.S. Federal Trade Commission, the European Competition Commission and the Swiss Takeover Board are all still pending, the Australia Financial Review reports.
Delays in the regulatory approval process are not unusual, Vifor noted. Vifor said the two firms are continuing to work with the remaining antitrust authorities, and CSL said it remains confident in completing the buyout.
Winning antitrust green lights represent the last hurdle in the Vifor acquisition. Back in March, CSL said (PDF) it had collected 74% of Vifor shares and therefore declared the tender offer successful. At the time, the Australian company said the antitrust review process was on track and it reconfirmed the mid-2022 deal closure timeline.
CSL has its eyes on Vifor’s kidney disease and iron deficiency offerings. CSL’s biotech business, CSL Behring, is currently heavily dependent on its immunoglobulin portfolio, which is facing some difficulties during the pandemic due to plasma collection constraints. Elsewhere, the company’s hereditary angioedema therapy Haegarda is under pressure from Takeda’s Takhzyro and BioCryst Pharma’s newly launched oral drug Orladeyo.
The Australian biotech also sells hemophilia B product Idelvion, and its hemophilia B gene therapy program, bought from uniQure, recently turned up positive results in a phase 3 trial.
Vifor itself had a setback since the CSL takeover’s announcement in December. The FDA recently rejected Akebia Therapeutics’ chronic kidney disease anemia therapy vadadustat. Vifor has a license to sell the drug through its Fresenius dialysis facilities and other third-party sites.
Vifor boasts 37 programs in development, which can give CSL’s own pipeline a 32% boost.