AUSTRALIA – Australian biotech giant CSL announced that the regulatory review of its US$11.7 billion acquisition of Switzerland’s Vifor Pharma been postponed as antitrust investigations continue.

The acquisition will take “a few more months,” implying that the transaction will not be completed by June 2022, as previously anticipated.

The acquisition, the largest in CSL’s history, means the company is diversifying beyond its core immunoglobulin-based therapies for immunodeficiency and bleeding diseases, as well as its Seqirus flu vaccines business.

Vifor said in a statement that some antitrust authorities have yet to render a decision. A spokesperson for Vifor declined to say which regulators are still undecided or whether any specific concerns have been raised.

The final hurdles for the US$11.7 billion (AUS$16.4 billion) transaction, announced in December, are approvals from the European Commission, the Swiss Takeover Board, and the US Federal Trade Commission (FTC), all of which are still pending.

CSL stated in March that the process was on track, but it is understood that the company recently received a notice from one regulator requiring additional information. The regulator has 30 days after receiving the new information to review it.

Looking to expand presence in nephrology market

The blood products company said in a statement that it is still confident that its acquisition of Vifor will be completed and that it “looks forward to expanding its presence in the rapidly growing nephrology market, as well as leveraging the companies’ combined expertise to continue to deliver innovative solutions to rare and serious illness.”

As part of its US$4 billion debt raising to help fund the acquisition, CSL issued a 40-year senior bond in late April, the longest-dated coupon ever issued by an Australian or New Zealand company, financial or government borrower.

Delays in the regulatory approval process are not uncommon, according to Vifor. Vifor stated that the two companies are continuing to work with the remaining antitrust authorities, and CSL stated that it is confident that the buyout will be completed.

Winning antitrust approval is the final hurdle in the Vifor acquisition. CSL announced in March that it had collected 74 percent of Vifor shares and thus declared the tender offer successful.

At the time, the Australian firm stated that the antitrust review process was on track, and it confirmed the deal closure date of mid-2022.

CSL is interested in Vifor’s kidney disease and iron deficiency products. Ferinject, which treats iron deficiency, is one of Vifor’s most profitable products. Vifor also has four late-stage drugs set to be released this year.

CSL Behring, CSL’s biotech business, is currently heavily reliant on its immunoglobulin portfolio, which is experiencing some difficulties during the pandemic due to plasma collection constraints.

In other news, Takeda’s Takhzyro and BioCryst Pharma’s newly launched oral drug Orladeyo are putting pressure on the company’s hereditary angioedema therapy Haegarda.

The Australian biotech also sells Idelvion, a hemophilia B treatment, and its hemophilia B gene therapy program, which it acquired from uniQure, recently produced positive results in a phase 3 trial.

Since the announcement of the CSL takeover in December, Vifor has suffered a setback. The FDA recently rejected vadadustat, a chronic kidney disease anemia therapy developed by Akebia Therapeutics.

The same regulatory authority approved GSK’s daprodustat for people with chronic kidney disease (CKD) who also have anemia last month.

Vifor has a license to sell the drug through Fresenius dialysis centers as well as other third-party sites. Vifor has 37 programs in development, which could boost CSL’s pipeline by 32%.

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