BioBlast®

Seagen’s SEC filing has disclosed that Pfizer withdrew its notification to the Federal Trade Commission (FTC) and Department of Justice (DOJ) to acquire Seagen for US$43B.  The filing also notes that the companies expect to complete the acquisition in late 2023 or early 2024.

On 12 March 2023, Seagen and Pfizer entered into an agreement to merge, in which Seagen would become a wholly-owned subsidiary of Pfizer.  On 12 May 2023, Seagen and Pfizer each filed a Notification and Report Form relating to the merger with the FTC and DOJ as required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Act). Only a few days later, the FTC brought proceedings to block Amgen’s US$27.8B acquisition of Horizon Therapeutics.  On 30 May 2023, Seagen shareholders approved the acquisition by Pfizer.

By withdrawing the form, the statutory waiting period under the Act will now expire on 14 July 2023 (which can be extended if the FTC requests additional information / documents).  Whilst it is possible that Pfizer’s notification withdrawal is in response to FTC proceedings against Amgen, it has not yet been confirmed by either Pfizer or Seagen.

Pfizer also filed the requisite documentation with the European Commission pursuant to Article 4(5) of the EU Merger Regulation, alerting it of the intended merger on 1 June 2023.

The FDA provided an update on its collaboration with the Federal Trade Commission (FTC) which it announced in February 2020.  The FDA and FTC have been working together on issues including exchanging information about how to combat anti-competitive activities and those that harm public health.  The two agencies have developed an educational resource for consumers about biosimilars to address common community misconceptions. 

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US Senators Chuck Grassley and Amy Klobuchar urge FTC to investigate ‘pay-for delay’ settlements, in particular AbbVie’s Humira settlements, for anti-competitive behaviour.  Of particular concern is investigating whether these settlements are keeping biosimilars out of the hands of patients.

The US House Judiciary Committee voted in favour of the Preserve Access to Affordable Generics and Biosimilars Act. If passed, this act would allow the FTC to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connected with the sale of a drug or biological product.

US President Biden signed an executive order aimed at promoting competition in the US economy. The order directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, and encourages the FTC to ban ‘pay for delay’ agreements.