Takeda's Crohn's Disease Fistulas Candidates Fall Short In Mid-Stage Study, Settles Tax Dispute With Irish Revenue Commissioners

Takeda Pharmaceutical Co Ltd TAK released topline data from the Phase 3 ADMIRE-CD II study, assessing Alofisel (darvadstrocel) for complex Crohn's Perianal Fistulas (CPF).

Typical symptoms of perianal fistulas are anal pain with defecation, perianal itching, bleeding, and discharge of pus.

The study did not meet its primary endpoint of combined remission at 24 weeks.

The safety profile for darvadstrocel was consistent with prior studies, and no new safety signals were identified.

The study's full results will be presented at a future medical meeting or published in a peer-reviewed journal.

Alofisel is approved in the European Union, Israel, Switzerland, Serbia, the U.K., and Japan based on previously completed ADMIRE-CD study data. 

Also Read: Takeda Withdraws Lung Cancer Drug From US After Failed Confirmatory Trial.

Takeda has also agreed with the Irish Revenue Commissioners to settle a tax assessment related to the treatment of an acquisition break fee received by Shire plc in October 2014 from AbbVie Inc ABBV, for €130 million, resulting in a tax expense reduction of about ¥63 billion for Takeda.

On November 28, 2018, Shire received a tax assessment from the Irish Revenue for €398 million concerning the $1.635 billion break fee Shire received in connection with the terminated offer by AbbVie to acquire Shire in 2014.

Takeda appealed the assessment, and in late 2020, a hearing occurred before the Irish Tax Appeals Commission (TAC).

On July 30, 2021, Takeda received a ruling on the matter, with the TAC ruling in favor of Irish Revenue. 

While Takeda intended to appeal the TAC ruling and continued to assert that the AbbVie break fee was not subject to Irish tax, Takeda recorded a tax provision for the case in the fiscal quarter ended June 30, 20211. 

Subsequently, the TAC was required to rehear the matter in 2023. The rehearing process was still ongoing when the parties reached the agreement, Takeda said in a statement.

Price Action: TAK shares are down 1.47% at $14.75 premarket on the last check Wednesday.