European Commission Releases Takeda From Commitment to Divest Shire’s Pipeline Compound SHP647

Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) (“Takeda”) today announces that on May 28, the European Commission (the “EC”) has released Takeda from the obligation to divest the pipeline compound SHP647 and certain associated rights (“SHP647”), a commitment that was provided by Takeda to secure regulatory clearance of its acquisition of Shire plc (“Shire”). Takeda will discontinue the current SHP647 clinical trial program, and it will be providing all eligible trial participants with the opportunity to have continued access to SHP647 in a post-trial access (“PTA”) study. In addition, subject to obtaining trial participant consents and the satisfaction of regulatory and ethical considerations, Takeda will make SHP647 clinical trial data and biosamples available to the scientific community through the Crohn’s & Colitis Foundation (“Foundation”).

Takeda announced on November 20, 2018, that the EC approved its proposed acquisition of Shire (the “Acquisition”). The EC’s approval was conditioned on Takeda fulfilling commitments provided to the EC in connection with the regulatory clearance. Specifically, in relation to the future potential overlap in the area of inflammatory bowel diseases between Takeda’s marketed product Entyvio (vedolizumab) and Shire’s pipeline compound SHP647, Takeda committed to divest SHP647. The divestment of SHP647 was not a condition to the completion of the Acquisition, which became effective on January 8, 2019.

Subsequent to the completion of the Shire acquisition, the SHP647 clinical trial program was affected by exceptional circumstances, which have caused the EC to conclude that the competition concerns previously identified by the EC no longer arise. Accordingly, the EC found that Takeda’s obligation to divest SHP647 was no longer justified and the EC waived the commitment.

Takeda engaged in two formal and rigorous sale processes spanning 14-months to identify and engage with potential purchasers of SHP647. The first sales process was conducted by Takeda and the second by an independent Divestiture Trustee, which was appointed under the standard procedure provided for in Takeda’s commitments to the EC. Takeda and the Divestiture Trustee each engaged with more than 60 potential purchasers, but the sale process was unsuccessful.