The European Commission (EC) has released Takeda Pharmaceutical (NYSE:TAK)
from the obligation to divest the pipeline compound SHP647 and certain
associated rights, a commitment that was provided the company to secure
regulatory clearance of its acquisition of Shire plc.
Takeda will discontinue the current SHP647
clinical trial program, and will provide all eligible trial participants
with the opportunity to have continued access to SHP647 in a post-trial
access (“PTA”) study.
In addition, Takeda will make SHP647 data and
biosamples available to the scientific community through the Crohn’s
& Colitis Foundation.
On November 20, 2018, EC approved Takeda’s proposed acquisition of Shire with divestment condition.
The condition was Takeda fulfilling commitments,
in relation to the future potential overlap in the area of inflammatory
bowel diseases between Takeda’s Entyvio (vedolizumab) and Shire’s
SHP647, Takeda committed to divest SHP647.
Subsequent to the completion of the Shire
acquisition, the SHP647 trial program was affected by exceptional
circumstances, which caused EC to conclude that the competition concerns
no longer arise.
Accordingly, EC found that Takeda’s obligation to divest SHP647 was no longer justified and it waived the commitment.
Takeda will no longer develop the SHP647 compound
in any inflammatory bowel disease indication, including Ulcerative
Colitis or Crohn’s Disease.
https://seekingalpha.com/news/3578600-ec-waives-takedas-obligation-to-divest-shire-s-shp647
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