European Commission Releases Takeda From Commitment to Divest Shire’s Pipeline Compound SHP647 - Seite 2

Takeda will no longer develop the SHP647 compound in any inflammatory bowel disease indication, including Ulcerative Colitis or Crohn’s Disease. The SHP647 clinical trial program will be discontinued in an orderly manner over the coming months. New patient enrolment into the study protocols was already stopped in late March due to the risks associated with the COVID-19 pandemic. The trials will be unblinded and not restarted. Takeda is committed to providing all eligible patients already in the SHP647 clinical trials and responding to treatment with the opportunity to have continued access to SHP647 in a PTA study. The parameters for this PTA study will be determined in collaboration with the SHP647 program’s steering committee and relevant regulatory authorities, and subsequently launched, subject to applicable local regulations and ethical considerations. Patients should continue to adhere to the current study protocol until contacted by their study site after guidance has been provided by the Takeda study team members. Treatment will be made available to patients enrolled in this PTA study to meet their individual treatment needs.

In addition, Takeda will make SHP647 clinical trial data and biosamples available to the scientific community through the Foundation, via the IBD Plexus platform, a first-of-its-kind research information exchange platform and biobank that centralizes data and biosamples from diverse research studies, subject to applicable local regulations and ethical considerations. The Foundation will serve as an independent body to review requests from investigators and physicians seeking access to anonymised SHP647 clinical trial data and biosamples, and to make final decisions on data sharing. Takeda is committed to sharing clinical trial data and biosamples that benefit patients and foster scientific discovery in a way that ensures patient consent to the use of the data, privacy and preserves the integrity of research.

Assets and liabilities related to SHP647, which were previously classified as held for sale on Takeda’s consolidated statements of financial position, have ceased to be classified as held for sale as the result of the EC’s decision. Takeda will reverse previously estimated liabilities and reassess the estimates of the future costs related to SHP647 such as program termination costs, which will have a net impact of gain on our Operating Profit in Q1 of the current fiscal year ending March 31, 2021 (i.e., FY2020). This impact will be disclosed in due course, after it becomes available.