JPMA's Sanctions Against Takeda Regarding Promotional Activities for Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J)

April 03, 2014

Osaka, Japan, April 3, 2014 – Takeda Pharmaceutical Company Limited (“Takeda”) today received notice of sanctions imposed by the Japan Pharmaceutical Manufacturers Association (“JPMA”) for promotional activities regarding CASE-J. The sanctions against Takeda relate to part of its promotional activities regarding CASE-J which were inviolation of the “Prescription Drugs Promotion Code” of the JPMA and as a result, Takeda’s activities as Vice President of the JPMA will be temporarily suspended for 6 months, effective April 3, 2014.

The JPMA is imposing sanctions against Takeda because of the promotional activities in Japan that continued after January 2007 to refer to CASE-J study data presented at the International Society for Hypertension, without replacing such data in promotional materials for candesartan after the publication of the academic paper describing the CASE-J study results. A third-party investigation related to CASE-J activities of Takeda is now ongoing and Takeda is fully cooperating with a third-party investigation initiated to examine this incident.

Takeda takes this sanction imposed by the JPMA very seriously, and sincerely apologizes to all stakeholders including patients and healthcare professionals for the concern caused by its actions. To both prevent similar incidents in the future and to further enforce preventive measures, Takeda is continuing to fully cooperate with the ongoing third-party investigation into all of Takeda's promotional activities to identify areas requiring improvement.

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