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Takeda Pharmaceutical Co. Ltd cardiovascular news

July 14, 2014 7:00 AM UTC

Takeda said law firm Jones Day, a third-party investigator, did not find evidence that the pharma falsified or fabricated data or had direct involvement in statistical analysis work related to the investigator-initiated Phase III CASE-J trial of Takeda’s hypertension drug Blopress candesartan cilexetil. Takeda said Jones Day did find “multiple incidences of involvement and encouragement by Takeda employees” in CASE-J and that these incidences “may raise suspicions about the impartiality” of CASE-J. The open-label, Japanese CASE-J, which was conducted by Kyoto University, compared Blopress to amlodipine besilate in high-risk hypertensive patients during 2001-06. Takeda used a graph in promotional literature indicating that Blopress was more effective than Norvasc amlodipine besilate from Pfizer Inc. (NYSE:PFE, New York, N.Y.), despite final data from the trial published in Hypertension concluding there was no difference between the two drugs. According to Takeda, Jones Day did not find evidence that Takeda manipulated the graph data or that the graph was intentionally modified to appear advantageous for the pharma. Takeda appointed Jones Day as investigator in March. ...