January 19, 2009

Teijin Pharma Limited
Takeda Pharmaceutical Company Limited

Review of Febuxostat New Drug Application to Continue after PDUFA Date

Osaka, Japan, January 19, 2009 - Teijin Pharma Limited (“Teijin Pharma”) and Takeda Pharmaceutical Company Limited (“Takeda”) announced today that Takeda Global Research & Development Center, Inc. (“TGRD”), a wholly owned U.S. subsidiary of Takeda, had received notification from the U.S. Food and Drug Administration (FDA) that the FDA would not be able to complete its review of the New Drug Application (NDA) for febuxostat, a treatment of hyperuricemia in patients with gout discovered by Teijin Pharma, before the Prescription Drug User Fee Act (PDUFA) date, which was January 18, 2009.

“The FDA raised no issues with the NDA submission or the data included in it, rather FDA stated that due to its inability to complete routine inspections at investigator sites and at a Clinical Research Organization vendor involved in the development of febuxostat, the PDUFA date for febuxostat would be missed by FDA," said Dean Sundberg, senior vice president, regulatory affairs at TGRD. "Takeda has taken all necessary steps and provided all necessary information at this point in the NDA review process and we await FDA’s completion of these routine inspections and look forward to receiving a final approval date for febuxostat."

Febuxostat is an oral, once-daily, novel highly potent non-purine selective inhibitor of xanthine oxidase for treatment of hyperuricemia in patients with gout. The NDA for febuxostat included data from multiple clinical trials involving more than 4,000 patients. In November 2008, FDA's Arthritis Advisory Committee recommended febuxostat for approval by a vote of 12-0 with one panel member abstaining.

# # #