Osaka, Japan, November 19, 2013 – Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda has initiated enrollment of patients in Japan in an ongoing global phase 3 clinical study (TOURMALINE-MM1 study) of a novel oral proteasome inhibitor MLN9708 (ixazomib citrate) in relapsed and/or refractory multiple myeloma.

The study is a phase 3, randomized, double-blind, multi-center, international study comparing MLN9708 plus lenalidomide*1 and dexamethasone*2 to placebo plus lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma. The study was initiated in Europe, North America, and the Asia-Pacific region in June 2012. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), OS in high-risk patients, overall response rate (ORR), duration of response (DOR), time to progression (TTP), safety, QOL, etc.

MLN9708 is a proteasome inhibitor and is the first to enter clinical trials as an oral preparation. Currently, phase 3 clinical studies are ongoing in newly diagnosed multiple myeloma and in relapsed and/or refractory AL amyloidosis*3 as well as in relapsed and/or refractory multiple myeloma.

Takeda is committed to developing new therapies which respond to unmet medical needs of patients so as to achieve its mission, ‘We strive towards better health for people worldwide through leading innovation in medicine.’

*1 An immunomodulatory agent
*2 A synthetic hormone (corticosteroid)
*3 A disease in which amyloid proteins derived from monoclonal immunoglobulin light chain produced by abnormal plasma cells (B cells that are activated by antigens and produce antibodies) form deposits in any organs in the body, leading to organ disorders.