Millennium Initiates Pivotal Phase 3 Trial of MLN8237 in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

CAMBRIDGE, Mass., March 5, 2012 and Osaka, Japan, March 6, 2012 –Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced the initiation of an international phase 3 clinical trial evaluating MLN8237 in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), an aggressive form of lymphoma. The multi-center study with MLN8237, an investigational, oral, selective inhibitor of Aurora A kinase, will be conducted in Europe, North America, Latin America and the Asia-Pacific region.

“There is a significant unmet medical need for patients suffering from PTCL. As a leader in the development of novel therapies Millennium continues to work toward filling that need,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “MLN8237 is being explored across a broad range of hematological malignancies and solid tumors. The initiation of this trial represents another major achievement in advancing the Millennium pipeline.”

Study design

The study is a phase 3, randomized, two-arm, open-label, multi-center, international trial of MLN8237 (alisertib) or investigator’s choice (selected single agent) in patients with relapsed or refractory PTCL. The primary endpoints are overall response rate (ORR) and progression-free survival (PFS). Secondary endpoints include safety, complete response (CR) rate, overall survival (OS), and time to progression (TTP).

About MLN8237

MLN8237 (alisertib) is an oral, selective, inhibitor of Aurora A kinase. Aurora A kinase is required for cells to divide and has been shown to be over-expressed in a variety of cancers. Inhibition of Aurora A kinase represents a novel approach in cancer research.

About Peripheral T-cell lymphoma

Peripheral T-cell lymphoma (PTCL) comprises a group of rare and usually aggressive non-Hodgkin lymphomas (NHL) that develop from mature T-cells, which is one of the lymphocytes derived from myeloid stem cell, differentiated and matured in the thymus gland. Peripheral T-cell lymphoma represents a spectrum of T-cell lymphomas and accounts for approximately 10 percent to 15 percent of all NHL cases in the United States.

Editor’s Note: This press release is also available under the Media section of the Company’s website at: www.millennium.com/InTheNews.aspx.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company’s research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.