Millennium Initiates TOURMALINE-MM1 Pivotal Phase 3 Trial of MLN9708 in Patients With Relapsed and/or Refractory Multiple Myeloma

-- First oral proteasome inhibitor to enter phase 3 clinical trials --

CAMBRIDGE, Mass.--()--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 MLN9708 in patients with relapsed and/or refractory multiple myeloma. The multi-center study with MLN9708, an investigational, oral proteasome inhibitor, will be conducted in Europe, North America, Latin America and the Asia-Pacific region.

“As the leader in the area of protein homeostasis Millennium continually strives to develop new therapies and new options to meet the needs of patients dealing with cancer,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “This is the first all oral combination regimen, which includes a proteasome inhibitor and IMiD being studied in multiple myeloma. The initiation of this trial represents another major achievement in advancing the Millennium pipeline.”

Study Design

The study, known as TOURMALINE-MM1, is a phase 3, randomized, double-blind, multi-center, international study comparing oral MLN9708 plus lenalidomide and dexamethasone to placebo plus lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma. The primary endpoint is progression-free survival (PFS). Secondary endpoints include safety, overall survival (OS), OS in high-risk patients, overall response rate (ORR), duration of response (DOR) and time to progression (TTP).

About MLN9708

MLN9708 is an investigational oral, potent, proteasome inhibitor, which is being studied in multiple myeloma, various hematologic malignancies and solid tumors. It is the first oral proteasome inhibitor to enter clinical trials in patients.

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.

Contacts

Millennium
Manisha Pai, +1-617-551-7877
Manisha.pai@mpi.com
or
David Albaugh, +1-617-444-4456
david.albaugh@mpi.com
or
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
+81-3-3278-2037

Contacts

Millennium
Manisha Pai, +1-617-551-7877
Manisha.pai@mpi.com
or
David Albaugh, +1-617-444-4456
david.albaugh@mpi.com
or
Takeda Pharmaceutical Company Limited
Corporate Communications Dept. (PR/IR)
+81-3-3278-2037