Takeda Pharma : January 27, 2012 Anti-Prostate Cancer Agent Orteronel(TAK-700) Enters into Phase III Clinical Trials in Japan

January 27, 2012

Takeda Pharmaceutical Company Limited
Millennium Pharmaceuticals, Inc. Anti-Prostate Cancer Agent Orteronel(TAK-700) Enters into Phase III Clinical Trials in Japan

Osaka, Japan, Cambridge, Mass and Tokyo, Japan, January 27, 2012 - Takeda Pharmaceutical Company Limited ("Takeda") and Millennium: The Takeda Oncology Company ("Millennium") today announced that Takeda Bio Development Center Limited ("Takeda Bio") has initiated enrollment of patients in Japan for the two ongoing global Phase III clinical trials for the anti-prostate cancer investigational agent, orteronel(TAK-700).

Orteronel, discovered by Takeda, is an oral, non-steroidal androgen synthesis inhibitor that has been shown in pre-clinical studies to selectively inhibit the 17, 20 lyase enzymes*1 which are central to the production of steroidal androgens in the testes and adrenal glands.

The two trials are known as the ELM-PC (Evaluation of the Lyase inhibitor in Metastatic Prostate Cancer) trials. One of the trials (C21004) is a randomized, double-blind and multi-center trial of prednisolone*2 plus orteronel or placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer ("mCRPC"). The primary endpoints are Overall Survival ("OS") and Progression Free Survival ("PFS"). The second (C21005) is a randomized, double-blind and multi-center trial of prednisolone plus TAK-700 or placebo in patients with mCRPC that have progressed during or following docetaxel-based therapy. The primary endpoint is OS.

"We are very pleased with the initiation of the Phase III clinical trials of orteronel in Japan," said Karen Ferrante, M.D., Chief Medical Officer, Millennium. "At present, mCRPC remains an incurable disease, and novel treatments are needed. We regard orteronel as one of our high-priority development programs, and will work to accelerate its development."

"We expect orteronel has a potential to become a treatment option for prostate cancer with novel mechanism of action. We will strive to develop this drug as a new treatment to meet unmet medical needs," said Hiroyasu Nakamura, President of Takeda Bio.

• *1 The 17, 20 lyase is one of enzymes which present in both the testes and adrenal glands. It is a cytochrome P450 enzyme which cleaves steroid C17-C20 bonds to produce androgens.
• *2 Synthetic adrenal corticosteroid

About orteronel

Orteronel, discovered by Takeda Pharmaceutical Company Limited, is an oral, non-steroidal androgen synthesis inhibitor that selectively inhibits the 17,20 lyase enzyme. This enzyme, which is present in both the testes and adrenal glands, is central to the production of steroidal androgens. Synthesis of androgens outside the testes contributes to disease progression in castration-resistant prostate cancer (CRPC).

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,

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor in the US, and has a robust clinical development pipeline of global 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 respective websites, .

About Takeda Bio Development Center

Located in Tokyo, Japan, Takeda Bio Development Center Limited, a wholly owned subsidiary of Takeda, plays a central role in clinical development of Takeda's oncology products in Japan.

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