Anti-Cancer Agent AMG 479 Enters into the Phase III Clinical Trial in Japan

Osaka, Japan, CAMBRIDGE, Mass. and Tokyo, Japan, April 14, 2011 – Takeda Pharmaceutical Company Limited (“Takeda”), Millennium: The Takeda Oncology Company and Takeda Bio Development Center Limited (“Takeda Bio”) today announced that Takeda and Millennium had reached a decision to participate in the phase III clinical trial on anti-cancer agent AMG 479 (generic name: ganitumab). The trial is being conducted by Amgen, Inc. ("Amgen") globally and Takeda Bio has initiated the Japanese portion of the trial and will lead the molecule’s ongoing development in Japan.

AMG 479 is a human monoclonal antibody against insulin-like growth factor^* 1 receptor (IGF-1R), which was discovered and developed by Amgen and is being developed by Takeda Bio in Japan. The IGF-1R signal created by the binding of IGF-1 and IGF-2 stimulates cell survival and proliferation pathways, and leads to tumor growth and invasion. AMG 479 inhibits the binding of IGF-1 and IGF-2 to its receptor (IGF-1R), and thus, it suppresses tumor cell growth and invasion.

The global phase III clinical trial is a randomized, double-blind trial of gemcitabine plus AMG 479 or placebo in about 825 patients with metastatic pancreas cancer. The primary endpoint is overall survival.

“We are pleased with the initiation of the phase III clinical trial of AMG 479 in Japan,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “Pancreas cancer, which is one of the more common cancers in Japan, is a high unmet medical need because of the difficulty of detection and the prognosis. We will accelerate the development of AMG 479 with the hope of providing it to patients and medical experts as soon as possible.”

"There are very few treatment options which can satisfy the medical needs of patients with pancreas cancer,” said Hiroyasu Nakamura, President of Takeda Bio. “We will devote ourselves to progress AMG 479’s development so that we can offer a novel treatment option for patients with pancreas cancer."

^* Insulin-like growth factor is a peptide that has been shown to control critical aspects of cellular growth, survival, and metabolic activity.

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

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, www.millennium.com.

About Takeda Bio

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. http://www.takeda.co.jp/tbdc/

CONTACTS:
Takeda
Corporate Communications Department
81- 3278- 2037

Millennium
Manisha Pai
1- 617- 551- 7877
Manisha.Paimpi.com

Takeda Bio
Katsuaki Kato
81- 50- 3116- 9994
Kato_Katsuakitakeda.co.jp

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