July - September 2012
August 9, 2012
Takeda Pharmaceutical Company Limited
Millennium Pharmaceuticals, Inc.
OSAKA, Japan, and CAMBRIDGE, Mass, August 9, 2012 – Takeda Pharmaceutical Company Limited (TSE: 4502, “Takeda”) and Millennium: The Takeda Oncology Company, a subsidiary of Takeda (“Millennium”), today announced a decision to stop the Japanese portion of ganitumab (AMG 479) Phase 3 GAMMA*1 (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas) global trial following the decision of Amgen Inc. (“Amgen”) to halt the global trial. This decision was based on the review of a pre-planned interim analysis by the independent Data Monitoring Committee (DMC) which concluded that the addition of ganitumab to gemcitabine is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to gemcitabine alone.
There were no safety concerns raised in the DMC review of the study.
Ganitumab is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF1R*2) of Amgen, and Takeda is responsible for development and commercialization in Japan, with the Japanese portion of GAMMA trial being conducted by Takeda Bio Development Center, Inc., a subsidiary of Takeda located in Tokyo, Japan.
Regulatory authorities and study investigators have been notified that treatment with ganitumab should be discontinued in the GAMMA trial. Takeda and Millennium will evaluate the future development plan of AMG 479 in Japan.
*1 The GAMMA study is a randomized, multicenter, double-blind, Phase 3 trial to determine if ganitumab plus gemcitabine improves overall survival, compared to placebo plus gemcitabine, in the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.
*2 Insulin-like growth factor is a peptide that has been shown to control critical aspects of cellular growth, survival, and metabolic activity.
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.
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor in the United States, 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 .