Takeda and M2Gen Collaborate with ORIEN to Speed Clinical Development and Discovery of Cancer Treatments Through Health Informatics

June 16, 2016

Cambridge, Mass., Osaka, Japan and Tampa, Fla. –Takeda Pharmaceutical Company Limited (TSE: 4502) and M2Gen^®, a healthcare informatics solutions company, have established a new collaboration to generate broad genomic data from consenting cancer patients. Under the agreement, Takeda will help build the Oncology Research Information Exchange Network (ORIEN) Avatar^TM Research Program based on the Total Cancer Care^® Protocol, a prospective observational study enrolling patients with various cancers, and access information generated under this program.

Understanding and mapping the genetic profiles of patients with various types of cancer has the potential to speed new treatment discovery and development for millions of cancer patients worldwide. The data provided through M2Gen’s ORIEN Avatar Research Program has the potential to enable ORIEN cancer centers to more rapidly find and enroll patients with specific biomarkers into Takeda clinical studies, among others. In addition, the genomic data will accompany clinical information such as stage of disease, demographics and treatment history, further enhancing translational medicine efforts. This collaborative approach, which brings together leading pharmaceutical companies, cancer research centers and patients, may allow for more effective and efficient development of treatments across many different cancers.

“One of the biggest challenges in oncology research is identifying the right cohort of patients for enrollment into clinical trials,” said Phil Rowlands, Interim Head, Oncology Therapeutic Area Unit, Takeda. “Our innovative partnership with M2Gen has the potential to enable us to more quickly and precisely enroll patients at sites with a strong commitment to high quality translational medicine.”

Through the agreement, Takeda will have access to patient de-identified information generated through the ORIEN Avatar Program, representing ORIEN’s growing network of participating cancer centers. These 12 institutions, all leaders in cancer care, treat diverse populations of patients, who can elect to join the Total Cancer Care Protocol to potentially gain access to groundbreaking therapies and clinical trials. Patients who consent to participate in the protocol agree to be followed throughout their lifetime. ORIEN Avatar is focused on the use of rich clinical and molecular data to anticipate patient need, especially for novel cancer treatments through clinical trials open at ORIEN institutions.

“Our health informatics solutions allow us to share clinically meaningful data across the entire cancer care and research community – from patients to healthcare providers to the companies developing novel medicines,” said William S. Dalton, Ph.D., M.D., Founder and CEO, M2Gen.

“We are excited to welcome Takeda as one of the founding partners for our ORIEN Avatar program and look forward to working together to open new doors in oncology research,” said Michael A. Caligiuri, M.D., Director, The Ohio State University Comprehensive Cancer Center and CEO, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute.

This agreement is partially developed on the experience of Takeda and M2Gen, which previously partnered in 2014 to identify patients for several Phase 2 studies in gastric and pancreatic cancer. This pilot program demonstrated M2Gen’s capability to identify patients who might benefit from enrollment in the clinical trials and to facilitate rapid trial enrollment. Through ongoing collaborative learning, Takeda and M2Gen see the continued potential for success in scientific and clinical trial development and in meeting patient needs.

About the Oncology Research Information Exchange Network (ORIEN)
The Oncology Research Information Exchange Network (ORIEN) is a unique research partnership among North America’s top cancer centers that recognize collaboration and access to data are the keys to cancer discovery. Through ORIEN, founders Moffitt Cancer Center in Tampa and The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute in Columbus leverage multiple data sources and match patients to targeted treatments. More information is at http://www.oriencancer.org/.

About M2Gen
M2Gen is an informatics solution company advancing personalized medicine by partnering with key stakeholders using high quality tissue, clinical data, and molecular technology to accelerate the discovery and delivery of personalized medicine. Using a rapid learning approach, M2Gen delivers evidence-based solutions to identify a patient’s susceptibility to disease, predict how the patient will respond to a particular drug, and match patients to the best therapies for an optimal treatment outcome. M2Gen has partnered with the nation’s leading cancer centers through ORIEN to create a large, cancer-focused data warehouse and biorepository linking clinical and molecular data. For more information visit www.m2gen.com.

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com.

Contacts:

Takeda, Japanese Media

Tsuyoshi Tada

tsuyoshi.tada@takeda.com

+81 (0) 3-3278-2417

M2Gen

Kim Polacek
media@M2Gen.com

+1-813-745-7408

Takeda, Media outside Japan

Amy Atwood

amy.atwood@takeda.com

+1-617-444-2147