Takeda Announces Formalization of Takeda Oncology to Enhance Discovery, Development and Global Commercialization of Breakthrough Cancer Medicines

CAMBRIDGE, Mass. & OSAKA, Japan

Takeda Pharmaceutical Company Limited (TSE:4502) today announced its global oncology business unit, headquartered in Cambridge, MA, will be called Takeda Oncology. The creation of Takeda Oncology will improve the company’s ability to meet the unique and urgent needs of cancer patients, their loved ones and health care providers worldwide. Takeda will sustain its long-standing entrepreneurial approach to oncology research and development while expanding its global commercial network and resources as Takeda Oncology. Takeda is retiring the Millennium: The Takeda Oncology Company brand, and replacing it with Takeda Oncology to reflect the new global oncology business unit.

“Despite the progress made in the fight against cancer, serious unmet needs persist across many forms of the disease,” said Christophe Bianchi, M.D., President, Global Oncology Business Unit. “Takeda Oncology has a deep understanding of patient needs and applies scientific rigor and resources to work to meet these needs. Now, our agile business model optimally organizes us to quickly meet the diverse needs of cancer patients, health care providers and systems around the world, and bring the next generation of cancer treatments to cancer patients who need them.”

Comprised of Takeda’s global oncology commercial operations, the Oncology Business Unit remains closely aligned with Takeda’s dedicated global oncology R&D function, the Oncology Therapeutic Area Unit, and Takeda’s Oncology Drug Discovery Unit to together drive forward the company’s portfolio of products while maintaining a focus on expanding new product launches in the near and longer terms. As a fully integrated unit within Takeda’s global network, the Oncology Business Unit will leverage expertise from diverse oncology markets to help accelerate global and local capabilities, ensure continued understanding of evolving patient needs, and drive the oncology business worldwide.

“Less than 2 years ago, Takeda reorganized research and development within oncology to provide an expanded, global reach while maintaining focus and dedicated resources to our therapeutic area. As a result, our research and development infrastructure across Takeda in oncology, which is focused on innovative products, is the strongest and most integrated it has ever been,” said Michael Vasconcelles, M.D., Head, Oncology Therapeutic Area Unit, Takeda. “Our preclinical and clinical studies as well as our scientific collaborations extend across a broad range of hematologic cancers and solid tumors in all regions, and we are looking forward to potential near term regulatory filings for our late stage compounds, including investigational alisertib and ixazomib, the latter of which was recently granted Breakthrough Therapy status for systemic light-chain (AL) amyloidosis by the U.S. Food & Drug Administration.”

“Our commitment to science, breakthrough innovation and passion for improving the lives of patients is stronger than ever,” said Christopher Claiborne, Ph.D., Head, Oncology Drug Discovery Unit, Takeda. “In working towards our aspiration to cure cancer, our singular focus has been on the discovery and development of breakthrough medicines for cancer patients, particularly for those battling forms of the disease that have not traditionally been the focus of oncology R&D. Now, with a more robust global network and resources, we are optimally positioned to leverage all scientific and clinical platforms and tools at our disposal to quickly identify new targets and develop compounds for cancer patients around the world.”

Takeda’s legacy in oncology extends more than 25 years, and includes a range of paradigm-changing therapies for hematologic cancers and solid tumors. Today, the company is investigating compounds across more than 17 forms of cancer, including ixazomib in AL amyloidosis and multiple myeloma as well as alisertib in relapsed/refractory peripheral T-cell lymphoma, recurrent ovarian cancer, and small cell lung cancer, among other malignancies. Data on ixazomib and alisertib, along with three additional investigational agents, will be presented this year at the 56^th American Society of Hematology (ASH) annual meeting in San Francisco, CA.

About Ixazomib

Ixazomib (MLN9708) is an investigational oral proteasome inhibitor, which is being studied in multiple myeloma (MM), systemic light-chain (AL) amyloidosis and other malignancies. Ixazomib was granted orphan drug designation in MM in both the U.S. and Europe in 2011, and for AL amyloidosis in both the U.S. and Europe in 2012. It is the first oral proteasome inhibitor to enter Phase 3 clinical trials. Four global Phase 3 trials are ongoing: TOURMALINE-MM1, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in relapsed and/or refractory MM; TOURMALINE-AL1, investigating ixazomib plus dexamethasone in patients with relapsed or refractory AL amyloidosis; TOURMALINE-MM2, investigating ixazomib vs. placebo in combination with lenalidomide and dexamethasone in patients with newly diagnosed MM; and TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed MM following induction therapy and autologous stem cell transplant. For additional information on the ongoing Phase 3 studies please visit www.tourmalinetrials.com or www.clinicaltrials.gov.

About Alisertib

Alisertib (MLN8237) is an investigational, oral, selective, inhibitor of Aurora A kinase, a novel approach in cancer research. Aurora A kinase is required for cells to divide properly and has been shown to be over-expressed in a variety of cancers. Alisertib is being explored for the treatment of a broad range of hematological malignancies and solid tumors, including relapsed or refractory peripheral T-cell lymphoma (PTCL), recurrent ovarian cancer, and small cell lung cancer, among other malignancies. For additional information on the ongoing clinical studies please visit www.lumieretrial.com or www.clinicaltrials.gov.

About Takeda Oncology

The Takeda Oncology Business Unit, headquartered in Cambridge, MA, is co-located with the leadership of Takeda’s globally-integrated oncology research and development enterprise, overseen by the Oncology Therapeutic Area Unit. Takeda Oncology delivers novel medicines to patients with cancer worldwide through its commitment to science, breakthrough innovation and passion for improving the lives of patients. Takeda Oncology was formerly known as Millennium: The Takeda Oncology Company. Additional information about Takeda Oncology is available through its website, www.takedaoncology.com.

About Takeda Pharmaceutical Company Limited

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 people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.