takeda pharmaceutical co ltd (TKPHF) Key Developments
Center for iPS Cell Research Application and Takeda Pharmaceutical Company Limited to Work Together to Develop Clinical Applications of Induced Pluripotent Stem Cells in Areas Such as Heart Failure, Diabetes Mellitus, Neurological Disorders and Cancer Immunotherapy
Apr 17 15
Center for iPS Cell Research Application (CiRA) of Kyoto University and Takeda Pharmaceutical Company Limited (Takeda) announced that they will work together to develop clinical applications of induced pluripotent stem cells in areas such as heart failure, diabetes mellitus, neurological disorders and cancer immunotherapy. The "Takeda-CiRA Joint Program for iPS Cell Applications" (T-CiRA) is designed to expedite multiple research projects for drug discovery and cell therapy using iPS cells. CiRA Director Shinya Yamanaka, a Nobel laureate for his work on iPS cells, will direct the Program, while Takeda provides long-term funding, recommendations on research management, and facilities at its Shonan Research Center, Fujisawa, Japan. iPS cell technologies have the potential to bring about ground-breaking transformations to future medical treatments, and their applications span a variety of fields, including drug discovery, cell therapy and drug safety assessments. During a period of 10 years, Takeda and CiRA will jointly run projects led by research experts invited from CiRA. The collaboration is expected to make significant contributions to the science and application of iPS cell technology into clinical practice, which requires a significant amount of time, effort and investment. This collaboration is aligned with the purpose of National Projects of Japan on clinical applications of iPS cell technologies. Takeda will provide research facilities at its Shonan Research Center and collaborative funding of ¥20 billion over a 10-year period. In addition, Takeda will provide more than ¥12 billion worth of research support (facility, equipment, Takeda researchers and various research services) over the 10-year collaboration period. About 100 researchers including new researchers recruited globally are to be based at Takeda'sShonan Research Center engaged in joint research, with each contributing about 50 researchers. Also, the access to special research assets, such as Takeda's compound libraries, will be provided for the collaboration. Potential initial research projects include heart failure, diabetes mellitus, neuro-psychiatric disorders, and cancer immunotherapy. Additional projects will be included as the collaboration moves forward. Once set up, around 10 projects will be pursued concurrently.
FDA Advisory Committee Reviews Takeda Pharmaceuticals U.S.A., Inc. and Takeda Pharmaceutical Company Limited Alogliptin Examine Cardiovascular Safety Outcomes Trial
Apr 15 15
Takeda Pharmaceuticals U.S.A., Inc. and Takeda Pharmaceutical Company Limited announced that members of the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the United States (U.S.) Food and Drug Administration (FDA) convened to review one of the first cardiovascular (CV) outcomes trials (CVOT) in patients with Type 2 diabetes, EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome). The Committee voted that, based on the data presented, the results of EXAMINE demonstrate that the use of alogliptin in patients with Type 2 diabetes has an acceptable CV risk profile. All 16 voting members of the Committee supported this recommendation. In addition, 13 out of 16 Committee members voted that safety information from the EXAMINE study should be added to the alogliptin labeling and the other three members voted for no change to the labeling. EXAMINE, a large, randomized, double-blind, placebo-controlled outcomes study, was completed as a result of the U.S. FDA 2008 Guidance, titled "Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes," for all Type 2 diabetes treatments under development since the issuance of the guidance. The EXAMINE trial was designed to evaluate CV safety following treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care, in patients with Type 2 diabetes who were at high risk for major adverse cardiovascular events (MACE) due to recent acute coronary syndrome (ACS). The trial's primary objective was to evaluate non-inferiority of CV risk based on a primary composite endpoint of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke. The FDA also asked the Committee to discuss whether additional alogliptin studies are needed and to make any recommendations regarding the evaluation of the risk-benefit profile for alogliptin. In addition to discussing EXAMINE's pre-specified primary CV outcome data, the Committee discussed other study analyses including heart failure, study data by geographic region, and other data including renal safety findings. The outcome of the Advisory Committee meeting is non-binding and will be taken into consideration by the FDA.
Takeda Pharmaceutical Co Ltd to Invest About EUR 100 Million in its Facility in Oranienburg
Apr 7 15
Takeda Pharmaceutical Co Ltd. announced that it plans to invest about EUR 100 million in its facility in Oranienburg. The investment will help create 180 new jobs and apprenticeship positions. The company plans to build a third production hall and a building for the packaging operations. The project should be completed at the end of 2016.
Takeda Opens Office at in Tecom, Dubai
Apr 6 15
Takeda announced expansion plans for the Middle East at the inauguration of its new UAE office at i-Rise Tower in Tecom, Dubai.
Takeda Reportedly Offers $2.2 Billion to Settle Actos Lawsuits
Apr 3 15
Takeda has offered to pay over $2.2 billion to resolve claims of hiding its Type 2 drug Actos' (pioglitazone) cancer risks, potentially making it one of the large US settlements of patient lawsuits related to drugs or devices, Bloomberg reported, citing three people familiar with the matter. Takeda is proposing to settle over 8,000 lawsuits in US federal and state courts. The deal would constitute a payment of approximately $275,000 for each case. However, a final deal has yet to be agreed. In addition, some of the lawyers who have sued Takeda over Actos oppose the potential deal, arguing that $2.2 billion is inadequate compensation for all patients who developed bladder cancer after taking the drug. Takeda's offer only applies to Actos patients who have already sued or who have already hired a lawyer to file a lawsuit.