Sumitomo Dainippon Pharma Annual Report 2017
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Message from the PresidentWe made substantial progress on late-stage development products and significantly expanded our product pipeline through in-licensing and acquisitions.What is your evaluation of activitieson the R&D front?In terms of clinical development, in Psychiatry & Neurology, we completed a pivotal study in the U.S. of dasotraline in attention-deficit hyperactivity disorder (ADHD) and we plan to submit an NDA in the second quarter of fiscal 2017 for adult and pediatric ADHD. Also with regard to dasotraline, we are moving ahead with our second pivotal study, again in the U.S., which is investigating binge eating disorder (BED) in adults. Our October 2016 acquisition of Cynapsus Therapeutics Inc. added to our pipeline APL-130277, which is currently undergoing, in the U.S., a Phase 3 study for management of OFF episodes associated with Parkinson’s disease. We aim to submit an NDA in the second half of fiscal 2017. In Japan, since a primary endpoint was met in a Phase 3 study evaluating the effects of TRERIEF® in patients with parkinsonism in dementia with Lewy bodies (DLB), we plan to submit an sNDA in the first half of fiscal 2017. And, with regard to lurasidone, we are aiming to submit an NDA in Japan in fiscal 2019 for schizophrenia and bipolar disorder (depression/bipolar maintenance).In Oncology, we initiated a new R&D framework in April 2017. Considering that the January 2017 acquisition of Tolero Pharmaceuticals, Inc. expanded the scope of our oncology business and increased the depth of human resources in A2Q2Oncology, we determined that we had reached the stage for transitioning to a new management framework focused on the Group’s overall oncology business. Under the leadership of our newly established Global Head of Oncology, we are developing our Oncology-related business through collaboration among our divisions that focus on oncology, as well as Boston Biomedical, Inc. and Tolero Pharmaceuticals. As regards personnel, Kazuo Koshiya, who has experience managing businesses in Oncology, has been appointed Global Head of Oncology, while Patricia Andrews, who has management experience in oncology with major U.S. pharmaceutical manufacturers, has been appointed as the new CEO of Boston Biomedical. Former Boston Biomedical CEO Chiang Li will continue to provide R&D support in Oncology as Senior Special Oncology Advisor.With regard to progress on research and development in Oncology, we decided in June 2017 to unblind our Phase 3 study of gastric and gastro-esophageal junction adenocarcinoma based on a recommendation by the study’s independent Data and Safety Monitoring Board, which determined that the study was unlikely to reach its primary endpoint of superior overall survival. As the unexpected outcome does not directly negate the efficacy of napabucasin, other Phase 3 studies are ongoing, including colorectal cancer (Japan and U.S. NDAs targeted for FY2020) and pancreatic cancer (Japan and U.S. NDA targeted for FY2021). For alvocidib, which was added to our pipeline with the acquisition of Tolero Pharmaceuticals, we are carrying out a Phase 2 study in acute myeloid leukemia (AML) and aim to submit an NDA in the U.S. in fiscal 2018.In the fields of Regenerative Medicine and Cell Therapy, we are advancing five projects: chronic stroke (allogeneic mesenchymal stem cells), age-related macular degeneration (allogeneic iPS cells), Parkinson’s disease (allogeneic iPS cells), New global oncology organization (changed April 2017)15Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017Chief Executive OfcerScientic Advisory BoardDSP Scientic Advisory Panel OncologyGlobal Head of OncologySumitomoDainippon Pharma(Oncology department)Boston BiomedicalTolero Pharmaceuticals

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