Sumitomo Dainippon Pharma Annual Report 2017

New Chemical EntitiesNew Indication, etc.Submission targetFY2017FY2018FY2019FY2020-2022Psychiatry&NeurologyOncologyAreaDevelopmentSEP-225289(Adult, Pediatric ADHD) U.S.APL-130277(Parkinson’s disease) U.S.TRERIEF®(Parkinsonism in Dementia with Lewy Bodies) JapanSEP-225289(BED) U.S.LONASEN®(Schizophrenia / Transdermal patch) JapanSM-13496(Schizophrenia / Bipolar l depression / Bipolar maintenance)JapanBBI608(Colorectal cancer / Combination therapy) U.S./ JapanBBI608(Pancreatic cancer / Combination therapy) U.S./ JapanAlong with further strengthening ourNorth America business and raisingoperational efficiency in Japan,we are continuing to review our long-term vision as we work toward formulating our next Mid-term Business Plan.Could you give us any details on key strategies for fiscal 2017 and the structure of the next Mid-term Business Plan?In fiscal 2017, we will dedicate our efforts to further growth in LATUDA® sales in North America, while also expanding sales of strategic products such as APTIOM® and BROVANA®. In addition, we intend to focus on growing sales of treatments for chronic obstructive pulmonary disease (COPD), including SUN-101, which is planned for launch during fiscal 2017, and three treatments in-licensed from Novartis: UTIBRON™ NEOHALER®, SEEBRI™ NEOHALER®, and ARCAPTA® NEOHALER®. We are continuing to leverage an efficient sales organization with a view to long-term growth. Meanwhile, within Japan, we will work to grow sales of promoted products while boosting productivity by in-licensing new products, collaborating with partners, and reforming work styles. We will also strive for increased operational efficiency through ongoing cost reductions and other measures.With regard to our next Mid-term Business Plan, we have started discussing a five-year plan to cover fiscal years 2018 through 2022. We want to start by reaching a consensus as to the kind of company we want to be 15 years from now; then, we will incorporate into our next Mid-term Business Plan our first five-year strategy for achieving that shared vision.A3Q3retinitis pigmentosa (allogeneic iPS cells), and spinal cord injury (allogeneic iPS cells). Our Parkinson’s disease project was designated as a “Sakigake Designation System” product by the Ministry of Health, Labour and Welfare in February 2017. We also started building a cell production and processing facility and we are proceeding to establish a manufacturing framework for full-fledged practical use and commercialization at an early date.While aiming to bring “post-LATUDA” candidates to market, we are continuing with proactive research and development. With ¥88 billion budgeted for investment in R&D in fiscal 2017, our concerted efforts will be focused on late-stage development products. Also, with regard to acquisitions and new in-licensing in order to expand and enhance our pipeline, we estimate total investment of up to ¥150–200 billion. Whereas we focused these activities on North America in fiscal 2016, we plan to consider and implement them mainly in Japan in fiscal 2017.Submission Target of Key Late-stage Pipeline (as of July 2017)16Sumitomo Dainippon Pharma Co., Ltd. Annual Report 2017

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