Financial Section Annual Report 2014 _  Astellas Pharma Inc.  95 For enzalutamide (generic name/development code:  MDV3100), approval was obtained in Europe in June  2013 for the treatment of adult men with metastatic  castration-resistant prostate cancer whose disease has  progressed on or after docetaxel therapy. The product was  launched in the U.K. the following month under the brand  name XTANDI. In May 2013, the Company obtained approval in the  Netherlands for a combination drug (development code:  EC905) containing the OAB treatment solifenacin succinate  (generic name) and the benign prostatic hyperplasia treat- ment tamsulosin hydrochloride (generic name). The  approval is for the indication of treatment of moderate to  severe storage symptoms (urgency, increased micturition  frequency) and voiding symptoms associated with benign  prostatic hyperplasia in men who are not adequately  responding to treatment with monotherapy. The product  was launched under the brand name VESOMNI in September 2013. (Clinical Development Outside of Japan) With respect to the HER1/EGFR tyrosine kinase inhibitor  Tarceva (generic name: erlotinib), approval was obtained in  May 2013 in the U.S. for the additional indication of first- line treatment of people with metastatic non-small cell  lung cancer whose tumors have certain epidermal growth  factor receptor activating mutations as detected by an  FDA-approved test. Astellas is working to accelerate the pace of product devel- opment by channeling resources into high-priority projects  while further reinforcing its global development structure.  The following are the main development advances made  during fiscal 2013. Initiatives for Clinical Development and Main  Development Advances With the aim of ensuring a stable supply of active pharma- ceutical ingredients with high pharmacological activities, for  which demand is expected to increase in line with expan- sion of the development pipeline focused on oncology,  construction of Building No. 8 at Takahagi Technology  Center of Astellas Pharma Tech Co., Ltd. was completed  in August 2013. Our drug discovery research, in which we are concentrating  management resources, focuses on the following prioritized  therapeutic areas: urology, immunology (including transplan- tation) & infectious diseases, oncology, neuroscience and  diabetes mellitus (DM) complications & kidney diseases. Technical Development Initiatives Drug Discovery Research Measures In drug discovery research, we aim to discover innova- tive new medicines, while promoting the Precision Medicine  approach, which is based on molecular targeting and pre- cision diagnostics, and proactively making use of leading- edge technologies and know-how through alliances with  outside organizations. In the field of regenerative medicine,  in addition to the regenerative medicine research and  development we already carry out, we will expand the  scope of our research for the utilization of cells themselves  in medical treatment (cell therapy). As part of these efforts,  we established the “Regenerative Medicine Unit” in April  2014 as a new organization that will specialize in research  of regenerative medicine and cell therapy. In May 2013, we decided to reshape our research  framework and introduce new initiatives. By optimizing the  allocation of resources for our research and development  capabilities through this reform, we aim to achieve the  following objectives: i) to utilize more external capabilities  and resources, ii) to undertake initiatives related to new  therapeutic areas and innovative technologies including  regenerative medicine and vaccines, iii) to accelerate devel- opment of our promising preclinical pipeline, and iv) to  ensure sufficient investment in the late-stage clinical pipe- line. We established Astellas Innovation Management in  October 2013 in order to enhance the process of identify- ing and obtaining external opportunities to strengthen inno- vation during the preclinical development stage. In addition,  we are pushing ahead with strengthening our research  management framework and promoting a “Multi-Track  R&D” approach. Furthermore, in order to facilitate the stra- tegic reallocation of resources and to enhance our opera- tional excellence, we are reorganizing our research  functions and structures in a sequential manner. This  includes closing and scaling back research institutes and  transferring certain functions.