## Drug Discovery Research Measures 

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. 

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. 

## Technical Development Initiatives 

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. 

## Initiatives for Clinical Development and Main Development Advances 

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. 

(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. 

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. 

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. 

