Sef Kurstjens,  M.D., Ph.D. Chief Medical Officer  and President, Global  Development Clinical Development: Bringing Innovative Therapeutics to Patients new molecular entities XTANDI and Suglat. We have main- tained this momentum in fiscal 2014, and these efforts are  continuing to produce many successful results. Our com- petitive advantage in each therapeutic area and region is  supported by the world class talent who are attracted to  our organization. Looking ahead, we will continue to pursue development in  line with our Global Category Leader (GCL) strategy. In the  fields of urology, immunology and infectious diseases for  example, we will seek to maximize the potential of our existing  franchises, while expanding our focus to cover new and  related diseases. In oncology, our goals are to establish a  business platform with our cornerstone treatments, and to  channel advances in research into expanding the patient  population for those treatments and adding further indications. Through these efforts we will contribute even more to  Astellas’ goal of delivering effective new drugs to patients as  quickly as possible. In clinical development, we aim to maximize the potential of  Astellas’ portfolio by extracting the full value from both pipeline  medicines and approved products. We are focused on obtain- ing regulatory approvals with commercially desirable labels and  bringing innovative medicines to patients. Currently, we have over 15 Phase 3 projects in the devel- opment pipeline, along with many unique projects at earlier  stages. In fiscal 2013, we obtained regulatory approvals for  10 projects in Japan, the U.S. and Europe, including the  Status of R&D Pipeline (as of August 1, 2014) Products approved in/after April 2013  Code No.  Generic Name Product Name  (Approval Date) Classification Target Disease Area Dosage  Form Origin* 1 Remarks erlotinib Tarceva (May 2013) HER1/EGFR tyrosine kinase  inhibitor 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 US Oral In-house (co-development  with Roche/  Genentech) New indication EC905 solifenacin/  tamsulosin VESOMNI (May 2013) Fixed dose  combination of  solifenacin and  tamsulosin 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 Europe Oral In-house MDV3100 enzalutamide XTANDI (Jun. 2013) Androgen receptor inhibitor Metastatic castration-resistant prostate cancer  in patients whose disease has progressed on or  after docetaxel therapy Europe Oral Medivation XTANDI (Mar. 2014) Castration-resistant prostate cancer* 2 Japan FK506 tacrolimus Prograf (Jun. 2013) Immuno- suppressant Interstitial pneumonia associated with  polymyositis/dermatomyositis Japan Oral In-house New indication ASTAGRAF XL (Jul. 2013) Prophylaxis of organ rejection in adult kidney  transplant recipients (Extended release capsules) US Oral New formulation FK463 micafungin MYCAMINE (Jun. 2013) Candin-type  antifungal agent Treatment of pediatric patients four months  and older with candidemia, acute disseminated  candidiasis,  Candida  peritonitis and abscesses,  esophageal candidiasis, prophylaxis of  Candida infections in patients undergoing hematopoietic  stem cell transplants US Injection In-house New indication YM060  ramosetron Irribow OD tablets (Aug. 2013) 5-HT3 receptor  antagonist Diarrhea-predominant irritable bowel syndrome  in males (Orally-disintegrating tablet) Japan Oral In-house New formulation midazolam Dormicum (Dec. 2013) Benzodiazepine  sedative Sedation during surgery and procedures for  dental, oral and maxillofacial care Japan Injection Roche New indication ASP1941 ipragliflozin Suglat (Jan. 2014) SGLT2 inhibitor Type 2 diabetes Japan Oral In-house (co-development  with Kotobuki) *1 “In-house” shown in the “Origin” column includes discovery through collaborative research (same below). *2 Precautions regarding indication include the description that the efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy. Annual Report 2014 _  Astellas Pharma Inc.  37 Review of Operations