The Company obtained approval in the U.S. in June 2013 for MyCAMINE (generic name: micafungin sodium), a candin-type antifungal agent, for additional indication. The indication is for injection by intravenous infusion for the treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, candida peri- tonitis and abscesses, esophageal candidiasis, and the prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation. 

The Company obtained approval in the U.S. in July 2013 for extended release capsules of tacrolimus hydrate (generic name), an immunosuppressant, for the indication of prophylaxis of organ rejection in patients receiving a kidney transplant. The product was launched the following month under the brand name ASTAGRAF XL. 

For XTANDI (generic name: enzalutamide, develop- ment code: MDV3100) additional indication applications were submitted in the U.S. in March 2014 and in Europe the following month for the treatment of men with meta- static castration-resistant prostate cancer who have not received chemotherapy. 

(Clinical Development in Japan) 

The Company obtained approval in June 2013 for Prograf (generic name: tacrolimus hydrate), an immunosuppres- sant, for the additional indication of interstitial pneumonia associated with polymyositis/dermatomyositis. 

With respect to the orally disintegrating tablet that is being developed as an additional formulation of Irribow (generic name: ramosetron hydrochloride) for the indication of diarrhea-predominant irritable bowel syndrome in males, the Company obtained approval in August 2013. The product was launched under the brand name Irribow OD Tablets in January 2014. 

With respect to the hypnosedative Dormicum (generic name: midazolam), the Company obtained approval for an additional indication for use in sedation during surgery and procedures for dental, oral and maxillofacial care in Decem- ber 2013. 

In January 2014, the Company obtained approval for the selective SGLT2 inhibitor Suglat (generic name: Ipragliflozin L-Proline, development code: ASP1941) for the treatment of type 2 diabetes, and launched it in April of the same year. 

For XTANDI, the Company obtained approval for the indication of castration-resistant prostate cancer in March 2014, and launched it in May of the same year. 

## Initiatives to Optimize the Allocation of Resources in R&D 

In April 2013, the Company entered into a collaboration agreement with Ambrx Inc. of the U.S. regarding technol- ogy for next-generation antibody drug conjugates (“ADCs”) in the field of oncology. Under the agreement, the Com- pany received worldwide rights to develop and commer- cialize ADCs for oncology. 

The Company is proactively promoting utilization of the “Multi-Track” process. This approach includes having mul- tiple strategies at every stage of the R&D process and promoting the uptake of innovative research, as well as constructing a high-quality and robust pipeline for the Company while at the same time managing risks and costs through the effective use of outside resources. As part of this approach, in April 2013 the Company entered into an exclusive license agreement with Tacurion Pharma, Inc., a company operated by Drais Pharmaceuticals, Inc. of the U.S., regarding ASP7035, which is currently developed for the treatment of nocturia. 

In May 2013, the Company entered into an agreement for a strategic alliance in Japan with Amgen Inc. of the U.S. The alliance consists of two elements. The first element is a long-term collaboration between the two companies that will focus on the co-development and co-commercializa- tion in Japan of five Amgen pipeline medicines, which are mainly biological products. The five medicines are a hyper- lipidemia agent (development code: AMG 145), an osteo- porosis agent (development code: AMG 785) and three treatments for cancer (development code: AMG 102, AMG 337 and AMG 103). The second element is the establish- ment of a joint venture company (Amgen Astellas Bio- Pharma KK), through which the two companies will work together. Having started operations in October 2013, Amgen Astellas BioPharma KK will work with the Company on the co-development and co-commercialization in Japan of the above-mentioned five pipeline medicines. 

