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* In this section, all figures for sales and year-on-year changes are based on J-GAAP. 

## Ur ology 

W ith V esicare and mirabegron, Astellas aims to reinforce its overactive bladder (OAB) franchise. 

Urology is a therapeutic area in which Astellas has already established its status as a Global Category Leader (GCL). Through sales of Harnal, Vesicare and mirabegron (generic name), we command a strong presence in the market for drugs used to treat the conditions of benign prostatic hyperplasia (BPH) and OAB. 

Our OAB franchise expanded steadily due to the growth of Vesicare and a contribution from mirabegron. In fiscal 2013, aggregate sales of these two OAB treatments grew 40% year on year to ¥163.9 billion. On a regional basis, we recorded double-digit sales growth in Japan, EMEA, the Americas and Asia & Oceania. 

Anticholinergics such as Vesicare are still the standard therapy for OAB. Mirabegron, which is a beta-3 adrenergic receptor agonist, has a different mechanism of action. Since its launch in Japan in 2011, it has become a well- established new treatment option for OAB patients. We plan to strengthen our OAB franchise further by focusing 

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on promoting sales of mirabegron, which is marketed under the brand names of Myrbetriq in the U.S.; BETMIGA in EMEA, Asia & Oceania; and Betanis in Japan. The product is currently available in over 25 countries around the world. 

Sales of Harnal fell in Japan and EMEA, reflecting  erosion by generic competition. In contrast, sales of Harnal continued to increase in Asia & Oceania. 

We are working to maintain Astellas’ GCL status in urology by introducing a stream of new products. We gained regulatory approval in Europe for VESOMNI, a combination drug of Vesicare and Harnal, in May 2013, and launched it in September 2013. We are also advanc- ing several projects in various stages of clinical develop- ment, including EB178 (a combination therapy comprising solifenacin and mirabegron). Currently in Phase 3 trials, EB178 is an important development program in our efforts to reinforce the OAB franchise. 

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