Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe

Staines, England (ots/PRNewswire) -

Astellas Pharma Inc. [http://www.astellas.com/en/corporate ]
today announced the submission of a New Drug Application and Market
Authorisation Application for mirabegron (generic name / code name:
YM178) to the U.S. Food and Drug Administration and the European
Medicines Agency. The submissions were sent on August 24 and 26, 2011
(Europe and US, respectively). Astellas is seeking approval for this
first in a new class of medicine for the indication of overactive
bladder (OAB*) associated with symptoms of urgency, urinary
frequency, and urge urinary incontinence.

Mirabegron is a once daily oral selective beta3-adrenoceptor
agonist discovered and developed by Astellas. The pivotal Phase 3
clinical trials in the U.S. and Europe met primary endpoints compared
to placebo.

Astellas has been developing mirabegron as a global project. In
Japan, Astellas was granted marketing approval under the trade name
of Betanis(R) tablet in July 2011. Additionally, there is an on-going
multiregional Phase 3 study in China, Korea, Taiwan, and India.

Astellas markets the OAB medication solifenacin succinate (known
as Vesicare) in **67 countries/areas and has contributed to improving
OAB associated symptoms.

*OAB is associated with symptoms such as urinary frequency,
urgency, nocturia and urge incontinence. In the U.S. and Europe, >12%
of adults and 30-40% of adults 75 years of age and over are estimated
to have some sort of OAB symptoms (Wein AJ, Rovner ES. The overactive
bladder: an overview for primary care health providers. Int J Fertil
Womens Med. 1999;44:56-66).

** as of July 2011

About Astellas Pharma Europe Ltd.:

Astellas Pharma Europe Ltd., located in the UK, is a European
subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceuticals. The organisation is committed to becoming a global
company by combining outstanding R&D and marketing capabilities and
continuing to grow in the world pharmaceutical market. Astellas
Pharma Europe Ltd. is responsible for 21 affiliate offices located
across Europe, the Middle East and Africa, an R&D site and three
manufacturing plants. The company employs approximately 4,000 staff
across these regions. For more information about Astellas Pharma
Europe, please visit http://www.astellas.eu.

http://www.astellas.com/en

ots Originaltext: Astellas Pharma Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For inquiries or additional information: Astellas Pharma Inc.,
Corporate Communications, Tel: +81-3-3244-3201, Fax:
+81-3-5201-7473.