Phase III Results Show Mirabegron Improves Key OAB Symptoms

By Astellas Pharma Inc., PRNE
Sunday, March 20, 2011

First Presentations of European-Australian and North American Phase III Trials at European Association of Urology Congress

TOKYO, March 21, 2011 - Astellas Pharma Inc. (
(TSE:4503,"Astellas") today announced the results of two pivotal phase III
clinical trials for mirabegron, the first of a new class of compounds under
development for the treatment of overactive bladder (OAB), show mirabegron
significantly improves key OAB symptoms - urinary incontinence and frequency
of micturition.(1,2) These data were presented for the first time this week
at the 26th annual congress of the European Association of Urology, in
Vienna, Austria, 18-22 March 2011.

After 12 weeks treatment with once daily mirabegron, significant
improvements from baseline were seen in the co-primary endpoints,
incontinence episodes/24 hours and micturitions/24 hours, compared with
placebo (p<0.05)(1,2). Significant improvements were also recorded in the
key secondary endpoints - incontinence episodes/24 hours and micturitions/24
hours at week 4 of treatment (p<0.05 vs placebo), and volume of urine
voided/micturition at the final visit (p<0.05 vs placebo)(1,2). In both
studies, mirabegron was well tolerated with low levels of adverse

"The findings of these studies are very exciting. Mirabegron would
represent the first oral OAB drug treatment with a completely new mode of
action since the launch of oxybutynin several decades ago, and, if approved,
would represent the first beta-3 adrenoceptor agonist to ever come to the
market. Unlike antimuscarinics, mirabegron works by improving the storage
capacity of the bladder. As these two studies suggest mirabegron has the
potential to provide an effective new treatment option for OAB patients who
continue to suffer from the distressing symptoms of incontinence and frequent
need to pass urine" said Mr. Vik Khullar, from St. Mary's Hospital, Imperial
College, London, and principal investigator of the European-Australian Phase
III trial.

Mirabegron is a potent and selective beta-3 adrenoceptor (Beta3-AR) agonist
which activates Beta3-ARs on the detrusor muscle of the bladder to facilitate
filling of the bladder and storage of urine(3,4). It is being developed by
Astellas whose global drug, Vesicare(R) (solifenacin) is currently one of the
most widely used treatments for OAB(5).

"Vesicare has brought health benefits to people with OAB around the world
since it was first launched in 2004, while mirabegron, with its different
mode of action, complements Vesicare and is an important addition to our
urology portfolio" said Masafumi Nogimori, President and Chief Executive
Officer of Astellas Pharma Inc.

The new Phase III data confirm and support findings from smaller Phase
II, dose-finding studies in which significant improvements were seen in a
broad range of OAB symptoms, including incontinence episodes and micturition

"By improving symptoms through its action on beta-3 receptors, mirabegron
offers an entirely different approach to existing OAB management which may
provide good news for the many patients who are unable to achieve the right
balance of efficacy and tolerability from current available treatments for
OAB," said Dr. Victor Nitti, from NYU Langone Medical Center, New York, USA,
and principal investigator of the North American Phase III trial.

Astellas submitted a market authorization application for mirabegron in
Japan in June 2010, and Astellas expects it will be submitted to FDA and EMA
later this year (July to September 2011).

About Astellas Pharma Inc.

Astellas Pharma Inc., located in Tokyo, Japan, is a global pharmaceutical
company dedicated to improving the health of people around the world through
the provision of innovative and reliable pharmaceutical products. Astellas
has approximately 16,000 employees worldwide. The organization is committed
to becoming a global category leader in urology, immunology and infectious
diseases, neuroscience, DM complications and metabolic diseases and oncology.
For more information on Astellas Pharma Inc., please visit our website at


1) Khullar V, Cambronero J, Ströberg P, Angulo J, Boerrigter P,
Blauwet MB, Wooning M The efficacy and tolerability of mirabegron in
patients with overactive bladder - results from a European-Australian
Phase III trial. Presented at the 26th Annual Congress of the European
Association of Urology, Vienna, Austria, 18-22 March 2011.

2) Nitti V, Herschorn S, Auerbach S, Ayers M, Lee M, Martin N. The
efficacy and safety of mirabegron in patients with overactive bladder
syndrome - results from a North-American Phase III trial. Presented at
the 26th Annual Congress of the European Association of Urology, Vienna,
, 18-22 March 2011.

3) Tyagi P, Tyagi V. Mirabegron, a Beta3-adrenoceptor agonist for the
potential treatment of urinary frequency, urinary incontinence or urgency
associated with overactive bladder. IDrugs 2010: 13: 713-722

4) Yamaguchi O, Chapple CR. Beta3-adrenoceptors in urinary bladder.
Neurourol Urodyn. 2007;26(6):752-6.

5) IMS February 2011

6) Chapple C.R., Yamaguchi O., Ridder A et al. Clinical proof of
concept study (BLOSSOM) shows novel Beta3 adrenoceptor agonist YM178 is
effective and well tolerated in the treatment of symptoms of overactive
bladder. Eur Urol Suppl 2008; 7(3): 239

7) Chapple C, Wyndaele JJ, Van Kerrebroeck P et al. Dose-ranging
study of once-daily mirabegron (YM178), a novel selective Beta3-adrenoceptor
agonist, in patients with overactive bladder (OAB). Eur
Urol Suppl 2010; 9(2): 249.

    Contacts for inquiries or additional information

    Astellas Pharma Inc. (Japan)
    Corporate Communications
    Tel: +81-3-3244-3201 Fax: +81-3-5201-7473

    Astellas Pharma US, Inc. (US)
    Jenny Keeney
    Tel: +1-847-317-5405

    Astellas Pharma Europe Limited (EU)
    Mindy Dooa
    Tel: +44-(0)1784-419-408

Contacts for inquiries or additional information; Astellas Pharma Inc. (Japan) , Corporate Communications, Tel: +81-3-3244-3201 Fax: +81-3-5201-7473 , Astellas Pharma US, Inc. (US) , Jenny Keeney , Tel: +1-847-317-5405 , Astellas Pharma Europe Limited (EU) , Mindy Dooa , Tel: +44-(0)1784-419-408 ,

will not be displayed