Phase III Results Show Mirabegron Improves Key OAB Symptoms

Tokyo (ots/PRNewswire) - Astellas Pharma Inc.
(http://www.astellas.com/en/corporate/) 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 events(1,2).

"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 frequency(6,7).

"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 http://www.astellas.com/en.

References

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, Austria, 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 http://www.astellas.com/en
Astellas Pharma US, Inc. (US) Jenny Keeney Tel:
+1-847-317-5405 http://www.astellas.us Astellas Pharma Europe
Limited (EU) Mindy Dooa Tel: +44-(0)1784-419-408
http://www.astellas-europe.co.uk

Rückfragehinweis:
Contacts for inquiries or additional information; Astellas PharmaInc.
(Japan) , Corporate Communications, Tel: +81-3-3244-3201
Fax:+81-3-5201-7473 , http://www.astellas.com/en. Astellas Pharma US,
Inc. (US), Jenny Keeney , Tel: +1-847-317-5405 ,
http://www.astellas.us. AstellasPharma Europe Limited (EU) , Mindy
Dooa , Tel: +44-(0)1784-419-408 ,http://www.astellas-europe.co.uk

OTS-ORIGINALTEXT PRESSEAUSSENDUNG UNTER AUSSCHLIESSLICHER INHALTLICHER VERANTWORTUNG DES AUSSENDERS - WWW.OTS.AT | PRN

print