Allergan's BOTOX® (botulinum toxin type A) Receives a Positive Opinion in Fourteen European Countries for Idiopathic Overactive Bladder

Marlow, England (ots/PRNewswire) -

Data demonstrates BOTOX(R)injections can reduce urinary leakage
episodes for up to six months in patients who have had an inadequate
response to, or are intolerant of,

anticholinergic medication

Today, Allergan Inc. announced that BOTOX(R)has received a
positive opinion from the Irish Medicines Board for the treatment of
idiopathic overactive bladder (OAB) with symptoms of urinary
incontinence, urgency and frequency in adult patients who have an
inadequate response to, or are intolerant of, anticholinergic
medications.This is an important step towards securing national
licences in the 14 European countries involved in the Mutual
Recognition Procedure and marks a key milestone in bringing this
innovative treatment to patients suffering from idiopathic OAB. The
positive opinion is specific for BOTOX(R) and is based on Allergan's
successful global phase III programme in idiopathic OAB.

Idiopathic overactive bladder is surprisingly common in Europe,
with studies indicating that up to 16.6% of the population may have
the condition.[1],[2] Of these, up to 36% will experience urinary
incontinence (leaking) associated with urgency.[1] Two multi-national
studies report that between 16-28% of idiopathic OAB patients receive
a prescription medication to manage their condition.[3],[4] However,
research also indicates that more than 50% of patients stop taking at
least one oral medication within 12 months, likely due to lack of
efficacy or side-effects.[5],[6]Idiopathic OAB can be a disabling and
socially isolating condition, considerably affecting daily
activities, work-life, mental health and sleep quality, thus reducing
patients' quality of life.[7] It can negatively impact emotional
well-being, causing embarrassment, low self esteem, depression and
loss of independence.[8]

"We are pleased that BOTOX(R) has received a positive opinion from
the Irish Medicines Board for the treatment of idiopathic OAB in
patients who are struggling to control their bladder symptoms with
anticholinergic medications. For these patients, gaining effective
control over their bladder without the fear of leakage after only one
treatment can be a significant step towards improving quality of
life," said Douglas Ingram, President of Allergan in Europe, Africa
and the Middle East. "This is a critical milestone for the
organisation, extending our commitment to urology beyond neurogenic
detrusor overactivity and building on our long-term commitment to
innovation in botulinum toxin research. Our task now is to work
closely with the national health authorities in Europe to secure the
relevant national licences so that we can bring this valuable
treatment option to patients, as quickly as possible."

The positive opinion is based on the results of two randomised,
placebo-controlled, multi-centre, phase III trials (the EMBARK
studies) involving over 1,100 patients.[9] In these studies, patients
who received targeted injections of BOTOX(R) (100 Units) into the
bladder muscle experienced a significant and clinically relevant
response to treatment compared to placebo in the reduction of urinary
incontinence, including more patients becoming dry (no urinary
leakage at 12 weeks). Significant improvements compared with placebo
were also observed for all other symptoms of idiopathic OAB. Patients
treated with Allergan's botulinum toxin type A product reported
significant improvements in their quality of life compared to
patients treated with placebo. In these studies, Allergan's botulinum
toxin type A product was generally well tolerated. The most common
adverse events reported were urinary tract infection and dysuria
(painful urination).[9]

"There are currently very limited treatment options for idiopathic
OAB patients who have not achieved bladder control with existing
anticholinergic medications. Many patients find these daily
medications are difficult to adhere to and sometimes have limited
effect, and they continue to live with the potentially debilitating
impact of their condition," said Professor Christopher Chapple,
Urology Department, Royal Hallamshire Hospital, Sheffield Teaching
Hospitals NHS Foundation Trust and a key investigator in the
idiopathic overactive bladder registration trials. "There is a need
for additional treatments that are effective, well-tolerated,
minimally invasive options to help patients gain better control of
these distressing symptoms."

Notes to Editors

Countries involved in the Mutual Recognition Procedure (MRP)

For BOTOX(R), Ireland serves as the Reference Member State in the
Mutual Recognition Procedure. The other countries involved are
Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy,
Luxemburg, Norway, Portugal, Spain and Sweden.

About Idiopathic Overactive Bladder

While the exact cause is often unknown, idiopathic overactive
bladder (iOAB) is a medical condition where involuntary contractions
of the bladder can cause an uncontrolled urge to urinate (urgency),
frequent urination (frequency) and unexpected leakage of urine
(urinary incontinence).

About BOTOX(R)

BOTOX(R) (botulinum toxin type A) from Allergan is a
prescription-only medicine that contains tiny amounts of highly
purified botulinum toxin protein refined from the bacterium,
Clostridium botulinum. Allergan's botulinum toxin type A product
received the first licence from the US Food and Drug Administration
in 1989 and is now available in approximately 85 countries.
Worldwide, approximately 30 million vials of Allergan's botulinum
toxin type A products have been distributed over the past 20 years
(1990-2010). The safety and efficacy of BOTOX(R) has been
well-established with approximately 65 randomized, placebo-controlled
clinical trials involving approximately 15,000 patients, and with
more than 2,500 articles in scientific and medical journals,
Allergan's neurotoxin is one of the most widely researched medicines
in the world.[10]

About Allergan

Allergan, Inc. is a multi-specialty health care company
established more than 60 years ago with a commitment to uncover the
best of science and develop and deliver innovative and meaningful
treatments to help people reach their life's potential. Today, we
have more than 10,500 highly dedicated and talented employees, global
marketing and sales capabilities with a presence in more than 100
countries, a rich and ever-evolving portfolio of pharmaceuticals,
biologics, over-the-counter medicines and medical devices, and
state-of-the-art resources in R&D, manufacturing and safety
surveillance that help millions of patients see more clearly, move
more freely and express themselves more fully. From our beginnings as
an eye care company to our focus today on several medical
specialties, including ophthalmology, neurosciences, obesity,
urologics, medical aesthetics and dermatology, Allergan is proud to
celebrate more than 60 years of medical advances and proud to support
the patients and physicians who rely on our products and the
employees and communities in which we live and work.

Forward-Looking Statement

This press release contains "forward-looking statements",
including but not limited to the statements by Mr. Ingram, Professor
Christopher Chapple and other statements regarding research and
development outcomes, efficacy, adverse reactions, market and product
potential, product availability and other statements regarding
idiopathic overactive bladder and BOTOX(R). These statements are
based on current expectations of future events. If underlying
assumptions prove inaccurate or unknown risks or uncertainties
materialise, actual results could vary materially from Allergan's
expectations and projections. Risks and uncertainties include, among
other things, general industry and pharmaceutical market conditions;
technological advances and patents attained by competitors;
challenges inherent in the research and development and regulatory
processes; challenges related to new product marketing, such as the
unpredictability of market acceptance for new pharmaceutical products
and/or the acceptance of new indications for such products;
inconsistency of treatment results among patients; potential
difficulties in manufacturing a new product; general economic
conditions; and governmental laws and regulations affecting domestic
and foreign operations. Additional information concerning these and
other risk factors can be found in press releases issued by Allergan,
as well as Allergan's public periodic filings with the U.S.
Securities and Exchange Commission, including the discussion under
the heading "Risk Factors" in Allergan's 2010 Annual Report on Form
10-K and subsequent Quarterly Reports on Form 10-Q.

(c) Allergan Ltd. BOTOX(R) is a registered trademark owned by
Allergan, Inc.

References:

1) Milsom I et al. How widespread are the symptoms of an overactive bladder
and how are they managed? A population-based prevalence study. BJU International,
2001;87;760-766
2) Irwin DE. et al. Population-Based Survey of Urinary Incontinence, Overactive
Bladder, and Other Lower Urinary Tract Symptoms in Five Countries: Results of the EPIC
Study. European Urology, 2006;50: 1306-1315
3) Reeves P et al. The current and future burden and cost of overactive bladder
in five European countries. European Urology, 2006; 50: 1050-1057
4) Cruz F et al. Patient attitudes and patterns of treatment utilization in a
European population with overactive bladder symptoms. Eur Urol. 2012;11(Suppl 1):e577
5) Pelletier EM et al. Pharmacotherapy adherence and costs versus
nonpharmacologic management in overactive bladder. Am J Manag Care 2009;15:S108-14
6) D'Souza A et al. Persistence, adherence and switch rates among
extended-release and immediate-release overactive bladder medications in a regional
managed care plan. JMCP, 2008; 14: 291-301
7) Tubaro A. Defining Overactive bladder: Epidemiology and burden of disease.
Urology, 2004; 64 (Suppl 6A): 2-6
8) NIH Consensus and State-of-the-Science Statements, Prevention of Fecal and
Urinary Incontinence in Adults. Dec 12-14 2007:24(1):1-37
http://consensus.nih.gov/2007/incontinencestatement.pdf - Last accessed November
2012
9) Allergan Data On File
10) Allergan Data On File

Media contacts
For further information please contact:
Janet Kettels, Allergan - kettels_janet@allergan.com or +44(0)7738-506-476
Victoria Bramham, CCA London - v.bramham@cca-uk.com or +44(0)207-632-1896

ots Originaltext: ALLERGAN, INC.
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