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

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

  PR Newswire

  MARLOW, England, December 19, 2012

MARLOW, England, December 19, 2012 /PRNewswire/ --

 Data demonstrates BOTOX ^®  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 ^® 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 ^® 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 ^® 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

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 ^® (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 ^® , 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®

BOTOX ^® (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® 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 ^]

A bout 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 ^® . 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. 

^© Allergan Ltd. BOTOX ^® is a registered trademark owned by Allergan, Inc.


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    Overactive Bladder, and Other Lower Urinary Tract Symptoms in Five
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    2012;11(Suppl 1):e577
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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 -Last accessed
    November 2012
9.Allergan Data On File
10.Allergan Data On File

Media contacts For further information please contact:Janet Kettels, Allergan
- or +44(0)7738-506-476Victoria Bramham, CCA London
- or +44(0)207-632-1896
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