Allergan's VISTABEL® (Botulinum Toxin Type A) Receives Europe's First Positive Opinion for Treatment of Moderate to Severe

Allergan's VISTABEL® (Botulinum Toxin Type A) Receives Europe's First Positive
Opinion for Treatment of Moderate to Severe Lateral Canthal Lines (Crow's Feet
                           Lines) in Adult Patients

  PR Newswire

  MARLOW, England, October 23, 2013

MARLOW, England, October 23, 2013 /PRNewswire/ --

Positive Opinion Paves the Way for a Second Aesthetic Indication for VISTABEL®
                           in 29 European Countries

Today, Allergan Inc. announced that VISTABEL® has received a Positive Opinion
from the Agence Nationale de Sécurité du Médicament et des Produits de Santé
(ANSM) for the temporary improvement in the appearance of moderate to severe
lateral canthal lines (crow's feet lines) seen at maximum smile, either alone
or when treated at the same time as glabellar (or frown) lines seen at maximum
frown in adult patients. This is an important step towards securing national
licences in the 27 countries of the European Union as well as Norway and
Iceland. This Positive Opinion follows the recent authorisation for a similar
indication by the U.S. Food and Drug Administration (FDA). The Positive
Opinion is specific to Allergan's botulinum toxin type A product and is based
on Allergan's successful global Phase III clinical trial programme in Crow's
Feet Lines.

"At Allergan, we have a long-term commitment to innovation in neuromodulator
research, and this Positive Opinion is testament to this," said Paul Navarre,
President of Allergan EAME. "This is an important milestone for Allergan,
extending our commitment to support medical aesthetics practitioners by
delivering the scientific evidence, the appropriate country licences to
promote the drug and the educational training programs to yield the best
possible outcomes for patients."

The European Positive Opinion for the use of VISTABEL®to treat crow's feet
lines is based on the results of two randomised, multi-centre,
placebo-controlled clinical studies involving more than 1,350 patients. ^[ ^1
^] These studies met their primary endpoint, demonstrating that patients who
received treatment with VISTABEL® achieved none or mild lines according to
investigator assessment at day 30, compared to those patients who did not
receive botulinum toxin type A treatment and this significant reduction in the
appearance of crow's feet lines lasting an average of four months
post-treatment. ^[ ^1 ^] Patients treated with VISTABEL® reported that they
looked younger and more attractive. ^[ ^1 ^] In these studies, Allergan's
botulinum toxin type A product was generally well tolerated. ^[ ^1 ^] Like all
medicines, Allergan's botulinum toxin type A product may cause side effects,
although the incidence rate is variable. In general, adverse reactions
occurred within the first few days following injection and were temporary.

"Crow's Feet Lines are amongst the top ageing concerns for people in Europe.
Whilst these lines form a natural part of our eye expressions, over time they
can become fixed or elongated even when our faces are relaxed, which can make
us look tired or stressed," said Dr. Koenraad de Boulle, Dermatologist and a
key investigator in the registration trials. "I'm pleased Allergan invested in
the additional research to demonstrate that treatment with VISTABEL® can
deliver a refreshed look by softening the appearance of Crow's Feet Lines as
well as the glabellar lines."

Notes to Editor

About VISTABEL®

VISTABEL® (botulinum toxin type A) is a prescription medication that works by
relaxing the specific muscles that cause crow's feet lines or frown lines to
form. By decreasing muscle activity, it's possible to soften the appearance of
these lines and wrinkles without radically changing facial appearance or
making a patient look as if they have had "work done". The temporary effect
lasts for up to four months. ^[ ^1 ^] VISTABEL® should only be administered
in a clinical setting by appropriately trained physician.

About Allergan's botulinum toxin type A

Worldwide, approximately 35 million vials of Allergan's botulinum toxin type A
products have been distributed over the past 21 years (1990-2012). The safety
and efficacy of Allergan's botulinum toxin type A product has been
well-established with approximately 65 randomised, 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. ^[ ^2 ^]

About the Mutual Recognition Procedure

For VISTABEL®, France serves as the Reference Member State in the Mutual
Recognition Procedure. Following the Positive Opinion from Agence Nationale de
Sécurité du Médicament et des Produits de Santé (ANSM), the healthcare
regulatory agencies in the 27 countries of the European Union as well as
Norway and Iceland will finalise the relevant national licences.

About Allergan

Allergan 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 approximately 11,100 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, medical devices and over‐the‐counter consumer products, 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 eye care, neurosciences,
medical aesthetics, medical dermatology, breast aesthetics, obesity
intervention and urologics, 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 Paul Navarre and Dr Koenraad de Boulle and
other statements regarding the use of VISTABEL® to treat crow's feet lines.
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.
Allergan expressly disclaims any intent or obligation to update these
forward-looking statements except as required to do so by law. 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 2012 Annual Report on Form 10-K
and subsequent Quarterly Reports on Form 10-Q. 

© Allergan Ltd. VISTABEL® and VISTABEX® are registered trademarks owned by
Allergan, Inc.

References

1.Allergan Data on file - Draft SMPC for VISTABEL® 50 Units
2.Allergan Data On file

Contact: For further information please contact: Janet Kettels, Allergan -
kettels_janet@allergan.com or +44(0)7738-506-476 ; Julia Kendrick, Allergan -
kendrick_julia@allergan.com or +44(0)7894-395-988 ; Sophie Asker, Chandler
Chicco Agency - s.asker@cca-uk.com or +44(0)207-632-1886
 
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