| (IRVINE,
Calif., November 29, 2004) –
Responding to reports mentioning
BOTOX® in relation to a facility
in Florida, Allergan, Inc. (NYSE:
AGN) reported today that it is currently
working with the appropriate state
and federal public health authorities
to investigate the matter. This
isolated incident concerns patients
treated with an unknown substance
at one facility, Advanced Integrated
Medical Center, in Fort Lauderdale,
Florida. There are many facts that
remain unknown, including which
product or products have been used
in these cases. Contrary to certain
reports, authorities involved in
the investigation notified Allergan
today that they cannot confirm that
BOTOX® was administered to these
patients. Allergan is diligently
investigating this matter to determine
what substance may have been used
by the facility. Allergan
has confirmed that in all of 2004,
only two vials of BOTOX® were
shipped to Advanced Integrated
Medical Center and only one of
which was shipped within the last
6 months. Allergan has reviewed
all manufacturing and quality
assurance processes involved with
the vials and no deficiencies
or irregularities were found.
In addition, Allergan has reviewed
all safety surveillance reports
and found no medical adverse events
from the manufacturing lots from
which these two vials originated.
Based on the company’s investigation
to date, we are confident in the
worldwide safety and manufacturing
quality of BOTOX® and BOTOX®
Cosmetic.
BOTOX® is a
medical product containing tiny
amounts (only a few billionths
of a gram) of the highly purified
botulinum toxin protein refined
from the bacterium, Clostridium
botulinum. It is one of the most
widely researched medicines in
the world with 20 approved indications
in more than 70 countries and
has treated millions of patients
worldwide. Its proven 15-year
efficacy and safety profile, which
is supported by placebo-controlled
clinical trials involving more
than 10,000 patients, as well
as open-label studies and extensive
clinical practice involving millions
of patients, demonstrates the
benefits of this unique and versatile
therapy.
Allergan encourages physicians
and consumers with questions to
call 1-800-890-4345 to speak to
a company representative. Allergan
also encourages both physicians
and consumers to visit its web
sites at www.Allergan.com, www.BOTOX.com
and www.BOTOXCosmetic.com to learn
more about BOTOX® and BOTOX®
Cosmetic.
About Allergan,
Inc.
Allergan, Inc., with headquarters
in Irvine, California, is a technology-driven,
global health care company providing
specialty pharmaceutical products
worldwide. Allergan develops and
commercializes products in the
eye care, neuromodulator, skin
care and other specialty markets
that deliver value to its customers,
satisfy unmet medical needs, and
improve patients’ lives.
Allergan Contacts:
Jim Hindman (714) 246-4636 (investors)
Joann Bradley (714) 246-4766 (investors)
Ashwin Agarwal (714) 246-4582
(investors)
Caroline Van Hove (714) 246-5134
(media)
Stephanie Fagan (714) 246-5232
(media)
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