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BOTOX® Cosmetic U.S. FDA Approval -- One Year Later
IRVINE, Calif., Apr 30, 2003 (BUSINESS WIRE) --
One year after the approval by the U.S. Food and Drug Administration (FDA),
Allergan, Inc. (NYSE:AGN) today said BOTOX® Cosmetic (botulinum toxin type
A) ranks as the most successful launch in the Company's 53-year history and
the second most recognizable pharmaceutical brand in the United States.
Although BOTOX® was first approved by the FDA in 1989, clinical trial
investigations began over 20 years ago. BOTOX® has now been approved in
over 70 countries for a variety of uses, with millions of people worldwide
having benefited from BOTOX® treatments. In all, the BOTOX® product
has been used safely and effectively in over 7 million treatments for approximately
2 1/2 million people since its first approval in the U.S. The FDA approved
BOTOX® Cosmetic on April 12, 2002 specifically for the temporary improvement
of frown lines in adult patients. The FDA approval of BOTOX® Cosmetic immediately
ignited worldwide news coverage. Highlights in the first year of launch included:
-- Cosmetic use is now approved in 21 countries under the names BOTOX®,
BOTOX® Cosmetic and VISTABEL®;
-- More than 500,000 men and women were
treated with BOTOX® Cosmetic in 2002, making it the #1 cosmetic treatment
in America;
-- More than 10 million men and women were identified to be potential
candidates for BOTOX® Cosmetic treatments (Gallup Facial Appearance Improvement
Survey, 2002);
-- More than 7,000 broadcast stories and 6,500 articles on BOTOX®(R)/BOTOX® Cosmetic
were done in the U.S.;
-- Approximately 4,500 aesthetic-specialty
physicians were registered on the BOTOX® Cosmetic Physicians' Network, providing
BOTOX® Cosmetic treatments to residents of all 50 states; and
-- Over 600,000
searches for BOTOX® Cosmetic physicians were performed on www.BOTOX®cosmetic.com.
BOTOX® Cosmetic is approved and marketed specifically for temporary improvement
of frown lines in men and women aged 18 to 65. It's a natural, purified protein,
which in very low doses relaxes the overactive muscles that cause frown lines
to form. The effects last about four months, after which lines gradually revert
to their pre-treatment appearance. The most common side effects of BOTOX® Cosmetic,
if any occur, may include headache, respiratory infection, flu syndrome, temporary
eyelid droop and nausea. For more information, please see www.BOTOX®cosmetic.com.
BOTOX® is approved and marketed in the United States for painful abnormal
head and neck position (cervical dystonia), crossed eyes (strabismus) and uncontrollable
blinking (blepharospasm), and is currently being investigated for the treatment
of severe headache, excessive sweating and upper limb spasticity. For these
and other potential uses for BOTOX® therapy, Allergan has invested more
than $175 million in research and development over the past three years alone.
Medical pioneers the world over are developing a myriad of possible new uses
for a broad spectrum of under-treated or poorly managed conditions, potentially
sparing patients difficult surgeries or hard-to-tolerate oral drugs. For more
information about BOTOX®, please visit www.BOTOX®.com.
Forward-Looking Statements
Any of the above statements that refer to Allergan's estimated or anticipated
future results are forward-looking and reflect Allergan's current analysis
of existing trends and information. Actual results may differ from current
expectations based on a number of factors affecting Allergan's businesses,
including, among other things, the inherent uncertainties associated with the
research and development process and the regulatory approval process, technological
advances and patents attained by competitors, general competitive conditions
and changing market conditions, including changing consumer preferences and
the performance and acceptance of new products. These forward-looking statements
represent Allergan's judgment only as of the date of this press release. Actual
results could differ materially from those projected in this press release.
As a result, the reader is cautioned not to rely on these forward-looking statements.
The Company disclaims, however, any intent or obligation to update these forward-looking
statements. 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 Securities and Exchange Commission, including the
discussion under the heading "Certain Factors and Trends Affecting Allergan
and its Businesses" in Allergan's Form 10-K for the year ended December
31, 2002. Copies of Allergan press releases and additional information about
Allergan are available on the World Wide Web at www.allergan.com, or you can
contact the Allergan Investor Relations Department by calling 714-246-4636.
About Allergan, Inc.
Allergan, Inc., with headquarters in Irvine, California, is a technology-driven,
global health care company providing eye care and specialty pharmaceutical
products worldwide. Allergan develops and commercializes products in the eye
care, neuromodulator and skin care markets that deliver value to our customers,
satisfy unmet medical needs, and improve patients' lives.
SOURCE: Allergan, Inc.
Allergan, Inc., Irvine
Jim Hindman, 714/246-4636 (investors)Joann Bradley,
714/246-4766 (investors)Patrick O'Brien, 714/246-4514 (investors)Christine
Cassiano, 714/246-5134 (media)www.allergan.com
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