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Allergan's BOTOX Receives First North American Cosmetic Approval for Treatment of Glabellar Lines -Brow Furrow-.


Business Editors and Health/Medical Writers

IRVINE, Calif.--(BW HealthWire)--April 5, 2001

Allergan, Inc. (NYSE NYSE

See: New York Stock Exchange
:AGN AGN Again (Amateur Radio)
AGN Active Galactic Nucleus
AGN Acute Glomerulonephritis
AGN Accountants Global Network
AGN Air Gabon (ICAO code) 
) today announced it has received regulatory approval

from Canadian Health Authorities (Therapeutic Products Programme) for BOTOX(R) (Botulinum Toxin Type A botulinum toxin type A

Botox, Botox Cosmetic, Dysport (UK), Vistabel (UK)

Pharmacologic class: Neurotoxin

Therapeutic class: Neuromuscular blocker

Pregnancy risk category C

Action

) Purified Neurotoxin neurotoxin /neu·ro·tox·in/ (noor´o-tok?sin) a substance that is poisonous or destructive to nerve tissue.

neu·ro·tox·in
n.
See neurolysin.
 Complex for the cosmetic indication treating prominent lines of the brow. The approval is specifically for the treatment of glabellar lines associated with corrugator and/or procerus muscle pro·ce·rus muscle
n.
A muscle with origin from the membrane covering the bridge of the nose, with insertion into the frontal bone, with nerve supply from a branch of the facial nerve, and whose action assists the frontal bone.
 activity.

This is Allergan's first cosmetic approval based on its Phase 3 clinical program. The double-blind, placebo-controlled study of 264 subjects included both men and women ages 23 to 76 years old. A statistically and clinically significantly higher responder rate was demonstrated by the BOTOX(R)-treated group compared with the placebo-treated group at all timepoints from day 7 through day 120 (p(less than)0.001). BOTOX(R) met both primary efficacy endpoints, which were the investigator's rating of glabellar line severity at maximum frown and the subject's global assessment of change in appearance. At day 30, the timepoint of peak effect, the investigator's rating of a significant reduction in the severity of glabellar lines occurred in 83.7% of the subjects treated with BOTOX(R) versus 1.6% of subjects treated with placebo. Also a significant change in appearance as rated by the subject's self assessment occurred in 90.1% of the BOTOX(R)-treated group versus 1.6% of the placebo group.

The most frequently reported adverse event was headache, which was reported for 15.3% of subjects treated with BOTOX(R) and 15.0% of subjects treated with placebo. The only adverse event reported more frequently for subjects treated with BOTOX(R) than for subjects treated with placebo was blepharoptosis (5.4% versus 0%). Other adverse events reported for at least 3.0% of subjects treated with BOTOX(R) were infection (respiratory), nausea, flu syndrome, and muscle weakness. The incidence for these adverse events in the placebo group were comparable.

"The approval in Canada marks a significant step forward in our global strategy to seek additional indications for BOTOX(R). Our research and development team has been studying BOTOX(R) for over 10 years and has established a leadership position for multiple new uses of botulinum toxins Botulinum toxin (botulin)
A neurotoxin made by Clostridium botulinum; causes paralysis in high doses, but is used medically in small, localized doses to treat disorders associated with involuntary muscle contraction and spasms, in addition to strabismus.
," said Allergan's President of Research and Development and Global BOTOX(R), Lester J. Kaplan, Ph.D.

BOTOX(R) global net product sales for the year ended December 31, 2000 were $239.5 million. In January 2001, the Company submitted a Supplemental Biologics License Application to the U.S. Food and Drug Administration for BOTOX(R) for the treatment of glabellar lines.

Forward-Looking Statements

This press release contains "forward-looking statements", such as statements regarding future approved uses for BOTOX(R). These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations. Risks and uncertainties include general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; and the uncertainty inherent in the research, development and regulatory approval processes. 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 2000 Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
. Allergan's filings are available publicly and upon request from Allergan's Investor Relations Investor relations

The process by which the corporation communicates with its investors.
 Department: 714.246.4636 or http://www.allergan.com. Allergan is disseminating this press release in order to comply with Securities and Exchange Commission requirements under Regulation FD in the event that the approval and the associated clinical data are deemed material to its investors. For more product information refer to http://www.botox.com.

About Allergan, Inc.

Allergan, Inc., headquartered in Irvine, California Irvine is an incorporated city in Orange County, California, United States. It is a planned city, mainly developed by the Irvine Company since the 1960s. Formally incorporated on December 28 1971, the 69.7 square mile (180.5 km²) city has a population of 202,079 (as of 2007). , 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 pharmaceutical, ophthalmic surgical device, over-the-counter contact lens contact lens, thin plastic lens worn between the eye and eyelid that may be used instead of eyeglasses. Actors, models, and others wear them for appearance, and athletes use them for safety and convenience.  care, movement disorder List of Movement disorders
  • Akinesia (lack of movement)
  • Athetosis (contorted torsion or twisting)
  • Ataxia
  • Ballismus (violent involuntary rapid and irregular movements)
  • Hemiballismus (
, and dermatological dermatological, dermatologic

pertaining to dermatology; of or affecting the skin.
 markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Apr 5, 2001
Words:687
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