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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:AGN) today announced it has received regulatory approval

from Canadian Health Authorities (Therapeutic Products Programme) for BOTOX Bo·tox (btks(R) (Botulinum bot·u·li·nus (-ns)
n.
An anaerobic, rod-shaped bacterium (Clostridium botulinum) that secretes botulin and inhabits soils.
 Toxin Type A) Purified Neurotoxin Complex for the cosmetic indication treating prominent lines of the brow. The approval is specifically for the treatment of glabellar lines associated with corrugator cor·ru·ga·tor (kôr-gt and/or procerus muscle 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 blepharoptosis /bleph·a·rop·to·sis/ (blef?ah-rop-to´sis) ptosis (2).

bleph·a·rop·to·sis (blf
 (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," 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. Allergan's filings are available publicly and upon request from Allergan's Investor Relations 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, 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 care, movement disorder, and dermatological markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives.
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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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