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| |  Canada Approves Botox (Botulinum Toxin Type A) For Cosmetic Treatment Of Glabellar Lines IRVINE, CA -- April 6, 2001 -- Allergan, Inc. announced it has received regulatory approval from Canadian Health Authorities (Therapeutic Products Programme) for Botox (botulinum 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 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®-treated group compared with the placebo-treated group at all timepoints from day seven through day 120 (p(less than)0.001). Botox 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 percent of the subjects treated with Botox versus 1.6 percent of subjects treated with placebo. Also a significant change in appearance as rated by the subject's self assessment occurred in 90.1 percent of the Botox-treated group versus 1.6 percent of the placebo group. The most frequently reported adverse event was headache, which was reported for 15.3 percent of subjects treated with Botox and 15.0 percent of subjects treated with placebo. The only adverse event reported more frequently for subjects treated with Botox than for subjects treated with placebo was blepharoptosis (5.4 percent versus 0 percent). Other adverse events reported for at least 3.0 percent of subjects treated with Botox 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. Our research and development team has been studying Botox 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, Lester J. Kaplan, Ph.D. Botox 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 for the treatment of glabellar lines. SOURCE: Allergan Inc.
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