Clinical Researchers Announce Positive Results With BOTOX-R For Treating Brow Furrow; New Data on BOTOX-R Presented at American Academy of Dermatology Meeting.

Health/Medical Writers

IRVINE, Calif.--(BW HealthWire)--March 13, 2000

At the American Academy of Dermatology meeting in San Francisco, California, clinical researchers presented the results of the first of Allergan's (NYSE: AGN) Phase III pivotal trials evaluating BOTOX(R) (Botulinum Toxin Type A) Purified Neurotoxin Complex for the treatment of glabellar lines (brow furrow).

In this double-blind study comparing a 20 unit dose of BOTOX(R) to placebo (BOTOX(R) vehicle) in the treatment of glabellar lines, the clinical trial outcome goals that were established within the protocol were met or exceeded with a high level of statistical significance.

A total of 263 subjects with moderate to severe glabellar lines at maximum frown enrolled in this study. Subjects were injected at day 0 with either a 20 unit dose of BOTOX(R) or placebo. Follow-up visits were scheduled at days 7, 30, 60, 90, and 120 post-injection. At day 30 post-injection, 83.7% (170/203) of the BOTOX(R) treated group had glabellar lines severity rated none or mild at maximum frown by the investigator, compared with 0% (0/60) of the placebo treated group (p less than 0.001). In patient self assessments, at day 30 post-injection, 90.1% (183/203) of the BOTOX(R) treated group rated their appearance at least moderately improved, compared with 0% (0/60) of the placebo treated group (p less than 0.001). For both of these measures, the results favored BOTOX(R) over placebo and were statistically significant (p less than 0.001) at every time point starting at day 7 post-injection and monthly thereafter until the end of the study at day 120. A secondary efficacy measure, the investigator's rating of glabellar lines at rest, also showed statistically significant benefit for BOTOX(R) compared with placebo at every time point (p less than 0.036).

BOTOX(R) treatment was generally well tolerated. There were no statistically significant differences between the BOTOX(R) treated group and the placebo treated group in any adverse events.

Allergan believes that the study demonstrated statistically significant benefits of a single 20 unit treatment of BOTOX(R) for glabellar lines. These results were reported both by investigators and patients starting within a week of treatment and lasting up to four months, with a peak benefit occurring at one month.

The results of this study have been confirmed in a second study of similar design.

"The robust and extremely encouraging results of this trial confirm our belief that the use of BOTOX(R) shows great promise in substantially reducing glabellar lines for the vast majority of patients," said Dr. Lester J. Kaplan, Corporate Vice President and President, Research and Development of Allergan.

The study reported today is part of an ongoing clinical program designed to evaluate BOTOX(R) for the treatment of glabellar lines. In addition, BOTOX(R) is being studied as a treatment for a number of other disorders including cerebral palsy, hyperhidrosis, cervical dystonia (involuntary muscle spasms in the neck and shoulders), post-stroke spasticity, back pain, migraine headache, and tension headache. BOTOX(R) is approved by the United States Food and Drug Administration for the treatment of strabismus and blepharospasm associated with dystonia (disorder of the eye muscles that control blinking), including benign essential blepharospasm or VII nerve disorders in patients 12 years of age and above. BOTOX(R) is the only botulinum toxin currently approved for marketing in the U.S.

BOTOX(R) is a highly purified form of botulinum toxin Type A, which is produced by the bacteria, clostridium botulinum. It is administered as an injectable product containing minute quantities of the isolated toxin that contains no intact clostridium botulinum bacteria. When injected directly into overactive muscles, BOTOX(R) inhibits the release of acetylcholine, a neurotransmitter released from nerve endings that causes muscles to contract. The result is inhibition, or relaxation, of the muscle over-activity.

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.

Forward-looking Statements

Any of the above statements that refer to the Company's estimated or anticipated future results are forward-looking and reflect the Company'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 competitive conditions and changing market conditions, and product performance, including patients, physicians and managed care organization's acceptance of BOTOX(R), as well as the outcome of the United States Food and Drug Administration's review of the Company's request for approval of additional indications for BOTOX(R). These forward-looking statements represent the Company's judgment only as of the date of this press release. Actual results could differ materially from those described in this 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.

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