Allergan's BOTOX Receives Positive Opinion for Approval in Fourteen European Countries for Focal Spasticity in Adults.

Business Editors & Health/Medical Writers

IRVINE, Calif.--(BW HealthWire)--Oct. 11, 2001

Allergan, Inc. (NYSE:AGN) today announced that BOTOX(R) Botulinum Toxin Type A has been granted a positive opinion by the European Commission for focal spasticity of the wrist and hand in adult post-stroke patients. This positive opinion represents the intent to approve BOTOX(R) for focal spasticity in post-stroke adults in 14 individual countries and is a key step in the approval process. Ireland served as the Reference Member State in the Mutual Recognition Process. The other countries involved are Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy, Luxembourg, Norway, Portugal, Spain and Sweden.

Post-stroke adult spasticity occurs when the muscle does not respond to the nervous system's signal to relax. As a result, the muscle remains contracted, which can result in pain, restricted mobility and seriously interfere with the patient's ability to perform daily activities such as dressing and hygiene. Characteristic postures of a patient suffering from spasticity may be a clenched fist, flexed wrist, bent elbow or arm pressed against the chest. BOTOX(R) injection therapy treats spasticity by directly targeting the affected muscle to block the release of acetylcholine, thereby allowing the muscle to relax.

In a Phase 3, randomized, multi-centre, placebo-controlled parallel trial, the safety and efficacy of BOTOX(R) therapy in the treatment of wrist and finger spasticity after stroke, as well as the effect on the functional disabilities of hygiene, dressing, pain and limb position, were evaluated in 126 patients. At all post-treatment visits, BOTOX(R) therapy was shown to be clinically and statistically superior versus placebo in the decrease in wrist and finger flexor muscle tone as measured on the Ashworth scale with the maximum difference occurring at week four. The patient/caregiver global assessment showed improvement in those treated with BOTOX(R) at all post-injection visits. There was also significant improvement favoring BOTOX(R) in a targeted, patient-selected disability rating starting four weeks after treatment. The treatment effect was sustained, even up to the end of the study, which concluded 16 weeks after treatment. Results from this study indicate that BOTOX(R) safely and effectively decreases post-stroke spasticity and improves functional disability in daily life for at least three months after the first treatment.

The most commonly reported adverse events reported during the trial were mild in severity and included pain at the injection site (7.8%), headache, dizziness and muscle weakness (6.3%).

"This positive opinion is excellent news for patients who require treatment for spasticity. BOTOX(R) therapy offers real benefits in terms of meeting treatment goals to reduce disability and improve quality of life for patients and their careers," commented Dr. Anthony Ward, Consultant Physician in Rehabilitation Medicine, Director of the North Staffordshire Rehabilitation Centre U.K.

"This positive opinion illustrates the growing acceptance of the diversity of BOTOX(R) therapy in a vast array of medical conditions," said Lester J. Kaplan, President of Research and Development and Global BOTOX(R). "This also underscores our strategy to be at the forefront in neurotoxin research and development and maintain our global leadership with BOTOX(R)."

BOTOX(R) global net product sales for the year ended December 31, 2000 were $239.5 million. In the United States, the Company is in Phase 3 development of BOTOX(R) for the treatment of spasticity in adults.

Forward-Looking Statements

This press release contains "forward-looking statements", such as statements regarding the effectiveness of BOTOX(R) and prospects for regulatory approval for this indication. 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 Companies' expectations and projections. Risks and uncertainties include general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in new product marketing such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or acceptance of new indications for such products; the possibility that BOTOX(R) therapy may produce varying results among patients; health care reforms; and trends toward managed care and health care cost containment, and governmental laws and regulations affecting domestic and foreign operations. 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 Form 10-K and Form 10-Q for the quarter ended June 29, 2001. 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 healthcare 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.