Allergan Receives Approval From the FDA for AVAGE to Treat Fine Facial Wrinkles; Provides a Complementary Treatment To BOTOX Cosmetic.

Business Editors & Health/Medical Writers

IRVINE, Calif.--(BUSINESS WIRE)--Oct. 1, 2002

Allergan, Inc. (NYSE:AGN) today announced its leading retinoid product, tazarotene, has received approval from the United States Food & Drug Administration (FDA) for AVAGE(TM) (tazarotene) cream 0.1% as an adjunctive agent in the topical treatment of facial fine wrinkling, mottled hypo- and hyperpigmentation (blotchy skin discoloration), and benign facial lentigines (flat patches of skin discoloration) in patients using a comprehensive skin care and sunlight avoidance program.

Chronic exposure to the sun can result in skin damage. Unlike treatments that merely exfoliate and moisturize the skin, AVAGE(TM) is proven to significantly reduce some of the specific signs, as mentioned above, associated with overexposure to the sun. Although AVAGE(TM) does not reverse this process, it provides significant improvement in the appearance of the skin.

"Combined with our recent approval by the FDA for BOTOX(R) Cosmetic, we can now offer complementary treatments with AVAGE(TM) for fine facial wrinkles and BOTOX(R) Cosmetic for the deeper wrinkles between the brow," commented F. Michael Ball, Corporate Vice President and President of North America for Allergan. "We are pleased to have worked with the FDA to bring proven treatment alternatives to the marketplace to address consumer needs."

In two double-blind, vehicle-controlled clinical studies, AVAGE(TM) Cream 0.1% was applied once daily for 24 weeks to the facial skin of 567 patients (Study A: AVAGE(TM) Cream: N = 283; vehicle: N = 280; Study B: AVAGE(TM) Cream: N = 284; vehicle: N = 281) with moderate to severe fine wrinkling, mottled hypo- and hyperpigmentation and benign facial lentigines due to overexposure to the sun. Treatment was as an adjunct to a comprehensive skin care and sun avoidance program. At two to four week intervals, the severity of fine wrinkling, mottled hypo- and hyperpigmentation and lentigines were graded on a scale of 0 (none) to 4 (severe). The results of both studies demonstrated that AVAGE(TM) was significantly superior to its vehicle for these four key signs of damaged skin with an improvement of at least one grade from baseline. At week 24, the average percentage of patients in the two studies with fine wrinkling who improved by at least one grade point from baseline was 49% for AVAGE(TM) and 20% for vehicle. At week 24, the average percentage of patients in the two studies with mottled hypo- and hyperpigmentation who improved by at least one grade point from baseline, was 70% for AVAGE(TM) and 29% for vehicle.

The most frequent treatment-related adverse reactions (greater than or equal to)5% reported during the clinical trials with AVAGE(TM) for this treatment were limited to the skin. Those occurring in greater than 10%, in descending order, included: desquamation (exfoliation), erythema (skin redness), burning sensation and dry skin. Events occurring in (greater than or equal to)1% to (less than or equal to)10% of patients, in descending order included: skin irritation, pruritus (itching), irritant contact dermatitis, stinging, acne, rash or cheilitis (chapped lips). AVAGE(TM) Cream is contraindicated in women who are or may become pregnant while using this product.

Tazarotene is also marketed as Tazorac(R) Cream and Gel for the topical treatment of psoriasis and acne. It is a topical, receptor-selective retinoid specifically designed to deliver effective retinoid action.

Tazorac(R) has been one of Allergan's fastest growing products with worldwide net product sales of $26.7 million for the six months ended June 28, 2002, up 45% over last year. Since the first of the year in the United States, Tazorac(R) total prescriptions have grown 45%, according to VeriSpan August 30, 2002 data.

BOTOX(R) COSMETIC (botulinum toxin type A) is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult men and women 65 or younger. The most common side effects are headache, respiratory infection, temporary eyelid droop, and nausea. BOTOX(R) Cosmetic should not be used if there is an infection at injection site.

Forward-Looking Statements

This press release contains "forward-looking statements," such as the statements of Mr. Ball and statements regarding growth rates. 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 and projections. Risks and uncertainties include general industry and pharmaceutical market conditions; general domestic and international economic conditions, technological advances and patents attained by competitors; challenges inherent in new product marketing such as the unpredictability of market acceptance for a new pharmaceutical product or approved indication; potential difficulties in manufacturing a new product formulation; domestic and foreign 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 Business" in Allergan's 2001 Form 10-K for the year ended December 31, 2001 and Allergan's Form 10-Q for the quarter ended June 28, 2002. Copies of Allergan press releases, the full prescribing information for the products mentioned 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 health care company providing eye care and specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator and skin care markets that deliver value to our customers, satisfy unmet medical needs, and improve patients' lives.