Allergan Announces Ruling in Product Classification Lawsuit

    Business Editors/Legal Writers/Healthcare Writers

    IRVINE, Calif.--(BUSINESS WIRE)--Jan. 21, 2005--Allergan, Inc. (NYSE:AGN) today announced that the U.S. District Court for the District of Columbia has ruled that the U.S. Food and Drug Administration's (FDA) classification of Allergan's product Restasis(R) (cyclosporine ophthalmic emulsion 0.05%) as an antibiotic is supported by the FDA's Modernization Act of 1997 (FDAMA) and thus has dismissed Allergan's lawsuit seeking to reclassify Restasis(R) as a non-antibiotic.
    Allergan brought its lawsuit in October 2003 in an effort to have the FDA reclassify Restasis(R) as a non-antibiotic and to obtain the certainty of three years of marketing exclusivity under the Hatch-Waxman Act. The court's ruling should have a limited effect on Restasis(R) or Restasis(R) competition for the following reasons:

1. Allergan believes it has a solid patent estate covering Restasis(R), with a use patent that does not expire until August 2009 and a formulation patent that does not expire until May 2014;

2. Allergan brought its lawsuit to augment its Restasis(R) patent estate with the certainty of three years of Hatch-Waxman marketing exclusivity. Because Restasis(R) was approved by the FDA in December 2002, however, such marketing exclusivity would have expired in December 2005; and

3. Cyclosporine, the active ingredient in Restasis(R), is a challenging compound to formulate as an eye care product. As noted above, Allergan has a formulation patent that expires in 2014. It is Allergan's belief that a competitor attempting to develop an alternative formulation would have a difficult time successfully replicating the efficacy and safety profile of Restasis(R).

    "Allergan has spent considerable effort developing the first FDA-approved dry eye medication - Restasis(R) - and we had hoped to have been rewarded for our technological innovation with Hatch-Waxman marketing exclusivity," said Douglas S. Ingram, Allergan's Executive Vice President, General Counsel and Secretary. "Fortunately, Restasis(R) has intellectual property protection through a patent estate that extends until May 2014 and thus there should be no practical need for separate Hatch-Waxman marketing exclusivity."

    Forward-Looking Statements

    This press release contains "forward-looking statements," including the statements by Mr. Ingram, statements regarding research and development outcomes, competition, patent protection, efficacy, and market and product potential. 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 Allergan's expectations and projections. Risks and uncertainties include general industry and pharmaceutical market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents obtained 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; potential difficulties in manufacturing a new product formulation; domestic and foreign health care reforms; the timing and uncertainty of the research and development and regulatory processes; trends toward managed care and health care cost containment; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. 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 2003 Form 10-K and Allergan's Form 10-Q for the quarter ended September 24, 2004. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.

    About Allergan, Inc.

    Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.

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CONTACT: Allergan, Inc. Jim Hindman, 714-246-4636 (Investors) Joann Bradley, 714-246-4766 (Investors) Ashwin Agarwal, 714-246-4582 (Investors) Stephanie Fagan, 714-246-5232 (Media) Caroline Van Hove, 714-246-5134 (Media) www.allergan.com

KEYWORD: CALIFORNIA DISTRICT OF COLUMBIA INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL PRODUCT CLASS ACTION LAWSUITS SOURCE: Allergan, Inc.

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