Allergan Receives Written Response From FDA On Oral Tazarotene For Psoriasis

Main Category: Eczema / Psoriasis
Article Date: 01 Jun 2005 - 17:00 PDT

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Allergan, Inc has received a written response from the US Food and Drug Administration (FDA) regarding Allergan's request for formal dispute resolution on its oral tazarotene capsule New Drug Application (NDA). In the response, the FDA outlined multiple potential options for improving oral tazarotene's risk-benefit profile. Allergan currently believes it can fund a pivotal clinical trial requested by the FDA and complete the study in a reasonable amount of time. Allergan also plans to provide some additional pharmacokinetic and toxicology data to the FDA.

"We appreciate the FDA's willingness to work with Allergan to explore the clinical data necessary for approval and we are encouraged to have defined potential pathways to approval for oral tazarotene," said Dr. Scott Whitcup, Allergan's Executive Vice President, Research and Development. "We remain committed to providing oral tazarotene to psoriasis patients."

Based on the FDA's recommendations, Allergan plans to submit a development plan to the FDA and will provide details on the plan once an agreement has been reached with the FDA.

Forward-Looking Statements

This press release contains "forward-looking statements," including, among other statements, the statements by Dr. Whitcup, statements regarding research and development outcomes, 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 product marketing such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or the acceptance of new indications for such products; 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 2004 Form 10-K and Allergan's Form 10-Q for the quarter ended March 25, 2005. 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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