IRVINE, Calif. -- Allergan, Inc. (NYSE:AGN) announced today that it has filed a motion with the United States District Court for the Northern District of California, San Francisco Division, requesting a temporary restraining order and preliminary injunction prohibiting the sale of a proposed generic version of Allergan's non-steroidal anti-inflammatory drug ACULAR(R) (ketorolac tromethamine ophthalmic solution) 0.5% while the court conducts further proceedings in a patent infringement lawsuit brought by Allergan and Syntex (U.S.A.) LLC against Apotex, Inc., Apotex Corp., and Novex Pharma Inc. (the "Apotex Defendants").
On January 27, 2004, the District Court entered a judgment in favor of Allergan and Syntex in the patent infringement action, finding that the patent covering ACULAR(R) is valid, enforceable and infringed by the Apotex Defendants' proposed generic drug. Apotex appealed to the U.S. Court of Appeals for the Federal Circuit, which on May 18, 2005, left undisturbed the finding of infringement but remanded the matter for re-hearing by the District Court on one issue. Subsequently, on December 15, 2005, the Federal Circuit vacated the District Court's permanent injunction barring the sale of the Apotex Defendants' product but indicated that Allergan and Syntex could request a preliminary injunction from the District Court. Accordingly, on December 16, 2005, Allergan filed a motion for temporary restraining order and preliminary injunction with the District Court.
ACULAR(R) is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis and the treatment of post-operative inflammation in patients who have undergone cataract surgery.
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 ophthalmology, neurosciences, medical dermatology, medical aesthetics and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
Forward-Looking Statements
This press release contains "forward-looking statements," including, but not limited to, statements regarding possible outcomes of the litigation and the timing of generic versions of the Company's products. 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, among other things, the uncertainties associated with the litigation and appeal process; the uncertainties regarding the regulatory approval process and the timing associated therewith; 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 September 30, 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.
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