Andrx Comments on Court of Appeals Decision on its Wellbutrin SR/Zyban ANDAs

Business Wire, Sept 23, 2003

Business Editors/Legal, Health & Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Sept. 23, 2003

Andrx Corporation (Nasdaq:ADRX) commented on yesterday's decision of the United States Court of Appeals for the Federal Circuit remanding the case back to the District Court for the Southern District of Florida for further proceedings. This decision relates to a District Court decision granting Andrx's motion for summary judgment of non-infringement with regard to Andrx's abbreviated new drug applications (ANDAs) for bioequivalent versions of Wellbutrin SR(R) and Zyban(R). The Court of Appeals determined that the District Court misconstrued claims of Glaxo Wellcome Plc's ("Glaxo") patent (U.S. Patent Number 5,427,798), and that the existence of several factual issues precluded the entry of summary judgment of non-infringement by the lower court. The Court of Appeals did not make a final determination as to whether the Andrx products infringe the '798 patent. In fact, the broadest claim of the '798 patent was recently determined to be invalid by a New York federal district court in a case involving Glaxo and another ANDA applicant for these products. The Court of Appeals decision did not determine whether such claim, or any other claim of the '798 patent, is valid, and does not preclude Andrx from asserting its other defenses.

Andrx believes that its ANDAs were the first filed with the FDA for these products, and that both strengths of its products are entitled to 180-days of marketing exclusivity. Andrx believes that this Court of Appeals decision does not affect either its continuing right to such market exclusivity period or its previously announced Exclusivity Transfer Agreement with Impax Corporation, which has also filed ANDAs for these products, and Impax's marketing partner, a subsidiary of Teva Pharmaceutical Industries Ltd. Andrx also believes that yesterday's Court of Appeals decision should not have any bearing on the outcome of Glaxo's appeal of the summary judgment decision in favor of Impax, as there are different issues and panels of judges involved in the two appellate cases.

Commenting on the news, Richard J. Lane, Andrx Chief Executive Officer, stated: "While we are disappointed with the decision of the Court of Appeals, we continue to believe that Andrx's generic versions of Wellbutrin SR and Zyban do not infringe any valid patents and we will continue to vigorously work towards resolving the litigation, and FDA and USP issues that have to date delayed their approval and marketing. Andrx will continue to strive to bring these important products to market, thereby benefiting both consumers and our shareholders alike."

Marketed by Glaxo, Wellbutrin SR is a buproprion hydrochloride extended-release tablet marketed for the treatment of depression, and Zyban is a buproprion hydrochloride extended-release tablet prescribed for the cessation of smoking. Wellbutrin SR and Zybanhad had U.S. sales of approximately $1.6 billion for the twelve-month period ending March 31, 2003 according to IMS.

About Andrx

Andrx Corporation develops and commercializes: bioequivalent versions of controlled-release brand name pharmaceuticals, using its proprietary drug delivery technologies; bioequivalent versions of specialty, niche and immediate-release pharmaceutical products, including oral contraceptives; and brand name or proprietary controlled-release formulations of existing immediate-release or controlled-release drugs where it believes the application of Andrx's drug delivery technologies may improve the efficacy or other characteristics of those products. Andrx also has distribution operations, which purchase primarily generic pharmaceuticals manufactured by third parties and sell them primarily to independent pharmacies, pharmacy chains which do not maintain their own central warehousing facilities, pharmacy buying groups and, to a lesser extent, physicians' offices.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, the timing and outcome of litigation and future product launches; government regulation generally; competition; manufacturing capacities and output; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company's Annual Report on Form 10-K for the year ended December 31, 2002 and Forms 10-Q for the quarters ended March 31, 2003 and June 30, 2003.