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April 26, 2004
For Immediate Release

Apotex Victory in Generic Paxil® Confirmed
Federal Circuit Court of Appeals Affirms District Court’s Judgment in Favor of Apotex.

WESTON, FLORIDA, U.S.A. – Apotex Corp. today praised the decision of the U.S. Court of Appeals for the Federal Circuit holding that GlaxoSmithKline’s U.S. Patent No. 4,721,723 (the '723 patent), covering the antidepressant Paxil® (paroxetine hydrochloride), is invalid.

“We feel vindicated with this decision,” said Apotex Chief Executive Officer Dr. Barry Sherman. “This confirms what we have been arguing since 1998: our generic version of Paxil® does not infringe any valid patents and deserves to be on the market,” Dr. Sherman said.

“This is further affirmation that Glaxo has kept a low-cost alternative to the brand-name product from consumers for years by asserting patents that they knew, or ought to have known, either were invalid or not infringed by our product,” Dr. Sherman added.

Apotex has filed a separate antitrust action with the U.S. District Court in the Eastern District of Pennsylvania regarding GSK’s conduct in filing and asserting invalid patents to unlawfully prevent generic competition. “The federal circuit ruling further supports our claims that the stall tactics used by GSK unlawfully prevented us from entering the market, meaning consumers have been denied a safe and affordable equivalent to this important medication for far too long,”” commented Dr. Sherman.

In 1998, Apotex submitted to the FDA the first application to manufacture and supply generic Paxil®. Subsequent to that application, GSK filed nine additional patents with the FDA, leading to four additional patent infringement lawsuits. Apotex launched its paroxetine product in September 2003, after receiving final approval from the FDA. Annual sales of paroxetine in the U.S exceed $2.1 billion.

Paroxetine hydrochloride is the active ingredient in Paxil®.
Paxil® is a registered trademark of GlaxoSmithKline.

Apotex Corp. is the U.S subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of prescription drugs in Canada. Through its U.S. sales and marketing headquarters located in Weston, Florida; operation centers in Indianapolis, Indiana and research and development facilities in Lincolnshire, Illinois; Apotex Corp. is committed to providing high quality, safe and affordable generic medicines. Apotex manufactured generic pharmaceuticals are sold in 115 countries around the world. Its extensive product line includes oral solids, liquids, injectables, nasal sprays, ophthalmics, and inhalation solutions. For more information visit www.apotexcorp.com

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For additional information, please contact:

Mr. Elie Betito
Director Public & Government Affairs
Tel: 416-749-9300 Ext. 7366
ebetito@apotex.com

or

Apotex Public Affairs
800-706-5575 ext. 4205
usmarketing@apotex.com

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Last Modified: April 28, 2004 10:25:47 AM