Apotex Launches Generic Norvasc®

Weston, FL (May 24, 2007) - Apotex Corp. announced today that it has launched amlodipine besylate tablets (2.5 mg, 5 mg, and 10 mg), the generic equivalent of Pfizer's Norvasc®. The launch follows Monday's issuance of the mandate by the US Court of Appeals for the Federal Circuit's decision of March 22 invalidating Pfizer's US Patent 4,879,303 (the '303 patent) covering amlodipine besylate. The decision came in an action brought by Pfizer against Apotex. Apotex successfully invalidated the Pfizer patent.

Following Mylan's successful petitioning of the Court to enjoin FDA approval of all competitors' amlodipine applications after its March 23 launch of the product, the FDA announced on April 20th that because Apotex invalidated the '303 patent, Apotex would be eligible to enter the market once the mandate issued. The Agency did not indicate at that time how the issuance of the mandate would affect the status of other amlodipine applications. The issuance of the mandate came in concert with the Court's rejection of Pfizer's petition for a rehearing and rehearing en banc of its case with Apotex.

Apotex CEO Barry Sherman said, "While we are pleased that we are finally able to enter the market with our generic Norvasc®, we continue to believe this case screams out for reform of the generic drug approval process. We disagree unequivocally with the decision of the FDA that kept us off the market following our invalidation of the '303 patent. We should have been able to immediately enter the market."

"Moreover," Sherman added "this case illustrates the perversity of a generic drug approval system that prohibits the company that is the first to successfully open the market to generic competition from entering that market while allowing the company that lost its case to reap huge rewards from a victory it did not achieve simply because it was the first to file its application with the FDA. That makes no sense. The system should allow the first company that wins in the courts to enter the market irrespective of whether that company is the first to file. Allowing the first to successfully defend the patent lawsuit to enter the market immediately will benefit consumers by ensuring subsequent filers have the appropriate incentive to continue the patent fight - and thereby increase the chance of an earlier generic launch -- even though they might not have first to file status. Such a system would also benefit consumers by bringing a swift and needed end to the anti-consumer 'bottleneck' problem caused by anticompetitive patent settlements between brand and generic pharmaceutical companies that delay timely access to generic competition."

"We have been advocating for such a change to policymakers in Washington, DC and hope this example will help bring about the change in the system that is so sorely needed," Sherman added.

Norvasc® is a registered trademark of Pfizer, Inc.

Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of prescription drugs. Through its sales and marketing headquarters in Weston, Florida and operations center in Indianapolis, Apotex Corp. is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit www.apotexcorp.com.