Attention: Business and News Editors
September 8, 2003
For Immediate Release

Apotex Launches First Generic Version of Paxil®
Affordable Product Kept from Consumers for Years Too Long!

WESTON, FLORIDA, U.S.A. – Apotex Corp. today announced that it has launched paroxetine hydrochloride tablets, 10mg, 20mg, 30mg and 40mg. The U.S. Food and Drug Administration has determined that Apotex’ paroxetine tablets are therapeutically equivalent to GlaxoSmithKline’s (GSK) Paxil®. 

Apotex was the first drug manufacturer to challenge the validity of patents covering Paxil® and the first to gain FDA approval and bring a low-cost Paxil® alternative to consumers.

“We consider it outrageous that GSK has kept an affordable alternative from consumers for years by asserting patents that they knew, or ought to have known, were either invalid or that our product did not infringe,” said Apotex CEO Dr. Barry Sherman.

“Not only has Apotex experienced serious financial harm by this delay, but consumers have paid the price throughout this process. We are elated that finally we can bring this product to market,” stated Tammy McIntire, president of Apotex’ U.S. division.

In addition to making the finished product at its FDA-inspected, state-of-the-art manufacturing facility, Apotex also produces the active bulk ingredient through its Brantford Chemicals subsidiary.

“We are confident that we have made the right investment in this molecule and that our production capacity and inventory are sophisticated enough to handle the entire requirements of not only the U.S. market, but Canada and Europe as well,” Sherman noted.

Paroxetine hydrochloride is the active ingredient in Paxil®. U.S. sales of the brand drug were approximately $2.34 billion in 2002.

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 sales and marketing headquarters in Weston, Florida, operations center in Indianapolis, and research facility 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 apotexcorp.com. 
 

 - 30 - 

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