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Apotex First to Market Generic Version of Ticlid.

WESTON, Fla.--(BW HealthWire)--July 6, 1999--

Making its official U.S. debut, Apotex Corp. announced today that it has received FDA approval to market Ticlopidine, the generic version of Roche's Ticlid(R).

The company was the first to file an abbreviated new drug application (ANDA) for the drug with paragraph IV certification and, under FDA guidelines, will market Ticlopidine exclusively for a period of 180 days.

"This is good news for Apotex," said Jack Bleau, the company's vice president of sales. "Being the first to market a new generic product is a key success factor in our industry. We're proud to be the only company to offer customers a less expensive version of Ticlid."

Tammy McIntire, president of Apotex Corp., went on to say that the introduction of Ticlopidine marks the Canadian-based manufacturer's official company launch in the U.S. generic drug market.

With its entry into the United States, Apotex has moved into every corner of the world with the objective of expanding exports, transferring high technology and building trade in global markets. The company's products can be found in virtually every pharmacy and healthcare facility in Canada and are exported to 115 countries around the globe. Apotex aims to be a dominant player in the U.S. generic drug industry by focusing on the fundamentals of research and development, and bringing to healthcare providers programmatic innovation.

"Our Ticlopidine introduction has provided a great opportunity to present The Apotex Commitment to our customers," said Michael Hight, vice president of marketing. "We're committed to developing a broad product line, providing continuing education for pharmacists, offering intelligent packaging options and assuring all of our customers that we'll be here for them, today and tomorrow. The market spoke to us about these issues, and we listened carefully."

Hight concluded, "Our business philosophy at Apotex is strongly founded on frequent, open dialogue with customers. We realize that we can't possibly understand our customers' needs without talking to them first. Apotex truly believes that this principle will be well received in the U.S. marketplace."

Apotex has been in the pharmaceuticals business for 25 years. The company cites its position as Canada's leader in the research and development, manufacture and distribution of quality, affordable generic pharmaceuticals as an impetus to make an impact on the U.S. marketplace. Founded in 1974, Apotex employs more than 3,000 people worldwide. Sales of the Apotex Group of Companies exceed $800 million per year.

Roche Laboratories originally launched Ticlid(R) in October of 1991. With its AB, or therapeutically equivalent, rated version of Ticlopidine, Apotex will offer a 250mg tablet that is packaged in bottles of 30s, 60s and 500s. Bottles of 1000s will be available soon.

Ticlopidine is only approved for use in patients who are intolerant or allergic to aspirin therapy or who have failed aspirin therapy.

Ticlopidine can cause life-threatening hematological adverse reactions, including neutropenia/agranulocytosis and thrombotic thrombocytopenic purpura (TTP) and aplastic anemia. During the first three months of treatment, patients receiving Ticlopidine must therefore be hematologically and clinically monitored for evidence of neutropenia or TTP. If any such evidence is seen, Ticlopidine should be immediately discontinued. All healthcare professionals should report observed serious and fatal adverse events associated with Ticlopidine administration to Medwatch. For full prescribing information on Ticlopidine, including risk information, warnings, precautions and contraindications, contact Apotex Corp. at http://www.apotex.com or 1-800-706-5575.

Ticlid(R) is a registered trademark of Roche Laboratories.
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Date:Jul 6, 1999
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