Wall Street Journal - April 3, 2001

MONTREAL -- Abbott Laboratories said Monday that it received approval to market its HIV/AIDS drug Kaletra in Canada.

Kaletra is a protease inhibitor that works to prevent the enzyme on which the HIV virus depends from replicating itself. The drug won approval in the U.S. late last year.

Abbott, an Abbott Park, Ill., pharmaceuticals concern, said the Canadian approval was based on extensive clinical data from studies conducted around the world. Phase II and Phase III clinical trials included more than 700 patients from a broad range of patient groups, including those not previously treated with HIV therapy and those who have failed other HIV treatment regimens.

Findings from key clinical studies conducted with Kaletra showed lack of a development of resistance to Kaletra in treatment-naive patients, even after a year or more of treatment. Findings also found a long-term effectiveness of Kaletra when used as a first-choice protease inhibitor.

Also, studies showed Kaletra's effectiveness in treating children and treatment-experienced patients, Abbot said.

"Kaletra has a unique balance of potency, tolerability and durability not found in currently available drug regimens," Sharon Walmsley, M.D., an investigator in Kaletra's clinical trials, said in a prepared statement.

"It provides a new treatment that is particularly effective for use in patients new to HIV therapy, including children."

Kaletra, which sells at about $6,500 in the U.S., is now available in capsule and liquid form in pharmacies throughout Canada.

The most commonly reported adverse effects of Kaletra include abdominal pain, abnormal stools, diarrhea, feelings of weakness or sleepiness, headaches, nausea and vomiting.

World-wide sales of Kaletra are expected to reach $200 million this year.

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