Chicago Tribune - September 19, 2000
Bruce Japsen, Tribune Staff Writer

In a head-to-head comparison with a leading rival, Abbott's Kaletra proved effective in more patients than Pfizer Inc.'s Viracept, the top-selling U.S. "protease inhibitor" used in the fight against the AIDS virus.

The study, released Monday, was funded by Abbott and was done in the course of the company's application for approval from the Food and Drug Administration. Companies typically sponsor their own trials but use independent clinical research firms to conduct studies on new drugs they want to bring to market.

"These data are promising for the potential role of Kaletra," said Dr. Sharon Walmsley, an infectious-disease specialist and professor at the University of Toronto who was involved in the study. . "We want to keep the disease at bay for as long as possible and keep it at bay in as many people as possible."

Shares of Abbott stock are up 81 cents since the close of regular New York Stock Exchange trading Friday afternoon, when Abbott announced the drug had received approval from the FDA. In after-hours trading Friday, the shares reached $48, surpassing a 52-week high, and ended Monday at $44.25 in heavy trading.

The results of the latest clinical trials are good news for about 1 million Americans and an estimated 43 million people worldwide who have HIV.

And for Abbott, Kaletra promises to improve the North Chicago-based medical product-maker's share of the $6.5 billion market for HIV and AIDS treatments.

"This is the first material piece of positive news from Abbott's internal pharmaceutical pipeline in a while," said Bruce Cranna, an analyst with ABN AMRO Inc., who Monday raised his rating on Abbott to "buy" from "outperform" based in part on the new study.

In another promising sign for Kaletra, Dr. David Ho, one of the foremost U.S. AIDS researchers, recently began using it in clinical trials with three other pharmaceuticals in hopes of coming up with a therapy that could lead to slowing the spread of the virus.

"He's looking for a cocktail of drugs that patients would take that would show no evidence of viral replication," said Dr. Eugene Sun, head of antiviral drug development at Abbott.

Ho's study includes 12 patients, but Sun said it will eventually enroll about 40. Abbott is a sponsor of the study. "In every treatment regimen he's looked at [so far], he has found evidence of viral replication," Sun said of Ho's research.

Kaletra is considered to be a next-generation protease inhibitor, a class of drugs that blocks enzymes in the human immunodeficiency virus.

Results from Abbott's study were released at the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting in Toronto. They show that Abbott's Kaletra reduced levels of HIV, the virus that causes AIDS, to undetectable levels in 79 percent of patients who hadn't previously been treated.

In comparison, the 40-week study said, Pfizer's Viracept reduced levels of the AIDS virus in 64 percent of patients.

Both Kaletra and Viracept are taken with two other drugs known as nucleoside reverse transcriptase inhibitors, drugs used with protease inhibitors to make up so-called AIDS cocktails.

Indeed, protease inhibitors have been on the market for the last four years--including another Abbott drug known as Norvir--but such existing treatments are known to become ineffective over time for some patients. Kaletra, however, is proving to be effective in patients who have failed other treatments and doesn't cause side effects like headache, nausea or vomiting in most patients. Side effects can often keep patients from following their treatment regimens.

With such an impressive side-effect profile and potency, researchers are beginning to think doctors using Kaletra will eventually figure out a way to keep the virus suppressed indefinitely.

"If we can't cure the virus, we want to keep it at bay for the lifetime of patients," Sun said

Investors have been critical of Abbott in recent years for the lack of a promising blockbuster in its drug pipeline. To restore its pharmaceutical division to double-digit sales growth, Abbott Chief Executive Miles White has engineered several acquisitions and marketing and licensing agreements since he became the company's top executive in January 1999.

In Kaletra, analysts expect Abbott to generate about $500 million in worldwide annual sales three years from now.
000919
CT000902

Always watch for outdated information. This article first appeared in 2000. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2000. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .