Wall Street Journal - Monday, 27 January 1997.
Rhonda L. Rundle, Staff Reporter of The Wall Street Journal

This advantage could propel Viracept, which is awaiting federal approval, into the front ranks of AIDS therapies. Lab studies also raise at least the possibility that Viracept may turn out to help people who have developed resistance to the three medicines in the class that have already been approved. Protease inhibitors have driven the AIDS virus down to undetectable levels in thousands of people.

The "activity of Viracept is very much equivalent to that of the best of the other protease inhibitors, while the severity of side effects is much less than typically seen" in studies of the other drugs, said William Powderly, associate professor of medicine at the Washington University School of Medicine in St. Louis and a lead Agouron investigator. "Personally," he said, "I would be inclined to use [Viracept] as a first protease inhibitor."

Results from Agouron's human tests of Viracept will be presented by Dr. Powderly today at the Conference on Retroviruses and Opportunistic Infections in Washington. Agouron submitted the data last month to the Food and Drug Administration as part of a marketing application for Viracept, its first product. The small San Diego company is hoping that it will be approved soon.

Agouron shares fell $5.438, or 6.5%, to $78.313 in Nasdaq Stock Market trading after the company released a scientific summary of the human test results yesterday. Analysts said the drop mainly came from profit-taking by investors who bought the stock at much lower prices. Since July, when the stock hit a low of $29, the shares nearly tripled to a 52-week intraday high of $85.25 this month.

Virus levels were reduced below the level of detection in 81% of the patients who received a triple-drug combination of Viracept with two older medicines. While the 700-patient study focused on patients after 24 weeks of therapy, "we're still seeing antiviral responses with no uptick after 48 weeks," Dr. Powderly said. The only notable side effect was "moderately severe" diarrhea in about 16% of patients, he said. Meanwhile, Abbott Laboratories released early data on its next-generation protease-inhibitor drug, known as ABT-378. The North Chicago, Ill., company said that in laboratory studies so far, the drug is "a more potent inhibitor of the HIV protease than any other agent identified to date," including Abbott's Norvir.

Compared with Norvir and Crixivan, made by Merck & Co., Viracept "is very user-friendly," said Joseph Gathe, an infectious-disease specialist in Houston. Viracept is taken three times a day with meals, while other protease inhibitors must be taken on an empty stomach on a strict schedule. The diarrhea suffered by some Viracept patients is manageable, "which is very different from what I've seen with other agents," Dr. Gathe said, noting that, "the best drug in the world doesn't help patients who can't take it."

One of the most important questions about Viracept is whether it will fight HIV in people who are developing resistance to protease inhibitors already on the market, including Invirase, sold by Switzerland's F. Hoffmann-La Roche & Co., a unit of Roche Holding Ltd. Agouron scientists, hoping that patients will take Viracept first and not last, are only now beginning to seriously study whether their drug will work as a last resort.

Test-tube data suggest that people who develop resistance to Viracept will still benefit from other protease inhibitors. Conversely, researchers hope that patients who are resistant to the other drugs will be able to benefit from Viracept. But "whether that pans out in people, we don't know yet," said Dr. Gathe.

Viracept was developed by Agouron in collaboration with a pharmaceutical unit of Japan's Japan Tobacco Inc.

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