AEGiS-WSJ: FDA Approves AIDS Drug To Be Marketed by Glaxo

Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

FDA Approves AIDS Drug To Be Marketed by Glaxo

The Wall Street Journal - Friday, April 16, 1999

LONDON -- Glaxo Wellcome PLC said Friday that the Food and Drug Administration has approved its AIDS drug Agenerase, the fifth entrant into the $1 billion national market for HIV-fighting protease inhibitors.

After a "fast-track" FDA review, Agenerase was approved for use in combination with other antiretroviral medicines for the treatment of HIV infection in adults and children. Glaxo will market the drug, which was created by Vertex Pharmaceuticals Inc.

Agenerase is the first protease inhibitor to be approved in the U.S. in more than two years, and the first medicine of this class to be brought to the market by Glaxo. It will compete with the current market leader, Agouron Pharmaceuticals Inc.'s Viracept, with some $450 million in annual U.S. sales; Merck & Co.'s Crixivan; Roche Holding AG's Fortovase/Invirase; and Abbott Laboratories' Norvir.

The drugs inhibit the replication of protease, an enzyme that helps HIV to spread. In many people, this can drive down HIV to undetectable levels in the bloodstream. Protease inhibitors commonly are taken together with older AIDS drugs such as AZT or 3TC in combination or "cocktail" therapy.

Agenerase is one of the most dramatic examples to date of drugs that are created by structuring their molecular shape to optimize their disease-fighting capability. This form of drug design, which relies heavily on three-dimensional computer imaging, allowed Vertex to come up with Agenerase in two years, rather than the six years it normally takes before a drug is ready to test in humans.

More importantly, the imaging technology allowed Vertex to engineer a molecule with several potential advantages. The drug lingers in the body an unusually long time, so it needs to be taken only twice a day, compared with three times for several competing drugs. Therefore, Agenerase can help simplify the complicated regimen of cocktail therapy. Glaxo already sells another drug that has helped simplify the therapy, Combivir, a one-pill combination of AZT and 3TC.

Agenerase also attaches to the protease in a different way from existing drugs, so it is likely to be useful against mutant strains of the virus that have increasingly stymied doctors. The technique, called structure-based drug design, involves using X-rays to get a detailed picture of an enzyme involved in causing a disease -- in this case the protease -- then using computer images to concoct the ideal molecule to disable it.
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