The Wall Street Journal - December 8, 1995
Laurie McGinley, Staff Reporter of The Wall Street Journal
Saquinavir, manufactured by the Hoffmann La-Roche Inc. unit of Roche Holding Ltd., the Swiss pharmaceutical company, is the first so-called protease inhibitor approved anywhere in the world. The prescription drug, an antiviral compound that will be marketed under the brand name Invirase, is expected to become available this weekend. It works by blocking the reproduction of the human immunodeficiency virus (HIV) by disabling a crucial enzyme called protease.
A number of other companies, including Abbott Laboratories and Merck & Co., are developing their own protease inhibitors for the coming intense competition.
The FDA approved saquinavir to be used with existing AIDS drugs such as AZT or ddC. Studies showed that using saquinavir with the older drugs, called nucleoside analogs, moderately boosted CD4 cell counts, an indication of immune-system strength. The best results occurred when saquinavir was used with a nucleoside analog that the patient hadn't already tried. Future protease inhibitors, from Hoffman La-Roche and other drugmakers, are expected to be more potent.
Hoffmann La-Roche said that the wholesale price for the drug would be about $5,800 a year; it didn't provide a retail price estimate. Martin Delaney, founding director of Project Inform, an AIDS treatment and advocacy group in San Francisco, said he was "appalled" by the price, saying it was triple the cost of existing AIDS drugs.
A company spokeswoman acknowledged that saquinavir is a "really expensive product," and said the company is setting up a program to help patients get insurance coverage for the drug and to make it available to those who are uninsured and can't afford it.
The protease inhibitors aren't cures, and some analysts fear that the wily virus that causes AIDS will mutate, blunting the drugs' effectiveness. Moreover, there are concerns among some in the AIDS community that patients who take saquinavir could develop resistance to superior drugs that aren't yet available.
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