Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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The Wall Street Journal - 15 March 1996
Michael Waldholz, Staff Reporter of The Wall Street Journal
Late Wednesday night, following a record review time of just six weeks, the Food and Drug Administration gave Merck the go-ahead to market its drug, Crixivan. The action comes 10 days after the FDA approved a similar drug, called Norvir, developed by Abbott Laboratories. The two medicines are part of new family of HIV protease drugs that, based on clinical trials, are likely to transform the treatment of AIDS.
"The early results [involving both the drugs] are very, very impressive," said David Ho, a physician and researcher at the Aaron Diamond AIDS Treatment Center in New York. "It's quite exciting for those of us doing AIDS research."
The FDA approval for the Merck drug was expected; in late February Crixivan and Norvir both received strong praise from an FDA advisory committee reviewing human trials of the drugs. Nobody considers either medicine a cure. But when used in combination with two other existing AIDS medicines, the new drugs significantly reduced the presence of the AIDS virus in the blood of patients.
What wasn't anticipated was Merck's announcement that it will price its drug at $12 a day at wholesale -- almost $6 a day, or $2,000 a year, less than what Abbott is charging for Norvir. A Merck spokesman said the price was set to be "competitive, to facilitate access, and to assure usage of the product."
The aggressive price is also certain to assure Merck positive public relations in the AIDS treatment community and, most especially, a large portion of the market for the new family of drugs. Researchers and doctors predict that perhaps 100,000 AIDS patients may soon be taking one of the two new drugs, perhaps generating $500 million or more in annual sales for the two companies.
"Merck has done a very humane thing with the price it's charging," said Jules Levin, who runs the National AIDS Treatment Advocacy Project in New York. "There's going to be a lot of pressure on Abbott to lower its price. There are sick and dying people who need these drugs, [Abbott] really needs to show some humanity here."
A spokesman for Abbott declined to comment on Merck's price.
The FDA approved Merck's drug based on several studies, including one especially promising study showing that patients who took Crixivan and two existing drugs -- AZT and 3TC, sold by Glaxo Wellcome PLC -- had their virus levels reduced by 98% after six months of therapy. When suppressed so strongly, the virus seems unable to mutate, or become resistant to treatment, as quickly as it does when treated with any of the existing drugs. Researchers hope the new therapy will allow patients to survive years longer than before.
"The big question now is how long the effect of this triple-drug combination can be maintained," said David Feigal, director of antiviral drug products at the FDA. "We've told the companies we're very interested in the follow-up data."
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