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| |  Ritonavir Reduces Mortality and Disease Progression WASHINGTON, Feb. 1, 1996 -- In striking new research presented today, mortality was reduced by approximately one-half among advanced AIDS patients who received Abbott Laboratories (NYSE: ABT) experimental HIV protease inhibitor ritonavir for up to seven months, compared to those who received placebo. The findings were reported at the Third Conference on Retroviruses and Opportunistic Infections in Washington, D.C. "The results from this large-scale clinical study demonstrated greater clinical benefit for advanced AIDS patients receiving ritonavir - containing treatment regimens compared to those not receiving ritonavir as part of their therapy regimen," says Andre Pernet, Ph.D., vice president of pharmaceutical research and development at Abbott Laboratories. Ritonavir is in development at Abbott for the treatment of AIDS/HIV. The randomized, double-blind, placebo-controlled study followed a total of 1,090 patients at 67 investigational sites in the United States, Canada, Europe and Australia. All patients entering the study had advanced AIDS with CD4 cell counts of less than 100. In the study, ritonavir 600 mg or placebo was administered twice daily and was added to existing approved nucleoside therapy, if any. Patients were followed for up to seven months. Thirteen percent of the 543 patients who received ritonavir died or had disease progression, compared with 27 percent of the 547 patients who received placebo. Disease progression was defined as the onset of a new AIDS-related illness. The mortality rate among patients receiving ritonavir was 4.8 percent -- approximately half that of the 8.4 percent mortality rate among patients not receiving ritonavir. Ritonavir was generally well-tolerated in the study. The most common side effects were diarrhea, nausea, vomiting, fatigue and a tingling sensation around the mouth. "It's significant that, in addition to showing improvement based on surrogate markers (e.g., CD4 cell count) in previous studies, ritonavir, with these data, now demonstrates improvement in clinical endpoints as well. This is a first among drugs in this class," says Dr. Pernet. Abbott filed a New Drug Application with the FDA on Dec. 21, 1995, seeking clearance for ritonavir for the treatment of advanced AIDS. Ritonavir is the second protease inhibitor for which an NDA has been filed. In December, Abbott announced an expanded access program for ritonavir, which makes the drug available via lottery to 2,000 AIDS patients worldwide. Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. In 1995, the company's sales and net earnings were $10 billion and $1.7 billion, respectively, with earnings per share of $2.12.
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