Important note: Information in this article was accurate in 1995. The state of the art may have changed since the publication date.
PR Newswire - December 4, 1995
AIDS patients who have CD4 cell counts of 50 or fewer and who meet other health status-related criteria will be eligible to apply for the program, which was developed in cooperation with AIDS community representatives. Details regarding the application procedure for the lottery in the U.S. will be provided to patient advocate groups and physicians who treat AIDS patients. Physicians and patients may call 1-800-414-AIDS for additional information and application forms. Information about the program also will be available by several other means: by FAX at 1-800-336-2879, by e-mail at ritonavir ("at" symbol) pond.com; and on the Internet at http://www.pond.com/ritonavir.
Outside the U.S., patients will be enrolled in the program based on physician recommendation.
Enrollment for the lottery will be limited to patients over the age of 12.
Ritonavir is a member of a class of investigational compounds called protease inhibitors. In August, Abbott announced to AIDS advocate groups plans to establish an expanded access program for ritonavir.
"Abbott supports the expanded access distribution of therapeutic agents," says Andre Pernet, Ph.D., vice president, pharmaceutical products research and development, Abbott Laboratories. "In the case of ritonavir, we have been limited in our ability to make the drug available sooner through an expanded access program because of the extraordinarily difficult manufacturing process.
"To date, all of the bulk drug that has been manufactured has been needed for the clinical trial program to determine whether ritonavir is safe and effective in the treatment of AIDS," Dr. Pernet adds.
In early clinical trials with ritonavir, the most commonly seen adverse events have been those involving the digestive system, such as diarrhea and nausea.
Abbott Laboratories is a worldwide manufacturer of health care products, employing 50,000 people. In 1994, the company's sales and net earnings were $9.2 billion and $1.5 billion, respectively, with earnings per share of $1.87.
CONTACT: Douglas Petkus, 708-938-3531 or Laureen Cassidy, 708-938-7743, both of Abbott Laboratories/ 10:56 EST
Copyright (c) 1995/PR NewsWire. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, PR Newswire, 810 Seventh Avenue, New York, NY 10019.
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