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 14, 1995.
Up to now, the drug has been available to the AIDS community only through unregulated procurement from unknown sources.
Permission to dispense the drug legally to physicians treating AIDS patients was granted recently by the FDA and was followed in October by FDA approval of a request by Celgene to recover costs for supplying the drug and related clinical expenses. Both FDA actions are considered unusual for an experimental compound still in clinical trials.
Celgene said it has begun sending official documents to the first of hundreds of physicians who have expressed interest in entering patients in the open label compassionate use protocol.
Under provisions agreed to with the FDA, interested physicians must receive permission from their affiliated hospitals to enroll patients in the study. Celgene will then dispense the drug to the physicians.
It is estimated that roughly 100,000 US AIDS patients suffer from severe weight loss.
Celgene said the cost of Synovir will be about $550 for a 12-week supply. By comparison, recombinant human growth hormone, which is available to AIDS patients under a treatment IND, is currently priced at approximately $11,000 for a 12-week supply, according to industry sources. Synovir's price was established under FDA guidelines and enables Celgene to recover costs of manufacture, R&D and handling of the expanded access program.
A portion of the Synovir distributed will be provided free of charge to economically-disenfranchised patients.
The protocol for the expanded access trial of Synovir is complementary to Celgene's placebo-controlled HIV wasting trial and provides patients who fail to meet admission criteria of that study access to the drug.
The broad entry criteria, coupled with greater physician access, substantially increases the availability of Synovir to patients who may benefit from the therapy, Celgene said.
The expanded access program is open to patients suffering from AIDS-related weight loss including those with coincident opportunistic infections or malignancies and also to those who have previously failed to respond to other therapies aimed at treating HIV wasting. More severely ill patients may receive Synovir via a salvage arm of the trial.
Weight gain is the primary endpoint. Patients can continue the therapy after the initial 12-week treatment period, although informed consent will be required every six months.
Earlier this month Celgene was awarded a US patent for a scaleable process for making high purity thalidomide. The new method has already been used to make several hundred thousand capsules, the company said.
Celgene is managing the most comprehensive program for the clinical development of thalidomide in the US, involving both traditional clinical trials and an expanded access program.
Synovir is the lead compound being clinically studied in a broad immunotherapeutics program at Celgene. The company is also creating new therapeutics based on the immunologic properties of thalidomide, but having potentially enhanced therapeutic benefits.
The goal of Celgene's immunotherapeutics research is to create highly potent new drugs for regulating bodily production of tumor necrosis factor alpha (TNFa), a hormone-like protein responsible for inflammatory and immunological conditions of many serious disease states such as cachexia, rheumatoid arthritis, lupus, leprosy, inflammatory bowel disease and graft-versus-host disease.
The company said that Johns Hopkins University is currently performing preclinical evaluation of a number of its now anti-TNFa compounds for graft-versus-host disease.
Celgene Corporation, headquartered in Warren, NJ, uses proprietary expertise in small molecule chemistry to serve the pharmaceutical and allied industries.
CONTACT: Richard G. Wright, Chairman and CEO of Celgene, 908-271-4119; or Thomas Redington of Redington, Inc., 203-222-7399, or 212-926-1733, for Celgene/ 15:50 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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