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BRISTOL-MYERS SQUIBB MAKES EXPERIMENTAL AIDS DRUG, d4T, AVAILABLE TO PATIENTS IN CRITICAL NEED

 BRISTOL-MYERS SQUIBB MAKES EXPERIMENTAL AIDS DRUG,
 d4T, AVAILABLE TO PATIENTS IN CRITICAL NEED
 NEW YORK, Oct. 5 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY) announced today it has received U.S. Food and Drug Administration approval of a Parallel Track Program protocol for d4T (stavudine), an experimental drug to treat AIDS that is under development by the company. Through the program, AIDS patients who are intolerant to or failing on the only two drugs approved for use as single agents -- AZT (zidovudine) and VIDEX (didanosine, ddI) -- may be eligible to receive d4T. Patients who qualify will receive d4T at no charge via their physicians.
 Physicians interested in enrolling patients in this program should contact Bristol-Myers Squibb at 1-800-842-8036 to request registration kits and application forms. Completed applications for participation in the d4T Parallel Track program will be promptly reviewed by Bristol- Myers Squibb medical staff. The company is implementing the program voluntarily and will absorb the cost of d4T provided to Parallel Track participants.
 Background on d4T
 d4T is an experimental anti-HIV drug which was developed as a result of a collaboration between Bristol-Myers Squibb and Dr. William Prusoff of Yale University. It was originally synthesized by Dr. Jerome Horwitz of the Detroit Institute of Cancer Research as an anti-cancer agent. Like AZT and VIDEX, d4T belongs to a class of compounds called nucleoside analogues. Nucleosides are similar to the natural building blocks used to define the genetic information contained in DNA and RNA.
 d4T works by inhibiting a vital enzyme that the AIDS virus needs for its growth. d4T is converted to d4T triphosphate in the cell. It is postulated that this triphosphate inhibits the activity of the reverse transcriptase enzyme of HIV.
 d4T is now in Phase II/III clinical trials to determine its safety and efficacy profile. A double-blind, randomized comparison of d4T versus AZT in patients who have had more than six months prior experience with AZT began in May 1992, and patient accrual has exceeded expectations.
 Background on Parallel Track
 Earlier this year, the U.S. Department of Health and Human Services announced initiatives "to provide earlier access to important new drugs, ease unnecessary regulatory burdens and strengthen U.S. competitiveness." The "Parallel Track" policy, an effort of the National Institutes of Health and FDA, permits people with life threatening illness to access experimental drugs, while the drugs are in clinical trials. d4T is the first drug to be made available through the official Parallel Track mechanism.
 As a leading manufacturer of pharmaceuticals for life-threatening illnesses such as AIDS and cancer, Bristol-Myers Squibb has extensive experience in providing compassionate access to experimental drugs for patients lacking other therapeutic options. From September 1989 through December 1991, Bristol-Myers Squibb provided its now approved AIDS drug, VIDEX, to more than 23,000 patients concurrent with Phase II/III clinical trials. Many elements of the newly implemented Parallel Track program are similar to those pioneered in the VIDEX Expanded Access model.
 Bristol-Myers Squibb is a research-based, diversified health care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices.
 U.S. PHYSICIAN INFORMATION
 How to Obtain d4T (stauvdine) for Your Patient
 through the Parallel Track Program
 1. Bristol-Myers Squibb has established a toll-free number
 for calls regarding d4T. The number is 1-800-842-8036.
 Operators will be available Monday-Friday from
 8:30 a.m. - 5:00 p.m. Eastern Time.
 2. Patients calling will be given general information
 about d4T. If they wish to receive d4T under the
 Parallel Track Program, their physician must call.
 By law, no d4T can be released directly to a patient.
 3. A package of information and instructions will be sent
 to licensed physicians on request. The package will
 include the protocol and patient entry and physician
 registration forms required to comply with Federal laws
 concerning investigational drugs.
 4. In order to enroll patients who meet the entry
 criteria for d4T Parallel Track, the physician must
 complete and return both physician registration forms
 and patient enrollment forms. When a physician
 application is approved, the physician will be added to
 the list of registered investigators for the Parallel
 Track Program. Concurrently, patient entry forms will
 be reviewed by medical reviewers who will determine if
 the patient is eligible for the d4T Parallel Track
 Program.
 5. If the patient is deemed not eligible to participate in
 the program, his or her physician will be contacted
 with an explanation for the decision.
 6. If the patient is accepted into the program, a 30-day
 supply of the drug will be sent to his or her
 physician.
 7. The physician must submit patient follow-up and adverse
 experience forms monthly. Only when these forms are
 received can additional drug be provided.
 8. Patients may remain in the program as long as there is
 need, they do not voluntarily withdraw, they do not
 experience adverse effects, the program is still in
 effect, and d4T is not approved for sale in the U.S.
 -0- 10/5/92
 /CONTACT: Susan J. Yarin, 212-546-5709, or Elizabeth M. Sigler, 212-546-5764, both of Bristol-Myers Squibb/
 (BMY) CO: Bristol-Myers Squibb Company ST: New York IN: MTC SU: PDT


PS -- NY084 -- 6699 10/05/92 15:41 EDT
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