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RAPAMUNE (SIROLIMUS) THERAPY ALLOWS FOR EFFECTIVE WITHDRAWAL OF
CYCLOSPORINE IN KIDNEY TRANSPLANT PATIENTS


-- International Study Confirms Rapamune-treated Patients Fare Well
and Avoid Exposure to the Long-term Dangerous Side Effects of
Cyclosporine --


ROME, 31 August, 2000 -- Kidney transplant patients can
be effectively treated with the new anti-rejection medication Rapamune
(sirolimus) as
the long-term primary therapy, permitting the withdrawal of the
conventional immunosuppressant cyclosporine, a drug associated with a
number of serious adverse effects such as kidney damage, hypertension,
hirsuitism and gum overgrowth. An international clinical study, presented
here today at the XVIII International Congress of the Transplantation
Society, was conducted at 57 transplant centers in Europe, Australia and
Canada and included 525 kidney transplant patients.

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"These findings confirm that Sirolimus is an effective alternative to
cyclosporine for long-term immunosuppression. It has the major advantage
of not causing kidney damage and it is free from a number of other

unpleasant side effects associated with cyclosporine" said lead
investigator Robert Johnson, M.D., Director of Transplantation at the
Manchester Royal Infirmary, Manchester, United Kingdom. "The array of

adverse effects caused by calcineurin inhibitors point to the clear
imperative for an alternative
therapy to be fully integrated into the immunsuppressive regimen."

The kidney transplant study patients were randomly assigned to two
treatment groups: one group was maintained on triple therapy of
cyclosporine, corticosteroids and 2mg Rapamune; in the other group,
patients had their cyclosporine dosing stopped after three months of
treatment. The aim of the study was to determine whether cyclosporine,
which is part of the standard immunosuppressive drug regimen, could be
safely eliminated while maintaining patients on sirolimus and steroids.

No grafts were lost in the study and kidney function in the cyclosporine-
free patients was significantly improved. Graft survival at one year in
the sirolimus-alone group was 97.3%, compared with 95% in the controlled
group. There was a small increase of 6% in episodes of acute rejection in
the sirolimus-alone group, but this difference did not reach statistical
significance. All of the episodes of rejection were categorized as mild.

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Cyclosporine has long been the therapeutic mainstay for preventing organ
rejection after transplantation. However, it can cause...