Phase III Efficacy Results

8/18/99


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Table of Contents

Phase III Efficacy Results

Demographic Parameters US Multicenter Trial

Demographic Parameters Global Multicenter Trial

Other Parameters: Well Matched by Treatment Groups

Primary Composite Endpoint

RAPAMUNE Significantly Reduces Efficacy Failure

Acute Rejection Is the Major Component of Composite Endpoint

Higher Rates of Efficacy Failure in Global Trial May Be Due To Multiple Factors

Secondary Efficacy Endpoints

RAPAMUNE Decreases the Incidence of Biopsy-Confirmed Acute Rejection

RAPAMUNE Decreases Incidence of Grade II/III Acute Rejection

Lower Rates of Antibody Use for Acute Rejection in RAPAMUNE Groups

Excellent 1-Year Patient Survival* in All Treatment Groups

Excellent 1-Year Graft Survival* in All Treatment Groups

Lower Rate of Efficacy Failure in Black Patients Treated With RAPAMUNE 5 mg

Lower Rate of Acute Rejection in Black Patients Treated With RAPAMUNE 5 mg

RAPAMUNE Reduces Efficacy Failure in Recipients of Cadaveric and Living Mismatched Donor Grafts

RAPAMUNE Reduces Efficacy Failure in HLA Mismatched Patients

Efficacy Conclusions I Primary Endpoint

Efficacy Conclusions II Secondary Endpoints

Efficacy Conclusions III

Phase III efficacy results support the use of RAPAMUNE for the proposed indication of the prophylaxis of organ rejection in renal transplant recipients.

Author: James Sergi