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SANDOZ WILL LAUNCH ANTIPSYCHOTIC CLOZARIL FEB. 1, FOLLOWING PHYSICIAN EDUCATIONAL PROGRAM ON RISK/BENEFITS, AGRANULOCYTOSIS PATIENT MONITORING SYSTEM

Executive Summary

Sandoz plans to introduce its antipsychotic Clozaril (clozapine) on Feb. 1, once the company has put together an educational program for physicians and a nationwide agranulocytosis patient monitoring system. Clozaril was approved on Sept. 26, after a six-year review, for management of severely ill schizophrenic patients who fail to respond adequately to treatment with standard antipsychotic drugs. Clozaril is available in 25 and 100 mg tablets and has a twice-a-day dosing schedule. FDA classified Clozaril as a "1A" drug, a new molecular entity representing a significant therapeutic advantage over existing therapies. The company estimates that 5% to 20% of the 2 mil. schizophrenia patients in the U.S. do not respond to standard therapy. The approved labeling for Clozaril states: "Because of the significant risk of agranulocytosis and seizure associated with its use, Clozaril should be used only in patients, who have failed to respond adequately to treatment with appropriate courses of standard antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs." The Clozaril approval, based on Sandoz' willingness to implement a national patient monitoring system and to educate physicians about the drug's risks, represents a novel approach to dealing with important new drugs with significant and serious side effect potential. Sandoz is voluntarily implementing the Clozaril Patient Management System, which involves the monitoring of blood samples of patients on the drug in order to manage the risk of agranulocytosis. Under the system, a visiting nurse or other qualified person will take weekly blood samples from patients and send them to a national laboratory for analysis, the company said. Before a patient can receive a one-week supply of the drug, tests much show a normal white blood cell count. Sandoz has contracted Caremark Homecare, Inc. to assign case workers to patients and to handle the patient-monitoring databases. * Sandoz plans to educate physicians about the patient management system through the use of teleconferences and group meetings. Under the system, physicians will be able to prescribe the drug "by calling a toll free number or by mailing in a CPMS patient enrollment form." Sandoz said that it has tested the system by monitoring patients at several centers for a six-month period. The patients were either from clinical trials and continuing on Clozaril or were new patients receiving the drug on a compassionate basis. The system has shown a 99% compliance rate, Sandoz said. FDA's Psychopharmacologic Drugs Advisory Committee recommended approval of Clozaril on April 26, concluding that the drug's benefits outweigh the risk of agranulocytosis ("The Pink Sheet" May 1, p. 7). At the meeting, Sandoz presented a proposal for the CPMS. Several committee members felt the program was unnecessary.
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