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Executive Summary

HOECHST-ROUSSEL's U-400 INSULIN FOR USE IN IMPLANTABLE PUMP delivery systems is being evaluated in a clinical trials at Johns Hopkins Hospital. The firm holds an IND for the specially formulated U-400 insulin, which is being tested with MiniMed Technologies' Programmable Implantable Medication System (PIMS) insulin delivery system. On Nov. 10 at Johns Hopkins, the PIMS device was implanted in a patient, marking the first time that an implantable pump insulin system has been tested in man. The procedure was performed seven months after FDA approved MiniMed's investigational device exemption. The insulin pump protocol calls for implantation in a total of 40 patients, 20 at Johns Hopkins and 20 at the University of California at Irvine. With the highly concentrated U-400 formulation, insulin can be injected into the PIMS pump once every three months. While the pump theoretically could operate with commercially available U-100 insulins, refills would be necessary far more often, about once every three weeks. FDA will review Hoechst's IND and the MiniMed IDE separately. The clinical trials culminate over five years of preclinical investigation, underwritten by industry, academia and the government. NASA's Goddard Space Flight Center contributed both technology and $3 mil. in funds to stimulate technology transfer, while the National Institutes of Health provided $4 mil. for preclinical and clinical testing. The Johns Hopkins Applied Physics Laboratory Development Fund supplied seed money to begin the PIMS program. MiniMed, which originally began work on the device as a division of pacemaker firm Pacesetter Systems, and Parker-Hannifin, which provided fluid handling technology, contributed to an estimated $8 mil. industry investment in the device. Wilson Greatbatch developed the device's battery, and Teledyne added electronics expertise. MiniMed will have marketing rights to the system once it clears FDA.

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