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Executive Summary

MEDTRONIC TREATMENT IND FOR BACLOFEN IN SYNCHROMED IMPLANTABLE PUMP approved by FDA March 8. The first to involve a medical device, the Treatment IND covers use of the drug/device in patients with intractable spinal spasticity (caused by spinal cord injury or multiple sclerosis) that is resistant to standard therapy with oral baclofen (Ciba-Geigy's Lioresal). Ciba-Geigy will supply the baclofen solution, which it developed specifically for use in the Medtronic pump, free to patients in the Treatment IND. Minneapolis-based Medtronic, the official sponsor of the Treatment IND, will handle all other aspects of the expanded use investigational program. Medtronic plans to publicly announce details of the Treatment IND, including the commencement date and whether the firm will seek cost recovery for its device, early in the week of March 19. * Medtronic estimates that the potential U.S. treatment population for the drug/device combination is between 20,000 and 40,000. The drug/device treatment has orphan status and its development was supported by a grant from FDA's Office of Orphan Product Development. To date, the baclofen/SynchroMed pump therapy has been tested in about 150 patients. The combination has been in clinicals at Chicago's Rush-Presbyterian-St. Luke Medical Center, under the direction of principal investigator Richard Penn, MD. A double-blind cross-over study in 20 patients, conducted by Penn and reported in the June 8, 1989 New England Journal of Medicine, found that intrathecal infusion with the SynchroMed system achieved a ten-times higher level of baclofen in cerebrospinal fluid at a dose 100 times smaller than the oral treatment, greatly reducing the drug's toxicity. * In addition to the Treatment IND, Medtronic will be taking responsibility for obtaining regulatory approvals for the solution form of baclofen and for use of the agent in the implantable pump, which is already approved for use with several chemotherapeutic agents. Once approved, Ciba-Geigy will provide Medtronic with the baclofen solution under a purchasing agreement.

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