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Executive Summary

ABBOTT's SURVANTA IS SECOND LUNG SURFACTANT TREATMENT IND for the prevention and treatment of respiratory distress syndrome in premature infants. Abbott's Treatment IND, filed Sept. 8 and approved Oct. 3, comes less than three months after approval of Burroughs Wellcome's Treatment IND for Exosurf Pediatric ("The Pink Sheet" July 31, T&G-6). * Both Survanta and Exosurf are designated as orphan drugs. Orphan exclusivity, however, would probably not affect marketing of the two products due to their differences: Survanta is a modified bovine lung surfactant; Exosurf is a synthetic product. Abbott will be supplying Survanta free of charge to the roughly 1,000 hospitals with "neonatal intensive care units (NICU) that have personnel experienced in treating infants with respiratory distress syndrome," the firm said. The company is in the process of sending out information packages to the hospitals that include video tapes on how to use the product. Supplied as a ready to use sterile liquid, Survanta is administered intratracheally. Burroughs Wellcome's product is supplied as a lyophilized powder and administered through a tube to the lungs. * Respiratory distress syndrome afflicts "an estimated 50,000 premature infants each year who are born before they have developed the ability to produce surfactant which prevents the lungs from collapsing during breathing," Abbott said. The condition is fatal for roughly 10%, or 5,000, of the infants. Survanta has been studied "in over 30 centers internationally with more than 1,500 babies, [in which the drug] has been shown to significantly decrease mortality and to decrease the need for ventilation support," Abbott said. Abbott's Phase III studies with the drug were recently completed but the NDA has not yet been filed. Abbott licenses the drug from Tanabe, which currently markets the product in Japan.

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