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Executive Summary

SCHERING-PLOUGH WILL MARKET CARTER-WALLACE's ANTICONVULSANT FELBAMATE OUTSIDE North America and Mexico under an exclusive licensing agreement announced April 6. The licensing deal, the first between the two companies, provides Carter-Wallace with a $10 mil. upfront cash payment and royalties contingent on overseas approval of felbamate. Carter-Wallace filed an NDA for felbamate as a first-line therapy for epilepsy on Sept. 30. Studies published in 1990 and 1991 indicated that the anticonvulsant is effective in reducing seizure frequency. Carter-Wallace says the drug "has been studied in refractory patients with partial seizures, as monotherapy in patients with partial seizures, in patients with Lennox-Gastaut Syndrome, and as adjunctive therapy in patients with partial seizures" ("The Pink Sheet" Oct. 7, p. 18). Carter-Wallace is seeking orphan status for the Lennox-Gastaut indication. The syndrome is a "severe and incapacitating form of seizure disorder, primarily affecting children and for which generally effective treatments are lacking," Schering-Plough said. Schering will use U.S. clinical data obtained by Carter- Wallace and data from additional clinical studies conducted overseas for its international registrations. The company estimated there is a potential 2.2 mil. patient European market that could contribute sales of $350 mil. For the total overseas market, Schering estimated a potential patient population of 3.2 mil. and sales of up to $450 mil. Under a separate agreement announced the same day, Schering- Plough and Carter-Wallace will copromote an as-yet-unnamed product in the U.S. contingent on "certain circumstances," which were not disclosed. Carter-Wallace said the additional service fees and remuneration from the arrangement "may be significant."

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