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DAINIPPON’s ZONISAMIDE ANTI-EPILEPTIC ENTERS PHASE III CLINICALS

Executive Summary

DAINIPPON's ZONISAMIDE ANTI-EPILEPTIC ENTERS PHASE III CLINICALS in the U.S. for the treatment of incurable epileptic convulsions. Dainippon has contracted out the zonisamide trials and NDA to the Institute for Biological Research and Development (IBRD), a clinical test contractor based in Irvine, Calif. IBRD is owned by Kuraya, a major Japanese wholesaler ("The Pink Sheet" Oct. 29, 1990, T&G-8). IBRD reportedly plans to enroll 300 patients for the U.S. study, which will run for two to three years. Zonisamide currently is marketed in Japan under the brand name Excegran for the treatment of patients with refractory epilepsies. Dainippon originally granted zonisamide licensing rights in the U.S. to Warner-Lambert, who filed for an IND in 1982. The U.S. firm conducted patient trials until 1987 when it decided to discontinue studying the drug. Warner-Lambert returned the licensing rights to Dainippon; the two companies currently are in negotiations about an IND transfer. Dainippon opened its first U.S. office in New York three-and-a-half years ago. Zonisamide is one of three drugs under development by the Japanese company for sale in the U.S. market: interleukin-1 alpha, an anticancer/radioprotectant myelorestorative agent, is in Phase II clinicals, while biosynthetic human IL-8 is in development under a cooperative agreement with the National Cancer Insititute.
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