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Executive Summary

CIBA-GEIGY WILL FILE ORPHAN NDA FOR LEPROSY DRUG LAMPRENE, the company announced at a meeting of the United Nations Business Council in New York, April 11. "At Ciba-Geigy the availability of Lamprene (BRACKET)clofazimine(BRACKET) was raised as part of the broader issue of what role we should play as a research-based pharmaceutical company in the treatment of rare diseases," Ciba-Geigy U.S. Public Policy Director David Taylor, PhD, said. "The ensuing discussion resulted in the adoption of a new orphan drug policy by Ciba-Geigy and a commitment to submit an orphan drug NDA for Lamprene." Taylor explained that the decision to file an orphan NDA for Lamprene came following discussions with FDA. "Dr. Marion Finkel, Director of FDA's new Office of Orphan Drugs, independently concluded that there was a clear public health need to make Lamprene more readily available in the U.S.," Taylor noted. "Subsequently Dr. Finkel and her staff have assisted us in developing a process to expedite the approval of Lamprene as an orphan drug." Ciba-Geigy announced its intention to make the Lamprene filing in the context of a presentation of the company's programs related to health care in the Third World. The company said that it would place particular emphasis on making its leprosy drugs, including Lamprene, more available. Taylor explained that Lamprene has been available in the U.S. only under a treatment IND. The impetus to make the drug more readily available has come from the expanding number of cases being diagnosed in the U.S. "in part because of recent immigration from areas where the disease is widespread, primarily Latin America and Asia," Taylor said. Taylor noted that Public Health Service estimates show a rise of about 500% in the incidence of the disease here since 1960, to over 5,000 cases. Taylor said that another impetus for making Lamprene more readily available were indications from current work being done with the drug in medical centers here in the U.S. that it might have efficacy in the treatment of other immunologic disorders, including AIDS and MS, and mycobacterial infections. In this context Taylor announced that Ciba-Geigy will soon file an IND application for further research on the use of Lamprene for these other conditions. "We have initiated a process to look at other drugs for tropical diseases, drugs that are available elsewhere in the world but not currently in the U.S., to see if they are appropriate orphan drug candidates in the U.S., and to proceed as quickly as possible to make them available as well," Taylor added.

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