The FDA granted orphan drug designation to Celgene Corp.(NASDAQ:CELG) of Warren. N.J., for the use of thalidomide fortreating the clinical manifestations of mycobacterial infectionscaused by (ital.) Mycobacterium tuberculosis, M. avium, M.intracellulare and M. kansasi.

Gilla Kaplan, an associate professor at Rockefeller University,has shown that thalidomide may have broad utility forblocking dangerous inflammatory responses. Such responsesare responsible for much of the morbidity and mortalityassociated with tuberculosis caused by mycobacterial infection.Kaplan's research has also demonstrated that thalidomideblocks the production of tumor necrosis factor alpha.

Thalidomide is a chiral glutarimide. Celgene, which specializesin producing chiral drug intermediates, had already taken anexclusive license for development and marketing of the drugand its analogues and metabolites.

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