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Thalidomide Now Approved By FDA For a Fourth Application WARREN, N.J., March 20, 1996 -- Celgene Corporation (Nasdaq-NNM: CELG) said the US FDA approved a fourth application for orphan drug designation of thalidomide, this one for treatment of cachexia, a severe wasting condition associated with AIDS. Last June, the FDA granted the company orphan drug status for using thalidomide for treatment of recurrent aphthous stomatitis (mouth ulcers or canker sores) in severely, terminally immunocompromised patients suffering from such conditions as AIDS and cancer. In January 1993, the company was granted orphan drug status for thalidomide in the treatment of clinical manifestations of mycobacterial infections. Additionally, the company received orphan drug designation for thalidomide for use in leprosy. Celgene said orphan designations can provide drug companies seven years of sales exclusivity and tax credits on research and development expenses devoted to drugs to treat patients with rare disorders. The company is currently sponsoring a pivotal clinical trial of its thalidomide drug Synovir(TM) for the treatment of AIDS-related cachexia and is supplying the drug with cost recovery under an unusual expanded access protocol approved by the FDA. Other ongoing human clinical studies testing Synovir include a cancer cachexia program in the UK and a rheumatoid arthritis treatment study at New York University's Hospital For Joint Diseases. The US government is studying the drug for its potential effects on halting the progression of HIV. In addition, Celgene has developed a new class of therapeutic products, all structurally related to thalidomide. In laboratory tests, some of these experimental compounds have demonstrated up to 4000 times greater potency than the original compound. In addition to greater potency, the new compounds may present lower side effects. Human testing of one or more of these new drug leads is planned by the end of this year, the company said. Celgene Corporation, headquartered in Warren, N.J., uses proprietary expertise in small molecule chemistry to serve the pharmaceutical and allied industries. E-mail this page to a friend or colleague! To print, use this version