Medarex Inc. announced Monday that the FDA has grantedorphan drug status to the company's bispecific antibodyproduct for treating ovarian cancer.
The compound, MDX-210, consists of fragments of twomonoclonal antibodies linked together. It is designed to inducetumor killing by simultaneously binding to a protein known asHER-2 on the surface of breast and ovarian cancer cells and to akey receptor on monocytes and other white blood cells.
MDX-210 entered Phase I/II clinical trials on breast andovarian cancer patients at Dartmouth-Hitchcock Medical Centerin Lebanon, N.H., in late May.
Orphan drug status is awarded to drugs for rare diseases, suchas those that affect 200,000 or fewer people annually. Ovariancancer, which causes 4 percent of all cancers, is diagnosed innearly 22,000 women in the U.S. annually, claiming about13,000 lives.
By obtaining orphan drug designation for MDX-210, Medarex(NASDAQ:MEDX) of Princeton, N.J., may be entitled to tax creditsand, upon the drug's approval by FDA, seven years of marketexclusivity.
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