MORPHOTEK'S MORAB-009 WINS ORPHAN DRUG STATUS FOR PANCREATIC CANCER

Morphotek announced that the FDA has granted orphan drug status to MORAb-009, a monoclonal antibody, for the indication of pancreatic cancer.

To achieve orphan drug designation, the prevalence of the indication in the target United States population cannot exceed 200,000. Approximately 23,000 new cases of pancreatic cancer are diagnosed annually in the United States, according to Morphotek. Under orphan drug status, MORAb-009 is allowed certain tax and user fee benefits including grant funding to help support development, as well as a period of marketing exclusivity upon FDA approval.

MORAb-009 is an antibody that recognizes mesothelin, a cell surface glycoprotein over-expressed in a number of cancers. Researchers at the National Cancer Institute and Johns Hopkins University have independently validated the association of this protein in cancer and the therapeutic potential of drugs that can specifically target it. Studies have demonstrated a high correlation of mesothelin expression with mesothelioma and pancreatic, ovarian and non-small-cell lung carcinomas, as well as several epithelial cancers.