XTL Biopharmaceuticals Ltd. (Pink Sheets:XTLBY); TASE:XTL) has applied to the US Food and Drug Administration (FDA) for orphan drug status for its erythropoietin (EPO) drug for the treatment of multiple myeloma blood cancer. The drug is undergoing a Phase II clinical trial.
XTL has a patent for EPO that is valid until 2019.
Orphan drug status applies to drugs for treating diseases that affect a small number of people; the FDA sets a figure of a disease affects fewer 200,000 persons a year. FDA orphan status grants various incentives for developing these drugs, including shortened approval procedures, tax breaks on R&D costs, and financing assistance. If the drug is the first to reach market, it also receives seven years exclusivity.
XTL closed at $0.31 in New York yesterday, giving a market cap of $22 million, and rose 6.5% on the TASE today to NIS 0.64.
Published by Globes [online], Israel business news - www.globes-online.com - on April 21, 2011
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