BioLineRX obtains FDA orphan drug status for leukemia drug

The company has obtained orphan drugs designation for BL-8040 as a therapeutic for the treatment of acute myeloid leukemia.

BiolineRX Ltd. (Nasdaq: BLRX); TASE:BLRX) has obtained orphan drugs designation from the US Food and Drug Administration (FDA) for BL-8040 as a therapeutic for the treatment of acute myeloid leukemia.

The FDA grants Orphan Drug Designation to therapeutics intended to treat rare diseases that affect no more than 200,000 people in the US. The designation entitles the sponsor to seven years market exclusivity, clinical protocol assistance with the FDA, and federal grants and tax credits.

BL-8040 is also suited for treating other cancers, but because these are larger markets, Orphan Drug Designation is inapplicable to them. BiolineRX is already conducting a Phase II clinical trial of the drug for acute myeloid leukemia.

“Currently, acute myeloid leukemia treatment options, especially in patients with a relapse of the disease, are extremely limited. BL-8040 has the potential to be a significant addition to the drug arsenal for this disease, especially when considering its promising pre-clinical results, unique biological mechanism and ability to synergize with other drugs already approved for this disease. Therefore, we are eagerly looking forward to the partial results of BL-8040′s Phase 2 study expected towards the end of 2013," said BiolineRX CEO Dr. Kinneret Savitsky.

Published by Globes [online], Israel business news - - on September 9, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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