Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role in deciding whether or not to invest in a particular company. Pipelines are of paramount importance as far as pharma/biotech companies are concerned and more often than not these companies spend a significant amount in developing theirs.
BioLineRx Ltd.’s (BLRX) pipeline looks promising with candidates like BL-5010 (non-surgical removal of skin lesions); BL-1040 (ventricular remodeling following a myocardial infarction); BL-8040 (acute myeloid leukemia (:AML) and other hematological cancer indications) and BL-7010 (celiac disease). Recently, the U.S. Food and Drug Administration (:FDA) granted an orphan drug designation to BioLineRx’ BL-8040 for the treatment of stem cell mobilization.
The orphan drug designation is granted by the FDA to candidates being developed for the treatment/prevention of rare diseases (affecting less than 200,000 people in the U.S.) having significant unmet medical needs. Moreover, the status makes the drug eligible for seven years of marketing exclusivity in the U.S. following approval for the orphan indication. The granting of orphan drug status for the BioLineRx candidate will ensure clinical protocol assistance from the FDA besides federal grants and tax credits.
We note that BL-8040 already enjoys an orphan drug status for the treatment of AML.
The phase I study on BL-8040 for the treatment of mobilization of stem cells is likely to start in the second quarter of 2014. Top-line results are expected in the second half of 2014. BioLineRx is also studying BL-8040 in phase II for the treatment of adults suffering from relapsed/refractory AML. BioLineRx expects results in the second half of 2014.
We remind investors that in Sep 2012, the rights to BL-8040 were in-licensed by BioLineRx from Biokine Therapeutics Ltd.
BioLineRx carries a Zacks Rank #3 (Hold). Some better ranked players in the pharma industry include Actelion Ltd. (ALIOF), Forest Laboratories Inc. (FRX) and Lannett Co. Inc. (LCI). All the three stocks carry a Zacks Rank #1 (Strong Buy).