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.
) 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
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
Forest Laboratories Inc.
Lannett Co. Inc.
). All the three stocks carry a Zacks Rank #1 (Strong Buy).
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