The United States Patent and Trademark Office (USPTO) issued a
Notice of Allowance for a patent application for the composition
) BL-5010. BL-5010 is being developed for the non-surgical
removal of skin lesions.
The U.S. patent for BL-5010 is valid till 2022 from the date of
issue. Meanwhile, the corresponding patents for BL-5010 in Europe
and Israel have already been granted. BioLineRx also has a
pending patent application for the candidate around the world.
The pending patent application, if allowed, will be valid until
BL-5010 demonstrated encouraging results in a phase I/II study.
In the phase I/II pilot study (n=60), BL-5010 was effective in
96.7% of the cases for removal of the target lesion within a
month. Moreover, BL-5010 was well tolerated and no persistent
irreversible adverse effect was noticed during the study.
BioLineRx is also exploring potential partnership options.
BioLineRx now intends to initiate a pivotal CE-mark registration
study on the final product, known as BL-5010P. The study is
expected to begin by year end. The successful completion of the
study will enable the company to apply for CE-mark registration
of the candidate. BioLineRx expects the candidate to be approved
in Europe by the end of next year. The company also has plans to
expand the candidate's label in additional therapeutic
indications like actinic keratosis.
We note that BioLineRx has a worldwide exclusive license
agreement with Innovative Pharmaceutical Concepts, Ltd. for
Apart from BL-5010, other interesting candidates in BioLineRx'
pipeline include BL-1040 for preventing pathological cardiac
remodelling following a myocardial infarction (CE-Mark
registration trial), BL-8040 for treating acute myeloid leukemia
and other hematological cancer (phase II) and BL-7010 for celiac
disease (expected to be in phase I/II by the end of 2013).
BioLineRx carries a Zacks Rank #3 (Hold). Stocks such as
Endo Health Solutions Inc.
Isis Pharmaceuticals, Inc.
) currently look better positioned with a Zacks Rank #1 (Strong
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