The United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application for the composition of BioLineRx Ltd.’s (BLRX - Free Report) 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 2033.
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 BL-5010.
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. (ENDP - Free Report) , Isis Pharmaceuticals, Inc. and Actelion Ltd. currently look better positioned with a Zacks Rank #1 (Strong Buy).