The U.S. Patent and Trademark Office (USPTO) recently issued a Notice of Allowance for BioLineRx, Ltd.’s BL-8020.
The patent, which will not expire at least before 2031, will cover BL-8020 for the treatment of hepatitis C virus (HCV)-infected patients who are resistant to anti-HCV therapy.
BL-8020 is a proprietary, fixed dose candidate comprising ribavirin plus hydroxychloroquine (HCQ). BL-8020 is currently in a phase I/II study, open-label study being conducted across two sites in France and will enroll up to 32 HCV-infected patients who have either failed or relapsed after undergoing treatment with the current standard-of-care. The study is specially designed to carry on intra-subject analysis so as to ascertain the extent to which HCQ enhances Ribavirin’s antiviral activity. The company expects partial results from the study in the beginning of 2014.
The HCV market represents huge commercial opportunity for BioLineRx. As per data from a 2011 report from Decision Resources, approximately 180 million people are suffering from chronic HCV globally. The global HCV market is expected to be worth $20 billion by 2020 as opposed to $6 billion in 2011.
Currently approved HCV therapies include Vertex Pharmaceuticals Incorporated’s Incivek and Merck & Co. Inc.’s Victrelis.
Apart from BL-8020, other interesting candidates in BioLineRx’s pipeline include BL-1040 for preventing pathological cardiac remodeling following a myocardial infarction (in CE-Mark registration trial), BL-5010 for non-surgical removal of skin lesions (pivotal CE-Mark registration trial to commence), BL-8040 for acute myeloid leukemia (phase II).
BioLineRx carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Gilead Sciences Inc. with a Zacks Rank #1 (Strong Buy).