“At the beginning of 2012, we entered the competitive HCV market with the in-licensing of two orally-available compounds for the treatment of Hepatitis C from world renowned experts in the field. BL-8020, an orally available, interferon-free treatment for HCV, is a novel compound with pan-genotypic efficacy, a unique mechanism of action and a synergistic effect with other HCV therapies. We have successfully and rapidly completed pre-clinical development for BL-8020 and expect to launch a Phase 1/2 trial next month. Meanwhile, BL-8030, our other orally-available HCV program, continues to undergo rigorous pre-clinical development in preparation for eventual clinical testing. We have been engaged in advanced discussions with a potential regional co-development partner, which we believe will substantially expedite the development process,” continued Dr. Savitsky.

“In addition, during 2012, we significantly strengthened the patent protection for several key compounds, including BL-1020, which was granted two new patents in Europe, in addition to a new patent granted in the U.S., which effectively extended patent protection for the product by nine years, through 2031. We also reported the receipt of a notice of extension from the USPTO for BL-1040, effectively extending patent protection on this asset for five years, through 2029. We plan to continue to invest substantial efforts at strengthening our IP portfolio.”

Dr. Savitsky concluded, “BioLineRx continues to mature and progress on all fronts, as we anticipate upcoming clinical results and the initiation of new clinical studies for numerous programs in 2013. We are committed to building our business as we discover new compounds, meet current portfolio milestones, and identify partnering opportunities.”

Significant Anticipated 2013 Milestones
  • BL-1020 (Schizophrenia) – results of interim analysis by independent DMC of ongoing Phase 2/3 CLARITY trial expected during the week of March 18
  • BL-8040 (Leukemia and other hematological cancers) – Phase 2 clinical trial expected to commence in Q2 2013
  • BL-5010 (Skin lesions) – development of a new unique applicator prototype for the product should be completed by Q2 2013; pivotal CE Mark registration trial expected to commence in Europe during H2 2013
  • BL-7040 (Inflammatory bowel disease or IBD) – results of Phase 2a proof-of-concept study expected in April 2013
  • BL-8020 (HCV) – Phase 1/2 clinical study expected to commence in April 2013

Philip Serlin, BioLineRx's Chief Financial and Operating Officer, added, “In 2012 we witnessed the increased presence of BioLineRx in the U.S. financial market, with an associated increase in investor awareness. In particular, two U.S. analysts initiated coverage of the Company, and we held a very successful Analyst/Investor Day in New York in December 2012. As a result, currently almost 50% of the Company’s outstanding shares are held by North American investors, and we have seen a nice increase in the trading volume of our shares. In addition, we recently raised $8 million through a direct equity placement, with no underwriting fees or placement commissions, to the OrbiMed group. This additional capital improved the Company’s balance sheet for advancing our pipeline, while strengthening our position as we negotiate potential partnering arrangements. The capital raise will help fund our programs through 2014."

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