BioLineRx is a drug development company focused on advancing research products into the clinic. The company was formed in 2003 to bring Israeli biotech to global attention, but has since expanded its interests and now in-licenses preclinical and early-stage clinical projects—wherever they are found—and advances them until they are ready for out-licensing and commercialization.
Many of the in-licensed projects began within Israel’s leading universities. “Israel is known for its world-leading early-stage research. However, a relatively low number of drugs on the market have originated from Israeli technology. BioLineRx was founded to bridge this gap,” Kinneret Savitsky, Ph.D., CEO of BioLineRx, explains. To do that, the company maintains strategic relationships “…with all the leading universities in Israel, as well as substantial connections with many incubators and biotech companies.”
It’s a win-win approach. The inventors gain experienced managers and drug developers, thus giving their projects a better chance of success than they may find in a typical start-up environment. And for BioLineRx, the close relationships enable access to these projects from leading academic institutions and young companies while they can be shaped most easily to meet regulatory and commercial demands.
Generally, BioLineRx considers in-licensing only projects with in vivo efficacy data and information regarding the mechanism of action (MOA). Additional criteria include the strength and age of the intellectual property, market need, clinical development timelines, and costs.
“We believe that our competitive advantage comes best into play when applied to early-stage projects,” Dr. Savitsky says. BioLineRx’ focus on early-stage projects allows much more flexibility and creativity in the development process. “In many projects, we make significant changes in the route of administration or in the chemistry, manufacturing, and control of the compound.”
BioLineRx also sometimes has the opportunity to alter the regulatory path the drug takes toward approval. For example, Dr. Savitsky says, “BL-1040, an asset to prevent ventricular remodeling after an acute myocardial infarction, was considered a drug when we in-licensed the program. Our development team, after much research, obtained a device designation from the regulatory authorities, and also changed the route of administration to an intra-coronary injection via catheter. Because we were able to implement this change at the preclinical stage, we saved substantial time and resources and increased the value of the asset.” It was out-licensed to Ikaria in 2009.