BioLineRx Ltd. isn’t your everyday biotech start-up.
The reason? A quick glance at the two-year-old firm’s portfolio reveals 10 products, some of which are in late-stage preclinical research and expected to move into human studies later this year. The Jerusalem-based company used the Biotechnology Industry Organization’s recent CEO & Investor Conference as an initial opportunity to showcase its plan to bridge the gap between R&D and the drug industry, and CEO Morris Laster said BioLineRx was well received.
"This is our coming out party," he told BioWorld Today at the two-day conference, held last month in New York. Describing the company as "a drug development machine," Laster noted that the model on which it is based "ensures success."
Already funded with about $43 million - almost evenly split between venture capital backers and an Israeli government grant - BioLineRx was built to in-license early stage therapeutic candidates from around the world, run them through a gamut of preclinical feasibility testing and move them into clinical studies if appropriate. If not, they are dropped, and the company’s attention moves to others in its pipeline, all the while maintaining a "robust" base of 10 compounds, Laster said.
"It’s an incredibly unique model," he added, noting that it establishes an incentive for BioLineRx to only test products "that work best." That’s because its in-licensing deals are structured as revenue-sharing arrangements with the licensors - typically academic or research organizations, or small biotech firms. Once BioLineRx introduces a new product to its portfolio, it shoulders further development costs through proof-of-concept testing and would share profits upon commercialization, to be carried out under sales and marketing partnerships.
Of course, the company doesn’t buy into just any compound. Its candidates must exhibit promise in an area of unmet medical need, across all therapeutic areas, and are subject to quarterly pipeline reviews - a continuous screening process. Already, BioLineRx has terminated two programs when it became apparent that the products would never reach the market.
Once the company has brought a compound in house, it designs, implements and monitors preclinical testing designed to support an investigational new drug application from the FDA. The feasibility testing costs about $200,000 over six months, Laster said.
Such work is outsourced to multiple contract research organizations, all of which comply with FDA standards, and BioLineRx also contracts with industry consultants and indication-specific clinical advisors for further input on a candidate’s potential.
So far, a trio of compounds from its portfolio is on the cusp of clinical studies.
BL-1020, a neurotransmission modulator for schizophrenia, is scheduled to enter Phase I at the beginning of April. Laster noted that it "works just as well" as other antipsychotic drugs, but lacks the side-effect profile that frequently leads patients to halt therapy. Importantly, he added, the drug’s rapid clip through extensive preclinical testing illustrates BioLineRx’s ability to move "from bench to bedside in less than two years with an academic compound."
Next in line is BL-1040, a biodegradable alginate polymer scaffold designed to treat acute myocardial infarction. An injectable liquid, it is delivered via catheter to the damaged heart tissue and essentially forms "an in situ cast," Laster said, treating the infarct and then disappearing in two months. That profile has led BioLineRx to pursue its clinical testing under an investigational device exemption, setting up a potentially quick regulatory route that could get it to the market as soon as 2009.
BL-2040, an oral small molecule for hypertension and metabolic syndrome, has been shown to reduce blood pressure, weight and triglycerides. An ACE inhibitor that promotes metabolic normalization, it also improves insulin levels.
Laster, an industry veteran who has taken public three of the four companies he founded, was drawn instantly to BioLineRx’s promise when first approached to take its reins. In his past businesses, "I was able to see a lot of the problems with a classic biotech company," he said, such as "being married" to a single compound. But the BioLineRx model, which he said appeals to strong R&D regions that lack deep venture capital and management resources, "eliminates" tunnel vision problems associated with single-product companies.
Laster is part of a four-person management team, which operates alongside 26 employees tasked with everyday oversight of the company’s 10-product pipeline. The company is positioning itself for a mezzanine round of financing late next year, when two of those products should be completing Phase II.
BioLineRx’s initial investors, all of which are based in Israel, have poured $23 million into the business so far. They include Teva Pharmaceuticals Industries Ltd., Giza Venture Capital, Pitango Venture Capital, Star Ventures, the Jerusalem Development Authority and Hadasit, a subsidiary of Hadassah Medical Center. Those funds are supplemented by a $21 million Israeli National Biotech Initiative grant.