Incubator takes promising new Israeli drug technologies through the first clinical testing stages and sends them on their way for finishing touches.

 Moving remedies from lab to pharmacy

 

BioLineRx CFO-COO Phil Serlin

By Avigayil Kadesh

Potential drugs for pain, schizophrenia, inflammatory bowel disease and 11 other common conditions are all in the pipeline of the Jerusalem-based BioLineRx, which operates the only government-approved biotechnology incubator in Israel.

With up to 80 percent funding from the Office of the Chief Scientist, the company fills an unusual "middleman" role between the discovery of a new treatment molecule and its final development by a pharmaceutical company.

"Very few players can take a drug from the initial research stages to the end, so the industry is highly segmented," explains chief financial and operating officer Phil Serlin. "We take promising molecules into our portfolio, and we bring forward only those that prove themselves to have therapeutic potential and will interest international pharma. Few companies in the world have this model."

Founded in 2003 by Israeli generic drug giant Teva Pharmaceuticals and several life science venture capital funds to turn more of Israel’s basic research into products, BioLineRx has so far sent along two molecules to advanced clinical testing.

The first, dubbed BL-1020, could become the world’s first antipsychotic drug for schizophrenia that also offers cognition enhancement. "The whole world has been looking for this, because 90 percent of schizophrenia patients suffer cognition impairment to some degree," Serlin explains.

Based on a molecule invented by researchers at Tel Aviv and Bar-Ilan universities, BL-1020 taps into one of the largest markets in the world. "Close to 1% of the world’s population suffers from schizophrenia and the US antipsychotic market had estimated sales in excess of $10 billion in 2010," says Serlin. "We are hopeful this might be a big breakthrough with the potential to be a serious blockbuster."

A ‘cast’ for the heart

The second drug in advanced clinical trials is BL-1040, invented jointly by Ben-Gurion and Tel Aviv university labs to prevent irreversible damage to the heart muscle following a heart attack.

Heart attacks result from a blocked artery causing damage to part of the heart muscle. Current treatment methods clear the blockage but do nothing to heal the muscle, which usually remains weak as it is covered with a thin scar. BL-1040, injected as a liquid during catheterization to open the blocked artery, mixes with calcium coming out of the damaged tissue and turns into a gel that strengthens the damaged area as it heals. "This is an unmet medical need," says Serlin. "Our product is almost like a cast for the heart while it’s healing."

BioLineRx out-licensed the molecule in 2009 for final testing to the US drug company Ikaria for a total deal value of $282.5 million, in addition to sales royalties if the drug is approved. Because BL-1040 causes no chemical changes, the US Food and Drug Administration (FDA) considers it a medical device for regulatory purposes.

Like drilling for oil

Getting branded drugs to patients is a long, risky and costly process that Serlin compares to drilling for oil. "You might have to drill a thousand wells to find one good one, and that can take a decade, but the rewards are great." BioLineRx obtains licensing rights for molecules that have been proven in animal models – almost all coming from Israeli university labs or biotech incubators – usually around the third year of the 12- to 14-year process of drug development.

Potential drugs must go through three phases of human trials for FDA approval. BioLineRx does the first two, testing for safety and efficacy before licensing the successful ones to another company for the expensive phase-three trials.

The publicly traded company, listed on the Tel Aviv Stock Exchange and recently the NASDAQ as well, has 55 employees under CEO Kinneret Savitsky, who has a doctorate in human genetics and was formerly a vice president at Compugen.

"A company our size is often a one- or two-product company, but we have an unusually broad pipeline and can fund initial stages because of our franchise from the Office of the Chief Scientist," says Serlin, a Miami native. "Only if a project is successful in getting revenues later on do we have to pay back the funding, so it’s risk-free."

BioLineRx accepts four to eight new projects each year, most of which go no further. Right now, it has 14 projects. Of the nine in preclinical stages of testing (in oncology and central nervous system, infectious, cardiovascular and autoimmune diseases), only a few will go forward and additional molecules will be brought in. The five more advanced clinical projects include a drug for inflammatory bowel disease as well as a novel treatment developed at Tel Aviv University for neuropathic and chronic pain, which affects millions of people worldwide.

"There aren’t good solutions at present because of bad side effects – like morphine, which can be addictive and puts you to sleep. There’s a huge search for a drug that will be effective without safety issues," says Serlin. Chronic neuropathic or inflammatory pain is a leading cause of disability and one of the most common reasons patients visit a family physician. The market was estimated at $2.4 billion in 2009.