It is the most expensive seaweed known to medical history: a new heart-healing gel based on brown seaweed has just been rewarded with a record investment deal.
The Israeli company BioLineRx , founded in 2003, just released the news that one if its two compounds – the BL-1040 – to repair damaged heart muscles after cardiac arrest, has been licensed by the New Jersey-based company Ikaria Holdings in a $282.5 million deal, confirms a BioLineRx representative, Dganit Bar.
Ikaria now owns the worldwide exclusive license to BL-1040, and what could be a potential breakthrough treatment for preventing repeat heart attacks after an initial event.
Injected into the heart as a liquid, when inside the body BL-1040 turns into a protective gel scaffold, sheathing the heart muscles and giving them the ability to heal properly. In effect it enhances the mechanical strength of the heart muscle during recovery and repair.
Animal model experiments completed by the company earlier revealed that some 90 percent of animals treated with the gel survived a heart attack, while among those untreated, only 40% survived.
Set to complete milestones
“We are very excited about this deal,” Bar tells ISRAEL21c, explaining that BioLineRx, a publicly traded company in Israel, was created to in-license early stage medical research, and to take promising ideas and turn them into commercial products.
Until now the company has been looking to two promising compounds, BL-1020 for schizophrenia and BL-1040 for the heart, now in Phase I-II clinical trials in Europe.
According to the terms of the deal with Ikaria, BioLineRx will get half of the money upfront in order to meet regulatory and developmental milestones. “The other half is sales based and doesn’t include royalties, about 11-15%,” Bar tells ISRAEL21c.
It’s the first big deal for BioLineRx. The latest trial, Bar continues, is a clinical trial consisting of 23 patients in Germany and Belgium. “They are doing fine,” she says. Toxicity tests have shown the product is safe, and “we did have some hints on its efficacy,” she adds, stressing the main points were safety.
“We also have extensive pre-clinical data and saw that it was very effective in preventative cardiac remodeling,” says Bar. “The BL-1040 is being injected in the body in the occluded vessel; it gets into the ischemic tissue and turns into a gel from a liquid –– which like a solid –– prevents the heart from dilating and prevents damage.”
Jointly invented by Prof. Smadar Cohen from Ben Gurion University and Prof. Jonathan Leor from Tel Aviv University, both in Israel, BioLineRx had in-licensed the technology in 2005 from Ben Gurion University which then owned the rights to the patent.
Healing hearts from the sea
Based on a common brown seaweed, with other active ingredients, Bar believes that the product now financed by Ikaria could see very swift development: as early as 2012 the compound could be ready for use.
The quick time to market has to do with the fact that it is being marketed as a medical device and not a drug, says Bar. “Ikaria will fund the rest of the studies, and since we have experience [with the compound] we will form a joint committee and be a part of the new clinical trial,” says Bar.
Ikaria Holdings is a biotherapeutics company. Its lead product INOmax is a nitric oxide inhalation product, the only one regulated for the treatment of hypoxic respiratory failure in term and near-term newborns.
The company also owns the North American rights to terlipressin, currently under review by the FDA for treating hepatorenal syndrome Type 1.
Daniel Tassé the president and CEO of Ikaria said in a press announcement: “The acquisition of the rights to BL-1040 reinforces our commitment to deliver novel treatments to critically ill patients around the world.”
And hopefully coming to heal hearts near you.