Novartis partner BioLineRx in-licenses NASH drug after joint evaluation


Novartis ($NVS) is set to support the development of a nonalcoholic steatohepatitis (NASH) drug by its Israeli partner BioLineRx ($BLRX). The arrangement sees BioLineRx, which Novartis works with to scout opportunities in Israel, in-license the NASH asset under its R&D framework with the Swiss Big Pharma.

Tel Aviv, Israel-based BioLineRx picked up the NASH drug, now known as BL-1210, from Hadasit, the tech transfer wing of Hadassah Medical Organization. Novartis was involved in the evaluation of the drug, which was developed by Dr. Rifaat Safadi at Hadassah Medical Center. Safadi, a liver disease specialist, is known for his work on possible links between the immune system and NASH, research that led to the development of Immuron’s (ASX:IMC) IMM-124E.

BioLineRx describes the asset it has in-licensed from Safadi as an immunomodulator. The expectation is that BL-1210 will reduce liver fibrogenesis--and, by extension, minimize scarring--by modulating the activity of the immune system. In recent years, Safadi’s research has looked at treating liver disorders by modulating natural killer cell activity through inhibition of NGn4 expression. Safadi filed for patent protection of the idea in nonalcoholic fatty liver disease, the most extreme form of which is NASH, last year.

Having picked up the rights to BL-1210, BioLineRx now plans to advance the preclinical program, receiving advice from Novartis as it goes. The arrangement is the result of a deal struck late in 2014, at which time Novartis made a $10 million (€9 million) investment in BioLineRx. The deal entrusted BioLineRx with scouting out promising drugs for Novartis in Israel, a country that the Swiss drugmaker has tried to increase its exposure to in recent years.

BL-1210 is the first drug the partners have decided to bring into their collaboration. The pathway laid out in the 2014 deal gives Novartis an option to select projects that advance as far as the clinic. Once Novartis has selected a drug, it will pay BioLineRx $5 million and sign up to pay half of the forecast cost of reaching clinical proof of concept. The R&D payment will take the form of an equity investment. If a drug achieves clinical proof of concept, Novartis has exclusive right of first negotiation for the asset.

While it took BioLineRx more than 18 months to get the first drug into the program, it now thinks it can accelerate. “We expect to bring additional promising projects to the collaboration by the end of the year,” BioLineRx CEO Kinneret Savitsky said in a statement. The original plan was for BioLineRx and Novartis to develop up to three programs.

- read the release

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