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news.BioLineRx has signed an exclusive, worldwide agreement with BGN Technologies, the Technology Transfer Company of Ben-Gurion University, and Hadasit, the Technology Transfer Company of Hadassah Medical Organization, for the in-licensing of a novel treatment for various liver failure conditions such as end-stage liver disease (ESLD) and for conditions potentially leading to liver failure such as non-alcoholic steatohepatitis (NASH).
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This novel treatment, to be named BL-1220, is the second project in-licensed under the framework of the Company’s strategic collaboration with Novartis Pharma AG for the screening and development of novel drug candidates.
BL-1220 is an orally administered, novel composition of sodium alginate, developed by Professor Smadar Cohen from the Department of Biotechnology Engineering, Ben-Gurion University of the Negev, Israel, and Professor Yaron Ilan, Head of Internal Medicine Department A, Hadassah Medical Center, Jerusalem, Israel.
Pre-clinical results obtained in animal models of liver impairment suggest that BL-1220 has strong hepato-protective effects. Collectively, the data demonstrate that BL-1220 is able to restore liver function. This technology could be directed toward rapid regeneration of normal liver in both acute and chronic conditions of liver injury.
BioLineRx Chief Financial and Operating Officer Philip Serlin said: "In August this year, we in-licensed the first compound under our multi-year strategic partnership with Novartis, a novel drug candidate for controlling liver fibrosis through modulation of the immune system.
"Today, we are pleased to announce the second compound under the Novartis collaboration, also for the treatment of liver pathologies. Both of these projects fit our strategic focus on the immunology space. We continue to work closely with Novartis to identify cutting-edge, novel therapies and we expect to bring additional promising projects to the collaboration by the end of the year.”
In December 2014, BioLineRx and Novartis Pharma AG entered into a multi-year strategic collaboration to facilitate development and commercialization of Israeli-sourced drug candidates.
Leveraging BioLineRx’s close and long-lasting ties with academic institutions, hospitals and biomedical companies in Israel, as well as its proven project screening process and development expertise, Novartis will evaluate projects identified and presented by BioLineRx for co-development and potential future licensing under the collaboration.
The companies intend to co-develop a number of pre-clinical and early clinical therapeutic projects through clinical proof-of-concept. As part of the agreement, Novartis made an equity investment in BioLineRx of $10 million.
About Non-Alcoholic Steatohepatitis and End-Stage Liver Disease
Non-alcoholic steatohepatitis (NASH) is the progressive form of non-alcoholic fatty liver disease (NAFLD), and in many cases the resulting liver scarring is associated with liver cirrhosis. It is estimated that NASH affects 2% to 5% of the global population, and according to the US Association of Liver Disease, of those who will develop NASH, 15%-25% will progress to end stage liver disease (ESLD) and hepatocellular carcinoma (HCC) over 10-20 years.
To date, a third of liver transplants and HCC cases are caused by NASH and it is expected to be the principal cause for transplantation by 2020. Currently there are no FDA-approved treatments for NAFLD or NASH, thus new potent therapeutics are an unmet medical need.