TEL AVIV, Israel, September 23, 2016 /PRNewswire/ --
BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage
biopharmaceutical company dedicated to identifying, in-licensing
and developing promising therapeutic candidates, announced today
that it 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). 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.
Philip Serlin, Chief Financial
and Operating Officer of BioLineRx, 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.
About BioLineRx
BioLineRx is a clinical-stage biopharmaceutical company
dedicated to identifying, in-licensing and developing promising
therapeutic candidates. The Company in-licenses novel compounds,
primarily from academic institutions and biotech companies based in
Israel, develops them through
pre-clinical and/or clinical stages, and then partners with
pharmaceutical companies for advanced clinical development and/or
commercialization.
BioLineRx's leading therapeutic candidates are: BL-8040, a
cancer therapy platform, which has successfully completed a Phase
2a study for relapsed/refractory AML, is in the midst of a Phase 2b
study as an AML consolidation treatment, and has recently initiated
a Phase 2 study in stem cell mobilization for allogeneic
transplantation; and BL-7010 for celiac disease and gluten
sensitivity, which has successfully completed a Phase 1/2 study. In
addition, BioLineRx has a strategic collaboration with Novartis for
the co-development of selected Israeli-sourced novel drug
candidates; a collaboration agreement with MSD (known as Merck in
the US and Canada) to run a Phase
2a study in pancreatic cancer using the combination of BL-8040 and
Merck's KEYTRUDA®; and has recently signed a collaboration
agreement with Genentech, a member of the Roche Group, to
investigate the combination of BL-8040 and Genentech's Atezolizumab
in several Phase 1b studies for multiple solid tumor indications
and AML.
For additional information on BioLineRx, please visit the
Company's website at http://www.biolinerx.com, where you can review
the Company's SEC filings, press releases, announcements and
events. BioLineRx industry updates are also regularly updated on
Facebook, Twitter, and LinkedIn.
About Hadasit
Hadasit is the Technology Transfer company of the Hadassah
Medical Organization in Jerusalem,
Israel. The Hadassah Medical Center, established 100 years
ago and regarded as one of Israel's primary hospitals, has accumulated a
vast amount of knowledge, medical research, dedication and
innovation. The combination of practical experience, ability to
pinpoint medical needs and cutting-edge research has yielded a huge
potential of ideas, innovation and developments in all aspects of
medicine, including therapeutics, diagnostics and medical
devices.
In order to realize this potential, Hadassah established Hadasit
- the business arm which was founded in 1986 as its vehicle for
commercialization of medical technologies developed at the
hospitals - and has been investing in turning ideas into viable
products and services for the benefit of humanity. Hadasit
collaborates with leading international companies and research
facilities as well as incubators and venture capital groups.
About BGN Technologies
BGN Technologies is the technology transfer and
commercialization company of Ben-Gurion
University (BGU) and serves as the link between industry and
academic research. BGN assists the university and its faculty to
translate their inventions and academic achievements into
commercially valuable products by collaborating with established
Israeli and global companies as well as with new start-ups
established for the development of specific BGU inventions. BGN
innovations and commercialization cover diverse fields such as
pharmaceuticals, drug delivery, biotechnology, medical devices,
information technology, security, electro-optics, nanotechnologies,
chemical processes, agro-technology, environment and energy
big-data and e-health. For more information, please visit
http://www.bgu.ac.il/bgn.
Various statements in this
release concerning BioLineRx's future
expectations constitute "forward-looking
statements" within the meaning
of the Private Securities
Litigation Reform Act of 1995.
These statements include words
such as "may," "expects,"
"anticipates," "believes," and
"intends," and describe opinions
about future events. These
forward-looking statements involve
known and unknown risks and
uncertainties that may cause the
actual results, performance or
achievements of BioLineRx to be
materially different from any
future results, performance or
achievements expressed or implied
by such forward-looking statements.
Some of these risks are:
changes in relationships with
collaborators; the impact of
competitive products and technological
changes; risks relating to the
development of new products; and
the ability to implement
technological improvements. These and
other factors are more fully
discussed in the "Risk Factors"
section of BioLineRx's most
recent annual report on Form
20-F filed with the Securities
and Exchange Commission on March
10, 2016. In addition, any
forward-looking statements represent
BioLineRx's views only as of
the date of this release
and should not be relied
upon as representing its views
as of any subsequent date.
BioLineRx does not assume any
obligation to update any
forward-looking statements unless
required by law.
Contacts:
PCG Advisory
Vivian Cervantes
Investor Relations
+1-212-554-5482
vivian@pcgadvisory.com
or
Tsipi Haitovsky
Public Relations
+972-52-989892
tsipihai5@gmail.com
SOURCE BioLineRx Ltd.