BioLineRx Announces Successful Completion of Pre-Clinical Development for BL-8020, an Oral, Interferon-Free Treatment for

  BioLineRx Announces Successful Completion of Pre-Clinical Development for
  BL-8020, an Oral, Interferon-Free Treatment for Hepatitis C

        - Phase I/II clinical study expected to commence in Q1 2013 -

Business Wire

JERUSALEM -- October 16, 2012

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development
company, announced today that it has successfully completed the pre-clinical
development of BL-8020, an orally available, interferon-free treatment for the
Hepatitis C virus (HCV), and plans to commence a Phase I/II safety and
efficacy study for BL-8020 in Europe during the first quarter of 2013.

Since in-licensing BL-8020 in January 2012, BioLineRx has successfully
completed a number of pre-clinical studies with the therapy. The data package
is now ready for the regulatory submissions required to begin the clinical
phase of development. BioLineRx is currently engaged in the regulatory
submission process and expects to receive approval from the regulatory
authorities by the end of this year.

BL-8020 is an orally available HCV treatment with a unique mechanism of
action, as compared to other currently used anti-HCV agents, which suggests
pan-genotypic efficacy and the ability to be combined with other HCV
therapeutics as part of an interferon-free regimen. BL-8020's mechanism of
action involves the inhibition of HCV-induced autophagy in the host cells.
Autophagy is a mechanism by which cells degrade damaged or unnecessary
cellular components, including invading viruses. However, HCV has found a way
to take advantage of this mechanism in order to replicate inside the cell. By
inhibiting this mechanism, BL-8020 reduces the ability of HCV to replicate.

BL-8020's safety and efficacy have been demonstrated in a number of studies.
These studies have shown that BL-8020 has a synergistic effect with other
anti-HCV agents. This effect on other therapies is likely to increase their
potency and reduce the numerous adverse effects often associated with these
drugs by enabling utilization of lower dosages. In addition BL-8020 may reduce
therapy duration. The use of multiple therapies with different mechanisms is
also likely to be beneficial for patients who have developed resistance or do
not respond to current treatments and is a common practice in current HCV
treatment regimens.

BL-8020 was licensed under a worldwide, exclusive agreement from Genoscience,
a French company focused on viral disease therapeutics. It was developed as an
anti-viral therapy by Professor Philippe Halfon, Co-Founder and President of
Genoscience and a world renowned scientist for his work on HIV (AIDS virus),
HPV (human papilloma virus causing cervical cancer) and Hepatitis. In
addition, Prof. Halfon is the founder of several biotechnology companies
focusing on antiviral drug discovery and development, including ACTgene,
Alphabio and Genoscience.

“We are excited that this project has successfully completed the pre-clinical
stage," stated Dr. Kinneret Savitsky, CEO of BioLineRx. “The unique
characteristics of BL-8020 make it attractive as an adjunct therapy to other
oral cocktail therapies, therefore not directly competing in the crowded HCV
market of currently approved therapies or those under development. Recent
toxicity issues seen with NS5B inhibitors stress the need for additional
targets and approaches in HCV treatment. We look forward to entering the
clinic with this promising drug at the beginning of next year," Dr. Savitsky
added.

"I am very pleased with BioLineRx's accelerated development program for
BL-8020," said Prof. Philippe Halfon, Co-Founder and President of Genoscience.
"According to the World Health Organization, approximately 3% of the world’s
population is infected with the Hepatitis C virus. Most infected people
develop a chronic infection, making HCV the leading cause for liver
transplants in the US. While there have been some recent advancements in the
global HCV therapeutics pipeline, there is still a clear need for safe,
pan-genotypic therapies, as well as treatments for mutations which may develop
resistance to current and future therapies, and for partial and
non-responders. Based on the pre-clinical results of BL-8020, its unique
mechanism of action and synergistic effect, I believe that this product,
especially when combined with other available Hepatitis C drugs, has real
potential to meet these future market needs."

About Hepatitis C

Hepatitis C infection is a blood borne infection of the liver caused by the
Hepatitis C virus (HCV) which becomes chronic in about 85% of cases. According
to a 2011 report from Decision Resources, about 180 million people worldwide
are chronically infected with HCV. In addition, HCV infection is the leading
cause of liver transplantation and is a risk factor for liver cancer. The
global Hepatitis market was estimated at $6 billion in 2011 and is forecasted
to grow to $20 billion by the end of the decade.

About BioLineRx

BioLineRx is a publicly-traded biopharmaceutical development company.
BioLineRx is dedicated to building a portfolio of products for unmet medical
needs or with advantages over currently available therapies. BioLineRx’s
current portfolio consists of six clinical stage candidates: BL-1020 for
schizophrenia is currently undergoing a Phase II/III study; BL-1040, for
prevention of pathological cardiac remodeling following a myocardial
infarction, which has been out-licensed to Ikaria Inc., is currently
undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical
removal of skin lesions has completed a Phase I/II study; BL-1021 for
neuropathic pain is in Phase I development, BL-7040 for treating inflammatory
bowel disease (IBD) has commenced a Phase II trial, and BL-8040 for treating
acute myeloid leukemia (AML) has completed Phase I. In addition, BioLineRx has
nine products in various pre-clinical development stages for a variety of
indications, including central nervous system diseases, infectious diseases,
cardiovascular and autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules mainly from
biotechnological incubators and academic institutions. The Company performs
feasibility assessment studies and development through pre-clinical and
clinical stages, with partial funding from the Israeli Government’s Office of
the Chief Scientist (OCS). The final stage includes partnering with medium and
large pharmaceutical companies for advanced clinical development (Phase III)
and commercialization. For more information on BioLineRx, please visit
www.biolinerx.com.

Various statements in this release concerning BioLineRx’s future expectations,
including specifically those related to the development and commercialization
of BL-8020, 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 22, 2012. 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.

Contact:

KCSA Strategic Communications
Garth Russell / Todd Fromer
1 212-896-1250 / 1 212-896-1215
grussell@kcsa.com / tfromer@kcsa.com
or
BioLineRx
Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipih@netvision.net.il
 
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