BioLineRx Receives Approval from French Regulatory Authorities to Commence a Phase I/II Clinical Trial for BL-8020, an Oral,

  BioLineRx Receives Approval from French Regulatory Authorities to Commence a
  Phase I/II Clinical Trial for BL-8020, an Oral, Interferon-Free Treatment
  for Hepatitis C

             - Interim results are expected by the end of 2013 -

Business Wire

JERUSALEM -- March 13, 2013

BioLineRx (NASDAQ:BLRX)(TASE:BLRX), a biopharmaceutical development company,
announced today that it has received approval from the French regulatory
authorities to commence a Phase I/II trial for BL-8020, an orally available,
interferon-free treatment for the Hepatitis C virus (HCV). The study is an
open-label trial to evaluate the efficacy, safety and tolerability of BL-8020
in patients infected with HCV. It will be conducted at two clinical sites in
France and will include HCV-infected patients of any genotype who have
previously failed or relapsed following treatment with the standard-of-care.

“We are excited about the upcoming initiation of clinical trials for our first
anti-HCV agent, BL-8020. The Phase I/II trial will be led by Prof. Stanislas
Pol, M.D., Ph.D, from Hôpital Cochin in Paris, and Prof. Marc Bourliere, M.D.,
from Hôpital Saint Joseph in Marseille, both prominent international leaders
in the HCV field,” stated Dr. Kinneret Savitsky, CEO of BioLineRx. “Based on
BL-8020’s pre-clinical results, its unique mechanism of action and synergistic
effect, we have high hopes for this drug especially when combined with other
available Hepatitis C drugs. We look forward to the interim results from the
Phase I/II trial expected towards the end of 2013.”

BL-8020 is an orally available HCV treatment with a unique mechanism of
action, as compared to other currently used anti-HCV agents. This 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
pre-clinical 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.

About BL-8020

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, HPV (human
papilloma virus causing cervical cancer) and Hepatitis. In addition, Prof.
Halfon is the founder of other biotechnology companies focusing on antiviral
drug discovery and development, including ACTgene and Alphabio.

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) is currently undergoing a Phase II trial, and BL-8040 for
treating acute myeloid leukemia (AML) and other hematological cancers has
completed Phase I. In addition, BioLineRx has six 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, the content of which does not form a part of this press
release.

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 12, 2013. 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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