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BioLineRx to Announce Interim Results of Phase II/III Trial for Schizophrenia Drug During Week of March 18, 2013

  BioLineRx to Announce Interim Results of Phase II/III Trial for
  Schizophrenia Drug During Week of March 18, 2013

  - Cognition impairment is primary endpoint of CLARITY phase II/III trial -

 - Dr. Savitsky: "BL-1020's interim results mark an important landmark in the
        development of our lead product and the Company as a whole" -

Business Wire

JERUSALEM -- January 7, 2013

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development
company, announced today that the results of the interim analysis of the Phase
II/III CLARITY trial of BL-1020, a first in class, orally available,
GABA-enhanced antipsychotic for the treatment of schizophrenia, are expected
during the week beginning March 18, 2013. The interim analysis will be
performed on data of approximately 235 randomized patients from 27 sites in
Romania and India. The primary endpoint of the analysis will be the six-week
effect of the drug on cognitive function, which is a principal deficit in
schizophrenia patients.

The interim analysis will be performed by a fully independent, external Data
Monitoring Committee (DMC), which will maintain complete blinding of all study
data from the Company. As a result of the analysis, the DMC will provide the
Company with an estimate of the total number of patients required in the study
in order to achieve statistical significance on the cognitive endpoints of the
study.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated,“We are very excited with the
excellent development pace and huge potential of our lead product, BL-1020 for
the treatment of schizophrenia. Current schizophrenia drugs are ineffective at
improving the cognitive deficit associated with the vast majority of
schizophrenia patients. In our previous Phase IIb EAGLE study on 363 patients,
BL-1020 demonstrated a significant effect on cognitive function in
schizophrenia patients as an exploratory endpoint. The current CLARITY trial
is specifically designed and powered with cognition improvement as its primary
endpoint, using the MCCB testing battery - the most widely recognized battery
for cognition. In addition, the current trial also assesses both the
short-term and long-term effects of the drug on cognition.

"BL-1020's interim analysis is an important milestone for BioLineRx; one which
we believe will greatly enhance the commercialization prospects and market
value of this promising drug. We are already seeing significantly enhanced
interest by potential partners, as evidenced by the numerous meetings we have
this week at the JP Morgan Conference in San Francisco. We eagerly await the
results of the study, which mark an important landmark in the development of
our lead product and the Company as a whole," concluded Dr. Savitsky.

In October, 2012, the Company announced its intention to conduct an interim
analysis of the on-going Phase II/III CLARITY trial of BL-1020. The decision
followed a re-analysis of BL-1020's Phase IIb EAGLE study, showing a
substantially greater beneficial effect of the drug on cognitive function in
schizophrenia patients when compared to the original analysis of the study, in
addition to other positive ad-hoc analyses and BL-1020's excellent track
record in both clinical and pre-clinical studies.

About BL-1020

BL-1020 is a first-in-class GABA-enhanced antipsychotic that combines dopamine
antagonism with GABAergic activity. BL-1020 has demonstrated high efficacy and
safety with minimal EPS and no metabolic side effects. Most importantly,
BL-1020 may have the potential to improve cognition, which is a significant
unmet medical need in schizophrenia and other neurological/psychiatric
disorders. Three clinical studies have confirmed the safety and efficacy of
BL-1020, while pre-clinical studies have also shown that BL-1020’s GABA
enhancement may provide the basis for improved cognition.

In June 2011, BioLineRx commenced the Phase II/III CLARITY clinical trial of
BL-1020. This 450-patient trial aims to determine the short-term (6 weeks) and
the long-term (24 weeks) cognitive benefit and anti-psychotic efficacy, safety
and tolerability of BL-1020 in schizophrenia patients, compared with
Risperidone (one of the leading schizophrenia treatments). The CLARITY trial
is proceeding at approximately 30 sites in Romania and India.

About Schizophrenia

Schizophrenia is a serious mental disorder that affects about 1% of the
world’s population. It is a multi-factorial disease characterized by delusions
and hallucinations, emotional withdrawal and apathy, poor attention and
disorganization. The worldwide antipsychotic therapeutic market in 2011 was
estimated at approximately $20 billion.

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 eight 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-1020, 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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