BioLineRx Announces Publication of EAGLE Study Results Demonstrating BL-1020's Efficacy in Improving Cognitive Function in

  BioLineRx Announces Publication of EAGLE Study Results Demonstrating
  BL-1020's Efficacy in Improving Cognitive Function in Schizophrenia Patients

– Results of Phase IIb clinical trial from September 2009 now published in the
                       Journal of Clinical Psychiatry –

  – BL-1020 is currently undergoing Phase II/III CLARITY clinical trial with
                        results expected in H2 2013 –

Business Wire

JERUSALEM -- September 27, 2012

BioLineRx (NASDAQ: BLRX)(TASE: BLRX), a biopharmaceutical development
company, announced today the publication of results from the Phase II EAGLE
clinical trial for BL-1020, a first in class, orally available, GABA-enhanced
antipsychotic for the treatment of schizophrenia, showing that BL-1020 is safe
and effective in improving schizophrenia, in addition to improving cognitive
impairment associated with this condition. The findings, which were originally
announced in September 2009, were published in the September 2012 issue of the
Journal of Clinical Psychiatry.

"Significant cognitive impairment is very common in schizophrenia, affecting
the great majority of patients, yet currently available antipsychotics have
not been effective in treating core cognitive impairment for people suffering
from this disease. In fact, two recent landmark studies, in first-episode
patients and in chronically ill patients, did not find first- or
second-generation antipsychotics to be significantly effective in ameliorating
cognitive impairment," explained Richard Keefe, Ph.D., Professor of Psychiatry
and Behavioral Sciences and Psychology at Duke University Medical Center, and
co-author of the Paper. "Cognitive impairments are important targets for
intervention, as they affect vocational and social functioning and independent
living. Therefore, there is a clear need for new antipsychotic drugs that are
effective and that improve cognition. In the Phase IIb EAGLE study, BL-1020
shows a clear and significant effect in improving cognitive function in
schizophrenia patients."

The Paper describes the results of the Phase IIb EAGLE study for determining
safety, efficacy, and tolerability of low (10 mg/d) and flexible high (20–30
mg/d) doses of BL-1020 compared to Risperidone, an approved atypical
schizophrenia drug, and placebo. Results of the study shows that BL-1020 was
significantly better than the placebo and comparable with Risperidone in both
PANSS and CGI scores, which are widely recognized measures of severity and
improvement in schizophrenia. More importantly, the results show a significant
improvement in cognitive function as assessed by BACS (Brief Assessment of
Cognition in Schizophrenia), when compared to both placebo and Risperidone.

Dr. Kinneret Savitsky, CEO of BioLineRx, stated,"We are pleased with the
publication of the EAGLE trial results in a leading scientific journal. Nearly
1% of the world’s population suffers from schizophrenia, which often involves
cognitive impairment that may severely undermine daily living skills. Current
schizophrenia therapies do not address cognitive impairment, whereas the EAGLE
clinical trial shows that BL-1020 significantly enhances cognitive function in
schizophrenia patients and therefore has the potential to enhance the
functionality and independent living skills of patients with schizophrenia. In
order to further validate these results, we are currently conducting the
CLARITY clinical trial, which assesses cognition enhancement by BL-1020 as its
primary objective. We look forward to the expected results in the second half
of 2013.”

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 announced commencement of 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) 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

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.


KCSA Strategic Communications
Garth Russell / Todd Fromer
1 212-896-1250 / 1 212-896-1215 /
Tsipi Haitovsky
Public Relations
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