BioLineRx's EDP-14, for Treatment of Severe and Persistent Asthma, to Enter the Company's Main Therapeutic Pipeline as BL-9010

  BioLineRx's EDP-14, for Treatment of Severe and Persistent Asthma, to Enter
  the Company's Main Therapeutic Pipeline as BL-9010

  Preclinical data shows that EDP-14 significantly blocks allergic responses

Business Wire

JERUSALEM -- February 28, 2013

BioLineRx (NASDAQ: BLRX)(TASE: BLRX), a biopharmaceutical development company,
announced today that following promising pre-clinical data, EDP-14, for the
treatment of severe and persistent asthma, has been added to the Company's
main therapeutic pipeline. The project is now named BL-9010. Previously, the
project was developed under BioLineRx’s Early Development Program.

BL-9010, a novel bi-specific antibody treatment for severe and persistent
asthma, targets and links together two immunological modulators - IgE and
CD300a. Allergen-bound IgE activates cells involved in allergic responses,
such as mast cells, while CD300a inhibits immune responses. Professor
Francesca Levi-Schaffer from the Hebrew University of Jerusalem, the inventor
of BL-9010, found that CD300a is expressed on mast cells and that linking IgE
with CD300a using a bi-specific antibody leads to potent inhibition of
allergic reactions characteristic of asthma. In murine models of experimental
asthma, BL-9010 significantly blocked allergic responses. Importantly, this
could be reproduced in human mast cells, where BL-9010 was shown to inhibit
the allergic reaction of these cells in-vitro. The human mast cells were
activated by IgE molecules from allergic patients and by specific allergens,
mimicking the human disease, while BL-9010 prevented the release of
allergy-mediating substances by the cells.

"Asthma is a highly prevalent disease with no satisfactory cure that affects
millions of people around the world," said Dr. Kinneret Savitsky, CEO of
BioLineRx. "The results of the pre-clinical trials were extremely impressive
and convincing, and raise hopes that BL-9010 will be an effective treatment.
As a result, the project is now being advanced to our main product pipeline
and will be further developed at an accelerated pace. Due to its unique
mechanism of action, promising in-vivo results and the true unmet medical
need, this project, although still in pre-clinical stages of development, is
already attracting the interest of potential partners."

BL-9010 was developed to treat severe and persistent asthma patients, but may
also potentially treat chronic urticaria as well as additional allergic
conditions.

About Asthma
Acute asthma, also known as allergic asthma, is triggered by allergens
activating mast cells located beneath the mucous membranes of the lower
airways of the respiratory tract. Activation of mast cells triggers release of
substances that stimulate the nasal epithelium to produce mucus, as well as
the subsequent contraction of smooth muscle within the airway. This
contraction of smooth muscle constricts the airway, causing the characteristic
asthmatic wheezing. Chronic asthma is not caused by allergens, but rather is
the result of inflammation due to repeated episodes of acute asthma. About 90%
of children with childhood asthma have allergies, compared with about 50% of
adults with asthma. Asthma affects 300 million individuals worldwide, of which
24.5 million are in the U.S. The severe asthma market was estimated at $1.2
billion in 2011 (based on Xolair sales), and is forecasted to grow to $1.5
billion by 2016.

About BioLineRx’s Early Development Program (EDP)
EDP, a unique program to identify and advance novel and innovative therapeutic
research projects, was established by BioLineRx in June 2007. The program
seeks to identify and advance such projects from early stages, even before in
vivo activity has been demonstrated. In the framework of this program,
projects are provided with up to two years of funding, in addition to
obtaining professional and scientific support from BioLineRx's development
team. The program is principally funded via a $5 million grant received from
the Pan Atlantic Group (Albert Friedberg Family), and now includes 10 research
projects.

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, 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-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, 1-212-896-1250
grussell@kcsa.com
or
Todd Fromer, 1-212-896-1215
tfromer@kcsa.com
or
Tsipi Haitovsky, Public Relations
+972-52-598-9892
tsipih@netvision.net.il
 
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