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Microsoft word - pr - bl-7040 in-licensing english final

BioLineRx Signs Exclusive License Agreement with
Yissum for Oral Phase II Ready Treatment BL-7040 for
Inflammatory Bowel Disease

Jerusalem, June 27, 2011
- BioLineRx (TASE:BLRX), a biopharmaceutical
drug development company, and Yissum Research Development Company
Ltd., the Technology Transfer Company of the Hebrew University of
Jerusalem, announced today that they have signed a worldwide, exclusive
license agreement for BioLineRx to develop and commercialize BL-7040, an
orally available Phase II ready molecule for treating Inflammatory Bowel
Disease (IBD) and other inflammatory diseases.
BL-7040 has dual activity on both the nervous and immune systems,
rendering it highly suitable for treating both neurological diseases and immune
system related conditions such as inflammatory or autoimmune diseases. It
was invented by Professor Hermona Soreq, from the Alexander Silberman
Institute of Life Sciences, Faculty of Science and the Edmond and Lily Safra
Center of Brain Sciences at the Hebrew University of Jerusalem. Prof. Soreq
is a pioneer in molecular biology research responsible for the development of
RNA-targeted oligonucleotide drugs for mammalian stress reactions which
increase the risk of chronic diseases such as muscle fatigue, inflammation
and neurodegeneration.
BL-7040 was previously developed for Myasthenia Gravis (MG), a
neuromuscular disease, where it showed a high level of efficacy in Phase Ib
and IIa clinical trials. However, after discovering a new mechanism of action
for the drug, BioLineRx is designating BL-7040 for IBD and other inflammatory
diseases with a much wider market.
“We are excited to add BL-7040 to our pipeline. It has already demonstrated
safety as well as its pharmacokinetic profile in earlier clinical trials, so we
expect an accelerated development program as we plan to begin Phase II
clinical trials for the treatment of IBD," stated Dr. Kinneret Savitsky, CEO of
BioLineRx. “With this new addition, we now have five clinical-stage
therapeutic products in our pipeline, including three in mid-stage or pivotal
trials. BL-1020 for the treatment of schizophrenia is about to begin a Phase
II/III clinical trial; BL-1040 for treating patients following a myocardial infarction
is about to begin two pivotal trials; BL-5010 for non-surgical removal of skin
lesions has successfully completed a Phase I/II study, and BL-1021 for
neuropathic pain is currently in Phase I studies.”
"We are very pleased to once again collaborate with BioLineRx, which has the
drug development expertise to further develop this therapy," said Yaacov
Michlin, CEO of Yissum. "BL-7040 addresses the very mechanism causing
inflammatory diseases and therefore has the potential to offer a breakthrough
in the treatment of IBD and make a positive impact on millions of lives."
Prof. Hermona Soreq, added, "This new drug acts to suppress inflammatory
responses by directly activating an anti-inflammatory agent, namely TLR-9, an
innate immune system protein, and concomitantly by increasing the activity of
the cholinergic, anti-inflammatory, pathway. This dual action renders BL-7040
unique in the field of anti-inflammatory drugs, and presents a new and
improved treatment for inflammatory disease."
BL-7040 possesses anti-inflammatory properties, as shown in preclinical
studies. In these studies, BL-7040 led to amelioration of parameters
associated with inflammatory bowel disease, an inflammatory gastrointestinal
tract disorder. The efficacy of BL-7040 in these studies was shown to be
highly significant and comparable to that of dexamethasone, a steroid used
routinely for IBD that has multiple side effects.

About Inflammatory Bowel Disease (IBD)
IBD is a chronic inflammatory gastrointestinal disease characterized by
chronic abdominal pain, discomfort, bloating and alteration of bowel habits.
Approximately 1 in 500 people worldwide suffer from IBD. The condition has
few specific treatment options available. Sales of existing drugs are estimated
at $1.8 billion annually. However, current treatment options do not fully
address patients’ needs.

About BioLineRx
BioLineRx Ltd. 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 five clinical stage candidates: BL-1020 for
schizophrenia has completed a Phase IIb study; BL-1040, for treatment of
patients following a myocardial infarction has completed a Phase I/II study
and has been out-licensed to Ikaria Inc. for a total deal value of $282.5 million,
in addition to sales royalties; 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 and BL-7040 for treating Inflammatory Bowel Disease (IBD) 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, oncology, 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.
About Yissum
Yissum Research Development Company of the Hebrew University of
Jerusalem Ltd. was founded in 1964 to protect and commercialize the Hebrew
University’s intellectual property. Ranked among the top technology transfer
companies in the world, Yissum has registered over 7,000 patents covering
2,023 inventions; has licensed out 530 technologies and has spun-off 72
companies. Products that are based on Hebrew University technologies and
were commercialized by Yissum generate today over $2 billion in annual
sales. Yissum’s business partners span the globe and include companies
such as Syngenta, Vilmorin, Monsanto, Novartis, Johnson & Johnson, Roche,
Merck, Teva, Google, Adobe, Phillips and many more. For further information
please visit: www.yissum.co.il.

Forward-Looking Statements

The estimates and judgments with respect to the projects included in this
release are considered forward-looking statements, which involve certain risks
and uncertainties, and are based on information available to the Company at
the time of this release. Such estimates, including clinical trial commencement
dates, may not be realized or may be only partially realized, due to the
significant uncertainty characterizing research and development activities in
general, particularly those of drug development, including changes in
regulation or uncertainty relating to the application of regulation, unexpected
delays in obtaining regulatory approval, unexpected delays in patient
recruitment for clinical trials, unexpected delays in other clinical trial
preparatory activities, inefficiencies, inability to manufacture, toxicity, a high
level of risk/reward in comparison to current treatments available, as well as
new information regarding intellectual property rights which may affect the
economic viability of continued product development. The Company assumes
no responsibility for updating forward-looking statements made herein or
otherwise.

Contacts:
Jessica O’Neill (Investor Relations)
Stern Investor Relations, Inc.
212-362-1200
[email protected]
Tsipi Haitovsky (Public Relations)
+972-3-6240871
[email protected]

Source: http://yissum.co.il/sites/default/files/pr_-_bl-7040_in-licensing_english_final.pdf

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