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BioLineRx In-Licenses Novel Antisense Drug for the Treatment of Inflammatory Diseases

09 Sep 2006

BioLineRx, Ltd., Israel’s leading drug development company, announced today that it has signed an exclusive worldwide license agreement with B.G. Negev (BGN) Technologies Ltd., the technology transfer company of Ben-Gurion University of the Negev, and Mor Research Applications, Ltd., the Technology Transfer Office of Clalit Health Services for the development and commercialization of BL-3030, a novel antisense drug for the treatment of inflammatory diseases.

JERUSALEM, Israel | Sep 08, 2006 | BioLineRx, Ltd., Israel’s leading drug development company, announced today that it has

signed an exclusive worldwide license agreement with B.G. Negev (BGN) Technologies Ltd., the technology transfer company of Ben-Gurion University of the Negev, and Mor Research Applications, Ltd., the Technology Transfer Office of Clalit Health Services for the development and commercialization of BL-3030, a novel antisense drug for the treatment of inflammatory diseases. BL-3030 was initially discovered by Professor Rachel Levy of Ben-Gurion University and Soroka University Medical Center in Beer Sheva, Israel. BioLineRx plans to develop the drug through its subsidiary BioLine Innovations Jerusalem, under the National Biotech Grant received in November 2004 from the Israeli Office of the Chief Scientist. BioLineRx anticipates an investment of approximately $9 Million in order to achieve clinical proof of safety and efficacy for BL-3030. Financial terms of the agreement were not disclosed.

BL-3030 is an antisense oligonucleotide specifically designed to treat inflammatory diseases. Antisense oligonucleotides are short, synthetic DNA molecules, designed to prevent target protein formation. BL-3030 is aimed at inhibiting the formation of cPLA2 – an enzyme that plays a major role in a number of inflammatory diseases including rheumatoid arthritis (RA), asthma, and adult respiratory distress syndrome (ARDS). The beneficial effects of inhibiting cPLA2 have been effectively demonstrated in a wide array of animal models of inflammatory diseases. Experiments conducted at Ben Gurion University showed that BL-3030 is effective in vitro in inhibiting both the amount and level of activity of cPLA2 in human cells, and in vivo in treating sterile peritonitis and RA. BioLineRx plans to conduct further optimization studies in the coming year, with IND-focused preclinical activities for BL-3030 expected to begin in late 2007.

Currently, inflammatory diseases are treated either by non-steroidal anti-inflammatory drugs (NSAIDs), or by steroids. These drugs have either limited therapeutic benefit or severe side effects, which prevent long term use. BL-3030 is expected to be effective treatment for numerous inflammatory diseases currently treated with NSAID’s and steroids, without causing the undesirable side effects.

“BL-3030 is an exciting addition to our rich pipeline of clinical and pre-clinical innovative drug candidates, and we are pleased to continue our fruitful collaborations with Ben Gurion University,” said Morris C. Laster, MD, CEO of BioLineRx. “This is the second compound we have licensed from Ben Gurion, the first being BL-1040, an injectable polymer for the treatment of acute myocardial infarction, that we expect to enter Phase 1-2 trials in early 2007.”

Dr. Ora Horovitz, VP of BGN added: “Professor Levy’s invention is yet another example of the outstanding scientific research conducted at Ben-Gurion University that holds the promise of improving patient care. We believe that this agreement with BioLineRx brings us a step closer to turning this promise into reality."

Inflammation is a critical factor in numerous diseases affecting a significant part of the population worldwide. Rheumatoid arthritis, for example, is one of the most common and severe forms of arthritis. It is a chronic and often debilitating autoimmune disease in which the body's immune system attacks joint tissue, leading to pain, inflammation, deformity and disability that can be permanent. In the United States alone, over 2 million people suffer from RA and the total US market for rheumatoid arthritis therapeutic products forecasted for 2013 is $ 9.5 billion.

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About BioLineRx
BioLineRx is Israel’s leading drug development company dedicated to building a robust pipeline of promising therapeutics for unmet medical needs. BioLineRx advances projects from early stage discovery and lead generation to advanced clinical trials, regulatory approval, and marketing. Partnering with researchers, universities and biotech companies to further the commercialization of promising compounds, BioLineRx seeks to enrich the pipeline of large pharmaceutical companies seeking their next blockbuster drugs. The Company was founded in 2003 by leaders in the Israeli life science arena including Teva Pharmaceuticals Ltd, Giza, Pitango, Hadasit and the Jerusalem Development Authority. For more information, please visit www.biolinerx.com.

About BGN Technologies Ltd.
BGN, the technology transfer company of Ben-Gurion University, serves as the link between industry and academic research. BGN assists the university and its faculty to “translate” their inventions and academic results into commercially valuable products. BGN offers the industry inventions in the fields of pharmaceuticals and drug delivery, biotechnology and medical devices, information technology, security, electro-optics, nanotechnologies, chemical processes, agro-technology, environment and energy. For more information, please visit www.bgu.ac.il/bgn.

About Mor Research Applications
Mor Research Applications, Ltd. (MOR) was incorporated as the Technology Transfer Office of Clalit Health Services for the management and commercialization of inventions and patents derived from research projects originated by Clalit's physicians/researchers. MOR serves as Clalit’s extended arm for realizing it's strategic objectives to encourage and promote research projects performed by Clalit medical staff members as part of the quality infrastructure facilitating knowledgeable experienced physicians and better health services. Clalit Health Services is Israel's largest Health Management Organization (HMO). Out of a total population of six million, Clalit insures three and a half million people. Clalit facilities include 15 hospitals, all of which are attached with leading research Universities, and 1250 primary care and specialized clinics.

SOURCE: BioLineRx, Ltd

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