BioLineRx In-Licenses Second Oral Hepatitis C Treatment
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Hebrew version
Jerusalem, Israel - February 6, 2012 - BioLineRx (NASDAQ: BLRX; TASE: BLRX), a
biopharmaceutical development company, announced today it has signed a worldwide, exclusive license agreement with Genoscience and
RFS Pharma to develop and commercialize BL-8030, an orally available treatment for Hepatitis C. The agreement includes upfront
license fees, milestones and royalties payable to both companies, which terms are consistent with BioLineRx's standard
in-license agreements.
BL-8030 is a potent and selective second generation NS3 protease inhibitor. The NS3 protease is essential for
the replication of the Hepatitis C virus (HCV) and is an important target for HCV therapies. BL-8030 has been shown to have
excellent antiviral activity against various HCV genotypes. Pre-clinical studies have demonstrated an improved resistance
profile against common protease inhibitor mutants, resulting in a lower probability that the virus will develop
resistance to treatment. In addition, BL-8030 has demonstrated a good toxicity profile in pre-clinical studies,
exhibiting specificity only to the viral protease and lack of activity against a relevant panel of human
proteases as well as a clean profile versus human liver enzymes, which is expected to lead to less drug-drug interactions.
BL-8030 was invented by Professor Philippe Halfon and his team at Genoscience and co-developed with assistance from scientists
at RFS Pharma, LLC. Prof. Halfon, Co-Founder and President of Genoscience, is a specialist in molecular virology and infectious diseases,
especially HIV, HPV (Human Papilloma Virus) and Hepatitis. In addition he is the founder of several biotechnology companies focusing
on antiviral drug discovery and development including ACTgene, Alphabio and Genoscience. RFS Pharma was founded by
Professor Raymond F. Schinazi; he currently serves as the Frances Winship Walters Professor of Pediatrics at
Emory University. He is also a founder of Pharmasset, Idenix, Triangle and ActivBiotics Pharma.
Prof. Philippe Halfon said, "We were impressed by the drug development expertise of the BioLineRx team and are very pleased
to collaborate with them on a second HCV project. There is clearly a huge unmet medical need in finding a safe and effective treatment
for HCV, and based on pre-clinical results, we believe that our product, especially when combined with other available Hepatitis C
drugs, has the potential to become an important addition to HCV combination therapies and bring remedy to millions suffering
from this devastating disease."
"We worked closely with the group at Genoscience to determine the optimum characteristic that led to the discovery
of BL-8030 and related protease inhibitors," said Dr. Steven J. Coats, Senior Director of Chemistry at RFS Pharma.
"We are privileged and fortunate to partner with two world class groups in the development of viral therapeutics,"
said Dr. Kinneret Savitsky, CEO of BioLineRx. "Two years ago, we took a strategic decision to enter the dynamic and rapidly
growing field of Hepatitis C. Since that time, we have evaluated numerous projects in the field. A year ago, we identified
and decided to focus on the in-licensing of the two most promising candidates: BL-8020, which we've recently licensed,
and now BL-8030. We will do our utmost to develop these promising drugs as swiftly as possible for the benefit of
Hepatitis C infected individuals around the world."
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About Hepatitis C
Hepatitis C is a blood borne infection of the liver caused by the Hepatitis C virus (HCV) which becomes chronic in about 85% of cases.
According to the World Health Organization (WHO), up to 170 million people worldwide are chronically infected with HCV. In addition,
HCV infection is the leading cause of liver transplantation and is a risk factor for liver cancer. The Hepatitis C market is
growing rapidly and is forecasted to reach $16 billion in 2015 in the seven major markets (US, France, Germany, Italy,
Spain, UK and Japan).
About BioLineRx
BioLineRx Ltd. is a publicly-traded biopharmaceutical development company. It 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 commenced a Phase II/III study; BL-1040, for prevention of
pathological cardiac remodeling following a myocardial infarction, is currently undergoing a pivotal CE-Mark
registration trial 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 13 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.
Source: BIOLINERX
Contacts:
Garth Russell / Todd Fromer
KCSA Strategic Communications
1 212-896-1250 / 1 212-896-1250
grussell@kcsa.com / tfromer@kcsa.com
Tsipi Haitovsky
Public Relations
+972-3-6240871
tsipih@netvision.net.il
"Reproduced with permission - BioLineRx"
BioLineRx
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